Mary Ann Moon

In older adults who have diabetes, clinically significant hypoglycemic events are associated with a doubling of the risk for developing dementia, according to a report published online June 10 in JAMA Internal Medicine.

In addition, older adults with diabetes who already have cognitive impairment are more likely than others to experience severe hypoglycemic events, and these can further compromise their cognition, said Dr. Kristine Yaffe of the department of psychiatry, University of California, San Francisco, and her associates.

The findings "provide evidence for a reciprocal association between hypoglycemia and dementia," which can devolve into "a detrimental cycle" for some older patients, the investigators said (JAMA Intern. Med. 2013 June 10 [doi:10.1001/jamainternmed.2013.6176]).

"Our findings emphasize the importance of cognitive function in the clinical management of older adults with diabetes," they noted. "Certain medications known to carry a higher risk for hypoglycemia, such as insulin secretagogues and some sulfonylureas, may be inappropriate for older patients with or at risk for cognitive impairment."

Physicians "should also consider the implications for the management and care of patients with lesser, subclinical levels of cognitive dysfunction," Dr. Yaffe and her associates said. And caretakers should be educated about the symptoms and treatment of hypoglycemia.

The researchers examined the association between hypoglycemia and cognitive impairment because the few studies that have assessed the issue produced conflicting results. They used data collected in a large, prospective cohort study involving a random sample of 3,075 people aged 70-79 years who lived in Memphis or Pittsburgh at the study’s inception in 1997.

For their analysis, Dr. Yaffe and her colleagues included 783 of the study subjects who had diabetes at baseline or developed it during the 12-year follow-up. Approximately half the study population was black and half was white; approximately half of the patients were men and half were women.

During follow-up, 61 (7.8%) of the older adults with diabetes reported having at least one hypoglycemic event that required a hospital visit. Twenty-one of those patients had more than one such event.

Overall, 148 (18.9%) of the study patients developed dementia during follow-up.

The study subjects who were hospitalized for a hypoglycemic event were approximately twice as likely to develop dementia (21 of 61 patients, or 34.4%), compared with the 127 of 722 patients (17.6%) who did not have a hypoglycemic event.

After the data were adjusted to account for differences in age, sex, education level, insulin use, race/ethnicity, apo E–epsilon 4 allele status, baseline scores on the Modified Mini-Mental State Examination, and glycated hemoglobin level at baseline, analysis of the data produced similar results. Additional adjustment for MI, stroke, and hypertension did not change the results appreciably.

The association between hypoglycemia and dementia risk also remained significant in a sensitivity analysis, the investigators said.

"Hypoglycemia may contribute to the pathogenesis of dementia through several possible mechanisms," they noted. Hypoglycemia can directly induce neuronal damage, preferentially affecting the cerebral cortex and hippocampus. It also can act indirectly by causing a loss of ionic hemostasis or raising the number of reactive oxygen species, which in turn induce neuronal death.

Hypoglycemia also may contribute to the production of amyloid precursor protein, disruption of the metabolism of amyloid and tau proteins, an increase in inflammatory markers, and exacerbation of oxidative stress. In addition, it may precipitate microinfarcts in the brain, the researchers said.

This study was supported by the National Institute on Aging, the National Institute of Nursing Research, and the American Health Assistance Foundation. Dr. Yaffe reported ties to Medivation, Novartis, Pfizer, and Takeda.

In older adults who have diabetes, clinically significant hypoglycemic events are associated with a doubling of the risk for developing dementia, according to a report published online June 10 in JAMA Internal Medicine.

In addition, older adults with diabetes who already have cognitive impairment are more likely than others to experience severe hypoglycemic events, and these can further compromise their cognition, said Dr. Kristine Yaffe of the department of psychiatry, University of California, San Francisco, and her associates.

The findings "provide evidence for a reciprocal association between hypoglycemia and dementia," which can devolve into "a detrimental cycle" for some older patients, the investigators said (JAMA Intern. Med. 2013 June 10 [doi:10.1001/jamainternmed.2013.6176]).

"Our findings emphasize the importance of cognitive function in the clinical management of older adults with diabetes," they noted. "Certain medications known to carry a higher risk for hypoglycemia, such as insulin secretagogues and some sulfonylureas, may be inappropriate for older patients with or at risk for cognitive impairment."

Physicians "should also consider the implications for the management and care of patients with lesser, subclinical levels of cognitive dysfunction," Dr. Yaffe and her associates said. And caretakers should be educated about the symptoms and treatment of hypoglycemia.

The researchers examined the association between hypoglycemia and cognitive impairment because the few studies that have assessed the issue produced conflicting results. They used data collected in a large, prospective cohort study involving a random sample of 3,075 people aged 70-79 years who lived in Memphis or Pittsburgh at the study’s inception in 1997.

For their analysis, Dr. Yaffe and her colleagues included 783 of the study subjects who had diabetes at baseline or developed it during the 12-year follow-up. Approximately half the study population was black and half was white; approximately half of the patients were men and half were women.

During follow-up, 61 (7.8%) of the older adults with diabetes reported having at least one hypoglycemic event that required a hospital visit. Twenty-one of those patients had more than one such event.

Overall, 148 (18.9%) of the study patients developed dementia during follow-up.

The study subjects who were hospitalized for a hypoglycemic event were approximately twice as likely to develop dementia (21 of 61 patients, or 34.4%), compared with the 127 of 722 patients (17.6%) who did not have a hypoglycemic event.

After the data were adjusted to account for differences in age, sex, education level, insulin use, race/ethnicity, apo E–epsilon 4 allele status, baseline scores on the Modified Mini-Mental State Examination, and glycated hemoglobin level at baseline, analysis of the data produced similar results. Additional adjustment for MI, stroke, and hypertension did not change the results appreciably.

The association between hypoglycemia and dementia risk also remained significant in a sensitivity analysis, the investigators said.

"Hypoglycemia may contribute to the pathogenesis of dementia through several possible mechanisms," they noted. Hypoglycemia can directly induce neuronal damage, preferentially affecting the cerebral cortex and hippocampus. It also can act indirectly by causing a loss of ionic hemostasis or raising the number of reactive oxygen species, which in turn induce neuronal death.

Hypoglycemia also may contribute to the production of amyloid precursor protein, disruption of the metabolism of amyloid and tau proteins, an increase in inflammatory markers, and exacerbation of oxidative stress. In addition, it may precipitate microinfarcts in the brain, the researchers said.

This study was supported by the National Institute on Aging, the National Institute of Nursing Research, and the American Health Assistance Foundation. Dr. Yaffe reported ties to Medivation, Novartis, Pfizer, and Takeda.

In older adults who have diabetes, clinically significant hypoglycemic events are associated with a doubling of the risk for developing dementia, according to a report published online June 10 in JAMA Internal Medicine.

In addition, older adults with diabetes who already have cognitive impairment are more likely than others to experience severe hypoglycemic events, and these can further compromise their cognition, said Dr. Kristine Yaffe of the department of psychiatry, University of California, San Francisco, and her associates.

The findings "provide evidence for a reciprocal association between hypoglycemia and dementia," which can devolve into "a detrimental cycle" for some older patients, the investigators said (JAMA Intern. Med. 2013 June 10 [doi:10.1001/jamainternmed.2013.6176]).

"Our findings emphasize the importance of cognitive function in the clinical management of older adults with diabetes," they noted. "Certain medications known to carry a higher risk for hypoglycemia, such as insulin secretagogues and some sulfonylureas, may be inappropriate for older patients with or at risk for cognitive impairment."

Physicians "should also consider the implications for the management and care of patients with lesser, subclinical levels of cognitive dysfunction," Dr. Yaffe and her associates said. And caretakers should be educated about the symptoms and treatment of hypoglycemia.

The researchers examined the association between hypoglycemia and cognitive impairment because the few studies that have assessed the issue produced conflicting results. They used data collected in a large, prospective cohort study involving a random sample of 3,075 people aged 70-79 years who lived in Memphis or Pittsburgh at the study’s inception in 1997.

For their analysis, Dr. Yaffe and her colleagues included 783 of the study subjects who had diabetes at baseline or developed it during the 12-year follow-up. Approximately half the study population was black and half was white; approximately half of the patients were men and half were women.

During follow-up, 61 (7.8%) of the older adults with diabetes reported having at least one hypoglycemic event that required a hospital visit. Twenty-one of those patients had more than one such event.

Overall, 148 (18.9%) of the study patients developed dementia during follow-up.

The study subjects who were hospitalized for a hypoglycemic event were approximately twice as likely to develop dementia (21 of 61 patients, or 34.4%), compared with the 127 of 722 patients (17.6%) who did not have a hypoglycemic event.

After the data were adjusted to account for differences in age, sex, education level, insulin use, race/ethnicity, apo E–epsilon 4 allele status, baseline scores on the Modified Mini-Mental State Examination, and glycated hemoglobin level at baseline, analysis of the data produced similar results. Additional adjustment for MI, stroke, and hypertension did not change the results appreciably.

The association between hypoglycemia and dementia risk also remained significant in a sensitivity analysis, the investigators said.

"Hypoglycemia may contribute to the pathogenesis of dementia through several possible mechanisms," they noted. Hypoglycemia can directly induce neuronal damage, preferentially affecting the cerebral cortex and hippocampus. It also can act indirectly by causing a loss of ionic hemostasis or raising the number of reactive oxygen species, which in turn induce neuronal death.

Hypoglycemia also may contribute to the production of amyloid precursor protein, disruption of the metabolism of amyloid and tau proteins, an increase in inflammatory markers, and exacerbation of oxidative stress. In addition, it may precipitate microinfarcts in the brain, the researchers said.

This study was supported by the National Institute on Aging, the National Institute of Nursing Research, and the American Health Assistance Foundation. Dr. Yaffe reported ties to Medivation, Novartis, Pfizer, and Takeda.

An estimated 4,870 future cancers are induced each year because so many children are exposed to high radiation doses from CT scans, according to a report published online June 10 in JAMA Pediatrics.

Currently, the doses of radiation vary dramatically among radiologists, even for the same type of scan in children of the same age and size. Reducing the highest 25% of radiation doses to the median dose for that type of scan would prevent nearly half of these cancers from developing, said Diana L. Miglioretti, Ph.D., of the biostatistics unit at the Group Health Research Institute and the department of public health sciences at the University of Washington, Seattle, and her associates.

Noting that the ionizing radiation doses delivered by CT are 100-500 times higher than those of conventional radiography and fall within ranges that have been linked to increased cancer risk, Dr. Miglioretti and her colleagues examined time trends in CT imaging of pediatric patients from 1996 to 2010. CT exposure "is especially concerning for children because they are more sensitive to radiation-induced carcinogenesis [than are adults] and have many remaining years of life left for cancer to develop," they noted.

The researchers used data from the HMO Research Network to retrospectively assess randomly selected CT scans in children aged 15 years and younger enrolled in six health care systems covering diverse racial/ethnic and socioeconomic populations across the country. Between 152,419 and 371,095 patients were included for each year, for a total of 4,857,736 child-years of observation.

Radiation doses were calculated for a subset of 744 pediatric CTs of the head, chest, abdomen/pelvis, and spine. These regions together account for more than 95% of all pediatric CT scans. The study population was equally divided among boys and girls, and 29% of the patients were younger than 5 years at the time of their CT scans.

For children aged 5-15 years, the use of CT nearly tripled during the first decade of the study period, from 10.5 scans/1,000 in 1996 to 27.0/1,000 in 2006, then decreased somewhat to 23.9/1,000 in 2010, Dr. Miglioretti and her colleagues reported

The pattern was similar in children aged 0-5 years: CT scanning doubled from 11/1,000 in 1996 to 20/1,000 in 2006, and then dropped somewhat to 15.8/1,000 in 2010. This trend was seen across all six health care systems.

The stabilization and slight decline in pediatric CT scanning may have resulted from increased awareness about the cancer risks from pediatric imaging, particularly given the Image Gently campaign that began in 2007, they said.

Among the anatomic locations for CT scans, increases in the number of scans were greatest for abdominal and pelvic imaging, which happen to deliver the highest doses of radiation. The head was the most commonly scanned region for children of all ages, and head CTs increased by approximately 50% during the study period. Chest CTs also rose by 50%, and the number of spinal scans increased as much as ninefold, depending on the age of the patient.

Thus, the greater use of CT scans overall and the increased use of scans for regions that required higher radiation doses both contributed to the increase in radiation doses to the pediatric population, Dr. Miglioretti and her colleagues said.

However, variability in the radiation dose administered for a given type of scan also accounted for much of the increased exposure, and targeting the highest 25% of doses would yield the largest population benefits, the investigators said.

For example, radiation doses were highest for abdominal/pelvic scans, with a mean effective dose of 14.8 mSv for the oldest and largest children. But, as many as one-fourth of all the children who underwent a single abdominal/pelvic CT scan received a dose of 20 mSv or higher, Dr. Miglioretti and her associates said.

In another example, up to 14% of all head CTs delivered radiation doses of 50 mGy to the brain in a single examination and many children who require head CT undergo multiple such examinations. Reports in the literature cite 50 mGy of exposure as raising the risk of brain cancer by two- to threefold.

The investigators used the data on radiation exposure to estimate the lifetime attributable risks of various cancers nationwide.

One radiation-induced solid cancer was projected to arise from every 300-390 abdominal or pelvic scans among girls and for every 670-760 such scans among boys. For girls, one solid cancer was projected to arise from every 330-480 chest scans and from every 270-800 spinal scans, depending on the age of the child, Dr. Miglioretti and her colleagues said

The projected lifetime attributable risk of leukemia was highest among the youngest children who received head scans, and decreased with increasing age of the patient. For children younger than 5 years who underwent head CT scanning, leukemia was projected to develop in 1.9 patients/10,000 scans, while the rate was only 0.5 cases/10,000 for patients older than 10 years. Abdominal and pelvic CT scans also raised the risk of later leukemia.

"A case of leukemia was projected to result from 1 in 5,250 head scans performed for children younger than 5 years of age and from 1 in 21,160 scans for children 10-14 years of age. The risk of leukemia was 0.8-1.0 cases/10,000 abdomen and pelvic scans and 0.4-0.7 cases/10,000 chest and spine scans," the researchers said.

"Conservatively assuming that 4.25 million pediatric CT scans are performed each year in the United States, 4.0 million CT scans would be of the head, abdomen/pelvis, chest, or spine, based on our observed distribution. If radiation doses from those CT scans parallel our observed dose distributions, approximately 4,870 future cancers could be induced by pediatric CT scans each year," they wrote (JAMA Pediatr. 2013 June 10 [doi:10.1001/jamapediatrics.2013.311]).

"Cases of breast, thyroid, and lung cancers and cases of leukemia account for 68% of projected cancers in exposed girls, whereas cases of brain, lung, and colon cancers and cases of leukemia account for 51% of future cancers in boys."

The number of radiation-induced cancers could be markedly reduced if standard dose-reduction CT protocols were implemented more uniformly across the country. "Reducing the highest 25% of doses within age groups and anatomic regions to the median dose could prevent 2,090 (43%) of these cancers," Dr. Miglioretti and her colleagues said

The benefits of medically necessary CT scans far exceed the increase in cancer risk to a given patient, but CT scans that are not necessary place patients at risk for no reason. Some studies suggest that as many as one-third of pediatric CT scans are not medically necessary and eliminating them would reduce future cancers by another 33%.

"Combining these two strategies could prevent 3,020 (62%) of these cancers," Dr. Miglioretti and her colleagues said.

"It is important for both the referring physician and the radiologist to consider whether the risks of CT exceed the diagnostic value it provides over other tests," they noted.

For example, the indications for most of the abdominal and pelvic scans in this study were pain (40%), possible appendicitis (11%), or possible infection (6%). Ultrasound, which doesn’t use ionizing radiation, is a reasonable alternative for such assessments, with CT reserved for patients whose findings are equivocal or negative on ultrasonography.

Similarly, 23% of the head scans in this study were to evaluate trauma, 22% to assess upper respiratory issues, and 17% to evaluate headache. The use of CT for trauma can be reduced if highly sensitive prediction rules are used to select only the most appropriate patients, and CT has not been established as having value in the pediatric population for assessing headache or sinusitis, the researchers said.

They cautioned that their risk projections "are only estimates based on the best available evidence and are in no way definitive."

This study was supported by the National Cancer Institute. No financial conflicts of interest were reported.

An estimated 4,870 future cancers are induced each year because so many children are exposed to high radiation doses from CT scans, according to a report published online June 10 in JAMA Pediatrics.

Currently, the doses of radiation vary dramatically among radiologists, even for the same type of scan in children of the same age and size. Reducing the highest 25% of radiation doses to the median dose for that type of scan would prevent nearly half of these cancers from developing, said Diana L. Miglioretti, Ph.D., of the biostatistics unit at the Group Health Research Institute and the department of public health sciences at the University of Washington, Seattle, and her associates.

Noting that the ionizing radiation doses delivered by CT are 100-500 times higher than those of conventional radiography and fall within ranges that have been linked to increased cancer risk, Dr. Miglioretti and her colleagues examined time trends in CT imaging of pediatric patients from 1996 to 2010. CT exposure "is especially concerning for children because they are more sensitive to radiation-induced carcinogenesis [than are adults] and have many remaining years of life left for cancer to develop," they noted.

The researchers used data from the HMO Research Network to retrospectively assess randomly selected CT scans in children aged 15 years and younger enrolled in six health care systems covering diverse racial/ethnic and socioeconomic populations across the country. Between 152,419 and 371,095 patients were included for each year, for a total of 4,857,736 child-years of observation.

Radiation doses were calculated for a subset of 744 pediatric CTs of the head, chest, abdomen/pelvis, and spine. These regions together account for more than 95% of all pediatric CT scans. The study population was equally divided among boys and girls, and 29% of the patients were younger than 5 years at the time of their CT scans.

For children aged 5-15 years, the use of CT nearly tripled during the first decade of the study period, from 10.5 scans/1,000 in 1996 to 27.0/1,000 in 2006, then decreased somewhat to 23.9/1,000 in 2010, Dr. Miglioretti and her colleagues reported

The pattern was similar in children aged 0-5 years: CT scanning doubled from 11/1,000 in 1996 to 20/1,000 in 2006, and then dropped somewhat to 15.8/1,000 in 2010. This trend was seen across all six health care systems.

The stabilization and slight decline in pediatric CT scanning may have resulted from increased awareness about the cancer risks from pediatric imaging, particularly given the Image Gently campaign that began in 2007, they said.

Among the anatomic locations for CT scans, increases in the number of scans were greatest for abdominal and pelvic imaging, which happen to deliver the highest doses of radiation. The head was the most commonly scanned region for children of all ages, and head CTs increased by approximately 50% during the study period. Chest CTs also rose by 50%, and the number of spinal scans increased as much as ninefold, depending on the age of the patient.

Thus, the greater use of CT scans overall and the increased use of scans for regions that required higher radiation doses both contributed to the increase in radiation doses to the pediatric population, Dr. Miglioretti and her colleagues said.

However, variability in the radiation dose administered for a given type of scan also accounted for much of the increased exposure, and targeting the highest 25% of doses would yield the largest population benefits, the investigators said.

For example, radiation doses were highest for abdominal/pelvic scans, with a mean effective dose of 14.8 mSv for the oldest and largest children. But, as many as one-fourth of all the children who underwent a single abdominal/pelvic CT scan received a dose of 20 mSv or higher, Dr. Miglioretti and her associates said.

In another example, up to 14% of all head CTs delivered radiation doses of 50 mGy to the brain in a single examination and many children who require head CT undergo multiple such examinations. Reports in the literature cite 50 mGy of exposure as raising the risk of brain cancer by two- to threefold.

The investigators used the data on radiation exposure to estimate the lifetime attributable risks of various cancers nationwide.

One radiation-induced solid cancer was projected to arise from every 300-390 abdominal or pelvic scans among girls and for every 670-760 such scans among boys. For girls, one solid cancer was projected to arise from every 330-480 chest scans and from every 270-800 spinal scans, depending on the age of the child, Dr. Miglioretti and her colleagues said

The projected lifetime attributable risk of leukemia was highest among the youngest children who received head scans, and decreased with increasing age of the patient. For children younger than 5 years who underwent head CT scanning, leukemia was projected to develop in 1.9 patients/10,000 scans, while the rate was only 0.5 cases/10,000 for patients older than 10 years. Abdominal and pelvic CT scans also raised the risk of later leukemia.

"A case of leukemia was projected to result from 1 in 5,250 head scans performed for children younger than 5 years of age and from 1 in 21,160 scans for children 10-14 years of age. The risk of leukemia was 0.8-1.0 cases/10,000 abdomen and pelvic scans and 0.4-0.7 cases/10,000 chest and spine scans," the researchers said.

"Conservatively assuming that 4.25 million pediatric CT scans are performed each year in the United States, 4.0 million CT scans would be of the head, abdomen/pelvis, chest, or spine, based on our observed distribution. If radiation doses from those CT scans parallel our observed dose distributions, approximately 4,870 future cancers could be induced by pediatric CT scans each year," they wrote (JAMA Pediatr. 2013 June 10 [doi:10.1001/jamapediatrics.2013.311]).

"Cases of breast, thyroid, and lung cancers and cases of leukemia account for 68% of projected cancers in exposed girls, whereas cases of brain, lung, and colon cancers and cases of leukemia account for 51% of future cancers in boys."

The number of radiation-induced cancers could be markedly reduced if standard dose-reduction CT protocols were implemented more uniformly across the country. "Reducing the highest 25% of doses within age groups and anatomic regions to the median dose could prevent 2,090 (43%) of these cancers," Dr. Miglioretti and her colleagues said

The benefits of medically necessary CT scans far exceed the increase in cancer risk to a given patient, but CT scans that are not necessary place patients at risk for no reason. Some studies suggest that as many as one-third of pediatric CT scans are not medically necessary and eliminating them would reduce future cancers by another 33%.

"Combining these two strategies could prevent 3,020 (62%) of these cancers," Dr. Miglioretti and her colleagues said.

"It is important for both the referring physician and the radiologist to consider whether the risks of CT exceed the diagnostic value it provides over other tests," they noted.

For example, the indications for most of the abdominal and pelvic scans in this study were pain (40%), possible appendicitis (11%), or possible infection (6%). Ultrasound, which doesn’t use ionizing radiation, is a reasonable alternative for such assessments, with CT reserved for patients whose findings are equivocal or negative on ultrasonography.

Similarly, 23% of the head scans in this study were to evaluate trauma, 22% to assess upper respiratory issues, and 17% to evaluate headache. The use of CT for trauma can be reduced if highly sensitive prediction rules are used to select only the most appropriate patients, and CT has not been established as having value in the pediatric population for assessing headache or sinusitis, the researchers said.

They cautioned that their risk projections "are only estimates based on the best available evidence and are in no way definitive."

This study was supported by the National Cancer Institute. No financial conflicts of interest were reported.

An estimated 4,870 future cancers are induced each year because so many children are exposed to high radiation doses from CT scans, according to a report published online June 10 in JAMA Pediatrics.

Currently, the doses of radiation vary dramatically among radiologists, even for the same type of scan in children of the same age and size. Reducing the highest 25% of radiation doses to the median dose for that type of scan would prevent nearly half of these cancers from developing, said Diana L. Miglioretti, Ph.D., of the biostatistics unit at the Group Health Research Institute and the department of public health sciences at the University of Washington, Seattle, and her associates.

Noting that the ionizing radiation doses delivered by CT are 100-500 times higher than those of conventional radiography and fall within ranges that have been linked to increased cancer risk, Dr. Miglioretti and her colleagues examined time trends in CT imaging of pediatric patients from 1996 to 2010. CT exposure "is especially concerning for children because they are more sensitive to radiation-induced carcinogenesis [than are adults] and have many remaining years of life left for cancer to develop," they noted.

The researchers used data from the HMO Research Network to retrospectively assess randomly selected CT scans in children aged 15 years and younger enrolled in six health care systems covering diverse racial/ethnic and socioeconomic populations across the country. Between 152,419 and 371,095 patients were included for each year, for a total of 4,857,736 child-years of observation.

Radiation doses were calculated for a subset of 744 pediatric CTs of the head, chest, abdomen/pelvis, and spine. These regions together account for more than 95% of all pediatric CT scans. The study population was equally divided among boys and girls, and 29% of the patients were younger than 5 years at the time of their CT scans.

For children aged 5-15 years, the use of CT nearly tripled during the first decade of the study period, from 10.5 scans/1,000 in 1996 to 27.0/1,000 in 2006, then decreased somewhat to 23.9/1,000 in 2010, Dr. Miglioretti and her colleagues reported

The pattern was similar in children aged 0-5 years: CT scanning doubled from 11/1,000 in 1996 to 20/1,000 in 2006, and then dropped somewhat to 15.8/1,000 in 2010. This trend was seen across all six health care systems.

The stabilization and slight decline in pediatric CT scanning may have resulted from increased awareness about the cancer risks from pediatric imaging, particularly given the Image Gently campaign that began in 2007, they said.

Among the anatomic locations for CT scans, increases in the number of scans were greatest for abdominal and pelvic imaging, which happen to deliver the highest doses of radiation. The head was the most commonly scanned region for children of all ages, and head CTs increased by approximately 50% during the study period. Chest CTs also rose by 50%, and the number of spinal scans increased as much as ninefold, depending on the age of the patient.

Thus, the greater use of CT scans overall and the increased use of scans for regions that required higher radiation doses both contributed to the increase in radiation doses to the pediatric population, Dr. Miglioretti and her colleagues said.

However, variability in the radiation dose administered for a given type of scan also accounted for much of the increased exposure, and targeting the highest 25% of doses would yield the largest population benefits, the investigators said.

For example, radiation doses were highest for abdominal/pelvic scans, with a mean effective dose of 14.8 mSv for the oldest and largest children. But, as many as one-fourth of all the children who underwent a single abdominal/pelvic CT scan received a dose of 20 mSv or higher, Dr. Miglioretti and her associates said.

In another example, up to 14% of all head CTs delivered radiation doses of 50 mGy to the brain in a single examination and many children who require head CT undergo multiple such examinations. Reports in the literature cite 50 mGy of exposure as raising the risk of brain cancer by two- to threefold.

The investigators used the data on radiation exposure to estimate the lifetime attributable risks of various cancers nationwide.

One radiation-induced solid cancer was projected to arise from every 300-390 abdominal or pelvic scans among girls and for every 670-760 such scans among boys. For girls, one solid cancer was projected to arise from every 330-480 chest scans and from every 270-800 spinal scans, depending on the age of the child, Dr. Miglioretti and her colleagues said

The projected lifetime attributable risk of leukemia was highest among the youngest children who received head scans, and decreased with increasing age of the patient. For children younger than 5 years who underwent head CT scanning, leukemia was projected to develop in 1.9 patients/10,000 scans, while the rate was only 0.5 cases/10,000 for patients older than 10 years. Abdominal and pelvic CT scans also raised the risk of later leukemia.

"A case of leukemia was projected to result from 1 in 5,250 head scans performed for children younger than 5 years of age and from 1 in 21,160 scans for children 10-14 years of age. The risk of leukemia was 0.8-1.0 cases/10,000 abdomen and pelvic scans and 0.4-0.7 cases/10,000 chest and spine scans," the researchers said.

"Conservatively assuming that 4.25 million pediatric CT scans are performed each year in the United States, 4.0 million CT scans would be of the head, abdomen/pelvis, chest, or spine, based on our observed distribution. If radiation doses from those CT scans parallel our observed dose distributions, approximately 4,870 future cancers could be induced by pediatric CT scans each year," they wrote (JAMA Pediatr. 2013 June 10 [doi:10.1001/jamapediatrics.2013.311]).

"Cases of breast, thyroid, and lung cancers and cases of leukemia account for 68% of projected cancers in exposed girls, whereas cases of brain, lung, and colon cancers and cases of leukemia account for 51% of future cancers in boys."

The number of radiation-induced cancers could be markedly reduced if standard dose-reduction CT protocols were implemented more uniformly across the country. "Reducing the highest 25% of doses within age groups and anatomic regions to the median dose could prevent 2,090 (43%) of these cancers," Dr. Miglioretti and her colleagues said

The benefits of medically necessary CT scans far exceed the increase in cancer risk to a given patient, but CT scans that are not necessary place patients at risk for no reason. Some studies suggest that as many as one-third of pediatric CT scans are not medically necessary and eliminating them would reduce future cancers by another 33%.

"Combining these two strategies could prevent 3,020 (62%) of these cancers," Dr. Miglioretti and her colleagues said.

"It is important for both the referring physician and the radiologist to consider whether the risks of CT exceed the diagnostic value it provides over other tests," they noted.

For example, the indications for most of the abdominal and pelvic scans in this study were pain (40%), possible appendicitis (11%), or possible infection (6%). Ultrasound, which doesn’t use ionizing radiation, is a reasonable alternative for such assessments, with CT reserved for patients whose findings are equivocal or negative on ultrasonography.

Similarly, 23% of the head scans in this study were to evaluate trauma, 22% to assess upper respiratory issues, and 17% to evaluate headache. The use of CT for trauma can be reduced if highly sensitive prediction rules are used to select only the most appropriate patients, and CT has not been established as having value in the pediatric population for assessing headache or sinusitis, the researchers said.

They cautioned that their risk projections "are only estimates based on the best available evidence and are in no way definitive."

This study was supported by the National Cancer Institute. No financial conflicts of interest were reported.

In adult patients with obsessive-compulsive disorder who are thought to have comorbid attention-deficit/hyperactivity disorder, the symptoms of inattention, forgetfulness, and impaired executive function might actually be an epiphenomenon of OCD rather than a manifestation of ADHD, a study has shown.

OCD patients’ "continuous and excessive attempts to control behavior and thoughts" may cause a flooding of the executive system, interfering with attention, memory, and other executive processes, said Amitai Abramovitch, Ph.D., of the department of psychiatry, Harvard Medical School, Boston, and his associates.

"We believe that there is a growing convergence of evidence that may, at least in some cases, challenge the diagnostic validity of OCD and ADHD comorbidity." Making a clear distinction between the two disorders is crucial because stimulant medication given to treat ADHD is known to exacerbate OCD symptoms and has even been reported to induce full-blown OCD, the researchers noted in the second of two papers they have written on the topic (J. Obsessive Compuls. Relat. Disord. 2013;2:53-61).

Dr. Abramovitch and his colleagues began with the observation that OCD and ADHD have very different, even directly opposite, clinical presentations. ADHD is characterized primarily by impulsivity, risk taking, and novelty-seeking behavior. "In contrast, the behavioral manifestations of OCD seem to lie on the opposite end of an impulsive-compulsive spectrum," typified by inhibited temperament, avoidance of novel stimuli, increased risk avoidance, and lower than normal impulsivity.

In addition, the hallmark of OCD is performance of repetitive, precise, and accurately timed rituals, which requires extremely focused attention. "It seems highly unlikely that individuals with ADHD would be able to perform such precise and repetitive rituals," wrote Dr. Abramovitch, also with the department of psychiatry, OCD and related disorders program, at Massachusetts General Hospital, Boston.

Another distinction is that ADHD presents early in childhood, while the average age of onset for OCD is 19 years.

Physiologically, both disorders are characterized by abnormal frontostriatal activity, which until now might have been mistaken as a similarity between the two. But the pattern of this activity is very different.

OCD is associated with increased metabolic activity in certain areas of the frontostriatal network such as the orbitofrontal cortex, thalamus, and caudate nucleus, during resting state, performance on some neuropsychological tasks, and under symptom provocation conditions. This is thought to reflect "executive hypercontrol and a preference toward controlled information processing." In contrast, ADHD is associated with frontostriatal hypoactivity during resting state and provocation.

To test their hypothesis that OCD and ADHD are so fundamentally different that they’re unlikely to coexist in the same person, the researchers assessed 30 men with OCD, 30 men with ADHD, and 30 healthy control subjects who had no history of psychiatric, neurologic, developmental, or learning abnormalities. The three groups were well matched for age (mean, approximately 30 years) and level of education (mean, approximately 13 years) (J. Neuropsychology 2012;6:161-91).

All the subjects in the OCD and ADHD groups had their diagnoses validated using the Mini International Neuropsychiatric Interview (MINI), and the absence of mental disorders was verified in the control subjects using the same instrument. All the subjects completed a short computerized battery of neuropsychological tests, personal interviews, and assessments using the Eysenck Impulsiveness-Venturesomeness-Empathy (IVE) scale, an ADHD questionnaire based on DSM-IV criteria, and the Obsessive-Compulsive Inventory-Revised (OCI-R).

The ADHD group scored significantly higher on measures of impulsiveness than both the OCD group and the control subjects. Scores in the latter two groups were similar to each other. In contrast, the OCD group achieved significantly higher scores on the OCI-R than both the ADHD group and the control subjects. However, both the ADHD and OCD groups performed worse than controls on neuropsychological measures.

The ADHD and OCD groups also were significantly different from each other in an assessment of longitudinal behavioral traits from childhood through the present day. The subjects with ADHD showed continuity of inattention, impulsivity, and hyperactivity throughout their life spans.

In contrast, almost all the subjects with OCD reported that they never had symptoms during childhood similar to their current symptoms in adulthood. Only the five subjects with the most severe OCD reported such continuity of symptoms throughout their life spans.

These same five men with OCD scored high on inattention items on the ADHD questionnaire, but not on impulsivity or other items. This suggests that their inattention, which could mistakenly be interpreted as representing ADHD, was actually an epiphenomenon of executive impairment from the OCD, Dr. Abramovitch and his associates said.

"Our model may contribute to clinicians as well as individuals diagnosed with OCD in proposing that neuropsychological impairments may be viewed as a second-order consequence of OC symptoms," they wrote.

Their findings also challenge the "possibility comorbidity between the two disorders in the adult population," they wrote.

The investigators cited several limitations. Among them is that the study included only male participants and should be replicated with both sexes. In addition, the study used self-reported measures, including current and retrospective accounts of ADHD childhood symptoms, the latter of which "are prone to error."

Nevertheless, the authors cites studies demonstrating that self-report ADHD measures have equally sound psychometric properties as clinician administered ones.

The authors conclude that "clinicians ought to pay careful consideration to OCD symptoms in the diagnostic process of individuals suspected of having ADHD, and be mindful that [obsessive-compulsive] symptomatology has the possibility to manifest through ADHD-like symptoms," the investigators said.

No funding was received for this study, and the investigators reported no relevant financial conflicts.

In adult patients with obsessive-compulsive disorder who are thought to have comorbid attention-deficit/hyperactivity disorder, the symptoms of inattention, forgetfulness, and impaired executive function might actually be an epiphenomenon of OCD rather than a manifestation of ADHD, a study has shown.

OCD patients’ "continuous and excessive attempts to control behavior and thoughts" may cause a flooding of the executive system, interfering with attention, memory, and other executive processes, said Amitai Abramovitch, Ph.D., of the department of psychiatry, Harvard Medical School, Boston, and his associates.

"We believe that there is a growing convergence of evidence that may, at least in some cases, challenge the diagnostic validity of OCD and ADHD comorbidity." Making a clear distinction between the two disorders is crucial because stimulant medication given to treat ADHD is known to exacerbate OCD symptoms and has even been reported to induce full-blown OCD, the researchers noted in the second of two papers they have written on the topic (J. Obsessive Compuls. Relat. Disord. 2013;2:53-61).

Dr. Abramovitch and his colleagues began with the observation that OCD and ADHD have very different, even directly opposite, clinical presentations. ADHD is characterized primarily by impulsivity, risk taking, and novelty-seeking behavior. "In contrast, the behavioral manifestations of OCD seem to lie on the opposite end of an impulsive-compulsive spectrum," typified by inhibited temperament, avoidance of novel stimuli, increased risk avoidance, and lower than normal impulsivity.

In addition, the hallmark of OCD is performance of repetitive, precise, and accurately timed rituals, which requires extremely focused attention. "It seems highly unlikely that individuals with ADHD would be able to perform such precise and repetitive rituals," wrote Dr. Abramovitch, also with the department of psychiatry, OCD and related disorders program, at Massachusetts General Hospital, Boston.

Another distinction is that ADHD presents early in childhood, while the average age of onset for OCD is 19 years.

Physiologically, both disorders are characterized by abnormal frontostriatal activity, which until now might have been mistaken as a similarity between the two. But the pattern of this activity is very different.

OCD is associated with increased metabolic activity in certain areas of the frontostriatal network such as the orbitofrontal cortex, thalamus, and caudate nucleus, during resting state, performance on some neuropsychological tasks, and under symptom provocation conditions. This is thought to reflect "executive hypercontrol and a preference toward controlled information processing." In contrast, ADHD is associated with frontostriatal hypoactivity during resting state and provocation.

To test their hypothesis that OCD and ADHD are so fundamentally different that they’re unlikely to coexist in the same person, the researchers assessed 30 men with OCD, 30 men with ADHD, and 30 healthy control subjects who had no history of psychiatric, neurologic, developmental, or learning abnormalities. The three groups were well matched for age (mean, approximately 30 years) and level of education (mean, approximately 13 years) (J. Neuropsychology 2012;6:161-91).

All the subjects in the OCD and ADHD groups had their diagnoses validated using the Mini International Neuropsychiatric Interview (MINI), and the absence of mental disorders was verified in the control subjects using the same instrument. All the subjects completed a short computerized battery of neuropsychological tests, personal interviews, and assessments using the Eysenck Impulsiveness-Venturesomeness-Empathy (IVE) scale, an ADHD questionnaire based on DSM-IV criteria, and the Obsessive-Compulsive Inventory-Revised (OCI-R).

The ADHD group scored significantly higher on measures of impulsiveness than both the OCD group and the control subjects. Scores in the latter two groups were similar to each other. In contrast, the OCD group achieved significantly higher scores on the OCI-R than both the ADHD group and the control subjects. However, both the ADHD and OCD groups performed worse than controls on neuropsychological measures.

The ADHD and OCD groups also were significantly different from each other in an assessment of longitudinal behavioral traits from childhood through the present day. The subjects with ADHD showed continuity of inattention, impulsivity, and hyperactivity throughout their life spans.

In contrast, almost all the subjects with OCD reported that they never had symptoms during childhood similar to their current symptoms in adulthood. Only the five subjects with the most severe OCD reported such continuity of symptoms throughout their life spans.

These same five men with OCD scored high on inattention items on the ADHD questionnaire, but not on impulsivity or other items. This suggests that their inattention, which could mistakenly be interpreted as representing ADHD, was actually an epiphenomenon of executive impairment from the OCD, Dr. Abramovitch and his associates said.

"Our model may contribute to clinicians as well as individuals diagnosed with OCD in proposing that neuropsychological impairments may be viewed as a second-order consequence of OC symptoms," they wrote.

Their findings also challenge the "possibility comorbidity between the two disorders in the adult population," they wrote.

The investigators cited several limitations. Among them is that the study included only male participants and should be replicated with both sexes. In addition, the study used self-reported measures, including current and retrospective accounts of ADHD childhood symptoms, the latter of which "are prone to error."

Nevertheless, the authors cites studies demonstrating that self-report ADHD measures have equally sound psychometric properties as clinician administered ones.

The authors conclude that "clinicians ought to pay careful consideration to OCD symptoms in the diagnostic process of individuals suspected of having ADHD, and be mindful that [obsessive-compulsive] symptomatology has the possibility to manifest through ADHD-like symptoms," the investigators said.

No funding was received for this study, and the investigators reported no relevant financial conflicts.

In adult patients with obsessive-compulsive disorder who are thought to have comorbid attention-deficit/hyperactivity disorder, the symptoms of inattention, forgetfulness, and impaired executive function might actually be an epiphenomenon of OCD rather than a manifestation of ADHD, a study has shown.

OCD patients’ "continuous and excessive attempts to control behavior and thoughts" may cause a flooding of the executive system, interfering with attention, memory, and other executive processes, said Amitai Abramovitch, Ph.D., of the department of psychiatry, Harvard Medical School, Boston, and his associates.

"We believe that there is a growing convergence of evidence that may, at least in some cases, challenge the diagnostic validity of OCD and ADHD comorbidity." Making a clear distinction between the two disorders is crucial because stimulant medication given to treat ADHD is known to exacerbate OCD symptoms and has even been reported to induce full-blown OCD, the researchers noted in the second of two papers they have written on the topic (J. Obsessive Compuls. Relat. Disord. 2013;2:53-61).

Dr. Abramovitch and his colleagues began with the observation that OCD and ADHD have very different, even directly opposite, clinical presentations. ADHD is characterized primarily by impulsivity, risk taking, and novelty-seeking behavior. "In contrast, the behavioral manifestations of OCD seem to lie on the opposite end of an impulsive-compulsive spectrum," typified by inhibited temperament, avoidance of novel stimuli, increased risk avoidance, and lower than normal impulsivity.

In addition, the hallmark of OCD is performance of repetitive, precise, and accurately timed rituals, which requires extremely focused attention. "It seems highly unlikely that individuals with ADHD would be able to perform such precise and repetitive rituals," wrote Dr. Abramovitch, also with the department of psychiatry, OCD and related disorders program, at Massachusetts General Hospital, Boston.

Another distinction is that ADHD presents early in childhood, while the average age of onset for OCD is 19 years.

Physiologically, both disorders are characterized by abnormal frontostriatal activity, which until now might have been mistaken as a similarity between the two. But the pattern of this activity is very different.

OCD is associated with increased metabolic activity in certain areas of the frontostriatal network such as the orbitofrontal cortex, thalamus, and caudate nucleus, during resting state, performance on some neuropsychological tasks, and under symptom provocation conditions. This is thought to reflect "executive hypercontrol and a preference toward controlled information processing." In contrast, ADHD is associated with frontostriatal hypoactivity during resting state and provocation.

To test their hypothesis that OCD and ADHD are so fundamentally different that they’re unlikely to coexist in the same person, the researchers assessed 30 men with OCD, 30 men with ADHD, and 30 healthy control subjects who had no history of psychiatric, neurologic, developmental, or learning abnormalities. The three groups were well matched for age (mean, approximately 30 years) and level of education (mean, approximately 13 years) (J. Neuropsychology 2012;6:161-91).

All the subjects in the OCD and ADHD groups had their diagnoses validated using the Mini International Neuropsychiatric Interview (MINI), and the absence of mental disorders was verified in the control subjects using the same instrument. All the subjects completed a short computerized battery of neuropsychological tests, personal interviews, and assessments using the Eysenck Impulsiveness-Venturesomeness-Empathy (IVE) scale, an ADHD questionnaire based on DSM-IV criteria, and the Obsessive-Compulsive Inventory-Revised (OCI-R).

The ADHD group scored significantly higher on measures of impulsiveness than both the OCD group and the control subjects. Scores in the latter two groups were similar to each other. In contrast, the OCD group achieved significantly higher scores on the OCI-R than both the ADHD group and the control subjects. However, both the ADHD and OCD groups performed worse than controls on neuropsychological measures.

The ADHD and OCD groups also were significantly different from each other in an assessment of longitudinal behavioral traits from childhood through the present day. The subjects with ADHD showed continuity of inattention, impulsivity, and hyperactivity throughout their life spans.

In contrast, almost all the subjects with OCD reported that they never had symptoms during childhood similar to their current symptoms in adulthood. Only the five subjects with the most severe OCD reported such continuity of symptoms throughout their life spans.

These same five men with OCD scored high on inattention items on the ADHD questionnaire, but not on impulsivity or other items. This suggests that their inattention, which could mistakenly be interpreted as representing ADHD, was actually an epiphenomenon of executive impairment from the OCD, Dr. Abramovitch and his associates said.

"Our model may contribute to clinicians as well as individuals diagnosed with OCD in proposing that neuropsychological impairments may be viewed as a second-order consequence of OC symptoms," they wrote.

Their findings also challenge the "possibility comorbidity between the two disorders in the adult population," they wrote.

The investigators cited several limitations. Among them is that the study included only male participants and should be replicated with both sexes. In addition, the study used self-reported measures, including current and retrospective accounts of ADHD childhood symptoms, the latter of which "are prone to error."

Nevertheless, the authors cites studies demonstrating that self-report ADHD measures have equally sound psychometric properties as clinician administered ones.

The authors conclude that "clinicians ought to pay careful consideration to OCD symptoms in the diagnostic process of individuals suspected of having ADHD, and be mindful that [obsessive-compulsive] symptomatology has the possibility to manifest through ADHD-like symptoms," the investigators said.

No funding was received for this study, and the investigators reported no relevant financial conflicts.

A multidisciplinary postoperative care program of patient and staff education, early patient mobilization, and pulmonary interventions has begun to reduce the excessive rate of postsurgical pulmonary complications at a large urban safety-net hospital, according to a report published online June 5 in JAMA Surgery (formerly Archives of Surgery).

"We are eager to monitor our outcomes over a longer period, and we are stimulated by the possibility that postoperative complications may be diminished by adherence to simple, inexpensive, easily performed patient care strategies," said Dr. Michael R. Cassidy of the department of surgery, Boston University Medical Center, and his associates.

When data collected in the National Surgical Quality Improvement Program (NSQIP) revealed that their center "was a high outlier for all measured postoperative pulmonary complications," the investigators formed a multidisciplinary group to address the problem.

BUMC is the largest safety-net facility in New England. The annual income of more than half of its patients is below $20,420, approximately 25% of its patients do not speak English, and 70% belong to racial or ethnic minorities, the investigators noted.

The committee included representatives from the hospital’s departments of surgery, nursing, and quality improvement, as well as from the units on respiratory therapy, preoperative assessment, infection control, and physical therapy. To devise a program to reduce the incidence of adverse pulmonary complications, these members reviewed the sparse literature regarding prevention of postoperative pneumonia and audited postsurgical pulmonary practices at their medical center.

The audit found that patients received no formal preoperative education about the importance of lung expansion, mobility, and other strategies to prevent pulmonary complications, and that families usually weren’t included in whatever minimal education did take place. In addition, physicians’ orders for nurses regarding postoperative pulmonary care "were irregular or absent."

The program that was then developed was given the acronym "I COUGH" to help physicians, nurses, patients, and families remember its key principles: Incentive spirometry, Coughing and deep breathing, Oral care, Understanding, Getting out of bed frequently, and Head-of-the-bed elevation. It was intended for all patients on the general surgery and vascular surgery services.

I COUGH included brochures, a video, and posters to educate patients, families, nurses, and physicians about the importance of pulmonary care. Proper use of incentive spirometry was demonstrated, the use of mouthwash and toothbrushing was recommended at least twice a day, and elevation of the head of the bed to at least 30 degrees was advocated. All this information was reinforced at preoperative clinic visits and in the preoperative holding area just before surgery. Nursing staff also reiterated the information after the procedures, as did surgeons, attending physicians, and house staff during rounds.

The effort also included standardized electronic physician order sets with "specific and detailed orders for all elements of the I COUGH program." These included instructions for patients to perform deep breathing and coughing every 2 hours; for patients to perform incentive spirometry 10 times every hour while awake; for nurses to document incentive spirometry volume every 4 hours and to ensure that the head of the patient’s bed was elevated to at least 30 degrees; for patients to walk at least once on the day of operation unless contraindicated; and for patients to get out of bed and sit in a chair for a while at least 3 times per day.

Dr. Cassidy and his associates then compared data collected during the year before I COUGH was implemented to that collected during the year afterward.

Before I COUGH, 80% of 250 patients were in bed at the time of the audit, with only 19.6% seated in a chair or walking. After I COUGH, 69.1% of 250 patients were out of bed. Before I COUGH, only 52.8% of patients had an incentive spirometer within reach and an unknown number were using it appropriately, whereas afterward 77.2% of patients had the device within reach and were using it appropriately. Both findings were statistically significant.

The incidence of postoperative pneumonia was 2.6% before I COUGH, which dropped to 1.6% in the year afterward (P = .09). Similarly, the incidence of unplanned intubations was 2.0% before I COUGH, which decreased to 1.2% afterward, the authors reported (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.358]).

These successes are due in part to the involvement of the multidisciplinary team at all stages of development of the I COUGH program, the investigators said.

"We have not imposed a standard of care by mandate, but instead have involved nursing leadership and practicing ward and ICU nurses in the process of redefining the culture.

"We found that involvement of representatives of each discipline significantly increased acceptance of the I COUGH program, and instilled a sense of commitment and pride that could not have been achieved by simply instituting and enforcing a policy without input from all parties involved," Dr. Cassidy and his colleagues added.

While the study had several limitations, including variations in data-gathering techniques and NSQIP reporting protocols, the investigators pointed to "substantial differences in nursing practice documented between the audits before and after I COUGH implementation."

"We believe that a favorable change in practice occurred as a result of our program," they wrote.

The investigators reported having no financial conflicts of interest.

A multidisciplinary postoperative care program of patient and staff education, early patient mobilization, and pulmonary interventions has begun to reduce the excessive rate of postsurgical pulmonary complications at a large urban safety-net hospital, according to a report published online June 5 in JAMA Surgery (formerly Archives of Surgery).

"We are eager to monitor our outcomes over a longer period, and we are stimulated by the possibility that postoperative complications may be diminished by adherence to simple, inexpensive, easily performed patient care strategies," said Dr. Michael R. Cassidy of the department of surgery, Boston University Medical Center, and his associates.

When data collected in the National Surgical Quality Improvement Program (NSQIP) revealed that their center "was a high outlier for all measured postoperative pulmonary complications," the investigators formed a multidisciplinary group to address the problem.

BUMC is the largest safety-net facility in New England. The annual income of more than half of its patients is below $20,420, approximately 25% of its patients do not speak English, and 70% belong to racial or ethnic minorities, the investigators noted.

The committee included representatives from the hospital’s departments of surgery, nursing, and quality improvement, as well as from the units on respiratory therapy, preoperative assessment, infection control, and physical therapy. To devise a program to reduce the incidence of adverse pulmonary complications, these members reviewed the sparse literature regarding prevention of postoperative pneumonia and audited postsurgical pulmonary practices at their medical center.

The audit found that patients received no formal preoperative education about the importance of lung expansion, mobility, and other strategies to prevent pulmonary complications, and that families usually weren’t included in whatever minimal education did take place. In addition, physicians’ orders for nurses regarding postoperative pulmonary care "were irregular or absent."

The program that was then developed was given the acronym "I COUGH" to help physicians, nurses, patients, and families remember its key principles: Incentive spirometry, Coughing and deep breathing, Oral care, Understanding, Getting out of bed frequently, and Head-of-the-bed elevation. It was intended for all patients on the general surgery and vascular surgery services.

I COUGH included brochures, a video, and posters to educate patients, families, nurses, and physicians about the importance of pulmonary care. Proper use of incentive spirometry was demonstrated, the use of mouthwash and toothbrushing was recommended at least twice a day, and elevation of the head of the bed to at least 30 degrees was advocated. All this information was reinforced at preoperative clinic visits and in the preoperative holding area just before surgery. Nursing staff also reiterated the information after the procedures, as did surgeons, attending physicians, and house staff during rounds.

The effort also included standardized electronic physician order sets with "specific and detailed orders for all elements of the I COUGH program." These included instructions for patients to perform deep breathing and coughing every 2 hours; for patients to perform incentive spirometry 10 times every hour while awake; for nurses to document incentive spirometry volume every 4 hours and to ensure that the head of the patient’s bed was elevated to at least 30 degrees; for patients to walk at least once on the day of operation unless contraindicated; and for patients to get out of bed and sit in a chair for a while at least 3 times per day.

Dr. Cassidy and his associates then compared data collected during the year before I COUGH was implemented to that collected during the year afterward.

Before I COUGH, 80% of 250 patients were in bed at the time of the audit, with only 19.6% seated in a chair or walking. After I COUGH, 69.1% of 250 patients were out of bed. Before I COUGH, only 52.8% of patients had an incentive spirometer within reach and an unknown number were using it appropriately, whereas afterward 77.2% of patients had the device within reach and were using it appropriately. Both findings were statistically significant.

The incidence of postoperative pneumonia was 2.6% before I COUGH, which dropped to 1.6% in the year afterward (P = .09). Similarly, the incidence of unplanned intubations was 2.0% before I COUGH, which decreased to 1.2% afterward, the authors reported (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.358]).

These successes are due in part to the involvement of the multidisciplinary team at all stages of development of the I COUGH program, the investigators said.

"We have not imposed a standard of care by mandate, but instead have involved nursing leadership and practicing ward and ICU nurses in the process of redefining the culture.

"We found that involvement of representatives of each discipline significantly increased acceptance of the I COUGH program, and instilled a sense of commitment and pride that could not have been achieved by simply instituting and enforcing a policy without input from all parties involved," Dr. Cassidy and his colleagues added.

While the study had several limitations, including variations in data-gathering techniques and NSQIP reporting protocols, the investigators pointed to "substantial differences in nursing practice documented between the audits before and after I COUGH implementation."

"We believe that a favorable change in practice occurred as a result of our program," they wrote.

The investigators reported having no financial conflicts of interest.

A multidisciplinary postoperative care program of patient and staff education, early patient mobilization, and pulmonary interventions has begun to reduce the excessive rate of postsurgical pulmonary complications at a large urban safety-net hospital, according to a report published online June 5 in JAMA Surgery (formerly Archives of Surgery).

"We are eager to monitor our outcomes over a longer period, and we are stimulated by the possibility that postoperative complications may be diminished by adherence to simple, inexpensive, easily performed patient care strategies," said Dr. Michael R. Cassidy of the department of surgery, Boston University Medical Center, and his associates.

When data collected in the National Surgical Quality Improvement Program (NSQIP) revealed that their center "was a high outlier for all measured postoperative pulmonary complications," the investigators formed a multidisciplinary group to address the problem.

BUMC is the largest safety-net facility in New England. The annual income of more than half of its patients is below $20,420, approximately 25% of its patients do not speak English, and 70% belong to racial or ethnic minorities, the investigators noted.

The committee included representatives from the hospital’s departments of surgery, nursing, and quality improvement, as well as from the units on respiratory therapy, preoperative assessment, infection control, and physical therapy. To devise a program to reduce the incidence of adverse pulmonary complications, these members reviewed the sparse literature regarding prevention of postoperative pneumonia and audited postsurgical pulmonary practices at their medical center.

The audit found that patients received no formal preoperative education about the importance of lung expansion, mobility, and other strategies to prevent pulmonary complications, and that families usually weren’t included in whatever minimal education did take place. In addition, physicians’ orders for nurses regarding postoperative pulmonary care "were irregular or absent."

The program that was then developed was given the acronym "I COUGH" to help physicians, nurses, patients, and families remember its key principles: Incentive spirometry, Coughing and deep breathing, Oral care, Understanding, Getting out of bed frequently, and Head-of-the-bed elevation. It was intended for all patients on the general surgery and vascular surgery services.

I COUGH included brochures, a video, and posters to educate patients, families, nurses, and physicians about the importance of pulmonary care. Proper use of incentive spirometry was demonstrated, the use of mouthwash and toothbrushing was recommended at least twice a day, and elevation of the head of the bed to at least 30 degrees was advocated. All this information was reinforced at preoperative clinic visits and in the preoperative holding area just before surgery. Nursing staff also reiterated the information after the procedures, as did surgeons, attending physicians, and house staff during rounds.

The effort also included standardized electronic physician order sets with "specific and detailed orders for all elements of the I COUGH program." These included instructions for patients to perform deep breathing and coughing every 2 hours; for patients to perform incentive spirometry 10 times every hour while awake; for nurses to document incentive spirometry volume every 4 hours and to ensure that the head of the patient’s bed was elevated to at least 30 degrees; for patients to walk at least once on the day of operation unless contraindicated; and for patients to get out of bed and sit in a chair for a while at least 3 times per day.

Dr. Cassidy and his associates then compared data collected during the year before I COUGH was implemented to that collected during the year afterward.

Before I COUGH, 80% of 250 patients were in bed at the time of the audit, with only 19.6% seated in a chair or walking. After I COUGH, 69.1% of 250 patients were out of bed. Before I COUGH, only 52.8% of patients had an incentive spirometer within reach and an unknown number were using it appropriately, whereas afterward 77.2% of patients had the device within reach and were using it appropriately. Both findings were statistically significant.

The incidence of postoperative pneumonia was 2.6% before I COUGH, which dropped to 1.6% in the year afterward (P = .09). Similarly, the incidence of unplanned intubations was 2.0% before I COUGH, which decreased to 1.2% afterward, the authors reported (JAMA Surg. 2013 June 5 [doi: 10.1001/jamasurg.2013.358]).

These successes are due in part to the involvement of the multidisciplinary team at all stages of development of the I COUGH program, the investigators said.

"We have not imposed a standard of care by mandate, but instead have involved nursing leadership and practicing ward and ICU nurses in the process of redefining the culture.

"We found that involvement of representatives of each discipline significantly increased acceptance of the I COUGH program, and instilled a sense of commitment and pride that could not have been achieved by simply instituting and enforcing a policy without input from all parties involved," Dr. Cassidy and his colleagues added.

While the study had several limitations, including variations in data-gathering techniques and NSQIP reporting protocols, the investigators pointed to "substantial differences in nursing practice documented between the audits before and after I COUGH implementation."

"We believe that a favorable change in practice occurred as a result of our program," they wrote.

The investigators reported having no financial conflicts of interest.

In patients with mild to moderate obesity and poorly controlled type 2 diabetes, adding Roux-en-Y gastric bypass surgery to intensive lifestyle and medical management more than doubles the likelihood of achieving weight-loss and metabolic goals within 1 year, according to the results of a randomized trial reported in the June 5 issue of JAMA.

However, this potential benefit must be weighed against what appears to be a moderate risk of serious adverse events, even when the procedure is done by experienced medical teams, said Dr. Sayeed Ikramuddin of the department of surgery, University of Minnesota, Minneapolis, and his associates.

In addition, the permanence of weight loss and metabolic results following the first 1-2 years after the procedure remains uncertain, as do long-term adverse events, because so few studies have adequately followed patients past that point, the investigators wrote.

Dr. Ikramuddin and his colleagues drew these conclusions from their randomized trial of 120 patients with mild to moderate obesity (body mass index, 30.0-39.9 kg/m²) whose type 2 diabetes was poorly controlled on standard medical therapy.

In a separate report in the same issue of JAMA, Dr. Melinda Maggard-Gibbons of the University of California, Los Angeles, and her associates reported their findings from a systematic review of the literature regarding all types of bariatric surgery in similar patients with mild obesity (BMI, 30-35). They found that there still is not sufficient evidence to determine whether bariatric surgery is warranted in this patient population because of the lack of long-term data on safety and efficacy. They identified only four studies with a follow-up of more than 2 years, and those had small sample sizes or poor methodology that "preclude definitive conclusions."

Thus, neither of these investigations can support or refute the suggestion by some proponents that bariatric surgery should be extended to diabetic patients with low-grade obesity to improve their glycemic control.

In their prospective, unblinded clinical trial, Dr. Ikramuddin and his associates offered a free, intensive lifestyle and medical-therapy weight control program to the 120 study subjects at one academic medical center in Minnesota, one in New York, and two in Taiwan over a 3-year period. All patients were between 30 and 67 years of age and had hemoglobin A_1c (HbA_1c) levels of 8% or higher (mean, 9.6%); the average duration of diabetes was 9 years.

The program included daily weigh-ins and detailed diaries of eating and exercise, with caloric intake goals of 1,200-1,800 kcal/day and moderate physical activity for at least 325 min/week to achieve a weight loss of 1-2 pounds/week. The study subjects met regularly with trained interventionists to discuss weight management and to enhance adherence.

Patients could add orlistat or, until it was withdrawn from the market, sibutramine for weight control. Medications for glycemic control were added as necessary, as were aspirin therapy and medications to control cholesterol levels and blood pressure.

Half of the study subjects were then randomly assigned to undergo laparoscopic Roux-en-Y gastric bypass. This group was given multivitamin and mineral supplements.

The endpoint of the study was a triple outcome endorsed by the American Diabetes Association: an HbA_1c level of less than 7%, a low-density lipoprotein (LDL) cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg at 1-year follow-up.

A total of 28 patients (49%) in the gastric bypass group achieved this end point, compared with only 11 (19%) in the lifestyle/medical management group, Dr. Ikramuddin and his colleagues reported (JAMA 2013;309:2240-49).

Of these three components of the combined endpoint, only HbA_1c level showed a significant difference between the two study groups: 43 (75%) of the surgery group achieved an HbA_1c level under 7%, compared with just 18 (32%) of the lifestyle/medical management group.

The difference in outcomes between the two groups was attributed chiefly to their difference in weight loss. The mean loss at 1 year was 26% of baseline weight after gastric bypass, compared with 8% with the intensive lifestyle/medication program.

Patients in the surgery group continued to lose weight throughout the year of follow-up, while those in the other group tended to lose weight during the first 6 months and plateau after that.

On average, at 1 year the patients in the surgery group required three fewer medications than did those in the other group to manage glycemia, dyslipidemia, and hypertension.

However, patients who underwent gastric bypass had 50% more serious adverse events and 55% more nonserious adverse events than did those who did not. "All surgeons performing gastric bypass in this study were experts; thus the occurrence of serious complications must be factored into the design of larger trials of effectiveness for patients with moderate obesity," Dr. Ikramuddin and his associates said.

The 22 serious adverse events in the surgery group included 4 perioperative and 6 late postoperative complications. The most serious complications involved anastomotic leakage that was not detected on routine postoperative upper-GI contrast studies. One of these patients eventually required extracorporeal membrane oxygenation; she developed anoxic brain injury, required lower-extremity amputation, and remains permanently disabled.

Nutritional deficiencies also developed relatively often in the bypass group, despite supplementation. These included iron, vitamin B, and vitamin D deficiencies, as well as hypoalbuminemia.

Other adverse events known to develop more than 1 year after gastric bypass include weight regain, internal hernias, anastomotic ulcers, hypoglycemia, anastomotic strictures, bleeding, bowel obstruction, kidney stones, and fractures.

Overall, these findings show that "the merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make [these] risks acceptable," the investigators said.

In their systematic review of the literature, Dr. Maggard-Gibbons and her associates reviewed 1,291 studies but could find only 3 randomized trials that came close to directly comparing surgical against nonsurgical interventions in patients with BMIs of 30-35. The total number of patients in these trials was only 290, and individual-level data were available only for 13 patients with type 2 diabetes in this weight category.

They then altered their search criteria to include studies of patients with BMIs of 35-40 and studies that did not directly compare outcomes between surgical and nonsurgical approaches. Even then, "many of the studies were from single surgeons at single academic institutions and may not be representative of results in a general population of patients and surgeons."

Of greatest concern was the fact that "we found no long-term studies of postsurgery adverse events in patients with diabetes within our target BMI range," they said (JAMA 2013;309:2250-61).

The limited studies that were available consistently found that short-term weight loss and glycemic control were better for patients treated with bariatric surgery than for those who were not. However, the durability of these results is uncertain, and the amount of weight loss did not always correlate with the degree of improvement of metabolic factors. And it is not yet known whether these outcomes translate into reduction in the important macrovascular and microvascular effects of diabetes.

Moreover, although surgical complications were not common, those that did occur often were serious and required significant intervention. And of the few studies that did track later complications, most were not designed to do so and covered only "surgeon-reported outcomes from selected, experienced centers."

Thus, "the evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this patient population, [and] performance of these procedures in this target population should be under close scientific scrutiny," Dr. Maggard-Gibbons and her colleagues said.

Dr. Irkamuddin’s study was supported by Covidien and the National Center for Advancing Translational Sciences. Dr. Irkamuddin reported ties to Novo Nordisk, USGI, and other companies; his associates reported ties to numerous industry sources. Dr. Maggard-Gibbons’ study was supported by the Agency for Healthcare Research and Quality; she and her associates reported no relevant financial conflicts of interest.

In patients with mild to moderate obesity and poorly controlled type 2 diabetes, adding Roux-en-Y gastric bypass surgery to intensive lifestyle and medical management more than doubles the likelihood of achieving weight-loss and metabolic goals within 1 year, according to the results of a randomized trial reported in the June 5 issue of JAMA.

However, this potential benefit must be weighed against what appears to be a moderate risk of serious adverse events, even when the procedure is done by experienced medical teams, said Dr. Sayeed Ikramuddin of the department of surgery, University of Minnesota, Minneapolis, and his associates.

In addition, the permanence of weight loss and metabolic results following the first 1-2 years after the procedure remains uncertain, as do long-term adverse events, because so few studies have adequately followed patients past that point, the investigators wrote.

Dr. Ikramuddin and his colleagues drew these conclusions from their randomized trial of 120 patients with mild to moderate obesity (body mass index, 30.0-39.9 kg/m²) whose type 2 diabetes was poorly controlled on standard medical therapy.

In a separate report in the same issue of JAMA, Dr. Melinda Maggard-Gibbons of the University of California, Los Angeles, and her associates reported their findings from a systematic review of the literature regarding all types of bariatric surgery in similar patients with mild obesity (BMI, 30-35). They found that there still is not sufficient evidence to determine whether bariatric surgery is warranted in this patient population because of the lack of long-term data on safety and efficacy. They identified only four studies with a follow-up of more than 2 years, and those had small sample sizes or poor methodology that "preclude definitive conclusions."

Thus, neither of these investigations can support or refute the suggestion by some proponents that bariatric surgery should be extended to diabetic patients with low-grade obesity to improve their glycemic control.

In their prospective, unblinded clinical trial, Dr. Ikramuddin and his associates offered a free, intensive lifestyle and medical-therapy weight control program to the 120 study subjects at one academic medical center in Minnesota, one in New York, and two in Taiwan over a 3-year period. All patients were between 30 and 67 years of age and had hemoglobin A_1c (HbA_1c) levels of 8% or higher (mean, 9.6%); the average duration of diabetes was 9 years.

The program included daily weigh-ins and detailed diaries of eating and exercise, with caloric intake goals of 1,200-1,800 kcal/day and moderate physical activity for at least 325 min/week to achieve a weight loss of 1-2 pounds/week. The study subjects met regularly with trained interventionists to discuss weight management and to enhance adherence.

Patients could add orlistat or, until it was withdrawn from the market, sibutramine for weight control. Medications for glycemic control were added as necessary, as were aspirin therapy and medications to control cholesterol levels and blood pressure.

Half of the study subjects were then randomly assigned to undergo laparoscopic Roux-en-Y gastric bypass. This group was given multivitamin and mineral supplements.

The endpoint of the study was a triple outcome endorsed by the American Diabetes Association: an HbA_1c level of less than 7%, a low-density lipoprotein (LDL) cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg at 1-year follow-up.

A total of 28 patients (49%) in the gastric bypass group achieved this end point, compared with only 11 (19%) in the lifestyle/medical management group, Dr. Ikramuddin and his colleagues reported (JAMA 2013;309:2240-49).

Of these three components of the combined endpoint, only HbA_1c level showed a significant difference between the two study groups: 43 (75%) of the surgery group achieved an HbA_1c level under 7%, compared with just 18 (32%) of the lifestyle/medical management group.

The difference in outcomes between the two groups was attributed chiefly to their difference in weight loss. The mean loss at 1 year was 26% of baseline weight after gastric bypass, compared with 8% with the intensive lifestyle/medication program.

Patients in the surgery group continued to lose weight throughout the year of follow-up, while those in the other group tended to lose weight during the first 6 months and plateau after that.

On average, at 1 year the patients in the surgery group required three fewer medications than did those in the other group to manage glycemia, dyslipidemia, and hypertension.

However, patients who underwent gastric bypass had 50% more serious adverse events and 55% more nonserious adverse events than did those who did not. "All surgeons performing gastric bypass in this study were experts; thus the occurrence of serious complications must be factored into the design of larger trials of effectiveness for patients with moderate obesity," Dr. Ikramuddin and his associates said.

The 22 serious adverse events in the surgery group included 4 perioperative and 6 late postoperative complications. The most serious complications involved anastomotic leakage that was not detected on routine postoperative upper-GI contrast studies. One of these patients eventually required extracorporeal membrane oxygenation; she developed anoxic brain injury, required lower-extremity amputation, and remains permanently disabled.

Nutritional deficiencies also developed relatively often in the bypass group, despite supplementation. These included iron, vitamin B, and vitamin D deficiencies, as well as hypoalbuminemia.

Other adverse events known to develop more than 1 year after gastric bypass include weight regain, internal hernias, anastomotic ulcers, hypoglycemia, anastomotic strictures, bleeding, bowel obstruction, kidney stones, and fractures.

Overall, these findings show that "the merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make [these] risks acceptable," the investigators said.

In their systematic review of the literature, Dr. Maggard-Gibbons and her associates reviewed 1,291 studies but could find only 3 randomized trials that came close to directly comparing surgical against nonsurgical interventions in patients with BMIs of 30-35. The total number of patients in these trials was only 290, and individual-level data were available only for 13 patients with type 2 diabetes in this weight category.

They then altered their search criteria to include studies of patients with BMIs of 35-40 and studies that did not directly compare outcomes between surgical and nonsurgical approaches. Even then, "many of the studies were from single surgeons at single academic institutions and may not be representative of results in a general population of patients and surgeons."

Of greatest concern was the fact that "we found no long-term studies of postsurgery adverse events in patients with diabetes within our target BMI range," they said (JAMA 2013;309:2250-61).

The limited studies that were available consistently found that short-term weight loss and glycemic control were better for patients treated with bariatric surgery than for those who were not. However, the durability of these results is uncertain, and the amount of weight loss did not always correlate with the degree of improvement of metabolic factors. And it is not yet known whether these outcomes translate into reduction in the important macrovascular and microvascular effects of diabetes.

Moreover, although surgical complications were not common, those that did occur often were serious and required significant intervention. And of the few studies that did track later complications, most were not designed to do so and covered only "surgeon-reported outcomes from selected, experienced centers."

Thus, "the evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this patient population, [and] performance of these procedures in this target population should be under close scientific scrutiny," Dr. Maggard-Gibbons and her colleagues said.

Dr. Irkamuddin’s study was supported by Covidien and the National Center for Advancing Translational Sciences. Dr. Irkamuddin reported ties to Novo Nordisk, USGI, and other companies; his associates reported ties to numerous industry sources. Dr. Maggard-Gibbons’ study was supported by the Agency for Healthcare Research and Quality; she and her associates reported no relevant financial conflicts of interest.

In patients with mild to moderate obesity and poorly controlled type 2 diabetes, adding Roux-en-Y gastric bypass surgery to intensive lifestyle and medical management more than doubles the likelihood of achieving weight-loss and metabolic goals within 1 year, according to the results of a randomized trial reported in the June 5 issue of JAMA.

However, this potential benefit must be weighed against what appears to be a moderate risk of serious adverse events, even when the procedure is done by experienced medical teams, said Dr. Sayeed Ikramuddin of the department of surgery, University of Minnesota, Minneapolis, and his associates.

In addition, the permanence of weight loss and metabolic results following the first 1-2 years after the procedure remains uncertain, as do long-term adverse events, because so few studies have adequately followed patients past that point, the investigators wrote.

Dr. Ikramuddin and his colleagues drew these conclusions from their randomized trial of 120 patients with mild to moderate obesity (body mass index, 30.0-39.9 kg/m²) whose type 2 diabetes was poorly controlled on standard medical therapy.

In a separate report in the same issue of JAMA, Dr. Melinda Maggard-Gibbons of the University of California, Los Angeles, and her associates reported their findings from a systematic review of the literature regarding all types of bariatric surgery in similar patients with mild obesity (BMI, 30-35). They found that there still is not sufficient evidence to determine whether bariatric surgery is warranted in this patient population because of the lack of long-term data on safety and efficacy. They identified only four studies with a follow-up of more than 2 years, and those had small sample sizes or poor methodology that "preclude definitive conclusions."

Thus, neither of these investigations can support or refute the suggestion by some proponents that bariatric surgery should be extended to diabetic patients with low-grade obesity to improve their glycemic control.

In their prospective, unblinded clinical trial, Dr. Ikramuddin and his associates offered a free, intensive lifestyle and medical-therapy weight control program to the 120 study subjects at one academic medical center in Minnesota, one in New York, and two in Taiwan over a 3-year period. All patients were between 30 and 67 years of age and had hemoglobin A_1c (HbA_1c) levels of 8% or higher (mean, 9.6%); the average duration of diabetes was 9 years.

The program included daily weigh-ins and detailed diaries of eating and exercise, with caloric intake goals of 1,200-1,800 kcal/day and moderate physical activity for at least 325 min/week to achieve a weight loss of 1-2 pounds/week. The study subjects met regularly with trained interventionists to discuss weight management and to enhance adherence.

Patients could add orlistat or, until it was withdrawn from the market, sibutramine for weight control. Medications for glycemic control were added as necessary, as were aspirin therapy and medications to control cholesterol levels and blood pressure.

Half of the study subjects were then randomly assigned to undergo laparoscopic Roux-en-Y gastric bypass. This group was given multivitamin and mineral supplements.

The endpoint of the study was a triple outcome endorsed by the American Diabetes Association: an HbA_1c level of less than 7%, a low-density lipoprotein (LDL) cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg at 1-year follow-up.

A total of 28 patients (49%) in the gastric bypass group achieved this end point, compared with only 11 (19%) in the lifestyle/medical management group, Dr. Ikramuddin and his colleagues reported (JAMA 2013;309:2240-49).

Of these three components of the combined endpoint, only HbA_1c level showed a significant difference between the two study groups: 43 (75%) of the surgery group achieved an HbA_1c level under 7%, compared with just 18 (32%) of the lifestyle/medical management group.

The difference in outcomes between the two groups was attributed chiefly to their difference in weight loss. The mean loss at 1 year was 26% of baseline weight after gastric bypass, compared with 8% with the intensive lifestyle/medication program.

Patients in the surgery group continued to lose weight throughout the year of follow-up, while those in the other group tended to lose weight during the first 6 months and plateau after that.

On average, at 1 year the patients in the surgery group required three fewer medications than did those in the other group to manage glycemia, dyslipidemia, and hypertension.

However, patients who underwent gastric bypass had 50% more serious adverse events and 55% more nonserious adverse events than did those who did not. "All surgeons performing gastric bypass in this study were experts; thus the occurrence of serious complications must be factored into the design of larger trials of effectiveness for patients with moderate obesity," Dr. Ikramuddin and his associates said.

The 22 serious adverse events in the surgery group included 4 perioperative and 6 late postoperative complications. The most serious complications involved anastomotic leakage that was not detected on routine postoperative upper-GI contrast studies. One of these patients eventually required extracorporeal membrane oxygenation; she developed anoxic brain injury, required lower-extremity amputation, and remains permanently disabled.

Nutritional deficiencies also developed relatively often in the bypass group, despite supplementation. These included iron, vitamin B, and vitamin D deficiencies, as well as hypoalbuminemia.

Other adverse events known to develop more than 1 year after gastric bypass include weight regain, internal hernias, anastomotic ulcers, hypoglycemia, anastomotic strictures, bleeding, bowel obstruction, kidney stones, and fractures.

Overall, these findings show that "the merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make [these] risks acceptable," the investigators said.

In their systematic review of the literature, Dr. Maggard-Gibbons and her associates reviewed 1,291 studies but could find only 3 randomized trials that came close to directly comparing surgical against nonsurgical interventions in patients with BMIs of 30-35. The total number of patients in these trials was only 290, and individual-level data were available only for 13 patients with type 2 diabetes in this weight category.

They then altered their search criteria to include studies of patients with BMIs of 35-40 and studies that did not directly compare outcomes between surgical and nonsurgical approaches. Even then, "many of the studies were from single surgeons at single academic institutions and may not be representative of results in a general population of patients and surgeons."

Of greatest concern was the fact that "we found no long-term studies of postsurgery adverse events in patients with diabetes within our target BMI range," they said (JAMA 2013;309:2250-61).

The limited studies that were available consistently found that short-term weight loss and glycemic control were better for patients treated with bariatric surgery than for those who were not. However, the durability of these results is uncertain, and the amount of weight loss did not always correlate with the degree of improvement of metabolic factors. And it is not yet known whether these outcomes translate into reduction in the important macrovascular and microvascular effects of diabetes.

Moreover, although surgical complications were not common, those that did occur often were serious and required significant intervention. And of the few studies that did track later complications, most were not designed to do so and covered only "surgeon-reported outcomes from selected, experienced centers."

Thus, "the evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this patient population, [and] performance of these procedures in this target population should be under close scientific scrutiny," Dr. Maggard-Gibbons and her colleagues said.

Dr. Irkamuddin’s study was supported by Covidien and the National Center for Advancing Translational Sciences. Dr. Irkamuddin reported ties to Novo Nordisk, USGI, and other companies; his associates reported ties to numerous industry sources. Dr. Maggard-Gibbons’ study was supported by the Agency for Healthcare Research and Quality; she and her associates reported no relevant financial conflicts of interest.

Aspirin is an effective, safe, convenient, and inexpensive alternative to low-molecular-weight heparin for extended thromboprophylaxis after total hip arthroplasty, according to a report published online June 3 in Annals of Internal Medicine.

In a multicenter randomized trial involving 786 patients undergoing elective total hip replacement in Canada during a 3-year period, 28 days of oral aspirin prophylaxis was noninferior to and as safe as 28 days of subcutaneous dalteparin injections for preventing venous thromboembolism (VTE), according to Dr. David R. Anderson, who is professor of medicine, pathology, and community health and epidemiology of Dalhousie University, Halifax, N.S., and his associates in the EPCAT (Extended Prophylaxis Comparing Low-Molecular-Weight Heparin to Aspirin in Total Hip Arthroplasty) study.

During this trial, the novel oral anticoagulant rivaroxaban was approved for this indication in Canada, which prompted "a major shift" away from using dalteparin and toward using the new drug in clinical practice. In light of this development, it will be important to "evaluate the benefits and risks of aspirin as extended prophylaxis after [total hip replacement], compared with the new oral anticoagulant agents," noted the EPCAT investigators.

Their findings on the benefits of aspirin also indicate that its role for venous thromboprophylaxis in other settings should now be reconsidered as well, Dr. Anderson and his colleagues added.

In the EPCAT study, patients underwent elective unilateral total hip replacement at 12 university-affiliated tertiary medical centers and received thromboprophylaxis in the form of subcutaneous injections of dalteparin for 10 days. They were randomly assigned to continue receiving dalteparin injections and take placebo oral aspirin tablets (400 patients) or to receive placebo injections and begin taking oral aspirin (81 mg) every day for 28 days (386 patients).

The demographic, medical, and surgical characteristics of the two study groups were comparable. Patients, physicians, study coordinators, and members of the health care teams all were blinded to study assignment.

The introduction of rivaroxaban during the course of the study severely affected ongoing recruitment of subjects, because both patients and orthopedic surgeons became increasingly reluctant to participate in a study requiring daily injections for 38 days when a new oral agent was available. The EPCAT study was terminated early when completion of the intended enrollment appeared "unfeasible" and an interim analysis showed that the primary objective – establishing the noninferiority of aspirin – had been reached.

The primary efficacy outcome was the development of symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE), confirmed by objective testing, during the 90 days after randomization. This outcome occurred in only 0.3% of the aspirin group, compared with 1.3% of the dalteparin group, establishing the noninferiority of aspirin therapy.

There was a single case of proximal DVT in the aspirin group, compared with two cases of proximal DVT and three of PE in the dalteparin group. Another patient in the dalteparin group developed a symptomatic distal DVT in her calf, "but this was not considered an outcome event," the investigators said.

No major bleeding events developed in the aspirin group, but there was one such event in the dalteparin group for an overall rate of 0.3%. Similarly, there were two clinically significant nonmajor bleeding events for aspirin (0.5% rate), compared with four for dalteparin (1.0% rate). And there were eight minor bleeding events for aspirin (2.1% rate), compared with 18 for dalteparin (4.5% rate).

"In a composite analysis of net clinical benefit that combined VTE and clinically relevant major and nonmajor bleeding complications as outcomes," 0.8% of patients receiving aspirin had complications, compared with 2.5% of patients receiving dalteparin.

There were no differences between the two study groups in secondary outcomes such as wound infections, arterial vascular events, MI, stroke, or deaths.

The EPCAT trial was supported by the Canadian Institutes for Health Research. Aspirin was provided by Bayer HealthCare and dalteparin by Pfizer Pharmaceuticals, but neither Bayer nor Pfizer was involved in the design, conduct, or analysis of the study.

Aspirin is an effective, safe, convenient, and inexpensive alternative to low-molecular-weight heparin for extended thromboprophylaxis after total hip arthroplasty, according to a report published online June 3 in Annals of Internal Medicine.

In a multicenter randomized trial involving 786 patients undergoing elective total hip replacement in Canada during a 3-year period, 28 days of oral aspirin prophylaxis was noninferior to and as safe as 28 days of subcutaneous dalteparin injections for preventing venous thromboembolism (VTE), according to Dr. David R. Anderson, who is professor of medicine, pathology, and community health and epidemiology of Dalhousie University, Halifax, N.S., and his associates in the EPCAT (Extended Prophylaxis Comparing Low-Molecular-Weight Heparin to Aspirin in Total Hip Arthroplasty) study.

During this trial, the novel oral anticoagulant rivaroxaban was approved for this indication in Canada, which prompted "a major shift" away from using dalteparin and toward using the new drug in clinical practice. In light of this development, it will be important to "evaluate the benefits and risks of aspirin as extended prophylaxis after [total hip replacement], compared with the new oral anticoagulant agents," noted the EPCAT investigators.

Their findings on the benefits of aspirin also indicate that its role for venous thromboprophylaxis in other settings should now be reconsidered as well, Dr. Anderson and his colleagues added.

In the EPCAT study, patients underwent elective unilateral total hip replacement at 12 university-affiliated tertiary medical centers and received thromboprophylaxis in the form of subcutaneous injections of dalteparin for 10 days. They were randomly assigned to continue receiving dalteparin injections and take placebo oral aspirin tablets (400 patients) or to receive placebo injections and begin taking oral aspirin (81 mg) every day for 28 days (386 patients).

The demographic, medical, and surgical characteristics of the two study groups were comparable. Patients, physicians, study coordinators, and members of the health care teams all were blinded to study assignment.

The introduction of rivaroxaban during the course of the study severely affected ongoing recruitment of subjects, because both patients and orthopedic surgeons became increasingly reluctant to participate in a study requiring daily injections for 38 days when a new oral agent was available. The EPCAT study was terminated early when completion of the intended enrollment appeared "unfeasible" and an interim analysis showed that the primary objective – establishing the noninferiority of aspirin – had been reached.

The primary efficacy outcome was the development of symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE), confirmed by objective testing, during the 90 days after randomization. This outcome occurred in only 0.3% of the aspirin group, compared with 1.3% of the dalteparin group, establishing the noninferiority of aspirin therapy.

There was a single case of proximal DVT in the aspirin group, compared with two cases of proximal DVT and three of PE in the dalteparin group. Another patient in the dalteparin group developed a symptomatic distal DVT in her calf, "but this was not considered an outcome event," the investigators said.

No major bleeding events developed in the aspirin group, but there was one such event in the dalteparin group for an overall rate of 0.3%. Similarly, there were two clinically significant nonmajor bleeding events for aspirin (0.5% rate), compared with four for dalteparin (1.0% rate). And there were eight minor bleeding events for aspirin (2.1% rate), compared with 18 for dalteparin (4.5% rate).

"In a composite analysis of net clinical benefit that combined VTE and clinically relevant major and nonmajor bleeding complications as outcomes," 0.8% of patients receiving aspirin had complications, compared with 2.5% of patients receiving dalteparin.

There were no differences between the two study groups in secondary outcomes such as wound infections, arterial vascular events, MI, stroke, or deaths.

The EPCAT trial was supported by the Canadian Institutes for Health Research. Aspirin was provided by Bayer HealthCare and dalteparin by Pfizer Pharmaceuticals, but neither Bayer nor Pfizer was involved in the design, conduct, or analysis of the study.

Aspirin is an effective, safe, convenient, and inexpensive alternative to low-molecular-weight heparin for extended thromboprophylaxis after total hip arthroplasty, according to a report published online June 3 in Annals of Internal Medicine.

In a multicenter randomized trial involving 786 patients undergoing elective total hip replacement in Canada during a 3-year period, 28 days of oral aspirin prophylaxis was noninferior to and as safe as 28 days of subcutaneous dalteparin injections for preventing venous thromboembolism (VTE), according to Dr. David R. Anderson, who is professor of medicine, pathology, and community health and epidemiology of Dalhousie University, Halifax, N.S., and his associates in the EPCAT (Extended Prophylaxis Comparing Low-Molecular-Weight Heparin to Aspirin in Total Hip Arthroplasty) study.

During this trial, the novel oral anticoagulant rivaroxaban was approved for this indication in Canada, which prompted "a major shift" away from using dalteparin and toward using the new drug in clinical practice. In light of this development, it will be important to "evaluate the benefits and risks of aspirin as extended prophylaxis after [total hip replacement], compared with the new oral anticoagulant agents," noted the EPCAT investigators.

Their findings on the benefits of aspirin also indicate that its role for venous thromboprophylaxis in other settings should now be reconsidered as well, Dr. Anderson and his colleagues added.

In the EPCAT study, patients underwent elective unilateral total hip replacement at 12 university-affiliated tertiary medical centers and received thromboprophylaxis in the form of subcutaneous injections of dalteparin for 10 days. They were randomly assigned to continue receiving dalteparin injections and take placebo oral aspirin tablets (400 patients) or to receive placebo injections and begin taking oral aspirin (81 mg) every day for 28 days (386 patients).

The demographic, medical, and surgical characteristics of the two study groups were comparable. Patients, physicians, study coordinators, and members of the health care teams all were blinded to study assignment.

The introduction of rivaroxaban during the course of the study severely affected ongoing recruitment of subjects, because both patients and orthopedic surgeons became increasingly reluctant to participate in a study requiring daily injections for 38 days when a new oral agent was available. The EPCAT study was terminated early when completion of the intended enrollment appeared "unfeasible" and an interim analysis showed that the primary objective – establishing the noninferiority of aspirin – had been reached.

The primary efficacy outcome was the development of symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE), confirmed by objective testing, during the 90 days after randomization. This outcome occurred in only 0.3% of the aspirin group, compared with 1.3% of the dalteparin group, establishing the noninferiority of aspirin therapy.

There was a single case of proximal DVT in the aspirin group, compared with two cases of proximal DVT and three of PE in the dalteparin group. Another patient in the dalteparin group developed a symptomatic distal DVT in her calf, "but this was not considered an outcome event," the investigators said.

No major bleeding events developed in the aspirin group, but there was one such event in the dalteparin group for an overall rate of 0.3%. Similarly, there were two clinically significant nonmajor bleeding events for aspirin (0.5% rate), compared with four for dalteparin (1.0% rate). And there were eight minor bleeding events for aspirin (2.1% rate), compared with 18 for dalteparin (4.5% rate).

"In a composite analysis of net clinical benefit that combined VTE and clinically relevant major and nonmajor bleeding complications as outcomes," 0.8% of patients receiving aspirin had complications, compared with 2.5% of patients receiving dalteparin.

There were no differences between the two study groups in secondary outcomes such as wound infections, arterial vascular events, MI, stroke, or deaths.

The EPCAT trial was supported by the Canadian Institutes for Health Research. Aspirin was provided by Bayer HealthCare and dalteparin by Pfizer Pharmaceuticals, but neither Bayer nor Pfizer was involved in the design, conduct, or analysis of the study.

Vaccinating pregnant women to protect their newborns from pertussis appears to avert more cases of the disease, hospitalizations, and deaths than does vaccinating mothers immediately post partum, according to a report published online May 27 in Pediatrics.

In a decision-analysis modeling study, vaccination during pregnancy also was found to be more cost-effective than "postpartum cocooning" – a strategy of vaccinating close family contacts, ideally before the infant’s birth, and vaccinating the mother immediately post partum, said Dr. Andrew Terranella and his associates at the Centers for Disease Control and Prevention.

©AvailableLight/istockphoto.com

The U.S. Advisory Committee on Immunization Practices (ACIP) recommended the cocooning approach in 2005, but "programmatic challenges and institutional hurdles have prevented widespread implementation both in the United States and in other countries." In 2011, ACIP recommended vaccination during the second or third trimester as the preferred strategy. [Editor’s note: The new CDC immunization schedule, released in January 2013, recommends that a dose of the Tdap vaccine be administered to all women during each pregnancy, whether or not she has received the vaccine previously (MMWR 2013;62 [Suppl 1:9-19)].

Dr. Terranella and his colleagues compared the health benefits and costs of three approaches using a cohort model of the 4,131,019 infants born in the United States in 2009 and followed for 1 year.

They calculated the expected number of infant pertussis cases using information from a national database of notifiable diseases, assuming a conservative underreporting rate of 15%. Some studies have documented underreporting rates as high as 50%, they noted.

They calculated the probabilities of hospitalization, respiratory disease, encephalopathy, and death, given an annual rate of 62.6 cases of infant pertussis per 100,000 infants.

The model assumed 72% coverage of vaccination during pregnancy and the same rate of coverage for postpartum vaccination with and without and cocooning vaccination of the father in one grandparent. It also assumed vaccine effectiveness of 85%.

The model further assumed that transfer of maternal antibodies would be 100% and that the rate of infant protection would be 60% for the first 2 months of life. For postpartum vaccination, there would be a 2-week delay in protection of the infant, because it takes that long for sufficient antibodies to form in the mother after the inoculation.

The model showed that with no vaccination, an estimated 3,041 cases of infant pertussis would occur each year, causing 1,463 hospitalizations and 22 deaths. In comparison, postpartum vaccination alone could avert 596 infant cases annually, a 20% reduction from the base case. Postpartum vaccination with cocooning averted 987 cases annually, which represents a 32% reduction in incidence. Vaccination during pregnancy would avert even more – 1,012 cases each year, a 33% reduction in incidence, the investigators said (Pediatrics 2013 [doi:10.1542/peds.2012-3144]).

Vaccination during pregnancy prevented more infant deaths (a 49% reduction, compared with no vaccination) than did postpartum vaccination with cocooning (a 29% reduction). It also prevented more hospitalizations (a 38% reduction) than did postpartum vaccination with cocooning (a 32% reduction).

In addition, vaccination during pregnancy saved 396 quality-adjusted life years (QALYs) annually, compared with 253 QALYs saved with postpartum vaccination with cocooning.

The annual cost of vaccination during pregnancy was estimated to be $171 million, while that of postpartum vaccination with cocooning was estimated to be $513 million. The cost per QALY saved was calculated to be approximately $414,000 for vaccination during pregnancy, compared for both postpartum vaccination ($1.2 million) with cocooning ($2 million).

Several sensitivity analyses were performed to assess outcomes if a variety of underlying conditions were changed. In particular, changes in vaccine efficacy, vaccine coverage, maternal antibody effect, and potential infant "blunting" of vaccine efficacy (the interference of infant antibodies with the antibody response to the vaccine) were tested.

"Under nearly all scenarios, a pregnancy vaccination strategy would result in fewer overall cases and deaths at lower cost per case averted and per QALY saved," Dr. Terranella and his associates said.

In addition to these advantages, vaccination during pregnancy is more feasible than postpartum vaccination and cocooning because it can easily be administered during existing prenatal care visits. In contrast, reaching postpartum mothers and especially reaching close contacts such as fathers, grandparents, and siblings of the infant is more difficult, the researchers added.

No financial conflicts of interest were reported.

Vaccinating pregnant women to protect their newborns from pertussis appears to avert more cases of the disease, hospitalizations, and deaths than does vaccinating mothers immediately post partum, according to a report published online May 27 in Pediatrics.

In a decision-analysis modeling study, vaccination during pregnancy also was found to be more cost-effective than "postpartum cocooning" – a strategy of vaccinating close family contacts, ideally before the infant’s birth, and vaccinating the mother immediately post partum, said Dr. Andrew Terranella and his associates at the Centers for Disease Control and Prevention.

©AvailableLight/istockphoto.com

The U.S. Advisory Committee on Immunization Practices (ACIP) recommended the cocooning approach in 2005, but "programmatic challenges and institutional hurdles have prevented widespread implementation both in the United States and in other countries." In 2011, ACIP recommended vaccination during the second or third trimester as the preferred strategy. [Editor’s note: The new CDC immunization schedule, released in January 2013, recommends that a dose of the Tdap vaccine be administered to all women during each pregnancy, whether or not she has received the vaccine previously (MMWR 2013;62 [Suppl 1:9-19)].

Dr. Terranella and his colleagues compared the health benefits and costs of three approaches using a cohort model of the 4,131,019 infants born in the United States in 2009 and followed for 1 year.

They calculated the expected number of infant pertussis cases using information from a national database of notifiable diseases, assuming a conservative underreporting rate of 15%. Some studies have documented underreporting rates as high as 50%, they noted.

They calculated the probabilities of hospitalization, respiratory disease, encephalopathy, and death, given an annual rate of 62.6 cases of infant pertussis per 100,000 infants.

The model assumed 72% coverage of vaccination during pregnancy and the same rate of coverage for postpartum vaccination with and without and cocooning vaccination of the father in one grandparent. It also assumed vaccine effectiveness of 85%.

The model further assumed that transfer of maternal antibodies would be 100% and that the rate of infant protection would be 60% for the first 2 months of life. For postpartum vaccination, there would be a 2-week delay in protection of the infant, because it takes that long for sufficient antibodies to form in the mother after the inoculation.

The model showed that with no vaccination, an estimated 3,041 cases of infant pertussis would occur each year, causing 1,463 hospitalizations and 22 deaths. In comparison, postpartum vaccination alone could avert 596 infant cases annually, a 20% reduction from the base case. Postpartum vaccination with cocooning averted 987 cases annually, which represents a 32% reduction in incidence. Vaccination during pregnancy would avert even more – 1,012 cases each year, a 33% reduction in incidence, the investigators said (Pediatrics 2013 [doi:10.1542/peds.2012-3144]).

Vaccination during pregnancy prevented more infant deaths (a 49% reduction, compared with no vaccination) than did postpartum vaccination with cocooning (a 29% reduction). It also prevented more hospitalizations (a 38% reduction) than did postpartum vaccination with cocooning (a 32% reduction).

In addition, vaccination during pregnancy saved 396 quality-adjusted life years (QALYs) annually, compared with 253 QALYs saved with postpartum vaccination with cocooning.

The annual cost of vaccination during pregnancy was estimated to be $171 million, while that of postpartum vaccination with cocooning was estimated to be $513 million. The cost per QALY saved was calculated to be approximately $414,000 for vaccination during pregnancy, compared for both postpartum vaccination ($1.2 million) with cocooning ($2 million).

Several sensitivity analyses were performed to assess outcomes if a variety of underlying conditions were changed. In particular, changes in vaccine efficacy, vaccine coverage, maternal antibody effect, and potential infant "blunting" of vaccine efficacy (the interference of infant antibodies with the antibody response to the vaccine) were tested.

"Under nearly all scenarios, a pregnancy vaccination strategy would result in fewer overall cases and deaths at lower cost per case averted and per QALY saved," Dr. Terranella and his associates said.

In addition to these advantages, vaccination during pregnancy is more feasible than postpartum vaccination and cocooning because it can easily be administered during existing prenatal care visits. In contrast, reaching postpartum mothers and especially reaching close contacts such as fathers, grandparents, and siblings of the infant is more difficult, the researchers added.

No financial conflicts of interest were reported.

Vaccinating pregnant women to protect their newborns from pertussis appears to avert more cases of the disease, hospitalizations, and deaths than does vaccinating mothers immediately post partum, according to a report published online May 27 in Pediatrics.

In a decision-analysis modeling study, vaccination during pregnancy also was found to be more cost-effective than "postpartum cocooning" – a strategy of vaccinating close family contacts, ideally before the infant’s birth, and vaccinating the mother immediately post partum, said Dr. Andrew Terranella and his associates at the Centers for Disease Control and Prevention.

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The U.S. Advisory Committee on Immunization Practices (ACIP) recommended the cocooning approach in 2005, but "programmatic challenges and institutional hurdles have prevented widespread implementation both in the United States and in other countries." In 2011, ACIP recommended vaccination during the second or third trimester as the preferred strategy. [Editor’s note: The new CDC immunization schedule, released in January 2013, recommends that a dose of the Tdap vaccine be administered to all women during each pregnancy, whether or not she has received the vaccine previously (MMWR 2013;62 [Suppl 1:9-19)].

Dr. Terranella and his colleagues compared the health benefits and costs of three approaches using a cohort model of the 4,131,019 infants born in the United States in 2009 and followed for 1 year.

They calculated the expected number of infant pertussis cases using information from a national database of notifiable diseases, assuming a conservative underreporting rate of 15%. Some studies have documented underreporting rates as high as 50%, they noted.

They calculated the probabilities of hospitalization, respiratory disease, encephalopathy, and death, given an annual rate of 62.6 cases of infant pertussis per 100,000 infants.

The model assumed 72% coverage of vaccination during pregnancy and the same rate of coverage for postpartum vaccination with and without and cocooning vaccination of the father in one grandparent. It also assumed vaccine effectiveness of 85%.

The model further assumed that transfer of maternal antibodies would be 100% and that the rate of infant protection would be 60% for the first 2 months of life. For postpartum vaccination, there would be a 2-week delay in protection of the infant, because it takes that long for sufficient antibodies to form in the mother after the inoculation.

The model showed that with no vaccination, an estimated 3,041 cases of infant pertussis would occur each year, causing 1,463 hospitalizations and 22 deaths. In comparison, postpartum vaccination alone could avert 596 infant cases annually, a 20% reduction from the base case. Postpartum vaccination with cocooning averted 987 cases annually, which represents a 32% reduction in incidence. Vaccination during pregnancy would avert even more – 1,012 cases each year, a 33% reduction in incidence, the investigators said (Pediatrics 2013 [doi:10.1542/peds.2012-3144]).

Vaccination during pregnancy prevented more infant deaths (a 49% reduction, compared with no vaccination) than did postpartum vaccination with cocooning (a 29% reduction). It also prevented more hospitalizations (a 38% reduction) than did postpartum vaccination with cocooning (a 32% reduction).

In addition, vaccination during pregnancy saved 396 quality-adjusted life years (QALYs) annually, compared with 253 QALYs saved with postpartum vaccination with cocooning.

The annual cost of vaccination during pregnancy was estimated to be $171 million, while that of postpartum vaccination with cocooning was estimated to be $513 million. The cost per QALY saved was calculated to be approximately $414,000 for vaccination during pregnancy, compared for both postpartum vaccination ($1.2 million) with cocooning ($2 million).

Several sensitivity analyses were performed to assess outcomes if a variety of underlying conditions were changed. In particular, changes in vaccine efficacy, vaccine coverage, maternal antibody effect, and potential infant "blunting" of vaccine efficacy (the interference of infant antibodies with the antibody response to the vaccine) were tested.

"Under nearly all scenarios, a pregnancy vaccination strategy would result in fewer overall cases and deaths at lower cost per case averted and per QALY saved," Dr. Terranella and his associates said.

In addition to these advantages, vaccination during pregnancy is more feasible than postpartum vaccination and cocooning because it can easily be administered during existing prenatal care visits. In contrast, reaching postpartum mothers and especially reaching close contacts such as fathers, grandparents, and siblings of the infant is more difficult, the researchers added.

No financial conflicts of interest were reported.

For older Americans who are or used to be heavy smokers, annual CT screening for lung cancer appears to reduce mortality from the disease, according to a report published online in the New England Journal of Medicine.

The results from the initial round of screening in the National Lung Screening Trial show that over a 3-year period, annual low-dose helical CT detected significantly more early-stage lung cancers than conventional chest radiography did, said Dr. Timothy R. Church of the division of environmental health sciences, University of Minnesota School of Public Health, Minneapolis, and his associates in the NLST research group.

In the real-world clinical settings, "a reduction in mortality from lung cancer is achievable at U.S. screening centers that have staff experienced in chest CT," they added.

The findings were published online and simultaneously presented at the annual meeting of the American Thoracic Society.

For this first round of the study, 53,454 asymptomatic men and women aged 55-74 years participated. All had a history of at least 30 pack-years of smoking and were either current smokers or had quit within the preceding 15 years.

The study subjects were treated and followed at 33 sites across the country and were randomly assigned to undergo either low-dose helical CT (26,722 patients) or chest radiography (26,732 patients) to screen for lung cancer every year for 3 years. Eight of these subjects were found to have lung cancer before their first screening could be done and were excluded from the study.

The proportion of study subjects who had positive screening results was markedly higher with low-dose CT scanning (27.3%) than with radiography (9.2%). Lung cancer was diagnosed in 1.1% of the CT group, compared with 0.7% of the radiography group.

In the CT group, 92.5% of the patients who developed lung cancer had a positive screening result (a true-positive result) and 6.2% had a negative screening result (a false-negative result); the remaining subjects missed their scheduled screening visit.

In the radiography group, 71.6% of the patients who developed lung cancer had a true-positive screening result and 25.8% had a false-negative result; the remaining subjects missed their scheduled screening visit.

Thus, the sensitivity and specificity of lung CT were 93.8% and 73.4%, respectively, compared with 73.5% sensitivity and 91.3% specificity for radiography, Dr. Church and his colleagues said (N. Engl. J. Med. 2013 [doi:10.1056/NEJMoa1209120]).

"There were many more bronchioloalveolar carcinomas and adenocarcinomas in the low-dose CT group than in the radiography group (38 vs. 8 and 123 vs. 71, respectively), but the frequencies of other histologic features were similar in the two groups," the investigators said.

The difference between the two groups in the number of detected cancers was almost entirely accounted for by early, stage IA tumors, which were markedly more likely to be identified on CT screening. The rates of detection were fairly comparable between CT and radiography for all the more advanced malignancies.

The study was funded by the National Cancer Institute. No financial conflicts of interest were reported.

For older Americans who are or used to be heavy smokers, annual CT screening for lung cancer appears to reduce mortality from the disease, according to a report published online in the New England Journal of Medicine.

The results from the initial round of screening in the National Lung Screening Trial show that over a 3-year period, annual low-dose helical CT detected significantly more early-stage lung cancers than conventional chest radiography did, said Dr. Timothy R. Church of the division of environmental health sciences, University of Minnesota School of Public Health, Minneapolis, and his associates in the NLST research group.

In the real-world clinical settings, "a reduction in mortality from lung cancer is achievable at U.S. screening centers that have staff experienced in chest CT," they added.

The findings were published online and simultaneously presented at the annual meeting of the American Thoracic Society.

For this first round of the study, 53,454 asymptomatic men and women aged 55-74 years participated. All had a history of at least 30 pack-years of smoking and were either current smokers or had quit within the preceding 15 years.

The study subjects were treated and followed at 33 sites across the country and were randomly assigned to undergo either low-dose helical CT (26,722 patients) or chest radiography (26,732 patients) to screen for lung cancer every year for 3 years. Eight of these subjects were found to have lung cancer before their first screening could be done and were excluded from the study.

The proportion of study subjects who had positive screening results was markedly higher with low-dose CT scanning (27.3%) than with radiography (9.2%). Lung cancer was diagnosed in 1.1% of the CT group, compared with 0.7% of the radiography group.

In the CT group, 92.5% of the patients who developed lung cancer had a positive screening result (a true-positive result) and 6.2% had a negative screening result (a false-negative result); the remaining subjects missed their scheduled screening visit.

In the radiography group, 71.6% of the patients who developed lung cancer had a true-positive screening result and 25.8% had a false-negative result; the remaining subjects missed their scheduled screening visit.

Thus, the sensitivity and specificity of lung CT were 93.8% and 73.4%, respectively, compared with 73.5% sensitivity and 91.3% specificity for radiography, Dr. Church and his colleagues said (N. Engl. J. Med. 2013 [doi:10.1056/NEJMoa1209120]).

"There were many more bronchioloalveolar carcinomas and adenocarcinomas in the low-dose CT group than in the radiography group (38 vs. 8 and 123 vs. 71, respectively), but the frequencies of other histologic features were similar in the two groups," the investigators said.

The difference between the two groups in the number of detected cancers was almost entirely accounted for by early, stage IA tumors, which were markedly more likely to be identified on CT screening. The rates of detection were fairly comparable between CT and radiography for all the more advanced malignancies.

The study was funded by the National Cancer Institute. No financial conflicts of interest were reported.

For older Americans who are or used to be heavy smokers, annual CT screening for lung cancer appears to reduce mortality from the disease, according to a report published online in the New England Journal of Medicine.

The results from the initial round of screening in the National Lung Screening Trial show that over a 3-year period, annual low-dose helical CT detected significantly more early-stage lung cancers than conventional chest radiography did, said Dr. Timothy R. Church of the division of environmental health sciences, University of Minnesota School of Public Health, Minneapolis, and his associates in the NLST research group.

In the real-world clinical settings, "a reduction in mortality from lung cancer is achievable at U.S. screening centers that have staff experienced in chest CT," they added.

The findings were published online and simultaneously presented at the annual meeting of the American Thoracic Society.

For this first round of the study, 53,454 asymptomatic men and women aged 55-74 years participated. All had a history of at least 30 pack-years of smoking and were either current smokers or had quit within the preceding 15 years.

The study subjects were treated and followed at 33 sites across the country and were randomly assigned to undergo either low-dose helical CT (26,722 patients) or chest radiography (26,732 patients) to screen for lung cancer every year for 3 years. Eight of these subjects were found to have lung cancer before their first screening could be done and were excluded from the study.

The proportion of study subjects who had positive screening results was markedly higher with low-dose CT scanning (27.3%) than with radiography (9.2%). Lung cancer was diagnosed in 1.1% of the CT group, compared with 0.7% of the radiography group.

In the CT group, 92.5% of the patients who developed lung cancer had a positive screening result (a true-positive result) and 6.2% had a negative screening result (a false-negative result); the remaining subjects missed their scheduled screening visit.

In the radiography group, 71.6% of the patients who developed lung cancer had a true-positive screening result and 25.8% had a false-negative result; the remaining subjects missed their scheduled screening visit.

Thus, the sensitivity and specificity of lung CT were 93.8% and 73.4%, respectively, compared with 73.5% sensitivity and 91.3% specificity for radiography, Dr. Church and his colleagues said (N. Engl. J. Med. 2013 [doi:10.1056/NEJMoa1209120]).

"There were many more bronchioloalveolar carcinomas and adenocarcinomas in the low-dose CT group than in the radiography group (38 vs. 8 and 123 vs. 71, respectively), but the frequencies of other histologic features were similar in the two groups," the investigators said.

The difference between the two groups in the number of detected cancers was almost entirely accounted for by early, stage IA tumors, which were markedly more likely to be identified on CT screening. The rates of detection were fairly comparable between CT and radiography for all the more advanced malignancies.

The study was funded by the National Cancer Institute. No financial conflicts of interest were reported.