Jeff Evans

BETHESDA, MD. — The health effects of lactose intolerance in people who forgo consuming dairy foods have not been adequately studied to determine if such individuals have any nutritional deficiencies or long-term clinical sequelae on bone and cardiovascular health, according to findings from a panel of experts assembled by the National Institutes of Health.

In a draft “state of the science” statement released, the 14-member panel was not able to estimate the prevalence of lactose intolerance from a systematic review of 54 studies but was able to conclude that a substantial proportion of people who have little or no lactase activity do not have lactose intolerance and may be missing out on the health benefits provided by the nutrients in dairy foods, primarily calcium and vitamin D.

“Particularly in children and adolescents, it's very difficult for them to receive the required amounts of calcium and vitamin D if they avoid dairy products completely,” panel chairperson Dr. Frederick J. Suchy said in a press briefing.

“One of the key problems that we recognize is that sometimes parents perceive themselves as being lactose intolerant when they're not and then impose that condition on their child without any testing,” said Dr. Suchy, professor of pediatrics at Kravis Children's Hospital at Mount Sinai Hospital, New York.

The panel defined lactose intolerance as the onset of gastrointestinal symptoms in an individual with lactose malabsorption that are observed following a blinded, single-dose challenge of ingested lactose but not after ingestion of an indistinguishable placebo. None of the studies in the panel's review used this definition or evaluated a representative sample of the U.S. population.

Many of the studies that the panel reviewed did not verify if gastrointestinal symptoms resulted from lactose malabsorption (which may or may not be symptomatic) in people who have lost most or all lactase expression in their small intestine. These people, called lactase nonpersisters, form the majority of all people.

The panel also suggested that “determining the amounts of lactose that can be tolerated is an important step in developing evidence-based dietary recommendations that meet the needs of the individual.” Evidence suggests that adults and adolescents who have been diagnosed with lactose malabsorption could ingest at least 12 g of lactose (equivalent to the lactose content of 1 cup of milk) with no or minor symptoms.

In order that people with real or perceived lactose intolerance who do not eat dairy foods can obtain their nutritional benefits, the panel advised creating individualized strategies for patients, such as consuming small amounts of dairy foods with other meals and spreading their dairy intake throughout the day.

The panel noted that calcium-fortified soy or rice drinks, fruit juices, soy products, dried beans, and leafy greens are good nondairy dietary sources of calcium. None of the panelists had conflicts of interest.

BETHESDA, MD. — The health effects of lactose intolerance in people who forgo consuming dairy foods have not been adequately studied to determine if such individuals have any nutritional deficiencies or long-term clinical sequelae on bone and cardiovascular health, according to findings from a panel of experts assembled by the National Institutes of Health.

In a draft “state of the science” statement released, the 14-member panel was not able to estimate the prevalence of lactose intolerance from a systematic review of 54 studies but was able to conclude that a substantial proportion of people who have little or no lactase activity do not have lactose intolerance and may be missing out on the health benefits provided by the nutrients in dairy foods, primarily calcium and vitamin D.

“Particularly in children and adolescents, it's very difficult for them to receive the required amounts of calcium and vitamin D if they avoid dairy products completely,” panel chairperson Dr. Frederick J. Suchy said in a press briefing.

“One of the key problems that we recognize is that sometimes parents perceive themselves as being lactose intolerant when they're not and then impose that condition on their child without any testing,” said Dr. Suchy, professor of pediatrics at Kravis Children's Hospital at Mount Sinai Hospital, New York.

The panel defined lactose intolerance as the onset of gastrointestinal symptoms in an individual with lactose malabsorption that are observed following a blinded, single-dose challenge of ingested lactose but not after ingestion of an indistinguishable placebo. None of the studies in the panel's review used this definition or evaluated a representative sample of the U.S. population.

Many of the studies that the panel reviewed did not verify if gastrointestinal symptoms resulted from lactose malabsorption (which may or may not be symptomatic) in people who have lost most or all lactase expression in their small intestine. These people, called lactase nonpersisters, form the majority of all people.

The panel also suggested that “determining the amounts of lactose that can be tolerated is an important step in developing evidence-based dietary recommendations that meet the needs of the individual.” Evidence suggests that adults and adolescents who have been diagnosed with lactose malabsorption could ingest at least 12 g of lactose (equivalent to the lactose content of 1 cup of milk) with no or minor symptoms.

In order that people with real or perceived lactose intolerance who do not eat dairy foods can obtain their nutritional benefits, the panel advised creating individualized strategies for patients, such as consuming small amounts of dairy foods with other meals and spreading their dairy intake throughout the day.

The panel noted that calcium-fortified soy or rice drinks, fruit juices, soy products, dried beans, and leafy greens are good nondairy dietary sources of calcium. None of the panelists had conflicts of interest.

BETHESDA, MD. — The health effects of lactose intolerance in people who forgo consuming dairy foods have not been adequately studied to determine if such individuals have any nutritional deficiencies or long-term clinical sequelae on bone and cardiovascular health, according to findings from a panel of experts assembled by the National Institutes of Health.

In a draft “state of the science” statement released, the 14-member panel was not able to estimate the prevalence of lactose intolerance from a systematic review of 54 studies but was able to conclude that a substantial proportion of people who have little or no lactase activity do not have lactose intolerance and may be missing out on the health benefits provided by the nutrients in dairy foods, primarily calcium and vitamin D.

“Particularly in children and adolescents, it's very difficult for them to receive the required amounts of calcium and vitamin D if they avoid dairy products completely,” panel chairperson Dr. Frederick J. Suchy said in a press briefing.

“One of the key problems that we recognize is that sometimes parents perceive themselves as being lactose intolerant when they're not and then impose that condition on their child without any testing,” said Dr. Suchy, professor of pediatrics at Kravis Children's Hospital at Mount Sinai Hospital, New York.

The panel defined lactose intolerance as the onset of gastrointestinal symptoms in an individual with lactose malabsorption that are observed following a blinded, single-dose challenge of ingested lactose but not after ingestion of an indistinguishable placebo. None of the studies in the panel's review used this definition or evaluated a representative sample of the U.S. population.

Many of the studies that the panel reviewed did not verify if gastrointestinal symptoms resulted from lactose malabsorption (which may or may not be symptomatic) in people who have lost most or all lactase expression in their small intestine. These people, called lactase nonpersisters, form the majority of all people.

The panel also suggested that “determining the amounts of lactose that can be tolerated is an important step in developing evidence-based dietary recommendations that meet the needs of the individual.” Evidence suggests that adults and adolescents who have been diagnosed with lactose malabsorption could ingest at least 12 g of lactose (equivalent to the lactose content of 1 cup of milk) with no or minor symptoms.

In order that people with real or perceived lactose intolerance who do not eat dairy foods can obtain their nutritional benefits, the panel advised creating individualized strategies for patients, such as consuming small amounts of dairy foods with other meals and spreading their dairy intake throughout the day.

The panel noted that calcium-fortified soy or rice drinks, fruit juices, soy products, dried beans, and leafy greens are good nondairy dietary sources of calcium. None of the panelists had conflicts of interest.

BETHESDA, MD. — The health effects of lactose intolerance in people who avoid dairy foods have not been adequately studied to determine if there are nutritional deficiencies or long-term effects on bone and cardiovascular health, according to findings from a panel of experts assembled by the National Institutes of Health.

In a draft “state of the science” statement, the 14-member panel was not able to estimate the prevalence of lactose intolerance from a systematic review of 54 studies but concluded that a substantial proportion of people who have little or no lactase activity do not have lactose intolerance and may be missing out on the health benefits of nutrients in dairy foods, primarily calcium and vitamin D.

“Particularly in children and adolescents, it's very difficult for them to receive the required amounts of calcium and vitamin D if they avoid dairy products completely,” panel chairperson Dr. Frederick J. Suchy said in a press briefing. “Sometimes parents perceive themselves as being lactose intolerant when they're not and then impose that condition on their child without any testing,” said Dr. Suchy, professor of pediatrics at Kravis Children's Hospital at Mount Sinai Hospital, New York.

The panel defined lactose intolerance as onset of gastrointestinal symptoms in an individual with lactose malabsorption, after a blinded, single-dose challenge of ingested lactose but not after ingestion of an indistinguishable placebo. None of the studies in the panel's review used this definition or evaluated a representative sample of the U.S. population.

Many studies reviewed by the panel did not verify if gastrointestinal symptoms resulted from lactose malabsorption (which may or may not be symptomatic) in people who have lost most or all lactase expression in their small intestine. These so-called lactase nonpersisters form the majority of all people worldwide.

Evidence suggests that adults and adolescents who have been diagnosed with lactose malabsorption could ingest at least 12 g of lactose (equivalent to the lactose content of 1 cup of milk) with no or minor symptoms, the panel found.

The panel advised creating individualized strategies for patients with real or perceived lactose intolerance, such as eating small amounts of dairy foods with other meals and spreading dairy intake throughout the day. Calcium-fortified soy or rice drinks, fruit juices, soy products, dried beans, and leafy greens are good nondairy sources of calcium, the panel noted.

Disclosures: None of the panelists reported relevant conflicts of interest.

A copy of the draft statement is at http://consensus.nih.gov/2010/lactose.htm

BETHESDA, MD. — The health effects of lactose intolerance in people who avoid dairy foods have not been adequately studied to determine if there are nutritional deficiencies or long-term effects on bone and cardiovascular health, according to findings from a panel of experts assembled by the National Institutes of Health.

In a draft “state of the science” statement, the 14-member panel was not able to estimate the prevalence of lactose intolerance from a systematic review of 54 studies but concluded that a substantial proportion of people who have little or no lactase activity do not have lactose intolerance and may be missing out on the health benefits of nutrients in dairy foods, primarily calcium and vitamin D.

“Particularly in children and adolescents, it's very difficult for them to receive the required amounts of calcium and vitamin D if they avoid dairy products completely,” panel chairperson Dr. Frederick J. Suchy said in a press briefing. “Sometimes parents perceive themselves as being lactose intolerant when they're not and then impose that condition on their child without any testing,” said Dr. Suchy, professor of pediatrics at Kravis Children's Hospital at Mount Sinai Hospital, New York.

The panel defined lactose intolerance as onset of gastrointestinal symptoms in an individual with lactose malabsorption, after a blinded, single-dose challenge of ingested lactose but not after ingestion of an indistinguishable placebo. None of the studies in the panel's review used this definition or evaluated a representative sample of the U.S. population.

Many studies reviewed by the panel did not verify if gastrointestinal symptoms resulted from lactose malabsorption (which may or may not be symptomatic) in people who have lost most or all lactase expression in their small intestine. These so-called lactase nonpersisters form the majority of all people worldwide.

Evidence suggests that adults and adolescents who have been diagnosed with lactose malabsorption could ingest at least 12 g of lactose (equivalent to the lactose content of 1 cup of milk) with no or minor symptoms, the panel found.

The panel advised creating individualized strategies for patients with real or perceived lactose intolerance, such as eating small amounts of dairy foods with other meals and spreading dairy intake throughout the day. Calcium-fortified soy or rice drinks, fruit juices, soy products, dried beans, and leafy greens are good nondairy sources of calcium, the panel noted.

Disclosures: None of the panelists reported relevant conflicts of interest.

A copy of the draft statement is at http://consensus.nih.gov/2010/lactose.htm

BETHESDA, MD. — The health effects of lactose intolerance in people who avoid dairy foods have not been adequately studied to determine if there are nutritional deficiencies or long-term effects on bone and cardiovascular health, according to findings from a panel of experts assembled by the National Institutes of Health.

In a draft “state of the science” statement, the 14-member panel was not able to estimate the prevalence of lactose intolerance from a systematic review of 54 studies but concluded that a substantial proportion of people who have little or no lactase activity do not have lactose intolerance and may be missing out on the health benefits of nutrients in dairy foods, primarily calcium and vitamin D.

“Particularly in children and adolescents, it's very difficult for them to receive the required amounts of calcium and vitamin D if they avoid dairy products completely,” panel chairperson Dr. Frederick J. Suchy said in a press briefing. “Sometimes parents perceive themselves as being lactose intolerant when they're not and then impose that condition on their child without any testing,” said Dr. Suchy, professor of pediatrics at Kravis Children's Hospital at Mount Sinai Hospital, New York.

The panel defined lactose intolerance as onset of gastrointestinal symptoms in an individual with lactose malabsorption, after a blinded, single-dose challenge of ingested lactose but not after ingestion of an indistinguishable placebo. None of the studies in the panel's review used this definition or evaluated a representative sample of the U.S. population.

Many studies reviewed by the panel did not verify if gastrointestinal symptoms resulted from lactose malabsorption (which may or may not be symptomatic) in people who have lost most or all lactase expression in their small intestine. These so-called lactase nonpersisters form the majority of all people worldwide.

Evidence suggests that adults and adolescents who have been diagnosed with lactose malabsorption could ingest at least 12 g of lactose (equivalent to the lactose content of 1 cup of milk) with no or minor symptoms, the panel found.

The panel advised creating individualized strategies for patients with real or perceived lactose intolerance, such as eating small amounts of dairy foods with other meals and spreading dairy intake throughout the day. Calcium-fortified soy or rice drinks, fruit juices, soy products, dried beans, and leafy greens are good nondairy sources of calcium, the panel noted.

Disclosures: None of the panelists reported relevant conflicts of interest.

A copy of the draft statement is at http://consensus.nih.gov/2010/lactose.htm

Major Finding: Latrepirdine was well tolerated, had low adverse event rates, and significantly improved MMSE scores by 1 point over 90 days.

Data Source: Randomized, placebo-controlled, phase II trial of 90 patients with mild to moderate Huntington's disease

Disclosures: Some investigators are employees of Medivation Inc., which manufactures latrepirdine and sponsored the study sponsor; others reported receiving prior research support from the company.

Cognitive impairment improved in patients with mild to moderate Huntington's disease without any noticeable increase in adverse events after a 90-day course of treatment with the investigational drug latrepirdine.

The drug, known most widely outside of the United States under the trade name Dimebon, was well tolerated in the trial and showed no signs of increasing the risk for particular adverse events, reported Dr. Karl Kieburtz of the University of Rochester (N.Y.), and his colleagues in the Dimebon in Subjects With Huntington Disease (DIMOND) study (Arch. Neurol. 2010;67:154-60).

Latrepirdine is a synthetic molecule that is known to stabilize mitochondrial membranes and increase neurite outgrowth. It is currently also being tested in phase III trials of patients with Alzheimer's disease.

The patients had a mean age of about 53 years and had to be ambulatory, have a total functional capacity score of 5 or higher at baseline on the Unified Huntington Disease Rating Scale (UHDRS), and be living in the community without requiring skilled nursing care.

After starting latrepirdine at 10 mg/day on day 1 and then 30 mg/day for the following 6 days, the dose was titrated up to 60 mg/day after the first week. The study, comprising 90 subjects, was completed by 87% of patients in the latrepirdine group and by 82% on placebo.

In the trial, all efficacy outcomes were secondary end points. On the Mini-Mental State Examination (MMSE), 46 latrepirdine-treated patients had a mean improvement of nearly 1 point on the MMSE, compared with no change in 44 placebo-treated patients. No significant differences in outcomes could be detected between the groups on other measures of cognitive function, such as the Alzheimer's Disease Assessment Scale–Cognitive subscale or the cognitive tests in the UHDRS.

Dr. Kieburtz and his associates thought that the “significant finding on the MMSE was surprising, given that the [examination] is generally considered a relatively insensitive measure of cognitive function.”

However, the researchers noted that the “MMSE provides a broader assessment of cognition than the other end points assessed” and “it is highly stable during a 6-month to 12-month period with low variability in patients who were untreated.”

A “substantial number” of patients in both groups had maximum or near-maximum scores on the MMSE at baseline. To determine the effect of latrepirdine in patients with more severe cognitive impairment, the investigators analyzed the outcomes for 51 patients with an MMSE score of 26 or lower. At 90 days, the mean MMSE score of patients in this subgroup who received latrepirdine was 1.63 points greater than the score of those who received placebo.

Adverse events occurred in similar percentages of patients treated with latrepirdine (70%) or placebo (80%); about half of these were moderate to severe in intensity. The only adverse events that occurred more often in latrepirdine-treated patients than in placebo-treated patients were headache (15% vs. 7%, respectively) and somnolence (7% vs. 2%).

My Take

Stage Set for Future Trials

This effort by Dr. Kieburtz and his colleagues is noteworthy for a number of reasons. Although Xenazine (tetrabenazine) is approved for the treatment of chorea and other motor manifestations of HD, there are no approved medications available for cognitive and behavioral symptoms in the disease.

Dr. Kieburtz presents data on the safety and tolerability of latrepirdine given 20 mg three times daily compared with placebo in patients diagnosed with HD. The treatment and placebo groups were similar and randomization methods were strict.

Although the study was not designed to detect a minimally clinically significant effect on any efficacy measure, a small positive change observed in MMSE testing suggests that further study with this agent is warranted. The unique proposed mechanism of action of latrepirdine to stabilize mitochondrial membranes distinguishes it from medications commonly used in HD such as anticholinesterase inhibitors and N-methyl-D-aspartate antagonists, giving hope for a new avenue of therapeutic intervention in this challenging neurodegenerative disorder.

The investigators' carefully designed and executed work sets the stage for future treatment trials focused on cognitive and behavioral efficacy in HD.

Major Finding: Latrepirdine was well tolerated, had low adverse event rates, and significantly improved MMSE scores by 1 point over 90 days.

Data Source: Randomized, placebo-controlled, phase II trial of 90 patients with mild to moderate Huntington's disease

Disclosures: Some investigators are employees of Medivation Inc., which manufactures latrepirdine and sponsored the study sponsor; others reported receiving prior research support from the company.

Cognitive impairment improved in patients with mild to moderate Huntington's disease without any noticeable increase in adverse events after a 90-day course of treatment with the investigational drug latrepirdine.

The drug, known most widely outside of the United States under the trade name Dimebon, was well tolerated in the trial and showed no signs of increasing the risk for particular adverse events, reported Dr. Karl Kieburtz of the University of Rochester (N.Y.), and his colleagues in the Dimebon in Subjects With Huntington Disease (DIMOND) study (Arch. Neurol. 2010;67:154-60).

Latrepirdine is a synthetic molecule that is known to stabilize mitochondrial membranes and increase neurite outgrowth. It is currently also being tested in phase III trials of patients with Alzheimer's disease.

The patients had a mean age of about 53 years and had to be ambulatory, have a total functional capacity score of 5 or higher at baseline on the Unified Huntington Disease Rating Scale (UHDRS), and be living in the community without requiring skilled nursing care.

After starting latrepirdine at 10 mg/day on day 1 and then 30 mg/day for the following 6 days, the dose was titrated up to 60 mg/day after the first week. The study, comprising 90 subjects, was completed by 87% of patients in the latrepirdine group and by 82% on placebo.

In the trial, all efficacy outcomes were secondary end points. On the Mini-Mental State Examination (MMSE), 46 latrepirdine-treated patients had a mean improvement of nearly 1 point on the MMSE, compared with no change in 44 placebo-treated patients. No significant differences in outcomes could be detected between the groups on other measures of cognitive function, such as the Alzheimer's Disease Assessment Scale–Cognitive subscale or the cognitive tests in the UHDRS.

Dr. Kieburtz and his associates thought that the “significant finding on the MMSE was surprising, given that the [examination] is generally considered a relatively insensitive measure of cognitive function.”

However, the researchers noted that the “MMSE provides a broader assessment of cognition than the other end points assessed” and “it is highly stable during a 6-month to 12-month period with low variability in patients who were untreated.”

A “substantial number” of patients in both groups had maximum or near-maximum scores on the MMSE at baseline. To determine the effect of latrepirdine in patients with more severe cognitive impairment, the investigators analyzed the outcomes for 51 patients with an MMSE score of 26 or lower. At 90 days, the mean MMSE score of patients in this subgroup who received latrepirdine was 1.63 points greater than the score of those who received placebo.

Adverse events occurred in similar percentages of patients treated with latrepirdine (70%) or placebo (80%); about half of these were moderate to severe in intensity. The only adverse events that occurred more often in latrepirdine-treated patients than in placebo-treated patients were headache (15% vs. 7%, respectively) and somnolence (7% vs. 2%).

My Take

Stage Set for Future Trials

This effort by Dr. Kieburtz and his colleagues is noteworthy for a number of reasons. Although Xenazine (tetrabenazine) is approved for the treatment of chorea and other motor manifestations of HD, there are no approved medications available for cognitive and behavioral symptoms in the disease.

Dr. Kieburtz presents data on the safety and tolerability of latrepirdine given 20 mg three times daily compared with placebo in patients diagnosed with HD. The treatment and placebo groups were similar and randomization methods were strict.

Although the study was not designed to detect a minimally clinically significant effect on any efficacy measure, a small positive change observed in MMSE testing suggests that further study with this agent is warranted. The unique proposed mechanism of action of latrepirdine to stabilize mitochondrial membranes distinguishes it from medications commonly used in HD such as anticholinesterase inhibitors and N-methyl-D-aspartate antagonists, giving hope for a new avenue of therapeutic intervention in this challenging neurodegenerative disorder.

The investigators' carefully designed and executed work sets the stage for future treatment trials focused on cognitive and behavioral efficacy in HD.

Major Finding: Latrepirdine was well tolerated, had low adverse event rates, and significantly improved MMSE scores by 1 point over 90 days.

Data Source: Randomized, placebo-controlled, phase II trial of 90 patients with mild to moderate Huntington's disease

Disclosures: Some investigators are employees of Medivation Inc., which manufactures latrepirdine and sponsored the study sponsor; others reported receiving prior research support from the company.

Cognitive impairment improved in patients with mild to moderate Huntington's disease without any noticeable increase in adverse events after a 90-day course of treatment with the investigational drug latrepirdine.

The drug, known most widely outside of the United States under the trade name Dimebon, was well tolerated in the trial and showed no signs of increasing the risk for particular adverse events, reported Dr. Karl Kieburtz of the University of Rochester (N.Y.), and his colleagues in the Dimebon in Subjects With Huntington Disease (DIMOND) study (Arch. Neurol. 2010;67:154-60).

Latrepirdine is a synthetic molecule that is known to stabilize mitochondrial membranes and increase neurite outgrowth. It is currently also being tested in phase III trials of patients with Alzheimer's disease.

The patients had a mean age of about 53 years and had to be ambulatory, have a total functional capacity score of 5 or higher at baseline on the Unified Huntington Disease Rating Scale (UHDRS), and be living in the community without requiring skilled nursing care.

After starting latrepirdine at 10 mg/day on day 1 and then 30 mg/day for the following 6 days, the dose was titrated up to 60 mg/day after the first week. The study, comprising 90 subjects, was completed by 87% of patients in the latrepirdine group and by 82% on placebo.

In the trial, all efficacy outcomes were secondary end points. On the Mini-Mental State Examination (MMSE), 46 latrepirdine-treated patients had a mean improvement of nearly 1 point on the MMSE, compared with no change in 44 placebo-treated patients. No significant differences in outcomes could be detected between the groups on other measures of cognitive function, such as the Alzheimer's Disease Assessment Scale–Cognitive subscale or the cognitive tests in the UHDRS.

Dr. Kieburtz and his associates thought that the “significant finding on the MMSE was surprising, given that the [examination] is generally considered a relatively insensitive measure of cognitive function.”

However, the researchers noted that the “MMSE provides a broader assessment of cognition than the other end points assessed” and “it is highly stable during a 6-month to 12-month period with low variability in patients who were untreated.”

A “substantial number” of patients in both groups had maximum or near-maximum scores on the MMSE at baseline. To determine the effect of latrepirdine in patients with more severe cognitive impairment, the investigators analyzed the outcomes for 51 patients with an MMSE score of 26 or lower. At 90 days, the mean MMSE score of patients in this subgroup who received latrepirdine was 1.63 points greater than the score of those who received placebo.

Adverse events occurred in similar percentages of patients treated with latrepirdine (70%) or placebo (80%); about half of these were moderate to severe in intensity. The only adverse events that occurred more often in latrepirdine-treated patients than in placebo-treated patients were headache (15% vs. 7%, respectively) and somnolence (7% vs. 2%).

My Take

Stage Set for Future Trials

This effort by Dr. Kieburtz and his colleagues is noteworthy for a number of reasons. Although Xenazine (tetrabenazine) is approved for the treatment of chorea and other motor manifestations of HD, there are no approved medications available for cognitive and behavioral symptoms in the disease.

Dr. Kieburtz presents data on the safety and tolerability of latrepirdine given 20 mg three times daily compared with placebo in patients diagnosed with HD. The treatment and placebo groups were similar and randomization methods were strict.

Although the study was not designed to detect a minimally clinically significant effect on any efficacy measure, a small positive change observed in MMSE testing suggests that further study with this agent is warranted. The unique proposed mechanism of action of latrepirdine to stabilize mitochondrial membranes distinguishes it from medications commonly used in HD such as anticholinesterase inhibitors and N-methyl-D-aspartate antagonists, giving hope for a new avenue of therapeutic intervention in this challenging neurodegenerative disorder.

The investigators' carefully designed and executed work sets the stage for future treatment trials focused on cognitive and behavioral efficacy in HD.

Major Finding: Patients taking 2 mg/kg of daclizumab every 2 weeks plus interferon beta had significantly fewer new or enlarged gadolinium-enhancing lesions after 24 weeks of treatment than did those taking interferon beta plus placebo (1.32 vs. 4.75).

Data Source: CHOICE study: Double-blind, randomized, placebo-controlled, phase II trial of 230 patients with active relapsing MS

Disclosures: Many investigators reported potential conflicts of interest with Biogen Idec Inc., maker of the MS medications, Tysabri and Avonex. Some of the investigators are employed by and own stock with either Biogen Idec or Facet Biotech Corp., both of which funded the trial. Dr. Greenberg and Dr. Stüve disclosed potential conflicts of interest with several manufacturers of MS drugs.

Multiple sclerosis patients who experience relapsing disease while taking interferon beta might be able to reduce their number of new or enlarging lesions by adding the humanized monoclonal antibody daclizumab.

Besides reducing the risk of lesion growth and formation, the antibody might exert at least part of its effects through a mechanism that is now suggested by several lines of evidence to be a potential drug target and an important part of further understanding the pathogenesis of the disease, Dr. Daniel Wynn of Consultants in Neurology Multiple Sclerosis Center, Northbrook, Ill., and his associates reported (Lancet Neurol. 2010 Feb. 16 [doi:10.1016/S1474-4422(10)70033-8

Daclizumab (Zenapax) has been already approved by the Food and Drug Administration for the prophylaxis of acute organ rejection in patients receiving renal transplants.

“The true effects of this trial and previous observations on daclizumab might be more far-reaching than they seem at first glance,” Dr. Olaf Stüve and Dr. Benjamin M. Greenberg wrote in an editorial (Lancet Neurol. 2010 Feb. 16 [doi:10.1016/S1474-4422(10)70032-6

Daclizumab was thought to inhibit T-cell proliferation and activation by binding to the CD25 subunit of the human high-affinity interleukin-2 receptor, but in this and other studies of MS patients treated with daclizumab, T cells have shown normal proliferative and activation responses.

Rather than reduce the activation or proliferation of T cells, Dr. Wynn and his colleagues found that the reduction of disease activity with daclizumab appears to be associated with an expansion of a regulatory subset of CD56

In the 51-center CHOICE study, the investigators randomized 75 patients to daclizumab 2 mg/kg every 2 weeks, 78 patients to daclizumab 1 mg/kg every 4 weeks, and 77 patients to placebo. These patients had a mean age of about 40 years and continued to take their baseline interferon beta regimens. Patients in each treatment arm averaged about 2.5 relapses in the previous 2 years and had a mean Expanded Disability Status Scale score of 3 (0 = normal; 10 = death). All of the patients had experienced at least one relapse or at least one gadolinium-enhancing brain or spinal cord lesion in the previous year while on a stable interferon beta regimen.

No significant differences were noted between the low-dose daclizumab and placebo groups on any of the imaging or clinical end points.

However, at 24 weeks, significantly fewer new or enlarged gadolinium-enhancing lesions had developed in the high-dose daclizumab group, compared with the placebo-treated group (mean of 1.32 lesions vs. 4.75, respectively). Enlarged lesions were defined by at least a 50% increase in size for lesions measuring at least 5 mm in diameter and by at least a 20% increase in size for lesions less than 5 mm.

High-dose daclizumab also was associated with a significantly lower number of new gadolinium-enhancing lesions alone, compared with placebo (mean of 1.18 vs. 3.95).

By 24 weeks, the high-dose daclizumab patients developed significantly fewer T2 lesions than did placebo-treated patients (1.1 vs. 3.4).

None of the groups were significantly different in terms of the change in their T1 hypointensities, the change in the volume of their T2 lesions, or their annualized relapse rate or mean time to relapse.

When daclizumab treatment was discontinued in a 48-week posttreatment period, the formation of lesions returned to about the same level in all groups.

In a post hoc analysis, higher counts of CD56

Daclizumab-treated patients who were in the highest quartile of CD56

“Identifying the physiological mechanism or mechanisms that lead to the expansion of [CD56

Serious adverse events in patients treated with daclizumab most often consisted of infections and infestations, none of which were opportunistic or resulted in death. Two patients who received daclizumab developed malignant disease, one with breast cancer and one with a recurrence of pseudomyxoma peritonei.

My Take

Drug Is Good Candidate for Phase III

In this phase II trial, treatment with high-dose daclizumab significantly reduced the number of gadolinium-enhancing lesions in MS patients, which suggests that it is a good candidate to move forward into phase III clinical trials. However, because the treatment phase of the trial lasted only 6 months, we cannot know yet what effect the drug has on the rate of relapse and other clinical measures.

It seems to be a reasonable approach to further study the use of daclizumab as an add-on therapy to interferon beta, but it will be important to know the full safety profile of daclizumab when used with other MS therapies. Progressive multifocal leukoencephalopathy has been associated with other monoclonal antibodies such as natalizumab (Tysabri) and rituximab (Rituxan), especially when used in combination with other immunomodulating or immunosuppressive agents.

Daclizumab did not seem to have a worrisome side effect profile, but some patients developed a skin rash, particularly those in the group that was given low-dose daclizumab.

Major Finding: Patients taking 2 mg/kg of daclizumab every 2 weeks plus interferon beta had significantly fewer new or enlarged gadolinium-enhancing lesions after 24 weeks of treatment than did those taking interferon beta plus placebo (1.32 vs. 4.75).

Data Source: CHOICE study: Double-blind, randomized, placebo-controlled, phase II trial of 230 patients with active relapsing MS

Disclosures: Many investigators reported potential conflicts of interest with Biogen Idec Inc., maker of the MS medications, Tysabri and Avonex. Some of the investigators are employed by and own stock with either Biogen Idec or Facet Biotech Corp., both of which funded the trial. Dr. Greenberg and Dr. Stüve disclosed potential conflicts of interest with several manufacturers of MS drugs.

Multiple sclerosis patients who experience relapsing disease while taking interferon beta might be able to reduce their number of new or enlarging lesions by adding the humanized monoclonal antibody daclizumab.

Besides reducing the risk of lesion growth and formation, the antibody might exert at least part of its effects through a mechanism that is now suggested by several lines of evidence to be a potential drug target and an important part of further understanding the pathogenesis of the disease, Dr. Daniel Wynn of Consultants in Neurology Multiple Sclerosis Center, Northbrook, Ill., and his associates reported (Lancet Neurol. 2010 Feb. 16 [doi:10.1016/S1474-4422(10)70033-8

Daclizumab (Zenapax) has been already approved by the Food and Drug Administration for the prophylaxis of acute organ rejection in patients receiving renal transplants.

“The true effects of this trial and previous observations on daclizumab might be more far-reaching than they seem at first glance,” Dr. Olaf Stüve and Dr. Benjamin M. Greenberg wrote in an editorial (Lancet Neurol. 2010 Feb. 16 [doi:10.1016/S1474-4422(10)70032-6

Daclizumab was thought to inhibit T-cell proliferation and activation by binding to the CD25 subunit of the human high-affinity interleukin-2 receptor, but in this and other studies of MS patients treated with daclizumab, T cells have shown normal proliferative and activation responses.

Rather than reduce the activation or proliferation of T cells, Dr. Wynn and his colleagues found that the reduction of disease activity with daclizumab appears to be associated with an expansion of a regulatory subset of CD56

In the 51-center CHOICE study, the investigators randomized 75 patients to daclizumab 2 mg/kg every 2 weeks, 78 patients to daclizumab 1 mg/kg every 4 weeks, and 77 patients to placebo. These patients had a mean age of about 40 years and continued to take their baseline interferon beta regimens. Patients in each treatment arm averaged about 2.5 relapses in the previous 2 years and had a mean Expanded Disability Status Scale score of 3 (0 = normal; 10 = death). All of the patients had experienced at least one relapse or at least one gadolinium-enhancing brain or spinal cord lesion in the previous year while on a stable interferon beta regimen.

No significant differences were noted between the low-dose daclizumab and placebo groups on any of the imaging or clinical end points.

However, at 24 weeks, significantly fewer new or enlarged gadolinium-enhancing lesions had developed in the high-dose daclizumab group, compared with the placebo-treated group (mean of 1.32 lesions vs. 4.75, respectively). Enlarged lesions were defined by at least a 50% increase in size for lesions measuring at least 5 mm in diameter and by at least a 20% increase in size for lesions less than 5 mm.

High-dose daclizumab also was associated with a significantly lower number of new gadolinium-enhancing lesions alone, compared with placebo (mean of 1.18 vs. 3.95).

By 24 weeks, the high-dose daclizumab patients developed significantly fewer T2 lesions than did placebo-treated patients (1.1 vs. 3.4).

None of the groups were significantly different in terms of the change in their T1 hypointensities, the change in the volume of their T2 lesions, or their annualized relapse rate or mean time to relapse.

When daclizumab treatment was discontinued in a 48-week posttreatment period, the formation of lesions returned to about the same level in all groups.

In a post hoc analysis, higher counts of CD56

Daclizumab-treated patients who were in the highest quartile of CD56

“Identifying the physiological mechanism or mechanisms that lead to the expansion of [CD56

Serious adverse events in patients treated with daclizumab most often consisted of infections and infestations, none of which were opportunistic or resulted in death. Two patients who received daclizumab developed malignant disease, one with breast cancer and one with a recurrence of pseudomyxoma peritonei.

My Take

Drug Is Good Candidate for Phase III

In this phase II trial, treatment with high-dose daclizumab significantly reduced the number of gadolinium-enhancing lesions in MS patients, which suggests that it is a good candidate to move forward into phase III clinical trials. However, because the treatment phase of the trial lasted only 6 months, we cannot know yet what effect the drug has on the rate of relapse and other clinical measures.

It seems to be a reasonable approach to further study the use of daclizumab as an add-on therapy to interferon beta, but it will be important to know the full safety profile of daclizumab when used with other MS therapies. Progressive multifocal leukoencephalopathy has been associated with other monoclonal antibodies such as natalizumab (Tysabri) and rituximab (Rituxan), especially when used in combination with other immunomodulating or immunosuppressive agents.

Daclizumab did not seem to have a worrisome side effect profile, but some patients developed a skin rash, particularly those in the group that was given low-dose daclizumab.

Major Finding: Patients taking 2 mg/kg of daclizumab every 2 weeks plus interferon beta had significantly fewer new or enlarged gadolinium-enhancing lesions after 24 weeks of treatment than did those taking interferon beta plus placebo (1.32 vs. 4.75).

Data Source: CHOICE study: Double-blind, randomized, placebo-controlled, phase II trial of 230 patients with active relapsing MS

Disclosures: Many investigators reported potential conflicts of interest with Biogen Idec Inc., maker of the MS medications, Tysabri and Avonex. Some of the investigators are employed by and own stock with either Biogen Idec or Facet Biotech Corp., both of which funded the trial. Dr. Greenberg and Dr. Stüve disclosed potential conflicts of interest with several manufacturers of MS drugs.

Multiple sclerosis patients who experience relapsing disease while taking interferon beta might be able to reduce their number of new or enlarging lesions by adding the humanized monoclonal antibody daclizumab.

Besides reducing the risk of lesion growth and formation, the antibody might exert at least part of its effects through a mechanism that is now suggested by several lines of evidence to be a potential drug target and an important part of further understanding the pathogenesis of the disease, Dr. Daniel Wynn of Consultants in Neurology Multiple Sclerosis Center, Northbrook, Ill., and his associates reported (Lancet Neurol. 2010 Feb. 16 [doi:10.1016/S1474-4422(10)70033-8

Daclizumab (Zenapax) has been already approved by the Food and Drug Administration for the prophylaxis of acute organ rejection in patients receiving renal transplants.

“The true effects of this trial and previous observations on daclizumab might be more far-reaching than they seem at first glance,” Dr. Olaf Stüve and Dr. Benjamin M. Greenberg wrote in an editorial (Lancet Neurol. 2010 Feb. 16 [doi:10.1016/S1474-4422(10)70032-6

Daclizumab was thought to inhibit T-cell proliferation and activation by binding to the CD25 subunit of the human high-affinity interleukin-2 receptor, but in this and other studies of MS patients treated with daclizumab, T cells have shown normal proliferative and activation responses.

Rather than reduce the activation or proliferation of T cells, Dr. Wynn and his colleagues found that the reduction of disease activity with daclizumab appears to be associated with an expansion of a regulatory subset of CD56

In the 51-center CHOICE study, the investigators randomized 75 patients to daclizumab 2 mg/kg every 2 weeks, 78 patients to daclizumab 1 mg/kg every 4 weeks, and 77 patients to placebo. These patients had a mean age of about 40 years and continued to take their baseline interferon beta regimens. Patients in each treatment arm averaged about 2.5 relapses in the previous 2 years and had a mean Expanded Disability Status Scale score of 3 (0 = normal; 10 = death). All of the patients had experienced at least one relapse or at least one gadolinium-enhancing brain or spinal cord lesion in the previous year while on a stable interferon beta regimen.

No significant differences were noted between the low-dose daclizumab and placebo groups on any of the imaging or clinical end points.

However, at 24 weeks, significantly fewer new or enlarged gadolinium-enhancing lesions had developed in the high-dose daclizumab group, compared with the placebo-treated group (mean of 1.32 lesions vs. 4.75, respectively). Enlarged lesions were defined by at least a 50% increase in size for lesions measuring at least 5 mm in diameter and by at least a 20% increase in size for lesions less than 5 mm.

High-dose daclizumab also was associated with a significantly lower number of new gadolinium-enhancing lesions alone, compared with placebo (mean of 1.18 vs. 3.95).

By 24 weeks, the high-dose daclizumab patients developed significantly fewer T2 lesions than did placebo-treated patients (1.1 vs. 3.4).

None of the groups were significantly different in terms of the change in their T1 hypointensities, the change in the volume of their T2 lesions, or their annualized relapse rate or mean time to relapse.

When daclizumab treatment was discontinued in a 48-week posttreatment period, the formation of lesions returned to about the same level in all groups.

In a post hoc analysis, higher counts of CD56

Daclizumab-treated patients who were in the highest quartile of CD56

“Identifying the physiological mechanism or mechanisms that lead to the expansion of [CD56

Serious adverse events in patients treated with daclizumab most often consisted of infections and infestations, none of which were opportunistic or resulted in death. Two patients who received daclizumab developed malignant disease, one with breast cancer and one with a recurrence of pseudomyxoma peritonei.

My Take

Drug Is Good Candidate for Phase III

In this phase II trial, treatment with high-dose daclizumab significantly reduced the number of gadolinium-enhancing lesions in MS patients, which suggests that it is a good candidate to move forward into phase III clinical trials. However, because the treatment phase of the trial lasted only 6 months, we cannot know yet what effect the drug has on the rate of relapse and other clinical measures.

It seems to be a reasonable approach to further study the use of daclizumab as an add-on therapy to interferon beta, but it will be important to know the full safety profile of daclizumab when used with other MS therapies. Progressive multifocal leukoencephalopathy has been associated with other monoclonal antibodies such as natalizumab (Tysabri) and rituximab (Rituxan), especially when used in combination with other immunomodulating or immunosuppressive agents.

Daclizumab did not seem to have a worrisome side effect profile, but some patients developed a skin rash, particularly those in the group that was given low-dose daclizumab.

A concentrated oral solution of morphine sulfate has been approved by the Food and Drug Administration, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.

The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.

The solution is indicated for moderate to severe, acute, and chronic pain in opioid-tolerant patients (defined as those who are taking the equivalent of 60 mg of morphine per day). It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.

The FDA's decision is a part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.

“It is a significant step toward ensuring that patients needing this medicine have access to a high-quality product,” Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said during the briefing.

Dr. Throckmorton added that actions that “would limit the availability of this medicine could cause unnecessary hardship to these patients and limit the treatment options available to prescribers. As such, we are working with the manufacturer of the approved product, Roxane Laboratories, to make sure that here will be enough approved drug for all patients. We will also be working with patient organizations and prescribers, so that they are both aware of this approved product.

Roxane met the FDA's standard for establishing the safety and efficacy of the oral solution by referring to the agency's prior findings for similar products. The manufacturer also gave the product a standardized drug label and a medication guide.

A concentrated oral solution of morphine sulfate has been approved by the Food and Drug Administration, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.

The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.

The solution is indicated for moderate to severe, acute, and chronic pain in opioid-tolerant patients (defined as those who are taking the equivalent of 60 mg of morphine per day). It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.

The FDA's decision is a part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.

“It is a significant step toward ensuring that patients needing this medicine have access to a high-quality product,” Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said during the briefing.

Dr. Throckmorton added that actions that “would limit the availability of this medicine could cause unnecessary hardship to these patients and limit the treatment options available to prescribers. As such, we are working with the manufacturer of the approved product, Roxane Laboratories, to make sure that here will be enough approved drug for all patients. We will also be working with patient organizations and prescribers, so that they are both aware of this approved product.

Roxane met the FDA's standard for establishing the safety and efficacy of the oral solution by referring to the agency's prior findings for similar products. The manufacturer also gave the product a standardized drug label and a medication guide.

A concentrated oral solution of morphine sulfate has been approved by the Food and Drug Administration, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.

The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.

The solution is indicated for moderate to severe, acute, and chronic pain in opioid-tolerant patients (defined as those who are taking the equivalent of 60 mg of morphine per day). It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.

The FDA's decision is a part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.

“It is a significant step toward ensuring that patients needing this medicine have access to a high-quality product,” Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said during the briefing.

Dr. Throckmorton added that actions that “would limit the availability of this medicine could cause unnecessary hardship to these patients and limit the treatment options available to prescribers. As such, we are working with the manufacturer of the approved product, Roxane Laboratories, to make sure that here will be enough approved drug for all patients. We will also be working with patient organizations and prescribers, so that they are both aware of this approved product.

Roxane met the FDA's standard for establishing the safety and efficacy of the oral solution by referring to the agency's prior findings for similar products. The manufacturer also gave the product a standardized drug label and a medication guide.

Healthy term infants and their mothers should receive individualized care during their hospital stay, but pediatricians, obstetricians, nurses, and other health care providers should work together to determine the optimal time for hospital discharge for each mother-infant dyad, according to a policy statement issued by the American Academy of Pediatrics.

“There have been new studies since [the previous policy statement was published in 2004] to find out if there are better ways to assess the readiness for discharge of a healthy term infant, and these studies have shown that perceptions of readiness or unreadiness at the time of discharge often differ among pediatricians, obstetricians, and mothers,” said lead author Dr. Praveen Kumar, a neonatologist at Northwestern University, Chicago.

The new statement recommends that “the hospital stay of the mother and her healthy term newborn infant should be long enough to allow identification of early problems and to ensure that the family is able and prepared to care for the infant at home.”

Dr. Kumar and eight other members of the AAP's Committee on Fetus and Newborn wrote the statement, which recommends following a set of 16 minimum criteria before discharging a term newborn (Pediatrics 2010;125:405-9).

“It is our recommendation that all hospitals should develop guidelines in collaboration with appropriate community agencies and third-party payers, to establish hospital-stay and follow-up programs for healthy term infants that implement these recommendations,” Dr. Kumar said in an interview.

The statement also recommends that physicians use the AAP's Safe and Healthy Beginnings toolkit, which contains a discharge readiness checklist that can aid clinicians with the preparation of a newborn for discharge (http://practice.aap.org/public/Newborn_Discharge_SAMPLE.pdf

In making discharge assessments, the committee advises determining that the clinical course and physical examination of the newborn reveal no abnormalities that require additional hospitalization; vital signs are within normal ranges; and there is a history of successful feedings, urinations, and bowel movements and a lack of significant circumcisional bleeding.

Other examinations should assess for the clinical risk of hyperbilirubinemia, and for sepsis based on maternal risk factors and in accord with guidelines for preventing perinatal group B streptococcal disease.

Testing of newborns' blood type as well as their cord blood should be performed as clinically indicated, according to the statement.

Hospital protocols and state regulations may call for other metabolic and hearing screenings.

The initial hepatitis B vaccine also should be administered to the newborn according to the current immunization schedule.

Mothers should have certain blood tests performed, including screening tests for syphilis and hepatitis B surface antigen and other tests required by state regulations, such as HIV testing.

Other assessments need to be made of the mother's knowledge, ability, and confidence to provide adequate care for her infant—including barriers to adequate follow-up care for the newborn—as well as any family, environmental, and social risk factors.

“One of the take-home messages is that the length of stay should accommodate the unique characteristics of each mother-infant dyad, including the health of the mother, the health and stability of the infant, the ability and confidence of the mother to care for her infant, the adequacy of support systems at home, and access to appropriate follow-up care.

“To accomplish this, a pediatrician's decision to discharge a newborn should be made jointly with input from the mother, her obstetrician, and other health care providers who are involved in the care of the mother and her infant, such as nursing staff and social workers,” Dr. Kumar said.

“Everything should be considered as a mother-infant dyad rather than independently for the mother and infant. Just looking at the baby and making a decision that the baby can go home” is not adequate, he added.

Once a medical home for the newborn has been identified and a plan for timely communication of pertinent clinical information to the medical home is in place, the committee recommends making a follow-up appointment for the infant within 48 hours of discharge, but no later than 72 hours, if the infant was discharged less than 48 hours after deliver, according to the statement.

“It is very important for all babies to have a medical home, and it should be in place before a baby goes home,” Dr. Kumar said.

No disclosures were reported.

Healthy term infants and their mothers should receive individualized care during their hospital stay, but pediatricians, obstetricians, nurses, and other health care providers should work together to determine the optimal time for hospital discharge for each mother-infant dyad, according to a policy statement issued by the American Academy of Pediatrics.

“There have been new studies since [the previous policy statement was published in 2004] to find out if there are better ways to assess the readiness for discharge of a healthy term infant, and these studies have shown that perceptions of readiness or unreadiness at the time of discharge often differ among pediatricians, obstetricians, and mothers,” said lead author Dr. Praveen Kumar, a neonatologist at Northwestern University, Chicago.

The new statement recommends that “the hospital stay of the mother and her healthy term newborn infant should be long enough to allow identification of early problems and to ensure that the family is able and prepared to care for the infant at home.”

Dr. Kumar and eight other members of the AAP's Committee on Fetus and Newborn wrote the statement, which recommends following a set of 16 minimum criteria before discharging a term newborn (Pediatrics 2010;125:405-9).

“It is our recommendation that all hospitals should develop guidelines in collaboration with appropriate community agencies and third-party payers, to establish hospital-stay and follow-up programs for healthy term infants that implement these recommendations,” Dr. Kumar said in an interview.

The statement also recommends that physicians use the AAP's Safe and Healthy Beginnings toolkit, which contains a discharge readiness checklist that can aid clinicians with the preparation of a newborn for discharge (http://practice.aap.org/public/Newborn_Discharge_SAMPLE.pdf

In making discharge assessments, the committee advises determining that the clinical course and physical examination of the newborn reveal no abnormalities that require additional hospitalization; vital signs are within normal ranges; and there is a history of successful feedings, urinations, and bowel movements and a lack of significant circumcisional bleeding.

Other examinations should assess for the clinical risk of hyperbilirubinemia, and for sepsis based on maternal risk factors and in accord with guidelines for preventing perinatal group B streptococcal disease.

Testing of newborns' blood type as well as their cord blood should be performed as clinically indicated, according to the statement.

Hospital protocols and state regulations may call for other metabolic and hearing screenings.

The initial hepatitis B vaccine also should be administered to the newborn according to the current immunization schedule.

Mothers should have certain blood tests performed, including screening tests for syphilis and hepatitis B surface antigen and other tests required by state regulations, such as HIV testing.

Other assessments need to be made of the mother's knowledge, ability, and confidence to provide adequate care for her infant—including barriers to adequate follow-up care for the newborn—as well as any family, environmental, and social risk factors.

“One of the take-home messages is that the length of stay should accommodate the unique characteristics of each mother-infant dyad, including the health of the mother, the health and stability of the infant, the ability and confidence of the mother to care for her infant, the adequacy of support systems at home, and access to appropriate follow-up care.

“To accomplish this, a pediatrician's decision to discharge a newborn should be made jointly with input from the mother, her obstetrician, and other health care providers who are involved in the care of the mother and her infant, such as nursing staff and social workers,” Dr. Kumar said.

“Everything should be considered as a mother-infant dyad rather than independently for the mother and infant. Just looking at the baby and making a decision that the baby can go home” is not adequate, he added.

Once a medical home for the newborn has been identified and a plan for timely communication of pertinent clinical information to the medical home is in place, the committee recommends making a follow-up appointment for the infant within 48 hours of discharge, but no later than 72 hours, if the infant was discharged less than 48 hours after deliver, according to the statement.

“It is very important for all babies to have a medical home, and it should be in place before a baby goes home,” Dr. Kumar said.

No disclosures were reported.

Healthy term infants and their mothers should receive individualized care during their hospital stay, but pediatricians, obstetricians, nurses, and other health care providers should work together to determine the optimal time for hospital discharge for each mother-infant dyad, according to a policy statement issued by the American Academy of Pediatrics.

“There have been new studies since [the previous policy statement was published in 2004] to find out if there are better ways to assess the readiness for discharge of a healthy term infant, and these studies have shown that perceptions of readiness or unreadiness at the time of discharge often differ among pediatricians, obstetricians, and mothers,” said lead author Dr. Praveen Kumar, a neonatologist at Northwestern University, Chicago.

The new statement recommends that “the hospital stay of the mother and her healthy term newborn infant should be long enough to allow identification of early problems and to ensure that the family is able and prepared to care for the infant at home.”

Dr. Kumar and eight other members of the AAP's Committee on Fetus and Newborn wrote the statement, which recommends following a set of 16 minimum criteria before discharging a term newborn (Pediatrics 2010;125:405-9).

“It is our recommendation that all hospitals should develop guidelines in collaboration with appropriate community agencies and third-party payers, to establish hospital-stay and follow-up programs for healthy term infants that implement these recommendations,” Dr. Kumar said in an interview.

The statement also recommends that physicians use the AAP's Safe and Healthy Beginnings toolkit, which contains a discharge readiness checklist that can aid clinicians with the preparation of a newborn for discharge (http://practice.aap.org/public/Newborn_Discharge_SAMPLE.pdf

In making discharge assessments, the committee advises determining that the clinical course and physical examination of the newborn reveal no abnormalities that require additional hospitalization; vital signs are within normal ranges; and there is a history of successful feedings, urinations, and bowel movements and a lack of significant circumcisional bleeding.

Other examinations should assess for the clinical risk of hyperbilirubinemia, and for sepsis based on maternal risk factors and in accord with guidelines for preventing perinatal group B streptococcal disease.

Testing of newborns' blood type as well as their cord blood should be performed as clinically indicated, according to the statement.

Hospital protocols and state regulations may call for other metabolic and hearing screenings.

The initial hepatitis B vaccine also should be administered to the newborn according to the current immunization schedule.

Mothers should have certain blood tests performed, including screening tests for syphilis and hepatitis B surface antigen and other tests required by state regulations, such as HIV testing.

Other assessments need to be made of the mother's knowledge, ability, and confidence to provide adequate care for her infant—including barriers to adequate follow-up care for the newborn—as well as any family, environmental, and social risk factors.

“One of the take-home messages is that the length of stay should accommodate the unique characteristics of each mother-infant dyad, including the health of the mother, the health and stability of the infant, the ability and confidence of the mother to care for her infant, the adequacy of support systems at home, and access to appropriate follow-up care.

“To accomplish this, a pediatrician's decision to discharge a newborn should be made jointly with input from the mother, her obstetrician, and other health care providers who are involved in the care of the mother and her infant, such as nursing staff and social workers,” Dr. Kumar said.

“Everything should be considered as a mother-infant dyad rather than independently for the mother and infant. Just looking at the baby and making a decision that the baby can go home” is not adequate, he added.

Once a medical home for the newborn has been identified and a plan for timely communication of pertinent clinical information to the medical home is in place, the committee recommends making a follow-up appointment for the infant within 48 hours of discharge, but no later than 72 hours, if the infant was discharged less than 48 hours after deliver, according to the statement.

“It is very important for all babies to have a medical home, and it should be in place before a baby goes home,” Dr. Kumar said.

No disclosures were reported.

BETHESDA, MD. — Colorectal cancer screening initiatives that use evidence-based interventions to target underscreened populations while encouraging use of the full range of screening options should be implemented to improve the use and quality of colorectal cancer screening, according to findings from a panel convened by the National Institutes of Health.

In a draft “state-of-the-science” statement, the 13-member panel also recommended investing in a variety of quality monitoring methods to make sure that colorectal cancer screening is accompanied by high rates of cancer detection and prevention.

Efforts to further increase screening rates in the target population of adults aged 50 or older, which have risen from 20%–30% in 1997 to 55% in 2008, will need to address financial and geographical barriers to screening as well as appropriate follow-up of the results, the panel advised.

“We are convinced by evidence in the literature that efforts … to tailor strategies will be very important to test because in different communities and in different population subgroups there need to be different strategies tested to try and get high [screening] rates,” panel chairperson Donald M. Steinwachs, Ph.D., said in a press telebriefing that followed the release of the draft statement.

Systems that remind patients to get screened and one-on-one interactions with providers, educators, or patient navigators could help to increase screening, the panel noted. Systems of care that employ these techniques have much higher screening rates than the national average, such as Kaiser Permanente (75% in the Medicare population) and the Veterans Affairs health care system (80%), according to the statement.

The panel also found that a physician's recommendation is the only consistent physician-related factor that has been shown to predict screening.

“The decision on which approach to use is driven by factors like insurance and patient preferences,” said panelist Dr. Leonard E. Egede, professor of medicine in the division of general internal medicine and geriatrics at the Medical University of South Carolina. He noted that when patients have no preference for a particular screening method, most primary care physicians provide fecal occult blood test (FOBT)–based screening (followed by colonoscopy if necessary) or direct access to colonoscopy.

A wide variety of methods with varying screening intervals are available for screening adults aged 50 years and older, including annual FOBT (guaiac or immunochemical), flexible sigmoidoscopy, or double-contrast barium enema every 5 years, and colonoscopy every 10 years. The panel noted that CT colonography is a potentially viable screening option that could be expanded, but it is not currently covered by Medicare.

When colonoscopy overtook FOBT and flexible sigmoidoscopy in 2001 as the most widely used screening method, there was a subsequent decline in the use of flexible sigmoidoscopy. In that same time, double-barium contrast enema fell out of favor and the overall use of occult blood testing declined more gradually, although these stool tests are still widely used in the Veterans Affairs health care system and some managed care systems, according to the statement.

In order to provide colorectal cancer screening to low-income, uninsured, and underinsured populations, the panel noted that the Centers for Disease Control and Prevention recently began the Colorectal Cancer Control Program in 22 states. The program is modeled after the agency's successful breast and cervical cancer screening program, but “its reach so far has been limited,” Dr. Egede said.

Most current sources of information on screening rates, such as population-based surveys and administrative data sets, do not provide enough detail on the use and quality of colorectal cancer screening, according to the statement.

“Monitoring systems exists in some communities and in some health care organizations, but overall, we don't have systems that monitor whether or not people are receiving screening services appropriately and whether or not the quality of the services being rendered are the highest,” said Dr. Steinwachs, director of the Health Services Research and Development Center at Johns Hopkins University, Baltimore.

The panel suggested that a registry analogous to the existing Breast Cancer Surveillance Consortium should be established to monitor the rates of colorectal cancer screening, overuse, quality, and complications.

The statement is available at http://consensus.nih.gov/

BETHESDA, MD. — Colorectal cancer screening initiatives that use evidence-based interventions to target underscreened populations while encouraging use of the full range of screening options should be implemented to improve the use and quality of colorectal cancer screening, according to findings from a panel convened by the National Institutes of Health.

In a draft “state-of-the-science” statement, the 13-member panel also recommended investing in a variety of quality monitoring methods to make sure that colorectal cancer screening is accompanied by high rates of cancer detection and prevention.

Efforts to further increase screening rates in the target population of adults aged 50 or older, which have risen from 20%–30% in 1997 to 55% in 2008, will need to address financial and geographical barriers to screening as well as appropriate follow-up of the results, the panel advised.

“We are convinced by evidence in the literature that efforts … to tailor strategies will be very important to test because in different communities and in different population subgroups there need to be different strategies tested to try and get high [screening] rates,” panel chairperson Donald M. Steinwachs, Ph.D., said in a press telebriefing that followed the release of the draft statement.

Systems that remind patients to get screened and one-on-one interactions with providers, educators, or patient navigators could help to increase screening, the panel noted. Systems of care that employ these techniques have much higher screening rates than the national average, such as Kaiser Permanente (75% in the Medicare population) and the Veterans Affairs health care system (80%), according to the statement.

The panel also found that a physician's recommendation is the only consistent physician-related factor that has been shown to predict screening.

“The decision on which approach to use is driven by factors like insurance and patient preferences,” said panelist Dr. Leonard E. Egede, professor of medicine in the division of general internal medicine and geriatrics at the Medical University of South Carolina. He noted that when patients have no preference for a particular screening method, most primary care physicians provide fecal occult blood test (FOBT)–based screening (followed by colonoscopy if necessary) or direct access to colonoscopy.

A wide variety of methods with varying screening intervals are available for screening adults aged 50 years and older, including annual FOBT (guaiac or immunochemical), flexible sigmoidoscopy, or double-contrast barium enema every 5 years, and colonoscopy every 10 years. The panel noted that CT colonography is a potentially viable screening option that could be expanded, but it is not currently covered by Medicare.

When colonoscopy overtook FOBT and flexible sigmoidoscopy in 2001 as the most widely used screening method, there was a subsequent decline in the use of flexible sigmoidoscopy. In that same time, double-barium contrast enema fell out of favor and the overall use of occult blood testing declined more gradually, although these stool tests are still widely used in the Veterans Affairs health care system and some managed care systems, according to the statement.

In order to provide colorectal cancer screening to low-income, uninsured, and underinsured populations, the panel noted that the Centers for Disease Control and Prevention recently began the Colorectal Cancer Control Program in 22 states. The program is modeled after the agency's successful breast and cervical cancer screening program, but “its reach so far has been limited,” Dr. Egede said.

Most current sources of information on screening rates, such as population-based surveys and administrative data sets, do not provide enough detail on the use and quality of colorectal cancer screening, according to the statement.

“Monitoring systems exists in some communities and in some health care organizations, but overall, we don't have systems that monitor whether or not people are receiving screening services appropriately and whether or not the quality of the services being rendered are the highest,” said Dr. Steinwachs, director of the Health Services Research and Development Center at Johns Hopkins University, Baltimore.

The panel suggested that a registry analogous to the existing Breast Cancer Surveillance Consortium should be established to monitor the rates of colorectal cancer screening, overuse, quality, and complications.

The statement is available at http://consensus.nih.gov/

BETHESDA, MD. — Colorectal cancer screening initiatives that use evidence-based interventions to target underscreened populations while encouraging use of the full range of screening options should be implemented to improve the use and quality of colorectal cancer screening, according to findings from a panel convened by the National Institutes of Health.

In a draft “state-of-the-science” statement, the 13-member panel also recommended investing in a variety of quality monitoring methods to make sure that colorectal cancer screening is accompanied by high rates of cancer detection and prevention.

Efforts to further increase screening rates in the target population of adults aged 50 or older, which have risen from 20%–30% in 1997 to 55% in 2008, will need to address financial and geographical barriers to screening as well as appropriate follow-up of the results, the panel advised.

“We are convinced by evidence in the literature that efforts … to tailor strategies will be very important to test because in different communities and in different population subgroups there need to be different strategies tested to try and get high [screening] rates,” panel chairperson Donald M. Steinwachs, Ph.D., said in a press telebriefing that followed the release of the draft statement.

Systems that remind patients to get screened and one-on-one interactions with providers, educators, or patient navigators could help to increase screening, the panel noted. Systems of care that employ these techniques have much higher screening rates than the national average, such as Kaiser Permanente (75% in the Medicare population) and the Veterans Affairs health care system (80%), according to the statement.

The panel also found that a physician's recommendation is the only consistent physician-related factor that has been shown to predict screening.

“The decision on which approach to use is driven by factors like insurance and patient preferences,” said panelist Dr. Leonard E. Egede, professor of medicine in the division of general internal medicine and geriatrics at the Medical University of South Carolina. He noted that when patients have no preference for a particular screening method, most primary care physicians provide fecal occult blood test (FOBT)–based screening (followed by colonoscopy if necessary) or direct access to colonoscopy.

A wide variety of methods with varying screening intervals are available for screening adults aged 50 years and older, including annual FOBT (guaiac or immunochemical), flexible sigmoidoscopy, or double-contrast barium enema every 5 years, and colonoscopy every 10 years. The panel noted that CT colonography is a potentially viable screening option that could be expanded, but it is not currently covered by Medicare.

When colonoscopy overtook FOBT and flexible sigmoidoscopy in 2001 as the most widely used screening method, there was a subsequent decline in the use of flexible sigmoidoscopy. In that same time, double-barium contrast enema fell out of favor and the overall use of occult blood testing declined more gradually, although these stool tests are still widely used in the Veterans Affairs health care system and some managed care systems, according to the statement.

In order to provide colorectal cancer screening to low-income, uninsured, and underinsured populations, the panel noted that the Centers for Disease Control and Prevention recently began the Colorectal Cancer Control Program in 22 states. The program is modeled after the agency's successful breast and cervical cancer screening program, but “its reach so far has been limited,” Dr. Egede said.

Most current sources of information on screening rates, such as population-based surveys and administrative data sets, do not provide enough detail on the use and quality of colorectal cancer screening, according to the statement.

“Monitoring systems exists in some communities and in some health care organizations, but overall, we don't have systems that monitor whether or not people are receiving screening services appropriately and whether or not the quality of the services being rendered are the highest,” said Dr. Steinwachs, director of the Health Services Research and Development Center at Johns Hopkins University, Baltimore.

The panel suggested that a registry analogous to the existing Breast Cancer Surveillance Consortium should be established to monitor the rates of colorectal cancer screening, overuse, quality, and complications.

The statement is available at http://consensus.nih.gov/

Major Finding: The prevalence of abnormal lipid levels is estimated to be 14% for normal weight, 22% for overweight, and 43% for obese youths aged 12-19 years.

Data Source: Analysis of National Health and Nutrition Examination Survey data for 1999-2006.

Disclosures: The authors are employees of the CDC.

Abnormal lipid levels are present in 20% of U.S. youths aged 12-19 years, according to estimates reported by investigators at the Centers for Disease Control and Prevention.

An analysis of data derived from four cycles of the National Health and Nutrition Examination Survey during 1999-2006 found that the prevalence of abnormal lipid levels increased with rising body mass index (BMI), from 14% of normal weight to 22% of overweight and 43% of obese adolescents.

“Based on the findings in this study, clinicians should be aware of lipid screening guidelines and recommended interventions for children and youths who are overweight or obese,” the authors wrote (MMWR 2010;59:29-33).

Abnormal blood lipid levels were defined using the same cutoffs recommended by the American Academy of Pediatrics for targeted screening of children aged 2 years or older: an LDL cholesterol level of 130 mg/dL or greater, an HDL cholesterol level of 35 mg/dL or lower, and a triglyceride level of 150 mg/dL or greater.

The survey data covered a cross-sectional sample of 3,125 youths who had fasting blood samples taken for lipid testing. A total of 32% of the sample—15% of overweight and 17% of obese participants—would be candidates for screening for abnormal blood lipid levels based on the AAP recommendations for BMI screening.

A greater percentage of boys had low HDL cholesterol levels (11%), compared with girls (4%). Older participants aged 18-19 years had higher rates of low HDL cholesterol (10%) and high triglyceride levels (16%) than did participants aged 12-13 years (5% and 10%, respectively). Non-Hispanic white youths were more likely than non-Hispanic black youths to have low HDL cholesterol (9% vs. 5%) or high triglyceride levels (12% vs. 4%).

Although the AAP recommends considering pharmacologic treatment of children whose LDL cholesterol remains persistently high even after lifestyle counseling, less than 1% of the adolescents in this NHANES study and a previous analysis of the same NHANES data set were found to have “lipid levels high enough to warrant drug therapy according to AAP guidelines,” the CDC investigators reported.

Major Finding: The prevalence of abnormal lipid levels is estimated to be 14% for normal weight, 22% for overweight, and 43% for obese youths aged 12-19 years.

Data Source: Analysis of National Health and Nutrition Examination Survey data for 1999-2006.

Disclosures: The authors are employees of the CDC.

Abnormal lipid levels are present in 20% of U.S. youths aged 12-19 years, according to estimates reported by investigators at the Centers for Disease Control and Prevention.

An analysis of data derived from four cycles of the National Health and Nutrition Examination Survey during 1999-2006 found that the prevalence of abnormal lipid levels increased with rising body mass index (BMI), from 14% of normal weight to 22% of overweight and 43% of obese adolescents.

“Based on the findings in this study, clinicians should be aware of lipid screening guidelines and recommended interventions for children and youths who are overweight or obese,” the authors wrote (MMWR 2010;59:29-33).

Abnormal blood lipid levels were defined using the same cutoffs recommended by the American Academy of Pediatrics for targeted screening of children aged 2 years or older: an LDL cholesterol level of 130 mg/dL or greater, an HDL cholesterol level of 35 mg/dL or lower, and a triglyceride level of 150 mg/dL or greater.

The survey data covered a cross-sectional sample of 3,125 youths who had fasting blood samples taken for lipid testing. A total of 32% of the sample—15% of overweight and 17% of obese participants—would be candidates for screening for abnormal blood lipid levels based on the AAP recommendations for BMI screening.

A greater percentage of boys had low HDL cholesterol levels (11%), compared with girls (4%). Older participants aged 18-19 years had higher rates of low HDL cholesterol (10%) and high triglyceride levels (16%) than did participants aged 12-13 years (5% and 10%, respectively). Non-Hispanic white youths were more likely than non-Hispanic black youths to have low HDL cholesterol (9% vs. 5%) or high triglyceride levels (12% vs. 4%).

Although the AAP recommends considering pharmacologic treatment of children whose LDL cholesterol remains persistently high even after lifestyle counseling, less than 1% of the adolescents in this NHANES study and a previous analysis of the same NHANES data set were found to have “lipid levels high enough to warrant drug therapy according to AAP guidelines,” the CDC investigators reported.

Major Finding: The prevalence of abnormal lipid levels is estimated to be 14% for normal weight, 22% for overweight, and 43% for obese youths aged 12-19 years.

Data Source: Analysis of National Health and Nutrition Examination Survey data for 1999-2006.

Disclosures: The authors are employees of the CDC.

Abnormal lipid levels are present in 20% of U.S. youths aged 12-19 years, according to estimates reported by investigators at the Centers for Disease Control and Prevention.

An analysis of data derived from four cycles of the National Health and Nutrition Examination Survey during 1999-2006 found that the prevalence of abnormal lipid levels increased with rising body mass index (BMI), from 14% of normal weight to 22% of overweight and 43% of obese adolescents.

“Based on the findings in this study, clinicians should be aware of lipid screening guidelines and recommended interventions for children and youths who are overweight or obese,” the authors wrote (MMWR 2010;59:29-33).

Abnormal blood lipid levels were defined using the same cutoffs recommended by the American Academy of Pediatrics for targeted screening of children aged 2 years or older: an LDL cholesterol level of 130 mg/dL or greater, an HDL cholesterol level of 35 mg/dL or lower, and a triglyceride level of 150 mg/dL or greater.

The survey data covered a cross-sectional sample of 3,125 youths who had fasting blood samples taken for lipid testing. A total of 32% of the sample—15% of overweight and 17% of obese participants—would be candidates for screening for abnormal blood lipid levels based on the AAP recommendations for BMI screening.

A greater percentage of boys had low HDL cholesterol levels (11%), compared with girls (4%). Older participants aged 18-19 years had higher rates of low HDL cholesterol (10%) and high triglyceride levels (16%) than did participants aged 12-13 years (5% and 10%, respectively). Non-Hispanic white youths were more likely than non-Hispanic black youths to have low HDL cholesterol (9% vs. 5%) or high triglyceride levels (12% vs. 4%).

Although the AAP recommends considering pharmacologic treatment of children whose LDL cholesterol remains persistently high even after lifestyle counseling, less than 1% of the adolescents in this NHANES study and a previous analysis of the same NHANES data set were found to have “lipid levels high enough to warrant drug therapy according to AAP guidelines,” the CDC investigators reported.

BETHESDA, MD. — Efforts to improve colorectal cancer screening should rely on evidence-based interventions to target underscreened populations and should include a full range of screening options, according to findings from a panel convened by the National Institutes of Health.

In a draft “state-of-the-science” statement issued Feb. 4, the 13-member panel also recommended investing in a variety of quality monitoring methods to ensure that colorectal cancer screening is accompanied by high rates of cancer detection and prevention.

Efforts will need to address financial and geographic barriers to screening as well as appropriate follow-up, the panel advised. In the target population of adults aged 50 and older, screening rates were 55% in 2008.

“We are convinced by evidence in the literature that efforts … to tailor strategies will be very important to test. In different communities and in different population subgroups, there need to be different strategies tested in order to get high [screening] rates,” panel chairperson Donald M. Steinwachs, Ph.D., said in a press telebriefing that followed the release of the draft statement.

Systems that remind patients to get screened and one-on-one interactions with providers, educators, or patient navigators could help to increase screening, the panel noted. Systems of care that employ these techniques have much higher screening rates than the national average, such as Kaiser Permanente (75% in the Medicare population) and the Veterans Affairs health care system (80%), according to the statement.

The panel also found that a physician's recommendation is the only consistent physician-related factor that has been shown to predict screening.

“The decision on which approach to use is driven by factors like insurance and patient preferences,” said panelist Dr. Leonard E. Egede, a professor in the division of general internal medicine and geriatrics at the Medical University of South Carolina, Charleston.

He noted that when patients have no preference for a particular screening method, most primary care physicians provide fecal occult blood test (FOBT)–based screening (followed by colonoscopy if needed) or direct access to colonoscopy.

A wide variety of methods with varying screening intervals are available for screening adults aged 50 and older, including annual FOBT (guaiac or immunochemical), flexible sigmoidoscopy, or double-contrast barium enema every 5 years, and colonoscopy every 10 years. The panel noted that CT colonography is a potentially viable screening option that could be expanded, but it is not currently covered by Medicare. Any positive results from noncolonoscopic screenings need to be followed with a colonoscopy.

When colonoscopy overtook FOBT and flexible sigmoidoscopy in 2001 as the most widely used screening method, there was a subsequent decline in the use of flexible sigmoidoscopy.

In that same time, double-barium contrast enema fell out of favor and the overall use of FOBT declined more gradually, although these stool tests are still widely used in the Veterans Affairs health care system and some managed care systems.

To provide colorectal cancer screening to low-income, uninsured, and underinsured populations, the panel noted that the Centers for Disease Control and Prevention recently began the Colorectal Cancer Control Program in 22 states. T

The program is modeled after the agency's successful breast and cervical cancer screening program, but “its reach so far has been limited,” Dr. Egede said.

Most of the current sources of information about screening rates do not provide enough detail on the use and quality of colorectal cancer screening, according to the statement.

“Monitoring systems exists in some communities, but overall, we don't have systems that monitor whether or not people are receiving screening services appropriately and whether or not the quality of the services being rendered are the highest,” said Dr. Steinwachs, director of the Health Services Research and Development Center at Johns Hopkins University, Baltimore.

The panel suggested that a colorectal cancer screening registry analogous to the existing Breast Cancer Surveillance Consortium should be established to monitor the rates of colorectal cancer screening, overuse, quality, and complications.

The panel based its statement on a report commissioned by the Agency for Healthcare Research and Quality, data presented at an NIH conference, and input from attendees of the conference. The statement is available at http://consensus.nih.gov

“In different communities and in different population subgroups, there need to be different strategies tested in order to get high [screening] rates,” said panel chair Donald M. Steinwachs, Ph.D.

Source Courtesy NIH.gov

This Month's Talk Back Question

What strategy for colorectal cancer screening does your practice use?

My Take

Focus on Screening—By Any Method

We must get more patients screened for colon cancer—the second most common cause of cancer-related deaths in the United States—and the primary care physician is the key to successful screening of average-risk patients.

Which test you utilize may be less important than ensuring that all of your patients are screened in a timely and recurring manner. Colonoscopy every 10 years is widely favored as the ideal screening test, but annual stool guaiac testing coupled with flexible sigmoidoscopy every 3 years or with sigmoidoscopy and double-contrast barium enema every 5 years also are recommended. CT colonography, or virtual colonoscopy, is not yet approved for payment by Medicare but appears to be effective as a screening tool.

The issue is simple: Get your patients screened for colon cancer and precancerous polyps by one of the available methods.

BETHESDA, MD. — Efforts to improve colorectal cancer screening should rely on evidence-based interventions to target underscreened populations and should include a full range of screening options, according to findings from a panel convened by the National Institutes of Health.

In a draft “state-of-the-science” statement issued Feb. 4, the 13-member panel also recommended investing in a variety of quality monitoring methods to ensure that colorectal cancer screening is accompanied by high rates of cancer detection and prevention.

Efforts will need to address financial and geographic barriers to screening as well as appropriate follow-up, the panel advised. In the target population of adults aged 50 and older, screening rates were 55% in 2008.

“We are convinced by evidence in the literature that efforts … to tailor strategies will be very important to test. In different communities and in different population subgroups, there need to be different strategies tested in order to get high [screening] rates,” panel chairperson Donald M. Steinwachs, Ph.D., said in a press telebriefing that followed the release of the draft statement.

Systems that remind patients to get screened and one-on-one interactions with providers, educators, or patient navigators could help to increase screening, the panel noted. Systems of care that employ these techniques have much higher screening rates than the national average, such as Kaiser Permanente (75% in the Medicare population) and the Veterans Affairs health care system (80%), according to the statement.

The panel also found that a physician's recommendation is the only consistent physician-related factor that has been shown to predict screening.

“The decision on which approach to use is driven by factors like insurance and patient preferences,” said panelist Dr. Leonard E. Egede, a professor in the division of general internal medicine and geriatrics at the Medical University of South Carolina, Charleston.

He noted that when patients have no preference for a particular screening method, most primary care physicians provide fecal occult blood test (FOBT)–based screening (followed by colonoscopy if needed) or direct access to colonoscopy.

A wide variety of methods with varying screening intervals are available for screening adults aged 50 and older, including annual FOBT (guaiac or immunochemical), flexible sigmoidoscopy, or double-contrast barium enema every 5 years, and colonoscopy every 10 years. The panel noted that CT colonography is a potentially viable screening option that could be expanded, but it is not currently covered by Medicare. Any positive results from noncolonoscopic screenings need to be followed with a colonoscopy.

When colonoscopy overtook FOBT and flexible sigmoidoscopy in 2001 as the most widely used screening method, there was a subsequent decline in the use of flexible sigmoidoscopy.

In that same time, double-barium contrast enema fell out of favor and the overall use of FOBT declined more gradually, although these stool tests are still widely used in the Veterans Affairs health care system and some managed care systems.

To provide colorectal cancer screening to low-income, uninsured, and underinsured populations, the panel noted that the Centers for Disease Control and Prevention recently began the Colorectal Cancer Control Program in 22 states. T

The program is modeled after the agency's successful breast and cervical cancer screening program, but “its reach so far has been limited,” Dr. Egede said.

Most of the current sources of information about screening rates do not provide enough detail on the use and quality of colorectal cancer screening, according to the statement.

“Monitoring systems exists in some communities, but overall, we don't have systems that monitor whether or not people are receiving screening services appropriately and whether or not the quality of the services being rendered are the highest,” said Dr. Steinwachs, director of the Health Services Research and Development Center at Johns Hopkins University, Baltimore.

The panel suggested that a colorectal cancer screening registry analogous to the existing Breast Cancer Surveillance Consortium should be established to monitor the rates of colorectal cancer screening, overuse, quality, and complications.

The panel based its statement on a report commissioned by the Agency for Healthcare Research and Quality, data presented at an NIH conference, and input from attendees of the conference. The statement is available at http://consensus.nih.gov

“In different communities and in different population subgroups, there need to be different strategies tested in order to get high [screening] rates,” said panel chair Donald M. Steinwachs, Ph.D.

Source Courtesy NIH.gov

This Month's Talk Back Question

What strategy for colorectal cancer screening does your practice use?

My Take

Focus on Screening—By Any Method

We must get more patients screened for colon cancer—the second most common cause of cancer-related deaths in the United States—and the primary care physician is the key to successful screening of average-risk patients.

Which test you utilize may be less important than ensuring that all of your patients are screened in a timely and recurring manner. Colonoscopy every 10 years is widely favored as the ideal screening test, but annual stool guaiac testing coupled with flexible sigmoidoscopy every 3 years or with sigmoidoscopy and double-contrast barium enema every 5 years also are recommended. CT colonography, or virtual colonoscopy, is not yet approved for payment by Medicare but appears to be effective as a screening tool.

The issue is simple: Get your patients screened for colon cancer and precancerous polyps by one of the available methods.

BETHESDA, MD. — Efforts to improve colorectal cancer screening should rely on evidence-based interventions to target underscreened populations and should include a full range of screening options, according to findings from a panel convened by the National Institutes of Health.

In a draft “state-of-the-science” statement issued Feb. 4, the 13-member panel also recommended investing in a variety of quality monitoring methods to ensure that colorectal cancer screening is accompanied by high rates of cancer detection and prevention.

Efforts will need to address financial and geographic barriers to screening as well as appropriate follow-up, the panel advised. In the target population of adults aged 50 and older, screening rates were 55% in 2008.

“We are convinced by evidence in the literature that efforts … to tailor strategies will be very important to test. In different communities and in different population subgroups, there need to be different strategies tested in order to get high [screening] rates,” panel chairperson Donald M. Steinwachs, Ph.D., said in a press telebriefing that followed the release of the draft statement.

Systems that remind patients to get screened and one-on-one interactions with providers, educators, or patient navigators could help to increase screening, the panel noted. Systems of care that employ these techniques have much higher screening rates than the national average, such as Kaiser Permanente (75% in the Medicare population) and the Veterans Affairs health care system (80%), according to the statement.

The panel also found that a physician's recommendation is the only consistent physician-related factor that has been shown to predict screening.

“The decision on which approach to use is driven by factors like insurance and patient preferences,” said panelist Dr. Leonard E. Egede, a professor in the division of general internal medicine and geriatrics at the Medical University of South Carolina, Charleston.

He noted that when patients have no preference for a particular screening method, most primary care physicians provide fecal occult blood test (FOBT)–based screening (followed by colonoscopy if needed) or direct access to colonoscopy.

A wide variety of methods with varying screening intervals are available for screening adults aged 50 and older, including annual FOBT (guaiac or immunochemical), flexible sigmoidoscopy, or double-contrast barium enema every 5 years, and colonoscopy every 10 years. The panel noted that CT colonography is a potentially viable screening option that could be expanded, but it is not currently covered by Medicare. Any positive results from noncolonoscopic screenings need to be followed with a colonoscopy.

When colonoscopy overtook FOBT and flexible sigmoidoscopy in 2001 as the most widely used screening method, there was a subsequent decline in the use of flexible sigmoidoscopy.

In that same time, double-barium contrast enema fell out of favor and the overall use of FOBT declined more gradually, although these stool tests are still widely used in the Veterans Affairs health care system and some managed care systems.

To provide colorectal cancer screening to low-income, uninsured, and underinsured populations, the panel noted that the Centers for Disease Control and Prevention recently began the Colorectal Cancer Control Program in 22 states. T

The program is modeled after the agency's successful breast and cervical cancer screening program, but “its reach so far has been limited,” Dr. Egede said.

Most of the current sources of information about screening rates do not provide enough detail on the use and quality of colorectal cancer screening, according to the statement.

“Monitoring systems exists in some communities, but overall, we don't have systems that monitor whether or not people are receiving screening services appropriately and whether or not the quality of the services being rendered are the highest,” said Dr. Steinwachs, director of the Health Services Research and Development Center at Johns Hopkins University, Baltimore.

The panel suggested that a colorectal cancer screening registry analogous to the existing Breast Cancer Surveillance Consortium should be established to monitor the rates of colorectal cancer screening, overuse, quality, and complications.

The panel based its statement on a report commissioned by the Agency for Healthcare Research and Quality, data presented at an NIH conference, and input from attendees of the conference. The statement is available at http://consensus.nih.gov

“In different communities and in different population subgroups, there need to be different strategies tested in order to get high [screening] rates,” said panel chair Donald M. Steinwachs, Ph.D.

Source Courtesy NIH.gov

This Month's Talk Back Question

What strategy for colorectal cancer screening does your practice use?

My Take

Focus on Screening—By Any Method

We must get more patients screened for colon cancer—the second most common cause of cancer-related deaths in the United States—and the primary care physician is the key to successful screening of average-risk patients.

Which test you utilize may be less important than ensuring that all of your patients are screened in a timely and recurring manner. Colonoscopy every 10 years is widely favored as the ideal screening test, but annual stool guaiac testing coupled with flexible sigmoidoscopy every 3 years or with sigmoidoscopy and double-contrast barium enema every 5 years also are recommended. CT colonography, or virtual colonoscopy, is not yet approved for payment by Medicare but appears to be effective as a screening tool.

The issue is simple: Get your patients screened for colon cancer and precancerous polyps by one of the available methods.

Major Finding: The prevalence of abnormal lipid levels is estimated to be 14% for normal weight, 22% for overweight, and 43% for obese youths aged 12-19 years.

Data Source: Analysis of National Health and Nutrition Examination Survey data for 1999-2006.

Disclosures: The authors are employees of the CDC.

Abnormal lipid levels are present in 20% of young people in the United States aged 12-19 years, according to estimates reported by investigators at the Centers for Disease Control and Prevention.

An analysis of data derived from four cycles of the National Health and Nutrition Examination Survey during 1999-2006 found that the prevalence of abnormal lipid levels increased with rising body mass index, from 14% of normal weight to 22% of overweight and 43% of obese adolescents.

“Based on the findings in this study, clinicians should be aware of lipid screening guidelines and recommended interventions for children and youths who are overweight or obese,” the authors wrote (MMWR 2010;59:29-33).

Abnormal blood lipid levels were defined using the same cutoffs recommended by the American Academy of Pediatrics for targeted screening of children aged 2 years or older: an LDL cholesterol level of 130 mg/dL or greater, an HDL cholesterol level of 35 mg/dL or lower, and a triglyceride level of 150 mg/dL or greater.

The survey data covered a cross-sectional sample of 3,125 youths who had fasting blood samples taken for lipid testing.

A total of 32% of the sample—15% of overweight and 17% of obese participants—would be candidates for screening for abnormal blood lipid levels based on the AAP recommendations for BMI screening.

Some significant differences between participants were detected according to their gender, age, and race or ethnicity.

A greater percentage of boys had low HDL cholesterol levels (11%), compared with girls (4%). Older participants aged 18-19 years had higher rates of low HDL cholesterol (10%) and higher triglyceride levels (16%) than did participants aged 12-13 years (5% and 10%, respectively). Non-Hispanic white youths were more likely than were non-Hispanic black youths to have low HDL cholesterol (9% vs. 5%) or high triglyceride levels (12% vs. 4%).

The AAP also based its recommendations for targeted screening for abnormal blood lipid levels on family history and other risk factors related to cardiovascular disease, which were not considered in this study because NHANES data do not include family history information.

Although the AAP recommends considering pharmacologic treatment of children whose LDL cholesterol remains persistently high even after lifestyle counseling, less than 1% of the adolescents in this NHANES study and a previous analysis of the same NHANES data set were found to have “lipid levels high enough to warrant drug therapy according to AAP guidelines,” the CDC investigators reported.

The U.S. Preventive Services Task Force recently recommended screening for overweight and obesity in children aged 6 years and older and offering or referring children to intensive counseling and behavioral interventions.

Major Finding: The prevalence of abnormal lipid levels is estimated to be 14% for normal weight, 22% for overweight, and 43% for obese youths aged 12-19 years.

Data Source: Analysis of National Health and Nutrition Examination Survey data for 1999-2006.

Disclosures: The authors are employees of the CDC.

Abnormal lipid levels are present in 20% of young people in the United States aged 12-19 years, according to estimates reported by investigators at the Centers for Disease Control and Prevention.

An analysis of data derived from four cycles of the National Health and Nutrition Examination Survey during 1999-2006 found that the prevalence of abnormal lipid levels increased with rising body mass index, from 14% of normal weight to 22% of overweight and 43% of obese adolescents.

“Based on the findings in this study, clinicians should be aware of lipid screening guidelines and recommended interventions for children and youths who are overweight or obese,” the authors wrote (MMWR 2010;59:29-33).

Abnormal blood lipid levels were defined using the same cutoffs recommended by the American Academy of Pediatrics for targeted screening of children aged 2 years or older: an LDL cholesterol level of 130 mg/dL or greater, an HDL cholesterol level of 35 mg/dL or lower, and a triglyceride level of 150 mg/dL or greater.

The survey data covered a cross-sectional sample of 3,125 youths who had fasting blood samples taken for lipid testing.

A total of 32% of the sample—15% of overweight and 17% of obese participants—would be candidates for screening for abnormal blood lipid levels based on the AAP recommendations for BMI screening.

Some significant differences between participants were detected according to their gender, age, and race or ethnicity.

A greater percentage of boys had low HDL cholesterol levels (11%), compared with girls (4%). Older participants aged 18-19 years had higher rates of low HDL cholesterol (10%) and higher triglyceride levels (16%) than did participants aged 12-13 years (5% and 10%, respectively). Non-Hispanic white youths were more likely than were non-Hispanic black youths to have low HDL cholesterol (9% vs. 5%) or high triglyceride levels (12% vs. 4%).

The AAP also based its recommendations for targeted screening for abnormal blood lipid levels on family history and other risk factors related to cardiovascular disease, which were not considered in this study because NHANES data do not include family history information.

Although the AAP recommends considering pharmacologic treatment of children whose LDL cholesterol remains persistently high even after lifestyle counseling, less than 1% of the adolescents in this NHANES study and a previous analysis of the same NHANES data set were found to have “lipid levels high enough to warrant drug therapy according to AAP guidelines,” the CDC investigators reported.

The U.S. Preventive Services Task Force recently recommended screening for overweight and obesity in children aged 6 years and older and offering or referring children to intensive counseling and behavioral interventions.

Major Finding: The prevalence of abnormal lipid levels is estimated to be 14% for normal weight, 22% for overweight, and 43% for obese youths aged 12-19 years.

Data Source: Analysis of National Health and Nutrition Examination Survey data for 1999-2006.

Disclosures: The authors are employees of the CDC.

Abnormal lipid levels are present in 20% of young people in the United States aged 12-19 years, according to estimates reported by investigators at the Centers for Disease Control and Prevention.

An analysis of data derived from four cycles of the National Health and Nutrition Examination Survey during 1999-2006 found that the prevalence of abnormal lipid levels increased with rising body mass index, from 14% of normal weight to 22% of overweight and 43% of obese adolescents.

“Based on the findings in this study, clinicians should be aware of lipid screening guidelines and recommended interventions for children and youths who are overweight or obese,” the authors wrote (MMWR 2010;59:29-33).

Abnormal blood lipid levels were defined using the same cutoffs recommended by the American Academy of Pediatrics for targeted screening of children aged 2 years or older: an LDL cholesterol level of 130 mg/dL or greater, an HDL cholesterol level of 35 mg/dL or lower, and a triglyceride level of 150 mg/dL or greater.

The survey data covered a cross-sectional sample of 3,125 youths who had fasting blood samples taken for lipid testing.

A total of 32% of the sample—15% of overweight and 17% of obese participants—would be candidates for screening for abnormal blood lipid levels based on the AAP recommendations for BMI screening.

Some significant differences between participants were detected according to their gender, age, and race or ethnicity.

A greater percentage of boys had low HDL cholesterol levels (11%), compared with girls (4%). Older participants aged 18-19 years had higher rates of low HDL cholesterol (10%) and higher triglyceride levels (16%) than did participants aged 12-13 years (5% and 10%, respectively). Non-Hispanic white youths were more likely than were non-Hispanic black youths to have low HDL cholesterol (9% vs. 5%) or high triglyceride levels (12% vs. 4%).

The AAP also based its recommendations for targeted screening for abnormal blood lipid levels on family history and other risk factors related to cardiovascular disease, which were not considered in this study because NHANES data do not include family history information.

Although the AAP recommends considering pharmacologic treatment of children whose LDL cholesterol remains persistently high even after lifestyle counseling, less than 1% of the adolescents in this NHANES study and a previous analysis of the same NHANES data set were found to have “lipid levels high enough to warrant drug therapy according to AAP guidelines,” the CDC investigators reported.

The U.S. Preventive Services Task Force recently recommended screening for overweight and obesity in children aged 6 years and older and offering or referring children to intensive counseling and behavioral interventions.