Mary Ann Moon

Exemestane significantly decreases bone mineral density in healthy postmenopausal women who take it to reduce their risk of breast cancer, according to a study published online Feb. 7 in The Lancet Oncology.

Two years of daily oral treatment with the steroidal aromatase inhibitor was found to worsen age-related decreases in BMD "by about three times, even in the setting of adequate calcium and vitamin D intake," said Dr. Angela M. Cheung of the University Health Network in Toronto and her associates.

Dr. Cheung and her colleagues performed a safety substudy as part of the National Cancer Institute of Canada’s Mammary Prevention Trial 3 (MAP.3), a double-blind randomized study showing that exemestane significantly reduced the development of breast cancer in high-risk women, compared with placebo. Previous studies had suggested that exemestane exerted a small protective effect and caused less bone loss than other, nonsteroidal aromatase inhibitors such as anastrozole and letrozole.

This substudy focused on the drug’s effect on bone health and involved 351 subjects with T-scores above 2.0 at the lumbar spine, total hip, and femoral neck at baseline. The women had adequate dietary intake of calcium and vitamin D but received supplements as well. This was not a large enough sample to assess fracture risk directly, so the researchers instead assessed the intermediate end points of bone density and structure.

Theirs is the first study to use high-resolution peripheral quantitative CT scanning as well as the usual dual-energy x-ray absorptiometry to examine bone. Unlike the latter method, high-resolution peripheral quantitative CT captures aspects of bone fragility, including microarchitectural, geometric, and material properties that heavily influence fracture risk, the investigators noted.

The study subjects were treated and followed at three medical centers in Canada and two in the United States; median age was 61 years. A total of 176 were randomly assigned to receive daily oral exemestane and 175 to receive placebo.

The primary end point, percent change in total volumetric BMD at the distal radius after 2 years, was significantly greater with exemestane (mean loss of 6.1%) than placebo (mean loss of 1.8%). Exemestane also decreased cortical volumetric BMD at the distal radius by 4.6%, compared with 1.9% for placebo.

The drug also decreased total volumetric BMD at the distal tibia (loss of 5.0%) and cortical volumetric BMD at the distal tibia (loss of 5.3%), compared with placebo (losses of 1.3% and 2.3%, respectively).

In addition, exemestane was associated with a loss of 7.9% in mean cortical thickness at the distal radius (compared with –1.1% with placebo) and a loss of 7.6% in cortical thickness at the distal tibia (compared with –0.7% with placebo). Exemestane also cut mean total area and mean cortical area at both sites, compared with placebo, Dr. Cheung and her associates said (Lancet Oncol. 2012 [doi:10.1016/S1470-2045(11)70389-8]).

With exemestane, more women had clinically significant areal BMD loss at the lumbar spine (45%), total hip (26%), and femoral neck (22%), compared with placebo (20%, 19%, and 6%, respectively). Moreover, 65% of women taking exemestane showed clinically significant areal BMD loss at one of these three sites, compared with only 35% of women taking placebo.

These changes in bone strength, however, were not reflected in fracture rates during this relatively short study. There were no significant differences between the two study groups in fractures deemed to be attributable to bone fragility (1 with exemestane and 3 with placebo) or in total fractures (6 with exemestane and 11 with placebo), and the difference in height reduction (2 mm for exemestane vs. 1 mm for placebo) also was not significant, the researchers noted.

More importantly, "the minor areal BMD changes detected by dual-energy x-ray absorptiometry did not reflect the underlying structural deterioration seen with high-resolution peripheral quantitative CT. Although dual x-ray absorptiometry is the current clinical gold standard for skeletal assessment of fracture risk, it does not capture bone geometry, microarchitecture, or biomechanical properties, which also contribute to fracture risk," Dr. Cheung and her colleagues noted.

Unfortunately, this CT technique is not yet available for routine clinical care, they added.

This study was limited in that it involved healthy, predominantly white women with normal BMD and adequate calcium and vitamin D intake, so the findings may not be generalizable to women with osteoporosis, women with breast cancer, or nonwhite women. Also, follow-up was only 2 years; longer follow-up (up to 5 years) is needed to assess exemestane’s long-term effects on bone, the researchers said.

Nonetheless, the findings do reinforce the importance of monitoring bone health in these patients, they said.

This substudy was supported by the Canadian Breast Cancer Research Alliance, a joint initiative between the Canadian Institutes of Health Research and the Canadian Cancer Society. The main MAP.3 study also was supported by Pfizer. Jamieson Laboratories provided calcium and vitamin D supplements and Pfizer Pharmaceuticals provided exemestane and placebo. Dr. Cheung is supported in part by a Canadian Institutes of Health Research/Institute of Gender and Health Senior Investigator Award, and the Lillian Love Chair in Women’s Health at the University of Toronto/University Health Network. One of Dr. Cheung’s associates reported ties to Pfizer and Avon Foundation. None of the other researchers reported conflicts of interest.

Exemestane significantly decreases bone mineral density in healthy postmenopausal women who take it to reduce their risk of breast cancer, according to a study published online Feb. 7 in The Lancet Oncology.

Two years of daily oral treatment with the steroidal aromatase inhibitor was found to worsen age-related decreases in BMD "by about three times, even in the setting of adequate calcium and vitamin D intake," said Dr. Angela M. Cheung of the University Health Network in Toronto and her associates.

Dr. Cheung and her colleagues performed a safety substudy as part of the National Cancer Institute of Canada’s Mammary Prevention Trial 3 (MAP.3), a double-blind randomized study showing that exemestane significantly reduced the development of breast cancer in high-risk women, compared with placebo. Previous studies had suggested that exemestane exerted a small protective effect and caused less bone loss than other, nonsteroidal aromatase inhibitors such as anastrozole and letrozole.

This substudy focused on the drug’s effect on bone health and involved 351 subjects with T-scores above 2.0 at the lumbar spine, total hip, and femoral neck at baseline. The women had adequate dietary intake of calcium and vitamin D but received supplements as well. This was not a large enough sample to assess fracture risk directly, so the researchers instead assessed the intermediate end points of bone density and structure.

Theirs is the first study to use high-resolution peripheral quantitative CT scanning as well as the usual dual-energy x-ray absorptiometry to examine bone. Unlike the latter method, high-resolution peripheral quantitative CT captures aspects of bone fragility, including microarchitectural, geometric, and material properties that heavily influence fracture risk, the investigators noted.

The study subjects were treated and followed at three medical centers in Canada and two in the United States; median age was 61 years. A total of 176 were randomly assigned to receive daily oral exemestane and 175 to receive placebo.

The primary end point, percent change in total volumetric BMD at the distal radius after 2 years, was significantly greater with exemestane (mean loss of 6.1%) than placebo (mean loss of 1.8%). Exemestane also decreased cortical volumetric BMD at the distal radius by 4.6%, compared with 1.9% for placebo.

The drug also decreased total volumetric BMD at the distal tibia (loss of 5.0%) and cortical volumetric BMD at the distal tibia (loss of 5.3%), compared with placebo (losses of 1.3% and 2.3%, respectively).

In addition, exemestane was associated with a loss of 7.9% in mean cortical thickness at the distal radius (compared with –1.1% with placebo) and a loss of 7.6% in cortical thickness at the distal tibia (compared with –0.7% with placebo). Exemestane also cut mean total area and mean cortical area at both sites, compared with placebo, Dr. Cheung and her associates said (Lancet Oncol. 2012 [doi:10.1016/S1470-2045(11)70389-8]).

With exemestane, more women had clinically significant areal BMD loss at the lumbar spine (45%), total hip (26%), and femoral neck (22%), compared with placebo (20%, 19%, and 6%, respectively). Moreover, 65% of women taking exemestane showed clinically significant areal BMD loss at one of these three sites, compared with only 35% of women taking placebo.

These changes in bone strength, however, were not reflected in fracture rates during this relatively short study. There were no significant differences between the two study groups in fractures deemed to be attributable to bone fragility (1 with exemestane and 3 with placebo) or in total fractures (6 with exemestane and 11 with placebo), and the difference in height reduction (2 mm for exemestane vs. 1 mm for placebo) also was not significant, the researchers noted.

More importantly, "the minor areal BMD changes detected by dual-energy x-ray absorptiometry did not reflect the underlying structural deterioration seen with high-resolution peripheral quantitative CT. Although dual x-ray absorptiometry is the current clinical gold standard for skeletal assessment of fracture risk, it does not capture bone geometry, microarchitecture, or biomechanical properties, which also contribute to fracture risk," Dr. Cheung and her colleagues noted.

Unfortunately, this CT technique is not yet available for routine clinical care, they added.

This study was limited in that it involved healthy, predominantly white women with normal BMD and adequate calcium and vitamin D intake, so the findings may not be generalizable to women with osteoporosis, women with breast cancer, or nonwhite women. Also, follow-up was only 2 years; longer follow-up (up to 5 years) is needed to assess exemestane’s long-term effects on bone, the researchers said.

Nonetheless, the findings do reinforce the importance of monitoring bone health in these patients, they said.

This substudy was supported by the Canadian Breast Cancer Research Alliance, a joint initiative between the Canadian Institutes of Health Research and the Canadian Cancer Society. The main MAP.3 study also was supported by Pfizer. Jamieson Laboratories provided calcium and vitamin D supplements and Pfizer Pharmaceuticals provided exemestane and placebo. Dr. Cheung is supported in part by a Canadian Institutes of Health Research/Institute of Gender and Health Senior Investigator Award, and the Lillian Love Chair in Women’s Health at the University of Toronto/University Health Network. One of Dr. Cheung’s associates reported ties to Pfizer and Avon Foundation. None of the other researchers reported conflicts of interest.

Exemestane significantly decreases bone mineral density in healthy postmenopausal women who take it to reduce their risk of breast cancer, according to a study published online Feb. 7 in The Lancet Oncology.

Two years of daily oral treatment with the steroidal aromatase inhibitor was found to worsen age-related decreases in BMD "by about three times, even in the setting of adequate calcium and vitamin D intake," said Dr. Angela M. Cheung of the University Health Network in Toronto and her associates.

Dr. Cheung and her colleagues performed a safety substudy as part of the National Cancer Institute of Canada’s Mammary Prevention Trial 3 (MAP.3), a double-blind randomized study showing that exemestane significantly reduced the development of breast cancer in high-risk women, compared with placebo. Previous studies had suggested that exemestane exerted a small protective effect and caused less bone loss than other, nonsteroidal aromatase inhibitors such as anastrozole and letrozole.

This substudy focused on the drug’s effect on bone health and involved 351 subjects with T-scores above 2.0 at the lumbar spine, total hip, and femoral neck at baseline. The women had adequate dietary intake of calcium and vitamin D but received supplements as well. This was not a large enough sample to assess fracture risk directly, so the researchers instead assessed the intermediate end points of bone density and structure.

Theirs is the first study to use high-resolution peripheral quantitative CT scanning as well as the usual dual-energy x-ray absorptiometry to examine bone. Unlike the latter method, high-resolution peripheral quantitative CT captures aspects of bone fragility, including microarchitectural, geometric, and material properties that heavily influence fracture risk, the investigators noted.

The study subjects were treated and followed at three medical centers in Canada and two in the United States; median age was 61 years. A total of 176 were randomly assigned to receive daily oral exemestane and 175 to receive placebo.

The primary end point, percent change in total volumetric BMD at the distal radius after 2 years, was significantly greater with exemestane (mean loss of 6.1%) than placebo (mean loss of 1.8%). Exemestane also decreased cortical volumetric BMD at the distal radius by 4.6%, compared with 1.9% for placebo.

The drug also decreased total volumetric BMD at the distal tibia (loss of 5.0%) and cortical volumetric BMD at the distal tibia (loss of 5.3%), compared with placebo (losses of 1.3% and 2.3%, respectively).

In addition, exemestane was associated with a loss of 7.9% in mean cortical thickness at the distal radius (compared with –1.1% with placebo) and a loss of 7.6% in cortical thickness at the distal tibia (compared with –0.7% with placebo). Exemestane also cut mean total area and mean cortical area at both sites, compared with placebo, Dr. Cheung and her associates said (Lancet Oncol. 2012 [doi:10.1016/S1470-2045(11)70389-8]).

With exemestane, more women had clinically significant areal BMD loss at the lumbar spine (45%), total hip (26%), and femoral neck (22%), compared with placebo (20%, 19%, and 6%, respectively). Moreover, 65% of women taking exemestane showed clinically significant areal BMD loss at one of these three sites, compared with only 35% of women taking placebo.

These changes in bone strength, however, were not reflected in fracture rates during this relatively short study. There were no significant differences between the two study groups in fractures deemed to be attributable to bone fragility (1 with exemestane and 3 with placebo) or in total fractures (6 with exemestane and 11 with placebo), and the difference in height reduction (2 mm for exemestane vs. 1 mm for placebo) also was not significant, the researchers noted.

More importantly, "the minor areal BMD changes detected by dual-energy x-ray absorptiometry did not reflect the underlying structural deterioration seen with high-resolution peripheral quantitative CT. Although dual x-ray absorptiometry is the current clinical gold standard for skeletal assessment of fracture risk, it does not capture bone geometry, microarchitecture, or biomechanical properties, which also contribute to fracture risk," Dr. Cheung and her colleagues noted.

Unfortunately, this CT technique is not yet available for routine clinical care, they added.

This study was limited in that it involved healthy, predominantly white women with normal BMD and adequate calcium and vitamin D intake, so the findings may not be generalizable to women with osteoporosis, women with breast cancer, or nonwhite women. Also, follow-up was only 2 years; longer follow-up (up to 5 years) is needed to assess exemestane’s long-term effects on bone, the researchers said.

Nonetheless, the findings do reinforce the importance of monitoring bone health in these patients, they said.

This substudy was supported by the Canadian Breast Cancer Research Alliance, a joint initiative between the Canadian Institutes of Health Research and the Canadian Cancer Society. The main MAP.3 study also was supported by Pfizer. Jamieson Laboratories provided calcium and vitamin D supplements and Pfizer Pharmaceuticals provided exemestane and placebo. Dr. Cheung is supported in part by a Canadian Institutes of Health Research/Institute of Gender and Health Senior Investigator Award, and the Lillian Love Chair in Women’s Health at the University of Toronto/University Health Network. One of Dr. Cheung’s associates reported ties to Pfizer and Avon Foundation. None of the other researchers reported conflicts of interest.

Specially adapted cognitive therapy improved global function, motivation, and positive symptoms in low-functioning patients who had schizophrenia and significant cognitive impairment, according to a study in the February issue of the Archives of General Psychiatry.

"This is the first time, to our knowledge, that patients with chronic schizophrenia selected from the extreme end of the low-functioning continuum have shown statistically significant and clinically meaningful improvement in psychosocial functioning in response to a psychosocial intervention," said Paul M. Grant, Ph.D., of the University of Pennsylvania, Philadelphia, and his associates.

In their clinical trial, 60 such patients were randomly assigned to either a control group receiving standard outpatient treatment (29 subjects) or an experimental group receiving a novel form of cognitive therapy (31 subjects) for 18 months. Standard treatment included antipsychotic medication, case management, supportive counseling, day treatment services, housing services, peer support, and vocational rehabilitation – all provided by community clinicians (Arch. Gen. Psychiatry 2012;69:121-7).

The specially adapted cognitive therapy aimed to stimulate patients’ interest in and motivation to achieve easy short-term goals, such as participating in an enjoyable activity, as well as long-term goals, such as obtaining independent housing or employment. All the goals focused on moving them out of their withdrawn state.

A key feature of the therapy was overcoming patients’ dysfunctional, nihilistic beliefs such as "taking even a small risk is foolish because the loss is likely to be a disaster" and "making new friends isn’t worth the energy it takes."

The cognitive therapy was adapted to patients’ neurocognitive impairments and provided by PhD- and MD-level clinicians. Study subjects typically attended weekly 50-minute sessions, but the duration and frequency of sessions were flexible and tailored to the patients’ needs and progress.

The mean age of the study subjects was 38 years. Twenty (one-third) of the subjects were women, and 39 (two-thirds) were black. The mean duration of schizophrenia was 15 years. Approximately 92% of the subjects were taking at least 1 atypical antipsychotic agent.

The patients’ neurocognitive impairments included difficulties with information processing on tasks of memory, attention, and executive function. Many subjects also had residual positive symptoms, such as hallucinations, delusions, and disorganized thinking.

The primary outcome measure was improvement on the 100-point Global Assessment of Functioning scale at the end of the study. Only the subjects who received cognitive therapy showed such improvement, Dr. Grant and his colleagues wrote.

The experimental group also showed significantly greater improvement than the control group on the avolition-apathy subscale of the Scale for the Assessment of Negative Symptoms and on the total score of the Scale for the Assessment of Positive Symptoms.

"We hypothesize that [cognitive therapy] triggers the cycle of recovery by targeting self-defeating and dysfunctional beliefs that inhibit the patients’ active engagement in constructive activity. Alternatively, it is possible that improvement in avolition-apathy was largely secondary to improvement in positive symptoms. These are questions that can be addressed by future research," the investigators said.

The study findings indicate that cognitive therapy might be useful in reducing public health costs "for the most expensive per-patient psychiatric population while simultaneously improving patients’ quality of life," they noted.

This study was limited in that the experimental treatment involved more individual interaction between patient and therapist than did the control condition, "raising the possibility that nonspecific patient contact factors are contributing to the observed group differences," Dr. Grant and his associates added. In addition, both the study subjects and the clinicians were unblinded and aware that they were participating in an experiment, "introducing possible bias in the reported outcomes," the researchers said.

This study was supported by the National Alliance for Research on Schizophrenia and Depression, the Heinz Foundation, and the Barbara and Henry Jordan Foundation. Dr. Grant and two associates reported receiving royalties from Guilford Press.

Specially adapted cognitive therapy improved global function, motivation, and positive symptoms in low-functioning patients who had schizophrenia and significant cognitive impairment, according to a study in the February issue of the Archives of General Psychiatry.

"This is the first time, to our knowledge, that patients with chronic schizophrenia selected from the extreme end of the low-functioning continuum have shown statistically significant and clinically meaningful improvement in psychosocial functioning in response to a psychosocial intervention," said Paul M. Grant, Ph.D., of the University of Pennsylvania, Philadelphia, and his associates.

In their clinical trial, 60 such patients were randomly assigned to either a control group receiving standard outpatient treatment (29 subjects) or an experimental group receiving a novel form of cognitive therapy (31 subjects) for 18 months. Standard treatment included antipsychotic medication, case management, supportive counseling, day treatment services, housing services, peer support, and vocational rehabilitation – all provided by community clinicians (Arch. Gen. Psychiatry 2012;69:121-7).

The specially adapted cognitive therapy aimed to stimulate patients’ interest in and motivation to achieve easy short-term goals, such as participating in an enjoyable activity, as well as long-term goals, such as obtaining independent housing or employment. All the goals focused on moving them out of their withdrawn state.

A key feature of the therapy was overcoming patients’ dysfunctional, nihilistic beliefs such as "taking even a small risk is foolish because the loss is likely to be a disaster" and "making new friends isn’t worth the energy it takes."

The cognitive therapy was adapted to patients’ neurocognitive impairments and provided by PhD- and MD-level clinicians. Study subjects typically attended weekly 50-minute sessions, but the duration and frequency of sessions were flexible and tailored to the patients’ needs and progress.

The mean age of the study subjects was 38 years. Twenty (one-third) of the subjects were women, and 39 (two-thirds) were black. The mean duration of schizophrenia was 15 years. Approximately 92% of the subjects were taking at least 1 atypical antipsychotic agent.

The patients’ neurocognitive impairments included difficulties with information processing on tasks of memory, attention, and executive function. Many subjects also had residual positive symptoms, such as hallucinations, delusions, and disorganized thinking.

The primary outcome measure was improvement on the 100-point Global Assessment of Functioning scale at the end of the study. Only the subjects who received cognitive therapy showed such improvement, Dr. Grant and his colleagues wrote.

The experimental group also showed significantly greater improvement than the control group on the avolition-apathy subscale of the Scale for the Assessment of Negative Symptoms and on the total score of the Scale for the Assessment of Positive Symptoms.

"We hypothesize that [cognitive therapy] triggers the cycle of recovery by targeting self-defeating and dysfunctional beliefs that inhibit the patients’ active engagement in constructive activity. Alternatively, it is possible that improvement in avolition-apathy was largely secondary to improvement in positive symptoms. These are questions that can be addressed by future research," the investigators said.

The study findings indicate that cognitive therapy might be useful in reducing public health costs "for the most expensive per-patient psychiatric population while simultaneously improving patients’ quality of life," they noted.

This study was limited in that the experimental treatment involved more individual interaction between patient and therapist than did the control condition, "raising the possibility that nonspecific patient contact factors are contributing to the observed group differences," Dr. Grant and his associates added. In addition, both the study subjects and the clinicians were unblinded and aware that they were participating in an experiment, "introducing possible bias in the reported outcomes," the researchers said.

This study was supported by the National Alliance for Research on Schizophrenia and Depression, the Heinz Foundation, and the Barbara and Henry Jordan Foundation. Dr. Grant and two associates reported receiving royalties from Guilford Press.

Specially adapted cognitive therapy improved global function, motivation, and positive symptoms in low-functioning patients who had schizophrenia and significant cognitive impairment, according to a study in the February issue of the Archives of General Psychiatry.

"This is the first time, to our knowledge, that patients with chronic schizophrenia selected from the extreme end of the low-functioning continuum have shown statistically significant and clinically meaningful improvement in psychosocial functioning in response to a psychosocial intervention," said Paul M. Grant, Ph.D., of the University of Pennsylvania, Philadelphia, and his associates.

In their clinical trial, 60 such patients were randomly assigned to either a control group receiving standard outpatient treatment (29 subjects) or an experimental group receiving a novel form of cognitive therapy (31 subjects) for 18 months. Standard treatment included antipsychotic medication, case management, supportive counseling, day treatment services, housing services, peer support, and vocational rehabilitation – all provided by community clinicians (Arch. Gen. Psychiatry 2012;69:121-7).

The specially adapted cognitive therapy aimed to stimulate patients’ interest in and motivation to achieve easy short-term goals, such as participating in an enjoyable activity, as well as long-term goals, such as obtaining independent housing or employment. All the goals focused on moving them out of their withdrawn state.

A key feature of the therapy was overcoming patients’ dysfunctional, nihilistic beliefs such as "taking even a small risk is foolish because the loss is likely to be a disaster" and "making new friends isn’t worth the energy it takes."

The cognitive therapy was adapted to patients’ neurocognitive impairments and provided by PhD- and MD-level clinicians. Study subjects typically attended weekly 50-minute sessions, but the duration and frequency of sessions were flexible and tailored to the patients’ needs and progress.

The mean age of the study subjects was 38 years. Twenty (one-third) of the subjects were women, and 39 (two-thirds) were black. The mean duration of schizophrenia was 15 years. Approximately 92% of the subjects were taking at least 1 atypical antipsychotic agent.

The patients’ neurocognitive impairments included difficulties with information processing on tasks of memory, attention, and executive function. Many subjects also had residual positive symptoms, such as hallucinations, delusions, and disorganized thinking.

The primary outcome measure was improvement on the 100-point Global Assessment of Functioning scale at the end of the study. Only the subjects who received cognitive therapy showed such improvement, Dr. Grant and his colleagues wrote.

The experimental group also showed significantly greater improvement than the control group on the avolition-apathy subscale of the Scale for the Assessment of Negative Symptoms and on the total score of the Scale for the Assessment of Positive Symptoms.

"We hypothesize that [cognitive therapy] triggers the cycle of recovery by targeting self-defeating and dysfunctional beliefs that inhibit the patients’ active engagement in constructive activity. Alternatively, it is possible that improvement in avolition-apathy was largely secondary to improvement in positive symptoms. These are questions that can be addressed by future research," the investigators said.

The study findings indicate that cognitive therapy might be useful in reducing public health costs "for the most expensive per-patient psychiatric population while simultaneously improving patients’ quality of life," they noted.

This study was limited in that the experimental treatment involved more individual interaction between patient and therapist than did the control condition, "raising the possibility that nonspecific patient contact factors are contributing to the observed group differences," Dr. Grant and his associates added. In addition, both the study subjects and the clinicians were unblinded and aware that they were participating in an experiment, "introducing possible bias in the reported outcomes," the researchers said.

This study was supported by the National Alliance for Research on Schizophrenia and Depression, the Heinz Foundation, and the Barbara and Henry Jordan Foundation. Dr. Grant and two associates reported receiving royalties from Guilford Press.

Undergoing a first-trimester induced abortion does not raise the risk of readmission among women with a history of psychiatric hospitalization, according to a report in the February issue of the Archives of General Psychiatry.

It appears that induced first-trimester abortion doesn’t influence the disease course of any mental disorder, said Trine Munk-Olsen, Ph.D., of the National Centre for Register-Based Research, University of Aarhus (Denmark), and her associates.

Previous studies examining induced abortions’ adverse affects on mental health have produced conflicting results and have been flawed by low response rates (resulting in highly selected patient populations), high attrition rates, recall bias, and imprecise measures of both the abortion procedures and mental disorders.

To circumvent these problems, Dr. Munk-Olsen and her colleagues analyzed detailed data from Danish national registeries of all psychiatric admissions for any type of mental disorders and all induced abortions between 1994 and 2007 among women born during 1962-1992. For a comparison group, they assessed all live births in that same study period among women of the same ages with a history of psychiatric admissions for any type of mental disorder.

The researchers identified 2,838 women who had records of mental disorders and who underwent a first-time, first-trimester induced abortion in the study period. A total of 321 of these women had a psychiatric readmission during the interval from 9 months preceding to 12 months after the procedure.

In comparison, 5,293 women with records of mental disorders gave birth to a first child in the same study period. A total of 273 of these women had a psychiatric readmission during the interval from 9 months preceding to 12 months after the birth.

The crude incidence rates of psychiatric readmission declined during the interval from before the abortion to after the induced abortion. In contrast, the crude incidence rates of psychiatric readmission increased during the interval from before the childbirth to after the birth, the investigators said (Arch. Gen. Psychiatry 2012;69:159-65).

In addition, the risk of psychiatric readmission was higher at 1 month after childbirth than it was at 1 month after induced abortion.

The risks of psychiatric readmission around the time of undergoing an abortion were not significantly elevated at any particular time point or for any diagnostic category of mental disorder. In contrast, the risk of psychiatric readmission around the time of childbirth was significantly elevated during the first postpartum month and in the diagnostic categories of bipolar affective disorders and schizophrenialike disorders.

The researchers concluded that "the decision to undergo [an] induced abortion did not appear to influence the subsequent illness course in our study population."

Two prognostic factors were found to be strong predictors of readmission for all the study subjects: a shorter interval since the last psychiatric admission and a higher number of previous admissions. Therefore, previous studies that assessed the risk of readmission but failed to control for the proximity of the last hospitalization and the number of previous hospitalizations likely produced inaccurate results, Dr. Munk-Olsen and her associates said.

Although the registries collected much more accurate data than could be obtained by self-report, one limitation of this study is the lack of information on whether the pregnancies were wanted or unwanted or reasons for the abortion, they added.

This study was sponsored by the Susan Thompson Buffett Foundation and the Danish Medical Research Council. Dr. Munk-Olsen’s associates reported ties to Bayer Schering Pharma and the Stanley Medical Research Institute.

Undergoing a first-trimester induced abortion does not raise the risk of readmission among women with a history of psychiatric hospitalization, according to a report in the February issue of the Archives of General Psychiatry.

It appears that induced first-trimester abortion doesn’t influence the disease course of any mental disorder, said Trine Munk-Olsen, Ph.D., of the National Centre for Register-Based Research, University of Aarhus (Denmark), and her associates.

Previous studies examining induced abortions’ adverse affects on mental health have produced conflicting results and have been flawed by low response rates (resulting in highly selected patient populations), high attrition rates, recall bias, and imprecise measures of both the abortion procedures and mental disorders.

To circumvent these problems, Dr. Munk-Olsen and her colleagues analyzed detailed data from Danish national registeries of all psychiatric admissions for any type of mental disorders and all induced abortions between 1994 and 2007 among women born during 1962-1992. For a comparison group, they assessed all live births in that same study period among women of the same ages with a history of psychiatric admissions for any type of mental disorder.

The researchers identified 2,838 women who had records of mental disorders and who underwent a first-time, first-trimester induced abortion in the study period. A total of 321 of these women had a psychiatric readmission during the interval from 9 months preceding to 12 months after the procedure.

In comparison, 5,293 women with records of mental disorders gave birth to a first child in the same study period. A total of 273 of these women had a psychiatric readmission during the interval from 9 months preceding to 12 months after the birth.

The crude incidence rates of psychiatric readmission declined during the interval from before the abortion to after the induced abortion. In contrast, the crude incidence rates of psychiatric readmission increased during the interval from before the childbirth to after the birth, the investigators said (Arch. Gen. Psychiatry 2012;69:159-65).

In addition, the risk of psychiatric readmission was higher at 1 month after childbirth than it was at 1 month after induced abortion.

The risks of psychiatric readmission around the time of undergoing an abortion were not significantly elevated at any particular time point or for any diagnostic category of mental disorder. In contrast, the risk of psychiatric readmission around the time of childbirth was significantly elevated during the first postpartum month and in the diagnostic categories of bipolar affective disorders and schizophrenialike disorders.

The researchers concluded that "the decision to undergo [an] induced abortion did not appear to influence the subsequent illness course in our study population."

Two prognostic factors were found to be strong predictors of readmission for all the study subjects: a shorter interval since the last psychiatric admission and a higher number of previous admissions. Therefore, previous studies that assessed the risk of readmission but failed to control for the proximity of the last hospitalization and the number of previous hospitalizations likely produced inaccurate results, Dr. Munk-Olsen and her associates said.

Although the registries collected much more accurate data than could be obtained by self-report, one limitation of this study is the lack of information on whether the pregnancies were wanted or unwanted or reasons for the abortion, they added.

This study was sponsored by the Susan Thompson Buffett Foundation and the Danish Medical Research Council. Dr. Munk-Olsen’s associates reported ties to Bayer Schering Pharma and the Stanley Medical Research Institute.

Undergoing a first-trimester induced abortion does not raise the risk of readmission among women with a history of psychiatric hospitalization, according to a report in the February issue of the Archives of General Psychiatry.

It appears that induced first-trimester abortion doesn’t influence the disease course of any mental disorder, said Trine Munk-Olsen, Ph.D., of the National Centre for Register-Based Research, University of Aarhus (Denmark), and her associates.

Previous studies examining induced abortions’ adverse affects on mental health have produced conflicting results and have been flawed by low response rates (resulting in highly selected patient populations), high attrition rates, recall bias, and imprecise measures of both the abortion procedures and mental disorders.

To circumvent these problems, Dr. Munk-Olsen and her colleagues analyzed detailed data from Danish national registeries of all psychiatric admissions for any type of mental disorders and all induced abortions between 1994 and 2007 among women born during 1962-1992. For a comparison group, they assessed all live births in that same study period among women of the same ages with a history of psychiatric admissions for any type of mental disorder.

The researchers identified 2,838 women who had records of mental disorders and who underwent a first-time, first-trimester induced abortion in the study period. A total of 321 of these women had a psychiatric readmission during the interval from 9 months preceding to 12 months after the procedure.

In comparison, 5,293 women with records of mental disorders gave birth to a first child in the same study period. A total of 273 of these women had a psychiatric readmission during the interval from 9 months preceding to 12 months after the birth.

The crude incidence rates of psychiatric readmission declined during the interval from before the abortion to after the induced abortion. In contrast, the crude incidence rates of psychiatric readmission increased during the interval from before the childbirth to after the birth, the investigators said (Arch. Gen. Psychiatry 2012;69:159-65).

In addition, the risk of psychiatric readmission was higher at 1 month after childbirth than it was at 1 month after induced abortion.

The risks of psychiatric readmission around the time of undergoing an abortion were not significantly elevated at any particular time point or for any diagnostic category of mental disorder. In contrast, the risk of psychiatric readmission around the time of childbirth was significantly elevated during the first postpartum month and in the diagnostic categories of bipolar affective disorders and schizophrenialike disorders.

The researchers concluded that "the decision to undergo [an] induced abortion did not appear to influence the subsequent illness course in our study population."

Two prognostic factors were found to be strong predictors of readmission for all the study subjects: a shorter interval since the last psychiatric admission and a higher number of previous admissions. Therefore, previous studies that assessed the risk of readmission but failed to control for the proximity of the last hospitalization and the number of previous hospitalizations likely produced inaccurate results, Dr. Munk-Olsen and her associates said.

Although the registries collected much more accurate data than could be obtained by self-report, one limitation of this study is the lack of information on whether the pregnancies were wanted or unwanted or reasons for the abortion, they added.

This study was sponsored by the Susan Thompson Buffett Foundation and the Danish Medical Research Council. Dr. Munk-Olsen’s associates reported ties to Bayer Schering Pharma and the Stanley Medical Research Institute.

Short-term therapy with ulipristal acetate, a selective progesterone-receptor modulator, is superior to placebo and noninferior to leuprolide at controlling the bleeding, reducing the volume, and improving the pain of uterine fibroids, according to two reports in the Feb. 2 issue of the New England Journal of Medicine.

In two parallel international phase-III clinical trials, the duration of treatment with ulipristal acetate (PGL4001) was restricted to 13 weeks and limited to patients who were planning to undergo surgery for fibroids. "More data are needed to inform the benefits and risks of long-term treatment with ulipristal," as well as to compare the outcomes with therapy against those with surgery, said Dr. Jacques Donnez of the Cliniques Universitaires Saint-Luc Catholic University of Louvain, Brussels, and his associates in the PEARL I and PEARL II studies.

In the PEARL I (PGL4001 [Ulipristal Acetate] Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata) study, 242 premenopausal women with severe menorrhagia and associated anemia were randomly assigned to receive 5 mg ulipristal, 10 mg ulipristal, or placebo tablets once daily for 13 weeks. The study subjects were treated at 38 academic medical centers in six countries.

Excessive bleeding was controlled in 91% of the women who received the 5-mg dose and 92% of those who received the 10-mg dose, compared with only 19% of those who received placebo. Moreover, excessive bleeding was controlled rapidly – within 8 days – in more than 75% of women taking either dose of ulipristal, compared with only 6% of those taking placebo, the investigators said (N. Engl. J. Med. 2012;366:409-20).

"More data are needed to inform the benefits and risks of long-term treatment with ulipristal."

Most of the women in both ulipristal groups but few in the placebo group achieved amenorrhea after 4 weeks of treatment. Half of the patients receiving 5 mg and 70% of those receiving 10 mg of ulipristal became amenorrheic within 10 days.

At the same time, hemoglobin and hematocrit levels rose significantly higher in both ulipristal groups, compared with the placebo group. A significantly greater proportion of patients taking ulipristal showed reductions in fibroid volume of at least 25%, and more reported reduced pain.

The rate of adverse events was not significantly different among the three study groups. All patients showed modest changes in LDL and HDL cholesterol. There were no consistent effects on glucose, estradiol, corticotropin, or prolactin levels, and no differences between active treatment and placebo groups in liver function results or endometrial thickness.

Endometrial biopsies at the end of treatment showed nonphysiologic changes in 62% of women taking 5 mg ulipristal and 57% taking 10 mg ulipristal, compared with only 6% taking placebo. These changes had disappeared by the 6-month follow-up biopsy.

The PEARL II study was a noninferiority trial comparing the same two doses of daily oral ulipristal against once-monthly leuprolide injections for the preoperative treatment of fibroids in 307 women.

After 13 weeks of treatment, 90% of the patients receiving 5 mg ulipristal, 98% of those receiving 10 mg ulipristal, and 89% of those receiving leuprolide achieved control of excessive bleeding, indicating the noninferiority of both doses of ulipristal, Dr. Donnez and his colleagues said (N. Engl. J. Med. 2012;366:421-32).

Excessive bleeding was controlled much more rapidly with ulipristal than with leuprolide, and amenorrhea also was induced more rapidly. The median time to achieving amenorrhea was 7 days with 5 mg ulipristal, 5 days with 10 mg ulipristal, and 21 days with leuprolide, they reported.

All patients reported similar improvements in pain and quality of life, and all showed similar rebounds in hemoglobin levels.

All three treatments significantly reduced uterine volume, but leuprolide produced a significantly greater reduction (47%) than did either dose of ulipristal (20% and 22%).

Estradiol dropped to postmenopausal levels only in the women who received leuprolide. Accordingly, 40% of the leuprolide group reported moderate to severe hot flashes, compared with 11% of the women taking 5 mg ulipristal and 10% of those taking 10 mg ulipristal, Dr. Donnez and his colleagues wrote.

There were no significant differences among the three study groups in other adverse events. As in the PEARL I study, ulipristal induced benign endometrial changes that had disappeared at the 6-month follow-up.

Neither ulipristal nor leuprolide showed any clinically relevant effects on corticotropin, thyrotropin, prolactin, or glucose levels.

Both the PEARL I and PEARL II studies were funded by PregLem, manufacturer of ulipristal acetate. Dr. Donnez reported ties to PregLem, Serono, Merck, Organon, and Ferring; his associates reported ties to numerous industry sources.

Short-term therapy with ulipristal acetate, a selective progesterone-receptor modulator, is superior to placebo and noninferior to leuprolide at controlling the bleeding, reducing the volume, and improving the pain of uterine fibroids, according to two reports in the Feb. 2 issue of the New England Journal of Medicine.

In two parallel international phase-III clinical trials, the duration of treatment with ulipristal acetate (PGL4001) was restricted to 13 weeks and limited to patients who were planning to undergo surgery for fibroids. "More data are needed to inform the benefits and risks of long-term treatment with ulipristal," as well as to compare the outcomes with therapy against those with surgery, said Dr. Jacques Donnez of the Cliniques Universitaires Saint-Luc Catholic University of Louvain, Brussels, and his associates in the PEARL I and PEARL II studies.

In the PEARL I (PGL4001 [Ulipristal Acetate] Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata) study, 242 premenopausal women with severe menorrhagia and associated anemia were randomly assigned to receive 5 mg ulipristal, 10 mg ulipristal, or placebo tablets once daily for 13 weeks. The study subjects were treated at 38 academic medical centers in six countries.

Excessive bleeding was controlled in 91% of the women who received the 5-mg dose and 92% of those who received the 10-mg dose, compared with only 19% of those who received placebo. Moreover, excessive bleeding was controlled rapidly – within 8 days – in more than 75% of women taking either dose of ulipristal, compared with only 6% of those taking placebo, the investigators said (N. Engl. J. Med. 2012;366:409-20).

"More data are needed to inform the benefits and risks of long-term treatment with ulipristal."

Most of the women in both ulipristal groups but few in the placebo group achieved amenorrhea after 4 weeks of treatment. Half of the patients receiving 5 mg and 70% of those receiving 10 mg of ulipristal became amenorrheic within 10 days.

At the same time, hemoglobin and hematocrit levels rose significantly higher in both ulipristal groups, compared with the placebo group. A significantly greater proportion of patients taking ulipristal showed reductions in fibroid volume of at least 25%, and more reported reduced pain.

The rate of adverse events was not significantly different among the three study groups. All patients showed modest changes in LDL and HDL cholesterol. There were no consistent effects on glucose, estradiol, corticotropin, or prolactin levels, and no differences between active treatment and placebo groups in liver function results or endometrial thickness.

Endometrial biopsies at the end of treatment showed nonphysiologic changes in 62% of women taking 5 mg ulipristal and 57% taking 10 mg ulipristal, compared with only 6% taking placebo. These changes had disappeared by the 6-month follow-up biopsy.

The PEARL II study was a noninferiority trial comparing the same two doses of daily oral ulipristal against once-monthly leuprolide injections for the preoperative treatment of fibroids in 307 women.

After 13 weeks of treatment, 90% of the patients receiving 5 mg ulipristal, 98% of those receiving 10 mg ulipristal, and 89% of those receiving leuprolide achieved control of excessive bleeding, indicating the noninferiority of both doses of ulipristal, Dr. Donnez and his colleagues said (N. Engl. J. Med. 2012;366:421-32).

Excessive bleeding was controlled much more rapidly with ulipristal than with leuprolide, and amenorrhea also was induced more rapidly. The median time to achieving amenorrhea was 7 days with 5 mg ulipristal, 5 days with 10 mg ulipristal, and 21 days with leuprolide, they reported.

All patients reported similar improvements in pain and quality of life, and all showed similar rebounds in hemoglobin levels.

All three treatments significantly reduced uterine volume, but leuprolide produced a significantly greater reduction (47%) than did either dose of ulipristal (20% and 22%).

Estradiol dropped to postmenopausal levels only in the women who received leuprolide. Accordingly, 40% of the leuprolide group reported moderate to severe hot flashes, compared with 11% of the women taking 5 mg ulipristal and 10% of those taking 10 mg ulipristal, Dr. Donnez and his colleagues wrote.

There were no significant differences among the three study groups in other adverse events. As in the PEARL I study, ulipristal induced benign endometrial changes that had disappeared at the 6-month follow-up.

Neither ulipristal nor leuprolide showed any clinically relevant effects on corticotropin, thyrotropin, prolactin, or glucose levels.

Both the PEARL I and PEARL II studies were funded by PregLem, manufacturer of ulipristal acetate. Dr. Donnez reported ties to PregLem, Serono, Merck, Organon, and Ferring; his associates reported ties to numerous industry sources.

Short-term therapy with ulipristal acetate, a selective progesterone-receptor modulator, is superior to placebo and noninferior to leuprolide at controlling the bleeding, reducing the volume, and improving the pain of uterine fibroids, according to two reports in the Feb. 2 issue of the New England Journal of Medicine.

In two parallel international phase-III clinical trials, the duration of treatment with ulipristal acetate (PGL4001) was restricted to 13 weeks and limited to patients who were planning to undergo surgery for fibroids. "More data are needed to inform the benefits and risks of long-term treatment with ulipristal," as well as to compare the outcomes with therapy against those with surgery, said Dr. Jacques Donnez of the Cliniques Universitaires Saint-Luc Catholic University of Louvain, Brussels, and his associates in the PEARL I and PEARL II studies.

In the PEARL I (PGL4001 [Ulipristal Acetate] Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata) study, 242 premenopausal women with severe menorrhagia and associated anemia were randomly assigned to receive 5 mg ulipristal, 10 mg ulipristal, or placebo tablets once daily for 13 weeks. The study subjects were treated at 38 academic medical centers in six countries.

Excessive bleeding was controlled in 91% of the women who received the 5-mg dose and 92% of those who received the 10-mg dose, compared with only 19% of those who received placebo. Moreover, excessive bleeding was controlled rapidly – within 8 days – in more than 75% of women taking either dose of ulipristal, compared with only 6% of those taking placebo, the investigators said (N. Engl. J. Med. 2012;366:409-20).

"More data are needed to inform the benefits and risks of long-term treatment with ulipristal."

Most of the women in both ulipristal groups but few in the placebo group achieved amenorrhea after 4 weeks of treatment. Half of the patients receiving 5 mg and 70% of those receiving 10 mg of ulipristal became amenorrheic within 10 days.

At the same time, hemoglobin and hematocrit levels rose significantly higher in both ulipristal groups, compared with the placebo group. A significantly greater proportion of patients taking ulipristal showed reductions in fibroid volume of at least 25%, and more reported reduced pain.

The rate of adverse events was not significantly different among the three study groups. All patients showed modest changes in LDL and HDL cholesterol. There were no consistent effects on glucose, estradiol, corticotropin, or prolactin levels, and no differences between active treatment and placebo groups in liver function results or endometrial thickness.

Endometrial biopsies at the end of treatment showed nonphysiologic changes in 62% of women taking 5 mg ulipristal and 57% taking 10 mg ulipristal, compared with only 6% taking placebo. These changes had disappeared by the 6-month follow-up biopsy.

The PEARL II study was a noninferiority trial comparing the same two doses of daily oral ulipristal against once-monthly leuprolide injections for the preoperative treatment of fibroids in 307 women.

After 13 weeks of treatment, 90% of the patients receiving 5 mg ulipristal, 98% of those receiving 10 mg ulipristal, and 89% of those receiving leuprolide achieved control of excessive bleeding, indicating the noninferiority of both doses of ulipristal, Dr. Donnez and his colleagues said (N. Engl. J. Med. 2012;366:421-32).

Excessive bleeding was controlled much more rapidly with ulipristal than with leuprolide, and amenorrhea also was induced more rapidly. The median time to achieving amenorrhea was 7 days with 5 mg ulipristal, 5 days with 10 mg ulipristal, and 21 days with leuprolide, they reported.

All patients reported similar improvements in pain and quality of life, and all showed similar rebounds in hemoglobin levels.

All three treatments significantly reduced uterine volume, but leuprolide produced a significantly greater reduction (47%) than did either dose of ulipristal (20% and 22%).

Estradiol dropped to postmenopausal levels only in the women who received leuprolide. Accordingly, 40% of the leuprolide group reported moderate to severe hot flashes, compared with 11% of the women taking 5 mg ulipristal and 10% of those taking 10 mg ulipristal, Dr. Donnez and his colleagues wrote.

There were no significant differences among the three study groups in other adverse events. As in the PEARL I study, ulipristal induced benign endometrial changes that had disappeared at the 6-month follow-up.

Neither ulipristal nor leuprolide showed any clinically relevant effects on corticotropin, thyrotropin, prolactin, or glucose levels.

Both the PEARL I and PEARL II studies were funded by PregLem, manufacturer of ulipristal acetate. Dr. Donnez reported ties to PregLem, Serono, Merck, Organon, and Ferring; his associates reported ties to numerous industry sources.

Major Finding: The mean weight loss across all 28 studies of lifestyle intervention programs was approximately 4%, which is considered clinically meaningful.

Data Source: A meta-analysis of 28 published U.S. studies (including 2,916 subjects) of lifestyle intervention programs incorporating the findings of the U.S. Diabetes Prevention Program to prevent diabetes by promoting weight loss.

Disclosures: No disclosure information was provided.

Structured lifestyle interventions based on the U.S. Diabetes Prevention Program's curriculum were effective at promoting clinically significant weight loss of approximately 4% when applied in real-world settings, according to a meta-analysis.

The U.S. Diabetes Prevention Program conducted a clinical trial in 2002 showing that modest weight loss through caloric restriction and increased physical activity reduced the incidence of diabetes in high-risk patients by 58%. Weight loss was found to be the single most important factor in preventing diabetes from developing over the course of 3 years among patients who were at high risk for the disease. For every kilogram of weight lost, the incidence of diabetes decreased by 16%.

“Yet these results have not been 'translated' into routine clinical practice and public health policy,” said Dr. Mohammed K. Ali of Emory University, Atlanta, and his associates.

They performed what they described as the first meta-analysis of U.S. studies in which the structured intervention recommended by they Diabetes Prevention Program was applied to high-risk patients in real-world settings. The meta-analysis included 28 studies published in 2003–2011.

In all, 4 were randomized, controlled trials (RCTs), 2 were cluster RCTs, 20 were single-group studies comparing preintervention and postintervention weight, and 2 were nonrandomized, controlled studies.

Most of the studies were conducted in urban areas. In all, 12 were based in community centers, recreation centers, and church organizations, and 11 were based in health care facilities. The total number of patients was 2,916, and the median study duration was 1 year.

Across all the reviewed studies, the mean weight loss was 3.99%, which is considered clinically meaningful, Dr. Ali and his colleagues said (Health Aff. 2012 [doi:10.1377/hlthaff.2011.1009]).

Weight loss was comparable among programs that used medical and allied health professionals to implement the intervention (average 4.27% weight loss), programs that used lay community educators (3.15% weight loss), and programs that used electronic media-assisted interventions (4.20% weight loss).

Moreover, sensitivity analyses showed that programs with lay community educators achieved greater weight loss than those with medical and allied health professionals as educators. That finding “has enormous importance for the scalability and economic sustainability of diabetes interventions,” Dr. Ali and his colleagues noted, because lay educators required lower salaries and their training was neither costly nor time-consuming.

Programs that included more “core sessions” in which patients received counseling maintained the highest attendance rates. And higher attendance rates correlated positively with greater weight loss.

The rate of attrition varied greatly among the studies, ranging from 0% to 49%. In some studies that analyzed patient feedback, it appeared that attrition was more strongly related to patients' perceptions of their risk and to their readiness to change than it was to specific features of the intervention, such as the number of counseling sessions.

The weight-loss results of the U.S. Diabetes Prevention Program did not translate in real-world lifestyle interventions based on that DPP model, according to the meta-analysis.

Source Courtesy Bill Branson/National Cancer Institute

Major Finding: The mean weight loss across all 28 studies of lifestyle intervention programs was approximately 4%, which is considered clinically meaningful.

Data Source: A meta-analysis of 28 published U.S. studies (including 2,916 subjects) of lifestyle intervention programs incorporating the findings of the U.S. Diabetes Prevention Program to prevent diabetes by promoting weight loss.

Disclosures: No disclosure information was provided.

Structured lifestyle interventions based on the U.S. Diabetes Prevention Program's curriculum were effective at promoting clinically significant weight loss of approximately 4% when applied in real-world settings, according to a meta-analysis.

The U.S. Diabetes Prevention Program conducted a clinical trial in 2002 showing that modest weight loss through caloric restriction and increased physical activity reduced the incidence of diabetes in high-risk patients by 58%. Weight loss was found to be the single most important factor in preventing diabetes from developing over the course of 3 years among patients who were at high risk for the disease. For every kilogram of weight lost, the incidence of diabetes decreased by 16%.

“Yet these results have not been 'translated' into routine clinical practice and public health policy,” said Dr. Mohammed K. Ali of Emory University, Atlanta, and his associates.

They performed what they described as the first meta-analysis of U.S. studies in which the structured intervention recommended by they Diabetes Prevention Program was applied to high-risk patients in real-world settings. The meta-analysis included 28 studies published in 2003–2011.

In all, 4 were randomized, controlled trials (RCTs), 2 were cluster RCTs, 20 were single-group studies comparing preintervention and postintervention weight, and 2 were nonrandomized, controlled studies.

Most of the studies were conducted in urban areas. In all, 12 were based in community centers, recreation centers, and church organizations, and 11 were based in health care facilities. The total number of patients was 2,916, and the median study duration was 1 year.

Across all the reviewed studies, the mean weight loss was 3.99%, which is considered clinically meaningful, Dr. Ali and his colleagues said (Health Aff. 2012 [doi:10.1377/hlthaff.2011.1009]).

Weight loss was comparable among programs that used medical and allied health professionals to implement the intervention (average 4.27% weight loss), programs that used lay community educators (3.15% weight loss), and programs that used electronic media-assisted interventions (4.20% weight loss).

Moreover, sensitivity analyses showed that programs with lay community educators achieved greater weight loss than those with medical and allied health professionals as educators. That finding “has enormous importance for the scalability and economic sustainability of diabetes interventions,” Dr. Ali and his colleagues noted, because lay educators required lower salaries and their training was neither costly nor time-consuming.

Programs that included more “core sessions” in which patients received counseling maintained the highest attendance rates. And higher attendance rates correlated positively with greater weight loss.

The rate of attrition varied greatly among the studies, ranging from 0% to 49%. In some studies that analyzed patient feedback, it appeared that attrition was more strongly related to patients' perceptions of their risk and to their readiness to change than it was to specific features of the intervention, such as the number of counseling sessions.

The weight-loss results of the U.S. Diabetes Prevention Program did not translate in real-world lifestyle interventions based on that DPP model, according to the meta-analysis.

Source Courtesy Bill Branson/National Cancer Institute

Major Finding: The mean weight loss across all 28 studies of lifestyle intervention programs was approximately 4%, which is considered clinically meaningful.

Data Source: A meta-analysis of 28 published U.S. studies (including 2,916 subjects) of lifestyle intervention programs incorporating the findings of the U.S. Diabetes Prevention Program to prevent diabetes by promoting weight loss.

Disclosures: No disclosure information was provided.

Structured lifestyle interventions based on the U.S. Diabetes Prevention Program's curriculum were effective at promoting clinically significant weight loss of approximately 4% when applied in real-world settings, according to a meta-analysis.

The U.S. Diabetes Prevention Program conducted a clinical trial in 2002 showing that modest weight loss through caloric restriction and increased physical activity reduced the incidence of diabetes in high-risk patients by 58%. Weight loss was found to be the single most important factor in preventing diabetes from developing over the course of 3 years among patients who were at high risk for the disease. For every kilogram of weight lost, the incidence of diabetes decreased by 16%.

“Yet these results have not been 'translated' into routine clinical practice and public health policy,” said Dr. Mohammed K. Ali of Emory University, Atlanta, and his associates.

They performed what they described as the first meta-analysis of U.S. studies in which the structured intervention recommended by they Diabetes Prevention Program was applied to high-risk patients in real-world settings. The meta-analysis included 28 studies published in 2003–2011.

In all, 4 were randomized, controlled trials (RCTs), 2 were cluster RCTs, 20 were single-group studies comparing preintervention and postintervention weight, and 2 were nonrandomized, controlled studies.

Most of the studies were conducted in urban areas. In all, 12 were based in community centers, recreation centers, and church organizations, and 11 were based in health care facilities. The total number of patients was 2,916, and the median study duration was 1 year.

Across all the reviewed studies, the mean weight loss was 3.99%, which is considered clinically meaningful, Dr. Ali and his colleagues said (Health Aff. 2012 [doi:10.1377/hlthaff.2011.1009]).

Weight loss was comparable among programs that used medical and allied health professionals to implement the intervention (average 4.27% weight loss), programs that used lay community educators (3.15% weight loss), and programs that used electronic media-assisted interventions (4.20% weight loss).

Moreover, sensitivity analyses showed that programs with lay community educators achieved greater weight loss than those with medical and allied health professionals as educators. That finding “has enormous importance for the scalability and economic sustainability of diabetes interventions,” Dr. Ali and his colleagues noted, because lay educators required lower salaries and their training was neither costly nor time-consuming.

Programs that included more “core sessions” in which patients received counseling maintained the highest attendance rates. And higher attendance rates correlated positively with greater weight loss.

The rate of attrition varied greatly among the studies, ranging from 0% to 49%. In some studies that analyzed patient feedback, it appeared that attrition was more strongly related to patients' perceptions of their risk and to their readiness to change than it was to specific features of the intervention, such as the number of counseling sessions.

The weight-loss results of the U.S. Diabetes Prevention Program did not translate in real-world lifestyle interventions based on that DPP model, according to the meta-analysis.

Source Courtesy Bill Branson/National Cancer Institute

Major Finding: Patients lost 78.5% of excess weight after Roux-en-Y gastric bypass vs. 64.8% after gastric banding; the treatment failure rate after 6 years was 2.5% vs. 38.9%, respectively.

Data Source: A retrospective matched-pair study of 221 Roux-en-Y gastric bypass patients and 221 gastric banding patients at a single center who were followed for at least 6 years.

Disclosures: No financial conflicts of interest were reported.

Roux-en-Y gastric bypass surgery resulted in greater, more rapid, and more sustained weight loss compared with gastric banding, but also a higher number of complications in a matched-pair study.

The weight loss advantage achieved with Roux-en-Y leads to better correction of the comorbidities that accompany obesity, such as adverse lipid profiles and high fasting glucose levels, said Dr. Sébastein Romy of the department of visceral surgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and his associates.

Although there are more early complications with the Roux-en-Y procedure, they are outweighed by “the much higher long-term major morbidity seen after gastric banding, leading to a large number of major reoperations and their risks,” the investigators noted.

The sharp rise in bariatric surgeries performed in recent years in the United States has occurred predominantly in gastric banding procedures. “This is probably because gastric banding is perceived both by doctors and patients as a simple, safe, and reversible operation but also because of a huge industry-driven marketing campaign,” they said.

Dr. Romy and his colleagues performed a matched-pair analysis of patients who underwent the two procedures in 1998–2005. The study subjects, who had failed to lose weight with more conservative approaches, all had a body mass index of 40 or more, or a BMI of 35 plus at least one severe comorbidity. A total of 221 patients who underwent Roux-en-Y gastric bypass were matched for age, sex, and BMI with 221 who underwent gastric banding. Follow-up rates after 6 years were about 92% in both groups. The same team performed the operations at the same two hospitals.

Maximal weight loss was achieved at a mean of 18 months after Roux-en-Y gastric bypass, compared with 36 months after gastric banding. The percentage of excess weight lost was significantly higher after Roux-en-Y (78.5%) than after gastric banding (64.8%), and the mean nadir in BMI was significantly lower (26.7 vs. 29.4, respectively). After 6 years, only 5 patients (2.4%) in the Roux-en-Y group had a BMI greater than 40, compared with 21 patients (13.8%) in the gastric banding group.

As a result, significantly more patients who had Roux-en-Y surgery were rated as having excellent or acceptable results at all time points during follow-up, Dr. Romy and his associates said (Arch. Surg. 2012 Jan. 16 [doi:10. 1001/archsurg.2011.1708]).

Treatment failures were defined as a weight loss of less than 25% of baseline weight or the need to reverse the surgery or convert to a different bariatric procedure. At the 3-year mark, there were no treatment failures among Roux-en-Y patients, compared with 39 treatment failures (18.2%) among gastric banding patients. After 6 years, failure rates were 2.5% and 38.9%, respectively, in Roux-en-Y and gastric banding patients.

Improvement in lipid profiles was significantly greater after Roux-en-Y than after gastric banding. Total cholesterol, LDL cholesterol, and triglyceride levels decreased after Roux-en-Y but not after gastric banding. Fasting glucose levels also were lower after Roux-en-Y (89.55 mg/dL vs. 92.79 mg/dL).

There were significantly more early complications after Roux-en-Y (17.2%) than after gastric banding (5.4%), most of which required only conservative treatment. In contrast, gastric banding was associated with significantly more long-term complications than was Roux-en-Y (41.6% vs. 19%) and required more than twice as many reoperations (26.7% vs. 12.7%).

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Still a Few Caveats for Roux-en-Y

“I personally agree” with Romy et al. that Roux-en-Y gastric bypass is the better procedure, but “before we make from this conclusion a paradigm, a few caveats remain,” said Dr. Jacques Himpens.

A case-control study such as this one may be biased. Even though a prospective randomized trial comparing the two surgeries isn't feasible, a prospective rather than retrospective comparison of matched patients would yield better evidence, as would a multicenter rather than a single-center study.

In addition, a growing number of Roux-en-Y patients are showing neuroglycopenia and diabetes recurrence several years after surgery, which is concerning.

DR. HIMPENS is at the European School of Laparoscopy at Saint Pierre University Hospital, Brussels. He reported being a consultant for Ethicon Endo-Surgery, Covidien, and Gore. These remarks were taken from his invited critique that accompanied Dr. Romy's article (Arch. Surg. 2012 Jan. 16 [doi:10.1001/archsurg.2011.1855]).

Major Finding: Patients lost 78.5% of excess weight after Roux-en-Y gastric bypass vs. 64.8% after gastric banding; the treatment failure rate after 6 years was 2.5% vs. 38.9%, respectively.

Data Source: A retrospective matched-pair study of 221 Roux-en-Y gastric bypass patients and 221 gastric banding patients at a single center who were followed for at least 6 years.

Disclosures: No financial conflicts of interest were reported.

Roux-en-Y gastric bypass surgery resulted in greater, more rapid, and more sustained weight loss compared with gastric banding, but also a higher number of complications in a matched-pair study.

The weight loss advantage achieved with Roux-en-Y leads to better correction of the comorbidities that accompany obesity, such as adverse lipid profiles and high fasting glucose levels, said Dr. Sébastein Romy of the department of visceral surgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and his associates.

Although there are more early complications with the Roux-en-Y procedure, they are outweighed by “the much higher long-term major morbidity seen after gastric banding, leading to a large number of major reoperations and their risks,” the investigators noted.

The sharp rise in bariatric surgeries performed in recent years in the United States has occurred predominantly in gastric banding procedures. “This is probably because gastric banding is perceived both by doctors and patients as a simple, safe, and reversible operation but also because of a huge industry-driven marketing campaign,” they said.

Dr. Romy and his colleagues performed a matched-pair analysis of patients who underwent the two procedures in 1998–2005. The study subjects, who had failed to lose weight with more conservative approaches, all had a body mass index of 40 or more, or a BMI of 35 plus at least one severe comorbidity. A total of 221 patients who underwent Roux-en-Y gastric bypass were matched for age, sex, and BMI with 221 who underwent gastric banding. Follow-up rates after 6 years were about 92% in both groups. The same team performed the operations at the same two hospitals.

Maximal weight loss was achieved at a mean of 18 months after Roux-en-Y gastric bypass, compared with 36 months after gastric banding. The percentage of excess weight lost was significantly higher after Roux-en-Y (78.5%) than after gastric banding (64.8%), and the mean nadir in BMI was significantly lower (26.7 vs. 29.4, respectively). After 6 years, only 5 patients (2.4%) in the Roux-en-Y group had a BMI greater than 40, compared with 21 patients (13.8%) in the gastric banding group.

As a result, significantly more patients who had Roux-en-Y surgery were rated as having excellent or acceptable results at all time points during follow-up, Dr. Romy and his associates said (Arch. Surg. 2012 Jan. 16 [doi:10. 1001/archsurg.2011.1708]).

Treatment failures were defined as a weight loss of less than 25% of baseline weight or the need to reverse the surgery or convert to a different bariatric procedure. At the 3-year mark, there were no treatment failures among Roux-en-Y patients, compared with 39 treatment failures (18.2%) among gastric banding patients. After 6 years, failure rates were 2.5% and 38.9%, respectively, in Roux-en-Y and gastric banding patients.

Improvement in lipid profiles was significantly greater after Roux-en-Y than after gastric banding. Total cholesterol, LDL cholesterol, and triglyceride levels decreased after Roux-en-Y but not after gastric banding. Fasting glucose levels also were lower after Roux-en-Y (89.55 mg/dL vs. 92.79 mg/dL).

There were significantly more early complications after Roux-en-Y (17.2%) than after gastric banding (5.4%), most of which required only conservative treatment. In contrast, gastric banding was associated with significantly more long-term complications than was Roux-en-Y (41.6% vs. 19%) and required more than twice as many reoperations (26.7% vs. 12.7%).

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Still a Few Caveats for Roux-en-Y

“I personally agree” with Romy et al. that Roux-en-Y gastric bypass is the better procedure, but “before we make from this conclusion a paradigm, a few caveats remain,” said Dr. Jacques Himpens.

A case-control study such as this one may be biased. Even though a prospective randomized trial comparing the two surgeries isn't feasible, a prospective rather than retrospective comparison of matched patients would yield better evidence, as would a multicenter rather than a single-center study.

In addition, a growing number of Roux-en-Y patients are showing neuroglycopenia and diabetes recurrence several years after surgery, which is concerning.

DR. HIMPENS is at the European School of Laparoscopy at Saint Pierre University Hospital, Brussels. He reported being a consultant for Ethicon Endo-Surgery, Covidien, and Gore. These remarks were taken from his invited critique that accompanied Dr. Romy's article (Arch. Surg. 2012 Jan. 16 [doi:10.1001/archsurg.2011.1855]).

Major Finding: Patients lost 78.5% of excess weight after Roux-en-Y gastric bypass vs. 64.8% after gastric banding; the treatment failure rate after 6 years was 2.5% vs. 38.9%, respectively.

Data Source: A retrospective matched-pair study of 221 Roux-en-Y gastric bypass patients and 221 gastric banding patients at a single center who were followed for at least 6 years.

Disclosures: No financial conflicts of interest were reported.

Roux-en-Y gastric bypass surgery resulted in greater, more rapid, and more sustained weight loss compared with gastric banding, but also a higher number of complications in a matched-pair study.

The weight loss advantage achieved with Roux-en-Y leads to better correction of the comorbidities that accompany obesity, such as adverse lipid profiles and high fasting glucose levels, said Dr. Sébastein Romy of the department of visceral surgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and his associates.

Although there are more early complications with the Roux-en-Y procedure, they are outweighed by “the much higher long-term major morbidity seen after gastric banding, leading to a large number of major reoperations and their risks,” the investigators noted.

The sharp rise in bariatric surgeries performed in recent years in the United States has occurred predominantly in gastric banding procedures. “This is probably because gastric banding is perceived both by doctors and patients as a simple, safe, and reversible operation but also because of a huge industry-driven marketing campaign,” they said.

Dr. Romy and his colleagues performed a matched-pair analysis of patients who underwent the two procedures in 1998–2005. The study subjects, who had failed to lose weight with more conservative approaches, all had a body mass index of 40 or more, or a BMI of 35 plus at least one severe comorbidity. A total of 221 patients who underwent Roux-en-Y gastric bypass were matched for age, sex, and BMI with 221 who underwent gastric banding. Follow-up rates after 6 years were about 92% in both groups. The same team performed the operations at the same two hospitals.

Maximal weight loss was achieved at a mean of 18 months after Roux-en-Y gastric bypass, compared with 36 months after gastric banding. The percentage of excess weight lost was significantly higher after Roux-en-Y (78.5%) than after gastric banding (64.8%), and the mean nadir in BMI was significantly lower (26.7 vs. 29.4, respectively). After 6 years, only 5 patients (2.4%) in the Roux-en-Y group had a BMI greater than 40, compared with 21 patients (13.8%) in the gastric banding group.

As a result, significantly more patients who had Roux-en-Y surgery were rated as having excellent or acceptable results at all time points during follow-up, Dr. Romy and his associates said (Arch. Surg. 2012 Jan. 16 [doi:10. 1001/archsurg.2011.1708]).

Treatment failures were defined as a weight loss of less than 25% of baseline weight or the need to reverse the surgery or convert to a different bariatric procedure. At the 3-year mark, there were no treatment failures among Roux-en-Y patients, compared with 39 treatment failures (18.2%) among gastric banding patients. After 6 years, failure rates were 2.5% and 38.9%, respectively, in Roux-en-Y and gastric banding patients.

Improvement in lipid profiles was significantly greater after Roux-en-Y than after gastric banding. Total cholesterol, LDL cholesterol, and triglyceride levels decreased after Roux-en-Y but not after gastric banding. Fasting glucose levels also were lower after Roux-en-Y (89.55 mg/dL vs. 92.79 mg/dL).

There were significantly more early complications after Roux-en-Y (17.2%) than after gastric banding (5.4%), most of which required only conservative treatment. In contrast, gastric banding was associated with significantly more long-term complications than was Roux-en-Y (41.6% vs. 19%) and required more than twice as many reoperations (26.7% vs. 12.7%).

View on the News

Still a Few Caveats for Roux-en-Y

“I personally agree” with Romy et al. that Roux-en-Y gastric bypass is the better procedure, but “before we make from this conclusion a paradigm, a few caveats remain,” said Dr. Jacques Himpens.

A case-control study such as this one may be biased. Even though a prospective randomized trial comparing the two surgeries isn't feasible, a prospective rather than retrospective comparison of matched patients would yield better evidence, as would a multicenter rather than a single-center study.

In addition, a growing number of Roux-en-Y patients are showing neuroglycopenia and diabetes recurrence several years after surgery, which is concerning.

DR. HIMPENS is at the European School of Laparoscopy at Saint Pierre University Hospital, Brussels. He reported being a consultant for Ethicon Endo-Surgery, Covidien, and Gore. These remarks were taken from his invited critique that accompanied Dr. Romy's article (Arch. Surg. 2012 Jan. 16 [doi:10.1001/archsurg.2011.1855]).

Rates of re-excision after initial breast-conserving surgery for invasive breast cancer vary greatly across surgeons and across medical centers, according to a report in the Feb. 1 issue of JAMA.

These variations are only partly explained by the basic clinical and demographic factors that dictate treatment decisions, such as tumor size and patient age. The remaining reasons for the profound differences in re-excision rates remain unexplained.

Nevertheless, these variations certainly are a barrier to consistent, high-quality, cost-effective care for breast cancer. "Outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care," said Dr. Laurence E. McCahill of the Richard J. Lacks Cancer Center, Van Andel Research Institute, and department of surgery at Michigan State University, Grand Rapids, and his associates.

Noting that "currently, there are no readily identifiable quality measures that allow for meaningful comparisons of breast cancer surgical outcomes among treating surgeons and hospitals," the investigators examined re-excision rates across four geographically diverse health systems. Their chief goal was to determine whether significant variations existed, which would in turn determine whether the re-excision rate is a meaningful measure of surgical quality.

They assessed detailed data on initial and subsequent surgeries for invasive ductal carcinoma or invasive lobular carcinoma in 2,206 women who underwent an initial breast-conserving procedure for incident cancer.

Overall, 509 patients (23%) underwent re-excision of the affected breast during 5 years of follow-up. A total of 454 women had a single re-excision, 48 had two re-excisions, and 7 had three re-excisions. Approximately 9% of the study subjects (190 women) underwent total mastectomy after the initial breast-conserving surgery.

The rate of re-excision varied greatly from one surgeon to another, ranging from 0% to 70%. This implies that patients with the same clinical presentations are likely to undergo re-excision based on who is doing their procedure, not on their clinical traits, the investigators said (JAMA 2012;307:467-75).

This study was designed to determine whether such variations exist, not the reasons why they exist. But the researchers suggested that "differences in surgical training, surgeon confidence in their operative technique in localizing tumors, utilization of intraoperative assessment of margins, and surgeon’s and pathologist’s coordination of specimen orientation and margin interpretation" may all play a role.

Surprisingly, the volume of procedures a surgeon performs did not affect his or her re-excision rate in this study, so surgical experience may not play an important role in these variations, Dr. McCahill and his colleagues added.

The rate of re-excision also varied greatly from one medical center to another, ranging from 1.7% at the center with the lowest rate to 21% at the center with the highest rate. In particular, the rate of re-excision for cases with positive margins ranged from 74% to 94%. Any variation in this statistic is surprising because positive margins are known to correlate with local recurrence and are "almost always" re-excised, the researchers said.

Again, this study was not designed to determine why re-excision rates differ so greatly between medical centers, but the investigators suggested that "institutional variation in surgeon’s training, regional variation in interpretation of the required criteria for [re-excision], or both" may account, at least in part, for the variation.

The need for re-excision in patients who have negative (pathologically clear) margins at the initial surgery is controversial, because "there is no clear consensus on the appropriate distance required for a clear margin to be deemed adequate." So perhaps it should not be surprising that almost half of the re-excisions (242 of the 509) in this study were performed in patients who had negative margins, the researchers said.

One major limitation of this study was that some factors that greatly influence treatment decisions, including patient preferences, were not included in the data and so could not be factored into the analysis, they noted.

This study was funded by the National Institutes of Health under the American Recovery and Reinvestment Act. The authors reported no financial conflicts of interest.

Rates of re-excision after initial breast-conserving surgery for invasive breast cancer vary greatly across surgeons and across medical centers, according to a report in the Feb. 1 issue of JAMA.

These variations are only partly explained by the basic clinical and demographic factors that dictate treatment decisions, such as tumor size and patient age. The remaining reasons for the profound differences in re-excision rates remain unexplained.

Nevertheless, these variations certainly are a barrier to consistent, high-quality, cost-effective care for breast cancer. "Outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care," said Dr. Laurence E. McCahill of the Richard J. Lacks Cancer Center, Van Andel Research Institute, and department of surgery at Michigan State University, Grand Rapids, and his associates.

Noting that "currently, there are no readily identifiable quality measures that allow for meaningful comparisons of breast cancer surgical outcomes among treating surgeons and hospitals," the investigators examined re-excision rates across four geographically diverse health systems. Their chief goal was to determine whether significant variations existed, which would in turn determine whether the re-excision rate is a meaningful measure of surgical quality.

They assessed detailed data on initial and subsequent surgeries for invasive ductal carcinoma or invasive lobular carcinoma in 2,206 women who underwent an initial breast-conserving procedure for incident cancer.

Overall, 509 patients (23%) underwent re-excision of the affected breast during 5 years of follow-up. A total of 454 women had a single re-excision, 48 had two re-excisions, and 7 had three re-excisions. Approximately 9% of the study subjects (190 women) underwent total mastectomy after the initial breast-conserving surgery.

The rate of re-excision varied greatly from one surgeon to another, ranging from 0% to 70%. This implies that patients with the same clinical presentations are likely to undergo re-excision based on who is doing their procedure, not on their clinical traits, the investigators said (JAMA 2012;307:467-75).

This study was designed to determine whether such variations exist, not the reasons why they exist. But the researchers suggested that "differences in surgical training, surgeon confidence in their operative technique in localizing tumors, utilization of intraoperative assessment of margins, and surgeon’s and pathologist’s coordination of specimen orientation and margin interpretation" may all play a role.

Surprisingly, the volume of procedures a surgeon performs did not affect his or her re-excision rate in this study, so surgical experience may not play an important role in these variations, Dr. McCahill and his colleagues added.

The rate of re-excision also varied greatly from one medical center to another, ranging from 1.7% at the center with the lowest rate to 21% at the center with the highest rate. In particular, the rate of re-excision for cases with positive margins ranged from 74% to 94%. Any variation in this statistic is surprising because positive margins are known to correlate with local recurrence and are "almost always" re-excised, the researchers said.

Again, this study was not designed to determine why re-excision rates differ so greatly between medical centers, but the investigators suggested that "institutional variation in surgeon’s training, regional variation in interpretation of the required criteria for [re-excision], or both" may account, at least in part, for the variation.

The need for re-excision in patients who have negative (pathologically clear) margins at the initial surgery is controversial, because "there is no clear consensus on the appropriate distance required for a clear margin to be deemed adequate." So perhaps it should not be surprising that almost half of the re-excisions (242 of the 509) in this study were performed in patients who had negative margins, the researchers said.

One major limitation of this study was that some factors that greatly influence treatment decisions, including patient preferences, were not included in the data and so could not be factored into the analysis, they noted.

This study was funded by the National Institutes of Health under the American Recovery and Reinvestment Act. The authors reported no financial conflicts of interest.

Rates of re-excision after initial breast-conserving surgery for invasive breast cancer vary greatly across surgeons and across medical centers, according to a report in the Feb. 1 issue of JAMA.

These variations are only partly explained by the basic clinical and demographic factors that dictate treatment decisions, such as tumor size and patient age. The remaining reasons for the profound differences in re-excision rates remain unexplained.

Nevertheless, these variations certainly are a barrier to consistent, high-quality, cost-effective care for breast cancer. "Outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care," said Dr. Laurence E. McCahill of the Richard J. Lacks Cancer Center, Van Andel Research Institute, and department of surgery at Michigan State University, Grand Rapids, and his associates.

Noting that "currently, there are no readily identifiable quality measures that allow for meaningful comparisons of breast cancer surgical outcomes among treating surgeons and hospitals," the investigators examined re-excision rates across four geographically diverse health systems. Their chief goal was to determine whether significant variations existed, which would in turn determine whether the re-excision rate is a meaningful measure of surgical quality.

They assessed detailed data on initial and subsequent surgeries for invasive ductal carcinoma or invasive lobular carcinoma in 2,206 women who underwent an initial breast-conserving procedure for incident cancer.

Overall, 509 patients (23%) underwent re-excision of the affected breast during 5 years of follow-up. A total of 454 women had a single re-excision, 48 had two re-excisions, and 7 had three re-excisions. Approximately 9% of the study subjects (190 women) underwent total mastectomy after the initial breast-conserving surgery.

The rate of re-excision varied greatly from one surgeon to another, ranging from 0% to 70%. This implies that patients with the same clinical presentations are likely to undergo re-excision based on who is doing their procedure, not on their clinical traits, the investigators said (JAMA 2012;307:467-75).

This study was designed to determine whether such variations exist, not the reasons why they exist. But the researchers suggested that "differences in surgical training, surgeon confidence in their operative technique in localizing tumors, utilization of intraoperative assessment of margins, and surgeon’s and pathologist’s coordination of specimen orientation and margin interpretation" may all play a role.

Surprisingly, the volume of procedures a surgeon performs did not affect his or her re-excision rate in this study, so surgical experience may not play an important role in these variations, Dr. McCahill and his colleagues added.

The rate of re-excision also varied greatly from one medical center to another, ranging from 1.7% at the center with the lowest rate to 21% at the center with the highest rate. In particular, the rate of re-excision for cases with positive margins ranged from 74% to 94%. Any variation in this statistic is surprising because positive margins are known to correlate with local recurrence and are "almost always" re-excised, the researchers said.

Again, this study was not designed to determine why re-excision rates differ so greatly between medical centers, but the investigators suggested that "institutional variation in surgeon’s training, regional variation in interpretation of the required criteria for [re-excision], or both" may account, at least in part, for the variation.

The need for re-excision in patients who have negative (pathologically clear) margins at the initial surgery is controversial, because "there is no clear consensus on the appropriate distance required for a clear margin to be deemed adequate." So perhaps it should not be surprising that almost half of the re-excisions (242 of the 509) in this study were performed in patients who had negative margins, the researchers said.

One major limitation of this study was that some factors that greatly influence treatment decisions, including patient preferences, were not included in the data and so could not be factored into the analysis, they noted.

This study was funded by the National Institutes of Health under the American Recovery and Reinvestment Act. The authors reported no financial conflicts of interest.

Emergency departments at "safety-net" hospitals showed timelines similar to those of EDs in other hospitals for admitting, discharging, or transferring patients, according to a national survey published in the Feb. 1 issue of JAMA.

Several measures of ED length of stay have been proposed as indicators of quality of care, including the interval from patient arrival to admission and the interval from admission to discharge or transfer to another facility. Some organizations have suggested that length of stay before discharge should be less than 4 hours and length of stay before admission should be less than 8 hours.

EDs that fail to meet these deadlines would be considered poor performers, and EDs at safety-net hospitals – which provide a disproportionate share of services to poor, uninsured, and Medicaid patients – might be singled out unfairly. "If these measures are tied to pay-for-performance, chronically underfunded safety-net EDs could be at risk of further reductions in funding, which could only exacerbate the lack of resources available in those settings," said Dr. Christopher Fee of the department of emergency medicine, University of California, San Francisco, and his associates.

To examine the issue, the investigators assessed length of stay measures for 24,719 adult ED visits at hospitals across the United States in 2008, the most recent year for which data are available. They used data from the annual National Hospital Ambulatory Medical Care Survey conducted by the Centers for Disease Control and Prevention’s National Center for Health Statistics.

Approximately 42% of these visits were to safety-net EDs and 58% were to non–safety-net EDs.

There were no significant differences between these two types of EDs in any of the median length of stay measures assessed. "Our results show that both safety-net and non–safety-net EDs perform well on the ED length of stay goals that have been proposed, with median ED lengths of stay ... well under 8 hours for admissions and under 4 hours for discharges," Dr. Fee and his colleagues said (JAMA 2012;307:476-82).

The overall length of stay was 269 minutes for safety-net EDs and 281 minutes for non–safety-net EDs. The overall length of stay for critical care admissions was 236 minutes and 248 minutes, respectively.

For discharged patients, the median ED length of stay was 156 minutes in safety-net EDs and 148 minutes in non–safety-net EDs.

It is important to note that although these data are the most current available, they were collected before the economic recession. The recession may well have increased the uninsured and Medicaid populations, which may have affected ED visit volume and length of stay. In addition, the "effects of the sweeping health care reform currently under way remain to be seen," the investigators said.

This study was supported by a grant from the National Institutes of Health/National Center for Research Resources/University of California, San Francisco Clinical and Translational Science Institute and the Robert Wood Johnson Foundation Physician Faculty Scholars Program. Dr. Fee reported ties to Google, and a coauthor is an employee of the National Quality Forum.

Emergency departments at "safety-net" hospitals showed timelines similar to those of EDs in other hospitals for admitting, discharging, or transferring patients, according to a national survey published in the Feb. 1 issue of JAMA.

Several measures of ED length of stay have been proposed as indicators of quality of care, including the interval from patient arrival to admission and the interval from admission to discharge or transfer to another facility. Some organizations have suggested that length of stay before discharge should be less than 4 hours and length of stay before admission should be less than 8 hours.

EDs that fail to meet these deadlines would be considered poor performers, and EDs at safety-net hospitals – which provide a disproportionate share of services to poor, uninsured, and Medicaid patients – might be singled out unfairly. "If these measures are tied to pay-for-performance, chronically underfunded safety-net EDs could be at risk of further reductions in funding, which could only exacerbate the lack of resources available in those settings," said Dr. Christopher Fee of the department of emergency medicine, University of California, San Francisco, and his associates.

To examine the issue, the investigators assessed length of stay measures for 24,719 adult ED visits at hospitals across the United States in 2008, the most recent year for which data are available. They used data from the annual National Hospital Ambulatory Medical Care Survey conducted by the Centers for Disease Control and Prevention’s National Center for Health Statistics.

Approximately 42% of these visits were to safety-net EDs and 58% were to non–safety-net EDs.

There were no significant differences between these two types of EDs in any of the median length of stay measures assessed. "Our results show that both safety-net and non–safety-net EDs perform well on the ED length of stay goals that have been proposed, with median ED lengths of stay ... well under 8 hours for admissions and under 4 hours for discharges," Dr. Fee and his colleagues said (JAMA 2012;307:476-82).

The overall length of stay was 269 minutes for safety-net EDs and 281 minutes for non–safety-net EDs. The overall length of stay for critical care admissions was 236 minutes and 248 minutes, respectively.

For discharged patients, the median ED length of stay was 156 minutes in safety-net EDs and 148 minutes in non–safety-net EDs.

It is important to note that although these data are the most current available, they were collected before the economic recession. The recession may well have increased the uninsured and Medicaid populations, which may have affected ED visit volume and length of stay. In addition, the "effects of the sweeping health care reform currently under way remain to be seen," the investigators said.

This study was supported by a grant from the National Institutes of Health/National Center for Research Resources/University of California, San Francisco Clinical and Translational Science Institute and the Robert Wood Johnson Foundation Physician Faculty Scholars Program. Dr. Fee reported ties to Google, and a coauthor is an employee of the National Quality Forum.

Emergency departments at "safety-net" hospitals showed timelines similar to those of EDs in other hospitals for admitting, discharging, or transferring patients, according to a national survey published in the Feb. 1 issue of JAMA.

Several measures of ED length of stay have been proposed as indicators of quality of care, including the interval from patient arrival to admission and the interval from admission to discharge or transfer to another facility. Some organizations have suggested that length of stay before discharge should be less than 4 hours and length of stay before admission should be less than 8 hours.

EDs that fail to meet these deadlines would be considered poor performers, and EDs at safety-net hospitals – which provide a disproportionate share of services to poor, uninsured, and Medicaid patients – might be singled out unfairly. "If these measures are tied to pay-for-performance, chronically underfunded safety-net EDs could be at risk of further reductions in funding, which could only exacerbate the lack of resources available in those settings," said Dr. Christopher Fee of the department of emergency medicine, University of California, San Francisco, and his associates.

To examine the issue, the investigators assessed length of stay measures for 24,719 adult ED visits at hospitals across the United States in 2008, the most recent year for which data are available. They used data from the annual National Hospital Ambulatory Medical Care Survey conducted by the Centers for Disease Control and Prevention’s National Center for Health Statistics.

Approximately 42% of these visits were to safety-net EDs and 58% were to non–safety-net EDs.

There were no significant differences between these two types of EDs in any of the median length of stay measures assessed. "Our results show that both safety-net and non–safety-net EDs perform well on the ED length of stay goals that have been proposed, with median ED lengths of stay ... well under 8 hours for admissions and under 4 hours for discharges," Dr. Fee and his colleagues said (JAMA 2012;307:476-82).

The overall length of stay was 269 minutes for safety-net EDs and 281 minutes for non–safety-net EDs. The overall length of stay for critical care admissions was 236 minutes and 248 minutes, respectively.

For discharged patients, the median ED length of stay was 156 minutes in safety-net EDs and 148 minutes in non–safety-net EDs.

It is important to note that although these data are the most current available, they were collected before the economic recession. The recession may well have increased the uninsured and Medicaid populations, which may have affected ED visit volume and length of stay. In addition, the "effects of the sweeping health care reform currently under way remain to be seen," the investigators said.

This study was supported by a grant from the National Institutes of Health/National Center for Research Resources/University of California, San Francisco Clinical and Translational Science Institute and the Robert Wood Johnson Foundation Physician Faculty Scholars Program. Dr. Fee reported ties to Google, and a coauthor is an employee of the National Quality Forum.