Jeff Evans

WASHINGTON – The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention, said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement,” he said.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies appeared to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care (JAMA 2007;297:2373–80). There was “very little evidence that there was any intervention effect,” according to Dr. Mark.

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%) led to an average increase in the physicians' pay of about $40,000 (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90).

WASHINGTON – The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention, said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement,” he said.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies appeared to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care (JAMA 2007;297:2373–80). There was “very little evidence that there was any intervention effect,” according to Dr. Mark.

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%) led to an average increase in the physicians' pay of about $40,000 (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90).

WASHINGTON – The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention, said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement,” he said.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies appeared to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care (JAMA 2007;297:2373–80). There was “very little evidence that there was any intervention effect,” according to Dr. Mark.

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%) led to an average increase in the physicians' pay of about $40,000 (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90).

In women with polycystic ovary syndrome, insulin resistance may be more severe in those with metabolic syndrome than in those without it, according to data from a cross-sectional study of women with PCOS.

Even young women with PCOS should be screened for metabolic disturbances to more effectively prevent cardiovascular events later in life, wrote Dr. Hwi Ra Park of the Ewha Womans University College of Medicine, Seoul, South Korea, and colleagues.

The 113 women in the study had a mean age of 26 years and a 15% prevalence of metabolic syndrome (MS), which is lower than what has been reported in studies of PCOS patients in the United States (43%–46%) and Germany (31%). The prevalence of MS is about 4% in the general urban population of age-matched Korean women and about 6% in American women aged 20–29 years (Diabetes Res. Clin. Pract. 2007;77[suppl. 1]:S243–6).

Of the five components of the diagnosis of metabolic syndrome as per the National Cholesterol Education Program Adult Treatment Panel III, 45% of the women had a high-density lipoprotein cholesterol level of less than 50 mg/dL; 24% had a waist circumference greater than 80 cm; 20% had high systolic blood pressure (130 mm Hg or more) or high diastolic blood pressure (85 mm Hg or more); 13% had fasting triglyceride levels of at least 150 mg/dL; and 1% had fasting blood glucose levels of at least 110 mg/dL.

Compared with women who didn't have MS, those with MS had a higher body mass index, waist girth, systolic and diastolic blood pressures, fasting glucose, fasting and post-glucose load insulin levels, triglycerides, and free testosterone. Levels of HDL cholesterol, sex hormone-binding globulin, and luteinizing hormone were significantly lower in women with MS.

The results of a 75-g oral glucose tolerance test performed after an overnight fast showed plasma glucose and insulin levels were significantly higher in women with MS than in those without it.

“Insulin resistance is most likely the pathogenic link between PCOS and MS,” they said. Some data suggest women with PCOS and MS have higher rates of hyperandrogenemia, low serum sex hormone-binding globulin, and acanthosis nigricans, than do those without MS. That “may reflect more severe insulin resistance” in PCOS women with MS.

In women with polycystic ovary syndrome, insulin resistance may be more severe in those with metabolic syndrome than in those without it, according to data from a cross-sectional study of women with PCOS.

Even young women with PCOS should be screened for metabolic disturbances to more effectively prevent cardiovascular events later in life, wrote Dr. Hwi Ra Park of the Ewha Womans University College of Medicine, Seoul, South Korea, and colleagues.

The 113 women in the study had a mean age of 26 years and a 15% prevalence of metabolic syndrome (MS), which is lower than what has been reported in studies of PCOS patients in the United States (43%–46%) and Germany (31%). The prevalence of MS is about 4% in the general urban population of age-matched Korean women and about 6% in American women aged 20–29 years (Diabetes Res. Clin. Pract. 2007;77[suppl. 1]:S243–6).

Of the five components of the diagnosis of metabolic syndrome as per the National Cholesterol Education Program Adult Treatment Panel III, 45% of the women had a high-density lipoprotein cholesterol level of less than 50 mg/dL; 24% had a waist circumference greater than 80 cm; 20% had high systolic blood pressure (130 mm Hg or more) or high diastolic blood pressure (85 mm Hg or more); 13% had fasting triglyceride levels of at least 150 mg/dL; and 1% had fasting blood glucose levels of at least 110 mg/dL.

Compared with women who didn't have MS, those with MS had a higher body mass index, waist girth, systolic and diastolic blood pressures, fasting glucose, fasting and post-glucose load insulin levels, triglycerides, and free testosterone. Levels of HDL cholesterol, sex hormone-binding globulin, and luteinizing hormone were significantly lower in women with MS.

The results of a 75-g oral glucose tolerance test performed after an overnight fast showed plasma glucose and insulin levels were significantly higher in women with MS than in those without it.

“Insulin resistance is most likely the pathogenic link between PCOS and MS,” they said. Some data suggest women with PCOS and MS have higher rates of hyperandrogenemia, low serum sex hormone-binding globulin, and acanthosis nigricans, than do those without MS. That “may reflect more severe insulin resistance” in PCOS women with MS.

In women with polycystic ovary syndrome, insulin resistance may be more severe in those with metabolic syndrome than in those without it, according to data from a cross-sectional study of women with PCOS.

Even young women with PCOS should be screened for metabolic disturbances to more effectively prevent cardiovascular events later in life, wrote Dr. Hwi Ra Park of the Ewha Womans University College of Medicine, Seoul, South Korea, and colleagues.

The 113 women in the study had a mean age of 26 years and a 15% prevalence of metabolic syndrome (MS), which is lower than what has been reported in studies of PCOS patients in the United States (43%–46%) and Germany (31%). The prevalence of MS is about 4% in the general urban population of age-matched Korean women and about 6% in American women aged 20–29 years (Diabetes Res. Clin. Pract. 2007;77[suppl. 1]:S243–6).

Of the five components of the diagnosis of metabolic syndrome as per the National Cholesterol Education Program Adult Treatment Panel III, 45% of the women had a high-density lipoprotein cholesterol level of less than 50 mg/dL; 24% had a waist circumference greater than 80 cm; 20% had high systolic blood pressure (130 mm Hg or more) or high diastolic blood pressure (85 mm Hg or more); 13% had fasting triglyceride levels of at least 150 mg/dL; and 1% had fasting blood glucose levels of at least 110 mg/dL.

Compared with women who didn't have MS, those with MS had a higher body mass index, waist girth, systolic and diastolic blood pressures, fasting glucose, fasting and post-glucose load insulin levels, triglycerides, and free testosterone. Levels of HDL cholesterol, sex hormone-binding globulin, and luteinizing hormone were significantly lower in women with MS.

The results of a 75-g oral glucose tolerance test performed after an overnight fast showed plasma glucose and insulin levels were significantly higher in women with MS than in those without it.

“Insulin resistance is most likely the pathogenic link between PCOS and MS,” they said. Some data suggest women with PCOS and MS have higher rates of hyperandrogenemia, low serum sex hormone-binding globulin, and acanthosis nigricans, than do those without MS. That “may reflect more severe insulin resistance” in PCOS women with MS.

BARCELONA — Atrophic brain changes in patients with juvenile systemic lupus erythematosus may improve upon remission and reduction in corticosteroid dose, contrary to what has been seen in magnetic resonance imaging studies of adult patients with the disease.

Using MRI, Dr. Simone Appenzeller and colleagues prospectively compared the voxel-based morphometry of white and gray matter in 10 juvenile SLE patients (mean age 13 years), and 10 healthy age- and sex-matched controls.

SLE duration was 14 months. Patients had active CNS manifestations (primary to SLE) at enrollment. The investigators excluded six patients who were unable to undergo MRI due to a phobia or conditions that could influence cerebral atrophy, Dr. Appenzeller said at the annual European Congress of Rheumatology.

At entry, the juvenile SLE patients had significantly less deep white matter volume in the anterior region of the corpus callosum and significantly less gray matter volume in the hippocampus and amygdala than controls. The decrease in volume of white and gray matter was independently associated with score on the Systemic Lupus Erythematosus International Collaborating Clinics/American College of Rheumatology damage index and with disease duration. Total corticosteroid dose was only tied to gray matter atrophy.

After at least 1 year of follow-up, repeat MRI in the SLE patients showed significant increases in white and gray matter.

These improvements could have been due to normal brain growth or a decrease in disease activity and corticosteroid dose. But Dr. Appenzeller said these changes suggest atrophy reduction because the degree of atrophy seen in patients correlated significantly with disease severity at study entry, independent of age. Dr. Appenzeller conducted the study at the State University of Campinas (Brazil), but is now at McGill University, Montreal.

“This finding indicates that children may respond differently to cerebral insults than adults and may even recover from severe involvement,” she concluded.

In a previous study of adult SLE patients, Dr. Appenzeller found significantly reduced gray and white matter volumes on MRI, vs. healthy age- and sex-matched controls; the atrophy continued to progress over 1.5 years of follow-up (Neuroimage 2007;34:694–701).

BARCELONA — Atrophic brain changes in patients with juvenile systemic lupus erythematosus may improve upon remission and reduction in corticosteroid dose, contrary to what has been seen in magnetic resonance imaging studies of adult patients with the disease.

Using MRI, Dr. Simone Appenzeller and colleagues prospectively compared the voxel-based morphometry of white and gray matter in 10 juvenile SLE patients (mean age 13 years), and 10 healthy age- and sex-matched controls.

SLE duration was 14 months. Patients had active CNS manifestations (primary to SLE) at enrollment. The investigators excluded six patients who were unable to undergo MRI due to a phobia or conditions that could influence cerebral atrophy, Dr. Appenzeller said at the annual European Congress of Rheumatology.

At entry, the juvenile SLE patients had significantly less deep white matter volume in the anterior region of the corpus callosum and significantly less gray matter volume in the hippocampus and amygdala than controls. The decrease in volume of white and gray matter was independently associated with score on the Systemic Lupus Erythematosus International Collaborating Clinics/American College of Rheumatology damage index and with disease duration. Total corticosteroid dose was only tied to gray matter atrophy.

After at least 1 year of follow-up, repeat MRI in the SLE patients showed significant increases in white and gray matter.

These improvements could have been due to normal brain growth or a decrease in disease activity and corticosteroid dose. But Dr. Appenzeller said these changes suggest atrophy reduction because the degree of atrophy seen in patients correlated significantly with disease severity at study entry, independent of age. Dr. Appenzeller conducted the study at the State University of Campinas (Brazil), but is now at McGill University, Montreal.

“This finding indicates that children may respond differently to cerebral insults than adults and may even recover from severe involvement,” she concluded.

In a previous study of adult SLE patients, Dr. Appenzeller found significantly reduced gray and white matter volumes on MRI, vs. healthy age- and sex-matched controls; the atrophy continued to progress over 1.5 years of follow-up (Neuroimage 2007;34:694–701).

BARCELONA — Atrophic brain changes in patients with juvenile systemic lupus erythematosus may improve upon remission and reduction in corticosteroid dose, contrary to what has been seen in magnetic resonance imaging studies of adult patients with the disease.

Using MRI, Dr. Simone Appenzeller and colleagues prospectively compared the voxel-based morphometry of white and gray matter in 10 juvenile SLE patients (mean age 13 years), and 10 healthy age- and sex-matched controls.

SLE duration was 14 months. Patients had active CNS manifestations (primary to SLE) at enrollment. The investigators excluded six patients who were unable to undergo MRI due to a phobia or conditions that could influence cerebral atrophy, Dr. Appenzeller said at the annual European Congress of Rheumatology.

At entry, the juvenile SLE patients had significantly less deep white matter volume in the anterior region of the corpus callosum and significantly less gray matter volume in the hippocampus and amygdala than controls. The decrease in volume of white and gray matter was independently associated with score on the Systemic Lupus Erythematosus International Collaborating Clinics/American College of Rheumatology damage index and with disease duration. Total corticosteroid dose was only tied to gray matter atrophy.

After at least 1 year of follow-up, repeat MRI in the SLE patients showed significant increases in white and gray matter.

These improvements could have been due to normal brain growth or a decrease in disease activity and corticosteroid dose. But Dr. Appenzeller said these changes suggest atrophy reduction because the degree of atrophy seen in patients correlated significantly with disease severity at study entry, independent of age. Dr. Appenzeller conducted the study at the State University of Campinas (Brazil), but is now at McGill University, Montreal.

“This finding indicates that children may respond differently to cerebral insults than adults and may even recover from severe involvement,” she concluded.

In a previous study of adult SLE patients, Dr. Appenzeller found significantly reduced gray and white matter volumes on MRI, vs. healthy age- and sex-matched controls; the atrophy continued to progress over 1.5 years of follow-up (Neuroimage 2007;34:694–701).

BARCELONA — Patients who use high-dose glucocorticoids can maintain or improve their bone mineral density with risedronate prophylaxis, Dr. Chi Chiu Mok reported at the annual European Congress of Rheumatology.

“The [American College of Rheumatology] recommends the first-line use of bisphosphonates in patients with T scores below -1 who are expected to use corticosteroids for more than 3 months,” said Dr. Mok of the department of medicine at Tuen Mun Hospital, Hong Kong.

“Multiple clinical trials have confirmed the efficacy of bisphosphonates in the prevention and treatment of glucocorticoid-induced bone loss, and sometimes have demonstrated antifracture efficacy. But most [of these trials] recruited patients taking a relatively small dose of steroids,” an equivalent of 7.5 mg/week of prednisolone or more.

Dr. Mok and colleagues randomized 120 patients with conditions requiring 0.5 mg/kg per day prednisolone (or an equivalent glucocorticoid dose) for 6 weeks or more to 1,000 mg/day calcium plus 5 mg/day risedronate (Actonel) or placebo for 6 months. Mean age was 43 years, and 30% were postmenopausal.

At the end of the double-blind trial, risedronate patients had a significantly greater change in bone mineral density (BMD) at the lumbar spine (0.9%) than did placebo-treated patients (−0.5%). This was significant even after adjusting for baseline BMD, age, gender, body mass index, and cumulative steroid dosage. Risedronate patients maintained BMD in the hip and the whole body overall. Placebo patients lost BMD in both measurements.

Steroid-naive patients, who accounted for about 60% of all patients, had similar results. The maximum dosage of prednisolone given during the trial averaged 0.7 mg/kg per day.

Sanofi Aventis provided free daily-dosed risedronate, but did not otherwise fund the trial. Dr. Mok said that no investigators had conflicts of interest with Sanofi Aventis.

Overall, 51 risedronate- and 52 placebo-treated patients completed the trial. Withdrawals mainly occurred because of the daily drug protocol, but several patients died from their underlying medical condition; two withdrawals occurred in the risedronate group because of adverse events (one skin rash and one dyspepsia).

No patients had preexisting vertebral or hip fractures, although about 50% of the patients were osteopenic. The trial was not powered to test the antifracture efficacy of risedronate.

“Risedronate should be considered for primary prevention of bone mineral loss during periods of high-dose glucocorticoid therapy,” Dr. Mok concluded.

ELSEVIER GLOBAL MEDICAL NEWS

BARCELONA — Patients who use high-dose glucocorticoids can maintain or improve their bone mineral density with risedronate prophylaxis, Dr. Chi Chiu Mok reported at the annual European Congress of Rheumatology.

“The [American College of Rheumatology] recommends the first-line use of bisphosphonates in patients with T scores below -1 who are expected to use corticosteroids for more than 3 months,” said Dr. Mok of the department of medicine at Tuen Mun Hospital, Hong Kong.

“Multiple clinical trials have confirmed the efficacy of bisphosphonates in the prevention and treatment of glucocorticoid-induced bone loss, and sometimes have demonstrated antifracture efficacy. But most [of these trials] recruited patients taking a relatively small dose of steroids,” an equivalent of 7.5 mg/week of prednisolone or more.

Dr. Mok and colleagues randomized 120 patients with conditions requiring 0.5 mg/kg per day prednisolone (or an equivalent glucocorticoid dose) for 6 weeks or more to 1,000 mg/day calcium plus 5 mg/day risedronate (Actonel) or placebo for 6 months. Mean age was 43 years, and 30% were postmenopausal.

At the end of the double-blind trial, risedronate patients had a significantly greater change in bone mineral density (BMD) at the lumbar spine (0.9%) than did placebo-treated patients (−0.5%). This was significant even after adjusting for baseline BMD, age, gender, body mass index, and cumulative steroid dosage. Risedronate patients maintained BMD in the hip and the whole body overall. Placebo patients lost BMD in both measurements.

Steroid-naive patients, who accounted for about 60% of all patients, had similar results. The maximum dosage of prednisolone given during the trial averaged 0.7 mg/kg per day.

Sanofi Aventis provided free daily-dosed risedronate, but did not otherwise fund the trial. Dr. Mok said that no investigators had conflicts of interest with Sanofi Aventis.

Overall, 51 risedronate- and 52 placebo-treated patients completed the trial. Withdrawals mainly occurred because of the daily drug protocol, but several patients died from their underlying medical condition; two withdrawals occurred in the risedronate group because of adverse events (one skin rash and one dyspepsia).

No patients had preexisting vertebral or hip fractures, although about 50% of the patients were osteopenic. The trial was not powered to test the antifracture efficacy of risedronate.

“Risedronate should be considered for primary prevention of bone mineral loss during periods of high-dose glucocorticoid therapy,” Dr. Mok concluded.

ELSEVIER GLOBAL MEDICAL NEWS

BARCELONA — Patients who use high-dose glucocorticoids can maintain or improve their bone mineral density with risedronate prophylaxis, Dr. Chi Chiu Mok reported at the annual European Congress of Rheumatology.

“The [American College of Rheumatology] recommends the first-line use of bisphosphonates in patients with T scores below -1 who are expected to use corticosteroids for more than 3 months,” said Dr. Mok of the department of medicine at Tuen Mun Hospital, Hong Kong.

“Multiple clinical trials have confirmed the efficacy of bisphosphonates in the prevention and treatment of glucocorticoid-induced bone loss, and sometimes have demonstrated antifracture efficacy. But most [of these trials] recruited patients taking a relatively small dose of steroids,” an equivalent of 7.5 mg/week of prednisolone or more.

Dr. Mok and colleagues randomized 120 patients with conditions requiring 0.5 mg/kg per day prednisolone (or an equivalent glucocorticoid dose) for 6 weeks or more to 1,000 mg/day calcium plus 5 mg/day risedronate (Actonel) or placebo for 6 months. Mean age was 43 years, and 30% were postmenopausal.

At the end of the double-blind trial, risedronate patients had a significantly greater change in bone mineral density (BMD) at the lumbar spine (0.9%) than did placebo-treated patients (−0.5%). This was significant even after adjusting for baseline BMD, age, gender, body mass index, and cumulative steroid dosage. Risedronate patients maintained BMD in the hip and the whole body overall. Placebo patients lost BMD in both measurements.

Steroid-naive patients, who accounted for about 60% of all patients, had similar results. The maximum dosage of prednisolone given during the trial averaged 0.7 mg/kg per day.

Sanofi Aventis provided free daily-dosed risedronate, but did not otherwise fund the trial. Dr. Mok said that no investigators had conflicts of interest with Sanofi Aventis.

Overall, 51 risedronate- and 52 placebo-treated patients completed the trial. Withdrawals mainly occurred because of the daily drug protocol, but several patients died from their underlying medical condition; two withdrawals occurred in the risedronate group because of adverse events (one skin rash and one dyspepsia).

No patients had preexisting vertebral or hip fractures, although about 50% of the patients were osteopenic. The trial was not powered to test the antifracture efficacy of risedronate.

“Risedronate should be considered for primary prevention of bone mineral loss during periods of high-dose glucocorticoid therapy,” Dr. Mok concluded.

ELSEVIER GLOBAL MEDICAL NEWS

The Food and Drug Administration has requested manufacturers and distributors of unapproved cough suppressants containing hydrocodone to stop marketing their products or face legal action.

“The industry has been and is well aware that its drugs were and are being marketed illegally, and the industry continues to circumvent the law and put consumers' health at risk. Nonetheless, the CPG [the FDA's Compliance Policy Guide for marketed unapproved drugs] provided the industry with specific notice that any illegally marketed unapproved drug is subject to FDA enforcement at any time,” Deborah M. Autor, J.D., said during a teleconference.

The FDA has identified about 200 unapproved prescription antitussive drugs on the market that contain hydrocodone. Only seven prescription hydrocodone-containing cough suppressants are FDA approved: Hycodan (ENDO Pharms), Mycodone (Morton Grove), Tussicaps (Tyco Healthcare), Tussigon (King Pharmaceuticals), Tussionex Pennkinetic (UCB Inc.), Hydrocodone compound (Actavis Mid Atlantic), and Homatropine methylbromide and hydrocodone bitartrate (Actavis Totowa). Other approved cough suppressants do not contain hydrocodone. The agency did not identify any unapproved pain-relief medications containing hydrocodone.

Of particular concern to the agency are unapproved hydrocodone-containing cough suppressants that carry labels with dosing instructions for children as young as age 2 years, because no antitussive containing hydrocodone has been established as safe and effective for children younger than age 6 years. Other unapproved hydrocodone products have omitted important safety warnings and other information on their labeling, according to the FDA.

Hydrocodone-containing products have potential for adverse events such as psychotic behavior and drug abuse; nausea, vomiting, and constipation; cardiac arrest and respiratory depression; hypersensitivity, including pruritus, dermatitis, and pharyngeal edema; and intentional and unintentional overdose, according to the FDA.

More than 400 spontaneous reports of serious adverse events associated with antitussives containing hydrocodone have been reported to the FDA's voluntary MedWatch program since 2005, including deaths due to overdose, although the agency cannot separate out those pertaining to unapproved versus approved products, Dr. Jason Woo, associate director of medical and scientific affairs at the FDA's Office of Compliance, said during the teleconference.

The agency also received reports of medication errors associated with formulation changes of unapproved hydrocodone-containing antitussives, such as changing the strength of the active ingredient, and reports of confusion over the similarity between the trade names of these unapproved products and other drug products.

“These products might be confused with one another, leading to dosing problems,” said Ms. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. “For example, in our NDC [National Drug Code] Directory, which is a list of marketed products, there are drugs named Histex and drugs named Histinex, and there are also drugs names Histuss HC, Histussin D, and Histussin HC, and all of these are different products.”

Before the FDA approves a trade name for a drug, agency researchers perform an analysis “to make sure that we have done everything to prevent … names that sound alike or look alike or might be written alike. And when a drug evades the FDA approval process, that entire process is not brought to bear,” she added. These similarly named products can contain different ingredients, Ms. Autor said.

FDA officials were not concerned about a shortage of cough suppressants following this action because there are many other antitussive products available as well as grace periods that allow other manufacturers time to increase production if necessary. Companies marketing unapproved hydrocodone-containing products labeled for use in children younger than age 6 years were required to end manufacturing and distribution of the products by Oct. 31, 2007. Marketers of other unapproved hydrocodone-containing products must stop manufacturing these drugs by Dec. 31, 2007, and cease further shipment in interstate commerce by March 31, 2008.

The Food and Drug Administration has requested manufacturers and distributors of unapproved cough suppressants containing hydrocodone to stop marketing their products or face legal action.

“The industry has been and is well aware that its drugs were and are being marketed illegally, and the industry continues to circumvent the law and put consumers' health at risk. Nonetheless, the CPG [the FDA's Compliance Policy Guide for marketed unapproved drugs] provided the industry with specific notice that any illegally marketed unapproved drug is subject to FDA enforcement at any time,” Deborah M. Autor, J.D., said during a teleconference.

The FDA has identified about 200 unapproved prescription antitussive drugs on the market that contain hydrocodone. Only seven prescription hydrocodone-containing cough suppressants are FDA approved: Hycodan (ENDO Pharms), Mycodone (Morton Grove), Tussicaps (Tyco Healthcare), Tussigon (King Pharmaceuticals), Tussionex Pennkinetic (UCB Inc.), Hydrocodone compound (Actavis Mid Atlantic), and Homatropine methylbromide and hydrocodone bitartrate (Actavis Totowa). Other approved cough suppressants do not contain hydrocodone. The agency did not identify any unapproved pain-relief medications containing hydrocodone.

Of particular concern to the agency are unapproved hydrocodone-containing cough suppressants that carry labels with dosing instructions for children as young as age 2 years, because no antitussive containing hydrocodone has been established as safe and effective for children younger than age 6 years. Other unapproved hydrocodone products have omitted important safety warnings and other information on their labeling, according to the FDA.

Hydrocodone-containing products have potential for adverse events such as psychotic behavior and drug abuse; nausea, vomiting, and constipation; cardiac arrest and respiratory depression; hypersensitivity, including pruritus, dermatitis, and pharyngeal edema; and intentional and unintentional overdose, according to the FDA.

More than 400 spontaneous reports of serious adverse events associated with antitussives containing hydrocodone have been reported to the FDA's voluntary MedWatch program since 2005, including deaths due to overdose, although the agency cannot separate out those pertaining to unapproved versus approved products, Dr. Jason Woo, associate director of medical and scientific affairs at the FDA's Office of Compliance, said during the teleconference.

The agency also received reports of medication errors associated with formulation changes of unapproved hydrocodone-containing antitussives, such as changing the strength of the active ingredient, and reports of confusion over the similarity between the trade names of these unapproved products and other drug products.

“These products might be confused with one another, leading to dosing problems,” said Ms. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. “For example, in our NDC [National Drug Code] Directory, which is a list of marketed products, there are drugs named Histex and drugs named Histinex, and there are also drugs names Histuss HC, Histussin D, and Histussin HC, and all of these are different products.”

Before the FDA approves a trade name for a drug, agency researchers perform an analysis “to make sure that we have done everything to prevent … names that sound alike or look alike or might be written alike. And when a drug evades the FDA approval process, that entire process is not brought to bear,” she added. These similarly named products can contain different ingredients, Ms. Autor said.

FDA officials were not concerned about a shortage of cough suppressants following this action because there are many other antitussive products available as well as grace periods that allow other manufacturers time to increase production if necessary. Companies marketing unapproved hydrocodone-containing products labeled for use in children younger than age 6 years were required to end manufacturing and distribution of the products by Oct. 31, 2007. Marketers of other unapproved hydrocodone-containing products must stop manufacturing these drugs by Dec. 31, 2007, and cease further shipment in interstate commerce by March 31, 2008.

The Food and Drug Administration has requested manufacturers and distributors of unapproved cough suppressants containing hydrocodone to stop marketing their products or face legal action.

“The industry has been and is well aware that its drugs were and are being marketed illegally, and the industry continues to circumvent the law and put consumers' health at risk. Nonetheless, the CPG [the FDA's Compliance Policy Guide for marketed unapproved drugs] provided the industry with specific notice that any illegally marketed unapproved drug is subject to FDA enforcement at any time,” Deborah M. Autor, J.D., said during a teleconference.

The FDA has identified about 200 unapproved prescription antitussive drugs on the market that contain hydrocodone. Only seven prescription hydrocodone-containing cough suppressants are FDA approved: Hycodan (ENDO Pharms), Mycodone (Morton Grove), Tussicaps (Tyco Healthcare), Tussigon (King Pharmaceuticals), Tussionex Pennkinetic (UCB Inc.), Hydrocodone compound (Actavis Mid Atlantic), and Homatropine methylbromide and hydrocodone bitartrate (Actavis Totowa). Other approved cough suppressants do not contain hydrocodone. The agency did not identify any unapproved pain-relief medications containing hydrocodone.

Of particular concern to the agency are unapproved hydrocodone-containing cough suppressants that carry labels with dosing instructions for children as young as age 2 years, because no antitussive containing hydrocodone has been established as safe and effective for children younger than age 6 years. Other unapproved hydrocodone products have omitted important safety warnings and other information on their labeling, according to the FDA.

Hydrocodone-containing products have potential for adverse events such as psychotic behavior and drug abuse; nausea, vomiting, and constipation; cardiac arrest and respiratory depression; hypersensitivity, including pruritus, dermatitis, and pharyngeal edema; and intentional and unintentional overdose, according to the FDA.

More than 400 spontaneous reports of serious adverse events associated with antitussives containing hydrocodone have been reported to the FDA's voluntary MedWatch program since 2005, including deaths due to overdose, although the agency cannot separate out those pertaining to unapproved versus approved products, Dr. Jason Woo, associate director of medical and scientific affairs at the FDA's Office of Compliance, said during the teleconference.

The agency also received reports of medication errors associated with formulation changes of unapproved hydrocodone-containing antitussives, such as changing the strength of the active ingredient, and reports of confusion over the similarity between the trade names of these unapproved products and other drug products.

“These products might be confused with one another, leading to dosing problems,” said Ms. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. “For example, in our NDC [National Drug Code] Directory, which is a list of marketed products, there are drugs named Histex and drugs named Histinex, and there are also drugs names Histuss HC, Histussin D, and Histussin HC, and all of these are different products.”

Before the FDA approves a trade name for a drug, agency researchers perform an analysis “to make sure that we have done everything to prevent … names that sound alike or look alike or might be written alike. And when a drug evades the FDA approval process, that entire process is not brought to bear,” she added. These similarly named products can contain different ingredients, Ms. Autor said.

FDA officials were not concerned about a shortage of cough suppressants following this action because there are many other antitussive products available as well as grace periods that allow other manufacturers time to increase production if necessary. Companies marketing unapproved hydrocodone-containing products labeled for use in children younger than age 6 years were required to end manufacturing and distribution of the products by Oct. 31, 2007. Marketers of other unapproved hydrocodone-containing products must stop manufacturing these drugs by Dec. 31, 2007, and cease further shipment in interstate commerce by March 31, 2008.

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, according to Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because "people are making this association," said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that "what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement." Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had "quite small" effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. "If these had been clinical trials, they would have all been considered extremely underpowered and preliminary," Dr. Mark said.

Programs in four studies may have created unintended consequences, including "gaming the baseline level of illness," avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include information on the optimal duration of these programs or whether or not their effect persisted after the program was ended. Only one study had a preliminary examination of the program's cost-effectiveness.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMS' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was "very little evidence that there was any intervention effect," according to Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion that was allocated for the project was eaten by greater than predicted success in achieving the quality indicators. This led to an average increase in the physicians' pay of about £40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, "so it's not clear how much the program's achievements can actually be attributed to the program itself," he said (N. Engl. J. Med. 2007;357:181–90).

Another study showed that public reporting of measures alone could improve a set of quality indicators on heart failure and acute myocardial infarction by the same magnitude as a pay-for-performance program that included public reporting (N. Engl. J. Med. 2007;356:486–96).

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, according to Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because "people are making this association," said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that "what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement." Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had "quite small" effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. "If these had been clinical trials, they would have all been considered extremely underpowered and preliminary," Dr. Mark said.

Programs in four studies may have created unintended consequences, including "gaming the baseline level of illness," avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include information on the optimal duration of these programs or whether or not their effect persisted after the program was ended. Only one study had a preliminary examination of the program's cost-effectiveness.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMS' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was "very little evidence that there was any intervention effect," according to Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion that was allocated for the project was eaten by greater than predicted success in achieving the quality indicators. This led to an average increase in the physicians' pay of about £40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, "so it's not clear how much the program's achievements can actually be attributed to the program itself," he said (N. Engl. J. Med. 2007;357:181–90).

Another study showed that public reporting of measures alone could improve a set of quality indicators on heart failure and acute myocardial infarction by the same magnitude as a pay-for-performance program that included public reporting (N. Engl. J. Med. 2007;356:486–96).

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, according to Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because "people are making this association," said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that "what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement." Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had "quite small" effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. "If these had been clinical trials, they would have all been considered extremely underpowered and preliminary," Dr. Mark said.

Programs in four studies may have created unintended consequences, including "gaming the baseline level of illness," avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include information on the optimal duration of these programs or whether or not their effect persisted after the program was ended. Only one study had a preliminary examination of the program's cost-effectiveness.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMS' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was "very little evidence that there was any intervention effect," according to Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion that was allocated for the project was eaten by greater than predicted success in achieving the quality indicators. This led to an average increase in the physicians' pay of about £40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, "so it's not clear how much the program's achievements can actually be attributed to the program itself," he said (N. Engl. J. Med. 2007;357:181–90).

Another study showed that public reporting of measures alone could improve a set of quality indicators on heart failure and acute myocardial infarction by the same magnitude as a pay-for-performance program that included public reporting (N. Engl. J. Med. 2007;356:486–96).

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

More than 100 reward or incentive programs have started in the private U.S. health care sector under the control of employer groups or managed care organizations, according to Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention, he said.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because “people are making this association,” said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies appeared to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” according to Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion allocated for the project was eaten by greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%). This led to an average increase in the physicians' pay of about $40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90). And it is not clear what effect the program had on other conditions that were not a part of the incentive program. In any case, the U.K. government has significantly tightened up its requirements for earning extra money in the program in 2008, according to Dr. Mark.

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

More than 100 reward or incentive programs have started in the private U.S. health care sector under the control of employer groups or managed care organizations, according to Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention, he said.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because “people are making this association,” said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies appeared to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” according to Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion allocated for the project was eaten by greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%). This led to an average increase in the physicians' pay of about $40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90). And it is not clear what effect the program had on other conditions that were not a part of the incentive program. In any case, the U.K. government has significantly tightened up its requirements for earning extra money in the program in 2008, according to Dr. Mark.

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

More than 100 reward or incentive programs have started in the private U.S. health care sector under the control of employer groups or managed care organizations, according to Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention, he said.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because “people are making this association,” said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown that “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies appeared to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” according to Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373–80).

In the United Kingdom, family practice physicians participated in a pay-for-performance program in 2004 that focused on 146 quality indicators for 10 chronic diseases as well as measures related to the organization of care and the patient's experience. The National Health Service substantially increased its deficit that year because the approximately $3.2 billion allocated for the project was eaten by greater than predicted success in achieving the quality indicators (83% achieved vs. an expected 75%). This led to an average increase in the physicians' pay of about $40,000 that year (N. Engl. J. Med. 2006;355:375–84).

Other investigators noted that in the 1998–2003 period prior to the NHS project all of the quality indicators had already been improving, “so it's not clear how much the program's achievements can actually be attributed to the program itself,” he said (N. Engl. J. Med. 2007;357:181–90). And it is not clear what effect the program had on other conditions that were not a part of the incentive program. In any case, the U.K. government has significantly tightened up its requirements for earning extra money in the program in 2008, according to Dr. Mark.

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, said Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because “people are making this association,” said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies seemed to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” said Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373-80).

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, said Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because “people are making this association,” said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies seemed to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” said Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373-80).

WASHINGTON — The few studies that have examined the effectiveness of incentivized pay-for-performance programs have found a mix of moderate to no improvement in quality measures, which, in some instances, have led to unintended consequences, Dr. Daniel B. Mark said at the annual meeting of the Heart Failure Society of America.

There are more than 100 reward or incentive programs that have started in the private U.S. health care sector under the control of employer groups or managed care organizations, said Dr. Mark, but congressionally authorized programs by the Centers for Medicare and Medicaid Services have received the most attention.

It is important to examine the evidence base that pay-for-performance programs actually improve quality because “people are making this association,” said Dr. Mark, director of the Outcomes Research and Assessment Group at the Duke (University) Clinical Research Institute, Durham, N.C.

During the last 20 years, incentivized performance programs have shown “what you measure generally improves and what gets measured is generally what's easiest to measure. But the ease of measurement does not necessarily define the importance of the measurement.” Furthermore, very little, if anything, is known about whether these initiatives are cost effective for the health care system at large, Dr. Mark said, although he noted that that may be an oversimplification of the outcomes of such programs.

A systematic overview of 17 studies published during 1980–2005 on pay-for-performance programs found that 1 of 2 studies on system-level incentives had a positive result in which all performance measures improved. In nine studies of incentive programs aimed at the provider group level, seven had partially positive or fully positive results but had “quite small” effect sizes. Positive or partially-positive results were seen in five of six programs at the physician level (Ann. Int. Med. 2006;145:265–72).

Nine of the studies were randomized and controlled, but eight of these had a sample size of fewer than 100 physicians or groups; the other study had fewer than 200 groups. “If these had been clinical trials, they would have all been considered extremely underpowered and preliminary,” Dr. Mark said.

Programs in four studies seemed to have created unintended consequences, including “gaming the baseline level of illness,” avoiding sicker patients, and an improvement in documentation in immunization studies without any actual change in the number of immunizations given or effect on care. The studies did not include any information on the optimal duration of these programs or whether or not their effect persisted after the program was terminated. Only one study had a preliminary examination of the cost-effectiveness of a program.

Another study compared patients with acute non-ST-elevation myocardial infarction in 57 hospitals that participated in CMs' Hospital Quality Incentive Demonstration and 113 control hospitals that did not participate in the program to determine if a pay-for-performance strategy produced better quality of care. There was “very little evidence that there was any intervention effect,” said Dr. Mark. Measures that were not incentivized by CMS also did not appear to change (JAMA 2007;297:2373-80).

The prevalence of high blood pressure among children and adolescents rose during the late 1980s and into the early 2000s despite a downward trend that prevailed during much of the prior 30 years, according to the results of national surveys conducted during 1963–2002.

From 1988 to 2002, the prevalence of high blood pressure (HBP) in children and adolescents aged 8–17 years increased from 2.7% to 3.7%. During the same period, the prevalence of pre-HBP increased from 7.7% to 10% and rose significantly among blacks and Mexican Americans, Dr. Rebecca Din-Dzietham and her associates at Morehouse School of Medicine, Atlanta, reported.

“It is advisable to measure blood pressure at every visit with the appropriate technique to rank the child's measured blood pressure from the Centers for Disease Control and Prevention growth charts and the gender-, age-, and height-specific blood pressure table” the researchers advised (Circulation 2007;116:1392–1400).

They analyzed data on individuals aged 8–17 years from the second and third National Health Examination Surveys (1963–1965 and 1966–1970, respectively), the Hispanic Health and Nutrition Examination Survey (1982–1984), and the first, second, third, and continuous National Health and Nutrition Examination Surveys (1971–1975, 1976–1980, 1988–1994, and 1999–2002).

The overall trend of systolic and diastolic BP in the surveys paralleled the rise in HBP, although the mean increase in age-adjusted BP was greater for diastolic (8.4 mm Hg) than systolic BP (1.3 mm Hg). The increase in systolic BP was comparable among lean, at-risk-for-overweight, and overweight children and adolescents, but lean individuals had a significantly greater mean increase in diastolic BP than did their heavier counterparts.

The prevalence of high blood pressure among children and adolescents rose during the late 1980s and into the early 2000s despite a downward trend that prevailed during much of the prior 30 years, according to the results of national surveys conducted during 1963–2002.

From 1988 to 2002, the prevalence of high blood pressure (HBP) in children and adolescents aged 8–17 years increased from 2.7% to 3.7%. During the same period, the prevalence of pre-HBP increased from 7.7% to 10% and rose significantly among blacks and Mexican Americans, Dr. Rebecca Din-Dzietham and her associates at Morehouse School of Medicine, Atlanta, reported.

“It is advisable to measure blood pressure at every visit with the appropriate technique to rank the child's measured blood pressure from the Centers for Disease Control and Prevention growth charts and the gender-, age-, and height-specific blood pressure table” the researchers advised (Circulation 2007;116:1392–1400).

They analyzed data on individuals aged 8–17 years from the second and third National Health Examination Surveys (1963–1965 and 1966–1970, respectively), the Hispanic Health and Nutrition Examination Survey (1982–1984), and the first, second, third, and continuous National Health and Nutrition Examination Surveys (1971–1975, 1976–1980, 1988–1994, and 1999–2002).

The overall trend of systolic and diastolic BP in the surveys paralleled the rise in HBP, although the mean increase in age-adjusted BP was greater for diastolic (8.4 mm Hg) than systolic BP (1.3 mm Hg). The increase in systolic BP was comparable among lean, at-risk-for-overweight, and overweight children and adolescents, but lean individuals had a significantly greater mean increase in diastolic BP than did their heavier counterparts.

The prevalence of high blood pressure among children and adolescents rose during the late 1980s and into the early 2000s despite a downward trend that prevailed during much of the prior 30 years, according to the results of national surveys conducted during 1963–2002.

From 1988 to 2002, the prevalence of high blood pressure (HBP) in children and adolescents aged 8–17 years increased from 2.7% to 3.7%. During the same period, the prevalence of pre-HBP increased from 7.7% to 10% and rose significantly among blacks and Mexican Americans, Dr. Rebecca Din-Dzietham and her associates at Morehouse School of Medicine, Atlanta, reported.

“It is advisable to measure blood pressure at every visit with the appropriate technique to rank the child's measured blood pressure from the Centers for Disease Control and Prevention growth charts and the gender-, age-, and height-specific blood pressure table” the researchers advised (Circulation 2007;116:1392–1400).

They analyzed data on individuals aged 8–17 years from the second and third National Health Examination Surveys (1963–1965 and 1966–1970, respectively), the Hispanic Health and Nutrition Examination Survey (1982–1984), and the first, second, third, and continuous National Health and Nutrition Examination Surveys (1971–1975, 1976–1980, 1988–1994, and 1999–2002).

The overall trend of systolic and diastolic BP in the surveys paralleled the rise in HBP, although the mean increase in age-adjusted BP was greater for diastolic (8.4 mm Hg) than systolic BP (1.3 mm Hg). The increase in systolic BP was comparable among lean, at-risk-for-overweight, and overweight children and adolescents, but lean individuals had a significantly greater mean increase in diastolic BP than did their heavier counterparts.

The Food and Drug Administration has approved a new smallpox vaccine, ACAM2000, for active immunization against smallpox in individuals determined to be at high risk for smallpox infection. The vaccine also could be used to immunize populations during a bioterrorist attack.

Many doses of the vaccine will be stored in the Centers for Disease Control and Prevention's Strategic National Stockpile of medical supplies. The vaccine manufacturer, Acambis Inc., of Cambridge, England, and Cambridge, Mass., so far has supplied 192.5 million doses of ACAM2000 to the stockpile, according to the company.

The single-dose vaccine is approved under licensing that requires providers of the vaccine and patients to be educated about the risks of the virus through a Risk Minimization Action Plan. Patient education is supposed to be conducted through an FDA-approved medication guide, which describes the proper care of the vaccination site and the serious side effects that can occur.

Dryvax, the only other smallpox vaccine that is licensed by the FDA, was approved in 1931 and is now in limited supply because it is no longer manufactured. Dryvax was used to create ACAM2000, which is made using a live poxvirus called vaccinia. Vaccinia is related to, but different from, the virus that causes smallpox, and works by causing a mild infection that stimulates an immune response that will protect against smallpox, according to the FDA.

In one clinical study of ACAM2000, investigators found that the percentage of successful immunization reactions was similar for both ACAM2000 (96%) and Dryvax (99%) in patients who had never been vaccinated for smallpox prior to the trial.

Another study showed that ACAM2000 worked as successfully as Dryvax as a booster for those who previously had been vaccinated for smallpox (84% vs. 98%, respectively).

Cases of suspected myocarditis and/or pericarditis developed in 0.6% to 1% of all vaccinia-naive patients who received either ACAM2000 or Dryvax. Overall, 10 patients developed suspected myocarditis/pericarditis, which occurred at a mean of 11 days after vaccination with either vaccine. Only two of these patients required hospitalization. Eight of the cases were not detected until abnormalities were found on ECG. All patients had recovered by 9 months except for one, who had a persistent borderline abnormal left ventricular ejection fraction, according to the product label.

No cardiovascular inflammation or swelling occurred in previously vaccinated patients.

Patients who are vaccinated with ACAM2000 have to take precautions to prevent the virus from spreading from the inoculation site to other parts of the body and to other individuals, according to the vaccine's label.

The Food and Drug Administration has approved a new smallpox vaccine, ACAM2000, for active immunization against smallpox in individuals determined to be at high risk for smallpox infection. The vaccine also could be used to immunize populations during a bioterrorist attack.

Many doses of the vaccine will be stored in the Centers for Disease Control and Prevention's Strategic National Stockpile of medical supplies. The vaccine manufacturer, Acambis Inc., of Cambridge, England, and Cambridge, Mass., so far has supplied 192.5 million doses of ACAM2000 to the stockpile, according to the company.

The single-dose vaccine is approved under licensing that requires providers of the vaccine and patients to be educated about the risks of the virus through a Risk Minimization Action Plan. Patient education is supposed to be conducted through an FDA-approved medication guide, which describes the proper care of the vaccination site and the serious side effects that can occur.

Dryvax, the only other smallpox vaccine that is licensed by the FDA, was approved in 1931 and is now in limited supply because it is no longer manufactured. Dryvax was used to create ACAM2000, which is made using a live poxvirus called vaccinia. Vaccinia is related to, but different from, the virus that causes smallpox, and works by causing a mild infection that stimulates an immune response that will protect against smallpox, according to the FDA.

In one clinical study of ACAM2000, investigators found that the percentage of successful immunization reactions was similar for both ACAM2000 (96%) and Dryvax (99%) in patients who had never been vaccinated for smallpox prior to the trial.

Another study showed that ACAM2000 worked as successfully as Dryvax as a booster for those who previously had been vaccinated for smallpox (84% vs. 98%, respectively).

Cases of suspected myocarditis and/or pericarditis developed in 0.6% to 1% of all vaccinia-naive patients who received either ACAM2000 or Dryvax. Overall, 10 patients developed suspected myocarditis/pericarditis, which occurred at a mean of 11 days after vaccination with either vaccine. Only two of these patients required hospitalization. Eight of the cases were not detected until abnormalities were found on ECG. All patients had recovered by 9 months except for one, who had a persistent borderline abnormal left ventricular ejection fraction, according to the product label.

No cardiovascular inflammation or swelling occurred in previously vaccinated patients.

Patients who are vaccinated with ACAM2000 have to take precautions to prevent the virus from spreading from the inoculation site to other parts of the body and to other individuals, according to the vaccine's label.

The Food and Drug Administration has approved a new smallpox vaccine, ACAM2000, for active immunization against smallpox in individuals determined to be at high risk for smallpox infection. The vaccine also could be used to immunize populations during a bioterrorist attack.

Many doses of the vaccine will be stored in the Centers for Disease Control and Prevention's Strategic National Stockpile of medical supplies. The vaccine manufacturer, Acambis Inc., of Cambridge, England, and Cambridge, Mass., so far has supplied 192.5 million doses of ACAM2000 to the stockpile, according to the company.

The single-dose vaccine is approved under licensing that requires providers of the vaccine and patients to be educated about the risks of the virus through a Risk Minimization Action Plan. Patient education is supposed to be conducted through an FDA-approved medication guide, which describes the proper care of the vaccination site and the serious side effects that can occur.

Dryvax, the only other smallpox vaccine that is licensed by the FDA, was approved in 1931 and is now in limited supply because it is no longer manufactured. Dryvax was used to create ACAM2000, which is made using a live poxvirus called vaccinia. Vaccinia is related to, but different from, the virus that causes smallpox, and works by causing a mild infection that stimulates an immune response that will protect against smallpox, according to the FDA.

In one clinical study of ACAM2000, investigators found that the percentage of successful immunization reactions was similar for both ACAM2000 (96%) and Dryvax (99%) in patients who had never been vaccinated for smallpox prior to the trial.

Another study showed that ACAM2000 worked as successfully as Dryvax as a booster for those who previously had been vaccinated for smallpox (84% vs. 98%, respectively).

Cases of suspected myocarditis and/or pericarditis developed in 0.6% to 1% of all vaccinia-naive patients who received either ACAM2000 or Dryvax. Overall, 10 patients developed suspected myocarditis/pericarditis, which occurred at a mean of 11 days after vaccination with either vaccine. Only two of these patients required hospitalization. Eight of the cases were not detected until abnormalities were found on ECG. All patients had recovered by 9 months except for one, who had a persistent borderline abnormal left ventricular ejection fraction, according to the product label.

No cardiovascular inflammation or swelling occurred in previously vaccinated patients.

Patients who are vaccinated with ACAM2000 have to take precautions to prevent the virus from spreading from the inoculation site to other parts of the body and to other individuals, according to the vaccine's label.