Exploring Outcomes of Pediatric Status Epilepticus

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Exploring Outcomes of Pediatric Status Epilepticus
Seizure; ePub 2018 Apr 26; Jafarpour et al.

More attention needs to be paid to evaluating quality of life and cognitive/behavioral outcomes in children with status epilepticus, according to a review of the relevant medical literature.

  • An analysis of MEDLINE derived studies looked at the short-term and long-term outcomes in pediatric patients with status epilepticus.
  • The review found that mortality in this patient population was relatively low.
  • Health-related quality of life, neuroimaging, the use of continuous infusions, and cognitive/behavioral outcomes were not adequately addressed in the studies that were evaluated.
  • The researchers point out, however, that the full effects of status epilepticus on the outcomes being evaluated were difficult to accurately establish because there were so many differences in the way the studies were conducted.

Jafarpour S, Stredny CM, Piantino J, Chapman KE. Baseline and outcome assessment in pediatric status epilepticus. [Published online ahead of print April 26, 2018]. Seizure. DOI: https://doi.org/10.1016/j.seizure.2018.04.019

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Seizure; ePub 2018 Apr 26; Jafarpour et al.
Seizure; ePub 2018 Apr 26; Jafarpour et al.

More attention needs to be paid to evaluating quality of life and cognitive/behavioral outcomes in children with status epilepticus, according to a review of the relevant medical literature.

  • An analysis of MEDLINE derived studies looked at the short-term and long-term outcomes in pediatric patients with status epilepticus.
  • The review found that mortality in this patient population was relatively low.
  • Health-related quality of life, neuroimaging, the use of continuous infusions, and cognitive/behavioral outcomes were not adequately addressed in the studies that were evaluated.
  • The researchers point out, however, that the full effects of status epilepticus on the outcomes being evaluated were difficult to accurately establish because there were so many differences in the way the studies were conducted.

Jafarpour S, Stredny CM, Piantino J, Chapman KE. Baseline and outcome assessment in pediatric status epilepticus. [Published online ahead of print April 26, 2018]. Seizure. DOI: https://doi.org/10.1016/j.seizure.2018.04.019

More attention needs to be paid to evaluating quality of life and cognitive/behavioral outcomes in children with status epilepticus, according to a review of the relevant medical literature.

  • An analysis of MEDLINE derived studies looked at the short-term and long-term outcomes in pediatric patients with status epilepticus.
  • The review found that mortality in this patient population was relatively low.
  • Health-related quality of life, neuroimaging, the use of continuous infusions, and cognitive/behavioral outcomes were not adequately addressed in the studies that were evaluated.
  • The researchers point out, however, that the full effects of status epilepticus on the outcomes being evaluated were difficult to accurately establish because there were so many differences in the way the studies were conducted.

Jafarpour S, Stredny CM, Piantino J, Chapman KE. Baseline and outcome assessment in pediatric status epilepticus. [Published online ahead of print April 26, 2018]. Seizure. DOI: https://doi.org/10.1016/j.seizure.2018.04.019

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Epilepsy Research Reporting May Be Biased

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Epilepsy Res; ePub 2018 Mar 30; Rayi et al.

A cross-sectional analysis of epilepsy intervention trials suggests there may be bias in the reporting of these investigations according to a recent review of the research.

  • Investigators analyzed 126 epilepsy intervention trials, comparing two reporting periods: 2008 to 2011 and 2012 to 2015.
  • Twenty five percent of the trials were not reported (31/126).
  • 72 of the 126 trials were conducted in at least one US center.
  • 56 of 72 trials (78%) met the US Food and Drug Administration’s Amendments Act requirements.
  • Researchers found that the time it took to report trial results had become shorter over time, when comparing 2008-2011 to 2012-2015.
  • However, only a third of the trials (19/56) reported their results within the FDA’s mandated one-year time frame. 

Rayi A, Thompson S, Gloss D, Malhotra K. Reporting bias in completed epilepsy intervention trials: a cross-sectional analysis. Epilepsy Res. 2018;143:1-6

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Epilepsy Res; ePub 2018 Mar 30; Rayi et al.
Epilepsy Res; ePub 2018 Mar 30; Rayi et al.

A cross-sectional analysis of epilepsy intervention trials suggests there may be bias in the reporting of these investigations according to a recent review of the research.

  • Investigators analyzed 126 epilepsy intervention trials, comparing two reporting periods: 2008 to 2011 and 2012 to 2015.
  • Twenty five percent of the trials were not reported (31/126).
  • 72 of the 126 trials were conducted in at least one US center.
  • 56 of 72 trials (78%) met the US Food and Drug Administration’s Amendments Act requirements.
  • Researchers found that the time it took to report trial results had become shorter over time, when comparing 2008-2011 to 2012-2015.
  • However, only a third of the trials (19/56) reported their results within the FDA’s mandated one-year time frame. 

Rayi A, Thompson S, Gloss D, Malhotra K. Reporting bias in completed epilepsy intervention trials: a cross-sectional analysis. Epilepsy Res. 2018;143:1-6

A cross-sectional analysis of epilepsy intervention trials suggests there may be bias in the reporting of these investigations according to a recent review of the research.

  • Investigators analyzed 126 epilepsy intervention trials, comparing two reporting periods: 2008 to 2011 and 2012 to 2015.
  • Twenty five percent of the trials were not reported (31/126).
  • 72 of the 126 trials were conducted in at least one US center.
  • 56 of 72 trials (78%) met the US Food and Drug Administration’s Amendments Act requirements.
  • Researchers found that the time it took to report trial results had become shorter over time, when comparing 2008-2011 to 2012-2015.
  • However, only a third of the trials (19/56) reported their results within the FDA’s mandated one-year time frame. 

Rayi A, Thompson S, Gloss D, Malhotra K. Reporting bias in completed epilepsy intervention trials: a cross-sectional analysis. Epilepsy Res. 2018;143:1-6

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E-cigarette usage has changed

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Adults were more likely to try e-cigarettes in 2016 than they were in 2014, but they were less likely to use them regularly, according to a study published online on May 15 by JAMA.

The prevalence of ever use of e-cigarettes among adults aged 18 years and older rose significantly from 12.6% in 2014 to 15.3% in 2016, while the prevalence of current use (defined as use every day or some days) decreased significantly from 3.7% to 3.2% over that same period, suggesting “that some individuals are trying but not continuing use of e-cigarettes,” Wei Bao, MD, PhD, and his associates said in a research letter.

The patterns of increased ever use and decreased current use held for most age-, gender-, and race/ethnicity-related subgroups, although “current use of e-cigarettes declined among current smokers but increased among former smokers. This pattern may reflect e-cigarette use as adults are transitioning from current to former smokers, but further investigation is warranted,” wrote Dr. Bao of the University of Iowa College of Public Health, Iowa City, and his associates.

None of the investigators reported any conflicts of interest.

SOURCE: Bao W et al. JAMA. 2018 May 15;319(19):2039-41.

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Adults were more likely to try e-cigarettes in 2016 than they were in 2014, but they were less likely to use them regularly, according to a study published online on May 15 by JAMA.

The prevalence of ever use of e-cigarettes among adults aged 18 years and older rose significantly from 12.6% in 2014 to 15.3% in 2016, while the prevalence of current use (defined as use every day or some days) decreased significantly from 3.7% to 3.2% over that same period, suggesting “that some individuals are trying but not continuing use of e-cigarettes,” Wei Bao, MD, PhD, and his associates said in a research letter.

The patterns of increased ever use and decreased current use held for most age-, gender-, and race/ethnicity-related subgroups, although “current use of e-cigarettes declined among current smokers but increased among former smokers. This pattern may reflect e-cigarette use as adults are transitioning from current to former smokers, but further investigation is warranted,” wrote Dr. Bao of the University of Iowa College of Public Health, Iowa City, and his associates.

None of the investigators reported any conflicts of interest.

SOURCE: Bao W et al. JAMA. 2018 May 15;319(19):2039-41.

Adults were more likely to try e-cigarettes in 2016 than they were in 2014, but they were less likely to use them regularly, according to a study published online on May 15 by JAMA.

The prevalence of ever use of e-cigarettes among adults aged 18 years and older rose significantly from 12.6% in 2014 to 15.3% in 2016, while the prevalence of current use (defined as use every day or some days) decreased significantly from 3.7% to 3.2% over that same period, suggesting “that some individuals are trying but not continuing use of e-cigarettes,” Wei Bao, MD, PhD, and his associates said in a research letter.

The patterns of increased ever use and decreased current use held for most age-, gender-, and race/ethnicity-related subgroups, although “current use of e-cigarettes declined among current smokers but increased among former smokers. This pattern may reflect e-cigarette use as adults are transitioning from current to former smokers, but further investigation is warranted,” wrote Dr. Bao of the University of Iowa College of Public Health, Iowa City, and his associates.

None of the investigators reported any conflicts of interest.

SOURCE: Bao W et al. JAMA. 2018 May 15;319(19):2039-41.

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Fremanezumab may be an effective episodic migraine treatment

Monoclonal antibodies in migraine: Promising, with caveats
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Patients with episodic migraines had significantly fewer headache days when treated with a monoclonal antibody targeting calcitonin gene–related peptide (CGRP), results of a recent randomized clinical trial show.

The treatment was generally well tolerated, and also improved secondary efficacy outcomes; however, the investigators qualified the results, noting that the trial included patients who had failed two or fewer previous classes of migraine preventive medication.

“Further research is needed to assess effectiveness against other preventive medications, and in patients in whom multiple preventive drug classes have failed,” wrote David W. Dodick, MD, of Mayo Clinic, Phoenix, Ariz., and his coauthors. Long-term safety and efficacy also are needed, they added. Their report was published in JAMA.

Fremanezumab is a subcutaneously administered, fully humanized monoclonal antibody that binds to the CGRP ligand. A previous randomized phase 2b study showed that the treatment was effective in preventing migraine, with no serious treatment-related adverse events.


The current 12-week phase 3 trial (clinicaltrials.gov Identifier: NCT02629861) was designed to evaluate the efficacy and safety of fremanezumab in two different dosing regimens. A total of 875 patients (742 women; 85%) with episodic migraine were randomly assigned to fremanezumab monthly dosing (225 mg at baseline, 4 weeks, and 8 weeks), a single higher dose of fremanezumab (675 mg at baseline) intended to support a quarterly dosing regimen, or placebo.

Both dosing approaches significantly reduced the mean number of migraine days per month vs. placebo, Dr. Dodick and his coinvestigators reported.

In the monthly dosing group, the mean number of migraine days per month decreased from 8.9 to 4.9, and compared with placebo (with a decrease from 9.1 to 6.5 days), the mean number of migraine days at 12 weeks was 1.5 days lower (P less than .001). Similarly, the mean number of migraine days decreased from 9.2 to 5.3 days in the single higher dose group, with a difference of 1.3 days vs. placebo (P less than .001).

Significantly more patients receiving fremanezumab had a 50% or greater reduction in mean number of migraine days per month, suggesting a clinical response to the CGRP monoclonal antibody, the investigators said.

The most common adverse events leading to discontinuation included erythema at the injection site in three patients, along with induration, diarrhea, anxiety, and depression occurring in two patients each, according to the report. There was one death in the study due to suicide 109 days after the patient received a single higher dose of the study drug. However, the investigators determined that the death was unrelated to treatment.

One limitation of the study, investigators said, is that it excluded patients with treatment refractory migraine who had failed at least two previous preventive drug classes, and those who had continuous headache.

“Further studies are needed to define the full spectrum of efficacy and tolerability of fremanezumab, including in patients who are treatment refractory and who have a range of coexistent diseases,” they wrote.

Teva Pharmaceuticals supported the study. Dr. Dodick and his coauthors reported disclosures related to Teva, Amgen, Novartis, Pfizer, and Merck, among other entities.

SOURCE: Dodick DW et al. JAMA. 2018.319[19]:1999-2008.

Body

While this report on fremanezumab by Dr. Dodick and colleagues adds important evidence on the efficacy and safety of CGRP monoclonal antibodies, authors of a related editorial said several questions remain regarding this particular clinical trial and the drug class in general.

Of note, the study of fremanezumab excluded patients who failed two or more previous classes of medications. “This means the results of this trial may not necessarily apply to patients with severe, treatment-resistant migraine, who are the patients most likely to be prescribed and have access to these treatments in clinical practice,” Elizabeth W. Loder, MD, MPH, and Matthew S. Robbins, MD, wrote in their editorial (JAMA 2018 319[19]:1985-7).

Patients who received monthly fremanezumab had fewer migraine days per month versus placebo, as did patients who received a single higher dose of the medication. However, in both instances, the differences were smaller than the 1.6-day difference that was specified in the sample size calculation, added Dr. Loder and Dr. Robbins.

Though long-term safety data are needed, fremanezumab seemed generally well tolerated over 12 weeks in this study. “An important apparent benefit of fremanezumab and the other 3 CGRP monoclonal antibodies in development is their low burden of common nuisance adverse events,” they wrote.

However, it is “sobering to consider” the three deaths documented in clinical trials of CGRP monoclonal antibodies, they said. That total includes one patient in this study who committed suicide 109 days after receiving a 675-mg dose of fremanezumab.

The death may not have been related to treatment, the editorial authors said, noting that depression and other affective disorders are often comorbid with migraine.

“The [Food and Drug Administration] undoubtedly will scrutinize the deaths and adverse events reported in the trials of fremanezumab and other CGRP monoclonal antibodies,” they wrote. “If the result is restrictive labeling, it could greatly limit the patient population for these drugs, which are in any case likely to prove costly and challenging for patients to access.”

Dr. Loder is in the division of headache, department of neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston. Dr. Robbins is with Montefiore Headache Center, Albert Einstein College of Medicine, New York. These comments are derived from their editorial in JAMA. Dr Loder reported receiving grants and other funds from companies developing CGRP antibodies. Dr. Robbins reported that he is principal investigator for a clinical trial sponsored by eNeura.

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While this report on fremanezumab by Dr. Dodick and colleagues adds important evidence on the efficacy and safety of CGRP monoclonal antibodies, authors of a related editorial said several questions remain regarding this particular clinical trial and the drug class in general.

Of note, the study of fremanezumab excluded patients who failed two or more previous classes of medications. “This means the results of this trial may not necessarily apply to patients with severe, treatment-resistant migraine, who are the patients most likely to be prescribed and have access to these treatments in clinical practice,” Elizabeth W. Loder, MD, MPH, and Matthew S. Robbins, MD, wrote in their editorial (JAMA 2018 319[19]:1985-7).

Patients who received monthly fremanezumab had fewer migraine days per month versus placebo, as did patients who received a single higher dose of the medication. However, in both instances, the differences were smaller than the 1.6-day difference that was specified in the sample size calculation, added Dr. Loder and Dr. Robbins.

Though long-term safety data are needed, fremanezumab seemed generally well tolerated over 12 weeks in this study. “An important apparent benefit of fremanezumab and the other 3 CGRP monoclonal antibodies in development is their low burden of common nuisance adverse events,” they wrote.

However, it is “sobering to consider” the three deaths documented in clinical trials of CGRP monoclonal antibodies, they said. That total includes one patient in this study who committed suicide 109 days after receiving a 675-mg dose of fremanezumab.

The death may not have been related to treatment, the editorial authors said, noting that depression and other affective disorders are often comorbid with migraine.

“The [Food and Drug Administration] undoubtedly will scrutinize the deaths and adverse events reported in the trials of fremanezumab and other CGRP monoclonal antibodies,” they wrote. “If the result is restrictive labeling, it could greatly limit the patient population for these drugs, which are in any case likely to prove costly and challenging for patients to access.”

Dr. Loder is in the division of headache, department of neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston. Dr. Robbins is with Montefiore Headache Center, Albert Einstein College of Medicine, New York. These comments are derived from their editorial in JAMA. Dr Loder reported receiving grants and other funds from companies developing CGRP antibodies. Dr. Robbins reported that he is principal investigator for a clinical trial sponsored by eNeura.

Body

While this report on fremanezumab by Dr. Dodick and colleagues adds important evidence on the efficacy and safety of CGRP monoclonal antibodies, authors of a related editorial said several questions remain regarding this particular clinical trial and the drug class in general.

Of note, the study of fremanezumab excluded patients who failed two or more previous classes of medications. “This means the results of this trial may not necessarily apply to patients with severe, treatment-resistant migraine, who are the patients most likely to be prescribed and have access to these treatments in clinical practice,” Elizabeth W. Loder, MD, MPH, and Matthew S. Robbins, MD, wrote in their editorial (JAMA 2018 319[19]:1985-7).

Patients who received monthly fremanezumab had fewer migraine days per month versus placebo, as did patients who received a single higher dose of the medication. However, in both instances, the differences were smaller than the 1.6-day difference that was specified in the sample size calculation, added Dr. Loder and Dr. Robbins.

Though long-term safety data are needed, fremanezumab seemed generally well tolerated over 12 weeks in this study. “An important apparent benefit of fremanezumab and the other 3 CGRP monoclonal antibodies in development is their low burden of common nuisance adverse events,” they wrote.

However, it is “sobering to consider” the three deaths documented in clinical trials of CGRP monoclonal antibodies, they said. That total includes one patient in this study who committed suicide 109 days after receiving a 675-mg dose of fremanezumab.

The death may not have been related to treatment, the editorial authors said, noting that depression and other affective disorders are often comorbid with migraine.

“The [Food and Drug Administration] undoubtedly will scrutinize the deaths and adverse events reported in the trials of fremanezumab and other CGRP monoclonal antibodies,” they wrote. “If the result is restrictive labeling, it could greatly limit the patient population for these drugs, which are in any case likely to prove costly and challenging for patients to access.”

Dr. Loder is in the division of headache, department of neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston. Dr. Robbins is with Montefiore Headache Center, Albert Einstein College of Medicine, New York. These comments are derived from their editorial in JAMA. Dr Loder reported receiving grants and other funds from companies developing CGRP antibodies. Dr. Robbins reported that he is principal investigator for a clinical trial sponsored by eNeura.

Title
Monoclonal antibodies in migraine: Promising, with caveats
Monoclonal antibodies in migraine: Promising, with caveats

Patients with episodic migraines had significantly fewer headache days when treated with a monoclonal antibody targeting calcitonin gene–related peptide (CGRP), results of a recent randomized clinical trial show.

The treatment was generally well tolerated, and also improved secondary efficacy outcomes; however, the investigators qualified the results, noting that the trial included patients who had failed two or fewer previous classes of migraine preventive medication.

“Further research is needed to assess effectiveness against other preventive medications, and in patients in whom multiple preventive drug classes have failed,” wrote David W. Dodick, MD, of Mayo Clinic, Phoenix, Ariz., and his coauthors. Long-term safety and efficacy also are needed, they added. Their report was published in JAMA.

Fremanezumab is a subcutaneously administered, fully humanized monoclonal antibody that binds to the CGRP ligand. A previous randomized phase 2b study showed that the treatment was effective in preventing migraine, with no serious treatment-related adverse events.


The current 12-week phase 3 trial (clinicaltrials.gov Identifier: NCT02629861) was designed to evaluate the efficacy and safety of fremanezumab in two different dosing regimens. A total of 875 patients (742 women; 85%) with episodic migraine were randomly assigned to fremanezumab monthly dosing (225 mg at baseline, 4 weeks, and 8 weeks), a single higher dose of fremanezumab (675 mg at baseline) intended to support a quarterly dosing regimen, or placebo.

Both dosing approaches significantly reduced the mean number of migraine days per month vs. placebo, Dr. Dodick and his coinvestigators reported.

In the monthly dosing group, the mean number of migraine days per month decreased from 8.9 to 4.9, and compared with placebo (with a decrease from 9.1 to 6.5 days), the mean number of migraine days at 12 weeks was 1.5 days lower (P less than .001). Similarly, the mean number of migraine days decreased from 9.2 to 5.3 days in the single higher dose group, with a difference of 1.3 days vs. placebo (P less than .001).

Significantly more patients receiving fremanezumab had a 50% or greater reduction in mean number of migraine days per month, suggesting a clinical response to the CGRP monoclonal antibody, the investigators said.

The most common adverse events leading to discontinuation included erythema at the injection site in three patients, along with induration, diarrhea, anxiety, and depression occurring in two patients each, according to the report. There was one death in the study due to suicide 109 days after the patient received a single higher dose of the study drug. However, the investigators determined that the death was unrelated to treatment.

One limitation of the study, investigators said, is that it excluded patients with treatment refractory migraine who had failed at least two previous preventive drug classes, and those who had continuous headache.

“Further studies are needed to define the full spectrum of efficacy and tolerability of fremanezumab, including in patients who are treatment refractory and who have a range of coexistent diseases,” they wrote.

Teva Pharmaceuticals supported the study. Dr. Dodick and his coauthors reported disclosures related to Teva, Amgen, Novartis, Pfizer, and Merck, among other entities.

SOURCE: Dodick DW et al. JAMA. 2018.319[19]:1999-2008.

Patients with episodic migraines had significantly fewer headache days when treated with a monoclonal antibody targeting calcitonin gene–related peptide (CGRP), results of a recent randomized clinical trial show.

The treatment was generally well tolerated, and also improved secondary efficacy outcomes; however, the investigators qualified the results, noting that the trial included patients who had failed two or fewer previous classes of migraine preventive medication.

“Further research is needed to assess effectiveness against other preventive medications, and in patients in whom multiple preventive drug classes have failed,” wrote David W. Dodick, MD, of Mayo Clinic, Phoenix, Ariz., and his coauthors. Long-term safety and efficacy also are needed, they added. Their report was published in JAMA.

Fremanezumab is a subcutaneously administered, fully humanized monoclonal antibody that binds to the CGRP ligand. A previous randomized phase 2b study showed that the treatment was effective in preventing migraine, with no serious treatment-related adverse events.


The current 12-week phase 3 trial (clinicaltrials.gov Identifier: NCT02629861) was designed to evaluate the efficacy and safety of fremanezumab in two different dosing regimens. A total of 875 patients (742 women; 85%) with episodic migraine were randomly assigned to fremanezumab monthly dosing (225 mg at baseline, 4 weeks, and 8 weeks), a single higher dose of fremanezumab (675 mg at baseline) intended to support a quarterly dosing regimen, or placebo.

Both dosing approaches significantly reduced the mean number of migraine days per month vs. placebo, Dr. Dodick and his coinvestigators reported.

In the monthly dosing group, the mean number of migraine days per month decreased from 8.9 to 4.9, and compared with placebo (with a decrease from 9.1 to 6.5 days), the mean number of migraine days at 12 weeks was 1.5 days lower (P less than .001). Similarly, the mean number of migraine days decreased from 9.2 to 5.3 days in the single higher dose group, with a difference of 1.3 days vs. placebo (P less than .001).

Significantly more patients receiving fremanezumab had a 50% or greater reduction in mean number of migraine days per month, suggesting a clinical response to the CGRP monoclonal antibody, the investigators said.

The most common adverse events leading to discontinuation included erythema at the injection site in three patients, along with induration, diarrhea, anxiety, and depression occurring in two patients each, according to the report. There was one death in the study due to suicide 109 days after the patient received a single higher dose of the study drug. However, the investigators determined that the death was unrelated to treatment.

One limitation of the study, investigators said, is that it excluded patients with treatment refractory migraine who had failed at least two previous preventive drug classes, and those who had continuous headache.

“Further studies are needed to define the full spectrum of efficacy and tolerability of fremanezumab, including in patients who are treatment refractory and who have a range of coexistent diseases,” they wrote.

Teva Pharmaceuticals supported the study. Dr. Dodick and his coauthors reported disclosures related to Teva, Amgen, Novartis, Pfizer, and Merck, among other entities.

SOURCE: Dodick DW et al. JAMA. 2018.319[19]:1999-2008.

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Key clinical point: The CGRP monoclonal antibody fremanezumab significantly reduced the mean number of migraine days in patients with episodic migraine who had not previously failed multiple medication classes.

Major finding: The mean number of migraine days at 12 weeks was 1.5 days lower with monthly dosing and 1.3 days lower with a single higher dose.

Study details: A randomized clinical trial of 875 patients with episodic migraine who received fremanezumab monthly dosing, a single higher dose of fremanezumab, or placebo.

Disclosures: Teva Pharmaceuticals supported the study. The study authors reported disclosures related to Teva, Amgen, Novartis, Pfizer, and Merck, among other entities.

Source: Dodick DW et al. JAMA. 2018. 319(19):1999-2008.

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Advanced adenoma on colonoscopy linked to increased colorectal cancer incidence

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Advanced adenomas found on diagnostic colonoscopy were associated with increased risk of developing colorectal cancer, while nonadvanced adenomas were not, according to long-term follow-up results from a large screening study.

The findings come from a post hoc analysis of the Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial that enrolled 154,900 individuals, of whom 15,935 underwent colonoscopy following an abnormal flexible sigmoidoscopy screening result.

With a median of 13 years of follow-up, the incidence of colorectal cancer was 20.0 per 10,000 person-years for patients who had advanced adenoma found on colonoscopy, according to a report on the study published in JAMA. By comparison, colorectal cancer incidence was 9.1 and 7.5 per 10,000 person-years for nonadvanced adenoma and no adenoma, respectively.

“By demonstrating that individuals diagnosed with an advanced adenoma are at increased long-term risk for subsequent incident CRC, these findings support periodic, ongoing surveillance colonoscopy in these patients,” wrote Benjamin Click, MD, of the division of gastroenterology, hepatology, and nutrition, University of Pittsburgh, and his coauthors.

Compared with patients who had no adenoma, those with advanced adenoma were significantly more likely to develop colorectal cancer (rate ratio, 2.7; 95% confidence interval, 1.9-3.7; P less than .001). By contrast, there was no significant difference in risk of colorectal cancer for patients with nonadvanced adenoma and no adenoma (RR, 1.2; 95% CI, 0.8-1.7; P = .30).

Risk of death related to colorectal cancer was also significantly increased for patients with advanced adenoma versus no adenoma, and again, the investigators said, no such difference in mortality was found when nonadvanced adenoma was compared with no adenoma.

The PLCO screening study enrolled men and women aged 55-74 years beginning in 1993, with follow-up continuing until Dec. 31, 2013.

Small, nonadvanced adenomas are commonly found in colonoscopy, occurring in approximately 30% of patients, the investigators said. In the United States, when patients have one to two nonadvanced adenomas, they are typically advised to return in 5-10 years, the researchers noted. However, evidence is lacking in terms of who should return in 5 years, as opposed to 10 years.

“If appropriately powered prospective trials were to replicate these findings, demonstrating no significant difference in cancer incidence between participants with 1 to 2 nonadvanced adenoma(s) and no adenomas, colonoscopy use could be reduced by a large extent, as a surveillance examination at 5 years would not be needed,” the study authors said.

The National Cancer Institute Division of Cancer Prevention supported the study. One author reported receiving grant support from Medtronic.

SOURCE: Click B et al. JAMA. 2018;319(19):2021-31.

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Advanced adenomas found on diagnostic colonoscopy were associated with increased risk of developing colorectal cancer, while nonadvanced adenomas were not, according to long-term follow-up results from a large screening study.

The findings come from a post hoc analysis of the Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial that enrolled 154,900 individuals, of whom 15,935 underwent colonoscopy following an abnormal flexible sigmoidoscopy screening result.

With a median of 13 years of follow-up, the incidence of colorectal cancer was 20.0 per 10,000 person-years for patients who had advanced adenoma found on colonoscopy, according to a report on the study published in JAMA. By comparison, colorectal cancer incidence was 9.1 and 7.5 per 10,000 person-years for nonadvanced adenoma and no adenoma, respectively.

“By demonstrating that individuals diagnosed with an advanced adenoma are at increased long-term risk for subsequent incident CRC, these findings support periodic, ongoing surveillance colonoscopy in these patients,” wrote Benjamin Click, MD, of the division of gastroenterology, hepatology, and nutrition, University of Pittsburgh, and his coauthors.

Compared with patients who had no adenoma, those with advanced adenoma were significantly more likely to develop colorectal cancer (rate ratio, 2.7; 95% confidence interval, 1.9-3.7; P less than .001). By contrast, there was no significant difference in risk of colorectal cancer for patients with nonadvanced adenoma and no adenoma (RR, 1.2; 95% CI, 0.8-1.7; P = .30).

Risk of death related to colorectal cancer was also significantly increased for patients with advanced adenoma versus no adenoma, and again, the investigators said, no such difference in mortality was found when nonadvanced adenoma was compared with no adenoma.

The PLCO screening study enrolled men and women aged 55-74 years beginning in 1993, with follow-up continuing until Dec. 31, 2013.

Small, nonadvanced adenomas are commonly found in colonoscopy, occurring in approximately 30% of patients, the investigators said. In the United States, when patients have one to two nonadvanced adenomas, they are typically advised to return in 5-10 years, the researchers noted. However, evidence is lacking in terms of who should return in 5 years, as opposed to 10 years.

“If appropriately powered prospective trials were to replicate these findings, demonstrating no significant difference in cancer incidence between participants with 1 to 2 nonadvanced adenoma(s) and no adenomas, colonoscopy use could be reduced by a large extent, as a surveillance examination at 5 years would not be needed,” the study authors said.

The National Cancer Institute Division of Cancer Prevention supported the study. One author reported receiving grant support from Medtronic.

SOURCE: Click B et al. JAMA. 2018;319(19):2021-31.

Advanced adenomas found on diagnostic colonoscopy were associated with increased risk of developing colorectal cancer, while nonadvanced adenomas were not, according to long-term follow-up results from a large screening study.

The findings come from a post hoc analysis of the Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial that enrolled 154,900 individuals, of whom 15,935 underwent colonoscopy following an abnormal flexible sigmoidoscopy screening result.

With a median of 13 years of follow-up, the incidence of colorectal cancer was 20.0 per 10,000 person-years for patients who had advanced adenoma found on colonoscopy, according to a report on the study published in JAMA. By comparison, colorectal cancer incidence was 9.1 and 7.5 per 10,000 person-years for nonadvanced adenoma and no adenoma, respectively.

“By demonstrating that individuals diagnosed with an advanced adenoma are at increased long-term risk for subsequent incident CRC, these findings support periodic, ongoing surveillance colonoscopy in these patients,” wrote Benjamin Click, MD, of the division of gastroenterology, hepatology, and nutrition, University of Pittsburgh, and his coauthors.

Compared with patients who had no adenoma, those with advanced adenoma were significantly more likely to develop colorectal cancer (rate ratio, 2.7; 95% confidence interval, 1.9-3.7; P less than .001). By contrast, there was no significant difference in risk of colorectal cancer for patients with nonadvanced adenoma and no adenoma (RR, 1.2; 95% CI, 0.8-1.7; P = .30).

Risk of death related to colorectal cancer was also significantly increased for patients with advanced adenoma versus no adenoma, and again, the investigators said, no such difference in mortality was found when nonadvanced adenoma was compared with no adenoma.

The PLCO screening study enrolled men and women aged 55-74 years beginning in 1993, with follow-up continuing until Dec. 31, 2013.

Small, nonadvanced adenomas are commonly found in colonoscopy, occurring in approximately 30% of patients, the investigators said. In the United States, when patients have one to two nonadvanced adenomas, they are typically advised to return in 5-10 years, the researchers noted. However, evidence is lacking in terms of who should return in 5 years, as opposed to 10 years.

“If appropriately powered prospective trials were to replicate these findings, demonstrating no significant difference in cancer incidence between participants with 1 to 2 nonadvanced adenoma(s) and no adenomas, colonoscopy use could be reduced by a large extent, as a surveillance examination at 5 years would not be needed,” the study authors said.

The National Cancer Institute Division of Cancer Prevention supported the study. One author reported receiving grant support from Medtronic.

SOURCE: Click B et al. JAMA. 2018;319(19):2021-31.

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Key clinical point: The risk of developing colorectal cancer was significantly increased for individuals with an advanced adenoma at diagnostic colonoscopy.

Major finding: With a median follow-up of 12.9 years, the incidence of colorectal cancer was 20.0 per 10,000 person-years for advanced adenoma, compared with 9.1 and 7.5 per 10,000 person-years for nonadvanced adenoma and no adenoma, respectively.

Study details: A multicenter, prospective cohort study of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer randomized clinical trial of flexible sigmoidoscopy that enrolled 154,900 individuals.

Disclosures: The National Cancer Institute Division of Cancer Prevention supported the study. One author reported receiving grant support from Medtronic.

Source: Click B et al. JAMA. 2018;319(19):2021-31.

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MDedge Daily News: Gun ownership, suicide link largely ignored

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In today’s edition of the MDedge Daily News podcast, the link between gun ownership and suicide, insertable monitors are unequaled in the detection of atrial fibrillation, toddlers are showing signs of Internet addiction, and parents are smoking less tobacco in the home, but more cannabis.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

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In today’s edition of the MDedge Daily News podcast, the link between gun ownership and suicide, insertable monitors are unequaled in the detection of atrial fibrillation, toddlers are showing signs of Internet addiction, and parents are smoking less tobacco in the home, but more cannabis.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

In today’s edition of the MDedge Daily News podcast, the link between gun ownership and suicide, insertable monitors are unequaled in the detection of atrial fibrillation, toddlers are showing signs of Internet addiction, and parents are smoking less tobacco in the home, but more cannabis.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

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Words do matter – especially in psychiatry

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As psychiatrists, we must be more precise with our language. When we speak, we must not use psychiatric diagnoses to describe common, everyday problems in life.

For example, at the recent American Psychiatric Association meeting in New York City, I frequently heard my colleagues talking about being “traumatized” over a microinsult or a microaggression. Although these individuals suggested that they were so fragile and vulnerable that stressful events caused them to develop posttraumatic stress disorder (PTSD), I seriously doubted it. Moreover, with further dialogue, it became clear that they were stressed or distressed over the stressful event – not traumatized in the purest sense of the term.

Dr. Carl C. Bell
Stress is an event that causes a person to be bothered and upset by what happened: For example, your supervisor chews you out about your performance on the job. Such stress may cause some mild sleep-onset insomnia the night of the event, and usually by morning, the event is no longer as bothersome or upsetting, as it has been processed and neutralized by the mind’s adaptation skills. Distress is more serious, for example, your mother dies. Such a life event can cause people to be bothered and upset about their loss for 6 months, and the loss might still haunt them on Mother’s Day every year. Again, the mind is able to process the event and make peace with the reality that their mother is dead – and life goes on.

Traumatic stress, on the other hand, is an event that is so painful and disruptive that it runs the risk of breaking the mind’s ability to process or make peace with the event because it is so overwhelming that it disrupts or destroys normal psychic life. Such an event has the potential of causing PTSD, which is a chronic anxiety disorder that needs to be addressed clinically. This precision may seem nitpicky; however, the research on traumatic stress is clear. If you expose 100 people to a genuine traumatic experience, about 10% of the males and 20% of the females will develop PTSD, thus, something must be protecting people from developing PTSD from exposure to trauma. The research also is lucid that catastrophizing increases the risk of developing PTSD from exposure to a trauma by about 33%, and not having a sense of self-efficacy increases the risk by an additional 33%. Accordingly, I think it is unwise to label something traumatic when it is not, as this is catastrophizing and minimizes the belief in self-efficacy.

Similarly, we must be careful how we use the word “depression.” My understanding is depression is a clinical phenomenon that can be disabling. Unfortunately, I often hear patients and others talking about how they are depressed over various events in life that to me are a part of living, for example, being out of a job and not being able to make a way in life. Of course, if you are out actively looking for a job, that is probably not a clinical depression that would respond to antidepressant medication, but which would respond to finding a job. If a person were depressed from not having a job and unable to summon the energy to look for a job for 2 weeks or longer, I possibly would consider them clinically depressed. It seems laypeople are always using the word “depression” interchangeably for “unhappy,” “sad,” “grief,” or even “demoralization,” and although they all have common threads and are interlinked to one another, they are also very different.

Finally, the use of the word “bipolar” seems to be creeping into common usage, as I frequently hear patients who have poor affect regulation, for example, bad tempers, referring to themselves as being “bipolar.” However, after more dialogue, it becomes clear that they are describing a loss of self-control that lasts for maybe for 30 minutes or an hour. What is more distressing are the number of psychiatrists who are willing to take the patients’ word for it that they are “bipolar” and willing to prescribe mood stabilizers for such patients.

We must do better. We must not mislead the public into thinking that the ordinary problems of living are psychiatric disorders.
 

Dr. Bell is staff psychiatrist at Jackson Park Hospital Surgical-Medical/Psychiatric Inpatient Unit; clinical professor emeritus, department of psychiatry, University of Illinois at Chicago; and former director of the Institute for Juvenile Research (the birthplace of child psychiatry), all in Chicago. He also serves as chair of psychiatry at Windsor University, St. Kitts.

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As psychiatrists, we must be more precise with our language. When we speak, we must not use psychiatric diagnoses to describe common, everyday problems in life.

For example, at the recent American Psychiatric Association meeting in New York City, I frequently heard my colleagues talking about being “traumatized” over a microinsult or a microaggression. Although these individuals suggested that they were so fragile and vulnerable that stressful events caused them to develop posttraumatic stress disorder (PTSD), I seriously doubted it. Moreover, with further dialogue, it became clear that they were stressed or distressed over the stressful event – not traumatized in the purest sense of the term.

Dr. Carl C. Bell
Stress is an event that causes a person to be bothered and upset by what happened: For example, your supervisor chews you out about your performance on the job. Such stress may cause some mild sleep-onset insomnia the night of the event, and usually by morning, the event is no longer as bothersome or upsetting, as it has been processed and neutralized by the mind’s adaptation skills. Distress is more serious, for example, your mother dies. Such a life event can cause people to be bothered and upset about their loss for 6 months, and the loss might still haunt them on Mother’s Day every year. Again, the mind is able to process the event and make peace with the reality that their mother is dead – and life goes on.

Traumatic stress, on the other hand, is an event that is so painful and disruptive that it runs the risk of breaking the mind’s ability to process or make peace with the event because it is so overwhelming that it disrupts or destroys normal psychic life. Such an event has the potential of causing PTSD, which is a chronic anxiety disorder that needs to be addressed clinically. This precision may seem nitpicky; however, the research on traumatic stress is clear. If you expose 100 people to a genuine traumatic experience, about 10% of the males and 20% of the females will develop PTSD, thus, something must be protecting people from developing PTSD from exposure to trauma. The research also is lucid that catastrophizing increases the risk of developing PTSD from exposure to a trauma by about 33%, and not having a sense of self-efficacy increases the risk by an additional 33%. Accordingly, I think it is unwise to label something traumatic when it is not, as this is catastrophizing and minimizes the belief in self-efficacy.

Similarly, we must be careful how we use the word “depression.” My understanding is depression is a clinical phenomenon that can be disabling. Unfortunately, I often hear patients and others talking about how they are depressed over various events in life that to me are a part of living, for example, being out of a job and not being able to make a way in life. Of course, if you are out actively looking for a job, that is probably not a clinical depression that would respond to antidepressant medication, but which would respond to finding a job. If a person were depressed from not having a job and unable to summon the energy to look for a job for 2 weeks or longer, I possibly would consider them clinically depressed. It seems laypeople are always using the word “depression” interchangeably for “unhappy,” “sad,” “grief,” or even “demoralization,” and although they all have common threads and are interlinked to one another, they are also very different.

Finally, the use of the word “bipolar” seems to be creeping into common usage, as I frequently hear patients who have poor affect regulation, for example, bad tempers, referring to themselves as being “bipolar.” However, after more dialogue, it becomes clear that they are describing a loss of self-control that lasts for maybe for 30 minutes or an hour. What is more distressing are the number of psychiatrists who are willing to take the patients’ word for it that they are “bipolar” and willing to prescribe mood stabilizers for such patients.

We must do better. We must not mislead the public into thinking that the ordinary problems of living are psychiatric disorders.
 

Dr. Bell is staff psychiatrist at Jackson Park Hospital Surgical-Medical/Psychiatric Inpatient Unit; clinical professor emeritus, department of psychiatry, University of Illinois at Chicago; and former director of the Institute for Juvenile Research (the birthplace of child psychiatry), all in Chicago. He also serves as chair of psychiatry at Windsor University, St. Kitts.

 

As psychiatrists, we must be more precise with our language. When we speak, we must not use psychiatric diagnoses to describe common, everyday problems in life.

For example, at the recent American Psychiatric Association meeting in New York City, I frequently heard my colleagues talking about being “traumatized” over a microinsult or a microaggression. Although these individuals suggested that they were so fragile and vulnerable that stressful events caused them to develop posttraumatic stress disorder (PTSD), I seriously doubted it. Moreover, with further dialogue, it became clear that they were stressed or distressed over the stressful event – not traumatized in the purest sense of the term.

Dr. Carl C. Bell
Stress is an event that causes a person to be bothered and upset by what happened: For example, your supervisor chews you out about your performance on the job. Such stress may cause some mild sleep-onset insomnia the night of the event, and usually by morning, the event is no longer as bothersome or upsetting, as it has been processed and neutralized by the mind’s adaptation skills. Distress is more serious, for example, your mother dies. Such a life event can cause people to be bothered and upset about their loss for 6 months, and the loss might still haunt them on Mother’s Day every year. Again, the mind is able to process the event and make peace with the reality that their mother is dead – and life goes on.

Traumatic stress, on the other hand, is an event that is so painful and disruptive that it runs the risk of breaking the mind’s ability to process or make peace with the event because it is so overwhelming that it disrupts or destroys normal psychic life. Such an event has the potential of causing PTSD, which is a chronic anxiety disorder that needs to be addressed clinically. This precision may seem nitpicky; however, the research on traumatic stress is clear. If you expose 100 people to a genuine traumatic experience, about 10% of the males and 20% of the females will develop PTSD, thus, something must be protecting people from developing PTSD from exposure to trauma. The research also is lucid that catastrophizing increases the risk of developing PTSD from exposure to a trauma by about 33%, and not having a sense of self-efficacy increases the risk by an additional 33%. Accordingly, I think it is unwise to label something traumatic when it is not, as this is catastrophizing and minimizes the belief in self-efficacy.

Similarly, we must be careful how we use the word “depression.” My understanding is depression is a clinical phenomenon that can be disabling. Unfortunately, I often hear patients and others talking about how they are depressed over various events in life that to me are a part of living, for example, being out of a job and not being able to make a way in life. Of course, if you are out actively looking for a job, that is probably not a clinical depression that would respond to antidepressant medication, but which would respond to finding a job. If a person were depressed from not having a job and unable to summon the energy to look for a job for 2 weeks or longer, I possibly would consider them clinically depressed. It seems laypeople are always using the word “depression” interchangeably for “unhappy,” “sad,” “grief,” or even “demoralization,” and although they all have common threads and are interlinked to one another, they are also very different.

Finally, the use of the word “bipolar” seems to be creeping into common usage, as I frequently hear patients who have poor affect regulation, for example, bad tempers, referring to themselves as being “bipolar.” However, after more dialogue, it becomes clear that they are describing a loss of self-control that lasts for maybe for 30 minutes or an hour. What is more distressing are the number of psychiatrists who are willing to take the patients’ word for it that they are “bipolar” and willing to prescribe mood stabilizers for such patients.

We must do better. We must not mislead the public into thinking that the ordinary problems of living are psychiatric disorders.
 

Dr. Bell is staff psychiatrist at Jackson Park Hospital Surgical-Medical/Psychiatric Inpatient Unit; clinical professor emeritus, department of psychiatry, University of Illinois at Chicago; and former director of the Institute for Juvenile Research (the birthplace of child psychiatry), all in Chicago. He also serves as chair of psychiatry at Windsor University, St. Kitts.

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Tracking Down ‘Unusually’ Resistant Germs

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Last year, the CDC Antibiotic Resistance (AR) Lab Network found 221 instances of “nightmare bacteria” with unusual antibiotic resistance genes “hiding in plain sight.”

According to the Centers for Disease Control and Prevention’s (CDC) study, 1 in 4 germ samples sent to the AR Lab Network for testing had special genes that allow them to spread their resistance to other germs. Further investigation in facilities with unusual resistance revealed that about 1 in 10 screening tests from patients without symptoms identified a hard-to-treat germ that spreads easily, meaning the germ could have spread undetected in that health care facility, the CDC said.

The CDC containment strategy includes continued infection control assessments until spread is stopped, which takes a coordinated response among facilities, labs, health departments, and CDC through the AR Lab Network. Health departments using the approach have conducted infection control assessments and colonization screenings within 48 hours of finding unusual resistance and have reported no further transmission during follow-up over several weeks. Estimates show that for carbapenem-resistant Enterobacteriaceae alone, the containment strategy would prevent as many as 1,600 new infections in 3 years in a single state—a 76% reduction.

Health care practitioners can help by using contact precautions, asking patients about recent travel or health care, and communicating about status when patients are transferred.

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Last year, the CDC Antibiotic Resistance (AR) Lab Network found 221 instances of “nightmare bacteria” with unusual antibiotic resistance genes “hiding in plain sight.”
Last year, the CDC Antibiotic Resistance (AR) Lab Network found 221 instances of “nightmare bacteria” with unusual antibiotic resistance genes “hiding in plain sight.”

According to the Centers for Disease Control and Prevention’s (CDC) study, 1 in 4 germ samples sent to the AR Lab Network for testing had special genes that allow them to spread their resistance to other germs. Further investigation in facilities with unusual resistance revealed that about 1 in 10 screening tests from patients without symptoms identified a hard-to-treat germ that spreads easily, meaning the germ could have spread undetected in that health care facility, the CDC said.

The CDC containment strategy includes continued infection control assessments until spread is stopped, which takes a coordinated response among facilities, labs, health departments, and CDC through the AR Lab Network. Health departments using the approach have conducted infection control assessments and colonization screenings within 48 hours of finding unusual resistance and have reported no further transmission during follow-up over several weeks. Estimates show that for carbapenem-resistant Enterobacteriaceae alone, the containment strategy would prevent as many as 1,600 new infections in 3 years in a single state—a 76% reduction.

Health care practitioners can help by using contact precautions, asking patients about recent travel or health care, and communicating about status when patients are transferred.

According to the Centers for Disease Control and Prevention’s (CDC) study, 1 in 4 germ samples sent to the AR Lab Network for testing had special genes that allow them to spread their resistance to other germs. Further investigation in facilities with unusual resistance revealed that about 1 in 10 screening tests from patients without symptoms identified a hard-to-treat germ that spreads easily, meaning the germ could have spread undetected in that health care facility, the CDC said.

The CDC containment strategy includes continued infection control assessments until spread is stopped, which takes a coordinated response among facilities, labs, health departments, and CDC through the AR Lab Network. Health departments using the approach have conducted infection control assessments and colonization screenings within 48 hours of finding unusual resistance and have reported no further transmission during follow-up over several weeks. Estimates show that for carbapenem-resistant Enterobacteriaceae alone, the containment strategy would prevent as many as 1,600 new infections in 3 years in a single state—a 76% reduction.

Health care practitioners can help by using contact precautions, asking patients about recent travel or health care, and communicating about status when patients are transferred.

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FDA approves new use for Zika test

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The US Food and Drug Administration (FDA) has approved an additional use for the cobas Zika test.

The approval allows for the streamlined screening of multiple individual blood or plasma donations that have been pooled together.

The cobas Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from blood donors.

The test is used with the cobas 6800/8800 systems, which are fully automated, high-volume systems that perform sample pooling, sample preparation (nucleic acid extraction and purification), and polymerase chain reaction amplification and detection.

Automated data management is performed by the cobas 6800/8800 software, which assigns a test result of non-reactive, reactive, or invalid.

Roche deployed the cobas Zika test in April 2016 under the FDA’s investigational new drug application protocol to screen blood donations collected in Puerto Rico.

This initial testing protocol enabled the reinstatement of blood services in Puerto Rico after concerns over high rates of Zika infection posed a threat to the blood supply.

The cobas Zika test received commercial approval from the FDA in October 2017, enabling routine use of the test to support individual donor screening efforts throughout Puerto Rico and the continental US.

“More than 6 million blood donations from the United States and Puerto Rico have been screened with the cobas Zika test since its initial release under the investigational new drug application protocol in 2016 and subsequent commercial approval in 2017,” said Uwe Oberlaender, head of Roche Molecular Diagnostics.

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Photo from UAB Hospital
Blood for transfusion

The US Food and Drug Administration (FDA) has approved an additional use for the cobas Zika test.

The approval allows for the streamlined screening of multiple individual blood or plasma donations that have been pooled together.

The cobas Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from blood donors.

The test is used with the cobas 6800/8800 systems, which are fully automated, high-volume systems that perform sample pooling, sample preparation (nucleic acid extraction and purification), and polymerase chain reaction amplification and detection.

Automated data management is performed by the cobas 6800/8800 software, which assigns a test result of non-reactive, reactive, or invalid.

Roche deployed the cobas Zika test in April 2016 under the FDA’s investigational new drug application protocol to screen blood donations collected in Puerto Rico.

This initial testing protocol enabled the reinstatement of blood services in Puerto Rico after concerns over high rates of Zika infection posed a threat to the blood supply.

The cobas Zika test received commercial approval from the FDA in October 2017, enabling routine use of the test to support individual donor screening efforts throughout Puerto Rico and the continental US.

“More than 6 million blood donations from the United States and Puerto Rico have been screened with the cobas Zika test since its initial release under the investigational new drug application protocol in 2016 and subsequent commercial approval in 2017,” said Uwe Oberlaender, head of Roche Molecular Diagnostics.

Photo from UAB Hospital
Blood for transfusion

The US Food and Drug Administration (FDA) has approved an additional use for the cobas Zika test.

The approval allows for the streamlined screening of multiple individual blood or plasma donations that have been pooled together.

The cobas Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from blood donors.

The test is used with the cobas 6800/8800 systems, which are fully automated, high-volume systems that perform sample pooling, sample preparation (nucleic acid extraction and purification), and polymerase chain reaction amplification and detection.

Automated data management is performed by the cobas 6800/8800 software, which assigns a test result of non-reactive, reactive, or invalid.

Roche deployed the cobas Zika test in April 2016 under the FDA’s investigational new drug application protocol to screen blood donations collected in Puerto Rico.

This initial testing protocol enabled the reinstatement of blood services in Puerto Rico after concerns over high rates of Zika infection posed a threat to the blood supply.

The cobas Zika test received commercial approval from the FDA in October 2017, enabling routine use of the test to support individual donor screening efforts throughout Puerto Rico and the continental US.

“More than 6 million blood donations from the United States and Puerto Rico have been screened with the cobas Zika test since its initial release under the investigational new drug application protocol in 2016 and subsequent commercial approval in 2017,” said Uwe Oberlaender, head of Roche Molecular Diagnostics.

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Study reveals gender imbalance in cancer research funding

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A new study suggests male investigators in the UK receive more funding for cancer research than their female counterparts.

Researchers analyzed funding for more than 4000 studies and found that male primary investigators (PIs) were consistently awarded more funding.

The total investment value was 3.6 times greater for male PIs than for female PIs.

The mean award value was 1.6 times greater, and the median award value was 1.3 times greater for males.

Rifat Atun, MBBS, of Harvard T. H. Chan School of Public Health in Boston, Massachusetts, and his colleagues reported these findings in BMJ Open.

The researchers analyzed data on public and philanthropic cancer research funding awarded to UK institutions between 2000 and 2013.

From this data, the team identified 4186 eligible studies with a total investment value of £2.33 billion.

The researchers compared the total investment, number of awards, and mean and median award value between male and female PIs.

Male PIs were awarded 2890 (69%) grants with a total value of £1.8 billion (78%), while female PIs were awarded 1296 (31%) grants with a total value of £0.5 billion (22%).

The median award value was £252,647 (interquartile range, £127,343–£553,560) for men and £198,485 (interquartile range, £99,317–£382,650) for women.

The mean award value was £630,324 (standard deviation, £1,662,559) for men and £394,730 (standard deviation, £666,574) for women.

Dr Atun and his colleagues acknowledged that this study was dependent on the accuracy of original investment data from the funding bodies, and the team could not openly access data of private sector research funding nor obtain disaggregated data from Cancer Research UK, one of the largest funders of cancer research.

The researchers also noted that the gender discrepancies they observed “are likely multifactorial,” and the team was unable to “postulate the underlying mechanisms responsible.” Still, the data do suggest a “substantial” imbalance, which should be investigated.

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Researchers in the lab

A new study suggests male investigators in the UK receive more funding for cancer research than their female counterparts.

Researchers analyzed funding for more than 4000 studies and found that male primary investigators (PIs) were consistently awarded more funding.

The total investment value was 3.6 times greater for male PIs than for female PIs.

The mean award value was 1.6 times greater, and the median award value was 1.3 times greater for males.

Rifat Atun, MBBS, of Harvard T. H. Chan School of Public Health in Boston, Massachusetts, and his colleagues reported these findings in BMJ Open.

The researchers analyzed data on public and philanthropic cancer research funding awarded to UK institutions between 2000 and 2013.

From this data, the team identified 4186 eligible studies with a total investment value of £2.33 billion.

The researchers compared the total investment, number of awards, and mean and median award value between male and female PIs.

Male PIs were awarded 2890 (69%) grants with a total value of £1.8 billion (78%), while female PIs were awarded 1296 (31%) grants with a total value of £0.5 billion (22%).

The median award value was £252,647 (interquartile range, £127,343–£553,560) for men and £198,485 (interquartile range, £99,317–£382,650) for women.

The mean award value was £630,324 (standard deviation, £1,662,559) for men and £394,730 (standard deviation, £666,574) for women.

Dr Atun and his colleagues acknowledged that this study was dependent on the accuracy of original investment data from the funding bodies, and the team could not openly access data of private sector research funding nor obtain disaggregated data from Cancer Research UK, one of the largest funders of cancer research.

The researchers also noted that the gender discrepancies they observed “are likely multifactorial,” and the team was unable to “postulate the underlying mechanisms responsible.” Still, the data do suggest a “substantial” imbalance, which should be investigated.

Photo by Rhoda Baer
Researchers in the lab

A new study suggests male investigators in the UK receive more funding for cancer research than their female counterparts.

Researchers analyzed funding for more than 4000 studies and found that male primary investigators (PIs) were consistently awarded more funding.

The total investment value was 3.6 times greater for male PIs than for female PIs.

The mean award value was 1.6 times greater, and the median award value was 1.3 times greater for males.

Rifat Atun, MBBS, of Harvard T. H. Chan School of Public Health in Boston, Massachusetts, and his colleagues reported these findings in BMJ Open.

The researchers analyzed data on public and philanthropic cancer research funding awarded to UK institutions between 2000 and 2013.

From this data, the team identified 4186 eligible studies with a total investment value of £2.33 billion.

The researchers compared the total investment, number of awards, and mean and median award value between male and female PIs.

Male PIs were awarded 2890 (69%) grants with a total value of £1.8 billion (78%), while female PIs were awarded 1296 (31%) grants with a total value of £0.5 billion (22%).

The median award value was £252,647 (interquartile range, £127,343–£553,560) for men and £198,485 (interquartile range, £99,317–£382,650) for women.

The mean award value was £630,324 (standard deviation, £1,662,559) for men and £394,730 (standard deviation, £666,574) for women.

Dr Atun and his colleagues acknowledged that this study was dependent on the accuracy of original investment data from the funding bodies, and the team could not openly access data of private sector research funding nor obtain disaggregated data from Cancer Research UK, one of the largest funders of cancer research.

The researchers also noted that the gender discrepancies they observed “are likely multifactorial,” and the team was unable to “postulate the underlying mechanisms responsible.” Still, the data do suggest a “substantial” imbalance, which should be investigated.

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