Mary Ann Moon

Major Finding: Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of small size for gestational age, and an 8% risk of low birth weight. These rates were 4%, 4%, and 3.5%, respectively, among fetuses without growth restriction.

Data Source: A population-based prospective study of 1,631 pregnant women.

Disclosures: Dr. Mook-Kanamori reported no relevant conflicts of interest. Dr. Smith reported being a member of GlaxoSmith-Kline's preterm labor advisory boards.

Pregnant women who smoke, don't take folic acid supplements, or have higher than average blood pressure or hematocrit levels are at greater risk than others for fetal growth restriction during the first trimester.

In turn, such growth restriction is associated with a greater risk of poor outcomes such as preterm birth, small size for gestational age (SGA) at birth, and a compensatory accelerated rate of postnatal growth that persists until age 2 years, said Dr. Dennis O. Mook-Kanamori and his associates at Erasmus Medical Center, Rotterdam, the Netherlands.

These findings from a population-based prospective study involving 1,631 pregnant women suggest that growth patterns as early as the first trimester have a far-reaching influence, perhaps affecting disease risk in adulthood as well as in childhood, the investigators said.

They assessed fetal crown-to-rump length via ultrasound during the first trimester among women participating in a larger study in the Netherlands.

Higher than average diastolic blood pressure and hematocrit levels, smoking, and nonuse of folic acid supplements significantly correlated with shorter crown-to-rump length. There was even a dose-response relation between the number of cigarettes smoked and the degree of growth restriction.

Maternal weight and height showed no relation to the development of fetal growth restriction.

Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of SGA, and an 8% risk of low birth weight (LBW). In contrast, these rates were 4%, 4%, and 3.5%, respectively, among fetuses that did not show growth restriction.

This indicates a two- to threefold increase in risk for these complications, Dr. Mook-Kanamori and his colleagues said (JAMA 2010;303:527–34).

First-trimester fetal crown-to-rump length also correlated with head circumference, femur length, and weight not only throughout pregnancy and at birth, but also at 1-year and 14-month assessments. This correlation had disappeared by the time the study subjects were evaluated at age 2 years.

“Increased postnatal growth rate is a well-established risk factor for metabolic and cardiovascular disease in later life,” the researchers noted.

In an editorial, Dr. Gordon C.S. Smith of the University of Cambridge (England) said these findings suggest that “complications of late pregnancy may, at least for some women, already be determined in the first 3 months post conception, even before a woman has sought prenatal care” (JAMA 2010;303:561–2).

Major Finding: Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of small size for gestational age, and an 8% risk of low birth weight. These rates were 4%, 4%, and 3.5%, respectively, among fetuses without growth restriction.

Data Source: A population-based prospective study of 1,631 pregnant women.

Disclosures: Dr. Mook-Kanamori reported no relevant conflicts of interest. Dr. Smith reported being a member of GlaxoSmith-Kline's preterm labor advisory boards.

Pregnant women who smoke, don't take folic acid supplements, or have higher than average blood pressure or hematocrit levels are at greater risk than others for fetal growth restriction during the first trimester.

In turn, such growth restriction is associated with a greater risk of poor outcomes such as preterm birth, small size for gestational age (SGA) at birth, and a compensatory accelerated rate of postnatal growth that persists until age 2 years, said Dr. Dennis O. Mook-Kanamori and his associates at Erasmus Medical Center, Rotterdam, the Netherlands.

These findings from a population-based prospective study involving 1,631 pregnant women suggest that growth patterns as early as the first trimester have a far-reaching influence, perhaps affecting disease risk in adulthood as well as in childhood, the investigators said.

They assessed fetal crown-to-rump length via ultrasound during the first trimester among women participating in a larger study in the Netherlands.

Higher than average diastolic blood pressure and hematocrit levels, smoking, and nonuse of folic acid supplements significantly correlated with shorter crown-to-rump length. There was even a dose-response relation between the number of cigarettes smoked and the degree of growth restriction.

Maternal weight and height showed no relation to the development of fetal growth restriction.

Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of SGA, and an 8% risk of low birth weight (LBW). In contrast, these rates were 4%, 4%, and 3.5%, respectively, among fetuses that did not show growth restriction.

This indicates a two- to threefold increase in risk for these complications, Dr. Mook-Kanamori and his colleagues said (JAMA 2010;303:527–34).

First-trimester fetal crown-to-rump length also correlated with head circumference, femur length, and weight not only throughout pregnancy and at birth, but also at 1-year and 14-month assessments. This correlation had disappeared by the time the study subjects were evaluated at age 2 years.

“Increased postnatal growth rate is a well-established risk factor for metabolic and cardiovascular disease in later life,” the researchers noted.

In an editorial, Dr. Gordon C.S. Smith of the University of Cambridge (England) said these findings suggest that “complications of late pregnancy may, at least for some women, already be determined in the first 3 months post conception, even before a woman has sought prenatal care” (JAMA 2010;303:561–2).

Major Finding: Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of small size for gestational age, and an 8% risk of low birth weight. These rates were 4%, 4%, and 3.5%, respectively, among fetuses without growth restriction.

Data Source: A population-based prospective study of 1,631 pregnant women.

Disclosures: Dr. Mook-Kanamori reported no relevant conflicts of interest. Dr. Smith reported being a member of GlaxoSmith-Kline's preterm labor advisory boards.

Pregnant women who smoke, don't take folic acid supplements, or have higher than average blood pressure or hematocrit levels are at greater risk than others for fetal growth restriction during the first trimester.

In turn, such growth restriction is associated with a greater risk of poor outcomes such as preterm birth, small size for gestational age (SGA) at birth, and a compensatory accelerated rate of postnatal growth that persists until age 2 years, said Dr. Dennis O. Mook-Kanamori and his associates at Erasmus Medical Center, Rotterdam, the Netherlands.

These findings from a population-based prospective study involving 1,631 pregnant women suggest that growth patterns as early as the first trimester have a far-reaching influence, perhaps affecting disease risk in adulthood as well as in childhood, the investigators said.

They assessed fetal crown-to-rump length via ultrasound during the first trimester among women participating in a larger study in the Netherlands.

Higher than average diastolic blood pressure and hematocrit levels, smoking, and nonuse of folic acid supplements significantly correlated with shorter crown-to-rump length. There was even a dose-response relation between the number of cigarettes smoked and the degree of growth restriction.

Maternal weight and height showed no relation to the development of fetal growth restriction.

Fetuses in the lowest 20% of crown-to-rump length had a 7% risk of preterm birth, an 11% risk of SGA, and an 8% risk of low birth weight (LBW). In contrast, these rates were 4%, 4%, and 3.5%, respectively, among fetuses that did not show growth restriction.

This indicates a two- to threefold increase in risk for these complications, Dr. Mook-Kanamori and his colleagues said (JAMA 2010;303:527–34).

First-trimester fetal crown-to-rump length also correlated with head circumference, femur length, and weight not only throughout pregnancy and at birth, but also at 1-year and 14-month assessments. This correlation had disappeared by the time the study subjects were evaluated at age 2 years.

“Increased postnatal growth rate is a well-established risk factor for metabolic and cardiovascular disease in later life,” the researchers noted.

In an editorial, Dr. Gordon C.S. Smith of the University of Cambridge (England) said these findings suggest that “complications of late pregnancy may, at least for some women, already be determined in the first 3 months post conception, even before a woman has sought prenatal care” (JAMA 2010;303:561–2).

A 4-month exercise program of moderate intensity improved the inflammatory milieu, including markers of atherosclerosis, in overweight, sedentary diabetic patients.

The exercise did not alter body weight or insulin resistance, but it significantly improved glycemic, lipid, and cardiorespiratory factors, reported Dr. Nikolaos P. E. Kadoglou of Hippokratio General Hospital of Thessaloniki (Greece) and his associates (Diabetes Metab. 2010 Feb. 9 [10.1016/j.diabet.2009.11.004

The researchers compared outcomes in 50 sedentary, overweight, white patients with type 2 diabetes who were aged between 50 and 65 years and whose glycemic control had failed to improve after they had followed a diet and taken oral antidiabetic drugs for at least 4 months. The study subjects were randomly assigned in equal numbers to an exercise program or a control group.

Subjects were instructed to perform 30–60 minutes of brisk walking at least 4 days per week, with no more than 2 consecutive days of inactivity.

A total of 87% of the patients in the exercise group said they achieved their target of 150 minutes per week of moderate-intensity exercise.

After 4 months, the exercise group showed significantly increased exercise capacity, reduced hemoglobin A_1c levels, decreased blood pressure, and lower concentrations of total and LDL cholesterol, whereas the control group did not. The exercise group also showed greater reductions in CRP and fibrinogen levels. Dr. Kadoglou reported receiving a grant from the Alexander S. Onassis Public Benefit Foundation.

A 4-month exercise program of moderate intensity improved the inflammatory milieu, including markers of atherosclerosis, in overweight, sedentary diabetic patients.

The exercise did not alter body weight or insulin resistance, but it significantly improved glycemic, lipid, and cardiorespiratory factors, reported Dr. Nikolaos P. E. Kadoglou of Hippokratio General Hospital of Thessaloniki (Greece) and his associates (Diabetes Metab. 2010 Feb. 9 [10.1016/j.diabet.2009.11.004

The researchers compared outcomes in 50 sedentary, overweight, white patients with type 2 diabetes who were aged between 50 and 65 years and whose glycemic control had failed to improve after they had followed a diet and taken oral antidiabetic drugs for at least 4 months. The study subjects were randomly assigned in equal numbers to an exercise program or a control group.

Subjects were instructed to perform 30–60 minutes of brisk walking at least 4 days per week, with no more than 2 consecutive days of inactivity.

A total of 87% of the patients in the exercise group said they achieved their target of 150 minutes per week of moderate-intensity exercise.

After 4 months, the exercise group showed significantly increased exercise capacity, reduced hemoglobin A_1c levels, decreased blood pressure, and lower concentrations of total and LDL cholesterol, whereas the control group did not. The exercise group also showed greater reductions in CRP and fibrinogen levels. Dr. Kadoglou reported receiving a grant from the Alexander S. Onassis Public Benefit Foundation.

A 4-month exercise program of moderate intensity improved the inflammatory milieu, including markers of atherosclerosis, in overweight, sedentary diabetic patients.

The exercise did not alter body weight or insulin resistance, but it significantly improved glycemic, lipid, and cardiorespiratory factors, reported Dr. Nikolaos P. E. Kadoglou of Hippokratio General Hospital of Thessaloniki (Greece) and his associates (Diabetes Metab. 2010 Feb. 9 [10.1016/j.diabet.2009.11.004

The researchers compared outcomes in 50 sedentary, overweight, white patients with type 2 diabetes who were aged between 50 and 65 years and whose glycemic control had failed to improve after they had followed a diet and taken oral antidiabetic drugs for at least 4 months. The study subjects were randomly assigned in equal numbers to an exercise program or a control group.

Subjects were instructed to perform 30–60 minutes of brisk walking at least 4 days per week, with no more than 2 consecutive days of inactivity.

A total of 87% of the patients in the exercise group said they achieved their target of 150 minutes per week of moderate-intensity exercise.

After 4 months, the exercise group showed significantly increased exercise capacity, reduced hemoglobin A_1c levels, decreased blood pressure, and lower concentrations of total and LDL cholesterol, whereas the control group did not. The exercise group also showed greater reductions in CRP and fibrinogen levels. Dr. Kadoglou reported receiving a grant from the Alexander S. Onassis Public Benefit Foundation.

Prophylactic aspirin therapy did not reduce vascular events in a study of people who had a low ankle-brachial index but no clinical evidence of cardiovascular disease, according to results of a randomized trial.

“This trial is the first to report on the effectiveness of aspirin in reducing major cardiovascular and cerebrovascular events in individuals from the general population who were free of clinical cardiovascular disease but at higher risk as identified by ABI screening,” said Dr. F. Gerald R. Fowkes of the University of Edinburgh and his associates in the Aspirin for Asymptomatic Atherosclerosis trial.

The randomized, double-blind trial involved 3,350 men and women aged 50–75 years when they were screened for a low (0.95 or lower) ankle-brachial index in 1998–2001. The subjects, all of whom were residents of central Scotland, had no clinical evidence of cardiovascular disease, but their low ABI put them at risk for coronary and cerebrovascular disease.

The study subjects were randomly assigned to receive 100 mg of enteric-coated aspirin or a placebo daily. They were followed at regular intervals for a mean of 8 years.

The primary end point—a composite of fatal or nonfatal coronary event, stroke, or revascularization procedure—was not statistically lower in subjects who took prophylactic aspirin (13.7 events per 1,000 person-years) than in those who took placebo (13.3 events per 1,000 person-years).

The secondary end point, which was angina, intermittent claudication, or transient ischemic attack in addition to the primary end point component, also did not differ between the intervention group (22.8 events per 1,000 person-years) and the placebo group (22.9 events per 1,000 person-years).

In addition, there was no significant difference in all-cause mortality between the aspirin group (12.8 deaths per 1,000 person-years) and the placebo group (13.5 deaths per 1,000 person-years).

“Although numbers were small, the trial results suggested an increased incidence of major hemorrhage and gastrointestinal ulcer, although not severe anemia, in the aspirin group, and more participants in the aspirin group than in the placebo group had fatal intracranial adverse events,” Dr. Fowkes and his colleagues wrote (JAMA 2010;303:841–8).

Given the hazard ratios and confidence intervals in the data, the study could not rule out the possibility that aspirin prophylaxis might reduce cardiovascular risk by a small degree (16%) in healthy people found to have a low ABI.

“However, extrapolating from the [nearly 29,000 people] screened for participation in our trial, a risk reduction of this order means that between 500 and 600 people from the general population would need to be screened and prescribed aspirin to prevent a single major cardiovascular event over an 8-year period,” they addd.

The British Heart Foundation and Chief Scientist's Office, Scotland funded the study. Bayer HealthCare provided the aspirin and placebo tablets as well as funds for packaging and dispensing the drugs and conducting some statistical analysis. Dr. Fowkes reported financial ties to Bayer HealthCare, Sanofi-Aventis, and Bristol-Myers Squibb.

There were 13.7 events per 1,000 person-years in patients who took aspirin vs. 13.3 events in those who took placebo.

Source ©jimdeli/Fotolia.com

Prophylactic aspirin therapy did not reduce vascular events in a study of people who had a low ankle-brachial index but no clinical evidence of cardiovascular disease, according to results of a randomized trial.

“This trial is the first to report on the effectiveness of aspirin in reducing major cardiovascular and cerebrovascular events in individuals from the general population who were free of clinical cardiovascular disease but at higher risk as identified by ABI screening,” said Dr. F. Gerald R. Fowkes of the University of Edinburgh and his associates in the Aspirin for Asymptomatic Atherosclerosis trial.

The randomized, double-blind trial involved 3,350 men and women aged 50–75 years when they were screened for a low (0.95 or lower) ankle-brachial index in 1998–2001. The subjects, all of whom were residents of central Scotland, had no clinical evidence of cardiovascular disease, but their low ABI put them at risk for coronary and cerebrovascular disease.

The study subjects were randomly assigned to receive 100 mg of enteric-coated aspirin or a placebo daily. They were followed at regular intervals for a mean of 8 years.

The primary end point—a composite of fatal or nonfatal coronary event, stroke, or revascularization procedure—was not statistically lower in subjects who took prophylactic aspirin (13.7 events per 1,000 person-years) than in those who took placebo (13.3 events per 1,000 person-years).

The secondary end point, which was angina, intermittent claudication, or transient ischemic attack in addition to the primary end point component, also did not differ between the intervention group (22.8 events per 1,000 person-years) and the placebo group (22.9 events per 1,000 person-years).

In addition, there was no significant difference in all-cause mortality between the aspirin group (12.8 deaths per 1,000 person-years) and the placebo group (13.5 deaths per 1,000 person-years).

“Although numbers were small, the trial results suggested an increased incidence of major hemorrhage and gastrointestinal ulcer, although not severe anemia, in the aspirin group, and more participants in the aspirin group than in the placebo group had fatal intracranial adverse events,” Dr. Fowkes and his colleagues wrote (JAMA 2010;303:841–8).

Given the hazard ratios and confidence intervals in the data, the study could not rule out the possibility that aspirin prophylaxis might reduce cardiovascular risk by a small degree (16%) in healthy people found to have a low ABI.

“However, extrapolating from the [nearly 29,000 people] screened for participation in our trial, a risk reduction of this order means that between 500 and 600 people from the general population would need to be screened and prescribed aspirin to prevent a single major cardiovascular event over an 8-year period,” they addd.

The British Heart Foundation and Chief Scientist's Office, Scotland funded the study. Bayer HealthCare provided the aspirin and placebo tablets as well as funds for packaging and dispensing the drugs and conducting some statistical analysis. Dr. Fowkes reported financial ties to Bayer HealthCare, Sanofi-Aventis, and Bristol-Myers Squibb.

There were 13.7 events per 1,000 person-years in patients who took aspirin vs. 13.3 events in those who took placebo.

Source ©jimdeli/Fotolia.com

Prophylactic aspirin therapy did not reduce vascular events in a study of people who had a low ankle-brachial index but no clinical evidence of cardiovascular disease, according to results of a randomized trial.

“This trial is the first to report on the effectiveness of aspirin in reducing major cardiovascular and cerebrovascular events in individuals from the general population who were free of clinical cardiovascular disease but at higher risk as identified by ABI screening,” said Dr. F. Gerald R. Fowkes of the University of Edinburgh and his associates in the Aspirin for Asymptomatic Atherosclerosis trial.

The randomized, double-blind trial involved 3,350 men and women aged 50–75 years when they were screened for a low (0.95 or lower) ankle-brachial index in 1998–2001. The subjects, all of whom were residents of central Scotland, had no clinical evidence of cardiovascular disease, but their low ABI put them at risk for coronary and cerebrovascular disease.

The study subjects were randomly assigned to receive 100 mg of enteric-coated aspirin or a placebo daily. They were followed at regular intervals for a mean of 8 years.

The primary end point—a composite of fatal or nonfatal coronary event, stroke, or revascularization procedure—was not statistically lower in subjects who took prophylactic aspirin (13.7 events per 1,000 person-years) than in those who took placebo (13.3 events per 1,000 person-years).

The secondary end point, which was angina, intermittent claudication, or transient ischemic attack in addition to the primary end point component, also did not differ between the intervention group (22.8 events per 1,000 person-years) and the placebo group (22.9 events per 1,000 person-years).

In addition, there was no significant difference in all-cause mortality between the aspirin group (12.8 deaths per 1,000 person-years) and the placebo group (13.5 deaths per 1,000 person-years).

“Although numbers were small, the trial results suggested an increased incidence of major hemorrhage and gastrointestinal ulcer, although not severe anemia, in the aspirin group, and more participants in the aspirin group than in the placebo group had fatal intracranial adverse events,” Dr. Fowkes and his colleagues wrote (JAMA 2010;303:841–8).

Given the hazard ratios and confidence intervals in the data, the study could not rule out the possibility that aspirin prophylaxis might reduce cardiovascular risk by a small degree (16%) in healthy people found to have a low ABI.

“However, extrapolating from the [nearly 29,000 people] screened for participation in our trial, a risk reduction of this order means that between 500 and 600 people from the general population would need to be screened and prescribed aspirin to prevent a single major cardiovascular event over an 8-year period,” they addd.

The British Heart Foundation and Chief Scientist's Office, Scotland funded the study. Bayer HealthCare provided the aspirin and placebo tablets as well as funds for packaging and dispensing the drugs and conducting some statistical analysis. Dr. Fowkes reported financial ties to Bayer HealthCare, Sanofi-Aventis, and Bristol-Myers Squibb.

There were 13.7 events per 1,000 person-years in patients who took aspirin vs. 13.3 events in those who took placebo.

Source ©jimdeli/Fotolia.com

The use of medical technology has grown dramatically over the last decade, according to the federal government's annual health report.

That's just one finding in the massive “Health, United States, 2009,” a snapshot of Americans' health, which the Centers for Disease Control and Prevention compiles yearly as “an essential step in making sound health policy and setting research and program priorities.”

This year's edition, the 33rd, includes a special section on medical technology, which includes procedures, tests, drugs, devices, and support systems such as computerized records. The principal findings in this section include:

▸ The use of MRI, CT, and PET imaging soared during the past decade. The number of such imaging studies either ordered or provided by physician offices and hospital outpatient departments more than tripled; those ordered or provided by emergency departments quadrupled.

▸ The rate of knee replacement surgery performed in patients aged 45 years and older rose 70% during the same interval, from 26 to 45 per 10,000 population. The rate of total hip replacement surgery increased by 33%, and that of partial hip replacements increased by 60%.

▸ The rate of angioplasty without stent placement declined by 80% during the past decade. Drug-eluting stents have rapidly replaced bare-metal stents and were used in 75% of angioplasties in 2006.

▸ The number of assisted reproductive technology cycles doubled during the past decade, with the fastest rate of growth occurring in women older than 40 (11% per year).

▸ The rate of outpatient upper endoscopies rose by 90%, and the rate of outpatient colonoscopy tripled during the same interval.

▸ The use of diabetes drugs among patients aged 45 and older increased approximately 50%, and that of statins soared 10-fold in the past decade.

▸ The percentage of people taking at least one prescription drug during the preceding month rose from 38% in the 1980s and 1990s to 47% in recent years. The percentage taking three or more prescription drugs increased from 11% to 21% during that time.

The report also detailed trends in mortality. Both life expectancy and infant mortality have been improving but continue to lag behind levels found in most developed countries. Infant mortality in the United States is now 27% lower than it was in 1990.

American men now can expect to live 3.5 years longer, and women can expect to live 1.6 years longer, than they did in 1990. Overall U.S. life expectancy was 77.9 years in 2007, a record high.

Life expectancy increased more among blacks than among whites, but a gap between the races persists. In 1990, life expectancy for whites was 7 years longer than that for blacks; by 2007, that gap narrowed to 4.6 years.

Mortality from heart disease, stroke, and cancer continues to decline, while mortality from chronic respiratory diseases and unintentional injuries has remained stable. The leading cause of death for people aged 1-44 years is unintentional injuries; for people aged 45-64 years, cancer; and for people aged 65 and older, heart disease.

With regard to chronic physical, mental, or emotional conditions, the report noted that the proportion of working-age adults who reported that a chronic condition limited their activity has remained steady at approximately 10%. Arthritis and other musculoskeletal disorders were the most frequent causes of such limitations in adults.

Mental illness was the second-leading cause of limitation due to chronic conditions in adults aged 18-44 years; heart and circulatory disorders were the second-leading cause in older adults, but mental illness was frequently cited in this age group as well.

In adolescents, mental, emotional, or behavioral problems were frequently cited as chronic conditions that limited activity.

The full report is available at www.cdc.gov/nchs/hus.htm

The use of medical technology has grown dramatically over the last decade, according to the federal government's annual health report.

That's just one finding in the massive “Health, United States, 2009,” a snapshot of Americans' health, which the Centers for Disease Control and Prevention compiles yearly as “an essential step in making sound health policy and setting research and program priorities.”

This year's edition, the 33rd, includes a special section on medical technology, which includes procedures, tests, drugs, devices, and support systems such as computerized records. The principal findings in this section include:

▸ The use of MRI, CT, and PET imaging soared during the past decade. The number of such imaging studies either ordered or provided by physician offices and hospital outpatient departments more than tripled; those ordered or provided by emergency departments quadrupled.

▸ The rate of knee replacement surgery performed in patients aged 45 years and older rose 70% during the same interval, from 26 to 45 per 10,000 population. The rate of total hip replacement surgery increased by 33%, and that of partial hip replacements increased by 60%.

▸ The rate of angioplasty without stent placement declined by 80% during the past decade. Drug-eluting stents have rapidly replaced bare-metal stents and were used in 75% of angioplasties in 2006.

▸ The number of assisted reproductive technology cycles doubled during the past decade, with the fastest rate of growth occurring in women older than 40 (11% per year).

▸ The rate of outpatient upper endoscopies rose by 90%, and the rate of outpatient colonoscopy tripled during the same interval.

▸ The use of diabetes drugs among patients aged 45 and older increased approximately 50%, and that of statins soared 10-fold in the past decade.

▸ The percentage of people taking at least one prescription drug during the preceding month rose from 38% in the 1980s and 1990s to 47% in recent years. The percentage taking three or more prescription drugs increased from 11% to 21% during that time.

The report also detailed trends in mortality. Both life expectancy and infant mortality have been improving but continue to lag behind levels found in most developed countries. Infant mortality in the United States is now 27% lower than it was in 1990.

American men now can expect to live 3.5 years longer, and women can expect to live 1.6 years longer, than they did in 1990. Overall U.S. life expectancy was 77.9 years in 2007, a record high.

Life expectancy increased more among blacks than among whites, but a gap between the races persists. In 1990, life expectancy for whites was 7 years longer than that for blacks; by 2007, that gap narrowed to 4.6 years.

Mortality from heart disease, stroke, and cancer continues to decline, while mortality from chronic respiratory diseases and unintentional injuries has remained stable. The leading cause of death for people aged 1-44 years is unintentional injuries; for people aged 45-64 years, cancer; and for people aged 65 and older, heart disease.

With regard to chronic physical, mental, or emotional conditions, the report noted that the proportion of working-age adults who reported that a chronic condition limited their activity has remained steady at approximately 10%. Arthritis and other musculoskeletal disorders were the most frequent causes of such limitations in adults.

Mental illness was the second-leading cause of limitation due to chronic conditions in adults aged 18-44 years; heart and circulatory disorders were the second-leading cause in older adults, but mental illness was frequently cited in this age group as well.

In adolescents, mental, emotional, or behavioral problems were frequently cited as chronic conditions that limited activity.

The full report is available at www.cdc.gov/nchs/hus.htm

The use of medical technology has grown dramatically over the last decade, according to the federal government's annual health report.

That's just one finding in the massive “Health, United States, 2009,” a snapshot of Americans' health, which the Centers for Disease Control and Prevention compiles yearly as “an essential step in making sound health policy and setting research and program priorities.”

This year's edition, the 33rd, includes a special section on medical technology, which includes procedures, tests, drugs, devices, and support systems such as computerized records. The principal findings in this section include:

▸ The use of MRI, CT, and PET imaging soared during the past decade. The number of such imaging studies either ordered or provided by physician offices and hospital outpatient departments more than tripled; those ordered or provided by emergency departments quadrupled.

▸ The rate of knee replacement surgery performed in patients aged 45 years and older rose 70% during the same interval, from 26 to 45 per 10,000 population. The rate of total hip replacement surgery increased by 33%, and that of partial hip replacements increased by 60%.

▸ The rate of angioplasty without stent placement declined by 80% during the past decade. Drug-eluting stents have rapidly replaced bare-metal stents and were used in 75% of angioplasties in 2006.

▸ The number of assisted reproductive technology cycles doubled during the past decade, with the fastest rate of growth occurring in women older than 40 (11% per year).

▸ The rate of outpatient upper endoscopies rose by 90%, and the rate of outpatient colonoscopy tripled during the same interval.

▸ The use of diabetes drugs among patients aged 45 and older increased approximately 50%, and that of statins soared 10-fold in the past decade.

▸ The percentage of people taking at least one prescription drug during the preceding month rose from 38% in the 1980s and 1990s to 47% in recent years. The percentage taking three or more prescription drugs increased from 11% to 21% during that time.

The report also detailed trends in mortality. Both life expectancy and infant mortality have been improving but continue to lag behind levels found in most developed countries. Infant mortality in the United States is now 27% lower than it was in 1990.

American men now can expect to live 3.5 years longer, and women can expect to live 1.6 years longer, than they did in 1990. Overall U.S. life expectancy was 77.9 years in 2007, a record high.

Life expectancy increased more among blacks than among whites, but a gap between the races persists. In 1990, life expectancy for whites was 7 years longer than that for blacks; by 2007, that gap narrowed to 4.6 years.

Mortality from heart disease, stroke, and cancer continues to decline, while mortality from chronic respiratory diseases and unintentional injuries has remained stable. The leading cause of death for people aged 1-44 years is unintentional injuries; for people aged 45-64 years, cancer; and for people aged 65 and older, heart disease.

With regard to chronic physical, mental, or emotional conditions, the report noted that the proportion of working-age adults who reported that a chronic condition limited their activity has remained steady at approximately 10%. Arthritis and other musculoskeletal disorders were the most frequent causes of such limitations in adults.

Mental illness was the second-leading cause of limitation due to chronic conditions in adults aged 18-44 years; heart and circulatory disorders were the second-leading cause in older adults, but mental illness was frequently cited in this age group as well.

In adolescents, mental, emotional, or behavioral problems were frequently cited as chronic conditions that limited activity.

The full report is available at www.cdc.gov/nchs/hus.htm

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to a recent report.

Although the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid-1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad-based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical work weeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical workforce, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults. They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977-1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

Disclosures: This study was supported by the National Institutes of Health. No financial conflicts of interest were reported.

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to a recent report.

Although the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid-1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad-based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical work weeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical workforce, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults. They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977-1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

Disclosures: This study was supported by the National Institutes of Health. No financial conflicts of interest were reported.

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to a recent report.

Although the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid-1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad-based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical work weeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical workforce, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults. They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977-1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

Disclosures: This study was supported by the National Institutes of Health. No financial conflicts of interest were reported.

Oral ivermectin was found superior to malathion lotion in eliminating persistent head lice infestation in a study of children and their household contacts, according to a report in the March 11 issue of the New England Journal of Medicine.

“Ivermectin may be a good alternative to malathion when topical insecticide resistance is suspected,” said Dr. Olivier Chosidow of the Université Pierre et Marie Curie, Paris, and his associates.

Resistance of head lice to both pyrethroids and malathion appears to be increasing. Ivermectin has been used to treat onchocerciasis, lymphatic filariasis, helminthiases, and ectoparasite infections such as scabies.

Dr. Chosidow and his colleagues assessed the efficacy and safety of ivermectin against head lice in a randomized, double-blind controlled trial of patients recruited from the community who had persistent infestation despite using topical pyrethroid-based or malathion insecticide.

The study involved 812 children and their contacts in 376 households in the United Kingdom, Ireland, France, and Israel. The study households were randomly assigned to receive either active oral ivermectin plus a placebo lotion (185 households and 398 patients) or active malathion lotion plus a placebo tablet (191 households and 414 patients) to ensure blinding to treatment assignment. The medications were given by trained staff at clinics to ensure that they were used properly.

After two treatments, given 1 week apart, any patients who still had head lice infestation were switched to the alternative treatment.

The primary end point – clearance of head lice infestation on day 15 after the first two treatments – was achieved in more than 95% of the ivermectin patients, compared with 85% of the malathion patients. A total of 92% of households in the ivermectin group were cleared of head lice, compared with 79% of households in the malathion group.

Seventy patients with persistent infestation switched to the alternative treatment. After another 2 weeks, 100% of the patients using malathion and 97% of those using ivermectin achieved clearance of head lice, the investigators said (N. Engl. J. Med. 2010;362:896-905).

Seven patients in the ivermectin group (1.8%) and five in the malathion group (1.2%) discontinued treatment because of adverse effects, including impetigo, nausea or vomiting, gastroenteritis, and rash or urticaria.

Two serious adverse events occurred: One girl taking ivermectin developed seizures 6 days after the first dose, and one girl taking malathion developed a severe headache requiring hospitalization 6 days after the first application. Both girls recovered. The seizure was found to have a right rolandic focus, and the patient was given a prescription for oxcarbazepine.

The study was funded by Johnson & Johnson–Merck Sharp & Dohme–Chibret. Dr. Chosidow reported receiving consulting fees from Laboratoires Pierre Fabre and Johnson & Johnson, and lecture fees from Pohl Boskamp.

_{(Image Copyright: CDC/Reed and Carnrick Pharmaceuticals)}

Oral ivermectin was found superior to malathion lotion in eliminating persistent head lice infestation in a study of children and their household contacts, according to a report in the March 11 issue of the New England Journal of Medicine.

“Ivermectin may be a good alternative to malathion when topical insecticide resistance is suspected,” said Dr. Olivier Chosidow of the Université Pierre et Marie Curie, Paris, and his associates.

Resistance of head lice to both pyrethroids and malathion appears to be increasing. Ivermectin has been used to treat onchocerciasis, lymphatic filariasis, helminthiases, and ectoparasite infections such as scabies.

Dr. Chosidow and his colleagues assessed the efficacy and safety of ivermectin against head lice in a randomized, double-blind controlled trial of patients recruited from the community who had persistent infestation despite using topical pyrethroid-based or malathion insecticide.

The study involved 812 children and their contacts in 376 households in the United Kingdom, Ireland, France, and Israel. The study households were randomly assigned to receive either active oral ivermectin plus a placebo lotion (185 households and 398 patients) or active malathion lotion plus a placebo tablet (191 households and 414 patients) to ensure blinding to treatment assignment. The medications were given by trained staff at clinics to ensure that they were used properly.

After two treatments, given 1 week apart, any patients who still had head lice infestation were switched to the alternative treatment.

The primary end point – clearance of head lice infestation on day 15 after the first two treatments – was achieved in more than 95% of the ivermectin patients, compared with 85% of the malathion patients. A total of 92% of households in the ivermectin group were cleared of head lice, compared with 79% of households in the malathion group.

Seventy patients with persistent infestation switched to the alternative treatment. After another 2 weeks, 100% of the patients using malathion and 97% of those using ivermectin achieved clearance of head lice, the investigators said (N. Engl. J. Med. 2010;362:896-905).

Seven patients in the ivermectin group (1.8%) and five in the malathion group (1.2%) discontinued treatment because of adverse effects, including impetigo, nausea or vomiting, gastroenteritis, and rash or urticaria.

Two serious adverse events occurred: One girl taking ivermectin developed seizures 6 days after the first dose, and one girl taking malathion developed a severe headache requiring hospitalization 6 days after the first application. Both girls recovered. The seizure was found to have a right rolandic focus, and the patient was given a prescription for oxcarbazepine.

The study was funded by Johnson & Johnson–Merck Sharp & Dohme–Chibret. Dr. Chosidow reported receiving consulting fees from Laboratoires Pierre Fabre and Johnson & Johnson, and lecture fees from Pohl Boskamp.

_{(Image Copyright: CDC/Reed and Carnrick Pharmaceuticals)}

Oral ivermectin was found superior to malathion lotion in eliminating persistent head lice infestation in a study of children and their household contacts, according to a report in the March 11 issue of the New England Journal of Medicine.

“Ivermectin may be a good alternative to malathion when topical insecticide resistance is suspected,” said Dr. Olivier Chosidow of the Université Pierre et Marie Curie, Paris, and his associates.

Resistance of head lice to both pyrethroids and malathion appears to be increasing. Ivermectin has been used to treat onchocerciasis, lymphatic filariasis, helminthiases, and ectoparasite infections such as scabies.

Dr. Chosidow and his colleagues assessed the efficacy and safety of ivermectin against head lice in a randomized, double-blind controlled trial of patients recruited from the community who had persistent infestation despite using topical pyrethroid-based or malathion insecticide.

The study involved 812 children and their contacts in 376 households in the United Kingdom, Ireland, France, and Israel. The study households were randomly assigned to receive either active oral ivermectin plus a placebo lotion (185 households and 398 patients) or active malathion lotion plus a placebo tablet (191 households and 414 patients) to ensure blinding to treatment assignment. The medications were given by trained staff at clinics to ensure that they were used properly.

After two treatments, given 1 week apart, any patients who still had head lice infestation were switched to the alternative treatment.

The primary end point – clearance of head lice infestation on day 15 after the first two treatments – was achieved in more than 95% of the ivermectin patients, compared with 85% of the malathion patients. A total of 92% of households in the ivermectin group were cleared of head lice, compared with 79% of households in the malathion group.

Seventy patients with persistent infestation switched to the alternative treatment. After another 2 weeks, 100% of the patients using malathion and 97% of those using ivermectin achieved clearance of head lice, the investigators said (N. Engl. J. Med. 2010;362:896-905).

Seven patients in the ivermectin group (1.8%) and five in the malathion group (1.2%) discontinued treatment because of adverse effects, including impetigo, nausea or vomiting, gastroenteritis, and rash or urticaria.

Two serious adverse events occurred: One girl taking ivermectin developed seizures 6 days after the first dose, and one girl taking malathion developed a severe headache requiring hospitalization 6 days after the first application. Both girls recovered. The seizure was found to have a right rolandic focus, and the patient was given a prescription for oxcarbazepine.

The study was funded by Johnson & Johnson–Merck Sharp & Dohme–Chibret. Dr. Chosidow reported receiving consulting fees from Laboratoires Pierre Fabre and Johnson & Johnson, and lecture fees from Pohl Boskamp.

_{(Image Copyright: CDC/Reed and Carnrick Pharmaceuticals)}

A review of the recent literature confirms that “comparative effectiveness” research – studies designed to help physicians use existing treatments and treatment strategies more effectively – is severely lacking.

According to a report in the March 10 issue of JAMA, fewer than a third of the studies published in the six top journals covering general and internal medicine qualified as comparative effectiveness (CE) research. This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Massachusetts) Health Alliance and Harvard Medical School, Boston.

Noting that few data are available on the current status of CE research, Dr. Hochman and Dr. McCormick reviewed all clinical studies assessing medications that were published between June 2008 and October 2009 in the six “highest impact” medical journals: New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine.

These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951-8).

Of the 328 randomized trials, observational studies, or meta-analyses involving medications that were included in the analysis, only 104 (32%) were CE studies.

Only 11% of the CE studies compared medications with nonpharmacologic treatments, confirming that there is a relative lack of such research. CE studies that compare medications with nonpharmacologic interventions are particularly important because they help clinicians “make fundamental therapeutic decisions,” Dr. Hochman and Dr. McCormick said.

Nearly 90% of the CE studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is. “Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results.

In addition, 24% of the randomized trials that did use an active comparator sought to demonstrate only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Only 19% of the CE studies focused on patient safety, which implies that safety concerns are not adequately emphasized in medication studies.

Only 2% of the CE studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care. This absence may reflect policies or editorial priorities of journal editors favoring publication of clinical outcome reports rather than a true dearth of cost-effectiveness studies,” the investigators said.

In the United States, Congress recently passed legislation to provide more than $1 billion to support CE studies, and President Barack Obama’s budget for 2011 recommends further funding dedicated to CE research.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for CE studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

The investigators reported no financial conflicts of interest.

A review of the recent literature confirms that “comparative effectiveness” research – studies designed to help physicians use existing treatments and treatment strategies more effectively – is severely lacking.

According to a report in the March 10 issue of JAMA, fewer than a third of the studies published in the six top journals covering general and internal medicine qualified as comparative effectiveness (CE) research. This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Massachusetts) Health Alliance and Harvard Medical School, Boston.

Noting that few data are available on the current status of CE research, Dr. Hochman and Dr. McCormick reviewed all clinical studies assessing medications that were published between June 2008 and October 2009 in the six “highest impact” medical journals: New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine.

These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951-8).

Of the 328 randomized trials, observational studies, or meta-analyses involving medications that were included in the analysis, only 104 (32%) were CE studies.

Only 11% of the CE studies compared medications with nonpharmacologic treatments, confirming that there is a relative lack of such research. CE studies that compare medications with nonpharmacologic interventions are particularly important because they help clinicians “make fundamental therapeutic decisions,” Dr. Hochman and Dr. McCormick said.

Nearly 90% of the CE studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is. “Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results.

In addition, 24% of the randomized trials that did use an active comparator sought to demonstrate only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Only 19% of the CE studies focused on patient safety, which implies that safety concerns are not adequately emphasized in medication studies.

Only 2% of the CE studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care. This absence may reflect policies or editorial priorities of journal editors favoring publication of clinical outcome reports rather than a true dearth of cost-effectiveness studies,” the investigators said.

In the United States, Congress recently passed legislation to provide more than $1 billion to support CE studies, and President Barack Obama’s budget for 2011 recommends further funding dedicated to CE research.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for CE studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

The investigators reported no financial conflicts of interest.

A review of the recent literature confirms that “comparative effectiveness” research – studies designed to help physicians use existing treatments and treatment strategies more effectively – is severely lacking.

According to a report in the March 10 issue of JAMA, fewer than a third of the studies published in the six top journals covering general and internal medicine qualified as comparative effectiveness (CE) research. This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Massachusetts) Health Alliance and Harvard Medical School, Boston.

Noting that few data are available on the current status of CE research, Dr. Hochman and Dr. McCormick reviewed all clinical studies assessing medications that were published between June 2008 and October 2009 in the six “highest impact” medical journals: New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine.

These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951-8).

Of the 328 randomized trials, observational studies, or meta-analyses involving medications that were included in the analysis, only 104 (32%) were CE studies.

Only 11% of the CE studies compared medications with nonpharmacologic treatments, confirming that there is a relative lack of such research. CE studies that compare medications with nonpharmacologic interventions are particularly important because they help clinicians “make fundamental therapeutic decisions,” Dr. Hochman and Dr. McCormick said.

Nearly 90% of the CE studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is. “Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results.

In addition, 24% of the randomized trials that did use an active comparator sought to demonstrate only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Only 19% of the CE studies focused on patient safety, which implies that safety concerns are not adequately emphasized in medication studies.

Only 2% of the CE studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care. This absence may reflect policies or editorial priorities of journal editors favoring publication of clinical outcome reports rather than a true dearth of cost-effectiveness studies,” the investigators said.

In the United States, Congress recently passed legislation to provide more than $1 billion to support CE studies, and President Barack Obama’s budget for 2011 recommends further funding dedicated to CE research.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for CE studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

The investigators reported no financial conflicts of interest.

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to an analysis of employment data.

While the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid 1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad-based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical work weeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical work force, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults.

They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977–1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

The study was supported by the National Institutes of Health. No financial conflicts of interest were reported.

A downward trend in work hours will affect physician supply and health care policy.

Source ©Udo Kroener/Fotolia.com

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to an analysis of employment data.

While the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid 1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad-based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical work weeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical work force, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults.

They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977–1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

The study was supported by the National Institutes of Health. No financial conflicts of interest were reported.

A downward trend in work hours will affect physician supply and health care policy.

Source ©Udo Kroener/Fotolia.com

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to an analysis of employment data.

While the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid 1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad-based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical work weeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical work force, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults.

They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977–1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

The study was supported by the National Institutes of Health. No financial conflicts of interest were reported.

A downward trend in work hours will affect physician supply and health care policy.

Source ©Udo Kroener/Fotolia.com

Major Finding: After 5 years, lasofoxifene reduced the risk of vertebral and nonvertebral fractures by 9.3 cases per 1,000 person-years (HR 0.58) and 5.8 cases per 1,000 person-years (HR 0.76), respectively, compared with placebo.

Data Source: The PEARL study, which randomized 8,556 postmenopausal women with osteoporosis to receive lasofoxifene or placebo for 5 years.

Disclosures: Dr. Cummings has received consulting fees from Amgen, Eli Lilly, GlaxoSmithKline, and Organon, lecture fees from Eli Lilly and Novartis, and grant support from Amgen, Pfizer, and Eli Lilly.

The investigational drug lasofoxifene decreased the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis in a large, randomized, placebo-controlled trial.

The nonsteroidal selective estrogen-receptor modulator (SERM) also reduces the risk of ER-positive breast cancer, major coronary heart disease events, and stroke without raising the risk of endometrial cancer or hyperplasia. Like other SERMs, lasofoxifene raises the risk of venous thromboembolism and increases the rate of hot flushes and leg cramps, wrote Dr. Steven R. Cummings of California Pacific Medical Center Research Institute, San Francisco, and his associates in the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) study.

Taken together, these findings seem to indicate that lasofoxifene performs somewhat better than do other SERMs such as raloxifene, and also has advantages over hormone therapy, tamoxifen, and tibolone. However, in an editorial accompanying this report, Dr. Carolyn Becker of the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital, Boston, argued that the drug “offers no major clinically important benefits over raloxifene for the skeleton, breast, heart, or reproductive tract.

“Given the plethora of drugs currently available for osteoporosis, studies of new agents should show clear benefits over existing agents,” she wrote. Results of the PEARL study do not do so, Dr. Becker added.

Dr. Cummings and his colleagues performed the international, randomized, placebo-controlled PEARL study in 8,556 women aged 59–80 years who had a bone mineral density T score of −2.5 or less at the lumbar spine or femoral neck. A total of 28% already had at least one vertebral fracture at baseline.

After 5 years of follow-up, women who received 0.5 mg per day of lasofoxifene showed a 42% reduction in relative risk for vertebral fractures and a 24% reduction in relative risk for nonvertebral fractures, compared with those who received placebo. Bone density at the lumbar spine, femoral neck, and total hip improved by about 3% with the active drug, the investigators said (N. Engl. J. Med. 2010;362;686-96).

This decrease in risk of vertebral fractures is comparable with that reported in women taking raloxifene, estrogen therapy, oral bisphosphonates, and tibolone. The decrease in risk of nonvertebral fractures also is similar to that observed in women taking other antiresorptive therapies, and it stands in contrast to raloxifene's inability to reduce this risk, they said.

However, Dr. Becker noted in her editorial that nearly all the reduction in risk for nonvertebral fractures could be attributed to forearm and wrist fractures. “A significant effect in the overall group was not evident until 5 years, and absolute risk reductions were very small.

“On balance, lasofoxifene seems to offer little, if any, advantage over raloxifene as an agent against osteoporosis,” she said (N. Engl. J. Med. 2010;362;752-4).

Lasofoxifene also reduced the risk of ER-positive breast cancer by 85%, compared with placebo. Although this finding is “impressive,” it is similar to the risk reduction reported for raloxifene, Dr. Becker added.

Lasofoxifene was associated with a 32% reduction in relative risk of coronary heart disease events (5.1 cases per 1,000 person-years) and a 36% reduction in relative risk of stroke (2.5 cases per 1,000 person-years), compared with placebo (7.5 and 3.9 cases per 1,000 person-years, respectively), Dr. Cummings and his associates said.

However, Dr. Becker noted that the number of these events was quite small, and there were no differences in rates of fatal stroke. “Although the cardiovascular benefits reported in the PEARL trial seem impressive, one would need to treat 492 patients for 1 year to prevent a single major coronary event,” she said.

The PEARL investigators said that lasofoxifene raised the risk of venous thromboembolism to a similar degree as do raloxifene, tamoxifen, and oral estrogen therapies. Like these agents, lasofoxifene also significantly increased the rate of hot flushes and leg cramps. It did not raise the risk of endometrial cancer or endometrial hyperplasia.

Dr. Becker countered that although the increase in absolute risk of venous thromboembolism was small, lasofoxifene more than doubled the relative risk. In addition, rates of uterine polyps, endometrial hypertrophy, and vaginal candidiasis all were significantly higher than with placebo, she said.

The PEARL study was funded by Pfizer, manufacturer of lasofoxifene. Pfizer submitted a new drug application to the Food and Drug Administration in 2007, and in 2008 an advisory panel voted 9–3 that the benefits of the SERM outweighed this risk in postmenopausal women with osteoporosis. The FDA has not yet issued a decision.

Dr. Becker's financial disclosures are available with the text of the article at www.NEJM.org

Major Finding: After 5 years, lasofoxifene reduced the risk of vertebral and nonvertebral fractures by 9.3 cases per 1,000 person-years (HR 0.58) and 5.8 cases per 1,000 person-years (HR 0.76), respectively, compared with placebo.

Data Source: The PEARL study, which randomized 8,556 postmenopausal women with osteoporosis to receive lasofoxifene or placebo for 5 years.

Disclosures: Dr. Cummings has received consulting fees from Amgen, Eli Lilly, GlaxoSmithKline, and Organon, lecture fees from Eli Lilly and Novartis, and grant support from Amgen, Pfizer, and Eli Lilly.

The investigational drug lasofoxifene decreased the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis in a large, randomized, placebo-controlled trial.

The nonsteroidal selective estrogen-receptor modulator (SERM) also reduces the risk of ER-positive breast cancer, major coronary heart disease events, and stroke without raising the risk of endometrial cancer or hyperplasia. Like other SERMs, lasofoxifene raises the risk of venous thromboembolism and increases the rate of hot flushes and leg cramps, wrote Dr. Steven R. Cummings of California Pacific Medical Center Research Institute, San Francisco, and his associates in the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) study.

Taken together, these findings seem to indicate that lasofoxifene performs somewhat better than do other SERMs such as raloxifene, and also has advantages over hormone therapy, tamoxifen, and tibolone. However, in an editorial accompanying this report, Dr. Carolyn Becker of the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital, Boston, argued that the drug “offers no major clinically important benefits over raloxifene for the skeleton, breast, heart, or reproductive tract.

“Given the plethora of drugs currently available for osteoporosis, studies of new agents should show clear benefits over existing agents,” she wrote. Results of the PEARL study do not do so, Dr. Becker added.

Dr. Cummings and his colleagues performed the international, randomized, placebo-controlled PEARL study in 8,556 women aged 59–80 years who had a bone mineral density T score of −2.5 or less at the lumbar spine or femoral neck. A total of 28% already had at least one vertebral fracture at baseline.

After 5 years of follow-up, women who received 0.5 mg per day of lasofoxifene showed a 42% reduction in relative risk for vertebral fractures and a 24% reduction in relative risk for nonvertebral fractures, compared with those who received placebo. Bone density at the lumbar spine, femoral neck, and total hip improved by about 3% with the active drug, the investigators said (N. Engl. J. Med. 2010;362;686-96).

This decrease in risk of vertebral fractures is comparable with that reported in women taking raloxifene, estrogen therapy, oral bisphosphonates, and tibolone. The decrease in risk of nonvertebral fractures also is similar to that observed in women taking other antiresorptive therapies, and it stands in contrast to raloxifene's inability to reduce this risk, they said.

However, Dr. Becker noted in her editorial that nearly all the reduction in risk for nonvertebral fractures could be attributed to forearm and wrist fractures. “A significant effect in the overall group was not evident until 5 years, and absolute risk reductions were very small.

“On balance, lasofoxifene seems to offer little, if any, advantage over raloxifene as an agent against osteoporosis,” she said (N. Engl. J. Med. 2010;362;752-4).

Lasofoxifene also reduced the risk of ER-positive breast cancer by 85%, compared with placebo. Although this finding is “impressive,” it is similar to the risk reduction reported for raloxifene, Dr. Becker added.

Lasofoxifene was associated with a 32% reduction in relative risk of coronary heart disease events (5.1 cases per 1,000 person-years) and a 36% reduction in relative risk of stroke (2.5 cases per 1,000 person-years), compared with placebo (7.5 and 3.9 cases per 1,000 person-years, respectively), Dr. Cummings and his associates said.

However, Dr. Becker noted that the number of these events was quite small, and there were no differences in rates of fatal stroke. “Although the cardiovascular benefits reported in the PEARL trial seem impressive, one would need to treat 492 patients for 1 year to prevent a single major coronary event,” she said.

The PEARL investigators said that lasofoxifene raised the risk of venous thromboembolism to a similar degree as do raloxifene, tamoxifen, and oral estrogen therapies. Like these agents, lasofoxifene also significantly increased the rate of hot flushes and leg cramps. It did not raise the risk of endometrial cancer or endometrial hyperplasia.

Dr. Becker countered that although the increase in absolute risk of venous thromboembolism was small, lasofoxifene more than doubled the relative risk. In addition, rates of uterine polyps, endometrial hypertrophy, and vaginal candidiasis all were significantly higher than with placebo, she said.

The PEARL study was funded by Pfizer, manufacturer of lasofoxifene. Pfizer submitted a new drug application to the Food and Drug Administration in 2007, and in 2008 an advisory panel voted 9–3 that the benefits of the SERM outweighed this risk in postmenopausal women with osteoporosis. The FDA has not yet issued a decision.

Dr. Becker's financial disclosures are available with the text of the article at www.NEJM.org

Major Finding: After 5 years, lasofoxifene reduced the risk of vertebral and nonvertebral fractures by 9.3 cases per 1,000 person-years (HR 0.58) and 5.8 cases per 1,000 person-years (HR 0.76), respectively, compared with placebo.

Data Source: The PEARL study, which randomized 8,556 postmenopausal women with osteoporosis to receive lasofoxifene or placebo for 5 years.

Disclosures: Dr. Cummings has received consulting fees from Amgen, Eli Lilly, GlaxoSmithKline, and Organon, lecture fees from Eli Lilly and Novartis, and grant support from Amgen, Pfizer, and Eli Lilly.

The investigational drug lasofoxifene decreased the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis in a large, randomized, placebo-controlled trial.

The nonsteroidal selective estrogen-receptor modulator (SERM) also reduces the risk of ER-positive breast cancer, major coronary heart disease events, and stroke without raising the risk of endometrial cancer or hyperplasia. Like other SERMs, lasofoxifene raises the risk of venous thromboembolism and increases the rate of hot flushes and leg cramps, wrote Dr. Steven R. Cummings of California Pacific Medical Center Research Institute, San Francisco, and his associates in the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) study.

Taken together, these findings seem to indicate that lasofoxifene performs somewhat better than do other SERMs such as raloxifene, and also has advantages over hormone therapy, tamoxifen, and tibolone. However, in an editorial accompanying this report, Dr. Carolyn Becker of the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital, Boston, argued that the drug “offers no major clinically important benefits over raloxifene for the skeleton, breast, heart, or reproductive tract.

“Given the plethora of drugs currently available for osteoporosis, studies of new agents should show clear benefits over existing agents,” she wrote. Results of the PEARL study do not do so, Dr. Becker added.

Dr. Cummings and his colleagues performed the international, randomized, placebo-controlled PEARL study in 8,556 women aged 59–80 years who had a bone mineral density T score of −2.5 or less at the lumbar spine or femoral neck. A total of 28% already had at least one vertebral fracture at baseline.

After 5 years of follow-up, women who received 0.5 mg per day of lasofoxifene showed a 42% reduction in relative risk for vertebral fractures and a 24% reduction in relative risk for nonvertebral fractures, compared with those who received placebo. Bone density at the lumbar spine, femoral neck, and total hip improved by about 3% with the active drug, the investigators said (N. Engl. J. Med. 2010;362;686-96).

This decrease in risk of vertebral fractures is comparable with that reported in women taking raloxifene, estrogen therapy, oral bisphosphonates, and tibolone. The decrease in risk of nonvertebral fractures also is similar to that observed in women taking other antiresorptive therapies, and it stands in contrast to raloxifene's inability to reduce this risk, they said.

However, Dr. Becker noted in her editorial that nearly all the reduction in risk for nonvertebral fractures could be attributed to forearm and wrist fractures. “A significant effect in the overall group was not evident until 5 years, and absolute risk reductions were very small.

“On balance, lasofoxifene seems to offer little, if any, advantage over raloxifene as an agent against osteoporosis,” she said (N. Engl. J. Med. 2010;362;752-4).

Lasofoxifene also reduced the risk of ER-positive breast cancer by 85%, compared with placebo. Although this finding is “impressive,” it is similar to the risk reduction reported for raloxifene, Dr. Becker added.

Lasofoxifene was associated with a 32% reduction in relative risk of coronary heart disease events (5.1 cases per 1,000 person-years) and a 36% reduction in relative risk of stroke (2.5 cases per 1,000 person-years), compared with placebo (7.5 and 3.9 cases per 1,000 person-years, respectively), Dr. Cummings and his associates said.

However, Dr. Becker noted that the number of these events was quite small, and there were no differences in rates of fatal stroke. “Although the cardiovascular benefits reported in the PEARL trial seem impressive, one would need to treat 492 patients for 1 year to prevent a single major coronary event,” she said.

The PEARL investigators said that lasofoxifene raised the risk of venous thromboembolism to a similar degree as do raloxifene, tamoxifen, and oral estrogen therapies. Like these agents, lasofoxifene also significantly increased the rate of hot flushes and leg cramps. It did not raise the risk of endometrial cancer or endometrial hyperplasia.

Dr. Becker countered that although the increase in absolute risk of venous thromboembolism was small, lasofoxifene more than doubled the relative risk. In addition, rates of uterine polyps, endometrial hypertrophy, and vaginal candidiasis all were significantly higher than with placebo, she said.

The PEARL study was funded by Pfizer, manufacturer of lasofoxifene. Pfizer submitted a new drug application to the Food and Drug Administration in 2007, and in 2008 an advisory panel voted 9–3 that the benefits of the SERM outweighed this risk in postmenopausal women with osteoporosis. The FDA has not yet issued a decision.

Dr. Becker's financial disclosures are available with the text of the article at www.NEJM.org

Gastric banding allowed extremely obese adolescents to achieve a more substantial and durable weight loss than did an intensive lifestyle modification program, based on results of a prospective clinical trial.

The bariatric procedure improved overall health better than did lifestyle intervention, resolving all cases of metabolic syndrome and insulin resistance. It also improved the adolescents' quality of life to a greater degree, according to Dr. Paul E. O'Brien of the Centre for Obesity Research and Education at Monash University, Melbourne, and his associates.

They compared the two approaches in subjects aged 14–18 years with a body mass index of greater than 35. All individuals had related medical complications, including hypertension, metabolic syndrome, asthma, and back pain, as well as physical limitations such as the inability to play sports and problems performing activities of daily living. They also reported psychosocial problems including isolation, low self-esteem, and victimization by bullies.

The subjects were randomly assigned to undergo laparoscopic adjustable gastric binding with follow-up education and guidance or to participate in an intensive nonsurgical intervention program.

The program focused on reduced energy intake (800–2,000 kcal per day, depending on age and weight); increased physical activity (more than 10,000 steps per day as measured by pedometry), which included structured exercise for at least 30 minutes per day; and behavior modification. The subjects were advised to limit sedentary pursuits to 2 hours per day, and to participate in bike rides, hiking trips, kickboxing events, and bowling parties with other patients. They received 6 weeks of instruction from a personal trainer and met with a physician, dietitian, or exercise consultant every 6 weeks.

Twenty-four of the 25 subjects in the surgery group completed the full 2 years of follow-up, compared with 18 of the 25 in the lifestyle group. Twenty-one subjects in the surgery group but only three subjects in the lifestyle group achieved the primary outcome measure of a loss of at least 50% of excess weight.

At 2 years, surgery group subjects had lost a mean of 35 kg, which represents a mean loss of 28% of total body weight. Those in the lifestyle group lost a mean of 3 kg, which represents a mean loss of 3% of total body weight, wrote Dr. O'Brien and his colleagues (JAMA 2010;303:519-26).

At the study's inception, 9 subjects in the surgery group and 10 in the lifestyle group had metabolic syndrome. By the study's end, this had resolved in all surgery subjects and in six of the lifestyle subjects. Similarly, insulin resistance was abnormally high in more than half of the subjects at baseline. The problem resolved in all subjects in the surgery group but persisted in three subjects in the lifestyle group.

Those who underwent gastric banding also showed significant improvements in quality of life in the domains of physical functioning, general health, self-esteem, and family activities, whereas those who participated in the nonsurgical intervention did not.

There were no operative or postoperative complications, and the rates of adverse events were similar between the two groups. Two girls in each group became pregnant during follow-up, an unexpectedly high rate that “suggests sexual counseling may be appropriate in association with weight-loss programs” in adolescents, the researchers said.

Since “the need for revisional procedures for enlargement of the stomach above the band or injury to the tubing is intrinsic to the gastric banding procedure,” it was not surprising that seven patients in the surgery group required such revisions, they noted. “The need for a revisional procedure did not compromise the weight loss outcome or lead to additional adverse events,” the investigators stated.

However, compared with adults, adolescents may have more difficulty understanding and complying with instructions to eat only small meals and to eat very slowly to avoid the need for revisional procedures. Therefore, additional education and supervision of eating may be helpful for this age group, they added.

In an editorial, Dr. Edward H. Livingston of the University of Texas Southwestern Medical Center, Dallas, said the study provides another randomized controlled trial comparing bariatric surgery with nonsurgical treatments, culminating in more level 1 evidence. This is crucial because the quality of the current evidence in support of bariatric surgery is “poor,” he said (JAMA 2010;303:559-60).

Dr. Livingston cited the importance of the 28% rate of revisional procedures in the study “because O'Brien et al. are among the most experienced group in the world with these operations, suggesting that these complication rates will probably be higher in actual community practice.”

The study was supported in part by Allergan Inc., which provided the gastric bands. Dr. O'Brien reported no conflicts of interest. One of his associates is a consultant for Allergan, Bariatric Advantage, Scientific Intake Ltd., SP Health Co., Optifast, Abbott Australasia, Eli Lilly Australia, Merck Sharp & Dohme Australia, Nestle Australia, and Roche Products Australia. Dr. Livingston reported no conflicts.

Gastric banding allowed extremely obese adolescents to achieve a more substantial and durable weight loss than did an intensive lifestyle modification program, based on results of a prospective clinical trial.

The bariatric procedure improved overall health better than did lifestyle intervention, resolving all cases of metabolic syndrome and insulin resistance. It also improved the adolescents' quality of life to a greater degree, according to Dr. Paul E. O'Brien of the Centre for Obesity Research and Education at Monash University, Melbourne, and his associates.

They compared the two approaches in subjects aged 14–18 years with a body mass index of greater than 35. All individuals had related medical complications, including hypertension, metabolic syndrome, asthma, and back pain, as well as physical limitations such as the inability to play sports and problems performing activities of daily living. They also reported psychosocial problems including isolation, low self-esteem, and victimization by bullies.

The subjects were randomly assigned to undergo laparoscopic adjustable gastric binding with follow-up education and guidance or to participate in an intensive nonsurgical intervention program.

The program focused on reduced energy intake (800–2,000 kcal per day, depending on age and weight); increased physical activity (more than 10,000 steps per day as measured by pedometry), which included structured exercise for at least 30 minutes per day; and behavior modification. The subjects were advised to limit sedentary pursuits to 2 hours per day, and to participate in bike rides, hiking trips, kickboxing events, and bowling parties with other patients. They received 6 weeks of instruction from a personal trainer and met with a physician, dietitian, or exercise consultant every 6 weeks.

Twenty-four of the 25 subjects in the surgery group completed the full 2 years of follow-up, compared with 18 of the 25 in the lifestyle group. Twenty-one subjects in the surgery group but only three subjects in the lifestyle group achieved the primary outcome measure of a loss of at least 50% of excess weight.

At 2 years, surgery group subjects had lost a mean of 35 kg, which represents a mean loss of 28% of total body weight. Those in the lifestyle group lost a mean of 3 kg, which represents a mean loss of 3% of total body weight, wrote Dr. O'Brien and his colleagues (JAMA 2010;303:519-26).

At the study's inception, 9 subjects in the surgery group and 10 in the lifestyle group had metabolic syndrome. By the study's end, this had resolved in all surgery subjects and in six of the lifestyle subjects. Similarly, insulin resistance was abnormally high in more than half of the subjects at baseline. The problem resolved in all subjects in the surgery group but persisted in three subjects in the lifestyle group.

Those who underwent gastric banding also showed significant improvements in quality of life in the domains of physical functioning, general health, self-esteem, and family activities, whereas those who participated in the nonsurgical intervention did not.

There were no operative or postoperative complications, and the rates of adverse events were similar between the two groups. Two girls in each group became pregnant during follow-up, an unexpectedly high rate that “suggests sexual counseling may be appropriate in association with weight-loss programs” in adolescents, the researchers said.

Since “the need for revisional procedures for enlargement of the stomach above the band or injury to the tubing is intrinsic to the gastric banding procedure,” it was not surprising that seven patients in the surgery group required such revisions, they noted. “The need for a revisional procedure did not compromise the weight loss outcome or lead to additional adverse events,” the investigators stated.

However, compared with adults, adolescents may have more difficulty understanding and complying with instructions to eat only small meals and to eat very slowly to avoid the need for revisional procedures. Therefore, additional education and supervision of eating may be helpful for this age group, they added.

In an editorial, Dr. Edward H. Livingston of the University of Texas Southwestern Medical Center, Dallas, said the study provides another randomized controlled trial comparing bariatric surgery with nonsurgical treatments, culminating in more level 1 evidence. This is crucial because the quality of the current evidence in support of bariatric surgery is “poor,” he said (JAMA 2010;303:559-60).

Dr. Livingston cited the importance of the 28% rate of revisional procedures in the study “because O'Brien et al. are among the most experienced group in the world with these operations, suggesting that these complication rates will probably be higher in actual community practice.”

The study was supported in part by Allergan Inc., which provided the gastric bands. Dr. O'Brien reported no conflicts of interest. One of his associates is a consultant for Allergan, Bariatric Advantage, Scientific Intake Ltd., SP Health Co., Optifast, Abbott Australasia, Eli Lilly Australia, Merck Sharp & Dohme Australia, Nestle Australia, and Roche Products Australia. Dr. Livingston reported no conflicts.

Gastric banding allowed extremely obese adolescents to achieve a more substantial and durable weight loss than did an intensive lifestyle modification program, based on results of a prospective clinical trial.

The bariatric procedure improved overall health better than did lifestyle intervention, resolving all cases of metabolic syndrome and insulin resistance. It also improved the adolescents' quality of life to a greater degree, according to Dr. Paul E. O'Brien of the Centre for Obesity Research and Education at Monash University, Melbourne, and his associates.

They compared the two approaches in subjects aged 14–18 years with a body mass index of greater than 35. All individuals had related medical complications, including hypertension, metabolic syndrome, asthma, and back pain, as well as physical limitations such as the inability to play sports and problems performing activities of daily living. They also reported psychosocial problems including isolation, low self-esteem, and victimization by bullies.

The subjects were randomly assigned to undergo laparoscopic adjustable gastric binding with follow-up education and guidance or to participate in an intensive nonsurgical intervention program.

The program focused on reduced energy intake (800–2,000 kcal per day, depending on age and weight); increased physical activity (more than 10,000 steps per day as measured by pedometry), which included structured exercise for at least 30 minutes per day; and behavior modification. The subjects were advised to limit sedentary pursuits to 2 hours per day, and to participate in bike rides, hiking trips, kickboxing events, and bowling parties with other patients. They received 6 weeks of instruction from a personal trainer and met with a physician, dietitian, or exercise consultant every 6 weeks.

Twenty-four of the 25 subjects in the surgery group completed the full 2 years of follow-up, compared with 18 of the 25 in the lifestyle group. Twenty-one subjects in the surgery group but only three subjects in the lifestyle group achieved the primary outcome measure of a loss of at least 50% of excess weight.

At 2 years, surgery group subjects had lost a mean of 35 kg, which represents a mean loss of 28% of total body weight. Those in the lifestyle group lost a mean of 3 kg, which represents a mean loss of 3% of total body weight, wrote Dr. O'Brien and his colleagues (JAMA 2010;303:519-26).

At the study's inception, 9 subjects in the surgery group and 10 in the lifestyle group had metabolic syndrome. By the study's end, this had resolved in all surgery subjects and in six of the lifestyle subjects. Similarly, insulin resistance was abnormally high in more than half of the subjects at baseline. The problem resolved in all subjects in the surgery group but persisted in three subjects in the lifestyle group.

Those who underwent gastric banding also showed significant improvements in quality of life in the domains of physical functioning, general health, self-esteem, and family activities, whereas those who participated in the nonsurgical intervention did not.

There were no operative or postoperative complications, and the rates of adverse events were similar between the two groups. Two girls in each group became pregnant during follow-up, an unexpectedly high rate that “suggests sexual counseling may be appropriate in association with weight-loss programs” in adolescents, the researchers said.

Since “the need for revisional procedures for enlargement of the stomach above the band or injury to the tubing is intrinsic to the gastric banding procedure,” it was not surprising that seven patients in the surgery group required such revisions, they noted. “The need for a revisional procedure did not compromise the weight loss outcome or lead to additional adverse events,” the investigators stated.

However, compared with adults, adolescents may have more difficulty understanding and complying with instructions to eat only small meals and to eat very slowly to avoid the need for revisional procedures. Therefore, additional education and supervision of eating may be helpful for this age group, they added.

In an editorial, Dr. Edward H. Livingston of the University of Texas Southwestern Medical Center, Dallas, said the study provides another randomized controlled trial comparing bariatric surgery with nonsurgical treatments, culminating in more level 1 evidence. This is crucial because the quality of the current evidence in support of bariatric surgery is “poor,” he said (JAMA 2010;303:559-60).

Dr. Livingston cited the importance of the 28% rate of revisional procedures in the study “because O'Brien et al. are among the most experienced group in the world with these operations, suggesting that these complication rates will probably be higher in actual community practice.”

The study was supported in part by Allergan Inc., which provided the gastric bands. Dr. O'Brien reported no conflicts of interest. One of his associates is a consultant for Allergan, Bariatric Advantage, Scientific Intake Ltd., SP Health Co., Optifast, Abbott Australasia, Eli Lilly Australia, Merck Sharp & Dohme Australia, Nestle Australia, and Roche Products Australia. Dr. Livingston reported no conflicts.