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Christopher Palmer has been an associate editor at MDedge News since 2017. When he's not tidying grammar, he writes short pieces about breaking FDA announcements and approvals, as well as journal articles. He proudly holds a BA in English and philosophy. Follow him on Twitter @cmacmpalm.
FDA approves ixekizumab for pediatric plaque psoriasis
The according to an announcement from Lilly.
Patients need to be candidates for systemic therapy or phototherapy and have no known hypersensitivity to the biologic.
The safety, tolerability, and efficacy of the interleukin-17a antagonist were demonstrated in a phase 3 study that included 171 patients aged 6-17 years with moderate to severe plaque psoriasis. At 12 weeks, 89% those on ixekizumab achieved a 75% improvement on Psoriasis Area and Severity Index score, compared with 25% of those on placebo, and 81% achieved a static Physician’s Global Assessment of clear or almost clear, compared with 11% of those on placebo, according to the Lilly statement.
The safety profile seen with ixekizumab (Taltz) among the pediatric patients with plaque psoriasis is consistent with what has been observed among adult patients, although there were higher rates of conjunctivitis, influenza, and urticaria among the pediatric patients, the statement noted. The biologic may increase the risk of infection, and patients should be evaluated for tuberculosis, hypersensitivity, and inflammatory bowel disease. It is also recommended that routine immunizations be completed before initiating treatment.
Ixekizumab was initially approved for treating adults with moderate to severe plaque psoriasis in 2016, followed by approvals for treatment of adults with active psoriatic arthritis in 2017, and for adults with ankylosing spondylitis in August 2019.
The biologic therapies – etanercept, a tumor necrosis factor blocker, and ustekinumab (Stelara), an IL-12/23 antagonist – were previously approved by the FDA for pediatric psoriasis, in children ages 4 years and older and 12 years and older, respectively.
Updated prescribing information for ixekizumab can be found on the Lilly website.
cpalmer@mdedge.com
The according to an announcement from Lilly.
Patients need to be candidates for systemic therapy or phototherapy and have no known hypersensitivity to the biologic.
The safety, tolerability, and efficacy of the interleukin-17a antagonist were demonstrated in a phase 3 study that included 171 patients aged 6-17 years with moderate to severe plaque psoriasis. At 12 weeks, 89% those on ixekizumab achieved a 75% improvement on Psoriasis Area and Severity Index score, compared with 25% of those on placebo, and 81% achieved a static Physician’s Global Assessment of clear or almost clear, compared with 11% of those on placebo, according to the Lilly statement.
The safety profile seen with ixekizumab (Taltz) among the pediatric patients with plaque psoriasis is consistent with what has been observed among adult patients, although there were higher rates of conjunctivitis, influenza, and urticaria among the pediatric patients, the statement noted. The biologic may increase the risk of infection, and patients should be evaluated for tuberculosis, hypersensitivity, and inflammatory bowel disease. It is also recommended that routine immunizations be completed before initiating treatment.
Ixekizumab was initially approved for treating adults with moderate to severe plaque psoriasis in 2016, followed by approvals for treatment of adults with active psoriatic arthritis in 2017, and for adults with ankylosing spondylitis in August 2019.
The biologic therapies – etanercept, a tumor necrosis factor blocker, and ustekinumab (Stelara), an IL-12/23 antagonist – were previously approved by the FDA for pediatric psoriasis, in children ages 4 years and older and 12 years and older, respectively.
Updated prescribing information for ixekizumab can be found on the Lilly website.
cpalmer@mdedge.com
The according to an announcement from Lilly.
Patients need to be candidates for systemic therapy or phototherapy and have no known hypersensitivity to the biologic.
The safety, tolerability, and efficacy of the interleukin-17a antagonist were demonstrated in a phase 3 study that included 171 patients aged 6-17 years with moderate to severe plaque psoriasis. At 12 weeks, 89% those on ixekizumab achieved a 75% improvement on Psoriasis Area and Severity Index score, compared with 25% of those on placebo, and 81% achieved a static Physician’s Global Assessment of clear or almost clear, compared with 11% of those on placebo, according to the Lilly statement.
The safety profile seen with ixekizumab (Taltz) among the pediatric patients with plaque psoriasis is consistent with what has been observed among adult patients, although there were higher rates of conjunctivitis, influenza, and urticaria among the pediatric patients, the statement noted. The biologic may increase the risk of infection, and patients should be evaluated for tuberculosis, hypersensitivity, and inflammatory bowel disease. It is also recommended that routine immunizations be completed before initiating treatment.
Ixekizumab was initially approved for treating adults with moderate to severe plaque psoriasis in 2016, followed by approvals for treatment of adults with active psoriatic arthritis in 2017, and for adults with ankylosing spondylitis in August 2019.
The biologic therapies – etanercept, a tumor necrosis factor blocker, and ustekinumab (Stelara), an IL-12/23 antagonist – were previously approved by the FDA for pediatric psoriasis, in children ages 4 years and older and 12 years and older, respectively.
Updated prescribing information for ixekizumab can be found on the Lilly website.
cpalmer@mdedge.com
Focus groups seek transgender experience with HIV prevention
A pair of focus groups explored the experience of transgender patients with HIV prevention, finding many were discouraged by experiences of care that was not culturally competent and affirming.
The findings, including other important themes, were published in Pediatrics.
The pair of online asynchronous focus groups, conducted by Holly B. Fontenot, PhD, RN/NP, of the Fenway Institute in Boston, and colleagues, sought input from 30 transgender participants from across the United States. Eleven were aged 13-18 years, and 19 were aged 18-24 years, with an average age of 19. Most (70%) were white, and the remainder were African American (7%), Asian American (3%), multiracial (17%), and other (3%); 10% identified as Hispanic. Participants were given multiple options for reporting gender identity; 27% reported identifying as transgender males, 17% reported identifying as transgender females, and the rest identified with other terms, including 27% using one or more terms.
The quantitative analysis found four common themes, which the study explored in depth: “barriers to self-efficacy in sexual decision making; safety concerns, fear, and other challenges in forming romantic and/or sexual relationships; need for support and education; and desire for affirmative and culturally competent experiences and interactions.”
Based on their findings, the authors suggested ways of improving transgender youth experiences:
- Increasing provider knowledge and skills in providing affirming care through transgender health education programs.
- Addressing the barriers, such as stigma and lack of accessibility.
- Expanding sexual health education to be more inclusive regarding gender identities, sexual orientations, and definitions of sex.
Providers also need to include information on sexually transmitted infection and HIV prevention, including “discussion of safer sexual behaviors, negotiation and consent, sexual and physical assault, condoms, lubrication, STI and HIV testing, human papillomavirus vaccination, and PrEP [preexposure prophylaxis]” the authors emphasized.
Dr. Fontenot and associates determined that this study’s findings were consistent with what’s known about adult transgender patients, but this study provides more context regarding transgender youth experiences.
“It is important to elicit transgender youth experiences and perspectives related to HIV risk and preventive services,” they concluded. “This study provided a greater understanding of barriers to and facilitators of youth obtaining HIV preventive services and sexual health education.”
Limitations of the study included that non–English speaking participants were excluded, and that participants were predominantly white, non-Hispanic, and assigned female sex at birth.
This study was funded by the Centers for Disease Control and Prevention and NORC at The University of Chicago. The authors had no relevant financial disclosures.
SOURCE: Fontenot HB et al., Pediatrics. 2020. doi: 10.1542/peds.2019-2204.
A pair of focus groups explored the experience of transgender patients with HIV prevention, finding many were discouraged by experiences of care that was not culturally competent and affirming.
The findings, including other important themes, were published in Pediatrics.
The pair of online asynchronous focus groups, conducted by Holly B. Fontenot, PhD, RN/NP, of the Fenway Institute in Boston, and colleagues, sought input from 30 transgender participants from across the United States. Eleven were aged 13-18 years, and 19 were aged 18-24 years, with an average age of 19. Most (70%) were white, and the remainder were African American (7%), Asian American (3%), multiracial (17%), and other (3%); 10% identified as Hispanic. Participants were given multiple options for reporting gender identity; 27% reported identifying as transgender males, 17% reported identifying as transgender females, and the rest identified with other terms, including 27% using one or more terms.
The quantitative analysis found four common themes, which the study explored in depth: “barriers to self-efficacy in sexual decision making; safety concerns, fear, and other challenges in forming romantic and/or sexual relationships; need for support and education; and desire for affirmative and culturally competent experiences and interactions.”
Based on their findings, the authors suggested ways of improving transgender youth experiences:
- Increasing provider knowledge and skills in providing affirming care through transgender health education programs.
- Addressing the barriers, such as stigma and lack of accessibility.
- Expanding sexual health education to be more inclusive regarding gender identities, sexual orientations, and definitions of sex.
Providers also need to include information on sexually transmitted infection and HIV prevention, including “discussion of safer sexual behaviors, negotiation and consent, sexual and physical assault, condoms, lubrication, STI and HIV testing, human papillomavirus vaccination, and PrEP [preexposure prophylaxis]” the authors emphasized.
Dr. Fontenot and associates determined that this study’s findings were consistent with what’s known about adult transgender patients, but this study provides more context regarding transgender youth experiences.
“It is important to elicit transgender youth experiences and perspectives related to HIV risk and preventive services,” they concluded. “This study provided a greater understanding of barriers to and facilitators of youth obtaining HIV preventive services and sexual health education.”
Limitations of the study included that non–English speaking participants were excluded, and that participants were predominantly white, non-Hispanic, and assigned female sex at birth.
This study was funded by the Centers for Disease Control and Prevention and NORC at The University of Chicago. The authors had no relevant financial disclosures.
SOURCE: Fontenot HB et al., Pediatrics. 2020. doi: 10.1542/peds.2019-2204.
A pair of focus groups explored the experience of transgender patients with HIV prevention, finding many were discouraged by experiences of care that was not culturally competent and affirming.
The findings, including other important themes, were published in Pediatrics.
The pair of online asynchronous focus groups, conducted by Holly B. Fontenot, PhD, RN/NP, of the Fenway Institute in Boston, and colleagues, sought input from 30 transgender participants from across the United States. Eleven were aged 13-18 years, and 19 were aged 18-24 years, with an average age of 19. Most (70%) were white, and the remainder were African American (7%), Asian American (3%), multiracial (17%), and other (3%); 10% identified as Hispanic. Participants were given multiple options for reporting gender identity; 27% reported identifying as transgender males, 17% reported identifying as transgender females, and the rest identified with other terms, including 27% using one or more terms.
The quantitative analysis found four common themes, which the study explored in depth: “barriers to self-efficacy in sexual decision making; safety concerns, fear, and other challenges in forming romantic and/or sexual relationships; need for support and education; and desire for affirmative and culturally competent experiences and interactions.”
Based on their findings, the authors suggested ways of improving transgender youth experiences:
- Increasing provider knowledge and skills in providing affirming care through transgender health education programs.
- Addressing the barriers, such as stigma and lack of accessibility.
- Expanding sexual health education to be more inclusive regarding gender identities, sexual orientations, and definitions of sex.
Providers also need to include information on sexually transmitted infection and HIV prevention, including “discussion of safer sexual behaviors, negotiation and consent, sexual and physical assault, condoms, lubrication, STI and HIV testing, human papillomavirus vaccination, and PrEP [preexposure prophylaxis]” the authors emphasized.
Dr. Fontenot and associates determined that this study’s findings were consistent with what’s known about adult transgender patients, but this study provides more context regarding transgender youth experiences.
“It is important to elicit transgender youth experiences and perspectives related to HIV risk and preventive services,” they concluded. “This study provided a greater understanding of barriers to and facilitators of youth obtaining HIV preventive services and sexual health education.”
Limitations of the study included that non–English speaking participants were excluded, and that participants were predominantly white, non-Hispanic, and assigned female sex at birth.
This study was funded by the Centers for Disease Control and Prevention and NORC at The University of Chicago. The authors had no relevant financial disclosures.
SOURCE: Fontenot HB et al., Pediatrics. 2020. doi: 10.1542/peds.2019-2204.
FROM PEDIATRICS
FDA approves ozanimod for relapsing and secondary progressive forms of MS
The Food and Drug Administration has approved the oral medication ozanimod (Zeposia) for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, according to a release from Bristol-Myers Squibb.
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. Although its therapeutic mechanism of action in MS is unknown, it may involve the reduction of lymphocyte migration into the central nervous system. A genetic test is not required to start the drug, and no patient observation is required for the first dose, although up-titration of initial doses are required to reach the maintenance dose because a transient decrease in heart rate and atrioventricular conduction delays may occur, according to the company.
The approval is based on a pair of head-to-head studies that compared it with interferon beta-1a (Avonex) and together included more than 2,600 patients. It delivered better efficacy in terms of relative reduction in annualized relapse rate (48% at 1 year and 38% at 2 years). It also demonstrated better relative reduction of the number of T1-weighted gadolinium-enhanced brain lesions (63% fewer at 1 year and 53% fewer at 2 years) and number of new or enlarging T2 lesions (48% fewer at 1 year and 42% at 2 years).
Ozanimod is contraindicated in patients who, in the past 6 months, experienced a myocardial infarction, unstable angina, stroke, or other conditions. It is associated with other health risks, including infections, liver injury, additive immunosuppressive effects from prior immune-modulating therapies, and increased blood pressure. Certain assessments, such as recent complete blood count, ECG, liver function test, and current and prior medications and vaccinations, are required before initiation of treatment.
In its announcement, Bristol-Myers Squibb said that it has decided to delay the commercial launch of ozanimod during the COVID-19 pandemic until a later date.
The drug is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.
The full prescribing information can be found on the company’s website.
The Food and Drug Administration has approved the oral medication ozanimod (Zeposia) for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, according to a release from Bristol-Myers Squibb.
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. Although its therapeutic mechanism of action in MS is unknown, it may involve the reduction of lymphocyte migration into the central nervous system. A genetic test is not required to start the drug, and no patient observation is required for the first dose, although up-titration of initial doses are required to reach the maintenance dose because a transient decrease in heart rate and atrioventricular conduction delays may occur, according to the company.
The approval is based on a pair of head-to-head studies that compared it with interferon beta-1a (Avonex) and together included more than 2,600 patients. It delivered better efficacy in terms of relative reduction in annualized relapse rate (48% at 1 year and 38% at 2 years). It also demonstrated better relative reduction of the number of T1-weighted gadolinium-enhanced brain lesions (63% fewer at 1 year and 53% fewer at 2 years) and number of new or enlarging T2 lesions (48% fewer at 1 year and 42% at 2 years).
Ozanimod is contraindicated in patients who, in the past 6 months, experienced a myocardial infarction, unstable angina, stroke, or other conditions. It is associated with other health risks, including infections, liver injury, additive immunosuppressive effects from prior immune-modulating therapies, and increased blood pressure. Certain assessments, such as recent complete blood count, ECG, liver function test, and current and prior medications and vaccinations, are required before initiation of treatment.
In its announcement, Bristol-Myers Squibb said that it has decided to delay the commercial launch of ozanimod during the COVID-19 pandemic until a later date.
The drug is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.
The full prescribing information can be found on the company’s website.
The Food and Drug Administration has approved the oral medication ozanimod (Zeposia) for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, according to a release from Bristol-Myers Squibb.
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. Although its therapeutic mechanism of action in MS is unknown, it may involve the reduction of lymphocyte migration into the central nervous system. A genetic test is not required to start the drug, and no patient observation is required for the first dose, although up-titration of initial doses are required to reach the maintenance dose because a transient decrease in heart rate and atrioventricular conduction delays may occur, according to the company.
The approval is based on a pair of head-to-head studies that compared it with interferon beta-1a (Avonex) and together included more than 2,600 patients. It delivered better efficacy in terms of relative reduction in annualized relapse rate (48% at 1 year and 38% at 2 years). It also demonstrated better relative reduction of the number of T1-weighted gadolinium-enhanced brain lesions (63% fewer at 1 year and 53% fewer at 2 years) and number of new or enlarging T2 lesions (48% fewer at 1 year and 42% at 2 years).
Ozanimod is contraindicated in patients who, in the past 6 months, experienced a myocardial infarction, unstable angina, stroke, or other conditions. It is associated with other health risks, including infections, liver injury, additive immunosuppressive effects from prior immune-modulating therapies, and increased blood pressure. Certain assessments, such as recent complete blood count, ECG, liver function test, and current and prior medications and vaccinations, are required before initiation of treatment.
In its announcement, Bristol-Myers Squibb said that it has decided to delay the commercial launch of ozanimod during the COVID-19 pandemic until a later date.
The drug is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.
The full prescribing information can be found on the company’s website.
New ASAM guideline released amid COVID-19 concerns
Home-based buprenorphine induction deemed safe for OUD
The American Society of Addiction Medicine has released an updated practice guideline for patients with opioid use disorder.
The guideline, called a focused update, advances ASAM’s 2015 National Practice Guidelines for the Treament of Opioid Use Disorder. “During the ongoing COVID-19 pandemic and the associated need for social distancing, it is especially important that clinicians and health care providers across the country take steps to ensure that individuals with OUD can continue to receive evidence-based care,” said Paul H. Earley, MD, president of ASAM, in a press release announcing the new guideline.
The guideline specifies that home-based buprenorphine induction is safe and effective for treatment of opioid use disorder and that no individual entering the criminal justice system should be subjected to opioid withdrawal.
“The research is clear, providing methadone or buprenorphine, even without psychosocial treatment, reduces the patient’s risk of death,” said Kyle Kampman, MD, chair of the group’s Guideline Writing Committee, in the release. “Ultimately, keeping patients with the disease of addiction alive and engaged to become ready for recovery is absolutely critical in the context of the deadly overdose epidemic that has struck communities across our country.”
The society released this focused update to reflect new medications and formulations, published evidence, and clinical guidance related to treatment of OUD. This update includes the addition of 13 new recommendations and major revisions to 35 existing recommendations. One concern the society has is how to help patients being treated for OUD who are limited in their ability to leave their homes. Because of these same concerns, the Substance Abuse and Mental Health Services Administration relaxed regulations on March 16 regarding patient eligibility for take-home medications, such as buprenorphine and methadone, which dovetails with the society’s guidance regarding home-based induction.
, continuing on to pharmacologic treatment even if the patient declines recommended psychosocial treatment, keeping naloxone kits available in correctional facilities, and more. Additional information about this update can be found on ASAM’s website.
Home-based buprenorphine induction deemed safe for OUD
Home-based buprenorphine induction deemed safe for OUD
The American Society of Addiction Medicine has released an updated practice guideline for patients with opioid use disorder.
The guideline, called a focused update, advances ASAM’s 2015 National Practice Guidelines for the Treament of Opioid Use Disorder. “During the ongoing COVID-19 pandemic and the associated need for social distancing, it is especially important that clinicians and health care providers across the country take steps to ensure that individuals with OUD can continue to receive evidence-based care,” said Paul H. Earley, MD, president of ASAM, in a press release announcing the new guideline.
The guideline specifies that home-based buprenorphine induction is safe and effective for treatment of opioid use disorder and that no individual entering the criminal justice system should be subjected to opioid withdrawal.
“The research is clear, providing methadone or buprenorphine, even without psychosocial treatment, reduces the patient’s risk of death,” said Kyle Kampman, MD, chair of the group’s Guideline Writing Committee, in the release. “Ultimately, keeping patients with the disease of addiction alive and engaged to become ready for recovery is absolutely critical in the context of the deadly overdose epidemic that has struck communities across our country.”
The society released this focused update to reflect new medications and formulations, published evidence, and clinical guidance related to treatment of OUD. This update includes the addition of 13 new recommendations and major revisions to 35 existing recommendations. One concern the society has is how to help patients being treated for OUD who are limited in their ability to leave their homes. Because of these same concerns, the Substance Abuse and Mental Health Services Administration relaxed regulations on March 16 regarding patient eligibility for take-home medications, such as buprenorphine and methadone, which dovetails with the society’s guidance regarding home-based induction.
, continuing on to pharmacologic treatment even if the patient declines recommended psychosocial treatment, keeping naloxone kits available in correctional facilities, and more. Additional information about this update can be found on ASAM’s website.
The American Society of Addiction Medicine has released an updated practice guideline for patients with opioid use disorder.
The guideline, called a focused update, advances ASAM’s 2015 National Practice Guidelines for the Treament of Opioid Use Disorder. “During the ongoing COVID-19 pandemic and the associated need for social distancing, it is especially important that clinicians and health care providers across the country take steps to ensure that individuals with OUD can continue to receive evidence-based care,” said Paul H. Earley, MD, president of ASAM, in a press release announcing the new guideline.
The guideline specifies that home-based buprenorphine induction is safe and effective for treatment of opioid use disorder and that no individual entering the criminal justice system should be subjected to opioid withdrawal.
“The research is clear, providing methadone or buprenorphine, even without psychosocial treatment, reduces the patient’s risk of death,” said Kyle Kampman, MD, chair of the group’s Guideline Writing Committee, in the release. “Ultimately, keeping patients with the disease of addiction alive and engaged to become ready for recovery is absolutely critical in the context of the deadly overdose epidemic that has struck communities across our country.”
The society released this focused update to reflect new medications and formulations, published evidence, and clinical guidance related to treatment of OUD. This update includes the addition of 13 new recommendations and major revisions to 35 existing recommendations. One concern the society has is how to help patients being treated for OUD who are limited in their ability to leave their homes. Because of these same concerns, the Substance Abuse and Mental Health Services Administration relaxed regulations on March 16 regarding patient eligibility for take-home medications, such as buprenorphine and methadone, which dovetails with the society’s guidance regarding home-based induction.
, continuing on to pharmacologic treatment even if the patient declines recommended psychosocial treatment, keeping naloxone kits available in correctional facilities, and more. Additional information about this update can be found on ASAM’s website.
More inclusive assessment better predicts cognitive impairment in very preterm children
rather than just severe impairment, in ongoing monitoring, according to a study published in Pediatrics.
Carmina Erdei, MD, of Brigham and Women’s Hospital and the department of pediatrics at Harvard Medical school, both in Boston, and colleagues prospectively studied 103 children born VPT (32 weeks’ or less gestation) and 109 children born term. Exclusion criteria included congenital abnormalities and having non–English-speaking parents.
The investigators assessed the children’s cognitive abilities and neurodevelopment with age-appropriate measures at various ages: Bayley Scales of Infant Development (2nd ed.) at age 2 years, Wechsler Preschool and Primary Scale of Intelligence at age 4 and 6 years, and Wechsler Intelligence Scale for Children (4th ed.) at age 9 and 12 years.
When only severe cognitive impairment at ages 2, 4, and 6 years was used as the criterion for ongoing monitoring, between 18% and 44% of severely impaired children at 12 years were missed – and would not have received continued monitoring and support. However, when any cognitive impairment at the younger ages was the criterion for continued monitoring, 100% of cases of severe impairment at age 12 years were correctly predicted.
The authors suggest that adoption of this more inclusive approach may be warranted, given the long-term ramifications of even mild cognitive impairment.
Positive predictive value (66%), negative predictive value (89%), and specificity (73%) intersected in assessments performed at age 6 years, such that they had the best predictive ability for any cognitive impairment at age 12 years.
“Our findings highlight the potential benefit of monitoring children at high risk with early delay until elementary school,” the authors wrote. “We acknowledge that this would result in a higher number of referrals and potentially increased short-term costs. Developmental follow-up is costly, yet early developmental services are valuable and positively impact preterm children’s cognitive and preacademic skills.”
The investigators also assessed family-social risks, such as socioeconomic status and maternal education, and found that children born VPT were more than twice as likely to be raised in families with more risks than were those born term (33% vs. 13%, respectively).
Limitations of the study include the high false-positive rate (34%) seen with the assessments at age 6 years, but the authors suggested that could be mitigated with risk stratification.
The study was funded by the Neurological Foundation, Lottery Grants Board, Canterbury Medical Research Foundation, and Health Research Council of New Zealand. The authors reported having no relevant financial relationships or conflicts of interest.
SOURCE: Erdei C et al. Pediatrics. 2020 Mar 6. doi: 10.1542/peds.2019-1982.
rather than just severe impairment, in ongoing monitoring, according to a study published in Pediatrics.
Carmina Erdei, MD, of Brigham and Women’s Hospital and the department of pediatrics at Harvard Medical school, both in Boston, and colleagues prospectively studied 103 children born VPT (32 weeks’ or less gestation) and 109 children born term. Exclusion criteria included congenital abnormalities and having non–English-speaking parents.
The investigators assessed the children’s cognitive abilities and neurodevelopment with age-appropriate measures at various ages: Bayley Scales of Infant Development (2nd ed.) at age 2 years, Wechsler Preschool and Primary Scale of Intelligence at age 4 and 6 years, and Wechsler Intelligence Scale for Children (4th ed.) at age 9 and 12 years.
When only severe cognitive impairment at ages 2, 4, and 6 years was used as the criterion for ongoing monitoring, between 18% and 44% of severely impaired children at 12 years were missed – and would not have received continued monitoring and support. However, when any cognitive impairment at the younger ages was the criterion for continued monitoring, 100% of cases of severe impairment at age 12 years were correctly predicted.
The authors suggest that adoption of this more inclusive approach may be warranted, given the long-term ramifications of even mild cognitive impairment.
Positive predictive value (66%), negative predictive value (89%), and specificity (73%) intersected in assessments performed at age 6 years, such that they had the best predictive ability for any cognitive impairment at age 12 years.
“Our findings highlight the potential benefit of monitoring children at high risk with early delay until elementary school,” the authors wrote. “We acknowledge that this would result in a higher number of referrals and potentially increased short-term costs. Developmental follow-up is costly, yet early developmental services are valuable and positively impact preterm children’s cognitive and preacademic skills.”
The investigators also assessed family-social risks, such as socioeconomic status and maternal education, and found that children born VPT were more than twice as likely to be raised in families with more risks than were those born term (33% vs. 13%, respectively).
Limitations of the study include the high false-positive rate (34%) seen with the assessments at age 6 years, but the authors suggested that could be mitigated with risk stratification.
The study was funded by the Neurological Foundation, Lottery Grants Board, Canterbury Medical Research Foundation, and Health Research Council of New Zealand. The authors reported having no relevant financial relationships or conflicts of interest.
SOURCE: Erdei C et al. Pediatrics. 2020 Mar 6. doi: 10.1542/peds.2019-1982.
rather than just severe impairment, in ongoing monitoring, according to a study published in Pediatrics.
Carmina Erdei, MD, of Brigham and Women’s Hospital and the department of pediatrics at Harvard Medical school, both in Boston, and colleagues prospectively studied 103 children born VPT (32 weeks’ or less gestation) and 109 children born term. Exclusion criteria included congenital abnormalities and having non–English-speaking parents.
The investigators assessed the children’s cognitive abilities and neurodevelopment with age-appropriate measures at various ages: Bayley Scales of Infant Development (2nd ed.) at age 2 years, Wechsler Preschool and Primary Scale of Intelligence at age 4 and 6 years, and Wechsler Intelligence Scale for Children (4th ed.) at age 9 and 12 years.
When only severe cognitive impairment at ages 2, 4, and 6 years was used as the criterion for ongoing monitoring, between 18% and 44% of severely impaired children at 12 years were missed – and would not have received continued monitoring and support. However, when any cognitive impairment at the younger ages was the criterion for continued monitoring, 100% of cases of severe impairment at age 12 years were correctly predicted.
The authors suggest that adoption of this more inclusive approach may be warranted, given the long-term ramifications of even mild cognitive impairment.
Positive predictive value (66%), negative predictive value (89%), and specificity (73%) intersected in assessments performed at age 6 years, such that they had the best predictive ability for any cognitive impairment at age 12 years.
“Our findings highlight the potential benefit of monitoring children at high risk with early delay until elementary school,” the authors wrote. “We acknowledge that this would result in a higher number of referrals and potentially increased short-term costs. Developmental follow-up is costly, yet early developmental services are valuable and positively impact preterm children’s cognitive and preacademic skills.”
The investigators also assessed family-social risks, such as socioeconomic status and maternal education, and found that children born VPT were more than twice as likely to be raised in families with more risks than were those born term (33% vs. 13%, respectively).
Limitations of the study include the high false-positive rate (34%) seen with the assessments at age 6 years, but the authors suggested that could be mitigated with risk stratification.
The study was funded by the Neurological Foundation, Lottery Grants Board, Canterbury Medical Research Foundation, and Health Research Council of New Zealand. The authors reported having no relevant financial relationships or conflicts of interest.
SOURCE: Erdei C et al. Pediatrics. 2020 Mar 6. doi: 10.1542/peds.2019-1982.
FROM PEDIATRICS
Stillbirth linked to end-stage renal disease
and they were also at greater risk for chronic kidney disease (CKD), according to findings published in the American Journal of Obstetrics & Gynecology.
Peter M Barrett, MB, of the University College Cork (Ireland), and colleagues conducted a population-based cohort study using data from the Swedish Medical Birth Register, National Patient Register, and the Swedish Renal Register to identify women who had live births and stillbirths. They then used anonymized unique personal identification numbers to cross-reference the registries.
From a full cohort of nearly 2 million women who gave birth during 1973-2012, and during a median follow-up of 20.7 years, 13,032 women experienced stillbirth, which, until 2008, was defined as fetal death after 28 weeks’ gestation, and after 2008, as occurring after 22 weeks. Women were excluded if they had any diagnosis of renal disease before their first pregnancy, as well as for a history of cardiovascular disease, chronic hypertension, diabetes, and certain other conditions at baseline.
Overall, 18,017 women developed CKD, and 1,283 developed ESRD. The fully adjusted model showed adjusted hazard ratios of 1.26 for CKD (95% confidence interval, 1.09-1.45) and 2.25 for ESRD (95% CI, 1.55-3.25) in women who had experienced stillbirth, compared with those who had not experienced stillbirth.
The researchers reported that associations between stillbirth and renal disease existed independently of underlying medical and obstetric comorbidities, such as congenital malformations, being small for gestational age, and preeclampsia, and that when those comorbidities were excluded, “the associations between stillbirth and maternal renal disease were strengthened (CKD: aHR, 1.33; 95% CI, 1.13-1.57; and ESRD: aHR, 2.95; 95% CI, 1.86-4.68).”
In addition, they noted that there was no significant association between stillbirth and either CKD or ESRD in women who had prepregnancy medical comorbidities (CKD: aHR, 1.13; 95% CI 0.73-1.75; and ESRD: aHR 1.49; 95% CI, 0.78-2.85).
“Further research is required to better understand the underlying pathophysiology of this association and to determine whether affected women would benefit from closer surveillance and follow-up for future hypertension and renal disease,” the authors concluded.
The work was performed within the Irish Clinical Academic Training Programme and was funded by grants from several organizations. The authors reported no conflicts of interest.
SOURCE: Barret PM et al. Am J Obstet Gynecol. 2020 Feb 26. doi: 10.1016/j.ajog.2020.02.031.
and they were also at greater risk for chronic kidney disease (CKD), according to findings published in the American Journal of Obstetrics & Gynecology.
Peter M Barrett, MB, of the University College Cork (Ireland), and colleagues conducted a population-based cohort study using data from the Swedish Medical Birth Register, National Patient Register, and the Swedish Renal Register to identify women who had live births and stillbirths. They then used anonymized unique personal identification numbers to cross-reference the registries.
From a full cohort of nearly 2 million women who gave birth during 1973-2012, and during a median follow-up of 20.7 years, 13,032 women experienced stillbirth, which, until 2008, was defined as fetal death after 28 weeks’ gestation, and after 2008, as occurring after 22 weeks. Women were excluded if they had any diagnosis of renal disease before their first pregnancy, as well as for a history of cardiovascular disease, chronic hypertension, diabetes, and certain other conditions at baseline.
Overall, 18,017 women developed CKD, and 1,283 developed ESRD. The fully adjusted model showed adjusted hazard ratios of 1.26 for CKD (95% confidence interval, 1.09-1.45) and 2.25 for ESRD (95% CI, 1.55-3.25) in women who had experienced stillbirth, compared with those who had not experienced stillbirth.
The researchers reported that associations between stillbirth and renal disease existed independently of underlying medical and obstetric comorbidities, such as congenital malformations, being small for gestational age, and preeclampsia, and that when those comorbidities were excluded, “the associations between stillbirth and maternal renal disease were strengthened (CKD: aHR, 1.33; 95% CI, 1.13-1.57; and ESRD: aHR, 2.95; 95% CI, 1.86-4.68).”
In addition, they noted that there was no significant association between stillbirth and either CKD or ESRD in women who had prepregnancy medical comorbidities (CKD: aHR, 1.13; 95% CI 0.73-1.75; and ESRD: aHR 1.49; 95% CI, 0.78-2.85).
“Further research is required to better understand the underlying pathophysiology of this association and to determine whether affected women would benefit from closer surveillance and follow-up for future hypertension and renal disease,” the authors concluded.
The work was performed within the Irish Clinical Academic Training Programme and was funded by grants from several organizations. The authors reported no conflicts of interest.
SOURCE: Barret PM et al. Am J Obstet Gynecol. 2020 Feb 26. doi: 10.1016/j.ajog.2020.02.031.
and they were also at greater risk for chronic kidney disease (CKD), according to findings published in the American Journal of Obstetrics & Gynecology.
Peter M Barrett, MB, of the University College Cork (Ireland), and colleagues conducted a population-based cohort study using data from the Swedish Medical Birth Register, National Patient Register, and the Swedish Renal Register to identify women who had live births and stillbirths. They then used anonymized unique personal identification numbers to cross-reference the registries.
From a full cohort of nearly 2 million women who gave birth during 1973-2012, and during a median follow-up of 20.7 years, 13,032 women experienced stillbirth, which, until 2008, was defined as fetal death after 28 weeks’ gestation, and after 2008, as occurring after 22 weeks. Women were excluded if they had any diagnosis of renal disease before their first pregnancy, as well as for a history of cardiovascular disease, chronic hypertension, diabetes, and certain other conditions at baseline.
Overall, 18,017 women developed CKD, and 1,283 developed ESRD. The fully adjusted model showed adjusted hazard ratios of 1.26 for CKD (95% confidence interval, 1.09-1.45) and 2.25 for ESRD (95% CI, 1.55-3.25) in women who had experienced stillbirth, compared with those who had not experienced stillbirth.
The researchers reported that associations between stillbirth and renal disease existed independently of underlying medical and obstetric comorbidities, such as congenital malformations, being small for gestational age, and preeclampsia, and that when those comorbidities were excluded, “the associations between stillbirth and maternal renal disease were strengthened (CKD: aHR, 1.33; 95% CI, 1.13-1.57; and ESRD: aHR, 2.95; 95% CI, 1.86-4.68).”
In addition, they noted that there was no significant association between stillbirth and either CKD or ESRD in women who had prepregnancy medical comorbidities (CKD: aHR, 1.13; 95% CI 0.73-1.75; and ESRD: aHR 1.49; 95% CI, 0.78-2.85).
“Further research is required to better understand the underlying pathophysiology of this association and to determine whether affected women would benefit from closer surveillance and follow-up for future hypertension and renal disease,” the authors concluded.
The work was performed within the Irish Clinical Academic Training Programme and was funded by grants from several organizations. The authors reported no conflicts of interest.
SOURCE: Barret PM et al. Am J Obstet Gynecol. 2020 Feb 26. doi: 10.1016/j.ajog.2020.02.031.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Family history of MI may increase CVD mortality after bilateral salpingo-oophorectomy
Family history of premature MI (FHPMI) in women with bilateral salpingo-oophorectomy (BSO) modifies the increased mortality associated with heart disease and cardiovascular disease in those women, according to an analysis published in Menopause.
Duke Appiah, PhD, of the department of public health at Texas Tech University Health Sciences Center, Lubbock, and colleagues drew data for 4,066 postmenopausal women aged 40 years and older from the National Health and Nutrition Examination Survey III (1988-1994). Women were excluded if they had partial or unilateral oophorectomy; unknown or missing age at menopause; or prevalent MI, stroke, or heart failure, which left a sample of 2,763 women for the analysis.
Women with BSO were considered postmenopausal if they had not experienced a menstrual period within the previous 12 months. Women were asked whether any blood relatives, and especially any first-degree relatives, had a heart attack before age 50 years, which was considered premature MI. The average age at baseline was 62 years. Of those 2,763 women, 610 women had BSO, 338 had FHPMI, and 95 had both, which yields weighted proportions of 24%, 15%, and 5%, respectively.
When compared with having neither factor, presence of any FHPMI was modestly associated with increased risk of mortality from heart disease (HD), cardiovascular disease (CVD), and all causes in the multivariable adjusted analysis, and having undergone BSO was not significantly associated with any of those on its own. However, the combination of those two factors yielded much higher multivariable adjusted hazard ratios – HD mortality, 2.88; CVD mortality, 2.05; and all-cause mortality, 1.58.
These multivariable adjusted HRs were even more dramatic with first-degree FHPMI and BSO: 3.51 for HD mortality, 2.55 for CVD mortality, and 1.63 for all-cause mortality.
In the women who had the combination of FHPMI and BSO, the elevated risks of HD, CVD, and all-cause mortality “were stronger in women who underwent BSO before the age of 45 years than among those who had this procedure at or after the age of 45 years,” reported Dr. Appiah and colleagues. A significantly elevated risk of HD, CVD, or all-cause mortality was not evident in women with BSO alone “regardless of age at surgery.”
“This study provides additional evidence that removal of the ovaries before the natural age of menopause is associated with multiple adverse long-term health outcomes, including cardiovascular disease and early mortality and should be strongly discouraged in women who are not at increased genetic risk for ovarian cancer,” Stephanie Faubion, MD, medical director of North American of Menopause Science, commented in a press release. She was not involved in the study.
Limitations of the study include how FHPMI was self-reported; however, the investigators suggested that, given findings of other research regarding reporting family history (Genet Epidemiol. 1999;17:141-50), the true rate may actually have been underreported. The investigators cited the large, population-based sample size as one of the study’s strengths, suggesting it helps make the findings generalizable.
The investigators disclosed no external funding or conflicts of interest.
SOURCE: Appiah D et al. Menopause. 2020 Feb. doi: 10.1097/GME.0000000000001522.
Family history of premature MI (FHPMI) in women with bilateral salpingo-oophorectomy (BSO) modifies the increased mortality associated with heart disease and cardiovascular disease in those women, according to an analysis published in Menopause.
Duke Appiah, PhD, of the department of public health at Texas Tech University Health Sciences Center, Lubbock, and colleagues drew data for 4,066 postmenopausal women aged 40 years and older from the National Health and Nutrition Examination Survey III (1988-1994). Women were excluded if they had partial or unilateral oophorectomy; unknown or missing age at menopause; or prevalent MI, stroke, or heart failure, which left a sample of 2,763 women for the analysis.
Women with BSO were considered postmenopausal if they had not experienced a menstrual period within the previous 12 months. Women were asked whether any blood relatives, and especially any first-degree relatives, had a heart attack before age 50 years, which was considered premature MI. The average age at baseline was 62 years. Of those 2,763 women, 610 women had BSO, 338 had FHPMI, and 95 had both, which yields weighted proportions of 24%, 15%, and 5%, respectively.
When compared with having neither factor, presence of any FHPMI was modestly associated with increased risk of mortality from heart disease (HD), cardiovascular disease (CVD), and all causes in the multivariable adjusted analysis, and having undergone BSO was not significantly associated with any of those on its own. However, the combination of those two factors yielded much higher multivariable adjusted hazard ratios – HD mortality, 2.88; CVD mortality, 2.05; and all-cause mortality, 1.58.
These multivariable adjusted HRs were even more dramatic with first-degree FHPMI and BSO: 3.51 for HD mortality, 2.55 for CVD mortality, and 1.63 for all-cause mortality.
In the women who had the combination of FHPMI and BSO, the elevated risks of HD, CVD, and all-cause mortality “were stronger in women who underwent BSO before the age of 45 years than among those who had this procedure at or after the age of 45 years,” reported Dr. Appiah and colleagues. A significantly elevated risk of HD, CVD, or all-cause mortality was not evident in women with BSO alone “regardless of age at surgery.”
“This study provides additional evidence that removal of the ovaries before the natural age of menopause is associated with multiple adverse long-term health outcomes, including cardiovascular disease and early mortality and should be strongly discouraged in women who are not at increased genetic risk for ovarian cancer,” Stephanie Faubion, MD, medical director of North American of Menopause Science, commented in a press release. She was not involved in the study.
Limitations of the study include how FHPMI was self-reported; however, the investigators suggested that, given findings of other research regarding reporting family history (Genet Epidemiol. 1999;17:141-50), the true rate may actually have been underreported. The investigators cited the large, population-based sample size as one of the study’s strengths, suggesting it helps make the findings generalizable.
The investigators disclosed no external funding or conflicts of interest.
SOURCE: Appiah D et al. Menopause. 2020 Feb. doi: 10.1097/GME.0000000000001522.
Family history of premature MI (FHPMI) in women with bilateral salpingo-oophorectomy (BSO) modifies the increased mortality associated with heart disease and cardiovascular disease in those women, according to an analysis published in Menopause.
Duke Appiah, PhD, of the department of public health at Texas Tech University Health Sciences Center, Lubbock, and colleagues drew data for 4,066 postmenopausal women aged 40 years and older from the National Health and Nutrition Examination Survey III (1988-1994). Women were excluded if they had partial or unilateral oophorectomy; unknown or missing age at menopause; or prevalent MI, stroke, or heart failure, which left a sample of 2,763 women for the analysis.
Women with BSO were considered postmenopausal if they had not experienced a menstrual period within the previous 12 months. Women were asked whether any blood relatives, and especially any first-degree relatives, had a heart attack before age 50 years, which was considered premature MI. The average age at baseline was 62 years. Of those 2,763 women, 610 women had BSO, 338 had FHPMI, and 95 had both, which yields weighted proportions of 24%, 15%, and 5%, respectively.
When compared with having neither factor, presence of any FHPMI was modestly associated with increased risk of mortality from heart disease (HD), cardiovascular disease (CVD), and all causes in the multivariable adjusted analysis, and having undergone BSO was not significantly associated with any of those on its own. However, the combination of those two factors yielded much higher multivariable adjusted hazard ratios – HD mortality, 2.88; CVD mortality, 2.05; and all-cause mortality, 1.58.
These multivariable adjusted HRs were even more dramatic with first-degree FHPMI and BSO: 3.51 for HD mortality, 2.55 for CVD mortality, and 1.63 for all-cause mortality.
In the women who had the combination of FHPMI and BSO, the elevated risks of HD, CVD, and all-cause mortality “were stronger in women who underwent BSO before the age of 45 years than among those who had this procedure at or after the age of 45 years,” reported Dr. Appiah and colleagues. A significantly elevated risk of HD, CVD, or all-cause mortality was not evident in women with BSO alone “regardless of age at surgery.”
“This study provides additional evidence that removal of the ovaries before the natural age of menopause is associated with multiple adverse long-term health outcomes, including cardiovascular disease and early mortality and should be strongly discouraged in women who are not at increased genetic risk for ovarian cancer,” Stephanie Faubion, MD, medical director of North American of Menopause Science, commented in a press release. She was not involved in the study.
Limitations of the study include how FHPMI was self-reported; however, the investigators suggested that, given findings of other research regarding reporting family history (Genet Epidemiol. 1999;17:141-50), the true rate may actually have been underreported. The investigators cited the large, population-based sample size as one of the study’s strengths, suggesting it helps make the findings generalizable.
The investigators disclosed no external funding or conflicts of interest.
SOURCE: Appiah D et al. Menopause. 2020 Feb. doi: 10.1097/GME.0000000000001522.
FROM MENOPAUSE
China’s health authorities release large coronavirus case series
The Chinese Center for Disease Control and Prevention has released the largest case series to date for novel coronavirus 2019 (COVID-19), and a summary of key findings appears in JAMA.
- The virus, which spread from a single city to a whole country in only 30 days, has so far has caused over 72,314 cases as of Feb. 11, 2020, and 1,023 fatalities (2.3%) overall.
- The age distribution shows that most of the cases (87%) occurred in patients aged 30-79 years, while 10% were in patients 29 years and younger and 3% at 80 years and older.
- Following the SARS outbreak in 2002-2003, the Chinese government adjusted its epidemic response protocol. For example, according to the summary, while there were 300 cases and 5 deaths with SARS before the Chinese government reported it to the World Health Organization, there were only 27 cases and no deaths with COVID-19 before it was reported to that agency.
- A major goal, the authors wrote, is to buy enough time for scientific research, hopefully before the disease has become too widespread.
The summary argues that, while some measures the Chinese government has taken could be seen as extreme, the overall benefits and lives saved outweigh the potential infringement on civil liberties. It also suggests that countries need to work together in situations like this because disease pathogens do not respect geopolitical borders.
SOURCE: Wu Z, McGoogan JM. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.
The Chinese Center for Disease Control and Prevention has released the largest case series to date for novel coronavirus 2019 (COVID-19), and a summary of key findings appears in JAMA.
- The virus, which spread from a single city to a whole country in only 30 days, has so far has caused over 72,314 cases as of Feb. 11, 2020, and 1,023 fatalities (2.3%) overall.
- The age distribution shows that most of the cases (87%) occurred in patients aged 30-79 years, while 10% were in patients 29 years and younger and 3% at 80 years and older.
- Following the SARS outbreak in 2002-2003, the Chinese government adjusted its epidemic response protocol. For example, according to the summary, while there were 300 cases and 5 deaths with SARS before the Chinese government reported it to the World Health Organization, there were only 27 cases and no deaths with COVID-19 before it was reported to that agency.
- A major goal, the authors wrote, is to buy enough time for scientific research, hopefully before the disease has become too widespread.
The summary argues that, while some measures the Chinese government has taken could be seen as extreme, the overall benefits and lives saved outweigh the potential infringement on civil liberties. It also suggests that countries need to work together in situations like this because disease pathogens do not respect geopolitical borders.
SOURCE: Wu Z, McGoogan JM. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.
The Chinese Center for Disease Control and Prevention has released the largest case series to date for novel coronavirus 2019 (COVID-19), and a summary of key findings appears in JAMA.
- The virus, which spread from a single city to a whole country in only 30 days, has so far has caused over 72,314 cases as of Feb. 11, 2020, and 1,023 fatalities (2.3%) overall.
- The age distribution shows that most of the cases (87%) occurred in patients aged 30-79 years, while 10% were in patients 29 years and younger and 3% at 80 years and older.
- Following the SARS outbreak in 2002-2003, the Chinese government adjusted its epidemic response protocol. For example, according to the summary, while there were 300 cases and 5 deaths with SARS before the Chinese government reported it to the World Health Organization, there were only 27 cases and no deaths with COVID-19 before it was reported to that agency.
- A major goal, the authors wrote, is to buy enough time for scientific research, hopefully before the disease has become too widespread.
The summary argues that, while some measures the Chinese government has taken could be seen as extreme, the overall benefits and lives saved outweigh the potential infringement on civil liberties. It also suggests that countries need to work together in situations like this because disease pathogens do not respect geopolitical borders.
SOURCE: Wu Z, McGoogan JM. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.
FROM JAMA
Neurologists report low job satisfaction
The report found that only 18% of neurologists were very happy at work, and 41% overall identified themselves as burned out. Among reasons for burnout, 61% reported mounting bureaucratic tasks as their top reason, with 40% listing spending too many hours at work.
Coping strategies varied, with isolation from others topping the list at 46%, followed by talking with close friends and family and exercise tied at 40%.
Less than half (46%) claimed there was no impact on patients, but most (65%) don’t intend to seek professional help for depression and/or burnout and haven’t done so in the past. Similarly, 48% reported it’s unlikely they’d participate in a workplace program – in fact, only 33% said they would.
A slideshow laying out the findings in the report is available on Medscape.
A closer look at the numbers
Over 15,000 physicians across 29 specialties completed the 10-minute survey in the summer of 2019; 62% were men and most of the group were Baby Boomers (ages 55-73), then Generation X (ages 40-54), and lastly Millennials (ages 25-39). Of the specialties surveyed, neurologists scored lowest in the happiness-at-work category, with only 18% saying they were happy. Neurologists also scored lowest in happiness outside of work (44%). Half the neurologists surveyed said they were burned out, which was slightly more than the surveyed group of physicians in general. The biggest contributors to burnout were bureaucratic tasks, too many hours at work, and lack of control. Most coped by isolating themselves, talking with family members or friends, exercising and sleep. About 65% did not seek help for burnout or depression. The main reasons were being too busy, preferring to deal with it themselves, or feeling that the problem was not significant enough to warrant intervention.
A majority of the neurologists surveyed (70%-80%) are married and 85% say they have a good marriage. Almost half of neurologists take 3-4 weeks of vacation and a third take 1-2 weeks. Neurologists surveyed drive mostly Hondas and Toyotas; 4% drive Teslas and 3% drive Porsches. One third of neurologists exercise two to three times per week and 10% exercise daily. Only 20% have a drink more than four times per week.
Looking for solutions
“It is a bit distressing to see how many neurologists are unhappy at work and unhappy even outside of work,” said Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles. Many neurologists claim to be burned out and a small percent report depression. Most do not seek help, do not take care of themselves well enough, and do not vacation or exercise enough, added Dr. Rapoport, who also is a past president of the International Headache Society and is editor in chief of Neurology Reviews.
Dr. Rapoport believes that some studies about this situation should be done by the American Academy of Neurology and other subspecialty organizations (for example, the American Headache Society), and results should be published in the neurology and subspecialty journals. Further work in this area should include suggestions for rectifying the situation and encouraging neurologists to seek help and improve their lifestyle. “I think that one of the ways that headache specialists have avoided burnout and depression is by focusing on one subspecialty area and engaging in different types of activities, such as seeing patients in the office and hospital, giving lectures, traveling to meetings, writing papers, and balancing their professional and personal lives. It appears that we need help as a profession, and we had better help ourselves to get it.”
The report found that only 18% of neurologists were very happy at work, and 41% overall identified themselves as burned out. Among reasons for burnout, 61% reported mounting bureaucratic tasks as their top reason, with 40% listing spending too many hours at work.
Coping strategies varied, with isolation from others topping the list at 46%, followed by talking with close friends and family and exercise tied at 40%.
Less than half (46%) claimed there was no impact on patients, but most (65%) don’t intend to seek professional help for depression and/or burnout and haven’t done so in the past. Similarly, 48% reported it’s unlikely they’d participate in a workplace program – in fact, only 33% said they would.
A slideshow laying out the findings in the report is available on Medscape.
A closer look at the numbers
Over 15,000 physicians across 29 specialties completed the 10-minute survey in the summer of 2019; 62% were men and most of the group were Baby Boomers (ages 55-73), then Generation X (ages 40-54), and lastly Millennials (ages 25-39). Of the specialties surveyed, neurologists scored lowest in the happiness-at-work category, with only 18% saying they were happy. Neurologists also scored lowest in happiness outside of work (44%). Half the neurologists surveyed said they were burned out, which was slightly more than the surveyed group of physicians in general. The biggest contributors to burnout were bureaucratic tasks, too many hours at work, and lack of control. Most coped by isolating themselves, talking with family members or friends, exercising and sleep. About 65% did not seek help for burnout or depression. The main reasons were being too busy, preferring to deal with it themselves, or feeling that the problem was not significant enough to warrant intervention.
A majority of the neurologists surveyed (70%-80%) are married and 85% say they have a good marriage. Almost half of neurologists take 3-4 weeks of vacation and a third take 1-2 weeks. Neurologists surveyed drive mostly Hondas and Toyotas; 4% drive Teslas and 3% drive Porsches. One third of neurologists exercise two to three times per week and 10% exercise daily. Only 20% have a drink more than four times per week.
Looking for solutions
“It is a bit distressing to see how many neurologists are unhappy at work and unhappy even outside of work,” said Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles. Many neurologists claim to be burned out and a small percent report depression. Most do not seek help, do not take care of themselves well enough, and do not vacation or exercise enough, added Dr. Rapoport, who also is a past president of the International Headache Society and is editor in chief of Neurology Reviews.
Dr. Rapoport believes that some studies about this situation should be done by the American Academy of Neurology and other subspecialty organizations (for example, the American Headache Society), and results should be published in the neurology and subspecialty journals. Further work in this area should include suggestions for rectifying the situation and encouraging neurologists to seek help and improve their lifestyle. “I think that one of the ways that headache specialists have avoided burnout and depression is by focusing on one subspecialty area and engaging in different types of activities, such as seeing patients in the office and hospital, giving lectures, traveling to meetings, writing papers, and balancing their professional and personal lives. It appears that we need help as a profession, and we had better help ourselves to get it.”
The report found that only 18% of neurologists were very happy at work, and 41% overall identified themselves as burned out. Among reasons for burnout, 61% reported mounting bureaucratic tasks as their top reason, with 40% listing spending too many hours at work.
Coping strategies varied, with isolation from others topping the list at 46%, followed by talking with close friends and family and exercise tied at 40%.
Less than half (46%) claimed there was no impact on patients, but most (65%) don’t intend to seek professional help for depression and/or burnout and haven’t done so in the past. Similarly, 48% reported it’s unlikely they’d participate in a workplace program – in fact, only 33% said they would.
A slideshow laying out the findings in the report is available on Medscape.
A closer look at the numbers
Over 15,000 physicians across 29 specialties completed the 10-minute survey in the summer of 2019; 62% were men and most of the group were Baby Boomers (ages 55-73), then Generation X (ages 40-54), and lastly Millennials (ages 25-39). Of the specialties surveyed, neurologists scored lowest in the happiness-at-work category, with only 18% saying they were happy. Neurologists also scored lowest in happiness outside of work (44%). Half the neurologists surveyed said they were burned out, which was slightly more than the surveyed group of physicians in general. The biggest contributors to burnout were bureaucratic tasks, too many hours at work, and lack of control. Most coped by isolating themselves, talking with family members or friends, exercising and sleep. About 65% did not seek help for burnout or depression. The main reasons were being too busy, preferring to deal with it themselves, or feeling that the problem was not significant enough to warrant intervention.
A majority of the neurologists surveyed (70%-80%) are married and 85% say they have a good marriage. Almost half of neurologists take 3-4 weeks of vacation and a third take 1-2 weeks. Neurologists surveyed drive mostly Hondas and Toyotas; 4% drive Teslas and 3% drive Porsches. One third of neurologists exercise two to three times per week and 10% exercise daily. Only 20% have a drink more than four times per week.
Looking for solutions
“It is a bit distressing to see how many neurologists are unhappy at work and unhappy even outside of work,” said Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles. Many neurologists claim to be burned out and a small percent report depression. Most do not seek help, do not take care of themselves well enough, and do not vacation or exercise enough, added Dr. Rapoport, who also is a past president of the International Headache Society and is editor in chief of Neurology Reviews.
Dr. Rapoport believes that some studies about this situation should be done by the American Academy of Neurology and other subspecialty organizations (for example, the American Headache Society), and results should be published in the neurology and subspecialty journals. Further work in this area should include suggestions for rectifying the situation and encouraging neurologists to seek help and improve their lifestyle. “I think that one of the ways that headache specialists have avoided burnout and depression is by focusing on one subspecialty area and engaging in different types of activities, such as seeing patients in the office and hospital, giving lectures, traveling to meetings, writing papers, and balancing their professional and personal lives. It appears that we need help as a profession, and we had better help ourselves to get it.”
Prescription osteoarthritis relief gets OTC approval
The Food and Drug Administration has approved formerly prescription-only Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription use via a process known as a prescription to over-the-counter (Rx-to-OTC) switch, according to a news release from the agency.
“As a result of the Rx-to-OTC switch process, many products sold over the counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
This switch to nonprescription status is usually initiated by the manufacturer, who must provide data that demonstrates the drug in question is both safe and effective as self-medication in accordance with the proposed labeling and that consumers can use it safely and effectively without the supervision of a health care professional.
This particular therapy is a topical NSAID gel and was first approved by the FDA in 2007 with the indication for relief of osteoarthritis pain. It can take 7 days to have an effect, but if patients find it takes longer than that or they need to use it for more than 21 days, they should seek medical attention. The gel can cause severe allergic reactions, especially in people allergic to aspirin; patients who experience such reactions are advised to stop use and seek immediate medical care. Other concerns include potential for liver damage with extended use; the possibility of severe stomach bleeds; and risk of heart attack, heart failure, and stroke.
The gel will no longer be available in prescription form.
Full prescribing information can be found on the FDA website, as can the full news release regarding this approval.
The Food and Drug Administration has approved formerly prescription-only Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription use via a process known as a prescription to over-the-counter (Rx-to-OTC) switch, according to a news release from the agency.
“As a result of the Rx-to-OTC switch process, many products sold over the counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
This switch to nonprescription status is usually initiated by the manufacturer, who must provide data that demonstrates the drug in question is both safe and effective as self-medication in accordance with the proposed labeling and that consumers can use it safely and effectively without the supervision of a health care professional.
This particular therapy is a topical NSAID gel and was first approved by the FDA in 2007 with the indication for relief of osteoarthritis pain. It can take 7 days to have an effect, but if patients find it takes longer than that or they need to use it for more than 21 days, they should seek medical attention. The gel can cause severe allergic reactions, especially in people allergic to aspirin; patients who experience such reactions are advised to stop use and seek immediate medical care. Other concerns include potential for liver damage with extended use; the possibility of severe stomach bleeds; and risk of heart attack, heart failure, and stroke.
The gel will no longer be available in prescription form.
Full prescribing information can be found on the FDA website, as can the full news release regarding this approval.
The Food and Drug Administration has approved formerly prescription-only Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription use via a process known as a prescription to over-the-counter (Rx-to-OTC) switch, according to a news release from the agency.
“As a result of the Rx-to-OTC switch process, many products sold over the counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
This switch to nonprescription status is usually initiated by the manufacturer, who must provide data that demonstrates the drug in question is both safe and effective as self-medication in accordance with the proposed labeling and that consumers can use it safely and effectively without the supervision of a health care professional.
This particular therapy is a topical NSAID gel and was first approved by the FDA in 2007 with the indication for relief of osteoarthritis pain. It can take 7 days to have an effect, but if patients find it takes longer than that or they need to use it for more than 21 days, they should seek medical attention. The gel can cause severe allergic reactions, especially in people allergic to aspirin; patients who experience such reactions are advised to stop use and seek immediate medical care. Other concerns include potential for liver damage with extended use; the possibility of severe stomach bleeds; and risk of heart attack, heart failure, and stroke.
The gel will no longer be available in prescription form.
Full prescribing information can be found on the FDA website, as can the full news release regarding this approval.