Ob.Gyn. News

Children born before 27 weeks’ gestation had lower combined risk of death or severe neurodevelopmental impairment when exposed to antenatal corticosteroids and magnesium sulfate together, compared with exposure of either or neither therapy, according to a prospective observational study published in Obstetrics & Gynecology.

MichaelDeLeon/E+

“If there is sufficient time to administer antenatal corticosteroids, there should similarly be sufficient time to administer magnesium sulfate,” wrote Samuel J. Gentle, MD, of the University of Alabama at Birmingham, and colleagues. “Given the lower rate of severe neurodevelopmental impairment or death in children exposed to both antenatal corticosteroids and magnesium sulfate in the present study, compared with those exposed to antenatal corticosteroids alone, increasing the rates of magnesium sulfate exposure through quality improvement or other interventions may improve infant outcomes.”

Although previous randomized controlled trials had shown neurologic benefits of each therapy independently in preterm children, few data exist on extremely preterm children, the authors noted. They also pointed out differences in the findings when they analyzed neurodevelopmental outcomes and death separately.

“Whereas exposure to both therapies was associated with a lower rate of death, exposure to magnesium sulfate in addition to antenatal corticosteroids was not associated with a lower rate of severe neurodevelopmental impairment or components of severe neurodevelopmental impairment including Bayley scores, bilateral hearing impairment, and cerebral palsy,” Dr Gentle and his coauthors wrote.

The researchers used prospectively collected data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network Generic Database to track 3,093 children born extremely preterm – from 22 weeks 0 days to 26 weeks 6 days – during 2011-2014.

The researchers compared outcomes of death or severe neurodevelopmental impairment when the children were 18-26 months of corrected age based on whether they had been exposed to antenatal corticosteroids alone (betamethasone or dexamethasone) or antenatal corticosteroids in addition to magnesium sulfate. Severe neurodevelopmental impairment included “severe cerebral palsy, motor or cognitive composite score less than 70 on the Bayley-III exam, bilateral blindness, or bilateral severe functional hearing impairment with or without amplification.”

The researchers also looked at severe neurodevelopmental impairment and death among children with only magnesium sulfate exposure or with no exposure to steroids or magnesium.

In the study population, 73% of infants had been exposed to both therapies, 16% had been exposed to only corticosteroids, 3% to only magnesium sulfate, and 8% to neither therapy.

“Importantly, a larger proportion of mothers unexposed to either therapy, compared with both therapies, received high school or less education or had no maternal private health insurance which may suggest health inequity as a driver for antenatal therapy exposure rates,” Dr. Gentle and associates noted.

Children whose mothers received corticosteroids and magnesium had a 27% lower risk of severe neurodevelopmental impairment or death, compared with those whose mothers only received corticosteroids (adjusted odds ratio, 0.73). Just over a third of children exposed to both interventions (36%) had severe neurodevelopmental impairment or died, compared with 44% of those exposed only to steroids.

Similarly, corticosteroids and magnesium together were associated with approximately half the risk of death or severe neurodevelopmental impairment, compared with magnesium alone (aOR, 0.49) and 34% lower risk, compared with neither therapy (aOR 0.66).

When the researchers uncoupled the outcomes, severe neurodevelopmental impairment rates were similar among all exposure groups, but rates of death were lower among those who received both therapies than among those who received just one or neither therapy.

“The therapeutic mechanism for neuroprotection in children exposed to magnesium sulfate is unclear but may result from neuronal stabilization or anti-inflammatory properties,” Dr. Gentle and colleagues said.

They also compared rates in the exposure groups of grade 3-4 intracranial hemorrhage, which has been linked to poor neurodevelopmental outcomes in extremely preterm children.

“The rate of grade 3-4 intracranial hemorrhage did not differ between children exposed to both antenatal corticosteroids and magnesium sulfate and those exposed to antenatal corticosteroids alone,” they said. “These findings further support data from randomized controlled trials showing benefit for antenatal corticosteroids but not for magnesium sulfate.”

They further noted a Cochrane Review that found significantly reduced risk of severe or any intracranial hemorrhage among children exposed to antenatal corticosteroids. No similar reduction in intracranial hemorrhage occurred in a separate Cochrane Review of antenatal magnesium sulfate trials.

The research was funded by the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Center for Advancing Translational Sciences. One author is a consultant for Mednax who has received travel funds. Another author disclosed Catholic Health Professionals of Houston paid honorarium for an ethics talk he gave.

SOURCE: Gentle SJ et al. Obstet. Gynecol. 2020. doi: 10.1097/AOG.0000000000003882.

Children born before 27 weeks’ gestation had lower combined risk of death or severe neurodevelopmental impairment when exposed to antenatal corticosteroids and magnesium sulfate together, compared with exposure of either or neither therapy, according to a prospective observational study published in Obstetrics & Gynecology.

MichaelDeLeon/E+

“If there is sufficient time to administer antenatal corticosteroids, there should similarly be sufficient time to administer magnesium sulfate,” wrote Samuel J. Gentle, MD, of the University of Alabama at Birmingham, and colleagues. “Given the lower rate of severe neurodevelopmental impairment or death in children exposed to both antenatal corticosteroids and magnesium sulfate in the present study, compared with those exposed to antenatal corticosteroids alone, increasing the rates of magnesium sulfate exposure through quality improvement or other interventions may improve infant outcomes.”

Although previous randomized controlled trials had shown neurologic benefits of each therapy independently in preterm children, few data exist on extremely preterm children, the authors noted. They also pointed out differences in the findings when they analyzed neurodevelopmental outcomes and death separately.

“Whereas exposure to both therapies was associated with a lower rate of death, exposure to magnesium sulfate in addition to antenatal corticosteroids was not associated with a lower rate of severe neurodevelopmental impairment or components of severe neurodevelopmental impairment including Bayley scores, bilateral hearing impairment, and cerebral palsy,” Dr Gentle and his coauthors wrote.

The researchers used prospectively collected data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network Generic Database to track 3,093 children born extremely preterm – from 22 weeks 0 days to 26 weeks 6 days – during 2011-2014.

The researchers compared outcomes of death or severe neurodevelopmental impairment when the children were 18-26 months of corrected age based on whether they had been exposed to antenatal corticosteroids alone (betamethasone or dexamethasone) or antenatal corticosteroids in addition to magnesium sulfate. Severe neurodevelopmental impairment included “severe cerebral palsy, motor or cognitive composite score less than 70 on the Bayley-III exam, bilateral blindness, or bilateral severe functional hearing impairment with or without amplification.”

The researchers also looked at severe neurodevelopmental impairment and death among children with only magnesium sulfate exposure or with no exposure to steroids or magnesium.

In the study population, 73% of infants had been exposed to both therapies, 16% had been exposed to only corticosteroids, 3% to only magnesium sulfate, and 8% to neither therapy.

“Importantly, a larger proportion of mothers unexposed to either therapy, compared with both therapies, received high school or less education or had no maternal private health insurance which may suggest health inequity as a driver for antenatal therapy exposure rates,” Dr. Gentle and associates noted.

Children whose mothers received corticosteroids and magnesium had a 27% lower risk of severe neurodevelopmental impairment or death, compared with those whose mothers only received corticosteroids (adjusted odds ratio, 0.73). Just over a third of children exposed to both interventions (36%) had severe neurodevelopmental impairment or died, compared with 44% of those exposed only to steroids.

Similarly, corticosteroids and magnesium together were associated with approximately half the risk of death or severe neurodevelopmental impairment, compared with magnesium alone (aOR, 0.49) and 34% lower risk, compared with neither therapy (aOR 0.66).

When the researchers uncoupled the outcomes, severe neurodevelopmental impairment rates were similar among all exposure groups, but rates of death were lower among those who received both therapies than among those who received just one or neither therapy.

“The therapeutic mechanism for neuroprotection in children exposed to magnesium sulfate is unclear but may result from neuronal stabilization or anti-inflammatory properties,” Dr. Gentle and colleagues said.

They also compared rates in the exposure groups of grade 3-4 intracranial hemorrhage, which has been linked to poor neurodevelopmental outcomes in extremely preterm children.

“The rate of grade 3-4 intracranial hemorrhage did not differ between children exposed to both antenatal corticosteroids and magnesium sulfate and those exposed to antenatal corticosteroids alone,” they said. “These findings further support data from randomized controlled trials showing benefit for antenatal corticosteroids but not for magnesium sulfate.”

They further noted a Cochrane Review that found significantly reduced risk of severe or any intracranial hemorrhage among children exposed to antenatal corticosteroids. No similar reduction in intracranial hemorrhage occurred in a separate Cochrane Review of antenatal magnesium sulfate trials.

The research was funded by the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Center for Advancing Translational Sciences. One author is a consultant for Mednax who has received travel funds. Another author disclosed Catholic Health Professionals of Houston paid honorarium for an ethics talk he gave.

SOURCE: Gentle SJ et al. Obstet. Gynecol. 2020. doi: 10.1097/AOG.0000000000003882.

Children born before 27 weeks’ gestation had lower combined risk of death or severe neurodevelopmental impairment when exposed to antenatal corticosteroids and magnesium sulfate together, compared with exposure of either or neither therapy, according to a prospective observational study published in Obstetrics & Gynecology.

MichaelDeLeon/E+

“If there is sufficient time to administer antenatal corticosteroids, there should similarly be sufficient time to administer magnesium sulfate,” wrote Samuel J. Gentle, MD, of the University of Alabama at Birmingham, and colleagues. “Given the lower rate of severe neurodevelopmental impairment or death in children exposed to both antenatal corticosteroids and magnesium sulfate in the present study, compared with those exposed to antenatal corticosteroids alone, increasing the rates of magnesium sulfate exposure through quality improvement or other interventions may improve infant outcomes.”

Although previous randomized controlled trials had shown neurologic benefits of each therapy independently in preterm children, few data exist on extremely preterm children, the authors noted. They also pointed out differences in the findings when they analyzed neurodevelopmental outcomes and death separately.

“Whereas exposure to both therapies was associated with a lower rate of death, exposure to magnesium sulfate in addition to antenatal corticosteroids was not associated with a lower rate of severe neurodevelopmental impairment or components of severe neurodevelopmental impairment including Bayley scores, bilateral hearing impairment, and cerebral palsy,” Dr Gentle and his coauthors wrote.

The researchers used prospectively collected data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network Generic Database to track 3,093 children born extremely preterm – from 22 weeks 0 days to 26 weeks 6 days – during 2011-2014.

The researchers compared outcomes of death or severe neurodevelopmental impairment when the children were 18-26 months of corrected age based on whether they had been exposed to antenatal corticosteroids alone (betamethasone or dexamethasone) or antenatal corticosteroids in addition to magnesium sulfate. Severe neurodevelopmental impairment included “severe cerebral palsy, motor or cognitive composite score less than 70 on the Bayley-III exam, bilateral blindness, or bilateral severe functional hearing impairment with or without amplification.”

The researchers also looked at severe neurodevelopmental impairment and death among children with only magnesium sulfate exposure or with no exposure to steroids or magnesium.

In the study population, 73% of infants had been exposed to both therapies, 16% had been exposed to only corticosteroids, 3% to only magnesium sulfate, and 8% to neither therapy.

“Importantly, a larger proportion of mothers unexposed to either therapy, compared with both therapies, received high school or less education or had no maternal private health insurance which may suggest health inequity as a driver for antenatal therapy exposure rates,” Dr. Gentle and associates noted.

Children whose mothers received corticosteroids and magnesium had a 27% lower risk of severe neurodevelopmental impairment or death, compared with those whose mothers only received corticosteroids (adjusted odds ratio, 0.73). Just over a third of children exposed to both interventions (36%) had severe neurodevelopmental impairment or died, compared with 44% of those exposed only to steroids.

Similarly, corticosteroids and magnesium together were associated with approximately half the risk of death or severe neurodevelopmental impairment, compared with magnesium alone (aOR, 0.49) and 34% lower risk, compared with neither therapy (aOR 0.66).

When the researchers uncoupled the outcomes, severe neurodevelopmental impairment rates were similar among all exposure groups, but rates of death were lower among those who received both therapies than among those who received just one or neither therapy.

“The therapeutic mechanism for neuroprotection in children exposed to magnesium sulfate is unclear but may result from neuronal stabilization or anti-inflammatory properties,” Dr. Gentle and colleagues said.

They also compared rates in the exposure groups of grade 3-4 intracranial hemorrhage, which has been linked to poor neurodevelopmental outcomes in extremely preterm children.

“The rate of grade 3-4 intracranial hemorrhage did not differ between children exposed to both antenatal corticosteroids and magnesium sulfate and those exposed to antenatal corticosteroids alone,” they said. “These findings further support data from randomized controlled trials showing benefit for antenatal corticosteroids but not for magnesium sulfate.”

They further noted a Cochrane Review that found significantly reduced risk of severe or any intracranial hemorrhage among children exposed to antenatal corticosteroids. No similar reduction in intracranial hemorrhage occurred in a separate Cochrane Review of antenatal magnesium sulfate trials.

The research was funded by the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Center for Advancing Translational Sciences. One author is a consultant for Mednax who has received travel funds. Another author disclosed Catholic Health Professionals of Houston paid honorarium for an ethics talk he gave.

SOURCE: Gentle SJ et al. Obstet. Gynecol. 2020. doi: 10.1097/AOG.0000000000003882.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Coronavirus disease of 2019 (COVID-19) may lead to subacute thyroiditis in some patients, which is suspected to have viral or postviral origin, especially with upper respiratory tract infections, according to a case study in the Journal of Clinical Endocrinology & Metabolism.

Alessandro Brancatella, a PhD student at the University Hospital Pisa (Italy), and colleagues described the case of an 18-year-old woman who was tested Feb. 21 for SARS-CoV-2 infection after her father was hospitalized because of COVID-19. Her results were positive for the virus, and not long after, she developed mild symptoms. By March 13 and again on March 14, test swabs for SARS-CoV-2 were both negative.

On March 17, she presented with fever, fatigue, palpitations, and neck pain that radiated to her jaw. Testing and physical examination pointed to subacute thyroiditis, and she was soon diagnosed and treated with prednisone. Her neck pain and fever disappeared within 2 days, and the remaining symptoms went away within a week.

The authors noted that the woman’s thyroid had been evaluated before she tested positive for SARS-CoV-2, and at that time, thyroid disease was ruled out. They also pointed out that, although the exact etiology for subacute thyroiditis is unknown, “it is common opinion that the disease is due to a viral infection or to a post-viral inflammatory reaction in genetically predisposed subjects.” They cited examples of viruses with suspected causal associations, including mumps, Epstein-Barr virus, and HIV, and they suggested that, based on the timing of the woman’s subacute thyroiditis and the normal results of her thyroid evaluation before developing COVID-19, SARS-CoV-2 be added to that list.

“To our knowledge, this is the first case of [subacute thyroiditis] related to SARS-CoV-2,” they concluded. “We therefore believe that physicians should be alerted about the possibility of this additional clinical manifestation related to SARS-CoV-2 infection.”

One author reported funding from the University of Pisa.

cpalmer@mdedge.com

SOURCE: Brancatella A et al. J Clin Endocrinol Metab. 2020 May 21. doi: 10.1210/clinem/dgaa276.

Coronavirus disease of 2019 (COVID-19) may lead to subacute thyroiditis in some patients, which is suspected to have viral or postviral origin, especially with upper respiratory tract infections, according to a case study in the Journal of Clinical Endocrinology & Metabolism.

Alessandro Brancatella, a PhD student at the University Hospital Pisa (Italy), and colleagues described the case of an 18-year-old woman who was tested Feb. 21 for SARS-CoV-2 infection after her father was hospitalized because of COVID-19. Her results were positive for the virus, and not long after, she developed mild symptoms. By March 13 and again on March 14, test swabs for SARS-CoV-2 were both negative.

On March 17, she presented with fever, fatigue, palpitations, and neck pain that radiated to her jaw. Testing and physical examination pointed to subacute thyroiditis, and she was soon diagnosed and treated with prednisone. Her neck pain and fever disappeared within 2 days, and the remaining symptoms went away within a week.

The authors noted that the woman’s thyroid had been evaluated before she tested positive for SARS-CoV-2, and at that time, thyroid disease was ruled out. They also pointed out that, although the exact etiology for subacute thyroiditis is unknown, “it is common opinion that the disease is due to a viral infection or to a post-viral inflammatory reaction in genetically predisposed subjects.” They cited examples of viruses with suspected causal associations, including mumps, Epstein-Barr virus, and HIV, and they suggested that, based on the timing of the woman’s subacute thyroiditis and the normal results of her thyroid evaluation before developing COVID-19, SARS-CoV-2 be added to that list.

“To our knowledge, this is the first case of [subacute thyroiditis] related to SARS-CoV-2,” they concluded. “We therefore believe that physicians should be alerted about the possibility of this additional clinical manifestation related to SARS-CoV-2 infection.”

One author reported funding from the University of Pisa.

cpalmer@mdedge.com

SOURCE: Brancatella A et al. J Clin Endocrinol Metab. 2020 May 21. doi: 10.1210/clinem/dgaa276.

Coronavirus disease of 2019 (COVID-19) may lead to subacute thyroiditis in some patients, which is suspected to have viral or postviral origin, especially with upper respiratory tract infections, according to a case study in the Journal of Clinical Endocrinology & Metabolism.

Alessandro Brancatella, a PhD student at the University Hospital Pisa (Italy), and colleagues described the case of an 18-year-old woman who was tested Feb. 21 for SARS-CoV-2 infection after her father was hospitalized because of COVID-19. Her results were positive for the virus, and not long after, she developed mild symptoms. By March 13 and again on March 14, test swabs for SARS-CoV-2 were both negative.

On March 17, she presented with fever, fatigue, palpitations, and neck pain that radiated to her jaw. Testing and physical examination pointed to subacute thyroiditis, and she was soon diagnosed and treated with prednisone. Her neck pain and fever disappeared within 2 days, and the remaining symptoms went away within a week.

The authors noted that the woman’s thyroid had been evaluated before she tested positive for SARS-CoV-2, and at that time, thyroid disease was ruled out. They also pointed out that, although the exact etiology for subacute thyroiditis is unknown, “it is common opinion that the disease is due to a viral infection or to a post-viral inflammatory reaction in genetically predisposed subjects.” They cited examples of viruses with suspected causal associations, including mumps, Epstein-Barr virus, and HIV, and they suggested that, based on the timing of the woman’s subacute thyroiditis and the normal results of her thyroid evaluation before developing COVID-19, SARS-CoV-2 be added to that list.

“To our knowledge, this is the first case of [subacute thyroiditis] related to SARS-CoV-2,” they concluded. “We therefore believe that physicians should be alerted about the possibility of this additional clinical manifestation related to SARS-CoV-2 infection.”

One author reported funding from the University of Pisa.

cpalmer@mdedge.com

SOURCE: Brancatella A et al. J Clin Endocrinol Metab. 2020 May 21. doi: 10.1210/clinem/dgaa276.

A successful vaccine for prevention of SARS-CoV-2 infection will probably need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against infection. In mouse studies, T-cell immunity has protected against reinfection with the novel coronaviruses. And in some but not all studies of patients infected with the SARS virus, which shares 80% genetic overlap with the SARS-CoV-2 virus responsible for the COVID-19 pandemic, neutralizing antibodies have waned over time.

“In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco.

Dr. Matloubian is among those who are convinced that the ongoing massive global accelerated effort to develop a safe and effective vaccine affords the best opportunity to gain the upper hand in the COVID-19 pandemic. A large array of vaccines are in development.

A key safety concern to watch for in the coming months is whether a vaccine candidate is able to sidestep the issue of antibody-dependent enhancement, whereby prior infection with a non-SARS coronavirus, such as those that cause the common cold, might result in creation of rogue subneutralizing coronavirus antibodies in response to vaccination. There is concern that these nonneutralizing antibodies could facilitate entry of the virus into monocytes and other cells lacking the ACE2 receptor, its usual portal of entry. This in turn could trigger expanded viral replication, a hyperinflammatory response, and viral spread to sites beyond the lung, such as the heart or kidneys.
 

Little optimism about antivirals’ impact

Dr. Matloubian predicted that antiviral medications, including the much-ballyhooed remdesivir, are unlikely to be a game changer in the COVID-19 pandemic. That’s because most patients who become symptomatic don’t do so until at least 2 days post infection. By that point, their viral load has already peaked and is waning and the B- and T-cell immune responses are starting to gear up.

“Timing seems to be everything when it comes to treatment with antivirals,” he observed. “The virus titer is usually declining by the time people present with severe COVID-19, suggesting that at this time antiviral therapy might be of little use to change the course of the disease, especially if it’s mainly immune-mediated by then. Even with influenza virus, there’s a really short window where Tamiflu [oseltamivir] is effective. It’s going to be the same case for antivirals used for treatment of COVID-19.”

He noted that in a placebo-controlled, randomized trial of remdesivir in 236 Chinese patients with severe COVID-19, intravenous remdesivir wasn’t associated with a significantly shorter time to clinical improvement, although there was a trend in that direction in the subgroup with symptom duration of 10 days or less at initiation of treatment.

A National Institutes of Health press release announcing that remdesivir had a positive impact on duration of hospitalization in a separate randomized trial drew enormous attention from a public desperate for good news. However, the full study has yet to be published, and it’s unclear when during the disease course the antiviral agent was started.

“We need a blockbuster antiviral that’s oral, highly effective, and doesn’t have any side effects to be used in prophylaxis of health care workers and for people who are exposed by family members being infected. And so far there is no such thing, even on the horizon,” according to the rheumatologist.

Fellow panelist Jinoos Yazdany, MD, concurred.

“As we talk to experts around the country, it seems like there isn’t very much optimism about such a blockbuster drug. Most people are actually putting their hope in a vaccine,” said Dr. Yazdany, professor of medicine at the University of California, San Francisco, and chief of rheumatology at San Francisco General Hospital.

Another research priority is identification of biomarkers in blood or bronchoalveolar lavage fluid to identify early on the subgroup of infected patients who are likely to crash and develop severe disease. That would permit a targeted approach to inhibition of the inflammatory pathways contributing to development of acute respiratory distress syndrome before this full-blown cytokine storm-like syndrome can occur. There is great interest in trying to achieve this by repurposing many biologic agents widely used by rheumatologists, including the interleukin-1 blocker anakinra (Kineret) and the IL-6 blocker tocilizumab (Actemra).

Dr. Matloubian reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

A successful vaccine for prevention of SARS-CoV-2 infection will probably need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against infection. In mouse studies, T-cell immunity has protected against reinfection with the novel coronaviruses. And in some but not all studies of patients infected with the SARS virus, which shares 80% genetic overlap with the SARS-CoV-2 virus responsible for the COVID-19 pandemic, neutralizing antibodies have waned over time.

“In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco.

Dr. Matloubian is among those who are convinced that the ongoing massive global accelerated effort to develop a safe and effective vaccine affords the best opportunity to gain the upper hand in the COVID-19 pandemic. A large array of vaccines are in development.

A key safety concern to watch for in the coming months is whether a vaccine candidate is able to sidestep the issue of antibody-dependent enhancement, whereby prior infection with a non-SARS coronavirus, such as those that cause the common cold, might result in creation of rogue subneutralizing coronavirus antibodies in response to vaccination. There is concern that these nonneutralizing antibodies could facilitate entry of the virus into monocytes and other cells lacking the ACE2 receptor, its usual portal of entry. This in turn could trigger expanded viral replication, a hyperinflammatory response, and viral spread to sites beyond the lung, such as the heart or kidneys.
 

Little optimism about antivirals’ impact

Dr. Matloubian predicted that antiviral medications, including the much-ballyhooed remdesivir, are unlikely to be a game changer in the COVID-19 pandemic. That’s because most patients who become symptomatic don’t do so until at least 2 days post infection. By that point, their viral load has already peaked and is waning and the B- and T-cell immune responses are starting to gear up.

“Timing seems to be everything when it comes to treatment with antivirals,” he observed. “The virus titer is usually declining by the time people present with severe COVID-19, suggesting that at this time antiviral therapy might be of little use to change the course of the disease, especially if it’s mainly immune-mediated by then. Even with influenza virus, there’s a really short window where Tamiflu [oseltamivir] is effective. It’s going to be the same case for antivirals used for treatment of COVID-19.”

He noted that in a placebo-controlled, randomized trial of remdesivir in 236 Chinese patients with severe COVID-19, intravenous remdesivir wasn’t associated with a significantly shorter time to clinical improvement, although there was a trend in that direction in the subgroup with symptom duration of 10 days or less at initiation of treatment.

A National Institutes of Health press release announcing that remdesivir had a positive impact on duration of hospitalization in a separate randomized trial drew enormous attention from a public desperate for good news. However, the full study has yet to be published, and it’s unclear when during the disease course the antiviral agent was started.

“We need a blockbuster antiviral that’s oral, highly effective, and doesn’t have any side effects to be used in prophylaxis of health care workers and for people who are exposed by family members being infected. And so far there is no such thing, even on the horizon,” according to the rheumatologist.

Fellow panelist Jinoos Yazdany, MD, concurred.

“As we talk to experts around the country, it seems like there isn’t very much optimism about such a blockbuster drug. Most people are actually putting their hope in a vaccine,” said Dr. Yazdany, professor of medicine at the University of California, San Francisco, and chief of rheumatology at San Francisco General Hospital.

Another research priority is identification of biomarkers in blood or bronchoalveolar lavage fluid to identify early on the subgroup of infected patients who are likely to crash and develop severe disease. That would permit a targeted approach to inhibition of the inflammatory pathways contributing to development of acute respiratory distress syndrome before this full-blown cytokine storm-like syndrome can occur. There is great interest in trying to achieve this by repurposing many biologic agents widely used by rheumatologists, including the interleukin-1 blocker anakinra (Kineret) and the IL-6 blocker tocilizumab (Actemra).

Dr. Matloubian reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

A successful vaccine for prevention of SARS-CoV-2 infection will probably need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against infection. In mouse studies, T-cell immunity has protected against reinfection with the novel coronaviruses. And in some but not all studies of patients infected with the SARS virus, which shares 80% genetic overlap with the SARS-CoV-2 virus responsible for the COVID-19 pandemic, neutralizing antibodies have waned over time.

“In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco.

Dr. Matloubian is among those who are convinced that the ongoing massive global accelerated effort to develop a safe and effective vaccine affords the best opportunity to gain the upper hand in the COVID-19 pandemic. A large array of vaccines are in development.

A key safety concern to watch for in the coming months is whether a vaccine candidate is able to sidestep the issue of antibody-dependent enhancement, whereby prior infection with a non-SARS coronavirus, such as those that cause the common cold, might result in creation of rogue subneutralizing coronavirus antibodies in response to vaccination. There is concern that these nonneutralizing antibodies could facilitate entry of the virus into monocytes and other cells lacking the ACE2 receptor, its usual portal of entry. This in turn could trigger expanded viral replication, a hyperinflammatory response, and viral spread to sites beyond the lung, such as the heart or kidneys.
 

Little optimism about antivirals’ impact

Dr. Matloubian predicted that antiviral medications, including the much-ballyhooed remdesivir, are unlikely to be a game changer in the COVID-19 pandemic. That’s because most patients who become symptomatic don’t do so until at least 2 days post infection. By that point, their viral load has already peaked and is waning and the B- and T-cell immune responses are starting to gear up.

“Timing seems to be everything when it comes to treatment with antivirals,” he observed. “The virus titer is usually declining by the time people present with severe COVID-19, suggesting that at this time antiviral therapy might be of little use to change the course of the disease, especially if it’s mainly immune-mediated by then. Even with influenza virus, there’s a really short window where Tamiflu [oseltamivir] is effective. It’s going to be the same case for antivirals used for treatment of COVID-19.”

He noted that in a placebo-controlled, randomized trial of remdesivir in 236 Chinese patients with severe COVID-19, intravenous remdesivir wasn’t associated with a significantly shorter time to clinical improvement, although there was a trend in that direction in the subgroup with symptom duration of 10 days or less at initiation of treatment.

A National Institutes of Health press release announcing that remdesivir had a positive impact on duration of hospitalization in a separate randomized trial drew enormous attention from a public desperate for good news. However, the full study has yet to be published, and it’s unclear when during the disease course the antiviral agent was started.

“We need a blockbuster antiviral that’s oral, highly effective, and doesn’t have any side effects to be used in prophylaxis of health care workers and for people who are exposed by family members being infected. And so far there is no such thing, even on the horizon,” according to the rheumatologist.

Fellow panelist Jinoos Yazdany, MD, concurred.

“As we talk to experts around the country, it seems like there isn’t very much optimism about such a blockbuster drug. Most people are actually putting their hope in a vaccine,” said Dr. Yazdany, professor of medicine at the University of California, San Francisco, and chief of rheumatology at San Francisco General Hospital.

Another research priority is identification of biomarkers in blood or bronchoalveolar lavage fluid to identify early on the subgroup of infected patients who are likely to crash and develop severe disease. That would permit a targeted approach to inhibition of the inflammatory pathways contributing to development of acute respiratory distress syndrome before this full-blown cytokine storm-like syndrome can occur. There is great interest in trying to achieve this by repurposing many biologic agents widely used by rheumatologists, including the interleukin-1 blocker anakinra (Kineret) and the IL-6 blocker tocilizumab (Actemra).

Dr. Matloubian reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service (EMS) providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. A key goal is to ensure timely transfer of patients while minimizing the risk of infectious exposure for EMS personnel, coworkers, and other patients, the writing group says.

“Acute ischemic stroke is still a highly devastating disease and the Time Is Brain paradigm remains true during the COVID-19 pandemic as well,” said writing group chair Mayank Goyal, MD, of the University of Calgary (Alta.)

“We have highly effective and proven treatments available. As such, treatment delays due to additional screening requirements and personal protection equipment (PPE) should be kept at a minimum,” Dr. Goyal said.

“Practicing COVID-19 stroke work flows, through simulation training, can help to reduce treatment delays, minimize the risk of infectious exposure for patients and staff, and help alleviate stress,” he added.
 

A new layer of complexity

The guidance statement, Prehospital Triage of Acute Stroke Patients During the COVID-19 Pandemic, was published online May 13 in the journal Stroke.

“The need to limit infectious spread during the COVID-19 pandemic has added a new layer of complexity to prehospital stroke triage and transfer,” the writing group noted. “Timely and enhanced” communication between EMS, hospitals, and local coordinating authorities are critical, especially ambulance-and facility-based telestroke networks, they wrote.

The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of interhospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the available bed, staff, and PPE resources at the hospitals.

The group said it “seems reasonable” to lower the threshold to bypass hospitals that can’t provide acute stroke treatment in favor of transporting to a hospital that is “stroke ready,” particularly in patients likely to require advanced care. They cautioned, however, that taking all acute stroke patients to a comprehensive stroke center could overwhelm these centers and lead to clustering of COVID-19 patients.

They said it is equally important to ensure “necessary transfers” of stroke patients who would benefit from endovascular therapy or neurocritical care and avoid unnecessary patient transfers. “Doing so will likely require local hospital boards and health care authorities to collaborate and establish local guidelines and protocols,” the writing group said.

“During the COVID-19 pandemic, it is more important than ever to ensure that stroke patients are taken to the right hospital that can meet their urgent needs at the outset,” Dr. Goyal commented in an AHA news release.

The writing group emphasized that the principles put forth in the document are intended as suggestions rather than strict rules and will be adapted and updated to meet the evolving needs during the COVID-19 crisis and future pandemics.

“The process of improving stroke work flow and getting the correct patient to the correct hospital fast is dependent on training, protocols, simulation, technology, and – probably most importantly – teamwork. These principles are extremely important during the current pandemic but will be useful in improving stroke care afterwards as well,” Dr. Goyal said.

This research had no commercial funding. Members of the writing committee are on several AHA/ASA Council Science Subcommittees, including the Emergency Neurovascular Care, the Telestroke, and the Neurovascular Intervention committees. Goyal is a consultant for Medtronic, Stryker, Microvention, GE Healthcare, and Mentice. A complete list of author disclosures is available with the original article.

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

In 2019, the number of births in the United States dropped for the fifth consecutive year, as did the fertility rate, and birth rates for women under age 30 fell to record lows, according to the National Center for Health Statistics.

To be exact – at least as exact as is possible from these provisional data – there were 3,745,540 births in the United States last year. That’s down about 1% from 2018 and is the lowest number of births since 1985, Brady E. Hamilton, PhD, and associates at the NCHS said in a rapid release report.

As births go, so goes the general fertility rate. A 2% decrease from 2018 to 2019 left the fertility rate at its lowest point ever: 58.2 births per 1,000 women aged 15-44 years, compared with 59.1 per 1,000 in 2018, the investigators said, based on data from the National Vital Statistics System.

The total fertility rate – defined as “the number of births that a hypothetical group of 1,000 women would have over their lifetimes, based on the age-specific birth rate in a given year” – also reached a record low of 1,705 births per 1,000 women last year after falling 1% from 2018, they reported.

The falling birth rates did not include women over age 35. The birth rate among women aged 40-44 increased by 2% from 2018, as it reached 12.0 births per 1,000 in 2019. “The rate for this age group has risen almost continuously since 1985 by an average of 3% per year,” Dr. Hamilton and associates wrote.

The birth rate for women aged 30-34 years, 98.3 per 1,000, was down 1% from 2018 but was still the highest for any age category. Among younger women, rates all dropped to record lows: 16.6 (ages 15-19), 66.6 (ages 20-24), and 93.7 (ages 25-29), they said.

Preterm birth rates, on the other hand, rose for the fifth year in a row. The rate for 2019, 10.23% of all births, represents an increase of 2% over 2018 and is “the highest level reported in more than a decade,” the investigators noted.

rfranki@mdedge.com

In 2019, the number of births in the United States dropped for the fifth consecutive year, as did the fertility rate, and birth rates for women under age 30 fell to record lows, according to the National Center for Health Statistics.

To be exact – at least as exact as is possible from these provisional data – there were 3,745,540 births in the United States last year. That’s down about 1% from 2018 and is the lowest number of births since 1985, Brady E. Hamilton, PhD, and associates at the NCHS said in a rapid release report.

As births go, so goes the general fertility rate. A 2% decrease from 2018 to 2019 left the fertility rate at its lowest point ever: 58.2 births per 1,000 women aged 15-44 years, compared with 59.1 per 1,000 in 2018, the investigators said, based on data from the National Vital Statistics System.

The total fertility rate – defined as “the number of births that a hypothetical group of 1,000 women would have over their lifetimes, based on the age-specific birth rate in a given year” – also reached a record low of 1,705 births per 1,000 women last year after falling 1% from 2018, they reported.

The falling birth rates did not include women over age 35. The birth rate among women aged 40-44 increased by 2% from 2018, as it reached 12.0 births per 1,000 in 2019. “The rate for this age group has risen almost continuously since 1985 by an average of 3% per year,” Dr. Hamilton and associates wrote.

The birth rate for women aged 30-34 years, 98.3 per 1,000, was down 1% from 2018 but was still the highest for any age category. Among younger women, rates all dropped to record lows: 16.6 (ages 15-19), 66.6 (ages 20-24), and 93.7 (ages 25-29), they said.

Preterm birth rates, on the other hand, rose for the fifth year in a row. The rate for 2019, 10.23% of all births, represents an increase of 2% over 2018 and is “the highest level reported in more than a decade,” the investigators noted.

rfranki@mdedge.com

In 2019, the number of births in the United States dropped for the fifth consecutive year, as did the fertility rate, and birth rates for women under age 30 fell to record lows, according to the National Center for Health Statistics.

To be exact – at least as exact as is possible from these provisional data – there were 3,745,540 births in the United States last year. That’s down about 1% from 2018 and is the lowest number of births since 1985, Brady E. Hamilton, PhD, and associates at the NCHS said in a rapid release report.

As births go, so goes the general fertility rate. A 2% decrease from 2018 to 2019 left the fertility rate at its lowest point ever: 58.2 births per 1,000 women aged 15-44 years, compared with 59.1 per 1,000 in 2018, the investigators said, based on data from the National Vital Statistics System.

The total fertility rate – defined as “the number of births that a hypothetical group of 1,000 women would have over their lifetimes, based on the age-specific birth rate in a given year” – also reached a record low of 1,705 births per 1,000 women last year after falling 1% from 2018, they reported.

The falling birth rates did not include women over age 35. The birth rate among women aged 40-44 increased by 2% from 2018, as it reached 12.0 births per 1,000 in 2019. “The rate for this age group has risen almost continuously since 1985 by an average of 3% per year,” Dr. Hamilton and associates wrote.

The birth rate for women aged 30-34 years, 98.3 per 1,000, was down 1% from 2018 but was still the highest for any age category. Among younger women, rates all dropped to record lows: 16.6 (ages 15-19), 66.6 (ages 20-24), and 93.7 (ages 25-29), they said.

Preterm birth rates, on the other hand, rose for the fifth year in a row. The rate for 2019, 10.23% of all births, represents an increase of 2% over 2018 and is “the highest level reported in more than a decade,” the investigators noted.

rfranki@mdedge.com

Use of a digital step counter improved mobility in women at high risk for thromboembolic events after a cesarean delivery, based on data from a randomized trial of 215 patients.

“Patient immobility after surgery is associated with an increased risk of VTE [venous thromboembolism], whereas adequate mobility offers the benefits of enhanced bowel movement resumption and decreasing hospitalization length,” wrote Hadas Ganer Herman, MD, of Tel Aviv University, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 108 women to a personalized feedback program using pedometers to promote mobility after cesarean delivery; 107 served as controls. Patient demographics and intrapartum experiences, including age, body mass index, and gestation week at delivery, were similar between the groups, as were postpartum complications and the use of analgesics.

Patients who used the pedometers took significantly more steps, compared with controls (5,918 vs. 4,161, P < .001). In addition, women in the pedometer group reported improved physical and mental postpartum recovery and higher levels of satisfaction with their delivery experience, the researchers noted.

The study findings were limited by several factors including potential selection bias among patients who completed the full follow-up, as well as the effect of preset visits from the research team during the study and lack of blinding of the participants. In addition, data on thromboembolic events after hospital discharge were available only through patient phone calls, the researchers noted.

“Our trial is notable for its novelty in exploring an intervention to improve postcesarean delivery mobility, using an objective means of digital step counters,” and for focusing on high-risk patients of clinical interest, Dr. Herman and associates wrote.

Larger studies are needed to explore interventions to improve mobility after cesarean deliveries, they emphasized. However, “because the integration between technology and medicine has continued to evolve and has successfully been proven for additional patient care issues in obstetrics, the current trial offers a basis for interpretation, with the possible use of low-cost interventions such as smart phone applications in maternity wards and simple digital feedback.”

“VTEs are still among the leading causes of maternal morbidity and mortality with peak incidence in the immediate postpartum period,” Martina L. Badell, MD, of Emory University, Atlanta, said in an interview. “As the age and body mass index of our pregnant patients continues to increase, focused attention to prevent VTEs in high-risk populations is very important.”

Dr. Badell said that pedometers are a feasible strategy “provided there is funding available to pay for and provide them.” Pedometers “don’t cause pain/discomfort and can be easily worn and reused. If the hospital isn’t able to provide them, however, then cost could be a barrier to high-risk women using pedometers in the immediate postpartum period.”

“The take-home message is that wearing a pedometer is a simple, low-risk strategy to encourage increased ambulation in a high-risk postpartum population with good patient satisfaction,” Dr. Badell said. The next step for research in this area “is to determine how many steps during the immediate postpartum period is optimal to reduce not only VTE risk, but potentially other postoperative markers such as pain and infection,” she added. Another research question is whether “focused feedback-based pedometers during the prolonged postpartum period result in improved weight loss.”

The researchers had no relevant financial disclosures. Dr. Badell said she had no relevant financial disclosures.

SOURCE: Herman HG et al. Obstet Gynecol. 2020 May 7. doi: 10.1097/AOG.0000000000003879.

Use of a digital step counter improved mobility in women at high risk for thromboembolic events after a cesarean delivery, based on data from a randomized trial of 215 patients.

“Patient immobility after surgery is associated with an increased risk of VTE [venous thromboembolism], whereas adequate mobility offers the benefits of enhanced bowel movement resumption and decreasing hospitalization length,” wrote Hadas Ganer Herman, MD, of Tel Aviv University, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 108 women to a personalized feedback program using pedometers to promote mobility after cesarean delivery; 107 served as controls. Patient demographics and intrapartum experiences, including age, body mass index, and gestation week at delivery, were similar between the groups, as were postpartum complications and the use of analgesics.

Patients who used the pedometers took significantly more steps, compared with controls (5,918 vs. 4,161, P < .001). In addition, women in the pedometer group reported improved physical and mental postpartum recovery and higher levels of satisfaction with their delivery experience, the researchers noted.

The study findings were limited by several factors including potential selection bias among patients who completed the full follow-up, as well as the effect of preset visits from the research team during the study and lack of blinding of the participants. In addition, data on thromboembolic events after hospital discharge were available only through patient phone calls, the researchers noted.

“Our trial is notable for its novelty in exploring an intervention to improve postcesarean delivery mobility, using an objective means of digital step counters,” and for focusing on high-risk patients of clinical interest, Dr. Herman and associates wrote.

Larger studies are needed to explore interventions to improve mobility after cesarean deliveries, they emphasized. However, “because the integration between technology and medicine has continued to evolve and has successfully been proven for additional patient care issues in obstetrics, the current trial offers a basis for interpretation, with the possible use of low-cost interventions such as smart phone applications in maternity wards and simple digital feedback.”

“VTEs are still among the leading causes of maternal morbidity and mortality with peak incidence in the immediate postpartum period,” Martina L. Badell, MD, of Emory University, Atlanta, said in an interview. “As the age and body mass index of our pregnant patients continues to increase, focused attention to prevent VTEs in high-risk populations is very important.”

Dr. Badell said that pedometers are a feasible strategy “provided there is funding available to pay for and provide them.” Pedometers “don’t cause pain/discomfort and can be easily worn and reused. If the hospital isn’t able to provide them, however, then cost could be a barrier to high-risk women using pedometers in the immediate postpartum period.”

“The take-home message is that wearing a pedometer is a simple, low-risk strategy to encourage increased ambulation in a high-risk postpartum population with good patient satisfaction,” Dr. Badell said. The next step for research in this area “is to determine how many steps during the immediate postpartum period is optimal to reduce not only VTE risk, but potentially other postoperative markers such as pain and infection,” she added. Another research question is whether “focused feedback-based pedometers during the prolonged postpartum period result in improved weight loss.”

The researchers had no relevant financial disclosures. Dr. Badell said she had no relevant financial disclosures.

SOURCE: Herman HG et al. Obstet Gynecol. 2020 May 7. doi: 10.1097/AOG.0000000000003879.

Use of a digital step counter improved mobility in women at high risk for thromboembolic events after a cesarean delivery, based on data from a randomized trial of 215 patients.

“Patient immobility after surgery is associated with an increased risk of VTE [venous thromboembolism], whereas adequate mobility offers the benefits of enhanced bowel movement resumption and decreasing hospitalization length,” wrote Hadas Ganer Herman, MD, of Tel Aviv University, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 108 women to a personalized feedback program using pedometers to promote mobility after cesarean delivery; 107 served as controls. Patient demographics and intrapartum experiences, including age, body mass index, and gestation week at delivery, were similar between the groups, as were postpartum complications and the use of analgesics.

Patients who used the pedometers took significantly more steps, compared with controls (5,918 vs. 4,161, P < .001). In addition, women in the pedometer group reported improved physical and mental postpartum recovery and higher levels of satisfaction with their delivery experience, the researchers noted.

The study findings were limited by several factors including potential selection bias among patients who completed the full follow-up, as well as the effect of preset visits from the research team during the study and lack of blinding of the participants. In addition, data on thromboembolic events after hospital discharge were available only through patient phone calls, the researchers noted.

“Our trial is notable for its novelty in exploring an intervention to improve postcesarean delivery mobility, using an objective means of digital step counters,” and for focusing on high-risk patients of clinical interest, Dr. Herman and associates wrote.

Larger studies are needed to explore interventions to improve mobility after cesarean deliveries, they emphasized. However, “because the integration between technology and medicine has continued to evolve and has successfully been proven for additional patient care issues in obstetrics, the current trial offers a basis for interpretation, with the possible use of low-cost interventions such as smart phone applications in maternity wards and simple digital feedback.”

“VTEs are still among the leading causes of maternal morbidity and mortality with peak incidence in the immediate postpartum period,” Martina L. Badell, MD, of Emory University, Atlanta, said in an interview. “As the age and body mass index of our pregnant patients continues to increase, focused attention to prevent VTEs in high-risk populations is very important.”

Dr. Badell said that pedometers are a feasible strategy “provided there is funding available to pay for and provide them.” Pedometers “don’t cause pain/discomfort and can be easily worn and reused. If the hospital isn’t able to provide them, however, then cost could be a barrier to high-risk women using pedometers in the immediate postpartum period.”

“The take-home message is that wearing a pedometer is a simple, low-risk strategy to encourage increased ambulation in a high-risk postpartum population with good patient satisfaction,” Dr. Badell said. The next step for research in this area “is to determine how many steps during the immediate postpartum period is optimal to reduce not only VTE risk, but potentially other postoperative markers such as pain and infection,” she added. Another research question is whether “focused feedback-based pedometers during the prolonged postpartum period result in improved weight loss.”

The researchers had no relevant financial disclosures. Dr. Badell said she had no relevant financial disclosures.

SOURCE: Herman HG et al. Obstet Gynecol. 2020 May 7. doi: 10.1097/AOG.0000000000003879.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Two reports of chilblain-like lesions in children suspected of having COVID-19 in Spain and Italy have been published, joining other recent reports of such cases in the United States and elsewhere.

These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, from hospitals in Milan and Madrid, published in Pediatric Dermatology.

In the first study, Cristiana Colonna, MD, and colleagues at Hospital Maggiore Polyclinic in Milan described four cases of chilblain-like lesions in children ages 5-11 years with mild COVID-19 symptoms.

In the second, David Andina, MD, and colleagues in the ED and the departments of dermatology and pathology at the Child Jesus University Children’s Hospital in Madrid published a retrospective study of 22 cases in children and adolescents ages 6-17 years who reported to the hospital ED from April 6 to 17, the peak of the pandemic in Madrid.

In all four of the Milan cases, the skin lesions appeared several days after the onset of COVID-19 symptoms, although all four patients initially tested negative for COVID-19. However, Dr. Colonna and colleagues wrote that, “given the fact that the sensitivity and specificity of both nasopharyngeal swabs and antibody tests for COVID-19 (when available) are not 100% reliable, the question of the origin of these strange chilblain-like lesions is still elusive.” Until further studies are available, they emphasized that clinicians should be “alert to the presentation of chilblain-like findings” in children with mild symptoms “as a possible sign of COVID-19 infection.”

All the patients had lesions on their feet or toes, and a 5-year-old boy also had lesions on the right hand. One patient, an 11-year-old girl, had a biopsy that revealed dense lymphocytic perivascular cuffing and periadnexal infiltration.

“The finding of an elevated d-dimer in one of our patients, along with the clinical features suggestive of a vasoocclusive phenomenon, supports consideration of laboratory evaluation for coagulation defects in asymptomatic or mildly symptomatic children with acrovasculitis-like findings,” Dr. Colonna and colleagues wrote. None of the four cases in Milan required treatment, with three cases resolving within 5 days.

Like the Milan cases, all 22 patients in the Madrid series had foot or toe lesions and three had lesions on the fingers. This larger series also reported more detailed symptoms about the lesions: pruritus in nine patients (41%) and mild pain in seven (32%). A total of 10 patients had systemic symptoms of COVID-19, predominantly cough and rhinorrhea in 9 patients (41%), but 2 (9%) had abdominal pain and diarrhea. These symptoms, the authors said, appeared a median of 14 days (range, 1-28 days) before they developed chilblains.

A total of 19 patients were tested for COVID-19, but only 1 was positive.

This retrospective study also included contact information, with one patient having household contact with a single confirmed case of COVID-19; 12 patients recalled household contact who were considered probable cases of COVID-19, with respiratory symptoms.

Skin biopsies were obtained from the acral lesions in six patients, all showing similar results, although with varying degrees of intensity. All biopsies showed features of lymphocytic vasculopathy. Some cases showed mild dermal and perieccrine mucinosis, lymphocytic eccrine hidradenitis, vascular ectasia, red cell extravasation and focal thrombosis described as “mostly confined to scattered papillary dermal capillaries, but also in vessels of the reticular dermis.”

The only treatments Dr. Andina and colleagues reported were oral analgesics for pain and oral antihistamines for pruritus when needed. One patient was given topical corticosteroids and another a short course of oral steroids, both for erythema multiforme.

Dr. Andina and colleagues wrote that the skin lesions in these patients “were unequivocally categorized as chilblains, both clinically and histopathologically,” and, after 7-10 days, began to fade. None of the patients had complications, and had an “excellent outcome,” they noted.

Dr. Colonna and colleagues had no conflicts of interest to declare. Dr. Andina and colleagues provided no disclosure statement.

SOURCES: Colonna C et al. Ped Derm. 2020 May 6. doi: 10.1111/pde.14210; Andina D et al. Ped Derm. 2020 May 9. doi: 10.1111/pde.14215.