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Severity of obesity matters in pediatric population
Children and adolescents with more severe obesity show a higher prevalence of cardiometabolic abnormalities than those with less severe obesity, so differentiating among levels of obesity is important in the pediatric population, according to a report published online Oct. 1 in New England Journal of Medicine.
Current screening guidelines for pediatric patients use only a single category for obesity, which doesn’t take into account their varying levels of risk for obesity-related disorders. To assess the distribution of cardiometabolic risk factors in obese children and adolescents, researchers performed a cross-sectional analysis of data from the National Health and Nutrition Examination Survey for 2011-2012.
They assessed a nationally representative sample of 8,579 participants aged 3-19 years, categorizing them by age- and gender-specific body mass index percentiles: overweight (85th-94th percentile), class I obesity (95th percentile to 119% of the 95th percentile), class II obesity (120% to 139% of the 95th percentile, or BMI of 35-39, whichever was lower), or class III obesity (140% of the 95th percentile, or BMI of 40 or greater, whichever was lower).
A total of 47% of the study participants were overweight, 36% had class I obesity, 12% had class II obesity, and 5% had class III obesity. The prevalence of abnormal values for total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, systolic BP, diastolic BP, glycated hemoglobin, and fasting glucose all increased with increasing severity of obesity, at most ages and across both genders. The correlations were more pronounced in boys than in girls, said Asheley C. Skinner, Ph.D., of the department of pediatrics and the department of health policy and management, University of North Carolina at Chapel Hill, and her associates.
The findings indicate that distinguishing among at least three levels of obesity severity “provides a more fine-tuned approach to identifying patients with the greatest risk of potential complications and death,” allowing targeted interventions to those at greatest risk. This is especially important because resources are too limited to provide services for every child with obesity, the investigators said (N Engl J Med. 2015 Oct 1. doi:10.1056/NEJMoa1502821). “As older adolescents transition to young adulthood, the recognition that teens with obesity have increased cardiometabolic risk will be important,” they added.
This study did not specify a source of funding. Dr. Skinner reported having no relevant financial disclosures; one of her associates reported receiving personal fees from Nestle unrelated to this work.
Children and adolescents with more severe obesity show a higher prevalence of cardiometabolic abnormalities than those with less severe obesity, so differentiating among levels of obesity is important in the pediatric population, according to a report published online Oct. 1 in New England Journal of Medicine.
Current screening guidelines for pediatric patients use only a single category for obesity, which doesn’t take into account their varying levels of risk for obesity-related disorders. To assess the distribution of cardiometabolic risk factors in obese children and adolescents, researchers performed a cross-sectional analysis of data from the National Health and Nutrition Examination Survey for 2011-2012.
They assessed a nationally representative sample of 8,579 participants aged 3-19 years, categorizing them by age- and gender-specific body mass index percentiles: overweight (85th-94th percentile), class I obesity (95th percentile to 119% of the 95th percentile), class II obesity (120% to 139% of the 95th percentile, or BMI of 35-39, whichever was lower), or class III obesity (140% of the 95th percentile, or BMI of 40 or greater, whichever was lower).
A total of 47% of the study participants were overweight, 36% had class I obesity, 12% had class II obesity, and 5% had class III obesity. The prevalence of abnormal values for total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, systolic BP, diastolic BP, glycated hemoglobin, and fasting glucose all increased with increasing severity of obesity, at most ages and across both genders. The correlations were more pronounced in boys than in girls, said Asheley C. Skinner, Ph.D., of the department of pediatrics and the department of health policy and management, University of North Carolina at Chapel Hill, and her associates.
The findings indicate that distinguishing among at least three levels of obesity severity “provides a more fine-tuned approach to identifying patients with the greatest risk of potential complications and death,” allowing targeted interventions to those at greatest risk. This is especially important because resources are too limited to provide services for every child with obesity, the investigators said (N Engl J Med. 2015 Oct 1. doi:10.1056/NEJMoa1502821). “As older adolescents transition to young adulthood, the recognition that teens with obesity have increased cardiometabolic risk will be important,” they added.
This study did not specify a source of funding. Dr. Skinner reported having no relevant financial disclosures; one of her associates reported receiving personal fees from Nestle unrelated to this work.
Children and adolescents with more severe obesity show a higher prevalence of cardiometabolic abnormalities than those with less severe obesity, so differentiating among levels of obesity is important in the pediatric population, according to a report published online Oct. 1 in New England Journal of Medicine.
Current screening guidelines for pediatric patients use only a single category for obesity, which doesn’t take into account their varying levels of risk for obesity-related disorders. To assess the distribution of cardiometabolic risk factors in obese children and adolescents, researchers performed a cross-sectional analysis of data from the National Health and Nutrition Examination Survey for 2011-2012.
They assessed a nationally representative sample of 8,579 participants aged 3-19 years, categorizing them by age- and gender-specific body mass index percentiles: overweight (85th-94th percentile), class I obesity (95th percentile to 119% of the 95th percentile), class II obesity (120% to 139% of the 95th percentile, or BMI of 35-39, whichever was lower), or class III obesity (140% of the 95th percentile, or BMI of 40 or greater, whichever was lower).
A total of 47% of the study participants were overweight, 36% had class I obesity, 12% had class II obesity, and 5% had class III obesity. The prevalence of abnormal values for total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, systolic BP, diastolic BP, glycated hemoglobin, and fasting glucose all increased with increasing severity of obesity, at most ages and across both genders. The correlations were more pronounced in boys than in girls, said Asheley C. Skinner, Ph.D., of the department of pediatrics and the department of health policy and management, University of North Carolina at Chapel Hill, and her associates.
The findings indicate that distinguishing among at least three levels of obesity severity “provides a more fine-tuned approach to identifying patients with the greatest risk of potential complications and death,” allowing targeted interventions to those at greatest risk. This is especially important because resources are too limited to provide services for every child with obesity, the investigators said (N Engl J Med. 2015 Oct 1. doi:10.1056/NEJMoa1502821). “As older adolescents transition to young adulthood, the recognition that teens with obesity have increased cardiometabolic risk will be important,” they added.
This study did not specify a source of funding. Dr. Skinner reported having no relevant financial disclosures; one of her associates reported receiving personal fees from Nestle unrelated to this work.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Children and adolescents with more severe obesity show a higher prevalence of cardiometabolic abnormalities, so differentiating among levels of obesity is important in the pediatric population.
Major finding: Forty-seven percent of the study participants were overweight, 36% had class I obesity, 12% had class II obesity, and 5% had class III obesity.
Data source: A cross-sectional analysis of NHANES data concerning 8,579 overweight/obese participants aged 3-19 years.
Disclosures: This study did not specify a source of funding. Dr. Skinner reported having no relevant financial disclosures; one of her associates reported receiving personal fees from Nestle unrelated to this work.
New composite measure improves warfarin anticoagulation monitoring
A new composite measure that incorporates both time in therapeutic range and international normalized ratio variability appears to be more accurate than either of these tests alone at monitoring warfarin anticoagulation, according to a report published online Sept. 29 in Circulation: Cardiovascular Quality and Outcomes.
Time in therapeutic range (TTR) and international normalized ratio (INR) variability track two different aspects of anticoagulation control. TTR measures the percentage of time that patients spend within the therapeutic range while taking warfarin, which reflects the amount of time that treatment intensity was appropriate. INR variability measures variations in the stability of warfarin’s anticoagulation effects over time. Most clinicians monitor their patients using one or the other of these measures, usually TTR. A composite measure that combines the two “would encourage providers to focus on all components of anticoagulation control, not just those measured by the current standard of care, TTR,” said Dr. Zayd Razouki of the Center for Health Services Research in Primary Care, Durham (N.C.) Veterans Affairs Medical Center, and his associates.
It is important to note that a substantial number of patients taking warfarin could be classified as having poor control of anticoagulation by one of these measures, but good control by the other. Combining TTR with INR variability would ensure that both appropriate intensity and appropriate stability of warfarin therapy were being used to judge each patient’s anticoagulation control, they noted.
The investigators devised such a measure, a summary score they called WCM (warfarin composite measure). They then compared the performance of all three measures at predicting major warfarin-related complications, using as a sample population 40,404 participants in the Veterans Affairs Study to Improve Anticoagulation (VARIA). These study subjects were aged 65 years or older (mean age 76), had been taking warfarin for at least 6 months to treat atrial fibrillation, and were followed for an average of 14 months for the development of ischemic stroke, major bleeding, and fatal bleeding.
A total of 3.1% of these patients developed ischemic stroke, 6.4% developed major bleeding, and 0.9% developed fatal bleeding while taking warfarin. After the data were adjusted to account for numerous potential confounding factors, WCM correlated most closely with risk for adverse warfarin-related clinical events, Dr. Razouki and his associates wrote (Circ Cardiovasc Qual Outcomes. 2015 Sep 29. doi:10.1161/circoutcomes.115.001789).
Their findings also indicate that WCM may be a more accurate measure of a clinic’s or a medical system’s performance at monitoring anticoagulation than either their average TTR or INR variability alone.
The study results may not be generalizable to all populations, because this VA sample was overwhelmingly male (98%), the investigators added.
A new composite measure that incorporates both time in therapeutic range and international normalized ratio variability appears to be more accurate than either of these tests alone at monitoring warfarin anticoagulation, according to a report published online Sept. 29 in Circulation: Cardiovascular Quality and Outcomes.
Time in therapeutic range (TTR) and international normalized ratio (INR) variability track two different aspects of anticoagulation control. TTR measures the percentage of time that patients spend within the therapeutic range while taking warfarin, which reflects the amount of time that treatment intensity was appropriate. INR variability measures variations in the stability of warfarin’s anticoagulation effects over time. Most clinicians monitor their patients using one or the other of these measures, usually TTR. A composite measure that combines the two “would encourage providers to focus on all components of anticoagulation control, not just those measured by the current standard of care, TTR,” said Dr. Zayd Razouki of the Center for Health Services Research in Primary Care, Durham (N.C.) Veterans Affairs Medical Center, and his associates.
It is important to note that a substantial number of patients taking warfarin could be classified as having poor control of anticoagulation by one of these measures, but good control by the other. Combining TTR with INR variability would ensure that both appropriate intensity and appropriate stability of warfarin therapy were being used to judge each patient’s anticoagulation control, they noted.
The investigators devised such a measure, a summary score they called WCM (warfarin composite measure). They then compared the performance of all three measures at predicting major warfarin-related complications, using as a sample population 40,404 participants in the Veterans Affairs Study to Improve Anticoagulation (VARIA). These study subjects were aged 65 years or older (mean age 76), had been taking warfarin for at least 6 months to treat atrial fibrillation, and were followed for an average of 14 months for the development of ischemic stroke, major bleeding, and fatal bleeding.
A total of 3.1% of these patients developed ischemic stroke, 6.4% developed major bleeding, and 0.9% developed fatal bleeding while taking warfarin. After the data were adjusted to account for numerous potential confounding factors, WCM correlated most closely with risk for adverse warfarin-related clinical events, Dr. Razouki and his associates wrote (Circ Cardiovasc Qual Outcomes. 2015 Sep 29. doi:10.1161/circoutcomes.115.001789).
Their findings also indicate that WCM may be a more accurate measure of a clinic’s or a medical system’s performance at monitoring anticoagulation than either their average TTR or INR variability alone.
The study results may not be generalizable to all populations, because this VA sample was overwhelmingly male (98%), the investigators added.
A new composite measure that incorporates both time in therapeutic range and international normalized ratio variability appears to be more accurate than either of these tests alone at monitoring warfarin anticoagulation, according to a report published online Sept. 29 in Circulation: Cardiovascular Quality and Outcomes.
Time in therapeutic range (TTR) and international normalized ratio (INR) variability track two different aspects of anticoagulation control. TTR measures the percentage of time that patients spend within the therapeutic range while taking warfarin, which reflects the amount of time that treatment intensity was appropriate. INR variability measures variations in the stability of warfarin’s anticoagulation effects over time. Most clinicians monitor their patients using one or the other of these measures, usually TTR. A composite measure that combines the two “would encourage providers to focus on all components of anticoagulation control, not just those measured by the current standard of care, TTR,” said Dr. Zayd Razouki of the Center for Health Services Research in Primary Care, Durham (N.C.) Veterans Affairs Medical Center, and his associates.
It is important to note that a substantial number of patients taking warfarin could be classified as having poor control of anticoagulation by one of these measures, but good control by the other. Combining TTR with INR variability would ensure that both appropriate intensity and appropriate stability of warfarin therapy were being used to judge each patient’s anticoagulation control, they noted.
The investigators devised such a measure, a summary score they called WCM (warfarin composite measure). They then compared the performance of all three measures at predicting major warfarin-related complications, using as a sample population 40,404 participants in the Veterans Affairs Study to Improve Anticoagulation (VARIA). These study subjects were aged 65 years or older (mean age 76), had been taking warfarin for at least 6 months to treat atrial fibrillation, and were followed for an average of 14 months for the development of ischemic stroke, major bleeding, and fatal bleeding.
A total of 3.1% of these patients developed ischemic stroke, 6.4% developed major bleeding, and 0.9% developed fatal bleeding while taking warfarin. After the data were adjusted to account for numerous potential confounding factors, WCM correlated most closely with risk for adverse warfarin-related clinical events, Dr. Razouki and his associates wrote (Circ Cardiovasc Qual Outcomes. 2015 Sep 29. doi:10.1161/circoutcomes.115.001789).
Their findings also indicate that WCM may be a more accurate measure of a clinic’s or a medical system’s performance at monitoring anticoagulation than either their average TTR or INR variability alone.
The study results may not be generalizable to all populations, because this VA sample was overwhelmingly male (98%), the investigators added.
FROM CIRCULATION: CARDIOVASCULAR QUALITY AND OUTCOMES
Key clinical point: A composite measure that combines TTR with INR variability appears more accurate than either of these individual tests at monitoring warfarin anticoagulation.
Major finding: Of the participants, 3.1% developed ischemic stroke, 6.4% developed major bleeding, and 0.9% developed fatal bleeding while taking warfarin.
Data source: A secondary analysis of data from the Veterans Affairs Study to Improve Anticoagulation, involving 40,404 VA patients taking warfarin for AF during a 2-year period.
Disclosures: This study was supported by the Durham VA Medical Center and VA Health Service Research and Development. Dr. Razouki and his associates reported having no relevant financial disclosures.
Study shows 23% of men don’t discuss male sex partners until HIV diagnosis
Twenty-three percent of men who tested positive for HIV at three North Carolina STD clinics initially hid the fact that they had sex with other men, according to a report published Sept. 25 in Morbidity and Mortality Weekly Reports.
As part of a prospective study assessing HIV diagnosis at 12 STD clinics in New York City, San Francisco, and North Carolina, 113 men being tested at the North Carolina sites were first asked about their sexual partners during pretest counseling and were then asked again during a partner services interview after their HIV-positive diagnosis. Most of these men were young (median age, 24 years) and African American (85%), noted Dr. Hsiu Wu, an epidemic intelligence service officer at the Centers for Disease Control and Prevention, Atlanta, and her associates.
Twenty-six of these men did not disclose having male sex partners at the initial visit but did so at the subsequent visit. Compared with men who did initially disclose their sexual contact with other men, these 26 men were over four times more likely to have reported having at least one female partner (30.8% vs. 6.9%). Other studies have shown that men who identify as bisexual or heterosexual are less likely than are those who identify as homosexual to report same-sex behaviors, the investigators said (MMWR 2015;64[37]:1037-41).
The 26 men reported having the same number of sexual partners as did the men who initially disclosed their homosexual activity, and many of them “shared sexual networks with other participants ... who also had newly diagnosed HIV infection.” This suggests there were missed opportunities to deliver effective prevention services. It also “highlights the importance of accurately identifying risks among this population, which remains the population most affected by HIV infection,” Dr. Wu and her associates reported.
They suggested that HIV prevention programs implement strategies to assess risk more accurately by customizing certain testing venues for young African American men who have sex with men, using technology such as mobile devices or tablet computers to administer more private risk screening, and educating the public about the benefits of new HIV prevention strategies such as PrEP.
Twenty-three percent of men who tested positive for HIV at three North Carolina STD clinics initially hid the fact that they had sex with other men, according to a report published Sept. 25 in Morbidity and Mortality Weekly Reports.
As part of a prospective study assessing HIV diagnosis at 12 STD clinics in New York City, San Francisco, and North Carolina, 113 men being tested at the North Carolina sites were first asked about their sexual partners during pretest counseling and were then asked again during a partner services interview after their HIV-positive diagnosis. Most of these men were young (median age, 24 years) and African American (85%), noted Dr. Hsiu Wu, an epidemic intelligence service officer at the Centers for Disease Control and Prevention, Atlanta, and her associates.
Twenty-six of these men did not disclose having male sex partners at the initial visit but did so at the subsequent visit. Compared with men who did initially disclose their sexual contact with other men, these 26 men were over four times more likely to have reported having at least one female partner (30.8% vs. 6.9%). Other studies have shown that men who identify as bisexual or heterosexual are less likely than are those who identify as homosexual to report same-sex behaviors, the investigators said (MMWR 2015;64[37]:1037-41).
The 26 men reported having the same number of sexual partners as did the men who initially disclosed their homosexual activity, and many of them “shared sexual networks with other participants ... who also had newly diagnosed HIV infection.” This suggests there were missed opportunities to deliver effective prevention services. It also “highlights the importance of accurately identifying risks among this population, which remains the population most affected by HIV infection,” Dr. Wu and her associates reported.
They suggested that HIV prevention programs implement strategies to assess risk more accurately by customizing certain testing venues for young African American men who have sex with men, using technology such as mobile devices or tablet computers to administer more private risk screening, and educating the public about the benefits of new HIV prevention strategies such as PrEP.
Twenty-three percent of men who tested positive for HIV at three North Carolina STD clinics initially hid the fact that they had sex with other men, according to a report published Sept. 25 in Morbidity and Mortality Weekly Reports.
As part of a prospective study assessing HIV diagnosis at 12 STD clinics in New York City, San Francisco, and North Carolina, 113 men being tested at the North Carolina sites were first asked about their sexual partners during pretest counseling and were then asked again during a partner services interview after their HIV-positive diagnosis. Most of these men were young (median age, 24 years) and African American (85%), noted Dr. Hsiu Wu, an epidemic intelligence service officer at the Centers for Disease Control and Prevention, Atlanta, and her associates.
Twenty-six of these men did not disclose having male sex partners at the initial visit but did so at the subsequent visit. Compared with men who did initially disclose their sexual contact with other men, these 26 men were over four times more likely to have reported having at least one female partner (30.8% vs. 6.9%). Other studies have shown that men who identify as bisexual or heterosexual are less likely than are those who identify as homosexual to report same-sex behaviors, the investigators said (MMWR 2015;64[37]:1037-41).
The 26 men reported having the same number of sexual partners as did the men who initially disclosed their homosexual activity, and many of them “shared sexual networks with other participants ... who also had newly diagnosed HIV infection.” This suggests there were missed opportunities to deliver effective prevention services. It also “highlights the importance of accurately identifying risks among this population, which remains the population most affected by HIV infection,” Dr. Wu and her associates reported.
They suggested that HIV prevention programs implement strategies to assess risk more accurately by customizing certain testing venues for young African American men who have sex with men, using technology such as mobile devices or tablet computers to administer more private risk screening, and educating the public about the benefits of new HIV prevention strategies such as PrEP.
FROM MMWR
Key clinical point: Twenty-three percent of men tested for HIV at three North Carolina STD clinics initially hid the fact that they had sex with other men.
Major finding: In a study of 113 men, 26 did not disclose having male sex partners at their initial clinic visits but did so at the subsequent visit, after being diagnosed as HIV-positive.
Data source: An observational cohort study of men who tested positive for HIV at three North Carolina STD clinics during a 2-year period.
Disclosures: The U.S. Centers for Disease Control and Prevention supported the study. Dr. Wu and her associates did not report their financial disclosures.
Computer-aided Detection Fails to Improve Mammographic Accuracy
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
FROM JAMA INTERNAL MEDICINE
Computer-aided Detection Fails to Improve Mammographic Accuracy
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
FROM JAMA INTERNAL MEDICINE
Tool Helps Patients, Clinicians Choose Depression Meds
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
FROM JAMA INTERNAL MEDICINE
Computer-aided detection fails to improve mammographic accuracy
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
This study is another large-sample, real-world evaluation suggesting that CAD yields no clinically significant benefits in typical mammography practice.
Congress should rescind Medicare coverage of CAD use. And in the future, broad societal investment in new medical technologies should be withheld until large-sample assessments prove their real-world effectiveness and justify their costs.
Dr. Joshua J. Fenton is in the department of family and community medicine, the Center for Healthcare Policy and Research, and the Cancer Center at the University of California, Davis Health System, Sacramento. He reported having no relevant financial disclosures. These comments are adapted from a commentary accompanying Dr. Lehman’s report (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5319).
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied in a series of 625,625 exams performed across the United States during a 7-year period, according to a report published online Sept. 28 in JAMA Internal Medicine.
In fact, the sensitivity of mammography was actually decreased by computer-aided detection (CAD) in a subgroup of radiologists who practiced at some sites that used CAD and others that did not.
“CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination,” wrote Dr. Constance D. Lehman of the department of radiology, Massachusetts General Hospital and the Avon Comprehensive Breast Evaluation Center, both in Boston. “The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes.”
Measuring the real-world impact of CAD on mammographic accuracy has been difficult and has yielded inconsistent and contradictory findings; most studies to date have been relatively small, have focused on older women only, or haven’t taken into account the early part of radiologists’ learning curves. To circumvent these problems, the investigators pooled data from five mammographic registries to include more than 625,000 full-field digital mammograms, included a demographically diverse population of women aged 40-89 years, and excluded the first year of CAD use for every radiologist in the study.
They assessed outcomes after routine screening mammography with CAD (495,818) or without CAD (129,807), which were interpreted by 271 radiologists. Breast cancer was diagnosed in 3,159 women within 1 year of these screening mammograms.
The overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it, all of which are nonsignificant differences. Also similar were mammography’s specificity, at 91.6% with CAD and 91.4% without CAD.
The overall cancer detection rate was exactly the same regardless of the use of CAD, at 4.1 cancers per 1,000 women screened. And the invasive cancer detection rate was nearly the same, at 2.9 cancers with CAD versus 3.0 cancers without CAD (JAMA Intern Med. 2015 Sep 28. doi:10.1001/jamainternmed.2015.5231).
Also, diagnostic accuracy was the same with or without CAD regardless of patient age, patient ethnicity, breast density, patient menopausal status, family history, or interval since the last mammogram. In the subgroup of 107 radiologists who sometimes used CAD and sometimes did not, the use of CAD actually decreased the sensitivity of mammography (83.3% with CAD and 89.6% without CAD).
“Given that the evidence of the current application of CAD in community practice does not show an improvement in diagnostic accuracy, we question the policy of continuing to charge for a technology that provides no established benefits to women,” Dr. Lehman and her associates wrote.
But the researchers noted that CAD may offer advantages beyond diagnostic accuracy, such as improved work flow or shorter times spent assessing faint calcifications. CAD also may be useful in guiding treatment decisions, perhaps reducing unnecessary biopsies of lesions that have specific benign features or ensuring biopsy of lesions that have specific malignant features, they added.
The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Augmenting digital screening mammography with computer-aided detection failed to improve diagnostic accuracy in every performance measure and every subgroup of women studied.
Major finding: Overall sensitivity of mammography was 85.3% with CAD and 87.3% without it; sensitivity for invasive cancer was 82.1% with CAD and 85.0% without it.
Data source: A large observational study comparing breast cancer detection between 495,818 mammograms that used CAD and 129,807 that did not.
Disclosures: The study was supported by the National Cancer Institute, the Breast Cancer Surveillance Consortium, several state public health departments, and cancer registries throughout the United States. Dr. Lehman reported receiving grant support from General Electric Healthcare and serving as a member of the company’s Comparative Effectiveness Research Advisory Board.
Tool helps patients, clinicians choose depression meds
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
FROM JAMA INTERNAL MEDICINE
Key clinical point: The Depression Medication Choice decision aid helps primary care physicians choose appropriate medication together with patients who have moderate to severe depression.
Major finding: Patients in the intervention group reported significantly greater comfort with the choice of antidepressant, were more knowledgeable about antidepressants (OR, 9.5), and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Data source: A cluster-randomized trial involving 117 primary care clinicians in 10 private practices who chose antidepressant therapy for and with 297 adult patients.
Disclosures: The Agency for Healthcare and Quality Research funded the study. Dr. LeBlanc and her associates reported having no relevant disclosures.
Sitting time linked to NAFLD
The more time middle-aged men and women spend sitting, the greater the likelihood they will show nonalcoholic fatty liver disease on ultrasonography at an annual physical examination, according to a report published online.
While this association may not be surprising, the fact that it remained robust regardless of an individual’s level of exercise and independent of his or her body mass index (BMI) was unexpected. Even adults with a BMI less than 23 kg/m2 and even those who exercised vigorously several times per week were more likely to develop nonalcoholic fatty liver disease (NAFLD) if they spent a substantial part of their day sitting down. So it appears that both increasing physical activity and reducing sitting time are important in reducing NAFLD risk, said Seungho Ryu, M.D., of the department of occupational and environmental medicine, Kangbuk Samsung Hospital, Seoul, and associates.
The investigators discovered the association between sitting and NAFLD in a large observational cohort study involving 72,914 Korean men and 66,142 Korean women undergoing routine annual physical examinations at two academic clinics during a 2-year period. These study participants (mean age, 39.9 years) answered questionnaires regarding the average time they spent sitting at work, home, and leisure, as well as their usual dietary intake and typical level of physical activity.
Sitting time was positively associated with the prevalence of NAFLD, independently of physical activity level. The prevalence ratios for the disorder were 1.05 for sitting 5-9 hr/day and 1.12 for sitting 10 hr/day or more, compared with the reference category of sitting for fewer than 5 hr/day. And the prevalence of NAFLD rose in a linear fashion with increased sitting time across all categories of physical activity, Dr. Ryu and associates said (J. Hepatol. 2015 Sep 15 [doi: 10.1016/j.hep.2015.07.010]).
The mechanism underlying this association is not yet known. A causal relationship cannot be assumed on the basis of these findings because this was a cross-sectional observational study, not a longitudinal or prospective randomized study. However, it seems reasonable that in real-world practice, replacing periods of sitting with periods of standing and light activity would be helpful to reduce the risk of NAFLD, they added.
The investigators noted that these study participants were all Korean, were well educated, and attended health examinations regularly, so the study results may not be generalizable to other populations with different demographic profiles.
The sources of funding for this study weren’t identified. Dr. Ryu and associates reported having no relevant financial disclosures.
The findings of Ryu et al. add to the strong and alarming evidence that sitting too much and moving too little have significant negative consequences for cardiometabolic health.
Our bodies are designed to move, so it shouldn’t be surprising that sedentary behavior has a direct impact on physiology. The adverse effects on our cardiovascular and respiratory systems have been well studied, but the impact on the liver has not. This is a promising area for future research.
Meanwhile, this study’s message is clear: Our chairs are slowly but surely killing us.
Dr. Michael I. Trenell is professor of metabolism and lifestyle medicine at the Institute of Cellular Medicine, Newcastle (England) University. He is supported by the U.K. National Institute for Health Research and the National Institute for Health Research Biomedical Research Centre for Ageing and Age-Related Disease. Dr. Trenell reported having no relevant financial disclosures. He made these remarks in an editorial accompanying Dr. Ryu’s report.
The findings of Ryu et al. add to the strong and alarming evidence that sitting too much and moving too little have significant negative consequences for cardiometabolic health.
Our bodies are designed to move, so it shouldn’t be surprising that sedentary behavior has a direct impact on physiology. The adverse effects on our cardiovascular and respiratory systems have been well studied, but the impact on the liver has not. This is a promising area for future research.
Meanwhile, this study’s message is clear: Our chairs are slowly but surely killing us.
Dr. Michael I. Trenell is professor of metabolism and lifestyle medicine at the Institute of Cellular Medicine, Newcastle (England) University. He is supported by the U.K. National Institute for Health Research and the National Institute for Health Research Biomedical Research Centre for Ageing and Age-Related Disease. Dr. Trenell reported having no relevant financial disclosures. He made these remarks in an editorial accompanying Dr. Ryu’s report.
The findings of Ryu et al. add to the strong and alarming evidence that sitting too much and moving too little have significant negative consequences for cardiometabolic health.
Our bodies are designed to move, so it shouldn’t be surprising that sedentary behavior has a direct impact on physiology. The adverse effects on our cardiovascular and respiratory systems have been well studied, but the impact on the liver has not. This is a promising area for future research.
Meanwhile, this study’s message is clear: Our chairs are slowly but surely killing us.
Dr. Michael I. Trenell is professor of metabolism and lifestyle medicine at the Institute of Cellular Medicine, Newcastle (England) University. He is supported by the U.K. National Institute for Health Research and the National Institute for Health Research Biomedical Research Centre for Ageing and Age-Related Disease. Dr. Trenell reported having no relevant financial disclosures. He made these remarks in an editorial accompanying Dr. Ryu’s report.
The more time middle-aged men and women spend sitting, the greater the likelihood they will show nonalcoholic fatty liver disease on ultrasonography at an annual physical examination, according to a report published online.
While this association may not be surprising, the fact that it remained robust regardless of an individual’s level of exercise and independent of his or her body mass index (BMI) was unexpected. Even adults with a BMI less than 23 kg/m2 and even those who exercised vigorously several times per week were more likely to develop nonalcoholic fatty liver disease (NAFLD) if they spent a substantial part of their day sitting down. So it appears that both increasing physical activity and reducing sitting time are important in reducing NAFLD risk, said Seungho Ryu, M.D., of the department of occupational and environmental medicine, Kangbuk Samsung Hospital, Seoul, and associates.
The investigators discovered the association between sitting and NAFLD in a large observational cohort study involving 72,914 Korean men and 66,142 Korean women undergoing routine annual physical examinations at two academic clinics during a 2-year period. These study participants (mean age, 39.9 years) answered questionnaires regarding the average time they spent sitting at work, home, and leisure, as well as their usual dietary intake and typical level of physical activity.
Sitting time was positively associated with the prevalence of NAFLD, independently of physical activity level. The prevalence ratios for the disorder were 1.05 for sitting 5-9 hr/day and 1.12 for sitting 10 hr/day or more, compared with the reference category of sitting for fewer than 5 hr/day. And the prevalence of NAFLD rose in a linear fashion with increased sitting time across all categories of physical activity, Dr. Ryu and associates said (J. Hepatol. 2015 Sep 15 [doi: 10.1016/j.hep.2015.07.010]).
The mechanism underlying this association is not yet known. A causal relationship cannot be assumed on the basis of these findings because this was a cross-sectional observational study, not a longitudinal or prospective randomized study. However, it seems reasonable that in real-world practice, replacing periods of sitting with periods of standing and light activity would be helpful to reduce the risk of NAFLD, they added.
The investigators noted that these study participants were all Korean, were well educated, and attended health examinations regularly, so the study results may not be generalizable to other populations with different demographic profiles.
The sources of funding for this study weren’t identified. Dr. Ryu and associates reported having no relevant financial disclosures.
The more time middle-aged men and women spend sitting, the greater the likelihood they will show nonalcoholic fatty liver disease on ultrasonography at an annual physical examination, according to a report published online.
While this association may not be surprising, the fact that it remained robust regardless of an individual’s level of exercise and independent of his or her body mass index (BMI) was unexpected. Even adults with a BMI less than 23 kg/m2 and even those who exercised vigorously several times per week were more likely to develop nonalcoholic fatty liver disease (NAFLD) if they spent a substantial part of their day sitting down. So it appears that both increasing physical activity and reducing sitting time are important in reducing NAFLD risk, said Seungho Ryu, M.D., of the department of occupational and environmental medicine, Kangbuk Samsung Hospital, Seoul, and associates.
The investigators discovered the association between sitting and NAFLD in a large observational cohort study involving 72,914 Korean men and 66,142 Korean women undergoing routine annual physical examinations at two academic clinics during a 2-year period. These study participants (mean age, 39.9 years) answered questionnaires regarding the average time they spent sitting at work, home, and leisure, as well as their usual dietary intake and typical level of physical activity.
Sitting time was positively associated with the prevalence of NAFLD, independently of physical activity level. The prevalence ratios for the disorder were 1.05 for sitting 5-9 hr/day and 1.12 for sitting 10 hr/day or more, compared with the reference category of sitting for fewer than 5 hr/day. And the prevalence of NAFLD rose in a linear fashion with increased sitting time across all categories of physical activity, Dr. Ryu and associates said (J. Hepatol. 2015 Sep 15 [doi: 10.1016/j.hep.2015.07.010]).
The mechanism underlying this association is not yet known. A causal relationship cannot be assumed on the basis of these findings because this was a cross-sectional observational study, not a longitudinal or prospective randomized study. However, it seems reasonable that in real-world practice, replacing periods of sitting with periods of standing and light activity would be helpful to reduce the risk of NAFLD, they added.
The investigators noted that these study participants were all Korean, were well educated, and attended health examinations regularly, so the study results may not be generalizable to other populations with different demographic profiles.
The sources of funding for this study weren’t identified. Dr. Ryu and associates reported having no relevant financial disclosures.
FROM JOURNAL OF HEPATOLOGY
Key clinical point: The more time that middle-aged men and women spend sitting, the greater their risk of having NAFLD, regardless of their exercise level.
Major finding: The prevalence ratios for NAFLD were 1.05 for sitting 5-9 hr/day and 1.12 for sitting 10 hr/day or more, compared with the reference category of sitting for fewer than 5 hr/day.
Data source: A 2-year observational cohort study involving 139,056 middle-aged Korean men and women who underwent abdominal ultrasound at annual health examinations.
Disclosures: The sources of funding for this study weren’t identified. Dr. Ryu and associates reported having no relevant financial disclosures.
Letrozole doesn’t cut multiple births compared to standard therapy
Among couples who have unexplained infertility, ovarian stimulation with letrozole doesn’t significantly reduce the rate of multiple gestation when compared with current standard ovarian stimulation, according to a report published online Sept. 24 in the New England Journal of Medicine.
Recent evidence suggested that aromatase inhibitors such as letrozole might be useful in some cases of infertility because they tend to stimulate monofollicular development, avoiding hyperstimulation of the ovary and thus multiple births. Researchers in the National Institute of Child Health and Human Development’s Cooperative Reproductive Medicine Network performed a randomized trial to determine whether letrozole would lower the rate of multiple gestations without reducing the likelihood of pregnancy: the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) study.
The trial involved 900 couples with unexplained infertility treated at 12 sites throughout the United States. The women all had regular menses and a normal uterine cavity with at least one patent fallopian tube, and the men all had semen specimens with at least 5 million sperm per milliliter.
The women were stratified by age and randomly assigned to receive subcutaneous injections of gonadotropin (301 patients), coated oral clomiphene tablets (300 patients), or coated oral letrozole tablets (299 patients) for up to four treatment cycles. A total of 746 couples completed the study, and dropout rates were similar across the three study groups, according to Dr. Michael P. Diamond of Georgia Regents University, Augusta, and his associates.
The primary outcome – the rate of multiple gestation among pregnancies in which fetal heart motion was confirmed on ultrasound at approximately 4-6 weeks – was not significantly lower with letrozole (9 of 67 pregnancies, 13%) than with a combined group of women receiving current standard therapy of gonadotropin or clomiphene (42 of 192 pregnancies, 22%), the investigators wrote (N Engl J Med. 2015;373:1230-40. doi:10.1056/NEJMoa1414827).
However, the rate of multiple gestation was significantly higher with gonadotropin alone (32%) than with either letrozole (13%) or clomiphene alone (9%). And all the multiple gestations in the latter two groups were twins, while there were 10 sets of triplets in the gonadotropin group.
With letrozole, rates of conception, clinical pregnancy, and live birth were within the prespecified boundary for noninferiority to standard therapy, but they still were significantly lower. In particular, the rate of live birth was only 18.7% for letrozole, compared with 32.2% for gonadotropin and 23.3% for clomiphene.
There were no significant differences among the three study groups regarding time to conception, rates of loss of an established pregnancy, the timing of pregnancy loss, rates of placental abnormalities, mean birth weights of singleton pregnancies, gender distribution of the neonates, rates of congenital abnormalities, rates of neonatal complications, or rates of maternal complications.
The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Research Resources, the National Center for Advancing Translational Sciences, and the American Recovery and Reinvestment Act funded the study. Dr. Diamond reported ties to Advanced Reproductive Care, AbbVie, Bayer, and EMD Serono; his associates reported ties to numerous industry sources.
Among couples who have unexplained infertility, ovarian stimulation with letrozole doesn’t significantly reduce the rate of multiple gestation when compared with current standard ovarian stimulation, according to a report published online Sept. 24 in the New England Journal of Medicine.
Recent evidence suggested that aromatase inhibitors such as letrozole might be useful in some cases of infertility because they tend to stimulate monofollicular development, avoiding hyperstimulation of the ovary and thus multiple births. Researchers in the National Institute of Child Health and Human Development’s Cooperative Reproductive Medicine Network performed a randomized trial to determine whether letrozole would lower the rate of multiple gestations without reducing the likelihood of pregnancy: the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) study.
The trial involved 900 couples with unexplained infertility treated at 12 sites throughout the United States. The women all had regular menses and a normal uterine cavity with at least one patent fallopian tube, and the men all had semen specimens with at least 5 million sperm per milliliter.
The women were stratified by age and randomly assigned to receive subcutaneous injections of gonadotropin (301 patients), coated oral clomiphene tablets (300 patients), or coated oral letrozole tablets (299 patients) for up to four treatment cycles. A total of 746 couples completed the study, and dropout rates were similar across the three study groups, according to Dr. Michael P. Diamond of Georgia Regents University, Augusta, and his associates.
The primary outcome – the rate of multiple gestation among pregnancies in which fetal heart motion was confirmed on ultrasound at approximately 4-6 weeks – was not significantly lower with letrozole (9 of 67 pregnancies, 13%) than with a combined group of women receiving current standard therapy of gonadotropin or clomiphene (42 of 192 pregnancies, 22%), the investigators wrote (N Engl J Med. 2015;373:1230-40. doi:10.1056/NEJMoa1414827).
However, the rate of multiple gestation was significantly higher with gonadotropin alone (32%) than with either letrozole (13%) or clomiphene alone (9%). And all the multiple gestations in the latter two groups were twins, while there were 10 sets of triplets in the gonadotropin group.
With letrozole, rates of conception, clinical pregnancy, and live birth were within the prespecified boundary for noninferiority to standard therapy, but they still were significantly lower. In particular, the rate of live birth was only 18.7% for letrozole, compared with 32.2% for gonadotropin and 23.3% for clomiphene.
There were no significant differences among the three study groups regarding time to conception, rates of loss of an established pregnancy, the timing of pregnancy loss, rates of placental abnormalities, mean birth weights of singleton pregnancies, gender distribution of the neonates, rates of congenital abnormalities, rates of neonatal complications, or rates of maternal complications.
The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Research Resources, the National Center for Advancing Translational Sciences, and the American Recovery and Reinvestment Act funded the study. Dr. Diamond reported ties to Advanced Reproductive Care, AbbVie, Bayer, and EMD Serono; his associates reported ties to numerous industry sources.
Among couples who have unexplained infertility, ovarian stimulation with letrozole doesn’t significantly reduce the rate of multiple gestation when compared with current standard ovarian stimulation, according to a report published online Sept. 24 in the New England Journal of Medicine.
Recent evidence suggested that aromatase inhibitors such as letrozole might be useful in some cases of infertility because they tend to stimulate monofollicular development, avoiding hyperstimulation of the ovary and thus multiple births. Researchers in the National Institute of Child Health and Human Development’s Cooperative Reproductive Medicine Network performed a randomized trial to determine whether letrozole would lower the rate of multiple gestations without reducing the likelihood of pregnancy: the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) study.
The trial involved 900 couples with unexplained infertility treated at 12 sites throughout the United States. The women all had regular menses and a normal uterine cavity with at least one patent fallopian tube, and the men all had semen specimens with at least 5 million sperm per milliliter.
The women were stratified by age and randomly assigned to receive subcutaneous injections of gonadotropin (301 patients), coated oral clomiphene tablets (300 patients), or coated oral letrozole tablets (299 patients) for up to four treatment cycles. A total of 746 couples completed the study, and dropout rates were similar across the three study groups, according to Dr. Michael P. Diamond of Georgia Regents University, Augusta, and his associates.
The primary outcome – the rate of multiple gestation among pregnancies in which fetal heart motion was confirmed on ultrasound at approximately 4-6 weeks – was not significantly lower with letrozole (9 of 67 pregnancies, 13%) than with a combined group of women receiving current standard therapy of gonadotropin or clomiphene (42 of 192 pregnancies, 22%), the investigators wrote (N Engl J Med. 2015;373:1230-40. doi:10.1056/NEJMoa1414827).
However, the rate of multiple gestation was significantly higher with gonadotropin alone (32%) than with either letrozole (13%) or clomiphene alone (9%). And all the multiple gestations in the latter two groups were twins, while there were 10 sets of triplets in the gonadotropin group.
With letrozole, rates of conception, clinical pregnancy, and live birth were within the prespecified boundary for noninferiority to standard therapy, but they still were significantly lower. In particular, the rate of live birth was only 18.7% for letrozole, compared with 32.2% for gonadotropin and 23.3% for clomiphene.
There were no significant differences among the three study groups regarding time to conception, rates of loss of an established pregnancy, the timing of pregnancy loss, rates of placental abnormalities, mean birth weights of singleton pregnancies, gender distribution of the neonates, rates of congenital abnormalities, rates of neonatal complications, or rates of maternal complications.
The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Research Resources, the National Center for Advancing Translational Sciences, and the American Recovery and Reinvestment Act funded the study. Dr. Diamond reported ties to Advanced Reproductive Care, AbbVie, Bayer, and EMD Serono; his associates reported ties to numerous industry sources.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Ovarian stimulation with letrozole doesn’t reduce the rate of multiple gestation, compared with current standard therapy.
Major finding: The primary outcome – the rate of multiple gestation – was not significantly lower with letrozole (13%) than with a combined group receiving gonadotropin or clomiphene (22%).
Data source: A multicenter randomized clinical trial comparing pregnancy outcomes in 900 U.S. couples treated for unexplained infertility.
Disclosures: The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Research Resources, the National Center for Advancing Translational Sciences, and the American Recovery and Reinvestment Act funded the study. Dr. Diamond reported ties to Advanced Reproductive Care, AbbVie, Bayer, and EMD Serono; his associates reported ties to numerous industry sources.





