Anakinra shows promise for hidradenitis suppurativa

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Anakinra shows promise for hidradenitis suppurativa

The results of a pilot study suggest that the interleukin-1(IL-1) receptor antagonist anakinra may be a potential treatment option for hidradenitis suppurativa (HS).

The cause of HS – a chronic skin disorder affecting areas with apocrine glands leading to nodules, inflammation, rupture, and scarring – is unknown but is thought to be related to excessive inflammation and autoinflammatory mechanisms, noted the authors, Dr. Vassiliki Tzanetakou of the Fourth Department of Internal Medicine at the University of Athens, and his associates.

They evaluated the safety and efficacy of anakinra for the treatment of HS in a double-blind, randomized, placebo-controlled study of 20 patients with Hurley stage II or III HS (10 in each arm). Participants received 12 weeks of once-daily subcutaneous injections of anakinra or placebo. The study, which the authors believe is the first double-blind, randomized study to evaluate the safety and efficacy of anakinra in people with HS, was published on-line in JAMA Dermatology on Nov. 18 (doi:10.1001/jamadermatol.2015.3903).

One patient in the anakinra arm was lost to follow-up. At week 12, the end of the treatment period, a decrease in the disease activity score – the primary endpoint – was seen in 67% (6 of 9) of those in the anakinra arm, vs. 20% (2 of 10) in the placebo arm (P = .04). HS clinical response at 12 weeks was demonstrated in 78% (7 of 9) with anakinra, vs. 30% (3 out of 10) with placebo (P = .04). In addition, the time to a new HS exacerbation, a secondary endpoint, “was significantly prolonged” among those on anakinra (P = .01), they said.

One patient in the anakinra group stopped the medication after 4 weeks because of diarrhea; however, the authors noted no serious adverse events.

At baseline, 12 and 24 weeks, peripheral blood mononuclear cells from the patients were isolated and stimulated for cytokine production. Peripheral blood mononuclear cells in the anakinra participants had decreased production of interferon-gamma, a proinflammatory cytokine, and significantly increased IL-22 production, the biggest differences. The authors noted in the patients treated with anakinra, the increase in IL-22 may have contributed to improvement in defense of the epithelial cells.

The main limitation of the study was the small population, but “despite the few enrolled patients, the results of anakinra use to treat HS are promising,” the authors concluded. Pointing out that anti–tumor necrosis factor (anti-TNF) therapy has been the most effective treatment for HS so far, they noted that “a major question that we cannot answer at this time is whether patients who show an insufficient response to anti-TNF treatment benefit from anakinra therapy.”

The study was supported by the Interleukin Foundation; the National Institutes of Health; the Hellenic Sepsis Study Group; and anakinra manufacturer, Swedish Orphan Biovitrum. One of the 10 authors, reported receiving grants and honoraria from pharmaceutical companies.

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The results of a pilot study suggest that the interleukin-1(IL-1) receptor antagonist anakinra may be a potential treatment option for hidradenitis suppurativa (HS).

The cause of HS – a chronic skin disorder affecting areas with apocrine glands leading to nodules, inflammation, rupture, and scarring – is unknown but is thought to be related to excessive inflammation and autoinflammatory mechanisms, noted the authors, Dr. Vassiliki Tzanetakou of the Fourth Department of Internal Medicine at the University of Athens, and his associates.

They evaluated the safety and efficacy of anakinra for the treatment of HS in a double-blind, randomized, placebo-controlled study of 20 patients with Hurley stage II or III HS (10 in each arm). Participants received 12 weeks of once-daily subcutaneous injections of anakinra or placebo. The study, which the authors believe is the first double-blind, randomized study to evaluate the safety and efficacy of anakinra in people with HS, was published on-line in JAMA Dermatology on Nov. 18 (doi:10.1001/jamadermatol.2015.3903).

One patient in the anakinra arm was lost to follow-up. At week 12, the end of the treatment period, a decrease in the disease activity score – the primary endpoint – was seen in 67% (6 of 9) of those in the anakinra arm, vs. 20% (2 of 10) in the placebo arm (P = .04). HS clinical response at 12 weeks was demonstrated in 78% (7 of 9) with anakinra, vs. 30% (3 out of 10) with placebo (P = .04). In addition, the time to a new HS exacerbation, a secondary endpoint, “was significantly prolonged” among those on anakinra (P = .01), they said.

One patient in the anakinra group stopped the medication after 4 weeks because of diarrhea; however, the authors noted no serious adverse events.

At baseline, 12 and 24 weeks, peripheral blood mononuclear cells from the patients were isolated and stimulated for cytokine production. Peripheral blood mononuclear cells in the anakinra participants had decreased production of interferon-gamma, a proinflammatory cytokine, and significantly increased IL-22 production, the biggest differences. The authors noted in the patients treated with anakinra, the increase in IL-22 may have contributed to improvement in defense of the epithelial cells.

The main limitation of the study was the small population, but “despite the few enrolled patients, the results of anakinra use to treat HS are promising,” the authors concluded. Pointing out that anti–tumor necrosis factor (anti-TNF) therapy has been the most effective treatment for HS so far, they noted that “a major question that we cannot answer at this time is whether patients who show an insufficient response to anti-TNF treatment benefit from anakinra therapy.”

The study was supported by the Interleukin Foundation; the National Institutes of Health; the Hellenic Sepsis Study Group; and anakinra manufacturer, Swedish Orphan Biovitrum. One of the 10 authors, reported receiving grants and honoraria from pharmaceutical companies.

The results of a pilot study suggest that the interleukin-1(IL-1) receptor antagonist anakinra may be a potential treatment option for hidradenitis suppurativa (HS).

The cause of HS – a chronic skin disorder affecting areas with apocrine glands leading to nodules, inflammation, rupture, and scarring – is unknown but is thought to be related to excessive inflammation and autoinflammatory mechanisms, noted the authors, Dr. Vassiliki Tzanetakou of the Fourth Department of Internal Medicine at the University of Athens, and his associates.

They evaluated the safety and efficacy of anakinra for the treatment of HS in a double-blind, randomized, placebo-controlled study of 20 patients with Hurley stage II or III HS (10 in each arm). Participants received 12 weeks of once-daily subcutaneous injections of anakinra or placebo. The study, which the authors believe is the first double-blind, randomized study to evaluate the safety and efficacy of anakinra in people with HS, was published on-line in JAMA Dermatology on Nov. 18 (doi:10.1001/jamadermatol.2015.3903).

One patient in the anakinra arm was lost to follow-up. At week 12, the end of the treatment period, a decrease in the disease activity score – the primary endpoint – was seen in 67% (6 of 9) of those in the anakinra arm, vs. 20% (2 of 10) in the placebo arm (P = .04). HS clinical response at 12 weeks was demonstrated in 78% (7 of 9) with anakinra, vs. 30% (3 out of 10) with placebo (P = .04). In addition, the time to a new HS exacerbation, a secondary endpoint, “was significantly prolonged” among those on anakinra (P = .01), they said.

One patient in the anakinra group stopped the medication after 4 weeks because of diarrhea; however, the authors noted no serious adverse events.

At baseline, 12 and 24 weeks, peripheral blood mononuclear cells from the patients were isolated and stimulated for cytokine production. Peripheral blood mononuclear cells in the anakinra participants had decreased production of interferon-gamma, a proinflammatory cytokine, and significantly increased IL-22 production, the biggest differences. The authors noted in the patients treated with anakinra, the increase in IL-22 may have contributed to improvement in defense of the epithelial cells.

The main limitation of the study was the small population, but “despite the few enrolled patients, the results of anakinra use to treat HS are promising,” the authors concluded. Pointing out that anti–tumor necrosis factor (anti-TNF) therapy has been the most effective treatment for HS so far, they noted that “a major question that we cannot answer at this time is whether patients who show an insufficient response to anti-TNF treatment benefit from anakinra therapy.”

The study was supported by the Interleukin Foundation; the National Institutes of Health; the Hellenic Sepsis Study Group; and anakinra manufacturer, Swedish Orphan Biovitrum. One of the 10 authors, reported receiving grants and honoraria from pharmaceutical companies.

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Key clinical point: Anakinra, an interleukin-1 receptor antagonist, may be a potential treatment option for hidradenitis suppurativa (HS).

Major finding: After 12 weeks, a decrease in disease activity score was found in 67% of patients with HS in the anakinra arm, vs. 20% of those in the placebo arm (P = .04).

Data source: A prospective double-blind, randomized, placebo-controlled pilot study compared anakinra to placebo in 20 patients with Hurley stage II or III HS.

Disclosures: The study was supported by the Interleukin Foundation; the National Institutes of Health; the Hellenic Sepsis Study Group; and anakinra manufacturer, Swedish Orphan Biovitrum. One of the authors reported receiving grants and honoraria from pharmaceutical companies.

Light therapy helpful in treating nonseasonal MDD

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Light therapy helpful in treating nonseasonal MDD

Bright light therapy, an effective treatment for seasonal affective disorder, also is efficacious for nonseasonal major depressive disorder either as a monotherapy or with fluoxetine, a new study shows.

Dr. Raymond W. Lam of the department of psychiatry at the University of British Columbia in Vancouver, and his colleagues conducted the study by recruiting 122 patients aged 19-60 years with a DSM-IV-TR diagnosis of major depressive disorder (MDD). The participants were randomized to receive one of four interventions: 30 minutes of morning light therapy plus a placebo pill; fluoxetine plus a sham negative-ion generator; a combination of light therapy plus fluoxetine; or placebo pill plus sham ion-negative ion generator. Their results were published online Nov. 18 in JAMA Psychiatry.

The patients were evaluated by a blinded, independent evaluator by telephone. Response was measured by 50% or more reduction of the baseline Montgomery-Åsberg Depression Rating Scale (MADRS). A MADRS score of 10 or less was considered remission.

The mean change in MADRS score from the start of the study through 8 weeks was 16.9 for combination therapy, 13.4 for light therapy, 8.8 for fluoxetine, and 6.5 for placebo. The differences were noted to be significant for combination therapy vs. placebo (P less than .001) and light therapy vs. placebo (P = .006). However, they noted no significant difference between fluoxetine vs. placebo (P = .32).

Response was achieved by 75.9% for those on the combination therapy, 50% for the light therapy alone, 33.3% for placebo, and 29% for fluoxetine therapy. Remission was achieved by 58.6% for combination therapy, 43.8% for light therapy, 30% for placebo, and 19.4% for fluoxetine. The number needed to treat for response and remission in the combination-therapy group, compared with the placebo group, was 2.4 (95% confidence interval, 1.6-5.8) and 3.5 (95% CI, 2.0-29.9), respectively.

Dr. Lam and his colleagues noted that the treatments were well tolerated overall.

“The main result of this study was that both light monotherapy and the combination treatment had significant benefits, compared with a sham-placebo condition in adults with nonseasonal MDD,” they wrote.

The study was supported by a grant from the Canadian Institutes of Health Research. Dr. Lam reported several disclosures, including receiving research funds from Lundbeck and Pfizer. He also served as a consultant to and/or received honoraria from several pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Lundbeck, Otsuka, Pfizer, and Takeda. The other authors also reported multiple disclosures.

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Bright light therapy, an effective treatment for seasonal affective disorder, also is efficacious for nonseasonal major depressive disorder either as a monotherapy or with fluoxetine, a new study shows.

Dr. Raymond W. Lam of the department of psychiatry at the University of British Columbia in Vancouver, and his colleagues conducted the study by recruiting 122 patients aged 19-60 years with a DSM-IV-TR diagnosis of major depressive disorder (MDD). The participants were randomized to receive one of four interventions: 30 minutes of morning light therapy plus a placebo pill; fluoxetine plus a sham negative-ion generator; a combination of light therapy plus fluoxetine; or placebo pill plus sham ion-negative ion generator. Their results were published online Nov. 18 in JAMA Psychiatry.

The patients were evaluated by a blinded, independent evaluator by telephone. Response was measured by 50% or more reduction of the baseline Montgomery-Åsberg Depression Rating Scale (MADRS). A MADRS score of 10 or less was considered remission.

The mean change in MADRS score from the start of the study through 8 weeks was 16.9 for combination therapy, 13.4 for light therapy, 8.8 for fluoxetine, and 6.5 for placebo. The differences were noted to be significant for combination therapy vs. placebo (P less than .001) and light therapy vs. placebo (P = .006). However, they noted no significant difference between fluoxetine vs. placebo (P = .32).

Response was achieved by 75.9% for those on the combination therapy, 50% for the light therapy alone, 33.3% for placebo, and 29% for fluoxetine therapy. Remission was achieved by 58.6% for combination therapy, 43.8% for light therapy, 30% for placebo, and 19.4% for fluoxetine. The number needed to treat for response and remission in the combination-therapy group, compared with the placebo group, was 2.4 (95% confidence interval, 1.6-5.8) and 3.5 (95% CI, 2.0-29.9), respectively.

Dr. Lam and his colleagues noted that the treatments were well tolerated overall.

“The main result of this study was that both light monotherapy and the combination treatment had significant benefits, compared with a sham-placebo condition in adults with nonseasonal MDD,” they wrote.

The study was supported by a grant from the Canadian Institutes of Health Research. Dr. Lam reported several disclosures, including receiving research funds from Lundbeck and Pfizer. He also served as a consultant to and/or received honoraria from several pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Lundbeck, Otsuka, Pfizer, and Takeda. The other authors also reported multiple disclosures.

Bright light therapy, an effective treatment for seasonal affective disorder, also is efficacious for nonseasonal major depressive disorder either as a monotherapy or with fluoxetine, a new study shows.

Dr. Raymond W. Lam of the department of psychiatry at the University of British Columbia in Vancouver, and his colleagues conducted the study by recruiting 122 patients aged 19-60 years with a DSM-IV-TR diagnosis of major depressive disorder (MDD). The participants were randomized to receive one of four interventions: 30 minutes of morning light therapy plus a placebo pill; fluoxetine plus a sham negative-ion generator; a combination of light therapy plus fluoxetine; or placebo pill plus sham ion-negative ion generator. Their results were published online Nov. 18 in JAMA Psychiatry.

The patients were evaluated by a blinded, independent evaluator by telephone. Response was measured by 50% or more reduction of the baseline Montgomery-Åsberg Depression Rating Scale (MADRS). A MADRS score of 10 or less was considered remission.

The mean change in MADRS score from the start of the study through 8 weeks was 16.9 for combination therapy, 13.4 for light therapy, 8.8 for fluoxetine, and 6.5 for placebo. The differences were noted to be significant for combination therapy vs. placebo (P less than .001) and light therapy vs. placebo (P = .006). However, they noted no significant difference between fluoxetine vs. placebo (P = .32).

Response was achieved by 75.9% for those on the combination therapy, 50% for the light therapy alone, 33.3% for placebo, and 29% for fluoxetine therapy. Remission was achieved by 58.6% for combination therapy, 43.8% for light therapy, 30% for placebo, and 19.4% for fluoxetine. The number needed to treat for response and remission in the combination-therapy group, compared with the placebo group, was 2.4 (95% confidence interval, 1.6-5.8) and 3.5 (95% CI, 2.0-29.9), respectively.

Dr. Lam and his colleagues noted that the treatments were well tolerated overall.

“The main result of this study was that both light monotherapy and the combination treatment had significant benefits, compared with a sham-placebo condition in adults with nonseasonal MDD,” they wrote.

The study was supported by a grant from the Canadian Institutes of Health Research. Dr. Lam reported several disclosures, including receiving research funds from Lundbeck and Pfizer. He also served as a consultant to and/or received honoraria from several pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Lundbeck, Otsuka, Pfizer, and Takeda. The other authors also reported multiple disclosures.

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Key clinical point: Light monotherapy or with fluoxetine is efficacious for nonseasonal major depressive disorder.

Major finding: Response was achieved by 75.9% for those on the combination therapy and 50% for those on the light therapy alone, and remission was achieved by 58.6% of those in the combination therapy group and 43.8% of those on the light therapy.

Data source: A randomized, double-blind, sham- and placebo-controlled trial over 8 weeks with adults with MDD.

Disclosures: The study was supported by a grant from the Canadian Institutes of Health Research. Dr. Lam reported several disclosures, including receiving research funds from Lundbeck and Pfizer. He also served as a consultant to and/or received honoraria from several pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Lundbeck, Otsuka, Pfizer, and Takeda. The other authors also reported multiple disclosures.

Glial fibrillary acidic protein may help identify youth with TBI

GFAP is promising, but more studies are needed
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Glial fibrillary acidic protein may help identify youth with TBI

Glial fibrillary acidic protein appears to be a candidate biomarker for detecting traumatic intracranial lesions on head CT after mild to moderate head trauma in youth, a study showed.

Previous studies have found that head CT scans in children less than 5 years old may contribute to the risk for brain cancer and leukemia because children are more sensitive to ionizing radiation. Ninety-nine different pediatric biomarkers have been researched for traumatic brain injury (TBI); some studies have indicated glial fibrillary acidic protein (GFAP) may be a promising biomarker for mild to moderate TBI in adults.

Dr. Linda Papa of the department of emergency medicine at Orlando Regional Medical Center and colleagues compared the GFAP level in the serum of children and youth evaluated for mild to moderate TBI with pediatric trauma patients without brain injury to see how these levels were related to evidence of traumatic lesions on head CT. Their results were published in Academic Emergency Medicine (2015 Nov;22[11]:1274-82. doi: 10.1111/acem.12795).

They conducted a prospective cohort study of 197 children and youth who presented with a Glasgow Coma Scale (GCS) score of 9-15 after blunt head trauma. The 60 control patients included those without head trauma and a GSC score of 15. A head CT scan was obtained in 152 patients, with 11% demonstrating traumatic intracranial lesions. Serum samples were drawn within 6 hours of injury, at a mean 3.3 hours in those with head injury and 4.1 hours in those without head injury.

Children with traumatic intracranial lesions on CT scan had higher median GFAP levels (1.01, interquartile range = 0.59-1.48), compared with those without lesions on CT (0.18, IQR = 0.06-0.47).

When GFAP was used to detect traumatic lesions on head CT, the area under the receiver operating characteristic curve (AUC) was 0.82 (95% confidence interval, 0.71-0.93); it was 0.80 (95% CI, 0.68-0.92) for those with a GCS of 15, and 0.83 (95% CI, 0.56-1.00) in those younger than 5 years old.

Using a cutoff level of 0.15 ng/mL for GFAP, Dr. Papa and colleagues noted a negative predictive value of 98%, a specificity of 47%, and a sensitivity of 94% for detecting intracranial lesions.

Several limitations to the study included not having research assistants available to enroll participants 24/7, a lack of long-term outcome data, and a small cohort without any participants requiring neurosurgical intervention.

The next steps would involve clinical validation with a large, multicenter study.

This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.

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Out of the 99 markers studied previously, glial fibrillary acidic protein appears to be the most promising in adults. The authors wanted to examine its usefulness in children.

Dr. Gregory L. Landry

This serum marker may be helpful to clinicians in deciding who needs a CT scan and who does not, but a larger study is still needed.

Serum markers seem to be most useful in patients with moderate to severe head trauma. The typical sports concussion (mild traumatic brain injury) does not cause enough damage to raise serum markers, and so far studies of markers in that group have shown that they are not helpful in determining severity of the injury.

Dr. Gregory L. Landry is affiliated with the University of Wisconsin–Madison, specializing in pediatric and adolescent primary care sports medicine. These comments were taken from an interview with Dr. Landry, who said he had no relevant financial disclosures.

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Out of the 99 markers studied previously, glial fibrillary acidic protein appears to be the most promising in adults. The authors wanted to examine its usefulness in children.

Dr. Gregory L. Landry

This serum marker may be helpful to clinicians in deciding who needs a CT scan and who does not, but a larger study is still needed.

Serum markers seem to be most useful in patients with moderate to severe head trauma. The typical sports concussion (mild traumatic brain injury) does not cause enough damage to raise serum markers, and so far studies of markers in that group have shown that they are not helpful in determining severity of the injury.

Dr. Gregory L. Landry is affiliated with the University of Wisconsin–Madison, specializing in pediatric and adolescent primary care sports medicine. These comments were taken from an interview with Dr. Landry, who said he had no relevant financial disclosures.

Body

Out of the 99 markers studied previously, glial fibrillary acidic protein appears to be the most promising in adults. The authors wanted to examine its usefulness in children.

Dr. Gregory L. Landry

This serum marker may be helpful to clinicians in deciding who needs a CT scan and who does not, but a larger study is still needed.

Serum markers seem to be most useful in patients with moderate to severe head trauma. The typical sports concussion (mild traumatic brain injury) does not cause enough damage to raise serum markers, and so far studies of markers in that group have shown that they are not helpful in determining severity of the injury.

Dr. Gregory L. Landry is affiliated with the University of Wisconsin–Madison, specializing in pediatric and adolescent primary care sports medicine. These comments were taken from an interview with Dr. Landry, who said he had no relevant financial disclosures.

Title
GFAP is promising, but more studies are needed
GFAP is promising, but more studies are needed

Glial fibrillary acidic protein appears to be a candidate biomarker for detecting traumatic intracranial lesions on head CT after mild to moderate head trauma in youth, a study showed.

Previous studies have found that head CT scans in children less than 5 years old may contribute to the risk for brain cancer and leukemia because children are more sensitive to ionizing radiation. Ninety-nine different pediatric biomarkers have been researched for traumatic brain injury (TBI); some studies have indicated glial fibrillary acidic protein (GFAP) may be a promising biomarker for mild to moderate TBI in adults.

Dr. Linda Papa of the department of emergency medicine at Orlando Regional Medical Center and colleagues compared the GFAP level in the serum of children and youth evaluated for mild to moderate TBI with pediatric trauma patients without brain injury to see how these levels were related to evidence of traumatic lesions on head CT. Their results were published in Academic Emergency Medicine (2015 Nov;22[11]:1274-82. doi: 10.1111/acem.12795).

They conducted a prospective cohort study of 197 children and youth who presented with a Glasgow Coma Scale (GCS) score of 9-15 after blunt head trauma. The 60 control patients included those without head trauma and a GSC score of 15. A head CT scan was obtained in 152 patients, with 11% demonstrating traumatic intracranial lesions. Serum samples were drawn within 6 hours of injury, at a mean 3.3 hours in those with head injury and 4.1 hours in those without head injury.

Children with traumatic intracranial lesions on CT scan had higher median GFAP levels (1.01, interquartile range = 0.59-1.48), compared with those without lesions on CT (0.18, IQR = 0.06-0.47).

When GFAP was used to detect traumatic lesions on head CT, the area under the receiver operating characteristic curve (AUC) was 0.82 (95% confidence interval, 0.71-0.93); it was 0.80 (95% CI, 0.68-0.92) for those with a GCS of 15, and 0.83 (95% CI, 0.56-1.00) in those younger than 5 years old.

Using a cutoff level of 0.15 ng/mL for GFAP, Dr. Papa and colleagues noted a negative predictive value of 98%, a specificity of 47%, and a sensitivity of 94% for detecting intracranial lesions.

Several limitations to the study included not having research assistants available to enroll participants 24/7, a lack of long-term outcome data, and a small cohort without any participants requiring neurosurgical intervention.

The next steps would involve clinical validation with a large, multicenter study.

This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.

Glial fibrillary acidic protein appears to be a candidate biomarker for detecting traumatic intracranial lesions on head CT after mild to moderate head trauma in youth, a study showed.

Previous studies have found that head CT scans in children less than 5 years old may contribute to the risk for brain cancer and leukemia because children are more sensitive to ionizing radiation. Ninety-nine different pediatric biomarkers have been researched for traumatic brain injury (TBI); some studies have indicated glial fibrillary acidic protein (GFAP) may be a promising biomarker for mild to moderate TBI in adults.

Dr. Linda Papa of the department of emergency medicine at Orlando Regional Medical Center and colleagues compared the GFAP level in the serum of children and youth evaluated for mild to moderate TBI with pediatric trauma patients without brain injury to see how these levels were related to evidence of traumatic lesions on head CT. Their results were published in Academic Emergency Medicine (2015 Nov;22[11]:1274-82. doi: 10.1111/acem.12795).

They conducted a prospective cohort study of 197 children and youth who presented with a Glasgow Coma Scale (GCS) score of 9-15 after blunt head trauma. The 60 control patients included those without head trauma and a GSC score of 15. A head CT scan was obtained in 152 patients, with 11% demonstrating traumatic intracranial lesions. Serum samples were drawn within 6 hours of injury, at a mean 3.3 hours in those with head injury and 4.1 hours in those without head injury.

Children with traumatic intracranial lesions on CT scan had higher median GFAP levels (1.01, interquartile range = 0.59-1.48), compared with those without lesions on CT (0.18, IQR = 0.06-0.47).

When GFAP was used to detect traumatic lesions on head CT, the area under the receiver operating characteristic curve (AUC) was 0.82 (95% confidence interval, 0.71-0.93); it was 0.80 (95% CI, 0.68-0.92) for those with a GCS of 15, and 0.83 (95% CI, 0.56-1.00) in those younger than 5 years old.

Using a cutoff level of 0.15 ng/mL for GFAP, Dr. Papa and colleagues noted a negative predictive value of 98%, a specificity of 47%, and a sensitivity of 94% for detecting intracranial lesions.

Several limitations to the study included not having research assistants available to enroll participants 24/7, a lack of long-term outcome data, and a small cohort without any participants requiring neurosurgical intervention.

The next steps would involve clinical validation with a large, multicenter study.

This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.

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Glial fibrillary acidic protein may help identify youth with TBI
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Key clinical point: GFAP appears to be associated with severity of injury and identification of lesions on head CT scan after head trauma in youth.

Major finding: The negative predictive value was 98%, the specificity was 47%, and the sensitivity was 94% for detecting intracranial lesions when a GFAP cutoff level of 0.15 ng/mL was used.

Data source: A prospective controlled cohort study of children and youth who presented with a Glasgow Coma Scale score of 9-15 after blunt head trauma.

Disclosures: This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.

Researchers highlight gaps in diabetes screening in patients on antipsychotics

Integration of mental, physical health needed
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Researchers highlight gaps in diabetes screening in patients on antipsychotics

Less than one-third of patients with severe mental illness who are on antipsychotic medications receive diabetes-specific screening, according to a new study.

Severe mental illness (SMI) and antipsychotics place patients at risk for type 2 diabetes. Premature cardiovascular disease is a major contributor to the 25-year lower life expectancy in those with severe mental illness.

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Dr. Christina Mangurian of the department of psychiatry at the University of California, San Francisco, and her colleagues looked at the prevalence of diabetes screening in patients with severe mental illness on antipsychotic medications. Their results were published Nov. 9 in a research letter in JAMA Internal Medicine online.

They conducted a retrospective cohort study using data from the Client and Service Information Systems, and California Medicaid during two study periods. The cohort included patients 18 years or older with severe mental illness diagnosed by a psychiatrist and use of antipsychotic medications during the study periods. The primary outcome was evidence of fasting serum glucose screening or glycated hemoglobin with a secondary outcome of a nonspecific screening, such as a nonfasting metabolic panel.

The cohort was made up of 50,915 participants, and 30.1% (n = 15,315) had a diabetes-specific screening test. No glucose screening during the studied year was found in nearly a third, or 31.1%, (n = 15,832) of the participants.

Interestingly, those with at least one primary care visit during the study period received diabetes-specific screening 35.8% of the time, compared with 19.6% of the time for those without a primary care visit.

“In this large cohort study of adults with SMI taking antipsychotic medications in the California public mental health care system, almost 70% were not screened for diabetes mellitus using validated screening measures,” the authors wrote. They emphasized the need for future studies to better understand barriers to screening in patients with SMI.

Dr. Mangurian reported no disclosures. Dr. Penelope K. Knapp, one of the authors, reported serving as medical director of the California Department of Mental Health. Dr. John W. Newcomer, another author, reported serving on several data safety monitoring boards for pharmaceutical companies and receiving honoraria from multiple sources. The authors reported multiple funding sources.

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The higher risk for premature death in those with serious mental illness also is affected by poor access to health care.

“To improve care for persons with serious mental illness, it will be necessary to break down the silos that separate the mental health and physical health care systems,” wrote Dr. Mitchell H. Katz. This research highlights the need for improved integrated health care for those with mental illness.

Dr. Katz is the deputy editor of JAMA Internal Medicine and director of the Los Angeles County Department of Health Services. He reported no conflicts of interest. These remarks were made in an editorial accompanying Dr. Mangurian’s research letter.

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The higher risk for premature death in those with serious mental illness also is affected by poor access to health care.

“To improve care for persons with serious mental illness, it will be necessary to break down the silos that separate the mental health and physical health care systems,” wrote Dr. Mitchell H. Katz. This research highlights the need for improved integrated health care for those with mental illness.

Dr. Katz is the deputy editor of JAMA Internal Medicine and director of the Los Angeles County Department of Health Services. He reported no conflicts of interest. These remarks were made in an editorial accompanying Dr. Mangurian’s research letter.

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The higher risk for premature death in those with serious mental illness also is affected by poor access to health care.

“To improve care for persons with serious mental illness, it will be necessary to break down the silos that separate the mental health and physical health care systems,” wrote Dr. Mitchell H. Katz. This research highlights the need for improved integrated health care for those with mental illness.

Dr. Katz is the deputy editor of JAMA Internal Medicine and director of the Los Angeles County Department of Health Services. He reported no conflicts of interest. These remarks were made in an editorial accompanying Dr. Mangurian’s research letter.

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Integration of mental, physical health needed
Integration of mental, physical health needed

Less than one-third of patients with severe mental illness who are on antipsychotic medications receive diabetes-specific screening, according to a new study.

Severe mental illness (SMI) and antipsychotics place patients at risk for type 2 diabetes. Premature cardiovascular disease is a major contributor to the 25-year lower life expectancy in those with severe mental illness.

©Tashatuvango/Thinkstockphotos.com

Dr. Christina Mangurian of the department of psychiatry at the University of California, San Francisco, and her colleagues looked at the prevalence of diabetes screening in patients with severe mental illness on antipsychotic medications. Their results were published Nov. 9 in a research letter in JAMA Internal Medicine online.

They conducted a retrospective cohort study using data from the Client and Service Information Systems, and California Medicaid during two study periods. The cohort included patients 18 years or older with severe mental illness diagnosed by a psychiatrist and use of antipsychotic medications during the study periods. The primary outcome was evidence of fasting serum glucose screening or glycated hemoglobin with a secondary outcome of a nonspecific screening, such as a nonfasting metabolic panel.

The cohort was made up of 50,915 participants, and 30.1% (n = 15,315) had a diabetes-specific screening test. No glucose screening during the studied year was found in nearly a third, or 31.1%, (n = 15,832) of the participants.

Interestingly, those with at least one primary care visit during the study period received diabetes-specific screening 35.8% of the time, compared with 19.6% of the time for those without a primary care visit.

“In this large cohort study of adults with SMI taking antipsychotic medications in the California public mental health care system, almost 70% were not screened for diabetes mellitus using validated screening measures,” the authors wrote. They emphasized the need for future studies to better understand barriers to screening in patients with SMI.

Dr. Mangurian reported no disclosures. Dr. Penelope K. Knapp, one of the authors, reported serving as medical director of the California Department of Mental Health. Dr. John W. Newcomer, another author, reported serving on several data safety monitoring boards for pharmaceutical companies and receiving honoraria from multiple sources. The authors reported multiple funding sources.

Less than one-third of patients with severe mental illness who are on antipsychotic medications receive diabetes-specific screening, according to a new study.

Severe mental illness (SMI) and antipsychotics place patients at risk for type 2 diabetes. Premature cardiovascular disease is a major contributor to the 25-year lower life expectancy in those with severe mental illness.

©Tashatuvango/Thinkstockphotos.com

Dr. Christina Mangurian of the department of psychiatry at the University of California, San Francisco, and her colleagues looked at the prevalence of diabetes screening in patients with severe mental illness on antipsychotic medications. Their results were published Nov. 9 in a research letter in JAMA Internal Medicine online.

They conducted a retrospective cohort study using data from the Client and Service Information Systems, and California Medicaid during two study periods. The cohort included patients 18 years or older with severe mental illness diagnosed by a psychiatrist and use of antipsychotic medications during the study periods. The primary outcome was evidence of fasting serum glucose screening or glycated hemoglobin with a secondary outcome of a nonspecific screening, such as a nonfasting metabolic panel.

The cohort was made up of 50,915 participants, and 30.1% (n = 15,315) had a diabetes-specific screening test. No glucose screening during the studied year was found in nearly a third, or 31.1%, (n = 15,832) of the participants.

Interestingly, those with at least one primary care visit during the study period received diabetes-specific screening 35.8% of the time, compared with 19.6% of the time for those without a primary care visit.

“In this large cohort study of adults with SMI taking antipsychotic medications in the California public mental health care system, almost 70% were not screened for diabetes mellitus using validated screening measures,” the authors wrote. They emphasized the need for future studies to better understand barriers to screening in patients with SMI.

Dr. Mangurian reported no disclosures. Dr. Penelope K. Knapp, one of the authors, reported serving as medical director of the California Department of Mental Health. Dr. John W. Newcomer, another author, reported serving on several data safety monitoring boards for pharmaceutical companies and receiving honoraria from multiple sources. The authors reported multiple funding sources.

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Key clinical point: Most patients with severe mental illness who are taking antipsychotics are not being screened for diabetes.

Major finding: Out of a cohort of 50,915 patients, 30.1% (n = 15,315) had a diabetes-specific screening test.

Data source: A retrospective cohort study using data from the Client and Service Information Systems, and California Medicaid.

Disclosures: Dr. Mangurian reported no disclosures. Dr. Penelope Knapp, one of the authors, reported serving as medical director of the California Department of Mental Health. Dr. John W. Newcomer reported serving on several data safety monitoring boards for pharmaceutical companies and receiving honoraria from multiple sources. The authors reported multiple funding sources.

Evidence insufficient on omega-3 fatty acids for major depression in adults

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Evidence insufficient on omega-3 fatty acids for major depression in adults

The amount of high-quality evidence is insufficient for using omega-3 fatty acids to treat major depressive disorder in adults, researchers said in a Cochrane Review.

“We found a small to modest positive effect of omega-3 fatty acids, compared with placebo, but the size of this effect is unlikely to be meaningful to people with depression, and we considered the evidence to be of low or very low quality. All studies contributing to our analyses were of direct relevance to our research question, but most of these studies are small and of low quality,” Katherine M. Appleton, Ph.D., associate professor of psychology at Bournemouth University in Poole, England, and her colleagues noted in a press release accompanying the paper.

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Major depressive disorder (MDD) affects about 7% of people in Western societies and accounts for 3% of global ill health, Dr. Appleton and her colleagues reported.

Several epidemiologic and clinical studies, and randomized controlled trials (RTCs) have suggested that n-3 polyunsaturated fatty acids or omega-3 fatty acids might be a useful treatment for MDD through their effects on cell communication, neurotransmitters, and inflammation. Omega-3 fatty acids also are known to be important in brain development and function, and have been linked to depression. However, other studies have found no association between the intake of omega-3 fatty acids and depressive illness.

Dr. Appleton and her colleagues sought to understand the role omega-3 fatty acids have in the treatment of MDD by conducting a Cochrane Review of available RCTs. Their paper was published online Nov. 4 in Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD004692.pub4).

The investigators found 26 trials with a total of 1,458 participants. In each RCT examined, the participants were randomized to receive omega-3 fatty acids or a comparator, such as a different dose of omega-3 fatty acid, placebo, or antidepressant. All included studies used a placebo except one trial, which compared omega-3 fatty acids to antidepressants. Some participants in the studies also were receiving adjunctive treatment for MDD, including antidepressants, psychotherapy, and benzodiazepines.

For the primary outcome of depressive symptoms, the effect of omega-3 fatty acids was small to modest, compared with placebo, and with only a small clinically significant effect, Dr. Appleton and her colleagues found. Meanwhile, the single study that compared antidepressants with omega-3 fatty acids found no differences between the groups for depressive symptoms.

Finally, the authors rated the quality of evidence for the outcomes to be low to very low and found that most of the studies were small and at high risk for bias.

In summary, Dr. Appleton and her colleagues found an absence of high-quality evidence to understand the impact of treatment with omega-3 fatty acids for MDD and said more complete evidence is needed. “It’s important that people who suffer from depression are aware of this, so that they can make more informed choices about treatment,” Dr. Appleton said in the press release.

“Future studies should compare [omega 3s] with usual antidepressant treatment and investigate the way these treatments may work,” they wrote in the study.

The authors report no conflicts of interest. The study was supported by Bournemouth University; the National Institute for Health Research Biomedical Research Unit in Nutrition, Diet and Lifestyle at University Hospitals; University Hospitals NHS Foundation Trust; and the University of Bristol, all in the United Kingdom.

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The amount of high-quality evidence is insufficient for using omega-3 fatty acids to treat major depressive disorder in adults, researchers said in a Cochrane Review.

“We found a small to modest positive effect of omega-3 fatty acids, compared with placebo, but the size of this effect is unlikely to be meaningful to people with depression, and we considered the evidence to be of low or very low quality. All studies contributing to our analyses were of direct relevance to our research question, but most of these studies are small and of low quality,” Katherine M. Appleton, Ph.D., associate professor of psychology at Bournemouth University in Poole, England, and her colleagues noted in a press release accompanying the paper.

©Clayton Hansen/iStockphoto

Major depressive disorder (MDD) affects about 7% of people in Western societies and accounts for 3% of global ill health, Dr. Appleton and her colleagues reported.

Several epidemiologic and clinical studies, and randomized controlled trials (RTCs) have suggested that n-3 polyunsaturated fatty acids or omega-3 fatty acids might be a useful treatment for MDD through their effects on cell communication, neurotransmitters, and inflammation. Omega-3 fatty acids also are known to be important in brain development and function, and have been linked to depression. However, other studies have found no association between the intake of omega-3 fatty acids and depressive illness.

Dr. Appleton and her colleagues sought to understand the role omega-3 fatty acids have in the treatment of MDD by conducting a Cochrane Review of available RCTs. Their paper was published online Nov. 4 in Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD004692.pub4).

The investigators found 26 trials with a total of 1,458 participants. In each RCT examined, the participants were randomized to receive omega-3 fatty acids or a comparator, such as a different dose of omega-3 fatty acid, placebo, or antidepressant. All included studies used a placebo except one trial, which compared omega-3 fatty acids to antidepressants. Some participants in the studies also were receiving adjunctive treatment for MDD, including antidepressants, psychotherapy, and benzodiazepines.

For the primary outcome of depressive symptoms, the effect of omega-3 fatty acids was small to modest, compared with placebo, and with only a small clinically significant effect, Dr. Appleton and her colleagues found. Meanwhile, the single study that compared antidepressants with omega-3 fatty acids found no differences between the groups for depressive symptoms.

Finally, the authors rated the quality of evidence for the outcomes to be low to very low and found that most of the studies were small and at high risk for bias.

In summary, Dr. Appleton and her colleagues found an absence of high-quality evidence to understand the impact of treatment with omega-3 fatty acids for MDD and said more complete evidence is needed. “It’s important that people who suffer from depression are aware of this, so that they can make more informed choices about treatment,” Dr. Appleton said in the press release.

“Future studies should compare [omega 3s] with usual antidepressant treatment and investigate the way these treatments may work,” they wrote in the study.

The authors report no conflicts of interest. The study was supported by Bournemouth University; the National Institute for Health Research Biomedical Research Unit in Nutrition, Diet and Lifestyle at University Hospitals; University Hospitals NHS Foundation Trust; and the University of Bristol, all in the United Kingdom.

The amount of high-quality evidence is insufficient for using omega-3 fatty acids to treat major depressive disorder in adults, researchers said in a Cochrane Review.

“We found a small to modest positive effect of omega-3 fatty acids, compared with placebo, but the size of this effect is unlikely to be meaningful to people with depression, and we considered the evidence to be of low or very low quality. All studies contributing to our analyses were of direct relevance to our research question, but most of these studies are small and of low quality,” Katherine M. Appleton, Ph.D., associate professor of psychology at Bournemouth University in Poole, England, and her colleagues noted in a press release accompanying the paper.

©Clayton Hansen/iStockphoto

Major depressive disorder (MDD) affects about 7% of people in Western societies and accounts for 3% of global ill health, Dr. Appleton and her colleagues reported.

Several epidemiologic and clinical studies, and randomized controlled trials (RTCs) have suggested that n-3 polyunsaturated fatty acids or omega-3 fatty acids might be a useful treatment for MDD through their effects on cell communication, neurotransmitters, and inflammation. Omega-3 fatty acids also are known to be important in brain development and function, and have been linked to depression. However, other studies have found no association between the intake of omega-3 fatty acids and depressive illness.

Dr. Appleton and her colleagues sought to understand the role omega-3 fatty acids have in the treatment of MDD by conducting a Cochrane Review of available RCTs. Their paper was published online Nov. 4 in Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD004692.pub4).

The investigators found 26 trials with a total of 1,458 participants. In each RCT examined, the participants were randomized to receive omega-3 fatty acids or a comparator, such as a different dose of omega-3 fatty acid, placebo, or antidepressant. All included studies used a placebo except one trial, which compared omega-3 fatty acids to antidepressants. Some participants in the studies also were receiving adjunctive treatment for MDD, including antidepressants, psychotherapy, and benzodiazepines.

For the primary outcome of depressive symptoms, the effect of omega-3 fatty acids was small to modest, compared with placebo, and with only a small clinically significant effect, Dr. Appleton and her colleagues found. Meanwhile, the single study that compared antidepressants with omega-3 fatty acids found no differences between the groups for depressive symptoms.

Finally, the authors rated the quality of evidence for the outcomes to be low to very low and found that most of the studies were small and at high risk for bias.

In summary, Dr. Appleton and her colleagues found an absence of high-quality evidence to understand the impact of treatment with omega-3 fatty acids for MDD and said more complete evidence is needed. “It’s important that people who suffer from depression are aware of this, so that they can make more informed choices about treatment,” Dr. Appleton said in the press release.

“Future studies should compare [omega 3s] with usual antidepressant treatment and investigate the way these treatments may work,” they wrote in the study.

The authors report no conflicts of interest. The study was supported by Bournemouth University; the National Institute for Health Research Biomedical Research Unit in Nutrition, Diet and Lifestyle at University Hospitals; University Hospitals NHS Foundation Trust; and the University of Bristol, all in the United Kingdom.

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Key clinical point: Patients should know that more evidence is needed to determine whether omega-3 fatty acids are an effective treatment for major depression.

Major finding: There is insufficient high-quality evidence for using omega-3 fatty acids for the treatment of major depressive disorder in adults.

Data source: For depressive symptoms, the effect of omega-3 fatty acids was small to modest, compared with placebo, and had only a small clinically significant effect.

Disclosures: The authors reported no conflicts of interest. The study was supported by Bournemouth University; the National Institute for Health Research Biomedical Research Unit in Nutrition, Diet and Lifestyle at University Hospitals; University Hospitals NHS Foundation Trust; and the University of Bristol, all in the United Kingdom.

Most Pediatricians, FPs Report Vaccine Refusal; 14% Dismiss Families From Practice

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Most Pediatricians, FPs Report Vaccine Refusal; 14% Dismiss Families From Practice

Most pediatricians and family physicians reported having some families refuse vaccines, and 21% of pediatricians reported dismissal of these families from their practices, findings of a recent survey showed.

Vaccine preventable outbreaks and vaccine refusal continue to be a concern. Despite discouragement by the Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP), some physicians have started to dismiss families from their practices for refusing vaccines for their children.

CDC/Amanda Mills

Dr. Sean T. O’Leary of The Adult and Child Center for Outcomes Research and Delivery Sciences, University of Colorado, Aurora, and colleagues set out to study the prevalence of parents refusing one or more infant vaccines, physician response, and the association of dismissal to state exemption laws, and practice and provider characteristics.

They conducted a nationally representative survey of family physicians (FPs) and pediatricians with multivariable analysis. Their results were published online in Pediatrics (2015, Nov. 2. doi: 10.1542/peds.2015-2086).

The response rate was 61% (252) for FPs, 70% (282) for pediatricians, and 66% overall (534/815). Of those who responded, data from 83 were excluded because they reported not administering vaccines to children less than 2 years old.

Most respondents (83%) reported at least some parents refusing vaccines in a typical month. In states where philosophical exemptions are not allowed, pediatricians reported no refusals in a typical month more often than in states where exemptions are allowed (17% versus 8%, P = .03); family physicians did not report this difference. Vaccine refusal in 1%-4% of parents was reported by 63% of respondents, with 15% reporting a refusal rate of 5%-9%, and 5% reporting refusal by 10% or more. Likewise, 11% of the respondents reported an increase in vaccine refusal compared with the prior 12 months, whereas 23% reported a decrease and 66% reported a similar frequency.

Overall, 51% of respondents noted always or often requiring parents to sign a form after vaccine refusal (pediatricians 64% versus FPs 29%, P less than .0001).

Fourteen percent of the respondents reported always or often dismissing a family for refusing one or more infant vaccines (pediatricians 21% versus FPs 4%, P less than .0001).

In states without philosophical exemptions, 34% of pediatricians reported dismissal of families for vaccine refusal, versus 9% in states that allow exemptions (P less than .0001).

Finally, pediatrician respondents who reported dismissing patients were more often located in the South, in a state without philosophical exemptions for vaccines, and in private practice.

The authors noted that there are still many aspects of vaccine refusal that are not well understood. “Because many [pediatricians] still dismiss families despite recommendations to the contrary, this practice should be better explored and understood both for its causes and its intended and unintended consequences,” they wrote.

This study was funded by the CDC administered through the Rocky Mountain Prevention Research Center, University of Colorado, Aurora (grant). The authors report no financial disclosures.

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Most pediatricians and family physicians reported having some families refuse vaccines, and 21% of pediatricians reported dismissal of these families from their practices, findings of a recent survey showed.

Vaccine preventable outbreaks and vaccine refusal continue to be a concern. Despite discouragement by the Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP), some physicians have started to dismiss families from their practices for refusing vaccines for their children.

CDC/Amanda Mills

Dr. Sean T. O’Leary of The Adult and Child Center for Outcomes Research and Delivery Sciences, University of Colorado, Aurora, and colleagues set out to study the prevalence of parents refusing one or more infant vaccines, physician response, and the association of dismissal to state exemption laws, and practice and provider characteristics.

They conducted a nationally representative survey of family physicians (FPs) and pediatricians with multivariable analysis. Their results were published online in Pediatrics (2015, Nov. 2. doi: 10.1542/peds.2015-2086).

The response rate was 61% (252) for FPs, 70% (282) for pediatricians, and 66% overall (534/815). Of those who responded, data from 83 were excluded because they reported not administering vaccines to children less than 2 years old.

Most respondents (83%) reported at least some parents refusing vaccines in a typical month. In states where philosophical exemptions are not allowed, pediatricians reported no refusals in a typical month more often than in states where exemptions are allowed (17% versus 8%, P = .03); family physicians did not report this difference. Vaccine refusal in 1%-4% of parents was reported by 63% of respondents, with 15% reporting a refusal rate of 5%-9%, and 5% reporting refusal by 10% or more. Likewise, 11% of the respondents reported an increase in vaccine refusal compared with the prior 12 months, whereas 23% reported a decrease and 66% reported a similar frequency.

Overall, 51% of respondents noted always or often requiring parents to sign a form after vaccine refusal (pediatricians 64% versus FPs 29%, P less than .0001).

Fourteen percent of the respondents reported always or often dismissing a family for refusing one or more infant vaccines (pediatricians 21% versus FPs 4%, P less than .0001).

In states without philosophical exemptions, 34% of pediatricians reported dismissal of families for vaccine refusal, versus 9% in states that allow exemptions (P less than .0001).

Finally, pediatrician respondents who reported dismissing patients were more often located in the South, in a state without philosophical exemptions for vaccines, and in private practice.

The authors noted that there are still many aspects of vaccine refusal that are not well understood. “Because many [pediatricians] still dismiss families despite recommendations to the contrary, this practice should be better explored and understood both for its causes and its intended and unintended consequences,” they wrote.

This study was funded by the CDC administered through the Rocky Mountain Prevention Research Center, University of Colorado, Aurora (grant). The authors report no financial disclosures.

Most pediatricians and family physicians reported having some families refuse vaccines, and 21% of pediatricians reported dismissal of these families from their practices, findings of a recent survey showed.

Vaccine preventable outbreaks and vaccine refusal continue to be a concern. Despite discouragement by the Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP), some physicians have started to dismiss families from their practices for refusing vaccines for their children.

CDC/Amanda Mills

Dr. Sean T. O’Leary of The Adult and Child Center for Outcomes Research and Delivery Sciences, University of Colorado, Aurora, and colleagues set out to study the prevalence of parents refusing one or more infant vaccines, physician response, and the association of dismissal to state exemption laws, and practice and provider characteristics.

They conducted a nationally representative survey of family physicians (FPs) and pediatricians with multivariable analysis. Their results were published online in Pediatrics (2015, Nov. 2. doi: 10.1542/peds.2015-2086).

The response rate was 61% (252) for FPs, 70% (282) for pediatricians, and 66% overall (534/815). Of those who responded, data from 83 were excluded because they reported not administering vaccines to children less than 2 years old.

Most respondents (83%) reported at least some parents refusing vaccines in a typical month. In states where philosophical exemptions are not allowed, pediatricians reported no refusals in a typical month more often than in states where exemptions are allowed (17% versus 8%, P = .03); family physicians did not report this difference. Vaccine refusal in 1%-4% of parents was reported by 63% of respondents, with 15% reporting a refusal rate of 5%-9%, and 5% reporting refusal by 10% or more. Likewise, 11% of the respondents reported an increase in vaccine refusal compared with the prior 12 months, whereas 23% reported a decrease and 66% reported a similar frequency.

Overall, 51% of respondents noted always or often requiring parents to sign a form after vaccine refusal (pediatricians 64% versus FPs 29%, P less than .0001).

Fourteen percent of the respondents reported always or often dismissing a family for refusing one or more infant vaccines (pediatricians 21% versus FPs 4%, P less than .0001).

In states without philosophical exemptions, 34% of pediatricians reported dismissal of families for vaccine refusal, versus 9% in states that allow exemptions (P less than .0001).

Finally, pediatrician respondents who reported dismissing patients were more often located in the South, in a state without philosophical exemptions for vaccines, and in private practice.

The authors noted that there are still many aspects of vaccine refusal that are not well understood. “Because many [pediatricians] still dismiss families despite recommendations to the contrary, this practice should be better explored and understood both for its causes and its intended and unintended consequences,” they wrote.

This study was funded by the CDC administered through the Rocky Mountain Prevention Research Center, University of Colorado, Aurora (grant). The authors report no financial disclosures.

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Most Pediatricians, FPs Report Vaccine Refusal; 14% Dismiss Families From Practice
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Most pediatricians, FPs report vaccine refusal; 14% dismiss families from practice

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Most pediatricians, FPs report vaccine refusal; 14% dismiss families from practice

Most pediatricians and family physicians reported having some families refuse vaccines, and 21% of pediatricians reported dismissal of these families from their practices, findings of a recent survey showed.

Vaccine preventable outbreaks and vaccine refusal continue to be a concern. Despite discouragement by the Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP), some physicians have started to dismiss families from their practices for refusing vaccines for their children.

CDC/Amanda Mills

Dr. Sean T. O’Leary of The Adult and Child Center for Outcomes Research and Delivery Sciences, University of Colorado, Aurora, and colleagues set out to study the prevalence of parents refusing one or more infant vaccines, physician response, and the association of dismissal to state exemption laws, and practice and provider characteristics.

They conducted a nationally representative survey of family physicians (FPs) and pediatricians with multivariable analysis. Their results were published online in Pediatrics (2015, Nov. 2. doi: 10.1542/peds.2015-2086).

The response rate was 61% (252) for FPs, 70% (282) for pediatricians, and 66% overall (534/815). Of those who responded, data from 83 were excluded because they reported not administering vaccines to children less than 2 years old.

Most respondents (83%) reported at least some parents refusing vaccines in a typical month. In states where philosophical exemptions are not allowed, pediatricians reported no refusals in a typical month more often than in states where exemptions are allowed (17% versus 8%, P = .03); family physicians did not report this difference. Vaccine refusal in 1%-4% of parents was reported by 63% of respondents, with 15% reporting a refusal rate of 5%-9%, and 5% reporting refusal by 10% or more. Likewise, 11% of the respondents reported an increase in vaccine refusal compared with the prior 12 months, whereas 23% reported a decrease and 66% reported a similar frequency.

Overall, 51% of respondents noted always or often requiring parents to sign a form after vaccine refusal (pediatricians 64% versus FPs 29%, P less than .0001).

Fourteen percent of the respondents reported always or often dismissing a family for refusing one or more infant vaccines (pediatricians 21% versus FPs 4%, P less than .0001).

In states without philosophical exemptions, 34% of pediatricians reported dismissal of families for vaccine refusal, versus 9% in states that allow exemptions (P less than .0001).

Finally, pediatrician respondents who reported dismissing patients were more often located in the South, in a state without philosophical exemptions for vaccines, and in private practice.

The authors noted that there are still many aspects of vaccine refusal that are not well understood. “Because many [pediatricians] still dismiss families despite recommendations to the contrary, this practice should be better explored and understood both for its causes and its intended and unintended consequences,” they wrote.

This study was funded by the CDC administered through the Rocky Mountain Prevention Research Center, University of Colorado, Aurora (grant). The authors report no financial disclosures.

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Most pediatricians and family physicians reported having some families refuse vaccines, and 21% of pediatricians reported dismissal of these families from their practices, findings of a recent survey showed.

Vaccine preventable outbreaks and vaccine refusal continue to be a concern. Despite discouragement by the Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP), some physicians have started to dismiss families from their practices for refusing vaccines for their children.

CDC/Amanda Mills

Dr. Sean T. O’Leary of The Adult and Child Center for Outcomes Research and Delivery Sciences, University of Colorado, Aurora, and colleagues set out to study the prevalence of parents refusing one or more infant vaccines, physician response, and the association of dismissal to state exemption laws, and practice and provider characteristics.

They conducted a nationally representative survey of family physicians (FPs) and pediatricians with multivariable analysis. Their results were published online in Pediatrics (2015, Nov. 2. doi: 10.1542/peds.2015-2086).

The response rate was 61% (252) for FPs, 70% (282) for pediatricians, and 66% overall (534/815). Of those who responded, data from 83 were excluded because they reported not administering vaccines to children less than 2 years old.

Most respondents (83%) reported at least some parents refusing vaccines in a typical month. In states where philosophical exemptions are not allowed, pediatricians reported no refusals in a typical month more often than in states where exemptions are allowed (17% versus 8%, P = .03); family physicians did not report this difference. Vaccine refusal in 1%-4% of parents was reported by 63% of respondents, with 15% reporting a refusal rate of 5%-9%, and 5% reporting refusal by 10% or more. Likewise, 11% of the respondents reported an increase in vaccine refusal compared with the prior 12 months, whereas 23% reported a decrease and 66% reported a similar frequency.

Overall, 51% of respondents noted always or often requiring parents to sign a form after vaccine refusal (pediatricians 64% versus FPs 29%, P less than .0001).

Fourteen percent of the respondents reported always or often dismissing a family for refusing one or more infant vaccines (pediatricians 21% versus FPs 4%, P less than .0001).

In states without philosophical exemptions, 34% of pediatricians reported dismissal of families for vaccine refusal, versus 9% in states that allow exemptions (P less than .0001).

Finally, pediatrician respondents who reported dismissing patients were more often located in the South, in a state without philosophical exemptions for vaccines, and in private practice.

The authors noted that there are still many aspects of vaccine refusal that are not well understood. “Because many [pediatricians] still dismiss families despite recommendations to the contrary, this practice should be better explored and understood both for its causes and its intended and unintended consequences,” they wrote.

This study was funded by the CDC administered through the Rocky Mountain Prevention Research Center, University of Colorado, Aurora (grant). The authors report no financial disclosures.

Most pediatricians and family physicians reported having some families refuse vaccines, and 21% of pediatricians reported dismissal of these families from their practices, findings of a recent survey showed.

Vaccine preventable outbreaks and vaccine refusal continue to be a concern. Despite discouragement by the Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP), some physicians have started to dismiss families from their practices for refusing vaccines for their children.

CDC/Amanda Mills

Dr. Sean T. O’Leary of The Adult and Child Center for Outcomes Research and Delivery Sciences, University of Colorado, Aurora, and colleagues set out to study the prevalence of parents refusing one or more infant vaccines, physician response, and the association of dismissal to state exemption laws, and practice and provider characteristics.

They conducted a nationally representative survey of family physicians (FPs) and pediatricians with multivariable analysis. Their results were published online in Pediatrics (2015, Nov. 2. doi: 10.1542/peds.2015-2086).

The response rate was 61% (252) for FPs, 70% (282) for pediatricians, and 66% overall (534/815). Of those who responded, data from 83 were excluded because they reported not administering vaccines to children less than 2 years old.

Most respondents (83%) reported at least some parents refusing vaccines in a typical month. In states where philosophical exemptions are not allowed, pediatricians reported no refusals in a typical month more often than in states where exemptions are allowed (17% versus 8%, P = .03); family physicians did not report this difference. Vaccine refusal in 1%-4% of parents was reported by 63% of respondents, with 15% reporting a refusal rate of 5%-9%, and 5% reporting refusal by 10% or more. Likewise, 11% of the respondents reported an increase in vaccine refusal compared with the prior 12 months, whereas 23% reported a decrease and 66% reported a similar frequency.

Overall, 51% of respondents noted always or often requiring parents to sign a form after vaccine refusal (pediatricians 64% versus FPs 29%, P less than .0001).

Fourteen percent of the respondents reported always or often dismissing a family for refusing one or more infant vaccines (pediatricians 21% versus FPs 4%, P less than .0001).

In states without philosophical exemptions, 34% of pediatricians reported dismissal of families for vaccine refusal, versus 9% in states that allow exemptions (P less than .0001).

Finally, pediatrician respondents who reported dismissing patients were more often located in the South, in a state without philosophical exemptions for vaccines, and in private practice.

The authors noted that there are still many aspects of vaccine refusal that are not well understood. “Because many [pediatricians] still dismiss families despite recommendations to the contrary, this practice should be better explored and understood both for its causes and its intended and unintended consequences,” they wrote.

This study was funded by the CDC administered through the Rocky Mountain Prevention Research Center, University of Colorado, Aurora (grant). The authors report no financial disclosures.

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Key clinical point: In a survey, most providers reported having some families refuse vaccines, and 21% of pediatricians reported subsequent dismissal.

Major finding: Most (83%) reported a least some parents refusing vaccines in a typical month and 14% reported always or often dismissing a family for refusing one or more infant vaccines (pediatricians 21% versus family physicians 4%, P less than .0001).

Data source: A nationally representative survey of family physicians (FPs) and pediatricians with multivariable analysis.

Disclosures: This study was funded by the Centers for Disease Control and Prevention, administered through the Rocky Mountain Prevention Research Center, University of Colorado, Aurora (grant). The authors report no financial disclosures.

USPSTF recommends glucose screening in overweight or obese adults

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USPSTF recommends glucose screening in overweight or obese adults

The U.S. Preventive Services Task Force (USPSTF) has added a B-level recommendation for abnormal blood glucose screening in overweight or obese adults aged 40-70 years as a part of their cardiovascular risk assessment. The guidelines were published in the Annals of Internal Medicine on Oct 26.

“Losing weight reduces the chances of developing diabetes, which is why our recommendation focuses on diet and exercise. Patients who have abnormal blood sugar levels can be referred to programs that help them eat a more healthful diet and exercise more often,” noted task force member Dr. William Phillips of the departments of health services and epidemiology at the University of Washington, Seattle, in a statement.

An estimated one-quarter of the cardiovascular disease (CVD) deaths are considered preventable. Likewise, abnormal blood glucose metabolism is considered a modifiable risk factor for CVD.

With the exception for some USPSTF recommendations involving breast cancer screening, the Affordable Care Act mandates that USPSTF recommendations with an A or B rating be covered by health insurance.

In 2008, the USPSTF gave a grade B-level recommendation to screening for type 2 diabetes in asymptomatic adults with treated or untreated hypertension (blood pressure greater than 135/80 mm Hg). They noted insufficient evidence to screen asymptomatic adults without a history of hypertension at that time.

The task force reviewed previous and new evidence on screening for type 2 diabetes, impaired fasting glucose, and impaired glucose tolerance and whether measurement of glucose resulted in improved outcomes and if interventions delayed progression to diabetes. Likewise, they wanted to know what, if any, harms could arise from screening for abnormal glucose metabolism.

The updated USPSTF recommendations call for the following:

• Screening for abnormal blood glucose in obese or overweight adults aged 40-70 years (Grade B).

• For those with abnormal glucose, referral for or offer intensive behavioral counseling on physical activity and healthful diet.

• Risk factors for abnormal glucose metabolism include physical inactivity, smoking, higher percentage of abdominal fat, overweight, and obesity. It is also often associated with other CVD risk factors such as hypertension and hyperlipidemia.

• Screening tests include: hemoglobin A1c, oral glucose tolerance test, or fasting plasma glucose with repeat testing for confirmation.

• No optimal screening interval was noted, but 3 years may be reasonable, based on previous studies.

• Interventions recommended included counseling on physical activity and a healthful diet, with insufficient evidence that medication has the same benefit to a behavioral approach.

The task force noted inadequate direct evidence that glucose measurement lessens CVD morbidity or mortality. However, they previously found evidence that intensive behavioral interventions in those at increased risk for CVD moderately lowered their CVD risk. This benefit was reported in those who are overweight or obese, have dyslipidemia, have hypertension, and/or have impaired glucose tolerance or impaired fasting glucose. Further, the task force highlighted studies that showed moderate reduction in progression to diabetes with lifestyle interventions in people with impaired glucose tolerance or impaired fasting glucose. They found that lifestyle interventions are more effective than metformin use.

Likewise, the task force noted little possible harm to initiating lifestyle intervention in order to reduce progression to diabetes and small to moderate harm in the use of drug therapy for diabetes prevention.

Furthermore, the recommendations include screening for obesity and referral to intensive behavioral interventions in those with a body mass index of 30 kg/m2 or more or a BMI greater than 25 kg/m2 and CVD risk factors.

Lifestyle interventions recommended for those at increased risk for type 2 diabetes include a combination of physical activity and dietary interventions. For example, among the effective approaches recommended are participating in individual and group sessions, setting weight loss goals, working with a trained diet or exercise counselor, and individualizing exercise or diet plans.

“The USPSTF assessed the overall benefit of screening for [impaired fasting glucose], [impaired glucose tolerance], and diabetes to be moderate. The effects of lifestyle interventions to prevent or delay progression to diabetes were consistent across a substantive body of literature.”

The USPSTF is funded by the Agency for Healthcare Research and Quality.

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The U.S. Preventive Services Task Force (USPSTF) has added a B-level recommendation for abnormal blood glucose screening in overweight or obese adults aged 40-70 years as a part of their cardiovascular risk assessment. The guidelines were published in the Annals of Internal Medicine on Oct 26.

“Losing weight reduces the chances of developing diabetes, which is why our recommendation focuses on diet and exercise. Patients who have abnormal blood sugar levels can be referred to programs that help them eat a more healthful diet and exercise more often,” noted task force member Dr. William Phillips of the departments of health services and epidemiology at the University of Washington, Seattle, in a statement.

An estimated one-quarter of the cardiovascular disease (CVD) deaths are considered preventable. Likewise, abnormal blood glucose metabolism is considered a modifiable risk factor for CVD.

With the exception for some USPSTF recommendations involving breast cancer screening, the Affordable Care Act mandates that USPSTF recommendations with an A or B rating be covered by health insurance.

In 2008, the USPSTF gave a grade B-level recommendation to screening for type 2 diabetes in asymptomatic adults with treated or untreated hypertension (blood pressure greater than 135/80 mm Hg). They noted insufficient evidence to screen asymptomatic adults without a history of hypertension at that time.

The task force reviewed previous and new evidence on screening for type 2 diabetes, impaired fasting glucose, and impaired glucose tolerance and whether measurement of glucose resulted in improved outcomes and if interventions delayed progression to diabetes. Likewise, they wanted to know what, if any, harms could arise from screening for abnormal glucose metabolism.

The updated USPSTF recommendations call for the following:

• Screening for abnormal blood glucose in obese or overweight adults aged 40-70 years (Grade B).

• For those with abnormal glucose, referral for or offer intensive behavioral counseling on physical activity and healthful diet.

• Risk factors for abnormal glucose metabolism include physical inactivity, smoking, higher percentage of abdominal fat, overweight, and obesity. It is also often associated with other CVD risk factors such as hypertension and hyperlipidemia.

• Screening tests include: hemoglobin A1c, oral glucose tolerance test, or fasting plasma glucose with repeat testing for confirmation.

• No optimal screening interval was noted, but 3 years may be reasonable, based on previous studies.

• Interventions recommended included counseling on physical activity and a healthful diet, with insufficient evidence that medication has the same benefit to a behavioral approach.

The task force noted inadequate direct evidence that glucose measurement lessens CVD morbidity or mortality. However, they previously found evidence that intensive behavioral interventions in those at increased risk for CVD moderately lowered their CVD risk. This benefit was reported in those who are overweight or obese, have dyslipidemia, have hypertension, and/or have impaired glucose tolerance or impaired fasting glucose. Further, the task force highlighted studies that showed moderate reduction in progression to diabetes with lifestyle interventions in people with impaired glucose tolerance or impaired fasting glucose. They found that lifestyle interventions are more effective than metformin use.

Likewise, the task force noted little possible harm to initiating lifestyle intervention in order to reduce progression to diabetes and small to moderate harm in the use of drug therapy for diabetes prevention.

Furthermore, the recommendations include screening for obesity and referral to intensive behavioral interventions in those with a body mass index of 30 kg/m2 or more or a BMI greater than 25 kg/m2 and CVD risk factors.

Lifestyle interventions recommended for those at increased risk for type 2 diabetes include a combination of physical activity and dietary interventions. For example, among the effective approaches recommended are participating in individual and group sessions, setting weight loss goals, working with a trained diet or exercise counselor, and individualizing exercise or diet plans.

“The USPSTF assessed the overall benefit of screening for [impaired fasting glucose], [impaired glucose tolerance], and diabetes to be moderate. The effects of lifestyle interventions to prevent or delay progression to diabetes were consistent across a substantive body of literature.”

The USPSTF is funded by the Agency for Healthcare Research and Quality.

The U.S. Preventive Services Task Force (USPSTF) has added a B-level recommendation for abnormal blood glucose screening in overweight or obese adults aged 40-70 years as a part of their cardiovascular risk assessment. The guidelines were published in the Annals of Internal Medicine on Oct 26.

“Losing weight reduces the chances of developing diabetes, which is why our recommendation focuses on diet and exercise. Patients who have abnormal blood sugar levels can be referred to programs that help them eat a more healthful diet and exercise more often,” noted task force member Dr. William Phillips of the departments of health services and epidemiology at the University of Washington, Seattle, in a statement.

An estimated one-quarter of the cardiovascular disease (CVD) deaths are considered preventable. Likewise, abnormal blood glucose metabolism is considered a modifiable risk factor for CVD.

With the exception for some USPSTF recommendations involving breast cancer screening, the Affordable Care Act mandates that USPSTF recommendations with an A or B rating be covered by health insurance.

In 2008, the USPSTF gave a grade B-level recommendation to screening for type 2 diabetes in asymptomatic adults with treated or untreated hypertension (blood pressure greater than 135/80 mm Hg). They noted insufficient evidence to screen asymptomatic adults without a history of hypertension at that time.

The task force reviewed previous and new evidence on screening for type 2 diabetes, impaired fasting glucose, and impaired glucose tolerance and whether measurement of glucose resulted in improved outcomes and if interventions delayed progression to diabetes. Likewise, they wanted to know what, if any, harms could arise from screening for abnormal glucose metabolism.

The updated USPSTF recommendations call for the following:

• Screening for abnormal blood glucose in obese or overweight adults aged 40-70 years (Grade B).

• For those with abnormal glucose, referral for or offer intensive behavioral counseling on physical activity and healthful diet.

• Risk factors for abnormal glucose metabolism include physical inactivity, smoking, higher percentage of abdominal fat, overweight, and obesity. It is also often associated with other CVD risk factors such as hypertension and hyperlipidemia.

• Screening tests include: hemoglobin A1c, oral glucose tolerance test, or fasting plasma glucose with repeat testing for confirmation.

• No optimal screening interval was noted, but 3 years may be reasonable, based on previous studies.

• Interventions recommended included counseling on physical activity and a healthful diet, with insufficient evidence that medication has the same benefit to a behavioral approach.

The task force noted inadequate direct evidence that glucose measurement lessens CVD morbidity or mortality. However, they previously found evidence that intensive behavioral interventions in those at increased risk for CVD moderately lowered their CVD risk. This benefit was reported in those who are overweight or obese, have dyslipidemia, have hypertension, and/or have impaired glucose tolerance or impaired fasting glucose. Further, the task force highlighted studies that showed moderate reduction in progression to diabetes with lifestyle interventions in people with impaired glucose tolerance or impaired fasting glucose. They found that lifestyle interventions are more effective than metformin use.

Likewise, the task force noted little possible harm to initiating lifestyle intervention in order to reduce progression to diabetes and small to moderate harm in the use of drug therapy for diabetes prevention.

Furthermore, the recommendations include screening for obesity and referral to intensive behavioral interventions in those with a body mass index of 30 kg/m2 or more or a BMI greater than 25 kg/m2 and CVD risk factors.

Lifestyle interventions recommended for those at increased risk for type 2 diabetes include a combination of physical activity and dietary interventions. For example, among the effective approaches recommended are participating in individual and group sessions, setting weight loss goals, working with a trained diet or exercise counselor, and individualizing exercise or diet plans.

“The USPSTF assessed the overall benefit of screening for [impaired fasting glucose], [impaired glucose tolerance], and diabetes to be moderate. The effects of lifestyle interventions to prevent or delay progression to diabetes were consistent across a substantive body of literature.”

The USPSTF is funded by the Agency for Healthcare Research and Quality.

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C difficile Risk Score Identifies High-risk Patients

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C difficile Risk Score Identifies High-risk Patients

Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

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Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

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C. difficile risk score identifies high-risk patients

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C. difficile risk score identifies high-risk patients

Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

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Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

Researchers have created a risk score to help identify patients at high risk for Clostridium difficile infection after hospitalization, for future use in vaccine trials, according to a new study.

C. difficile is the most common pathogen type in health care–associated infections and the leading cause of enterocolitis-associated deaths. Identification of patients who are at high risk for C. difficile is important in the development of future vaccines.

©luiscar/Thinkstockphotos.com

Dr. James Baggs, epidemiologist at the Centers for Disease Control and Prevention, and his colleagues conducted a retrospective cohort study to identify groups at high risk for C. difficile infection (CDI) for future vaccine trials. Their results were published in Vaccine online Oct. 9.

Data on medications and discharge were obtained from two large academic medical centers in Connecticut and New York. This information was linked to surveillance data from the Emerging Infections Program on active population-based CDIs. Participants were included if they had a hospital stay without a history of CDI with a primary outcome of infection 28 days or more after discharge.

To identify predictors of CDI after discharge, the investigators used a backward elimination employing a Cox proportional hazards model. They then created a CDI risk index based on the predictors.

During the study period, a total of 35,186 index hospitalizations were identified in Connecticut and New York. CDI diagnosis 28 days or more after discharge was observed in 288 patients (0.82%).

Initial models did not perform well in cross-site validation; however, a combined model that included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics was developed. This validation cohort resulted in a risk score that was predictive (P less than .001).

Finally, the study participants were divided into high-risk and low-risk groups based on the distribution of scores in the cohort. The low-risk group experienced CDI diagnosis 28 days or more after hospitalization at a rate of 0.3% versus 1.6% in the high-risk group.

“Our study identified specific parameters for a risk index that can be applied at hospital discharge to identify a patient population with increased risk of CDI [greater than or equal to] 28 days after discharge that could be targeted for vaccine trials,” Dr. Braggs and his coauthors wrote.

The authors noted several limitations to the study. For example, they indicated that data was obtained from two hospitals which may not represent some minority populations. Therefore, data from other hospitals may be able to help identify if the risk index is generalizable.

No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.

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Key clinical point: Researchers have created a risk score identifying patients at high risk for C. difficile infection after hospitalization, for future use in vaccine trials.

Major finding: A combined model which included age, past hospitalizations, use of 3rd/4th generation cephalosporin, clindamycin, or fluoroquinolone antibiotics resulted in a predictive risk score (P less than .001).

Data source: A retrospective cohort study with data from two large academic medical centers in Connecticut and New York which was linked to surveillance data from the Emerging Infections Program.

Disclosures: No conflicts of interest were reported. The study was partially funded by GlaxoSmithKline through the CDC Foundation, and GSK had the opportunity to review the preliminary manuscript.