Early sleep abnormalities linked to later obesity

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Early sleep abnormalities linked to later obesity

Sleep-disordered breathing and short sleep duration in early childhood are strongly and independently associated with obesity at ages 7, 10, and 15 years, according to a report published online Dec. 11 in the Journal of Pediatrics.

These findings underscore the importance of identifying and treating sleep-disordered breathing and insufficient sleep as early as possible to reduce later obesity, said Karen Bonuck, Ph.D., of the department of family medicine and social medicine, Albert Einstein College of Medicine, Bronx, N.Y., and her associates.

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Children with sleep abnormalities are at increased risk for developing obesity, the study suggests.

To examine the relationships between sleep abnormalities and obesity in the pediatric population, the investigators analyzed data from a large longitudinal cohort study of children born during 1991-1992 in southwest England. Participating mothers reported on their children’s sleep duration and on the presence and severity of sleep-disordered breathing, which was defined as snoring, observed episodes of apnea, and mouth-breathing during sleep. These were assessed at ages 18 months, 2.5 years, 4.75 years, 5.75 years, and 6.75 years. The children’s body mass index was calculated from height and weight measurements taken at ages 7, 10, and 15 years.

In this analysis of 1,844 of the participating children, those with the most severe sleep-disordered breathing at age 2.5 years were twice as likely as were asymptomatic children to be obese in later childhood. Similarly, children with short sleep duration at ages 5-6 years (less than 10 hours per night) were twice as likely to be obese at age 15 as were those with the longest sleep duration. These negative effects were independent of each other and of comparable magnitude, Dr. Bonuck and her associates said (J. Pediatr. 2014 Dec. 11 [doi:10.1016/j.jpeds.2014.11.001]).

“Our findings affirm the concept of healthy sleep ... as a foundation for healthy weight throughout childhood and into adulthood,” they added.

This study was supported by the U.S. National Heart, Lung, and Blood Institute, the U.K. Medical Research Council, and the University of Bristol (England) Dr. Bonuck and her associates reported having no financial disclosures.

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Sleep-disordered breathing and short sleep duration in early childhood are strongly and independently associated with obesity at ages 7, 10, and 15 years, according to a report published online Dec. 11 in the Journal of Pediatrics.

These findings underscore the importance of identifying and treating sleep-disordered breathing and insufficient sleep as early as possible to reduce later obesity, said Karen Bonuck, Ph.D., of the department of family medicine and social medicine, Albert Einstein College of Medicine, Bronx, N.Y., and her associates.

©deyangeorgiev/thinkstockphotos.com
Children with sleep abnormalities are at increased risk for developing obesity, the study suggests.

To examine the relationships between sleep abnormalities and obesity in the pediatric population, the investigators analyzed data from a large longitudinal cohort study of children born during 1991-1992 in southwest England. Participating mothers reported on their children’s sleep duration and on the presence and severity of sleep-disordered breathing, which was defined as snoring, observed episodes of apnea, and mouth-breathing during sleep. These were assessed at ages 18 months, 2.5 years, 4.75 years, 5.75 years, and 6.75 years. The children’s body mass index was calculated from height and weight measurements taken at ages 7, 10, and 15 years.

In this analysis of 1,844 of the participating children, those with the most severe sleep-disordered breathing at age 2.5 years were twice as likely as were asymptomatic children to be obese in later childhood. Similarly, children with short sleep duration at ages 5-6 years (less than 10 hours per night) were twice as likely to be obese at age 15 as were those with the longest sleep duration. These negative effects were independent of each other and of comparable magnitude, Dr. Bonuck and her associates said (J. Pediatr. 2014 Dec. 11 [doi:10.1016/j.jpeds.2014.11.001]).

“Our findings affirm the concept of healthy sleep ... as a foundation for healthy weight throughout childhood and into adulthood,” they added.

This study was supported by the U.S. National Heart, Lung, and Blood Institute, the U.K. Medical Research Council, and the University of Bristol (England) Dr. Bonuck and her associates reported having no financial disclosures.

Sleep-disordered breathing and short sleep duration in early childhood are strongly and independently associated with obesity at ages 7, 10, and 15 years, according to a report published online Dec. 11 in the Journal of Pediatrics.

These findings underscore the importance of identifying and treating sleep-disordered breathing and insufficient sleep as early as possible to reduce later obesity, said Karen Bonuck, Ph.D., of the department of family medicine and social medicine, Albert Einstein College of Medicine, Bronx, N.Y., and her associates.

©deyangeorgiev/thinkstockphotos.com
Children with sleep abnormalities are at increased risk for developing obesity, the study suggests.

To examine the relationships between sleep abnormalities and obesity in the pediatric population, the investigators analyzed data from a large longitudinal cohort study of children born during 1991-1992 in southwest England. Participating mothers reported on their children’s sleep duration and on the presence and severity of sleep-disordered breathing, which was defined as snoring, observed episodes of apnea, and mouth-breathing during sleep. These were assessed at ages 18 months, 2.5 years, 4.75 years, 5.75 years, and 6.75 years. The children’s body mass index was calculated from height and weight measurements taken at ages 7, 10, and 15 years.

In this analysis of 1,844 of the participating children, those with the most severe sleep-disordered breathing at age 2.5 years were twice as likely as were asymptomatic children to be obese in later childhood. Similarly, children with short sleep duration at ages 5-6 years (less than 10 hours per night) were twice as likely to be obese at age 15 as were those with the longest sleep duration. These negative effects were independent of each other and of comparable magnitude, Dr. Bonuck and her associates said (J. Pediatr. 2014 Dec. 11 [doi:10.1016/j.jpeds.2014.11.001]).

“Our findings affirm the concept of healthy sleep ... as a foundation for healthy weight throughout childhood and into adulthood,” they added.

This study was supported by the U.S. National Heart, Lung, and Blood Institute, the U.K. Medical Research Council, and the University of Bristol (England) Dr. Bonuck and her associates reported having no financial disclosures.

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Key clinical point: Sleep-disordered breathing and short sleep duration in early childhood are strongly and independently associated with obesity at ages 7, 10, and 15 years.

Major finding: Among 1,844 children, those who had the most severe sleep-disordered breathing at age 2.5 years were twice as likely as were asymptomatic children to be obese in later childhood.

Data source: A secondary analysis of data from a longitudinal cohort study in England of children followed from birth to age 15 years.

Disclosures: This study was supported by the U.S. National Heart, Lung, and Blood Institute, the U.K. Medical Research Council, and the University of Bristol (England) Dr. Bonuck and her associates reported having no financial disclosures.

Disparities narrowed after public reporting for hospitals began

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Disparities narrowed after public reporting for hospitals began

Racial/ethnic disparities in hospital care substantially narrowed after initiation of the Center for Medicare & Medicaid Services’ program to measure and publicly report the quality of care delivered at U.S. hospitals, according to a report published online Dec. 11 in the New England Journal of Medicine.

Investigators assessed changes in hospital performance between 2005-2010 by analyzing information in the program’s database regarding 12,447,154 hospitalizations of adults: 2,831,343 for acute MI, 4,718,790 for heart failure, and 4,897,021 for pneumonia. Over time, disparities in all 17 care quality measures between white patients and black patients narrowed so much that none of them exceeded 3.8%, and disparities between white and Hispanic patients narrowed so much that none of them exceeded 1.1%, said Dr. Amal N. Trivedi of Providence Veterans Affairs Medical Center and the department of health services, policy, and practice, Brown University, both in Providence, R.I., and his associates.

These important improvements were attributed both to increases in equitable care between white and minority patients within each hospital and to greater improvements in care at hospitals that disproportionately serve minority patients. “On some simple measures, such as the provision of aspirin and beta-blockers in patients with acute MI and documentation of assessment of left ventricular function in patients with HF, we observed nearly equivalent performances for white, black, and Hispanic patients,” the investigators said.

In addition, on quality measures with the largest disparities in 2005 – such as performing PCI within 90 minutes of MI presentation, and delivering influenza and pneumococcal vaccinations – “we observed the greatest overall improvement in performance and reductions in racial or ethnic differences over time,” they said (N. Engl. J. Med. 2014 Dec. 11 [doi:10.1056/NEJMoa1405003]).

No single intervention would explain these widespread findings. Rather, complex system-level reforms likely were rapidly disseminated among hospitals, particularly those that serve disproportionately minority patients. For example, the dramatic increase in the rates of providing influenza and pneumococcal immunizations was probably driven by hospitals adopting standing orders for nonphysician staff to vaccinate eligible patients, Dr. Trivedi and his associates said.

“Our study provides support for the notion that efforts to improve the overall quality of care may also reduce racial and ethnic disparities,” they noted.

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Racial/ethnic disparities in hospital care substantially narrowed after initiation of the Center for Medicare & Medicaid Services’ program to measure and publicly report the quality of care delivered at U.S. hospitals, according to a report published online Dec. 11 in the New England Journal of Medicine.

Investigators assessed changes in hospital performance between 2005-2010 by analyzing information in the program’s database regarding 12,447,154 hospitalizations of adults: 2,831,343 for acute MI, 4,718,790 for heart failure, and 4,897,021 for pneumonia. Over time, disparities in all 17 care quality measures between white patients and black patients narrowed so much that none of them exceeded 3.8%, and disparities between white and Hispanic patients narrowed so much that none of them exceeded 1.1%, said Dr. Amal N. Trivedi of Providence Veterans Affairs Medical Center and the department of health services, policy, and practice, Brown University, both in Providence, R.I., and his associates.

These important improvements were attributed both to increases in equitable care between white and minority patients within each hospital and to greater improvements in care at hospitals that disproportionately serve minority patients. “On some simple measures, such as the provision of aspirin and beta-blockers in patients with acute MI and documentation of assessment of left ventricular function in patients with HF, we observed nearly equivalent performances for white, black, and Hispanic patients,” the investigators said.

In addition, on quality measures with the largest disparities in 2005 – such as performing PCI within 90 minutes of MI presentation, and delivering influenza and pneumococcal vaccinations – “we observed the greatest overall improvement in performance and reductions in racial or ethnic differences over time,” they said (N. Engl. J. Med. 2014 Dec. 11 [doi:10.1056/NEJMoa1405003]).

No single intervention would explain these widespread findings. Rather, complex system-level reforms likely were rapidly disseminated among hospitals, particularly those that serve disproportionately minority patients. For example, the dramatic increase in the rates of providing influenza and pneumococcal immunizations was probably driven by hospitals adopting standing orders for nonphysician staff to vaccinate eligible patients, Dr. Trivedi and his associates said.

“Our study provides support for the notion that efforts to improve the overall quality of care may also reduce racial and ethnic disparities,” they noted.

Racial/ethnic disparities in hospital care substantially narrowed after initiation of the Center for Medicare & Medicaid Services’ program to measure and publicly report the quality of care delivered at U.S. hospitals, according to a report published online Dec. 11 in the New England Journal of Medicine.

Investigators assessed changes in hospital performance between 2005-2010 by analyzing information in the program’s database regarding 12,447,154 hospitalizations of adults: 2,831,343 for acute MI, 4,718,790 for heart failure, and 4,897,021 for pneumonia. Over time, disparities in all 17 care quality measures between white patients and black patients narrowed so much that none of them exceeded 3.8%, and disparities between white and Hispanic patients narrowed so much that none of them exceeded 1.1%, said Dr. Amal N. Trivedi of Providence Veterans Affairs Medical Center and the department of health services, policy, and practice, Brown University, both in Providence, R.I., and his associates.

These important improvements were attributed both to increases in equitable care between white and minority patients within each hospital and to greater improvements in care at hospitals that disproportionately serve minority patients. “On some simple measures, such as the provision of aspirin and beta-blockers in patients with acute MI and documentation of assessment of left ventricular function in patients with HF, we observed nearly equivalent performances for white, black, and Hispanic patients,” the investigators said.

In addition, on quality measures with the largest disparities in 2005 – such as performing PCI within 90 minutes of MI presentation, and delivering influenza and pneumococcal vaccinations – “we observed the greatest overall improvement in performance and reductions in racial or ethnic differences over time,” they said (N. Engl. J. Med. 2014 Dec. 11 [doi:10.1056/NEJMoa1405003]).

No single intervention would explain these widespread findings. Rather, complex system-level reforms likely were rapidly disseminated among hospitals, particularly those that serve disproportionately minority patients. For example, the dramatic increase in the rates of providing influenza and pneumococcal immunizations was probably driven by hospitals adopting standing orders for nonphysician staff to vaccinate eligible patients, Dr. Trivedi and his associates said.

“Our study provides support for the notion that efforts to improve the overall quality of care may also reduce racial and ethnic disparities,” they noted.

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Reduced resident duty hours haven’t changed patient outcomes

Major benefits lacking
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Patient mortality and morbidity outcomes have not changed since the most recent round of reforms to medical residents’ duty hours in 2011, according to two of the first nationwide studies to assess these “improvements,” which both were published online Dec. 9 in JAMA.

In addition, one of the studies found no difference between pre-reform and post-reform scores or on pass rates for oral or written national in-training and board certification examinations.

©Thinglass/thinkstockphotos.com

Thus, two separate studies involving millions of hospitalized patients across the country have both found that these reforms had no discernible effect on patient care. However, both groups of researchers cautioned that their studies were observational and therefore subject to potential biases and that they covered only the first 2 years that the duty-hours reforms have been in place.

The 2011 requirements expanded on those enacted in 2003 by further restricting residents’ duty hours, in the hope of reducing medical errors attributed to exhausted residents. The hours of continuous in-hospital duty were reduced from 30 to 16 for first-year residents and to 24 for upper-year residents, and the interval between shifts was increased to at least 8 hours off for first-year residents and at least 14 hours off for upper-year residents.

“Duty hour reform is arguably one of the largest efforts ever undertaken to improve the quality and safety of patient care in teaching hospitals,” said Dr. Mitesh S. Patel of the University of Pennsylvania and the Veterans Affairs Hospital Center for Health Equity Research and Promotion, both in Philadelphia, and his associates.

They assessed 30-day mortality and readmissions among 2,790,356 Medicare patients who were treated either for acute MI, stroke, gastrointestinal bleeding, or heart failure, or who underwent general, orthopedic, or vascular surgery, at 3,104 hospitals between 2009 and 2012. The investigators found no significant associations, either positive or negative, between the reforms to residents’ duty hours and any patient outcomes. Sensitivity analyses confirmed the results of the primary data analyses.

“Our findings suggest that ... the goals of improving the quality and safety of patient care ... were not being achieved. Conversely, concerns that outcomes might actually worsen because of decreased continuity of care have not been borne out,” Dr. Patel and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/jama.2014.15273]).

The investigators noted that their study was limited in that it could not take into account hospitals’ adherence to the new requirements. Their study also did not assess other outcomes such as patient safety indicators or complication rates, which “may better elucidate the relative effects of decreased resident fatigue and increased patient hand offs.” And their study couldn’t address any possible confounding effects from other concurrent policy initiatives aimed at improving care for Medicare beneficiaries, such as the Hospital Readmissions Reduction Program.

In the other study, a separate group of researchers used data from the American College of Surgeons National Surgical Quality Improvement Program to assess outcomes for 535,499 patients who underwent general surgery at 131 hospitals during the 2 years before and the 2 years after the reforms to residents’ duty hours were implemented. This included 23 teaching hospitals in which residents were involved in at least 95% of general surgeries, said Dr. Ravi Rajaram of the division of research and optimal patient care, American College of Surgeons, and the Institute for Public Health and Medicine at Northwestern University, both in Chicago, and his associates.

The reforms were not associated with any change in rates of patient mortality or serious morbidity, either in the study population as a whole or in the subgroups of high-risk and low-risk patients. They also had no effect on secondary outcomes such as surgical-site infection or sepsis. These results remained consistent across several sensitivity analyses.

Neither mean scores for in-training, written board, and oral board examinations nor pass rates for those examinations showed any significant changes during the study period.

“Moreover, first-year trainees, who were most directly affected by the 2011 reforms, did not improve their ABSITE [American Board of Surgery In-Training Examination] scores, despite presumably more free time to prepare,” Dr. Rajaram and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/JAMA.2014.15277]).

They cautioned that their study assessed only the first 2 years following duty-hour reform, and “there may be differences in patient care or resident examination performance that are evident only several years after implementation and adoption of new duty-hour requirements.” In addition, a retrospective observational study such as this one could not produce the high-level evidence needed to guide policy decisions. “To that end, a national multicenter cluster-randomized trial is being conducted (the Flexibility In duty hour Requirements for Surgical Trainees [FIRST] trial), comparing current duty-hour requirements with flexible duty hours to assess the effects of this intervention on patient outcomes and resident well-being. This trial may further inform the debate of how to optimally structure postgraduate training,” they said.

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Body

The results of these two large studies are aligned with those of most previous research into the effects of duty hour requirements on patient outcomes. There is a consistent theme: a lack of a major beneficial effect.

Complex problems often demand complex answers. The goal is for the medical profession to move forward with more comprehensive and nuanced approaches to help fulfill its responsibility to provide trainees with the necessary skills to manage fatigue and allow the safest environment for quality care.

Dr. James A. Arrigh is chair of the Accreditation Council for Graduate Medical Education (ACGME) residency review committee for internal medicine. Dr. James C. Hebert is chair of the ACGME Council of Review Committee Chairs. They made these remarks in an editorial accompanying the studies.

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Body

The results of these two large studies are aligned with those of most previous research into the effects of duty hour requirements on patient outcomes. There is a consistent theme: a lack of a major beneficial effect.

Complex problems often demand complex answers. The goal is for the medical profession to move forward with more comprehensive and nuanced approaches to help fulfill its responsibility to provide trainees with the necessary skills to manage fatigue and allow the safest environment for quality care.

Dr. James A. Arrigh is chair of the Accreditation Council for Graduate Medical Education (ACGME) residency review committee for internal medicine. Dr. James C. Hebert is chair of the ACGME Council of Review Committee Chairs. They made these remarks in an editorial accompanying the studies.

Body

The results of these two large studies are aligned with those of most previous research into the effects of duty hour requirements on patient outcomes. There is a consistent theme: a lack of a major beneficial effect.

Complex problems often demand complex answers. The goal is for the medical profession to move forward with more comprehensive and nuanced approaches to help fulfill its responsibility to provide trainees with the necessary skills to manage fatigue and allow the safest environment for quality care.

Dr. James A. Arrigh is chair of the Accreditation Council for Graduate Medical Education (ACGME) residency review committee for internal medicine. Dr. James C. Hebert is chair of the ACGME Council of Review Committee Chairs. They made these remarks in an editorial accompanying the studies.

Title
Major benefits lacking
Major benefits lacking

Patient mortality and morbidity outcomes have not changed since the most recent round of reforms to medical residents’ duty hours in 2011, according to two of the first nationwide studies to assess these “improvements,” which both were published online Dec. 9 in JAMA.

In addition, one of the studies found no difference between pre-reform and post-reform scores or on pass rates for oral or written national in-training and board certification examinations.

©Thinglass/thinkstockphotos.com

Thus, two separate studies involving millions of hospitalized patients across the country have both found that these reforms had no discernible effect on patient care. However, both groups of researchers cautioned that their studies were observational and therefore subject to potential biases and that they covered only the first 2 years that the duty-hours reforms have been in place.

The 2011 requirements expanded on those enacted in 2003 by further restricting residents’ duty hours, in the hope of reducing medical errors attributed to exhausted residents. The hours of continuous in-hospital duty were reduced from 30 to 16 for first-year residents and to 24 for upper-year residents, and the interval between shifts was increased to at least 8 hours off for first-year residents and at least 14 hours off for upper-year residents.

“Duty hour reform is arguably one of the largest efforts ever undertaken to improve the quality and safety of patient care in teaching hospitals,” said Dr. Mitesh S. Patel of the University of Pennsylvania and the Veterans Affairs Hospital Center for Health Equity Research and Promotion, both in Philadelphia, and his associates.

They assessed 30-day mortality and readmissions among 2,790,356 Medicare patients who were treated either for acute MI, stroke, gastrointestinal bleeding, or heart failure, or who underwent general, orthopedic, or vascular surgery, at 3,104 hospitals between 2009 and 2012. The investigators found no significant associations, either positive or negative, between the reforms to residents’ duty hours and any patient outcomes. Sensitivity analyses confirmed the results of the primary data analyses.

“Our findings suggest that ... the goals of improving the quality and safety of patient care ... were not being achieved. Conversely, concerns that outcomes might actually worsen because of decreased continuity of care have not been borne out,” Dr. Patel and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/jama.2014.15273]).

The investigators noted that their study was limited in that it could not take into account hospitals’ adherence to the new requirements. Their study also did not assess other outcomes such as patient safety indicators or complication rates, which “may better elucidate the relative effects of decreased resident fatigue and increased patient hand offs.” And their study couldn’t address any possible confounding effects from other concurrent policy initiatives aimed at improving care for Medicare beneficiaries, such as the Hospital Readmissions Reduction Program.

In the other study, a separate group of researchers used data from the American College of Surgeons National Surgical Quality Improvement Program to assess outcomes for 535,499 patients who underwent general surgery at 131 hospitals during the 2 years before and the 2 years after the reforms to residents’ duty hours were implemented. This included 23 teaching hospitals in which residents were involved in at least 95% of general surgeries, said Dr. Ravi Rajaram of the division of research and optimal patient care, American College of Surgeons, and the Institute for Public Health and Medicine at Northwestern University, both in Chicago, and his associates.

The reforms were not associated with any change in rates of patient mortality or serious morbidity, either in the study population as a whole or in the subgroups of high-risk and low-risk patients. They also had no effect on secondary outcomes such as surgical-site infection or sepsis. These results remained consistent across several sensitivity analyses.

Neither mean scores for in-training, written board, and oral board examinations nor pass rates for those examinations showed any significant changes during the study period.

“Moreover, first-year trainees, who were most directly affected by the 2011 reforms, did not improve their ABSITE [American Board of Surgery In-Training Examination] scores, despite presumably more free time to prepare,” Dr. Rajaram and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/JAMA.2014.15277]).

They cautioned that their study assessed only the first 2 years following duty-hour reform, and “there may be differences in patient care or resident examination performance that are evident only several years after implementation and adoption of new duty-hour requirements.” In addition, a retrospective observational study such as this one could not produce the high-level evidence needed to guide policy decisions. “To that end, a national multicenter cluster-randomized trial is being conducted (the Flexibility In duty hour Requirements for Surgical Trainees [FIRST] trial), comparing current duty-hour requirements with flexible duty hours to assess the effects of this intervention on patient outcomes and resident well-being. This trial may further inform the debate of how to optimally structure postgraduate training,” they said.

Patient mortality and morbidity outcomes have not changed since the most recent round of reforms to medical residents’ duty hours in 2011, according to two of the first nationwide studies to assess these “improvements,” which both were published online Dec. 9 in JAMA.

In addition, one of the studies found no difference between pre-reform and post-reform scores or on pass rates for oral or written national in-training and board certification examinations.

©Thinglass/thinkstockphotos.com

Thus, two separate studies involving millions of hospitalized patients across the country have both found that these reforms had no discernible effect on patient care. However, both groups of researchers cautioned that their studies were observational and therefore subject to potential biases and that they covered only the first 2 years that the duty-hours reforms have been in place.

The 2011 requirements expanded on those enacted in 2003 by further restricting residents’ duty hours, in the hope of reducing medical errors attributed to exhausted residents. The hours of continuous in-hospital duty were reduced from 30 to 16 for first-year residents and to 24 for upper-year residents, and the interval between shifts was increased to at least 8 hours off for first-year residents and at least 14 hours off for upper-year residents.

“Duty hour reform is arguably one of the largest efforts ever undertaken to improve the quality and safety of patient care in teaching hospitals,” said Dr. Mitesh S. Patel of the University of Pennsylvania and the Veterans Affairs Hospital Center for Health Equity Research and Promotion, both in Philadelphia, and his associates.

They assessed 30-day mortality and readmissions among 2,790,356 Medicare patients who were treated either for acute MI, stroke, gastrointestinal bleeding, or heart failure, or who underwent general, orthopedic, or vascular surgery, at 3,104 hospitals between 2009 and 2012. The investigators found no significant associations, either positive or negative, between the reforms to residents’ duty hours and any patient outcomes. Sensitivity analyses confirmed the results of the primary data analyses.

“Our findings suggest that ... the goals of improving the quality and safety of patient care ... were not being achieved. Conversely, concerns that outcomes might actually worsen because of decreased continuity of care have not been borne out,” Dr. Patel and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/jama.2014.15273]).

The investigators noted that their study was limited in that it could not take into account hospitals’ adherence to the new requirements. Their study also did not assess other outcomes such as patient safety indicators or complication rates, which “may better elucidate the relative effects of decreased resident fatigue and increased patient hand offs.” And their study couldn’t address any possible confounding effects from other concurrent policy initiatives aimed at improving care for Medicare beneficiaries, such as the Hospital Readmissions Reduction Program.

In the other study, a separate group of researchers used data from the American College of Surgeons National Surgical Quality Improvement Program to assess outcomes for 535,499 patients who underwent general surgery at 131 hospitals during the 2 years before and the 2 years after the reforms to residents’ duty hours were implemented. This included 23 teaching hospitals in which residents were involved in at least 95% of general surgeries, said Dr. Ravi Rajaram of the division of research and optimal patient care, American College of Surgeons, and the Institute for Public Health and Medicine at Northwestern University, both in Chicago, and his associates.

The reforms were not associated with any change in rates of patient mortality or serious morbidity, either in the study population as a whole or in the subgroups of high-risk and low-risk patients. They also had no effect on secondary outcomes such as surgical-site infection or sepsis. These results remained consistent across several sensitivity analyses.

Neither mean scores for in-training, written board, and oral board examinations nor pass rates for those examinations showed any significant changes during the study period.

“Moreover, first-year trainees, who were most directly affected by the 2011 reforms, did not improve their ABSITE [American Board of Surgery In-Training Examination] scores, despite presumably more free time to prepare,” Dr. Rajaram and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/JAMA.2014.15277]).

They cautioned that their study assessed only the first 2 years following duty-hour reform, and “there may be differences in patient care or resident examination performance that are evident only several years after implementation and adoption of new duty-hour requirements.” In addition, a retrospective observational study such as this one could not produce the high-level evidence needed to guide policy decisions. “To that end, a national multicenter cluster-randomized trial is being conducted (the Flexibility In duty hour Requirements for Surgical Trainees [FIRST] trial), comparing current duty-hour requirements with flexible duty hours to assess the effects of this intervention on patient outcomes and resident well-being. This trial may further inform the debate of how to optimally structure postgraduate training,” they said.

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Key clinical point: The newest (2011) reforms to resident duty hours haven’t changed patient mortality or morbidity outcomes.

Major finding: 30-day mortality and readmissions among almost 3 million Medicare patients at 3,104 hospitals did not change between 2009 and 2012.

Data source: Two observational cohort studies of millions of hospitalized adults across the country, comparing patient outcomes before with those after the 2011 reforms in duty hours for residents.

Disclosures: Dr. Patel’s study was funded in part by the National Heart, Lung, and Blood Institute, the Department of Veterans Affairs, and the Robert Wood Johnson Foundation. Dr. Rajaram’s study was supported by the Agency for Healthcare Research and Quality, the American College of Surgeons, and Merck. All of the investigators reported having no relevant financial conflicts of interest.

Most primary care physicians understand opioid risks

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Most primary care physicians are aware of the risks of prescribing opioids and have cut down on doing so, according to a Research Letter to the Editor published online Dec. 8 in JAMA Internal Medicine.

Investigators used an anonymous mailed survey of a nationally representative sample of 1,000 family physicians, internists, and general practitioners to examine their beliefs and self-reported practices regarding opioid prescribing. Understanding prescribing patterns, as well as the perceptions of adverse effects associated with these agents, is crucial because these physicians play a critical role in curtailing the prescription drug abuse epidemic, said Catherine S. Hwang of the Center for Drug Safety and Effectiveness and the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

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A total of 420 clinicians responded to the survey; 52% were family physicians, 46% were internists, and 2% were general practitioners. Whites accounted for 70%, 19% were Asian, and 11% were African American or other ethnicities/races. Nearly half were in solo or small-group practice, 13% were in an academic medical center–based practice, 12% were in a managed care organization, and 11% were in a public- or government-based practice. They saw a mean of 285 patients per month and prescribed an opioid for a mean of 35 patients per month.

A clear majority of the respondents (85%) were aware that opioids are overprescribed in clinical practice, and up to 85% were “moderately” or “very concerned” about patients’ possible addiction, death, or motor vehicle accidents while misusing the drugs. A total of 62% knew that tolerance could develop “often,” and most understood the risks of physical dependence. Nearly half reported that they were currently less likely to prescribe opioids than they had been a year before. Yet 88% said they were confident in their clinical skills related to opioid prescribing, and 49% said they were “very” or “moderately” comfortable prescribing the drugs for chronic noncancer pain, Ms. Hwang and her associates said (JAMA Intern. Med. 2014 Dec. 8 [doi:10.1001/jamainternmed. 2014.6520]).

The respondents expressed much less concern about adverse outcomes for themselves, such as malpractice claims or censure by state medical boards for questionable prescribing practices.

This study was sponsored by the Robert Wood Johnson Foundation Public Health Law Research Program and the Lipitz Public Health Policy Fund from Johns Hopkins Bloomberg School of Public Health. Ms. Hwang reported having no relevant financial disclosures; one of her associates reported being a medical expert for litigation involving Oxycontin, Neurontin, Zyprexa, Pfizer (Geodon), and AstraZeneca (Seroquel).

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Most primary care physicians are aware of the risks of prescribing opioids and have cut down on doing so, according to a Research Letter to the Editor published online Dec. 8 in JAMA Internal Medicine.

Investigators used an anonymous mailed survey of a nationally representative sample of 1,000 family physicians, internists, and general practitioners to examine their beliefs and self-reported practices regarding opioid prescribing. Understanding prescribing patterns, as well as the perceptions of adverse effects associated with these agents, is crucial because these physicians play a critical role in curtailing the prescription drug abuse epidemic, said Catherine S. Hwang of the Center for Drug Safety and Effectiveness and the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

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A total of 420 clinicians responded to the survey; 52% were family physicians, 46% were internists, and 2% were general practitioners. Whites accounted for 70%, 19% were Asian, and 11% were African American or other ethnicities/races. Nearly half were in solo or small-group practice, 13% were in an academic medical center–based practice, 12% were in a managed care organization, and 11% were in a public- or government-based practice. They saw a mean of 285 patients per month and prescribed an opioid for a mean of 35 patients per month.

A clear majority of the respondents (85%) were aware that opioids are overprescribed in clinical practice, and up to 85% were “moderately” or “very concerned” about patients’ possible addiction, death, or motor vehicle accidents while misusing the drugs. A total of 62% knew that tolerance could develop “often,” and most understood the risks of physical dependence. Nearly half reported that they were currently less likely to prescribe opioids than they had been a year before. Yet 88% said they were confident in their clinical skills related to opioid prescribing, and 49% said they were “very” or “moderately” comfortable prescribing the drugs for chronic noncancer pain, Ms. Hwang and her associates said (JAMA Intern. Med. 2014 Dec. 8 [doi:10.1001/jamainternmed. 2014.6520]).

The respondents expressed much less concern about adverse outcomes for themselves, such as malpractice claims or censure by state medical boards for questionable prescribing practices.

This study was sponsored by the Robert Wood Johnson Foundation Public Health Law Research Program and the Lipitz Public Health Policy Fund from Johns Hopkins Bloomberg School of Public Health. Ms. Hwang reported having no relevant financial disclosures; one of her associates reported being a medical expert for litigation involving Oxycontin, Neurontin, Zyprexa, Pfizer (Geodon), and AstraZeneca (Seroquel).

Most primary care physicians are aware of the risks of prescribing opioids and have cut down on doing so, according to a Research Letter to the Editor published online Dec. 8 in JAMA Internal Medicine.

Investigators used an anonymous mailed survey of a nationally representative sample of 1,000 family physicians, internists, and general practitioners to examine their beliefs and self-reported practices regarding opioid prescribing. Understanding prescribing patterns, as well as the perceptions of adverse effects associated with these agents, is crucial because these physicians play a critical role in curtailing the prescription drug abuse epidemic, said Catherine S. Hwang of the Center for Drug Safety and Effectiveness and the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates.

©Fuse/Thinkstock

A total of 420 clinicians responded to the survey; 52% were family physicians, 46% were internists, and 2% were general practitioners. Whites accounted for 70%, 19% were Asian, and 11% were African American or other ethnicities/races. Nearly half were in solo or small-group practice, 13% were in an academic medical center–based practice, 12% were in a managed care organization, and 11% were in a public- or government-based practice. They saw a mean of 285 patients per month and prescribed an opioid for a mean of 35 patients per month.

A clear majority of the respondents (85%) were aware that opioids are overprescribed in clinical practice, and up to 85% were “moderately” or “very concerned” about patients’ possible addiction, death, or motor vehicle accidents while misusing the drugs. A total of 62% knew that tolerance could develop “often,” and most understood the risks of physical dependence. Nearly half reported that they were currently less likely to prescribe opioids than they had been a year before. Yet 88% said they were confident in their clinical skills related to opioid prescribing, and 49% said they were “very” or “moderately” comfortable prescribing the drugs for chronic noncancer pain, Ms. Hwang and her associates said (JAMA Intern. Med. 2014 Dec. 8 [doi:10.1001/jamainternmed. 2014.6520]).

The respondents expressed much less concern about adverse outcomes for themselves, such as malpractice claims or censure by state medical boards for questionable prescribing practices.

This study was sponsored by the Robert Wood Johnson Foundation Public Health Law Research Program and the Lipitz Public Health Policy Fund from Johns Hopkins Bloomberg School of Public Health. Ms. Hwang reported having no relevant financial disclosures; one of her associates reported being a medical expert for litigation involving Oxycontin, Neurontin, Zyprexa, Pfizer (Geodon), and AstraZeneca (Seroquel).

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Key clinical point: Most primary care physicians are aware of the risks of prescribing opioids and have cut down on doing so.

Major finding: 85% of the respondents were aware that opioids are overprescribed in clinical practice, and up to 85% were “moderately” or “very concerned” about patients’ possible addiction, death, or motor vehicle accidents while misusing the drugs.

Data source: An analysis of an anonymous, nationally representative survey of 420 family physicians, internists, and general practitioners regarding opioid prescription.

Disclosures: This study was sponsored by the Robert Wood Johnson Foundation Public Health Law Research Program and the Lipitz Public Health Policy Fund from Johns Hopkins Bloomberg School of Public Health. Ms. Hwang reported having no relevant financial disclosures; one of her associates reported being a medical expert for litigation involving Oxycontin, Neurontin, Zyprexa, Pfizer (Geodon), and AstraZeneca (Seroquel).

More activity, less television prolongs life in colorectal Ca

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More exercise and less television were both associated with decreased all-cause mortality among older patients with colorectal cancer in a large, prospective cohort study, according to a report published online Dec. 8 in the Journal of Clinical Oncology.

Survivors of the disease have shown high a prevalence of sedentariness and TV viewing in previous research, so these findings “present an opportunity for clinicians to encourage behavioral changes to positively impact longevity,” said Hannah Arem, Ph.D., of the National Cancer Institute, Bethesda, Md., and her associates.

They assessed the relationships among both prediagnosis and postdiagnosis activity levels on the one hand and all-cause mortality and disease-specific mortality on the other using data from the National Institutes of Health–American Association of Retired Persons (NIH-AARP) Diet and Health Study. The original cohort included 566,398 men and women aged 50-71 years at baseline in 1995. These participants, who resided in six U.S. states and two metropolitan areas, completed mailed questionnaires regarding moderate to intense physical activities they performed, such as fast walking, running/jogging, biking, playing tennis, dancing, swimming, playing golf, and performing aerobics or heavy gardening.

For their study, Dr. Arem and her associates identified 3,784 of these participants who completed the survey a mean of 5 years before their diagnosis of colorectal cancer and 1,759 who did so a mean of 4.2 years after their diagnosis.

The investigators found that before a colorectal cancer diagnosis, increased activity (more than 7 hours per week) was associated with a 20% lower risk of all-cause mortality, compared with no such activity. After a colorectal cancer diagnosis, increased activity was associated with a 31% lower risk of all-cause mortality and a 47% lower risk of disease-specific mortality.

In contrast, watching more than 4 hours per day of TV, as opposed to watching 0-2 hours per day, was associated with a 20% increase in all-cause mortality both before and after a colorectal cancer diagnosis (J. Clin. Oncol. 2014 Dec. 8 [doi:10.1200/JCO.2014.58.1355]).

When the data were combined in a joint-effects analysis, patients who had the highest activity levels (more than 7 hours per week) and the lowest TV viewing levels (2 or fewer hours per day) showed the lowest all-cause mortality risk of all.

In addition, “our results suggest that physical activity was not as protective among those who performed high levels of [activity] but also watched 3 or more hours of TV per day, suggesting that encouraging both more exercise and less TV in this survivor population may lead to improved longevity outcomes,” Dr. Arem and her associates noted.

These associations were not influenced by the patient’s sex, exact disease site, body mass index, tumor stage or grade, type of surgery, or general health status, they added.

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More exercise and less television were both associated with decreased all-cause mortality among older patients with colorectal cancer in a large, prospective cohort study, according to a report published online Dec. 8 in the Journal of Clinical Oncology.

Survivors of the disease have shown high a prevalence of sedentariness and TV viewing in previous research, so these findings “present an opportunity for clinicians to encourage behavioral changes to positively impact longevity,” said Hannah Arem, Ph.D., of the National Cancer Institute, Bethesda, Md., and her associates.

They assessed the relationships among both prediagnosis and postdiagnosis activity levels on the one hand and all-cause mortality and disease-specific mortality on the other using data from the National Institutes of Health–American Association of Retired Persons (NIH-AARP) Diet and Health Study. The original cohort included 566,398 men and women aged 50-71 years at baseline in 1995. These participants, who resided in six U.S. states and two metropolitan areas, completed mailed questionnaires regarding moderate to intense physical activities they performed, such as fast walking, running/jogging, biking, playing tennis, dancing, swimming, playing golf, and performing aerobics or heavy gardening.

For their study, Dr. Arem and her associates identified 3,784 of these participants who completed the survey a mean of 5 years before their diagnosis of colorectal cancer and 1,759 who did so a mean of 4.2 years after their diagnosis.

The investigators found that before a colorectal cancer diagnosis, increased activity (more than 7 hours per week) was associated with a 20% lower risk of all-cause mortality, compared with no such activity. After a colorectal cancer diagnosis, increased activity was associated with a 31% lower risk of all-cause mortality and a 47% lower risk of disease-specific mortality.

In contrast, watching more than 4 hours per day of TV, as opposed to watching 0-2 hours per day, was associated with a 20% increase in all-cause mortality both before and after a colorectal cancer diagnosis (J. Clin. Oncol. 2014 Dec. 8 [doi:10.1200/JCO.2014.58.1355]).

When the data were combined in a joint-effects analysis, patients who had the highest activity levels (more than 7 hours per week) and the lowest TV viewing levels (2 or fewer hours per day) showed the lowest all-cause mortality risk of all.

In addition, “our results suggest that physical activity was not as protective among those who performed high levels of [activity] but also watched 3 or more hours of TV per day, suggesting that encouraging both more exercise and less TV in this survivor population may lead to improved longevity outcomes,” Dr. Arem and her associates noted.

These associations were not influenced by the patient’s sex, exact disease site, body mass index, tumor stage or grade, type of surgery, or general health status, they added.

More exercise and less television were both associated with decreased all-cause mortality among older patients with colorectal cancer in a large, prospective cohort study, according to a report published online Dec. 8 in the Journal of Clinical Oncology.

Survivors of the disease have shown high a prevalence of sedentariness and TV viewing in previous research, so these findings “present an opportunity for clinicians to encourage behavioral changes to positively impact longevity,” said Hannah Arem, Ph.D., of the National Cancer Institute, Bethesda, Md., and her associates.

They assessed the relationships among both prediagnosis and postdiagnosis activity levels on the one hand and all-cause mortality and disease-specific mortality on the other using data from the National Institutes of Health–American Association of Retired Persons (NIH-AARP) Diet and Health Study. The original cohort included 566,398 men and women aged 50-71 years at baseline in 1995. These participants, who resided in six U.S. states and two metropolitan areas, completed mailed questionnaires regarding moderate to intense physical activities they performed, such as fast walking, running/jogging, biking, playing tennis, dancing, swimming, playing golf, and performing aerobics or heavy gardening.

For their study, Dr. Arem and her associates identified 3,784 of these participants who completed the survey a mean of 5 years before their diagnosis of colorectal cancer and 1,759 who did so a mean of 4.2 years after their diagnosis.

The investigators found that before a colorectal cancer diagnosis, increased activity (more than 7 hours per week) was associated with a 20% lower risk of all-cause mortality, compared with no such activity. After a colorectal cancer diagnosis, increased activity was associated with a 31% lower risk of all-cause mortality and a 47% lower risk of disease-specific mortality.

In contrast, watching more than 4 hours per day of TV, as opposed to watching 0-2 hours per day, was associated with a 20% increase in all-cause mortality both before and after a colorectal cancer diagnosis (J. Clin. Oncol. 2014 Dec. 8 [doi:10.1200/JCO.2014.58.1355]).

When the data were combined in a joint-effects analysis, patients who had the highest activity levels (more than 7 hours per week) and the lowest TV viewing levels (2 or fewer hours per day) showed the lowest all-cause mortality risk of all.

In addition, “our results suggest that physical activity was not as protective among those who performed high levels of [activity] but also watched 3 or more hours of TV per day, suggesting that encouraging both more exercise and less TV in this survivor population may lead to improved longevity outcomes,” Dr. Arem and her associates noted.

These associations were not influenced by the patient’s sex, exact disease site, body mass index, tumor stage or grade, type of surgery, or general health status, they added.

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Key clinical point: Higher activity levels and lower TV viewing levels were associated with lower all-cause mortality in older adults with colorectal cancer.

Major finding: Before a colorectal cancer diagnosis, increased activity (more than 7 hours per week) was associated with a 20% lower risk of all-cause mortality, compared with no such activity; after a colorectal cancer diagnosis, increased activity was associated with a 31% lower risk of all-cause mortality and a 47% lower risk of disease-specific mortality.

Data source: A secondary analysis of data from the NIH-AARP Diet and Health Study, assessing activity and mortality in 3,784 patients before and 1,759 after they developed colorectal cancer.

Disclosures: This study was supported in part by the National Cancer Institute. Dr. Arem reported having no relevant financial disclosures; one of her associates reported ties to the Love/Avon Army of Women.

Preventing, treating HBV reactivation during immunosuppressive therapy

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Patients who are to undergo immunosuppressive therapy but are at high risk for reactivation of hepatitis B infection should receive antiviral prophylaxis, rather than being monitored for reactivation and treated only if it develops, according to a new guideline published online in Gastroenterology.

The American Gastroenterological Association conducted a rigorous review of the available evidence and compiled seven recommendations to guide clinicians and researchers in preventing HBV reactivation before patients initiate immunosuppressive therapy and in treating reactivated HBV if it arises during immunosuppressive therapy. “Despite the large number of published studies, in most cases our recommendations are weak because either (1) the quality of the available data and/or the baseline risk of HBV reactivation is low or uncertain, and/or (2) the balance of risks and benefits for a particular strategy does not overwhelmingly support its use,” said Dr. K. Rajender Reddy, lead writer of the guideline and professor of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and his associates.

CDC/Dr. Erskine Palmer
Patients in therapy but at risk for hepatitis B reactivation should receive antiviral prophylaxis, rather than treating only if it develops.

In contrast, the data supporting the recommendation to provide prophylaxis for high-risk patients are moderately robust, so that recommendation is strong, they noted.

Patients’ level of risk is based on their HBV serologic status and the type of immunosuppression they require. For example, patients are considered at high risk for HBV reactivation if they are hepatitis B surface antigen (HBsAg) positive/anti–hepatitis B core (HBc) positive or are HBsAg negative/anti-HBc positive and are to be treated with B-cell–depleting agents such as rituximab or ofatumumab. Also at high risk are HBsAg-positive/anti-HBc–positive patients to be treated with anthracycline derivatives such as doxorubicin or epirubicin, and HBsAg-positive/anti-HBc–positive patients to be treated with moderate- or high-dose corticosteroids for 4 weeks or longer.

In these high-risk patients, antiviral prophylaxis is definitely warranted, and it should extend for at least 6 months after the immunosuppressive therapy is completed, according to the guideline. In contrast, antiviral prophylaxis is “suggested” for moderate-risk patients, but those who place a higher value on avoiding antivirals and a lower value on avoiding HBV reactivation “may reasonably select no prophylaxis over antiviral prophylaxis,” Dr. Reddy and his associates said.

In contrast, routine antiviral prophylaxis is not recommended for patients undergoing immunosuppressive therapy who are at low risk for HBV reactivation.

Other recommendations in the new guideline concern which antiviral agents are preferred in different situations. The AGA strongly recommends antivirals that have a high barrier to resistance, in preference to lamivudine, in most patients. But it acknowledges that the evidence comparing various antivirals is weak, and that the drugs vary considerably in price. “Patients who put a higher value on cost and a lower value on avoiding the potentially small risk of resistance development may reasonably select the least expensive antiviral hepatitis B medication over more expensive antiviral drugs with a higher barrier to resistance,” Dr. Reddy and his associates said (Gastroenterol. 2014 [doi:10.1053/j.gastro.2014.10.039]).

The evidence regarding patient monitoring for HBV reactivation instead of prophylaxis is so sparse that the AGA makes no recommendation for or against this strategy at present. Most studies of the issue are of poor quality, use different definitions of HBV reactivation, have inconsistent reporting of patient outcomes, and disagree about the best methods and frequency of HBV DNA monitoring. Moreover, frequent monitoring requires “considerable” personnel resources, and the methods used in clinical studies may not even be adaptable to real world practice, the investigators said.

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Patients who are to undergo immunosuppressive therapy but are at high risk for reactivation of hepatitis B infection should receive antiviral prophylaxis, rather than being monitored for reactivation and treated only if it develops, according to a new guideline published online in Gastroenterology.

The American Gastroenterological Association conducted a rigorous review of the available evidence and compiled seven recommendations to guide clinicians and researchers in preventing HBV reactivation before patients initiate immunosuppressive therapy and in treating reactivated HBV if it arises during immunosuppressive therapy. “Despite the large number of published studies, in most cases our recommendations are weak because either (1) the quality of the available data and/or the baseline risk of HBV reactivation is low or uncertain, and/or (2) the balance of risks and benefits for a particular strategy does not overwhelmingly support its use,” said Dr. K. Rajender Reddy, lead writer of the guideline and professor of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and his associates.

CDC/Dr. Erskine Palmer
Patients in therapy but at risk for hepatitis B reactivation should receive antiviral prophylaxis, rather than treating only if it develops.

In contrast, the data supporting the recommendation to provide prophylaxis for high-risk patients are moderately robust, so that recommendation is strong, they noted.

Patients’ level of risk is based on their HBV serologic status and the type of immunosuppression they require. For example, patients are considered at high risk for HBV reactivation if they are hepatitis B surface antigen (HBsAg) positive/anti–hepatitis B core (HBc) positive or are HBsAg negative/anti-HBc positive and are to be treated with B-cell–depleting agents such as rituximab or ofatumumab. Also at high risk are HBsAg-positive/anti-HBc–positive patients to be treated with anthracycline derivatives such as doxorubicin or epirubicin, and HBsAg-positive/anti-HBc–positive patients to be treated with moderate- or high-dose corticosteroids for 4 weeks or longer.

In these high-risk patients, antiviral prophylaxis is definitely warranted, and it should extend for at least 6 months after the immunosuppressive therapy is completed, according to the guideline. In contrast, antiviral prophylaxis is “suggested” for moderate-risk patients, but those who place a higher value on avoiding antivirals and a lower value on avoiding HBV reactivation “may reasonably select no prophylaxis over antiviral prophylaxis,” Dr. Reddy and his associates said.

In contrast, routine antiviral prophylaxis is not recommended for patients undergoing immunosuppressive therapy who are at low risk for HBV reactivation.

Other recommendations in the new guideline concern which antiviral agents are preferred in different situations. The AGA strongly recommends antivirals that have a high barrier to resistance, in preference to lamivudine, in most patients. But it acknowledges that the evidence comparing various antivirals is weak, and that the drugs vary considerably in price. “Patients who put a higher value on cost and a lower value on avoiding the potentially small risk of resistance development may reasonably select the least expensive antiviral hepatitis B medication over more expensive antiviral drugs with a higher barrier to resistance,” Dr. Reddy and his associates said (Gastroenterol. 2014 [doi:10.1053/j.gastro.2014.10.039]).

The evidence regarding patient monitoring for HBV reactivation instead of prophylaxis is so sparse that the AGA makes no recommendation for or against this strategy at present. Most studies of the issue are of poor quality, use different definitions of HBV reactivation, have inconsistent reporting of patient outcomes, and disagree about the best methods and frequency of HBV DNA monitoring. Moreover, frequent monitoring requires “considerable” personnel resources, and the methods used in clinical studies may not even be adaptable to real world practice, the investigators said.

Patients who are to undergo immunosuppressive therapy but are at high risk for reactivation of hepatitis B infection should receive antiviral prophylaxis, rather than being monitored for reactivation and treated only if it develops, according to a new guideline published online in Gastroenterology.

The American Gastroenterological Association conducted a rigorous review of the available evidence and compiled seven recommendations to guide clinicians and researchers in preventing HBV reactivation before patients initiate immunosuppressive therapy and in treating reactivated HBV if it arises during immunosuppressive therapy. “Despite the large number of published studies, in most cases our recommendations are weak because either (1) the quality of the available data and/or the baseline risk of HBV reactivation is low or uncertain, and/or (2) the balance of risks and benefits for a particular strategy does not overwhelmingly support its use,” said Dr. K. Rajender Reddy, lead writer of the guideline and professor of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and his associates.

CDC/Dr. Erskine Palmer
Patients in therapy but at risk for hepatitis B reactivation should receive antiviral prophylaxis, rather than treating only if it develops.

In contrast, the data supporting the recommendation to provide prophylaxis for high-risk patients are moderately robust, so that recommendation is strong, they noted.

Patients’ level of risk is based on their HBV serologic status and the type of immunosuppression they require. For example, patients are considered at high risk for HBV reactivation if they are hepatitis B surface antigen (HBsAg) positive/anti–hepatitis B core (HBc) positive or are HBsAg negative/anti-HBc positive and are to be treated with B-cell–depleting agents such as rituximab or ofatumumab. Also at high risk are HBsAg-positive/anti-HBc–positive patients to be treated with anthracycline derivatives such as doxorubicin or epirubicin, and HBsAg-positive/anti-HBc–positive patients to be treated with moderate- or high-dose corticosteroids for 4 weeks or longer.

In these high-risk patients, antiviral prophylaxis is definitely warranted, and it should extend for at least 6 months after the immunosuppressive therapy is completed, according to the guideline. In contrast, antiviral prophylaxis is “suggested” for moderate-risk patients, but those who place a higher value on avoiding antivirals and a lower value on avoiding HBV reactivation “may reasonably select no prophylaxis over antiviral prophylaxis,” Dr. Reddy and his associates said.

In contrast, routine antiviral prophylaxis is not recommended for patients undergoing immunosuppressive therapy who are at low risk for HBV reactivation.

Other recommendations in the new guideline concern which antiviral agents are preferred in different situations. The AGA strongly recommends antivirals that have a high barrier to resistance, in preference to lamivudine, in most patients. But it acknowledges that the evidence comparing various antivirals is weak, and that the drugs vary considerably in price. “Patients who put a higher value on cost and a lower value on avoiding the potentially small risk of resistance development may reasonably select the least expensive antiviral hepatitis B medication over more expensive antiviral drugs with a higher barrier to resistance,” Dr. Reddy and his associates said (Gastroenterol. 2014 [doi:10.1053/j.gastro.2014.10.039]).

The evidence regarding patient monitoring for HBV reactivation instead of prophylaxis is so sparse that the AGA makes no recommendation for or against this strategy at present. Most studies of the issue are of poor quality, use different definitions of HBV reactivation, have inconsistent reporting of patient outcomes, and disagree about the best methods and frequency of HBV DNA monitoring. Moreover, frequent monitoring requires “considerable” personnel resources, and the methods used in clinical studies may not even be adaptable to real world practice, the investigators said.

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Key clinical point: The American Gastroenterological Association published a guideline for preventing the reactivation of HBV in patients who need immunosuppressive therapy and for treating reactivated HBV when it develops in patients undergoing immunosuppression.

Major finding: Robust evidence supports the recommendation that antiviral prophylaxis is warranted in patients at high risk for HBV reactivation, “suggested” for patients at moderate risk, and not recommended for patients at low risk.

Data source: A rigorous review and summary of the available evidence regarding prevention and treatment of HBV reactivation, and a compilation of recommendations for clinicians and researchers.

Disclosures: Dr. Reddy and his associates’ disclosure statements are available at the American Gastroenterological Association, Bethesda, Md. .

First-line crizotinib superior for ALK-positive NSCLC

Don’t forget crizotinib’s drawbacks
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Crizotinib proved superior to standard pemetrexed plus platinum chemotherapy as first-line treatment for adults with advanced ALK-positive non–small cell lung cancer in an international phase III clinical trial reported online Dec. 4 in the New England Journal of Medicine.

Crizotinib, an oral tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK), significantly prolonged progression-free survival; yielded a significantly higher response rate; and produced significantly greater improvements in patient-reported physical functioning, lung-cancer symptoms, and quality of life than the current standard of care chemotherapy in the industry-sponsored open-label study, said Dr. Benjamin J. Solomon of Peter MacCallum Cancer Centre, Melbourne, and his associates.

Rearrangements of the ALK gene are present in up to 5% of non–small cell lung cancers (NSCLCs) and characterize a distinct subgroup of tumors that typically occurs in younger patients who have never smoked. Crizotinib produced promising results in this subset of patients in phase I and II studies, but until now has not been tested as first-line therapy for the malignancy.

Dr. Solomon and his associates assessed the drug in adults with locally advanced, recurrent, or metastatic NSCLC that was positive for ALK rearrangements. During the 2.5-year study, they randomly assigned 172 patients to twice-daily oral crizotinb and 171 to IV chemotherapy (pemetrexed plus either cisplatin or carboplatin) every 3 weeks for a maximum of six cycles. Patients who showed disease progression while on chemotherapy were allowed to cross over to crizotinib treatment.

The median duration of follow-up was approximately 17 months. The primary endpoint of the study, progression-free survival, was 10.9 months with crizotinb and 7.0 months with chemotherapy, a significant difference (hazard ratio, 0.45). This beneficial effect was independent of patients’ performance status at baseline, race, and the presence or absence of brain metastases, the investigators said (N. Engl. J. Med. 2014 Dec. 4 [doi:10.1056/NEJMoa1408440]).

In addition, the objective treatment response rate was significantly higher with crizotinib (74%) than with chemotherapy (45%), and the median duration of response was significantly longer (11.3 month vs 5.3 months).

At the time of initial data analysis in this ongoing trial, overall survival did not differ between the two study groups. This is probably due to the low rate of death from any cause at that time (only 26% overall mortality) and to the fact that 70% of the chemotherapy group crossed over to crizotinib, confounding the results of the overall survival analysis, Dr. Solomon and his associates said.

In previous research, the most serious adverse events linked to crizotinib were hepatotoxicity and pulmonary toxicity. In this trial, 14% of patients taking crizotinib developed grade 3 or 4 elevations in aminotransferase levels, which was managed with dose interruptions or dose reductions. Two patients discontinued crizotinib because of interstitial lung disease, and one patient died from pneumonitis believed to be associated with the drug.

Other adverse events possibly related to crizotinib included vision disorder (71% of patients), diarrhea (61%), and edema (49%). Adverse events that were significantly more common in the chemotherapy group included fatigue (38%), anemia (32%), and neutropenia (30%). Patients given crizotinib reported significantly greater improvement than those given chemotherapy in global quality of life, as well as in the individual physical, social, emotional, and role-functioning domains of quality of life. They also reported significantly greater reduction in pain, dyspnea, and insomnia, and a significantly greater improvement in general health status. The study participants who received crizotinib also reported greater improvement in symptoms specifically related to lung cancer, such as cough, chest pain, and arm or shoulder pain, as well as a significantly longer delay in the worsening of lung cancer symptoms.

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Even though Solomon et al have demonstrated the superiority of crizotinib over chemotherapy in a rigorous way, it is premature to be opening the victory champagne bottles. We must remember that crizotinib and other ALK inhibitors have toxic effects, are enormously and inappropriately expensive, and haven’t cured anyone yet.

Dr. Dan L. Longo is a deputy editor of the New England Journal of Medicine. He reported having no financial disclosures. Dr. Longo made these remarks in an editorial accompanying Dr. Solomon’s report (N. Engl. J. Med. 2014 Dec. 4 [doi:10.1056/NEJMe1412624]).

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Body

Even though Solomon et al have demonstrated the superiority of crizotinib over chemotherapy in a rigorous way, it is premature to be opening the victory champagne bottles. We must remember that crizotinib and other ALK inhibitors have toxic effects, are enormously and inappropriately expensive, and haven’t cured anyone yet.

Dr. Dan L. Longo is a deputy editor of the New England Journal of Medicine. He reported having no financial disclosures. Dr. Longo made these remarks in an editorial accompanying Dr. Solomon’s report (N. Engl. J. Med. 2014 Dec. 4 [doi:10.1056/NEJMe1412624]).

Body

Even though Solomon et al have demonstrated the superiority of crizotinib over chemotherapy in a rigorous way, it is premature to be opening the victory champagne bottles. We must remember that crizotinib and other ALK inhibitors have toxic effects, are enormously and inappropriately expensive, and haven’t cured anyone yet.

Dr. Dan L. Longo is a deputy editor of the New England Journal of Medicine. He reported having no financial disclosures. Dr. Longo made these remarks in an editorial accompanying Dr. Solomon’s report (N. Engl. J. Med. 2014 Dec. 4 [doi:10.1056/NEJMe1412624]).

Title
Don’t forget crizotinib’s drawbacks
Don’t forget crizotinib’s drawbacks

Crizotinib proved superior to standard pemetrexed plus platinum chemotherapy as first-line treatment for adults with advanced ALK-positive non–small cell lung cancer in an international phase III clinical trial reported online Dec. 4 in the New England Journal of Medicine.

Crizotinib, an oral tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK), significantly prolonged progression-free survival; yielded a significantly higher response rate; and produced significantly greater improvements in patient-reported physical functioning, lung-cancer symptoms, and quality of life than the current standard of care chemotherapy in the industry-sponsored open-label study, said Dr. Benjamin J. Solomon of Peter MacCallum Cancer Centre, Melbourne, and his associates.

Rearrangements of the ALK gene are present in up to 5% of non–small cell lung cancers (NSCLCs) and characterize a distinct subgroup of tumors that typically occurs in younger patients who have never smoked. Crizotinib produced promising results in this subset of patients in phase I and II studies, but until now has not been tested as first-line therapy for the malignancy.

Dr. Solomon and his associates assessed the drug in adults with locally advanced, recurrent, or metastatic NSCLC that was positive for ALK rearrangements. During the 2.5-year study, they randomly assigned 172 patients to twice-daily oral crizotinb and 171 to IV chemotherapy (pemetrexed plus either cisplatin or carboplatin) every 3 weeks for a maximum of six cycles. Patients who showed disease progression while on chemotherapy were allowed to cross over to crizotinib treatment.

The median duration of follow-up was approximately 17 months. The primary endpoint of the study, progression-free survival, was 10.9 months with crizotinb and 7.0 months with chemotherapy, a significant difference (hazard ratio, 0.45). This beneficial effect was independent of patients’ performance status at baseline, race, and the presence or absence of brain metastases, the investigators said (N. Engl. J. Med. 2014 Dec. 4 [doi:10.1056/NEJMoa1408440]).

In addition, the objective treatment response rate was significantly higher with crizotinib (74%) than with chemotherapy (45%), and the median duration of response was significantly longer (11.3 month vs 5.3 months).

At the time of initial data analysis in this ongoing trial, overall survival did not differ between the two study groups. This is probably due to the low rate of death from any cause at that time (only 26% overall mortality) and to the fact that 70% of the chemotherapy group crossed over to crizotinib, confounding the results of the overall survival analysis, Dr. Solomon and his associates said.

In previous research, the most serious adverse events linked to crizotinib were hepatotoxicity and pulmonary toxicity. In this trial, 14% of patients taking crizotinib developed grade 3 or 4 elevations in aminotransferase levels, which was managed with dose interruptions or dose reductions. Two patients discontinued crizotinib because of interstitial lung disease, and one patient died from pneumonitis believed to be associated with the drug.

Other adverse events possibly related to crizotinib included vision disorder (71% of patients), diarrhea (61%), and edema (49%). Adverse events that were significantly more common in the chemotherapy group included fatigue (38%), anemia (32%), and neutropenia (30%). Patients given crizotinib reported significantly greater improvement than those given chemotherapy in global quality of life, as well as in the individual physical, social, emotional, and role-functioning domains of quality of life. They also reported significantly greater reduction in pain, dyspnea, and insomnia, and a significantly greater improvement in general health status. The study participants who received crizotinib also reported greater improvement in symptoms specifically related to lung cancer, such as cough, chest pain, and arm or shoulder pain, as well as a significantly longer delay in the worsening of lung cancer symptoms.

Crizotinib proved superior to standard pemetrexed plus platinum chemotherapy as first-line treatment for adults with advanced ALK-positive non–small cell lung cancer in an international phase III clinical trial reported online Dec. 4 in the New England Journal of Medicine.

Crizotinib, an oral tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK), significantly prolonged progression-free survival; yielded a significantly higher response rate; and produced significantly greater improvements in patient-reported physical functioning, lung-cancer symptoms, and quality of life than the current standard of care chemotherapy in the industry-sponsored open-label study, said Dr. Benjamin J. Solomon of Peter MacCallum Cancer Centre, Melbourne, and his associates.

Rearrangements of the ALK gene are present in up to 5% of non–small cell lung cancers (NSCLCs) and characterize a distinct subgroup of tumors that typically occurs in younger patients who have never smoked. Crizotinib produced promising results in this subset of patients in phase I and II studies, but until now has not been tested as first-line therapy for the malignancy.

Dr. Solomon and his associates assessed the drug in adults with locally advanced, recurrent, or metastatic NSCLC that was positive for ALK rearrangements. During the 2.5-year study, they randomly assigned 172 patients to twice-daily oral crizotinb and 171 to IV chemotherapy (pemetrexed plus either cisplatin or carboplatin) every 3 weeks for a maximum of six cycles. Patients who showed disease progression while on chemotherapy were allowed to cross over to crizotinib treatment.

The median duration of follow-up was approximately 17 months. The primary endpoint of the study, progression-free survival, was 10.9 months with crizotinb and 7.0 months with chemotherapy, a significant difference (hazard ratio, 0.45). This beneficial effect was independent of patients’ performance status at baseline, race, and the presence or absence of brain metastases, the investigators said (N. Engl. J. Med. 2014 Dec. 4 [doi:10.1056/NEJMoa1408440]).

In addition, the objective treatment response rate was significantly higher with crizotinib (74%) than with chemotherapy (45%), and the median duration of response was significantly longer (11.3 month vs 5.3 months).

At the time of initial data analysis in this ongoing trial, overall survival did not differ between the two study groups. This is probably due to the low rate of death from any cause at that time (only 26% overall mortality) and to the fact that 70% of the chemotherapy group crossed over to crizotinib, confounding the results of the overall survival analysis, Dr. Solomon and his associates said.

In previous research, the most serious adverse events linked to crizotinib were hepatotoxicity and pulmonary toxicity. In this trial, 14% of patients taking crizotinib developed grade 3 or 4 elevations in aminotransferase levels, which was managed with dose interruptions or dose reductions. Two patients discontinued crizotinib because of interstitial lung disease, and one patient died from pneumonitis believed to be associated with the drug.

Other adverse events possibly related to crizotinib included vision disorder (71% of patients), diarrhea (61%), and edema (49%). Adverse events that were significantly more common in the chemotherapy group included fatigue (38%), anemia (32%), and neutropenia (30%). Patients given crizotinib reported significantly greater improvement than those given chemotherapy in global quality of life, as well as in the individual physical, social, emotional, and role-functioning domains of quality of life. They also reported significantly greater reduction in pain, dyspnea, and insomnia, and a significantly greater improvement in general health status. The study participants who received crizotinib also reported greater improvement in symptoms specifically related to lung cancer, such as cough, chest pain, and arm or shoulder pain, as well as a significantly longer delay in the worsening of lung cancer symptoms.

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First-line crizotinib superior for ALK-positive NSCLC
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Key clinical point: Crizotinib proved superior to standard pemetrexed plus platinum chemotherapy for advanced ALK-positive NSCLC.

Major finding: The primary end point of the study, progression-free survival, was 10.9 months with crizotinb and 7.0 months with chemotherapy, a significant difference (HR, 0.45).

Data source: An international open-label randomized phase III clinical trial involving 343 adults with advanced ALK-positive NSCLC followed for a median of 17 months.

Disclosures: This trial was sponsored by Pfizer, which also was involved in the study design, data collection and analysis, and write-up of the results. Dr. Solomon reported ties to Pfizer, Roche, Novartis, AstraZeneca, Clovis Oncology, Bristol-Myers Squibb, Eli Lilly, and Boehringer Ingelheim; his associates reported having ties to numerous industry sources.

Men on Androgen Deprivation Therapy Not Getting Bisphosphonates

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Men on Androgen Deprivation Therapy Not Getting Bisphosphonates

The rate of prescribing bisphosphonates to protect the bone health of prostate cancer patients taking androgen deprivation therapy is extremely low in Ontario, even among those at high risk of fracture, according to a research letter published online Dec. 2 in JAMA.

Canadian guidelines have recommended bisphosphonates for men at risk for bone fracture since 2002, and specifically for men taking androgen deprivation therapy (ADT) since 2006. However, prescribing patterns for these agents are relatively unknown, said Dr. Husayn Gulamhusein of University Health Network, Toronto, and his associates.

The investigators assessed rates of these prescriptions over time by analyzing data in an Ontario cancer registry regarding 35,487 men aged 66 years and older who initiated ADT for prostate cancer between 1995 and 2012. They found that bisphosphonate prescriptions were filled for only 0.35/100 men in the earliest years of the study period, a rate that rose to only 3.40/100 men in the final years. “Even among those with prior osteoporosis or fragility fracture, rates remained low,” the researchers said (JAMA 2014;312:2285-6).Their findings indicate “limited awareness among clinicians regarding optimal bone health management,” they added.

There was a decrease in bisphosphonate prescriptions after 2009, which “may be partly due to negative media regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is concerning,” Dr. Gulamhusein and his associates noted.

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The rate of prescribing bisphosphonates to protect the bone health of prostate cancer patients taking androgen deprivation therapy is extremely low in Ontario, even among those at high risk of fracture, according to a research letter published online Dec. 2 in JAMA.

Canadian guidelines have recommended bisphosphonates for men at risk for bone fracture since 2002, and specifically for men taking androgen deprivation therapy (ADT) since 2006. However, prescribing patterns for these agents are relatively unknown, said Dr. Husayn Gulamhusein of University Health Network, Toronto, and his associates.

The investigators assessed rates of these prescriptions over time by analyzing data in an Ontario cancer registry regarding 35,487 men aged 66 years and older who initiated ADT for prostate cancer between 1995 and 2012. They found that bisphosphonate prescriptions were filled for only 0.35/100 men in the earliest years of the study period, a rate that rose to only 3.40/100 men in the final years. “Even among those with prior osteoporosis or fragility fracture, rates remained low,” the researchers said (JAMA 2014;312:2285-6).Their findings indicate “limited awareness among clinicians regarding optimal bone health management,” they added.

There was a decrease in bisphosphonate prescriptions after 2009, which “may be partly due to negative media regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is concerning,” Dr. Gulamhusein and his associates noted.

The rate of prescribing bisphosphonates to protect the bone health of prostate cancer patients taking androgen deprivation therapy is extremely low in Ontario, even among those at high risk of fracture, according to a research letter published online Dec. 2 in JAMA.

Canadian guidelines have recommended bisphosphonates for men at risk for bone fracture since 2002, and specifically for men taking androgen deprivation therapy (ADT) since 2006. However, prescribing patterns for these agents are relatively unknown, said Dr. Husayn Gulamhusein of University Health Network, Toronto, and his associates.

The investigators assessed rates of these prescriptions over time by analyzing data in an Ontario cancer registry regarding 35,487 men aged 66 years and older who initiated ADT for prostate cancer between 1995 and 2012. They found that bisphosphonate prescriptions were filled for only 0.35/100 men in the earliest years of the study period, a rate that rose to only 3.40/100 men in the final years. “Even among those with prior osteoporosis or fragility fracture, rates remained low,” the researchers said (JAMA 2014;312:2285-6).Their findings indicate “limited awareness among clinicians regarding optimal bone health management,” they added.

There was a decrease in bisphosphonate prescriptions after 2009, which “may be partly due to negative media regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is concerning,” Dr. Gulamhusein and his associates noted.

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Men on androgen deprivation therapy not getting bisphosphonates

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Men on androgen deprivation therapy not getting bisphosphonates

The rate of prescribing bisphosphonates to protect the bone health of prostate cancer patients taking androgen deprivation therapy is extremely low in Ontario, even among those at high risk of fracture, according to a research letter published online Dec. 2 in JAMA.

Canadian guidelines have recommended bisphosphonates for men at risk for bone fracture since 2002, and specifically for men taking androgen deprivation therapy (ADT) since 2006. However, prescribing patterns for these agents are relatively unknown, said Dr. Husayn Gulamhusein of University Health Network, Toronto, and his associates.

The investigators assessed rates of these prescriptions over time by analyzing data in an Ontario cancer registry regarding 35,487 men aged 66 years and older who initiated ADT for prostate cancer between 1995 and 2012. They found that bisphosphonate prescriptions were filled for only 0.35/100 men in the earliest years of the study period, a rate that rose to only 3.40/100 men in the final years. “Even among those with prior osteoporosis or fragility fracture, rates remained low,” the researchers said (JAMA 2014;312:2285-6).Their findings indicate “limited awareness among clinicians regarding optimal bone health management,” they added.

There was a decrease in bisphosphonate prescriptions after 2009, which “may be partly due to negative media regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is concerning,” Dr. Gulamhusein and his associates noted.

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The rate of prescribing bisphosphonates to protect the bone health of prostate cancer patients taking androgen deprivation therapy is extremely low in Ontario, even among those at high risk of fracture, according to a research letter published online Dec. 2 in JAMA.

Canadian guidelines have recommended bisphosphonates for men at risk for bone fracture since 2002, and specifically for men taking androgen deprivation therapy (ADT) since 2006. However, prescribing patterns for these agents are relatively unknown, said Dr. Husayn Gulamhusein of University Health Network, Toronto, and his associates.

The investigators assessed rates of these prescriptions over time by analyzing data in an Ontario cancer registry regarding 35,487 men aged 66 years and older who initiated ADT for prostate cancer between 1995 and 2012. They found that bisphosphonate prescriptions were filled for only 0.35/100 men in the earliest years of the study period, a rate that rose to only 3.40/100 men in the final years. “Even among those with prior osteoporosis or fragility fracture, rates remained low,” the researchers said (JAMA 2014;312:2285-6).Their findings indicate “limited awareness among clinicians regarding optimal bone health management,” they added.

There was a decrease in bisphosphonate prescriptions after 2009, which “may be partly due to negative media regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is concerning,” Dr. Gulamhusein and his associates noted.

The rate of prescribing bisphosphonates to protect the bone health of prostate cancer patients taking androgen deprivation therapy is extremely low in Ontario, even among those at high risk of fracture, according to a research letter published online Dec. 2 in JAMA.

Canadian guidelines have recommended bisphosphonates for men at risk for bone fracture since 2002, and specifically for men taking androgen deprivation therapy (ADT) since 2006. However, prescribing patterns for these agents are relatively unknown, said Dr. Husayn Gulamhusein of University Health Network, Toronto, and his associates.

The investigators assessed rates of these prescriptions over time by analyzing data in an Ontario cancer registry regarding 35,487 men aged 66 years and older who initiated ADT for prostate cancer between 1995 and 2012. They found that bisphosphonate prescriptions were filled for only 0.35/100 men in the earliest years of the study period, a rate that rose to only 3.40/100 men in the final years. “Even among those with prior osteoporosis or fragility fracture, rates remained low,” the researchers said (JAMA 2014;312:2285-6).Their findings indicate “limited awareness among clinicians regarding optimal bone health management,” they added.

There was a decrease in bisphosphonate prescriptions after 2009, which “may be partly due to negative media regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is concerning,” Dr. Gulamhusein and his associates noted.

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Key clinical point: Men taking androgen deprivation therapy for prostate cancer aren’t being prescribed bisphosphonates to protect their bone health.

Major finding: Bisphosphonate prescriptions were filled for only 0.35/100 men in the earliest years of the study period, a rate that rose to only 3.40/100 men in the final years.

Data source: A retrospective cohort study involving 35,487 prostate cancer patients in Ontario taking androgen deprivation therapy during a 17-year period.

Disclosures: This study was supported in part by Toronto General Hospital, the Toronto Western Hospital Research Foundation, the Canadian Cancer Society, and the Canadian Institutes of Health Research. Dr. Gulamhusein reported having no financial disclosures; one of his associates reported receiving honoraria from Merck.

Abortion rates reach historic low in 2011

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The total number of abortions, the rate of abortions per 1,000 women, and the ratio of abortions to live births all reached historic lows in 2011, according to a study published in Morbidity and Mortality Weekly Reports.

Analysis of data in the Centers for Disease Control and Prevention’s surveillance program of abortions in the United States showed a total of 730,322 abortions in 2011, the most recent year for which complete data are available. This represents a 5% decrease from the total in 2010, said Karen Pazol, Ph.D., of the division of reproductive health, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, and her associates (MMWR 2014;63(SS11):1-41).

The overall rate of abortions was 13.9 per 1,000 women of childbearing age (15-44 years). When broken down by age, abortion rates dropped by 21% among women aged 20-24 years and by 16% among women aged 25-29 years, the two age groups that account for the majority of the procedures.

The abortion rate also declined among adolescents aged 15-19 years by 34%, the largest reduction in any age group. This suggests that adolescent pregnancies continue to decline in the United States, the investigators said.

In contrast, the abortion rate increased by 8% among women aged 40 years and older, indicating that unintended pregnancy continues to be a problem throughout women’s reproductive years.

The percentage of abortions performed at 8 or fewer weeks’ gestation increased 6%, to 64.5% of all procedures, in 2011. The use of early medical abortion has risen 200% since the Food and Drug Administration approved mifespristone in 2002.

There is still a “small but persistent” percentage of women (8.6%) who obtain abortions after 13 weeks’ gestation. “A better understanding is needed of the factors that cause delays in obtaining abortions,” Dr. Pazol and her associates said.

The ratio of abortions to live births in 2011 declined 4% from the ratio in the preceding year, to 219 abortions per 1,000 live births.

Dr. Pazol and her associates reported having no financial disclosures.

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The total number of abortions, the rate of abortions per 1,000 women, and the ratio of abortions to live births all reached historic lows in 2011, according to a study published in Morbidity and Mortality Weekly Reports.

Analysis of data in the Centers for Disease Control and Prevention’s surveillance program of abortions in the United States showed a total of 730,322 abortions in 2011, the most recent year for which complete data are available. This represents a 5% decrease from the total in 2010, said Karen Pazol, Ph.D., of the division of reproductive health, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, and her associates (MMWR 2014;63(SS11):1-41).

The overall rate of abortions was 13.9 per 1,000 women of childbearing age (15-44 years). When broken down by age, abortion rates dropped by 21% among women aged 20-24 years and by 16% among women aged 25-29 years, the two age groups that account for the majority of the procedures.

The abortion rate also declined among adolescents aged 15-19 years by 34%, the largest reduction in any age group. This suggests that adolescent pregnancies continue to decline in the United States, the investigators said.

In contrast, the abortion rate increased by 8% among women aged 40 years and older, indicating that unintended pregnancy continues to be a problem throughout women’s reproductive years.

The percentage of abortions performed at 8 or fewer weeks’ gestation increased 6%, to 64.5% of all procedures, in 2011. The use of early medical abortion has risen 200% since the Food and Drug Administration approved mifespristone in 2002.

There is still a “small but persistent” percentage of women (8.6%) who obtain abortions after 13 weeks’ gestation. “A better understanding is needed of the factors that cause delays in obtaining abortions,” Dr. Pazol and her associates said.

The ratio of abortions to live births in 2011 declined 4% from the ratio in the preceding year, to 219 abortions per 1,000 live births.

Dr. Pazol and her associates reported having no financial disclosures.

The total number of abortions, the rate of abortions per 1,000 women, and the ratio of abortions to live births all reached historic lows in 2011, according to a study published in Morbidity and Mortality Weekly Reports.

Analysis of data in the Centers for Disease Control and Prevention’s surveillance program of abortions in the United States showed a total of 730,322 abortions in 2011, the most recent year for which complete data are available. This represents a 5% decrease from the total in 2010, said Karen Pazol, Ph.D., of the division of reproductive health, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, and her associates (MMWR 2014;63(SS11):1-41).

The overall rate of abortions was 13.9 per 1,000 women of childbearing age (15-44 years). When broken down by age, abortion rates dropped by 21% among women aged 20-24 years and by 16% among women aged 25-29 years, the two age groups that account for the majority of the procedures.

The abortion rate also declined among adolescents aged 15-19 years by 34%, the largest reduction in any age group. This suggests that adolescent pregnancies continue to decline in the United States, the investigators said.

In contrast, the abortion rate increased by 8% among women aged 40 years and older, indicating that unintended pregnancy continues to be a problem throughout women’s reproductive years.

The percentage of abortions performed at 8 or fewer weeks’ gestation increased 6%, to 64.5% of all procedures, in 2011. The use of early medical abortion has risen 200% since the Food and Drug Administration approved mifespristone in 2002.

There is still a “small but persistent” percentage of women (8.6%) who obtain abortions after 13 weeks’ gestation. “A better understanding is needed of the factors that cause delays in obtaining abortions,” Dr. Pazol and her associates said.

The ratio of abortions to live births in 2011 declined 4% from the ratio in the preceding year, to 219 abortions per 1,000 live births.

Dr. Pazol and her associates reported having no financial disclosures.

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Key clinical point: Abortion rates dropped by 21% in 2011 from 2010 among women aged 20-24 years, and by 16% among women aged 25-29 years, the two age groups that account for the majority of the procedures.

Major finding: A total of 730,322 abortions were reported to the Centers for Disease Control and Prevention in 2011, representing a 5% decrease from the total reported in 2010.

Data source: A national surveillance program documenting abortions reported to the CDC in 2011, the most recent year for which complete data are available.

Disclosures: Dr. Pazol and her associates reported having no financial disclosures.