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FDA approves Fensolvi for central precocious puberty treatment
Approval was based on results from a multicenter, open-label, single-arm, phase 3 study of 64 children with central precocious puberty, a rare disease described as onset of puberty before age 8 years in girls and before age 9 in boys. The primary study endpoint was achieved, with 87% of children achieving a serum luteinizing-hormone concentration of less than 4 IU/L within 6 months post injection. Sex hormones were suppressed to prepubertal levels, and clinical signs of puberty were halted or reversed.
Adverse events during the study were mostly mild or moderate; none led to withdrawal from the study. The most common adverse events reported were injection-site pain (31%), nasopharyngitis (22%), and fever (17%).
“Children with CPP require treatment for several years and missing treatment or stopping treatment too soon may lead to significant short stature and misalignment between chronological age and physical and emotional development. Fensolvi offers treating physicians and their patients with CPP a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance,” Karen Klein, MD, of Rady Children’s Hospital in San Diego, said in the press release.
Approval was based on results from a multicenter, open-label, single-arm, phase 3 study of 64 children with central precocious puberty, a rare disease described as onset of puberty before age 8 years in girls and before age 9 in boys. The primary study endpoint was achieved, with 87% of children achieving a serum luteinizing-hormone concentration of less than 4 IU/L within 6 months post injection. Sex hormones were suppressed to prepubertal levels, and clinical signs of puberty were halted or reversed.
Adverse events during the study were mostly mild or moderate; none led to withdrawal from the study. The most common adverse events reported were injection-site pain (31%), nasopharyngitis (22%), and fever (17%).
“Children with CPP require treatment for several years and missing treatment or stopping treatment too soon may lead to significant short stature and misalignment between chronological age and physical and emotional development. Fensolvi offers treating physicians and their patients with CPP a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance,” Karen Klein, MD, of Rady Children’s Hospital in San Diego, said in the press release.
Approval was based on results from a multicenter, open-label, single-arm, phase 3 study of 64 children with central precocious puberty, a rare disease described as onset of puberty before age 8 years in girls and before age 9 in boys. The primary study endpoint was achieved, with 87% of children achieving a serum luteinizing-hormone concentration of less than 4 IU/L within 6 months post injection. Sex hormones were suppressed to prepubertal levels, and clinical signs of puberty were halted or reversed.
Adverse events during the study were mostly mild or moderate; none led to withdrawal from the study. The most common adverse events reported were injection-site pain (31%), nasopharyngitis (22%), and fever (17%).
“Children with CPP require treatment for several years and missing treatment or stopping treatment too soon may lead to significant short stature and misalignment between chronological age and physical and emotional development. Fensolvi offers treating physicians and their patients with CPP a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance,” Karen Klein, MD, of Rady Children’s Hospital in San Diego, said in the press release.
USPSTF round-up
In 2019, the US Preventive Services Task Force published 19 recommendation statements on 11 topics. Two of the topics are new; 9 are topics the Task Force had previously reviewed and has updated (TABLE 1). Three of these topics have been covered in Practice Alert podcasts (mdedge.com/familymedicine) and will not be discussed here: risk assessment, genetic counseling, and genetic testing for breast cancer susceptibility gene mutations (October 2019); medications to reduce the risk of breast cancer (December 2019); and preexposure prophylaxis to prevent HIV infections (January 2020).
Of the 19 recommendation statements made in 2019 (TABLE 2), 5 were rated “A” and 5 were “B,” meaning the evidence shows that benefits outweigh harms and these interventions should be offered in primary care practice. There were 5 “D” recommendations for interventions that should not be offered because they are either ineffective or harms exceed benefits. There were 3 “I” statements on interventions having insufficient evidence on benefits or harms to warrant a recommendation. Only 1 recommendation was rated “C” (selectively offer based on individual factors); this assessment is the hardest one to interpret and implement. Keep in mind that all “A” and “B” recommendations must be covered by commercial health plans with no out-of-pocket cost to the patient (ie, no co-pay or deductible).
New recommendation on preventing perinatal depression
One of 2 new topics reviewed in 2019 was the prevention of perinatal depression. (As noted, the other on preexposure prophylaxis to prevent HIV infection has already been covered in a Practice Alert podcast.) The Task Force found that the prevalence of depression is estimated at 8.9% among pregnant women and 37% at any point in the first year postpartum.1
Depression during pregnancy and the postpartum period is associated with adverse effects on the mother and infant, including higher rates of suicide and suicidal ideation and thoughts of harming the infant.1 Women with perinatal depression are also more likely to exhibit significantly lower levels of positive maternal behaviors, such as praising and playing with their child,2 and higher rates of negative maternal behaviors.2 Perinatal depression is also associated with increased rates of preterm birth and low birth weight.3
Mothers with postpartum depression have higher rates of early termination of breast feeding and lower adherence for recommended child preventive services including vaccination.1 Children of mothers with perinatal depression develop more behavior problems, have lower cognitive functioning, and have an increased risk of psychiatric disorders than do children of mothers without this condition.4,5
A number of risk factors are associated with perinatal depression, but no screening tool was found to have enough predictive value to be recommended. In deciding who should receive an offer or referral for counseling, the Task Force recommends as a practical approach providing “counseling interventions to women with 1 or more of the following: a history of depression, current depressive symptoms (that do not reach a diagnostic threshold), certain socioeconomic risk factors such as low income or adolescent or single parenthood, recent intimate partner violence, or mental health-related factors such as elevated anxiety symptoms or a history of significant negative life events.”1
There is no conclusive evidence to guide timing of counseling interventions, but most studies reviewed started them in the second trimester. These studies included cognitive behavioral therapy and interpersonal therapy and involved counseling sessions that ranged from 4 to 20 sessions and lasted for 4 to 70 weeks. They involved group and individual sessions, mostly in-person visits, and were provided by a variety of health professionals.6
Continue to: The studies reviewed showed...
The studies reviewed showed that counseling interventions reduced the likelihood of developing depression symptoms by 39%, with a number needed to treat of 13.5.6 Studies that looked at pregnancy and maternal and infant clinical outcomes were mixed but usually found little to no difference with counseling.6 Even so, the Task Force felt that a reduction in depression itself was enough to warrant a “B” recommendation.
Screening for abdominal aortic aneurisms
Ultrasound is underused in screening for abdominal aortic aneurisms (AAA) and preventing death from their rupture. (See “Whom should you screen for abdominal aortic aneurysm?”) The prevalence of AAA is the United States is unknown; in other western countries it varies from 1.2% to 3.3% in men and is declining due to decreased rates of smoking, the primary risk factor.
The risk of AAA rupture is related to the size of the aneurism, and surgical repair (either endovascular or open repair) is usually reserved for lesions > 5.5 cm in diameter or for smaller ones that are rapidly increasing in size. The standard of care for most aneurysms < 5.5 cm is to periodically monitor growth using ultrasound.
The 2019 recommendations on AAA screening are essentially the same as those made in 2004; evaluation of new evidence supported the previous recommendations. The Task Force recommends one-time screening for men ages 65 to 75 years who have ever smoked (B recommendation). Selective screening is recommended for men in this age group who have never smoked, based mainly on personal factors such as a family history of AAA, the presence of other arterial aneurisms, and the number of risk factors for cardiovascular disease (C recommendation).
The Task Force recommends against screening women ages 65 to 75 years with no history of smoking or family history of AAA, while the evidence was felt to be insufficient to make a recommendation for women in this age range who have either risk factor. This is problematic for family physicians since women with these risk factors are at increased risk of AAA compared with women without risk factors.8 And aneurisms in women appear to rupture more frequently at smaller sizes, although at a later age than in men.8 Operative mortality is also higher in women than in men8 and there is no direct evidence that screening improves outcomes for women.
Continue to: Screening for asymptomatic bacteriuria
Screening for asymptomatic bacteriuria
The Task Force re-examined and reconfirmed its previous recommendations on screening for asymptomatic bacteriuria in adults. It recommends in favor of it for pregnant women, using a urine culture to screen, and against it for all other adults. There is good evidence that treating screen-detected asymptomatic bacteriuria in pregnant women reduces the incidence of pyelonephritis in pregnancy.
The Task Force made this a “B” recommendation based on a lower prevalence of pyelonephritis found in more recent studies, making the overall magnitude of benefits moderate. There is also good evidence that treating asymptomatic bacteriuria in nonpregnant adults offers no benefits.9 The Task Force has re-examined this topic 5 times since 1996 with essentially the same results.
Screening for elevated lead levels in children and pregnant women
In 2019 the Task Force changed its 2006 recommendation on screening for elevated lead levels. The earlier recommendation advised against screening both children ages 1 to 5 years and pregnant women at average risk for elevated blood lead levels. In 2006 the Task Force also felt that evidence was insufficient to make a recommendation regarding children ages 1 to 5 years at elevated risk.
The Task Force now believes the evidence is insufficient to make a recommendation for all children ages 1 to 5 years and for pregnant women, thus moving from a “D” to an “I” recommendation for children and pregnant women with average risk. Even though there is little evidence to support screening for elevated lead levels in children ages 1 to 5 years and in pregnant women, the Task Force apparently did not feel comfortable recommending against testing, given that the cutoff for elevated blood lead levels has been lowered from 10 to 5 mcg/dL and that other sources of lead may now be more prevalent than in 2006.10
Remember that the Medicaid Early and Periodic Screening, Diagnostic, and Treatment program requires that all children receive a blood lead test twice, at ages 12 and 24 months, and that previously unscreened children ages 36 to 72 months must be tested once.
Continue to: Additional updates with no recommendation changes
Additional updates with no recommendation changes
Four other topics were re-examined by the Task Force in 2019, resulting in no significant changes to recommendations (TABLE 2):
- Screen for hepatitis B infection in pregnant women at the first prenatal visit (A recommendation; updated from 2009).
- Screen for HIV infection in adolescents and adults ages 15 to 65 years, and in those younger and older who are at high risk, and during pregnancy (A recommendation; updated from 2013).
- Provide topical medication for all newborns to prevent gonococcal ophthalmia neonatorum (A recommendation; first recommendation in 1996, updated in 2005 and 2011).
- Avoid screening for pancreatic cancer in asymptomatic adults (D recommendation; updated from 2004).
Affirmation of USPSTF’s value
In only 1 out of 9 reassessments of past topics did the Task Force modify its previous recommendations in any significant way. This demonstrates that recommendations will usually stand the test of time if they are made using robust, evidence-based methods (that consider both benefits and harms) and they are not made when evidence is insufficient. That only 2 new topics could be addressed in 2019 may reflect a need for more resources for the Task Force.
1. USPSTF. Interventions to prevent perinatal depression: US Preventive Services Task Force recommendation statement. 2019;321:580-587.
2. Lovejoy MC, Graczyk PA, O’Hare E, et al. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000;20:561-592.
3. Szegda K, Markenson G, Bertone-Johnson ER, et al. Depression during pregnancy: a risk factor for adverse neonatal outcomes? A critical review of the literature. J Matern Fetal Neonatal Med. 2014;27:960-967.
4. Beck CT. The effects of postpartum depression on child development: a meta-analysis. Arch Psychiatr Nurs. 1998;12:12-20.
5. Santos IS, Matijasevich A, Barros AJ, et al. Antenatal and postnatal maternal mood symptoms and psychiatric disorders in pre-school children from the 2004 Pelotas Birth Cohort. J Affect Disord. 2014;164:112-117.
6. O’Connor E, Senger CA, Henniger ML, et al. Interventions to prevent perinatal depression. Evidence report and systematic review for the US preventive services task force. JAMA. 2019;321:588-601.
7. USPSTF. Screening for abdominal aortic aneurysm: US Preventive Services Task Force recommendation statement. 2019;322:2211-2218.
8. Guirguis-Blake JM, Beil TL, Senger CA, et al. Primary care screening for abdominal aortic aneurysm: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2019;322:2219-2238.
9. USPSTF. Owens DK, Davidson KW, Krist AH, et al. Screening for asymptomatic bacteriuria in adults: US Preventive Services Task Force recommendation statement. 2019;322:1188-1194.
10. USPSTF. Screening for elevated blood lead levels in children and pregnant women: US Preventive Services Task Force recommendation statement. 2019;321:1502-1509.
In 2019, the US Preventive Services Task Force published 19 recommendation statements on 11 topics. Two of the topics are new; 9 are topics the Task Force had previously reviewed and has updated (TABLE 1). Three of these topics have been covered in Practice Alert podcasts (mdedge.com/familymedicine) and will not be discussed here: risk assessment, genetic counseling, and genetic testing for breast cancer susceptibility gene mutations (October 2019); medications to reduce the risk of breast cancer (December 2019); and preexposure prophylaxis to prevent HIV infections (January 2020).
Of the 19 recommendation statements made in 2019 (TABLE 2), 5 were rated “A” and 5 were “B,” meaning the evidence shows that benefits outweigh harms and these interventions should be offered in primary care practice. There were 5 “D” recommendations for interventions that should not be offered because they are either ineffective or harms exceed benefits. There were 3 “I” statements on interventions having insufficient evidence on benefits or harms to warrant a recommendation. Only 1 recommendation was rated “C” (selectively offer based on individual factors); this assessment is the hardest one to interpret and implement. Keep in mind that all “A” and “B” recommendations must be covered by commercial health plans with no out-of-pocket cost to the patient (ie, no co-pay or deductible).
New recommendation on preventing perinatal depression
One of 2 new topics reviewed in 2019 was the prevention of perinatal depression. (As noted, the other on preexposure prophylaxis to prevent HIV infection has already been covered in a Practice Alert podcast.) The Task Force found that the prevalence of depression is estimated at 8.9% among pregnant women and 37% at any point in the first year postpartum.1
Depression during pregnancy and the postpartum period is associated with adverse effects on the mother and infant, including higher rates of suicide and suicidal ideation and thoughts of harming the infant.1 Women with perinatal depression are also more likely to exhibit significantly lower levels of positive maternal behaviors, such as praising and playing with their child,2 and higher rates of negative maternal behaviors.2 Perinatal depression is also associated with increased rates of preterm birth and low birth weight.3
Mothers with postpartum depression have higher rates of early termination of breast feeding and lower adherence for recommended child preventive services including vaccination.1 Children of mothers with perinatal depression develop more behavior problems, have lower cognitive functioning, and have an increased risk of psychiatric disorders than do children of mothers without this condition.4,5
A number of risk factors are associated with perinatal depression, but no screening tool was found to have enough predictive value to be recommended. In deciding who should receive an offer or referral for counseling, the Task Force recommends as a practical approach providing “counseling interventions to women with 1 or more of the following: a history of depression, current depressive symptoms (that do not reach a diagnostic threshold), certain socioeconomic risk factors such as low income or adolescent or single parenthood, recent intimate partner violence, or mental health-related factors such as elevated anxiety symptoms or a history of significant negative life events.”1
There is no conclusive evidence to guide timing of counseling interventions, but most studies reviewed started them in the second trimester. These studies included cognitive behavioral therapy and interpersonal therapy and involved counseling sessions that ranged from 4 to 20 sessions and lasted for 4 to 70 weeks. They involved group and individual sessions, mostly in-person visits, and were provided by a variety of health professionals.6
Continue to: The studies reviewed showed...
The studies reviewed showed that counseling interventions reduced the likelihood of developing depression symptoms by 39%, with a number needed to treat of 13.5.6 Studies that looked at pregnancy and maternal and infant clinical outcomes were mixed but usually found little to no difference with counseling.6 Even so, the Task Force felt that a reduction in depression itself was enough to warrant a “B” recommendation.
Screening for abdominal aortic aneurisms
Ultrasound is underused in screening for abdominal aortic aneurisms (AAA) and preventing death from their rupture. (See “Whom should you screen for abdominal aortic aneurysm?”) The prevalence of AAA is the United States is unknown; in other western countries it varies from 1.2% to 3.3% in men and is declining due to decreased rates of smoking, the primary risk factor.
The risk of AAA rupture is related to the size of the aneurism, and surgical repair (either endovascular or open repair) is usually reserved for lesions > 5.5 cm in diameter or for smaller ones that are rapidly increasing in size. The standard of care for most aneurysms < 5.5 cm is to periodically monitor growth using ultrasound.
The 2019 recommendations on AAA screening are essentially the same as those made in 2004; evaluation of new evidence supported the previous recommendations. The Task Force recommends one-time screening for men ages 65 to 75 years who have ever smoked (B recommendation). Selective screening is recommended for men in this age group who have never smoked, based mainly on personal factors such as a family history of AAA, the presence of other arterial aneurisms, and the number of risk factors for cardiovascular disease (C recommendation).
The Task Force recommends against screening women ages 65 to 75 years with no history of smoking or family history of AAA, while the evidence was felt to be insufficient to make a recommendation for women in this age range who have either risk factor. This is problematic for family physicians since women with these risk factors are at increased risk of AAA compared with women without risk factors.8 And aneurisms in women appear to rupture more frequently at smaller sizes, although at a later age than in men.8 Operative mortality is also higher in women than in men8 and there is no direct evidence that screening improves outcomes for women.
Continue to: Screening for asymptomatic bacteriuria
Screening for asymptomatic bacteriuria
The Task Force re-examined and reconfirmed its previous recommendations on screening for asymptomatic bacteriuria in adults. It recommends in favor of it for pregnant women, using a urine culture to screen, and against it for all other adults. There is good evidence that treating screen-detected asymptomatic bacteriuria in pregnant women reduces the incidence of pyelonephritis in pregnancy.
The Task Force made this a “B” recommendation based on a lower prevalence of pyelonephritis found in more recent studies, making the overall magnitude of benefits moderate. There is also good evidence that treating asymptomatic bacteriuria in nonpregnant adults offers no benefits.9 The Task Force has re-examined this topic 5 times since 1996 with essentially the same results.
Screening for elevated lead levels in children and pregnant women
In 2019 the Task Force changed its 2006 recommendation on screening for elevated lead levels. The earlier recommendation advised against screening both children ages 1 to 5 years and pregnant women at average risk for elevated blood lead levels. In 2006 the Task Force also felt that evidence was insufficient to make a recommendation regarding children ages 1 to 5 years at elevated risk.
The Task Force now believes the evidence is insufficient to make a recommendation for all children ages 1 to 5 years and for pregnant women, thus moving from a “D” to an “I” recommendation for children and pregnant women with average risk. Even though there is little evidence to support screening for elevated lead levels in children ages 1 to 5 years and in pregnant women, the Task Force apparently did not feel comfortable recommending against testing, given that the cutoff for elevated blood lead levels has been lowered from 10 to 5 mcg/dL and that other sources of lead may now be more prevalent than in 2006.10
Remember that the Medicaid Early and Periodic Screening, Diagnostic, and Treatment program requires that all children receive a blood lead test twice, at ages 12 and 24 months, and that previously unscreened children ages 36 to 72 months must be tested once.
Continue to: Additional updates with no recommendation changes
Additional updates with no recommendation changes
Four other topics were re-examined by the Task Force in 2019, resulting in no significant changes to recommendations (TABLE 2):
- Screen for hepatitis B infection in pregnant women at the first prenatal visit (A recommendation; updated from 2009).
- Screen for HIV infection in adolescents and adults ages 15 to 65 years, and in those younger and older who are at high risk, and during pregnancy (A recommendation; updated from 2013).
- Provide topical medication for all newborns to prevent gonococcal ophthalmia neonatorum (A recommendation; first recommendation in 1996, updated in 2005 and 2011).
- Avoid screening for pancreatic cancer in asymptomatic adults (D recommendation; updated from 2004).
Affirmation of USPSTF’s value
In only 1 out of 9 reassessments of past topics did the Task Force modify its previous recommendations in any significant way. This demonstrates that recommendations will usually stand the test of time if they are made using robust, evidence-based methods (that consider both benefits and harms) and they are not made when evidence is insufficient. That only 2 new topics could be addressed in 2019 may reflect a need for more resources for the Task Force.
In 2019, the US Preventive Services Task Force published 19 recommendation statements on 11 topics. Two of the topics are new; 9 are topics the Task Force had previously reviewed and has updated (TABLE 1). Three of these topics have been covered in Practice Alert podcasts (mdedge.com/familymedicine) and will not be discussed here: risk assessment, genetic counseling, and genetic testing for breast cancer susceptibility gene mutations (October 2019); medications to reduce the risk of breast cancer (December 2019); and preexposure prophylaxis to prevent HIV infections (January 2020).
Of the 19 recommendation statements made in 2019 (TABLE 2), 5 were rated “A” and 5 were “B,” meaning the evidence shows that benefits outweigh harms and these interventions should be offered in primary care practice. There were 5 “D” recommendations for interventions that should not be offered because they are either ineffective or harms exceed benefits. There were 3 “I” statements on interventions having insufficient evidence on benefits or harms to warrant a recommendation. Only 1 recommendation was rated “C” (selectively offer based on individual factors); this assessment is the hardest one to interpret and implement. Keep in mind that all “A” and “B” recommendations must be covered by commercial health plans with no out-of-pocket cost to the patient (ie, no co-pay or deductible).
New recommendation on preventing perinatal depression
One of 2 new topics reviewed in 2019 was the prevention of perinatal depression. (As noted, the other on preexposure prophylaxis to prevent HIV infection has already been covered in a Practice Alert podcast.) The Task Force found that the prevalence of depression is estimated at 8.9% among pregnant women and 37% at any point in the first year postpartum.1
Depression during pregnancy and the postpartum period is associated with adverse effects on the mother and infant, including higher rates of suicide and suicidal ideation and thoughts of harming the infant.1 Women with perinatal depression are also more likely to exhibit significantly lower levels of positive maternal behaviors, such as praising and playing with their child,2 and higher rates of negative maternal behaviors.2 Perinatal depression is also associated with increased rates of preterm birth and low birth weight.3
Mothers with postpartum depression have higher rates of early termination of breast feeding and lower adherence for recommended child preventive services including vaccination.1 Children of mothers with perinatal depression develop more behavior problems, have lower cognitive functioning, and have an increased risk of psychiatric disorders than do children of mothers without this condition.4,5
A number of risk factors are associated with perinatal depression, but no screening tool was found to have enough predictive value to be recommended. In deciding who should receive an offer or referral for counseling, the Task Force recommends as a practical approach providing “counseling interventions to women with 1 or more of the following: a history of depression, current depressive symptoms (that do not reach a diagnostic threshold), certain socioeconomic risk factors such as low income or adolescent or single parenthood, recent intimate partner violence, or mental health-related factors such as elevated anxiety symptoms or a history of significant negative life events.”1
There is no conclusive evidence to guide timing of counseling interventions, but most studies reviewed started them in the second trimester. These studies included cognitive behavioral therapy and interpersonal therapy and involved counseling sessions that ranged from 4 to 20 sessions and lasted for 4 to 70 weeks. They involved group and individual sessions, mostly in-person visits, and were provided by a variety of health professionals.6
Continue to: The studies reviewed showed...
The studies reviewed showed that counseling interventions reduced the likelihood of developing depression symptoms by 39%, with a number needed to treat of 13.5.6 Studies that looked at pregnancy and maternal and infant clinical outcomes were mixed but usually found little to no difference with counseling.6 Even so, the Task Force felt that a reduction in depression itself was enough to warrant a “B” recommendation.
Screening for abdominal aortic aneurisms
Ultrasound is underused in screening for abdominal aortic aneurisms (AAA) and preventing death from their rupture. (See “Whom should you screen for abdominal aortic aneurysm?”) The prevalence of AAA is the United States is unknown; in other western countries it varies from 1.2% to 3.3% in men and is declining due to decreased rates of smoking, the primary risk factor.
The risk of AAA rupture is related to the size of the aneurism, and surgical repair (either endovascular or open repair) is usually reserved for lesions > 5.5 cm in diameter or for smaller ones that are rapidly increasing in size. The standard of care for most aneurysms < 5.5 cm is to periodically monitor growth using ultrasound.
The 2019 recommendations on AAA screening are essentially the same as those made in 2004; evaluation of new evidence supported the previous recommendations. The Task Force recommends one-time screening for men ages 65 to 75 years who have ever smoked (B recommendation). Selective screening is recommended for men in this age group who have never smoked, based mainly on personal factors such as a family history of AAA, the presence of other arterial aneurisms, and the number of risk factors for cardiovascular disease (C recommendation).
The Task Force recommends against screening women ages 65 to 75 years with no history of smoking or family history of AAA, while the evidence was felt to be insufficient to make a recommendation for women in this age range who have either risk factor. This is problematic for family physicians since women with these risk factors are at increased risk of AAA compared with women without risk factors.8 And aneurisms in women appear to rupture more frequently at smaller sizes, although at a later age than in men.8 Operative mortality is also higher in women than in men8 and there is no direct evidence that screening improves outcomes for women.
Continue to: Screening for asymptomatic bacteriuria
Screening for asymptomatic bacteriuria
The Task Force re-examined and reconfirmed its previous recommendations on screening for asymptomatic bacteriuria in adults. It recommends in favor of it for pregnant women, using a urine culture to screen, and against it for all other adults. There is good evidence that treating screen-detected asymptomatic bacteriuria in pregnant women reduces the incidence of pyelonephritis in pregnancy.
The Task Force made this a “B” recommendation based on a lower prevalence of pyelonephritis found in more recent studies, making the overall magnitude of benefits moderate. There is also good evidence that treating asymptomatic bacteriuria in nonpregnant adults offers no benefits.9 The Task Force has re-examined this topic 5 times since 1996 with essentially the same results.
Screening for elevated lead levels in children and pregnant women
In 2019 the Task Force changed its 2006 recommendation on screening for elevated lead levels. The earlier recommendation advised against screening both children ages 1 to 5 years and pregnant women at average risk for elevated blood lead levels. In 2006 the Task Force also felt that evidence was insufficient to make a recommendation regarding children ages 1 to 5 years at elevated risk.
The Task Force now believes the evidence is insufficient to make a recommendation for all children ages 1 to 5 years and for pregnant women, thus moving from a “D” to an “I” recommendation for children and pregnant women with average risk. Even though there is little evidence to support screening for elevated lead levels in children ages 1 to 5 years and in pregnant women, the Task Force apparently did not feel comfortable recommending against testing, given that the cutoff for elevated blood lead levels has been lowered from 10 to 5 mcg/dL and that other sources of lead may now be more prevalent than in 2006.10
Remember that the Medicaid Early and Periodic Screening, Diagnostic, and Treatment program requires that all children receive a blood lead test twice, at ages 12 and 24 months, and that previously unscreened children ages 36 to 72 months must be tested once.
Continue to: Additional updates with no recommendation changes
Additional updates with no recommendation changes
Four other topics were re-examined by the Task Force in 2019, resulting in no significant changes to recommendations (TABLE 2):
- Screen for hepatitis B infection in pregnant women at the first prenatal visit (A recommendation; updated from 2009).
- Screen for HIV infection in adolescents and adults ages 15 to 65 years, and in those younger and older who are at high risk, and during pregnancy (A recommendation; updated from 2013).
- Provide topical medication for all newborns to prevent gonococcal ophthalmia neonatorum (A recommendation; first recommendation in 1996, updated in 2005 and 2011).
- Avoid screening for pancreatic cancer in asymptomatic adults (D recommendation; updated from 2004).
Affirmation of USPSTF’s value
In only 1 out of 9 reassessments of past topics did the Task Force modify its previous recommendations in any significant way. This demonstrates that recommendations will usually stand the test of time if they are made using robust, evidence-based methods (that consider both benefits and harms) and they are not made when evidence is insufficient. That only 2 new topics could be addressed in 2019 may reflect a need for more resources for the Task Force.
1. USPSTF. Interventions to prevent perinatal depression: US Preventive Services Task Force recommendation statement. 2019;321:580-587.
2. Lovejoy MC, Graczyk PA, O’Hare E, et al. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000;20:561-592.
3. Szegda K, Markenson G, Bertone-Johnson ER, et al. Depression during pregnancy: a risk factor for adverse neonatal outcomes? A critical review of the literature. J Matern Fetal Neonatal Med. 2014;27:960-967.
4. Beck CT. The effects of postpartum depression on child development: a meta-analysis. Arch Psychiatr Nurs. 1998;12:12-20.
5. Santos IS, Matijasevich A, Barros AJ, et al. Antenatal and postnatal maternal mood symptoms and psychiatric disorders in pre-school children from the 2004 Pelotas Birth Cohort. J Affect Disord. 2014;164:112-117.
6. O’Connor E, Senger CA, Henniger ML, et al. Interventions to prevent perinatal depression. Evidence report and systematic review for the US preventive services task force. JAMA. 2019;321:588-601.
7. USPSTF. Screening for abdominal aortic aneurysm: US Preventive Services Task Force recommendation statement. 2019;322:2211-2218.
8. Guirguis-Blake JM, Beil TL, Senger CA, et al. Primary care screening for abdominal aortic aneurysm: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2019;322:2219-2238.
9. USPSTF. Owens DK, Davidson KW, Krist AH, et al. Screening for asymptomatic bacteriuria in adults: US Preventive Services Task Force recommendation statement. 2019;322:1188-1194.
10. USPSTF. Screening for elevated blood lead levels in children and pregnant women: US Preventive Services Task Force recommendation statement. 2019;321:1502-1509.
1. USPSTF. Interventions to prevent perinatal depression: US Preventive Services Task Force recommendation statement. 2019;321:580-587.
2. Lovejoy MC, Graczyk PA, O’Hare E, et al. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000;20:561-592.
3. Szegda K, Markenson G, Bertone-Johnson ER, et al. Depression during pregnancy: a risk factor for adverse neonatal outcomes? A critical review of the literature. J Matern Fetal Neonatal Med. 2014;27:960-967.
4. Beck CT. The effects of postpartum depression on child development: a meta-analysis. Arch Psychiatr Nurs. 1998;12:12-20.
5. Santos IS, Matijasevich A, Barros AJ, et al. Antenatal and postnatal maternal mood symptoms and psychiatric disorders in pre-school children from the 2004 Pelotas Birth Cohort. J Affect Disord. 2014;164:112-117.
6. O’Connor E, Senger CA, Henniger ML, et al. Interventions to prevent perinatal depression. Evidence report and systematic review for the US preventive services task force. JAMA. 2019;321:588-601.
7. USPSTF. Screening for abdominal aortic aneurysm: US Preventive Services Task Force recommendation statement. 2019;322:2211-2218.
8. Guirguis-Blake JM, Beil TL, Senger CA, et al. Primary care screening for abdominal aortic aneurysm: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2019;322:2219-2238.
9. USPSTF. Owens DK, Davidson KW, Krist AH, et al. Screening for asymptomatic bacteriuria in adults: US Preventive Services Task Force recommendation statement. 2019;322:1188-1194.
10. USPSTF. Screening for elevated blood lead levels in children and pregnant women: US Preventive Services Task Force recommendation statement. 2019;321:1502-1509.
With life in the balance, a pediatric palliative care program expands its work to adults
In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.
The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.
“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”
When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
Stitching the QUILT
Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.
Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.
Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.
“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”
During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
‘They have no loved ones with them’
One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.
“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”
Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”
In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”
Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”
Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”
When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.
“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
No hospital cheeseburgers
QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.
QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”
Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.
Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”
Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.
“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’
I said, ‘What’s the matter with the cheeseburger made at the hospital?’
He said, ‘No! They can’t make the cheeseburger I want.’
I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
Self-care and the next chapter
Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”
She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”
Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.
“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”
An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.
In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.
The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.
“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”
When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
Stitching the QUILT
Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.
Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.
Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.
“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”
During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
‘They have no loved ones with them’
One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.
“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”
Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”
In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”
Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”
Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”
When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.
“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
No hospital cheeseburgers
QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.
QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”
Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.
Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”
Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.
“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’
I said, ‘What’s the matter with the cheeseburger made at the hospital?’
He said, ‘No! They can’t make the cheeseburger I want.’
I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
Self-care and the next chapter
Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”
She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”
Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.
“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”
An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.
In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.
The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.
“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”
When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
Stitching the QUILT
Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.
Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.
Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.
“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”
During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
‘They have no loved ones with them’
One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.
“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”
Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”
In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”
Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”
Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”
When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.
“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
No hospital cheeseburgers
QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.
QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”
Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.
Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”
Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.
“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’
I said, ‘What’s the matter with the cheeseburger made at the hospital?’
He said, ‘No! They can’t make the cheeseburger I want.’
I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
Self-care and the next chapter
Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”
She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”
Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.
“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”
An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.
Fewer than 20% of eligible children received the recommended two doses of flu vaccine
A second booster dose of the influenza vaccine in vaccine-naive children may significantly reduce their likelihood of getting the disease, new research suggests.
Writing for JAMA Pediatrics, researchers reported on a case-control study of 7,533 children presenting to outpatient clinics – all in the U.S. Influenza Vaccine Effectiveness Network – with acute respiratory tract illnesses from 2014 to 2018. The study looked at the effectiveness of vaccination against laboratory-confirmed influenza.
Current U.S. guidelines recommend that children aged 6 months to 8 years receive two doses of the influenza vaccine initially – a priming dose and a booster dose – while those aged 9 years or older are considered to be ‘immunologically primed’ and therefore only require one annual dose.
The study found that 60% of the children had received two doses of the influenza vaccine during their first vaccination season, and 68% were first vaccinated before the current influenza season. Of those who had been vaccinated, 89% had received their first influenza vaccine dose when they were younger than 2 years.
Among the 2,140 children who were unvaccinated before the current influenza season, the 436 children who received two doses of the influenza vaccine had 43% lower odds of influenza compared with the 466 children who received one dose. The overall vaccine effectiveness among this vaccine-naive group aged under 2 years was 38%; for those who received two doses it was 53%, and for those who received one dose it was 23%.
“The higher risk of infection resulting from underdeveloped immune and respiratory tract systems provides a reason to identify vaccination strategies focusing on this vulnerable population of younger children,” wrote Jessie R. Chung, MPH, of the Influenza Division of the Centers for Disease Control and Prevention, and coauthors. “Promoting efforts to improve influenza vaccine coverage—particularly with 2 doses in the first vaccination season – may reduce the burden of influenza illness among young children, who are particularly vulnerable to complications and death from influenza infection.”
Overall 52% of children were unvaccinated for the current influenza season and 9% were partially vaccinated. Of those who were fully vaccinated for the current season, 83% had received one dose in the current season, and 17% had received two doses.
The authors found that full vaccination against any influenza was associated with a 22% lower odds of influenza compared with partial vaccination (95% confidence interval, 0.61-1.01), with partial vaccination defined as anything less than two doses of vaccine in the current season – at least 4 weeks apart – or two or more doses before the current season and one or more doses in the current season. However, even children who were only partially vaccinated still showed statistically significant vaccine effectiveness, except for those who received one dose of vaccine in the current season and were aged under 2 years.
“Compared with older children, young children, even if healthy, are at an elevated risk of influenza infection and influenza-associated complications, such as hospitalization,” the authors wrote. “One recent simulation study reported that even small improvements in either vaccine coverage or VE [vaccine effectiveness], and ideally both, may avert substantial amounts of influenza-associated illnesses, medical visits, and hospitalizations.”
The study also noted that children who had received only a single previous vaccine dose rarely received two doses in the current season.
In an accompanying editorial, Claire Abraham, MD, and Melissa S. Stockwell, MD, of Columbia University Medical Center, New York, wrote that modeling suggested that in the 2017-2018 influenza season, vaccination prevented 1.3 million cases of infection, 895,000 medical visits, 10,500 hospitalizations and 111 deaths in children aged under 5 years.
“This study highlights the importance of administering 2 doses of the influenza vaccine to children younger than 9 years for whom 2 doses are needed, and especially to vaccine naive children younger than 2 years,” they wrote.
But despite many studies showing the impact and importance of influenza vaccination, uptake of this vaccine remained lower than for other pediatric vaccines.
“This present study reemphasizes the need for further research exploring why families who are seemingly willing to vaccinate their children against influenza, as indicated by their receiving the first needed dose of influenza vaccine, find barriers to receiving all of the needed doses, placing their children at higher risk for contracting a potentially devastating virus.”
The U.S. Influenza Vaccine Effectiveness Network is funded by the CDC, and this project also received support from the National Institutes of Health. Eight authors declared grants from the CDC during the conduct of the study, and five declared grants and other funding from private industry outside the study.
SOURCE: Chung J et al. JAMA Pediatrics 2020 May 4. doi: 10.1001/jamapediatrics.2020.0372.
A second booster dose of the influenza vaccine in vaccine-naive children may significantly reduce their likelihood of getting the disease, new research suggests.
Writing for JAMA Pediatrics, researchers reported on a case-control study of 7,533 children presenting to outpatient clinics – all in the U.S. Influenza Vaccine Effectiveness Network – with acute respiratory tract illnesses from 2014 to 2018. The study looked at the effectiveness of vaccination against laboratory-confirmed influenza.
Current U.S. guidelines recommend that children aged 6 months to 8 years receive two doses of the influenza vaccine initially – a priming dose and a booster dose – while those aged 9 years or older are considered to be ‘immunologically primed’ and therefore only require one annual dose.
The study found that 60% of the children had received two doses of the influenza vaccine during their first vaccination season, and 68% were first vaccinated before the current influenza season. Of those who had been vaccinated, 89% had received their first influenza vaccine dose when they were younger than 2 years.
Among the 2,140 children who were unvaccinated before the current influenza season, the 436 children who received two doses of the influenza vaccine had 43% lower odds of influenza compared with the 466 children who received one dose. The overall vaccine effectiveness among this vaccine-naive group aged under 2 years was 38%; for those who received two doses it was 53%, and for those who received one dose it was 23%.
“The higher risk of infection resulting from underdeveloped immune and respiratory tract systems provides a reason to identify vaccination strategies focusing on this vulnerable population of younger children,” wrote Jessie R. Chung, MPH, of the Influenza Division of the Centers for Disease Control and Prevention, and coauthors. “Promoting efforts to improve influenza vaccine coverage—particularly with 2 doses in the first vaccination season – may reduce the burden of influenza illness among young children, who are particularly vulnerable to complications and death from influenza infection.”
Overall 52% of children were unvaccinated for the current influenza season and 9% were partially vaccinated. Of those who were fully vaccinated for the current season, 83% had received one dose in the current season, and 17% had received two doses.
The authors found that full vaccination against any influenza was associated with a 22% lower odds of influenza compared with partial vaccination (95% confidence interval, 0.61-1.01), with partial vaccination defined as anything less than two doses of vaccine in the current season – at least 4 weeks apart – or two or more doses before the current season and one or more doses in the current season. However, even children who were only partially vaccinated still showed statistically significant vaccine effectiveness, except for those who received one dose of vaccine in the current season and were aged under 2 years.
“Compared with older children, young children, even if healthy, are at an elevated risk of influenza infection and influenza-associated complications, such as hospitalization,” the authors wrote. “One recent simulation study reported that even small improvements in either vaccine coverage or VE [vaccine effectiveness], and ideally both, may avert substantial amounts of influenza-associated illnesses, medical visits, and hospitalizations.”
The study also noted that children who had received only a single previous vaccine dose rarely received two doses in the current season.
In an accompanying editorial, Claire Abraham, MD, and Melissa S. Stockwell, MD, of Columbia University Medical Center, New York, wrote that modeling suggested that in the 2017-2018 influenza season, vaccination prevented 1.3 million cases of infection, 895,000 medical visits, 10,500 hospitalizations and 111 deaths in children aged under 5 years.
“This study highlights the importance of administering 2 doses of the influenza vaccine to children younger than 9 years for whom 2 doses are needed, and especially to vaccine naive children younger than 2 years,” they wrote.
But despite many studies showing the impact and importance of influenza vaccination, uptake of this vaccine remained lower than for other pediatric vaccines.
“This present study reemphasizes the need for further research exploring why families who are seemingly willing to vaccinate their children against influenza, as indicated by their receiving the first needed dose of influenza vaccine, find barriers to receiving all of the needed doses, placing their children at higher risk for contracting a potentially devastating virus.”
The U.S. Influenza Vaccine Effectiveness Network is funded by the CDC, and this project also received support from the National Institutes of Health. Eight authors declared grants from the CDC during the conduct of the study, and five declared grants and other funding from private industry outside the study.
SOURCE: Chung J et al. JAMA Pediatrics 2020 May 4. doi: 10.1001/jamapediatrics.2020.0372.
A second booster dose of the influenza vaccine in vaccine-naive children may significantly reduce their likelihood of getting the disease, new research suggests.
Writing for JAMA Pediatrics, researchers reported on a case-control study of 7,533 children presenting to outpatient clinics – all in the U.S. Influenza Vaccine Effectiveness Network – with acute respiratory tract illnesses from 2014 to 2018. The study looked at the effectiveness of vaccination against laboratory-confirmed influenza.
Current U.S. guidelines recommend that children aged 6 months to 8 years receive two doses of the influenza vaccine initially – a priming dose and a booster dose – while those aged 9 years or older are considered to be ‘immunologically primed’ and therefore only require one annual dose.
The study found that 60% of the children had received two doses of the influenza vaccine during their first vaccination season, and 68% were first vaccinated before the current influenza season. Of those who had been vaccinated, 89% had received their first influenza vaccine dose when they were younger than 2 years.
Among the 2,140 children who were unvaccinated before the current influenza season, the 436 children who received two doses of the influenza vaccine had 43% lower odds of influenza compared with the 466 children who received one dose. The overall vaccine effectiveness among this vaccine-naive group aged under 2 years was 38%; for those who received two doses it was 53%, and for those who received one dose it was 23%.
“The higher risk of infection resulting from underdeveloped immune and respiratory tract systems provides a reason to identify vaccination strategies focusing on this vulnerable population of younger children,” wrote Jessie R. Chung, MPH, of the Influenza Division of the Centers for Disease Control and Prevention, and coauthors. “Promoting efforts to improve influenza vaccine coverage—particularly with 2 doses in the first vaccination season – may reduce the burden of influenza illness among young children, who are particularly vulnerable to complications and death from influenza infection.”
Overall 52% of children were unvaccinated for the current influenza season and 9% were partially vaccinated. Of those who were fully vaccinated for the current season, 83% had received one dose in the current season, and 17% had received two doses.
The authors found that full vaccination against any influenza was associated with a 22% lower odds of influenza compared with partial vaccination (95% confidence interval, 0.61-1.01), with partial vaccination defined as anything less than two doses of vaccine in the current season – at least 4 weeks apart – or two or more doses before the current season and one or more doses in the current season. However, even children who were only partially vaccinated still showed statistically significant vaccine effectiveness, except for those who received one dose of vaccine in the current season and were aged under 2 years.
“Compared with older children, young children, even if healthy, are at an elevated risk of influenza infection and influenza-associated complications, such as hospitalization,” the authors wrote. “One recent simulation study reported that even small improvements in either vaccine coverage or VE [vaccine effectiveness], and ideally both, may avert substantial amounts of influenza-associated illnesses, medical visits, and hospitalizations.”
The study also noted that children who had received only a single previous vaccine dose rarely received two doses in the current season.
In an accompanying editorial, Claire Abraham, MD, and Melissa S. Stockwell, MD, of Columbia University Medical Center, New York, wrote that modeling suggested that in the 2017-2018 influenza season, vaccination prevented 1.3 million cases of infection, 895,000 medical visits, 10,500 hospitalizations and 111 deaths in children aged under 5 years.
“This study highlights the importance of administering 2 doses of the influenza vaccine to children younger than 9 years for whom 2 doses are needed, and especially to vaccine naive children younger than 2 years,” they wrote.
But despite many studies showing the impact and importance of influenza vaccination, uptake of this vaccine remained lower than for other pediatric vaccines.
“This present study reemphasizes the need for further research exploring why families who are seemingly willing to vaccinate their children against influenza, as indicated by their receiving the first needed dose of influenza vaccine, find barriers to receiving all of the needed doses, placing their children at higher risk for contracting a potentially devastating virus.”
The U.S. Influenza Vaccine Effectiveness Network is funded by the CDC, and this project also received support from the National Institutes of Health. Eight authors declared grants from the CDC during the conduct of the study, and five declared grants and other funding from private industry outside the study.
SOURCE: Chung J et al. JAMA Pediatrics 2020 May 4. doi: 10.1001/jamapediatrics.2020.0372.
FROM JAMA PEDIATRICS
Novel inflammatory syndrome in children possibly linked to COVID-19
according to reports from National Health Service England, The Lancet, and the New York City health department.
Fifteen children in New York City hospitals have presented with the condition, provisionally called pediatric multisystem inflammatory syndrome, between April 17 and May 1, according to a health alert from New York City health department deputy commissioner Demetre C. Daskalakis, MD, MPH, on May 4. On May 5, the New York state department of health released a health advisory that 64 suspected cases had been reported in children in New York state hospitals, including New York City.
The New York City reports follow a case study published April 7 in Hospital Pediatrics about the presentation. There also was a statement from the U.K.’s Paediatric Intensive Care Society (PICS) on April 27 that noted “blood parameters consistent with severe COVID-19 in children” as well as abdominal pain, gastrointestinal symptoms, and cardiac inflammation.
“Whilst it is too early to say with confidence, features appear to include high CRP [C-reactive protein], high [erythrocyte sedimentation rate] and high ferritin,” the PICS release stated. The cardiac inflammation consists of “myocarditis with raised troponin and [prohormone brain natriuretic peptide],” according to the PICS statement. “Some have an appearance of their coronary arteries in keeping with Kawasaki disease.”
The initial 15 New York City patients reportedly all had “subjective or measured fever, and more than half reported rash, abdominal pain, vomiting, or diarrhea,” but fewer than half had respiratory symptoms.
The case study described a 6-month-old infant who was admitted and diagnosed with classic Kawasaki disease, who also tested positive for COVID-19 with fever and mild respiratory symptoms, reported Veena G. Jones, MD, a pediatric hospitalist in Palo Alto, Calif., and associates.
While many of the U.K. children presenting with the symptoms had a positive polymerase chain reaction tests for infection from SARS-CoV-2, some also had a negative test. Polymerase chain reaction testing in New York City was positive for 4 children and negative for 11 children, but 6 of the those who tested negative had positive serology tests, potentially pointing to postinfection sequelae.
At press time, more cases were reported from the United Kingdom in The Lancet. In London, eight children with hyperinflammatory shock, showing features similar to atypical Kawasaki disease, Kawasaki disease shock syndrome, or toxic shock syndrome, presented within 10 days to Evelina London Children’s Hospital Paediatric ICU, Shelley Riphagen, MBChB, and colleagues revealed.
Clinically, their presentations were similar, with persistent fever, rash, conjunctivitis, peripheral edema, extremity pain, and gastrointestinal symptoms. They all developed warm vasoplegic shock that did not respond to volume resuscitation; noradrenaline and milrinone were administered for hemodynamic support. Seven of the children needed mechanical ventilation for cardiovascular stabilization, although most of them had no significant respiratory involvement.
Of note was development of small pleural, pericardial, and ascitic effusion – “suggestive of a diffuse inflammatory process,” Dr. Riphagen and associates wrote. None of the children initially was positive for SARS-CoV-2; laboratory evidence of infection or inflammation included “elevated concentrations of CRP, procalcitonin, ferritin, triglycerides or d-dimers.”
“A common echocardiographic finding was echobright coronary vessels,” they wrote. “One child developed arrhythmia with refractory shock, requiring extracorporeal life support, and died from a large cerebrovascular infarct.”
As the article went to press, the doctors in that same ICU had seen more than 20 children with similar clinical presentations, Dr. Riphagen and associates reported, and the first 10 tested positive for SARS-CoV-2 antibody, including the 8 described above.
“Most of the children appear to have antibodies to the novel coronavirus, even when they do not have virus detectable in their nose,” said Audrey John, MD, PhD, chief of the division of pediatric infectious diseases at Children’s Hospital of Philadelphia, where clinicians have seen several cases similar to those described by NHS England and the New York City health department. “This suggests that these symptoms are ‘postinfectious,’ likely due to an abnormal immune response that happens after viral infection.”
She noted at the time of her interview, however, that fewer than 100 U.S. pediatric cases appear to have been reported.
“While our understanding is evolving, given the scope of the COVID-19 pandemic, this suggests that this kind of severe disease in children is very rare indeed,” Dr. John said. “Because this syndrome is so newly described, we have to continue to be cautious in attributing this syndrome to COVID-19, as there are many other diseases that look quite similar.”
She advised clinicians to be “wary of attributing fever/rash/shock to this syndrome, as the differential is broad, and we do not want to fail to recognize and treat true toxic shock or tick-borne disease.”
Dawn Nolt, MD, MPH, an associate professor of pediatrics in infectious diseases at Oregon Health & Science University’s Doernbecher Children’s Hospital, Portland, also underscored the need to avoid drawing conclusions too quickly.
“At this time, there is no causality established between SARS-COV-2 and these inflammatory syndromes other than a temporal association,” said Dr. Nolt, whose hospital has not yet seen any of these cases. “If there is a link, then the symptoms may be from a ‘direct hit’ of the virus on tissues, or from an overly exuberant immune response.”
None of the initial 15 New York City children died, although 5 needed mechanical ventilation and over half needed blood pressure support. The one child in London died from a large cerebrovascular infarct.
If the cases are connected to COVID-19, one explanation for the presentation may be related to the leading hypothesis “that SARS-CoV-2 may stimulate the immune system in such a way to promote vasculitis,” Dr. Nolt said in an interview.
“It is unusual that this particular constellation was not reported from the known pediatric cases out of China, where the COVID-19 pandemic originated,” Dr. Nolt said. “If there is a link between SARS-CoV-2 and these inflammatory syndromes, this may have resulted from genetic/host differences, changes in the SARS-CoV-2 virus, or other factors yet to be determined.”
The New York City bulletin recommended that clinicians immediately refer children presenting with the described symptoms to a specialist in pediatric infectious disease, rheumatology, or critical care.
“Early diagnosis and treatment of patients meeting full or partial criteria for Kawasaki disease is critical to preventing end-organ damage and other long-term complications,” the bulletin stated. It recommended aspirin and intravenous immunoglobulin for those who met Kawasaki criteria.
Dr. John said that children with the presentation appear to be responding well to intravenous immunoglobulin and/or steroids. She further emphasized that virtually all pediatric patients recover from COVID-19.
“Physicians should advise families to bring their children and teens back in for evaluation if they develop new fever, rash, or abdominal pain and diarrhea,” Dr. John said. “Families should not be afraid to seek care when their kids are sick. Our pediatric hospitals and EDs are open for business and working hard to protect staff and patients.”
A Kawasaki syndrome diagnosis requires at least 5 days of a fever at 101-104° F or higher along with four of the following five symptoms: rash over the torso; redness and swelling on palms and soles of the feet with later skin peeling; bloodshot, light-sensitive eyes; swollen lymph glands in the neck; and irritation and inflammation of the mouth, lips and throat, sometimes with “strawberry” tongue, according to the American Heart Association.
A press release from the AHA noted that Kawasaki disease is the most common cause of acquired heart disease in developed countries, but the condition remains rare.
Kawasaki disease’s etiology is unknown, but “some evidence suggests an infectious trigger, with winter-spring seasonality of the disease,” wrote the case study authors, noting that past research has linked Kawasaki disease with previous or concurrent infections of rhinovirus/enterovirus, parainfluenza, respiratory syncytial virus, influenza, adenovirus, and the four common human coronavirus strains.
“We have to remember that our experience with this pandemic is less than 12 months,” Dr. Nolt said. “We are still accumulating information, and any additional manifestations, particularly severe ones, adds to our ability to more quickly detect and treat children.”
Dr. Nolt and Dr. John had no disclosures.
SOURCES: Jones VG et al. Hosp Pediatr. 2020 Apr 7. doi: 10.1542/hpeds.2020-0123; Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.
according to reports from National Health Service England, The Lancet, and the New York City health department.
Fifteen children in New York City hospitals have presented with the condition, provisionally called pediatric multisystem inflammatory syndrome, between April 17 and May 1, according to a health alert from New York City health department deputy commissioner Demetre C. Daskalakis, MD, MPH, on May 4. On May 5, the New York state department of health released a health advisory that 64 suspected cases had been reported in children in New York state hospitals, including New York City.
The New York City reports follow a case study published April 7 in Hospital Pediatrics about the presentation. There also was a statement from the U.K.’s Paediatric Intensive Care Society (PICS) on April 27 that noted “blood parameters consistent with severe COVID-19 in children” as well as abdominal pain, gastrointestinal symptoms, and cardiac inflammation.
“Whilst it is too early to say with confidence, features appear to include high CRP [C-reactive protein], high [erythrocyte sedimentation rate] and high ferritin,” the PICS release stated. The cardiac inflammation consists of “myocarditis with raised troponin and [prohormone brain natriuretic peptide],” according to the PICS statement. “Some have an appearance of their coronary arteries in keeping with Kawasaki disease.”
The initial 15 New York City patients reportedly all had “subjective or measured fever, and more than half reported rash, abdominal pain, vomiting, or diarrhea,” but fewer than half had respiratory symptoms.
The case study described a 6-month-old infant who was admitted and diagnosed with classic Kawasaki disease, who also tested positive for COVID-19 with fever and mild respiratory symptoms, reported Veena G. Jones, MD, a pediatric hospitalist in Palo Alto, Calif., and associates.
While many of the U.K. children presenting with the symptoms had a positive polymerase chain reaction tests for infection from SARS-CoV-2, some also had a negative test. Polymerase chain reaction testing in New York City was positive for 4 children and negative for 11 children, but 6 of the those who tested negative had positive serology tests, potentially pointing to postinfection sequelae.
At press time, more cases were reported from the United Kingdom in The Lancet. In London, eight children with hyperinflammatory shock, showing features similar to atypical Kawasaki disease, Kawasaki disease shock syndrome, or toxic shock syndrome, presented within 10 days to Evelina London Children’s Hospital Paediatric ICU, Shelley Riphagen, MBChB, and colleagues revealed.
Clinically, their presentations were similar, with persistent fever, rash, conjunctivitis, peripheral edema, extremity pain, and gastrointestinal symptoms. They all developed warm vasoplegic shock that did not respond to volume resuscitation; noradrenaline and milrinone were administered for hemodynamic support. Seven of the children needed mechanical ventilation for cardiovascular stabilization, although most of them had no significant respiratory involvement.
Of note was development of small pleural, pericardial, and ascitic effusion – “suggestive of a diffuse inflammatory process,” Dr. Riphagen and associates wrote. None of the children initially was positive for SARS-CoV-2; laboratory evidence of infection or inflammation included “elevated concentrations of CRP, procalcitonin, ferritin, triglycerides or d-dimers.”
“A common echocardiographic finding was echobright coronary vessels,” they wrote. “One child developed arrhythmia with refractory shock, requiring extracorporeal life support, and died from a large cerebrovascular infarct.”
As the article went to press, the doctors in that same ICU had seen more than 20 children with similar clinical presentations, Dr. Riphagen and associates reported, and the first 10 tested positive for SARS-CoV-2 antibody, including the 8 described above.
“Most of the children appear to have antibodies to the novel coronavirus, even when they do not have virus detectable in their nose,” said Audrey John, MD, PhD, chief of the division of pediatric infectious diseases at Children’s Hospital of Philadelphia, where clinicians have seen several cases similar to those described by NHS England and the New York City health department. “This suggests that these symptoms are ‘postinfectious,’ likely due to an abnormal immune response that happens after viral infection.”
She noted at the time of her interview, however, that fewer than 100 U.S. pediatric cases appear to have been reported.
“While our understanding is evolving, given the scope of the COVID-19 pandemic, this suggests that this kind of severe disease in children is very rare indeed,” Dr. John said. “Because this syndrome is so newly described, we have to continue to be cautious in attributing this syndrome to COVID-19, as there are many other diseases that look quite similar.”
She advised clinicians to be “wary of attributing fever/rash/shock to this syndrome, as the differential is broad, and we do not want to fail to recognize and treat true toxic shock or tick-borne disease.”
Dawn Nolt, MD, MPH, an associate professor of pediatrics in infectious diseases at Oregon Health & Science University’s Doernbecher Children’s Hospital, Portland, also underscored the need to avoid drawing conclusions too quickly.
“At this time, there is no causality established between SARS-COV-2 and these inflammatory syndromes other than a temporal association,” said Dr. Nolt, whose hospital has not yet seen any of these cases. “If there is a link, then the symptoms may be from a ‘direct hit’ of the virus on tissues, or from an overly exuberant immune response.”
None of the initial 15 New York City children died, although 5 needed mechanical ventilation and over half needed blood pressure support. The one child in London died from a large cerebrovascular infarct.
If the cases are connected to COVID-19, one explanation for the presentation may be related to the leading hypothesis “that SARS-CoV-2 may stimulate the immune system in such a way to promote vasculitis,” Dr. Nolt said in an interview.
“It is unusual that this particular constellation was not reported from the known pediatric cases out of China, where the COVID-19 pandemic originated,” Dr. Nolt said. “If there is a link between SARS-CoV-2 and these inflammatory syndromes, this may have resulted from genetic/host differences, changes in the SARS-CoV-2 virus, or other factors yet to be determined.”
The New York City bulletin recommended that clinicians immediately refer children presenting with the described symptoms to a specialist in pediatric infectious disease, rheumatology, or critical care.
“Early diagnosis and treatment of patients meeting full or partial criteria for Kawasaki disease is critical to preventing end-organ damage and other long-term complications,” the bulletin stated. It recommended aspirin and intravenous immunoglobulin for those who met Kawasaki criteria.
Dr. John said that children with the presentation appear to be responding well to intravenous immunoglobulin and/or steroids. She further emphasized that virtually all pediatric patients recover from COVID-19.
“Physicians should advise families to bring their children and teens back in for evaluation if they develop new fever, rash, or abdominal pain and diarrhea,” Dr. John said. “Families should not be afraid to seek care when their kids are sick. Our pediatric hospitals and EDs are open for business and working hard to protect staff and patients.”
A Kawasaki syndrome diagnosis requires at least 5 days of a fever at 101-104° F or higher along with four of the following five symptoms: rash over the torso; redness and swelling on palms and soles of the feet with later skin peeling; bloodshot, light-sensitive eyes; swollen lymph glands in the neck; and irritation and inflammation of the mouth, lips and throat, sometimes with “strawberry” tongue, according to the American Heart Association.
A press release from the AHA noted that Kawasaki disease is the most common cause of acquired heart disease in developed countries, but the condition remains rare.
Kawasaki disease’s etiology is unknown, but “some evidence suggests an infectious trigger, with winter-spring seasonality of the disease,” wrote the case study authors, noting that past research has linked Kawasaki disease with previous or concurrent infections of rhinovirus/enterovirus, parainfluenza, respiratory syncytial virus, influenza, adenovirus, and the four common human coronavirus strains.
“We have to remember that our experience with this pandemic is less than 12 months,” Dr. Nolt said. “We are still accumulating information, and any additional manifestations, particularly severe ones, adds to our ability to more quickly detect and treat children.”
Dr. Nolt and Dr. John had no disclosures.
SOURCES: Jones VG et al. Hosp Pediatr. 2020 Apr 7. doi: 10.1542/hpeds.2020-0123; Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.
according to reports from National Health Service England, The Lancet, and the New York City health department.
Fifteen children in New York City hospitals have presented with the condition, provisionally called pediatric multisystem inflammatory syndrome, between April 17 and May 1, according to a health alert from New York City health department deputy commissioner Demetre C. Daskalakis, MD, MPH, on May 4. On May 5, the New York state department of health released a health advisory that 64 suspected cases had been reported in children in New York state hospitals, including New York City.
The New York City reports follow a case study published April 7 in Hospital Pediatrics about the presentation. There also was a statement from the U.K.’s Paediatric Intensive Care Society (PICS) on April 27 that noted “blood parameters consistent with severe COVID-19 in children” as well as abdominal pain, gastrointestinal symptoms, and cardiac inflammation.
“Whilst it is too early to say with confidence, features appear to include high CRP [C-reactive protein], high [erythrocyte sedimentation rate] and high ferritin,” the PICS release stated. The cardiac inflammation consists of “myocarditis with raised troponin and [prohormone brain natriuretic peptide],” according to the PICS statement. “Some have an appearance of their coronary arteries in keeping with Kawasaki disease.”
The initial 15 New York City patients reportedly all had “subjective or measured fever, and more than half reported rash, abdominal pain, vomiting, or diarrhea,” but fewer than half had respiratory symptoms.
The case study described a 6-month-old infant who was admitted and diagnosed with classic Kawasaki disease, who also tested positive for COVID-19 with fever and mild respiratory symptoms, reported Veena G. Jones, MD, a pediatric hospitalist in Palo Alto, Calif., and associates.
While many of the U.K. children presenting with the symptoms had a positive polymerase chain reaction tests for infection from SARS-CoV-2, some also had a negative test. Polymerase chain reaction testing in New York City was positive for 4 children and negative for 11 children, but 6 of the those who tested negative had positive serology tests, potentially pointing to postinfection sequelae.
At press time, more cases were reported from the United Kingdom in The Lancet. In London, eight children with hyperinflammatory shock, showing features similar to atypical Kawasaki disease, Kawasaki disease shock syndrome, or toxic shock syndrome, presented within 10 days to Evelina London Children’s Hospital Paediatric ICU, Shelley Riphagen, MBChB, and colleagues revealed.
Clinically, their presentations were similar, with persistent fever, rash, conjunctivitis, peripheral edema, extremity pain, and gastrointestinal symptoms. They all developed warm vasoplegic shock that did not respond to volume resuscitation; noradrenaline and milrinone were administered for hemodynamic support. Seven of the children needed mechanical ventilation for cardiovascular stabilization, although most of them had no significant respiratory involvement.
Of note was development of small pleural, pericardial, and ascitic effusion – “suggestive of a diffuse inflammatory process,” Dr. Riphagen and associates wrote. None of the children initially was positive for SARS-CoV-2; laboratory evidence of infection or inflammation included “elevated concentrations of CRP, procalcitonin, ferritin, triglycerides or d-dimers.”
“A common echocardiographic finding was echobright coronary vessels,” they wrote. “One child developed arrhythmia with refractory shock, requiring extracorporeal life support, and died from a large cerebrovascular infarct.”
As the article went to press, the doctors in that same ICU had seen more than 20 children with similar clinical presentations, Dr. Riphagen and associates reported, and the first 10 tested positive for SARS-CoV-2 antibody, including the 8 described above.
“Most of the children appear to have antibodies to the novel coronavirus, even when they do not have virus detectable in their nose,” said Audrey John, MD, PhD, chief of the division of pediatric infectious diseases at Children’s Hospital of Philadelphia, where clinicians have seen several cases similar to those described by NHS England and the New York City health department. “This suggests that these symptoms are ‘postinfectious,’ likely due to an abnormal immune response that happens after viral infection.”
She noted at the time of her interview, however, that fewer than 100 U.S. pediatric cases appear to have been reported.
“While our understanding is evolving, given the scope of the COVID-19 pandemic, this suggests that this kind of severe disease in children is very rare indeed,” Dr. John said. “Because this syndrome is so newly described, we have to continue to be cautious in attributing this syndrome to COVID-19, as there are many other diseases that look quite similar.”
She advised clinicians to be “wary of attributing fever/rash/shock to this syndrome, as the differential is broad, and we do not want to fail to recognize and treat true toxic shock or tick-borne disease.”
Dawn Nolt, MD, MPH, an associate professor of pediatrics in infectious diseases at Oregon Health & Science University’s Doernbecher Children’s Hospital, Portland, also underscored the need to avoid drawing conclusions too quickly.
“At this time, there is no causality established between SARS-COV-2 and these inflammatory syndromes other than a temporal association,” said Dr. Nolt, whose hospital has not yet seen any of these cases. “If there is a link, then the symptoms may be from a ‘direct hit’ of the virus on tissues, or from an overly exuberant immune response.”
None of the initial 15 New York City children died, although 5 needed mechanical ventilation and over half needed blood pressure support. The one child in London died from a large cerebrovascular infarct.
If the cases are connected to COVID-19, one explanation for the presentation may be related to the leading hypothesis “that SARS-CoV-2 may stimulate the immune system in such a way to promote vasculitis,” Dr. Nolt said in an interview.
“It is unusual that this particular constellation was not reported from the known pediatric cases out of China, where the COVID-19 pandemic originated,” Dr. Nolt said. “If there is a link between SARS-CoV-2 and these inflammatory syndromes, this may have resulted from genetic/host differences, changes in the SARS-CoV-2 virus, or other factors yet to be determined.”
The New York City bulletin recommended that clinicians immediately refer children presenting with the described symptoms to a specialist in pediatric infectious disease, rheumatology, or critical care.
“Early diagnosis and treatment of patients meeting full or partial criteria for Kawasaki disease is critical to preventing end-organ damage and other long-term complications,” the bulletin stated. It recommended aspirin and intravenous immunoglobulin for those who met Kawasaki criteria.
Dr. John said that children with the presentation appear to be responding well to intravenous immunoglobulin and/or steroids. She further emphasized that virtually all pediatric patients recover from COVID-19.
“Physicians should advise families to bring their children and teens back in for evaluation if they develop new fever, rash, or abdominal pain and diarrhea,” Dr. John said. “Families should not be afraid to seek care when their kids are sick. Our pediatric hospitals and EDs are open for business and working hard to protect staff and patients.”
A Kawasaki syndrome diagnosis requires at least 5 days of a fever at 101-104° F or higher along with four of the following five symptoms: rash over the torso; redness and swelling on palms and soles of the feet with later skin peeling; bloodshot, light-sensitive eyes; swollen lymph glands in the neck; and irritation and inflammation of the mouth, lips and throat, sometimes with “strawberry” tongue, according to the American Heart Association.
A press release from the AHA noted that Kawasaki disease is the most common cause of acquired heart disease in developed countries, but the condition remains rare.
Kawasaki disease’s etiology is unknown, but “some evidence suggests an infectious trigger, with winter-spring seasonality of the disease,” wrote the case study authors, noting that past research has linked Kawasaki disease with previous or concurrent infections of rhinovirus/enterovirus, parainfluenza, respiratory syncytial virus, influenza, adenovirus, and the four common human coronavirus strains.
“We have to remember that our experience with this pandemic is less than 12 months,” Dr. Nolt said. “We are still accumulating information, and any additional manifestations, particularly severe ones, adds to our ability to more quickly detect and treat children.”
Dr. Nolt and Dr. John had no disclosures.
SOURCES: Jones VG et al. Hosp Pediatr. 2020 Apr 7. doi: 10.1542/hpeds.2020-0123; Riphagen S et al. Lancet. 2020 May 6. doi: 10.1016/S0140-6736(20)31094-1.
Adolescent obesity, diabetes linked to atherosclerotic signs
significantly greater than their normal-weight peers, according to a longitudinal study published online in the Journal of the American Heart Association.
The study evaluated 448 adolescents over 5 years for changes in a variety of metrics to determine changes in arterial structure, including carotid intima media thickness (cIMT), carotid-femoral pulse-wave velocity (PWV), and augmentation index (Aix). The average age of the study group was 17.6 years. The three study groups broke down accordingly: 141 with normal weight, 156 with obesity, and 151 with type 2 diabetes. Patients were evaluated at baseline and 5 years later.
“The presence of obesity and especially type 2 diabetes in adolescents accelerates the early vascular aging process associated with several key risk factors,” wrote Justin R. Ryder, PhD, an assistant professor of pediatrics at the University of Minnesota, Minneapolis, and colleagues.
The researchers also noted that systolic hypertension was associated with changes in cIMT and arterial stiffness comparable to obesity and diabetes. “These data add further evidence underscoring the importance of efforts targeting prevention and treatment of obesity, type 2 diabetes, and elevated blood pressure among youth, with a goal of delaying and/or preventing the progression of early vascular aging,” Dr. Ryder and colleagues wrote.
Obese patients, when compared with normal-weight participants, had the following average increases: common cIMT by 0.05 mm, bulb cIMT by 0.02 mm, internal cIMT by 0.03 mm, and PWV carotid-femoral by 0.38 m/sec, all statistically significant differences. Patients with diabetes, compared with normal-weight participants, registered the following average increases: common cIMT by 0.05 mm, bulb cIMT by 0.06 mm, internal cIMT by 0.04 mm, Aix by 4.67%, and PWV carotid-femoral by 0.74 m/sec. All differences were highly significant at P less than .001.
The results also showed that higher baseline systolic blood pressure was associated with significantly greater average increases in the following factors: common cIMT by 0.007 mm, bulb cIMT by 0.009 mm, internal cIMT by 0.008 mm, and PWV carotid-femoral by 0.66 m/sec.
Drilling down into the data, the study reported that males had greater increases in bulb cIMT and incremental elastic modulus as well as reduced Aix, compared with females. Nonwhites also had greater increases in bulb cIMT than did whites. Age was associated with greater increases in bulb and internal cIMT and Aix.
“Our data support the concept that male sex is an independent and primary risk factor for accelerated early vascular aging,” Dr. Ryder and colleagues wrote. The study also determined that type 2 diabetes is a more prominent risk factor than obesity for early vascular aging.
The size of the study population, specifically adolescents with diabetes, is a study strength, Dr. Ryder and colleagues noted. Other strengths they pointed to are the 5-year duration and the robust panel of noninvasive measures, although not using hard cardiovascular outcomes is an acknowledged limitation.
“It should also be noted that many of the youth with type 2 diabetes were on medications for glycemic control, lipids, and/or blood pressure regulation,” Dr. Ryder and colleagues wrote. “Despite this, the vascular profiles worsened over time.”
The study showed “a really significant change” in the carotid anatomy in adolescents with obesity and type 2 diabetes over 5 years, Robert Eckel, MD, professor at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Notably, the PWV is not just anatomy; now we’re talking about function. In other words, the augmentation index and PWV will assess the compliance of the artery.”
The findings suggest that atherosclerosis begins with thickening of the arterial walls. “The question is, is thickness reversible?” Dr. Eckel said. “It’s probably not very reversible, so these are early changes that ultimately in the middle years or latter years are associated with major cardiovascular disease.”
They key lesson from the study, Dr. Eckel noted, is to “prevent obesity. If you prevent obesity in the teenage years, you basically prevent diabetes.”
Dr. Ryder disclosed receiving support from Boehringer Ingelheim in the form of drug/placebo. The National Institutes of Health provided funding. Dr. Eckel has no relevant relationships to disclose.
SOURCE: Ryder JR et al. J Am Heart Assoc. 2020 May 6:e014891. doi: 10.1161/JAHA.119.014891.
significantly greater than their normal-weight peers, according to a longitudinal study published online in the Journal of the American Heart Association.
The study evaluated 448 adolescents over 5 years for changes in a variety of metrics to determine changes in arterial structure, including carotid intima media thickness (cIMT), carotid-femoral pulse-wave velocity (PWV), and augmentation index (Aix). The average age of the study group was 17.6 years. The three study groups broke down accordingly: 141 with normal weight, 156 with obesity, and 151 with type 2 diabetes. Patients were evaluated at baseline and 5 years later.
“The presence of obesity and especially type 2 diabetes in adolescents accelerates the early vascular aging process associated with several key risk factors,” wrote Justin R. Ryder, PhD, an assistant professor of pediatrics at the University of Minnesota, Minneapolis, and colleagues.
The researchers also noted that systolic hypertension was associated with changes in cIMT and arterial stiffness comparable to obesity and diabetes. “These data add further evidence underscoring the importance of efforts targeting prevention and treatment of obesity, type 2 diabetes, and elevated blood pressure among youth, with a goal of delaying and/or preventing the progression of early vascular aging,” Dr. Ryder and colleagues wrote.
Obese patients, when compared with normal-weight participants, had the following average increases: common cIMT by 0.05 mm, bulb cIMT by 0.02 mm, internal cIMT by 0.03 mm, and PWV carotid-femoral by 0.38 m/sec, all statistically significant differences. Patients with diabetes, compared with normal-weight participants, registered the following average increases: common cIMT by 0.05 mm, bulb cIMT by 0.06 mm, internal cIMT by 0.04 mm, Aix by 4.67%, and PWV carotid-femoral by 0.74 m/sec. All differences were highly significant at P less than .001.
The results also showed that higher baseline systolic blood pressure was associated with significantly greater average increases in the following factors: common cIMT by 0.007 mm, bulb cIMT by 0.009 mm, internal cIMT by 0.008 mm, and PWV carotid-femoral by 0.66 m/sec.
Drilling down into the data, the study reported that males had greater increases in bulb cIMT and incremental elastic modulus as well as reduced Aix, compared with females. Nonwhites also had greater increases in bulb cIMT than did whites. Age was associated with greater increases in bulb and internal cIMT and Aix.
“Our data support the concept that male sex is an independent and primary risk factor for accelerated early vascular aging,” Dr. Ryder and colleagues wrote. The study also determined that type 2 diabetes is a more prominent risk factor than obesity for early vascular aging.
The size of the study population, specifically adolescents with diabetes, is a study strength, Dr. Ryder and colleagues noted. Other strengths they pointed to are the 5-year duration and the robust panel of noninvasive measures, although not using hard cardiovascular outcomes is an acknowledged limitation.
“It should also be noted that many of the youth with type 2 diabetes were on medications for glycemic control, lipids, and/or blood pressure regulation,” Dr. Ryder and colleagues wrote. “Despite this, the vascular profiles worsened over time.”
The study showed “a really significant change” in the carotid anatomy in adolescents with obesity and type 2 diabetes over 5 years, Robert Eckel, MD, professor at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Notably, the PWV is not just anatomy; now we’re talking about function. In other words, the augmentation index and PWV will assess the compliance of the artery.”
The findings suggest that atherosclerosis begins with thickening of the arterial walls. “The question is, is thickness reversible?” Dr. Eckel said. “It’s probably not very reversible, so these are early changes that ultimately in the middle years or latter years are associated with major cardiovascular disease.”
They key lesson from the study, Dr. Eckel noted, is to “prevent obesity. If you prevent obesity in the teenage years, you basically prevent diabetes.”
Dr. Ryder disclosed receiving support from Boehringer Ingelheim in the form of drug/placebo. The National Institutes of Health provided funding. Dr. Eckel has no relevant relationships to disclose.
SOURCE: Ryder JR et al. J Am Heart Assoc. 2020 May 6:e014891. doi: 10.1161/JAHA.119.014891.
significantly greater than their normal-weight peers, according to a longitudinal study published online in the Journal of the American Heart Association.
The study evaluated 448 adolescents over 5 years for changes in a variety of metrics to determine changes in arterial structure, including carotid intima media thickness (cIMT), carotid-femoral pulse-wave velocity (PWV), and augmentation index (Aix). The average age of the study group was 17.6 years. The three study groups broke down accordingly: 141 with normal weight, 156 with obesity, and 151 with type 2 diabetes. Patients were evaluated at baseline and 5 years later.
“The presence of obesity and especially type 2 diabetes in adolescents accelerates the early vascular aging process associated with several key risk factors,” wrote Justin R. Ryder, PhD, an assistant professor of pediatrics at the University of Minnesota, Minneapolis, and colleagues.
The researchers also noted that systolic hypertension was associated with changes in cIMT and arterial stiffness comparable to obesity and diabetes. “These data add further evidence underscoring the importance of efforts targeting prevention and treatment of obesity, type 2 diabetes, and elevated blood pressure among youth, with a goal of delaying and/or preventing the progression of early vascular aging,” Dr. Ryder and colleagues wrote.
Obese patients, when compared with normal-weight participants, had the following average increases: common cIMT by 0.05 mm, bulb cIMT by 0.02 mm, internal cIMT by 0.03 mm, and PWV carotid-femoral by 0.38 m/sec, all statistically significant differences. Patients with diabetes, compared with normal-weight participants, registered the following average increases: common cIMT by 0.05 mm, bulb cIMT by 0.06 mm, internal cIMT by 0.04 mm, Aix by 4.67%, and PWV carotid-femoral by 0.74 m/sec. All differences were highly significant at P less than .001.
The results also showed that higher baseline systolic blood pressure was associated with significantly greater average increases in the following factors: common cIMT by 0.007 mm, bulb cIMT by 0.009 mm, internal cIMT by 0.008 mm, and PWV carotid-femoral by 0.66 m/sec.
Drilling down into the data, the study reported that males had greater increases in bulb cIMT and incremental elastic modulus as well as reduced Aix, compared with females. Nonwhites also had greater increases in bulb cIMT than did whites. Age was associated with greater increases in bulb and internal cIMT and Aix.
“Our data support the concept that male sex is an independent and primary risk factor for accelerated early vascular aging,” Dr. Ryder and colleagues wrote. The study also determined that type 2 diabetes is a more prominent risk factor than obesity for early vascular aging.
The size of the study population, specifically adolescents with diabetes, is a study strength, Dr. Ryder and colleagues noted. Other strengths they pointed to are the 5-year duration and the robust panel of noninvasive measures, although not using hard cardiovascular outcomes is an acknowledged limitation.
“It should also be noted that many of the youth with type 2 diabetes were on medications for glycemic control, lipids, and/or blood pressure regulation,” Dr. Ryder and colleagues wrote. “Despite this, the vascular profiles worsened over time.”
The study showed “a really significant change” in the carotid anatomy in adolescents with obesity and type 2 diabetes over 5 years, Robert Eckel, MD, professor at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Notably, the PWV is not just anatomy; now we’re talking about function. In other words, the augmentation index and PWV will assess the compliance of the artery.”
The findings suggest that atherosclerosis begins with thickening of the arterial walls. “The question is, is thickness reversible?” Dr. Eckel said. “It’s probably not very reversible, so these are early changes that ultimately in the middle years or latter years are associated with major cardiovascular disease.”
They key lesson from the study, Dr. Eckel noted, is to “prevent obesity. If you prevent obesity in the teenage years, you basically prevent diabetes.”
Dr. Ryder disclosed receiving support from Boehringer Ingelheim in the form of drug/placebo. The National Institutes of Health provided funding. Dr. Eckel has no relevant relationships to disclose.
SOURCE: Ryder JR et al. J Am Heart Assoc. 2020 May 6:e014891. doi: 10.1161/JAHA.119.014891.
FROM JOURNAL OF THE AMERICAN HEART ASSOCIATION
Starting school later in the morning improves adolescents’ sleep
according to results from a cohort study.
For their research published in JAMA Pediatrics, Rachel Widome, PhD, of the University of Minnesota, Minneapolis, and colleagues followed a cohort of students at five public high schools in suburban and rural Minneapolis, randomly selecting 455 (225 girls; mean age, 15 years) for wrist actigraphy to track sleep and activity.
The students were followed up over 2 years, from 2016 to 2018. Sleep and activity were monitored at baseline, at year 1, and at year 2. Baseline monitoring lasted a month, and each follow-up monitoring period lasted over 2 months.
Although all the high schools in the study had early start times when the study began, two moved within the first year to delay their starting times to after 8:30 a.m., after a decision by the local school district. The other three schools retained start times of 7:30 a.m. This allowed investigators to compare students’ sleep patterns between start times for an extended period.
Dr. Widome and colleagues found significant improvements in sleep at 1 year that did not attenuate in the second year. At the end of year 2, students in the delayed-start schools slept 43 minutes more on weeknights than their early-starting peers (95% confidence interval, 25-61, P < .001.) The investigators did not see significant between-group differences in weeknight bedtimes. On weekends, students in the delayed-start group slept a mean 34 minutes less at year 2 (95% CI, –65 to –3, P = .03) than their peers in the early groups.
The researchers described the study’s design, a natural experiment with long follow-up and objectively measured sleep data, as its key strength. “No previous studies have been performed of sufficient quality to conclude that later start times cause students to get more sleep and that this effect can be sustained,” they concluded.
In an editorial comment, Erika R. Cheng, PhD, and Aaron E. Carroll, MD, of Indiana University, Indianapolis, wrote that the study provides strong evidence that delaying early school start times “would help adolescents get the sleep they need to thrive,” and belies the commonly held argument that delayed school times would merely lead to them staying awake later on school nights.
Adolescents “experience natural circadian and physiological brain changes that shift their sleep preference to go to bed and wake up later than adults or younger children,” Dr. Cheng and Dr. Carroll noted, with 12th graders’ bedtimes typically after 11 p.m. on weekdays. Regardless, “more than 40% of high schools in the United States start before 8 a.m., and more than 20% of middle schools start at 7:45 a.m. or earlier.”
Dr. Cheng and Dr. Carroll cautioned that the population in this study comprised “relatively affluent students and schools,” and that there were “socioeconomic and racial differences in student characteristics between schools that did and did not adopt the later start times.” For instance, they noted, nearly 90% of students in the delayed-start schools reported having at least one college-educated parent, while in the comparison schools fewer than 75% did. Unmeasured characteristics associated with parent education may have “influenced the school district’s decision to delay schools’ start times and had an effect on student sleep duration.”
Dr. Widome and colleagues’ study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the authors received support from a grant from the Minnesota Population Center. One coauthor acknowledged receiving a consulting fee from Jazz Pharmaceuticals. Dr. Cheng and Dr. Carroll disclosed no relevant conflicts of interest.
SOURCES: Widome R et al. JAMA Pedatr. 2020 Apr 27. doi: 10.1001/jamapediatrics.2020.0344; Cheng ER, Carroll AE. JAMA Pediatr. 2020 Apr 27. oi: 10.1001/jamapediatrics.2020.0351.
according to results from a cohort study.
For their research published in JAMA Pediatrics, Rachel Widome, PhD, of the University of Minnesota, Minneapolis, and colleagues followed a cohort of students at five public high schools in suburban and rural Minneapolis, randomly selecting 455 (225 girls; mean age, 15 years) for wrist actigraphy to track sleep and activity.
The students were followed up over 2 years, from 2016 to 2018. Sleep and activity were monitored at baseline, at year 1, and at year 2. Baseline monitoring lasted a month, and each follow-up monitoring period lasted over 2 months.
Although all the high schools in the study had early start times when the study began, two moved within the first year to delay their starting times to after 8:30 a.m., after a decision by the local school district. The other three schools retained start times of 7:30 a.m. This allowed investigators to compare students’ sleep patterns between start times for an extended period.
Dr. Widome and colleagues found significant improvements in sleep at 1 year that did not attenuate in the second year. At the end of year 2, students in the delayed-start schools slept 43 minutes more on weeknights than their early-starting peers (95% confidence interval, 25-61, P < .001.) The investigators did not see significant between-group differences in weeknight bedtimes. On weekends, students in the delayed-start group slept a mean 34 minutes less at year 2 (95% CI, –65 to –3, P = .03) than their peers in the early groups.
The researchers described the study’s design, a natural experiment with long follow-up and objectively measured sleep data, as its key strength. “No previous studies have been performed of sufficient quality to conclude that later start times cause students to get more sleep and that this effect can be sustained,” they concluded.
In an editorial comment, Erika R. Cheng, PhD, and Aaron E. Carroll, MD, of Indiana University, Indianapolis, wrote that the study provides strong evidence that delaying early school start times “would help adolescents get the sleep they need to thrive,” and belies the commonly held argument that delayed school times would merely lead to them staying awake later on school nights.
Adolescents “experience natural circadian and physiological brain changes that shift their sleep preference to go to bed and wake up later than adults or younger children,” Dr. Cheng and Dr. Carroll noted, with 12th graders’ bedtimes typically after 11 p.m. on weekdays. Regardless, “more than 40% of high schools in the United States start before 8 a.m., and more than 20% of middle schools start at 7:45 a.m. or earlier.”
Dr. Cheng and Dr. Carroll cautioned that the population in this study comprised “relatively affluent students and schools,” and that there were “socioeconomic and racial differences in student characteristics between schools that did and did not adopt the later start times.” For instance, they noted, nearly 90% of students in the delayed-start schools reported having at least one college-educated parent, while in the comparison schools fewer than 75% did. Unmeasured characteristics associated with parent education may have “influenced the school district’s decision to delay schools’ start times and had an effect on student sleep duration.”
Dr. Widome and colleagues’ study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the authors received support from a grant from the Minnesota Population Center. One coauthor acknowledged receiving a consulting fee from Jazz Pharmaceuticals. Dr. Cheng and Dr. Carroll disclosed no relevant conflicts of interest.
SOURCES: Widome R et al. JAMA Pedatr. 2020 Apr 27. doi: 10.1001/jamapediatrics.2020.0344; Cheng ER, Carroll AE. JAMA Pediatr. 2020 Apr 27. oi: 10.1001/jamapediatrics.2020.0351.
according to results from a cohort study.
For their research published in JAMA Pediatrics, Rachel Widome, PhD, of the University of Minnesota, Minneapolis, and colleagues followed a cohort of students at five public high schools in suburban and rural Minneapolis, randomly selecting 455 (225 girls; mean age, 15 years) for wrist actigraphy to track sleep and activity.
The students were followed up over 2 years, from 2016 to 2018. Sleep and activity were monitored at baseline, at year 1, and at year 2. Baseline monitoring lasted a month, and each follow-up monitoring period lasted over 2 months.
Although all the high schools in the study had early start times when the study began, two moved within the first year to delay their starting times to after 8:30 a.m., after a decision by the local school district. The other three schools retained start times of 7:30 a.m. This allowed investigators to compare students’ sleep patterns between start times for an extended period.
Dr. Widome and colleagues found significant improvements in sleep at 1 year that did not attenuate in the second year. At the end of year 2, students in the delayed-start schools slept 43 minutes more on weeknights than their early-starting peers (95% confidence interval, 25-61, P < .001.) The investigators did not see significant between-group differences in weeknight bedtimes. On weekends, students in the delayed-start group slept a mean 34 minutes less at year 2 (95% CI, –65 to –3, P = .03) than their peers in the early groups.
The researchers described the study’s design, a natural experiment with long follow-up and objectively measured sleep data, as its key strength. “No previous studies have been performed of sufficient quality to conclude that later start times cause students to get more sleep and that this effect can be sustained,” they concluded.
In an editorial comment, Erika R. Cheng, PhD, and Aaron E. Carroll, MD, of Indiana University, Indianapolis, wrote that the study provides strong evidence that delaying early school start times “would help adolescents get the sleep they need to thrive,” and belies the commonly held argument that delayed school times would merely lead to them staying awake later on school nights.
Adolescents “experience natural circadian and physiological brain changes that shift their sleep preference to go to bed and wake up later than adults or younger children,” Dr. Cheng and Dr. Carroll noted, with 12th graders’ bedtimes typically after 11 p.m. on weekdays. Regardless, “more than 40% of high schools in the United States start before 8 a.m., and more than 20% of middle schools start at 7:45 a.m. or earlier.”
Dr. Cheng and Dr. Carroll cautioned that the population in this study comprised “relatively affluent students and schools,” and that there were “socioeconomic and racial differences in student characteristics between schools that did and did not adopt the later start times.” For instance, they noted, nearly 90% of students in the delayed-start schools reported having at least one college-educated parent, while in the comparison schools fewer than 75% did. Unmeasured characteristics associated with parent education may have “influenced the school district’s decision to delay schools’ start times and had an effect on student sleep duration.”
Dr. Widome and colleagues’ study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the authors received support from a grant from the Minnesota Population Center. One coauthor acknowledged receiving a consulting fee from Jazz Pharmaceuticals. Dr. Cheng and Dr. Carroll disclosed no relevant conflicts of interest.
SOURCES: Widome R et al. JAMA Pedatr. 2020 Apr 27. doi: 10.1001/jamapediatrics.2020.0344; Cheng ER, Carroll AE. JAMA Pediatr. 2020 Apr 27. oi: 10.1001/jamapediatrics.2020.0351.
FROM JAMA PEDIATRICS
Expert discusses red flags for interstitial lung disease in pediatric rheumatology
MAUI, HAWAII – Anti-Ro52 autoantibodies are the latest and most potent of the autoantibody predictors of interstitial lung disease (ILD) discovered in patients with juvenile dermatomyositis, Anne M. Stevens, MD, PhD, said at the 2020 Rheumatology Winter Clinical Symposium.
In addition to detailing the autoantibody red flags for ILD in juvenile dermatomyositis (JDM), she called for “hypervigilance” in patients with systemic juvenile idiopathic arthritis (SJIA) who exhibit any of a series of risk factors for ILD.
“Most of the lung disease in kids with systemic JIA is asymptomatic until very late, but it can be reversible if we treat it. So it’s worth finding and monitoring and giving everyone PCP [pneumocystis pneumonia] prophylaxis, because they have a high incidence of PCP if they have any of those risk factors,” observed Dr. Stevens, a pediatric rheumatologist at the University of Washington, Seattle, and senior director for the adaptive immunity research program at Janssen Pharmaceuticals.
Autoantibodies predict ILD in JDM
Dr. Stevens highlighted recent work by Sara Sabbagh, DO, of the National Institute of Arthritis and Musculoskeletal and Skin Diseases and coinvestigators in the Childhood Myositis Heterogeneity Collaborative Study Group. They reported the presence of anti-Ro52 autoantibodies in 14% of a cohort of 302 patients with JDM as well as in 12% of 25 patients with juvenile polymyositis and in 18% of 44 youths with an overlap of juvenile connective tissue disease and myositis. In addition, 13% of patients were positive for autoantibodies previously identified as being associated with ILD in these forms of juvenile myositis: Namely, 9% of the cohort were positive for antimelanoma differentiation–associated protein 5 (anti-MDA5) autoantibodies, and antiaminoacyl tRNA synthestase (anti-Jo-1) autoantibodies were present in 4%.
A total of 33 of the 371 juvenile myositis patients had ILD based upon CT imaging, chest X-ray, dyspnea on exertion, and/or biopsy. Most patients with anti-Ro52 also had other autoantibodies associated with ILD. Indeed, 31% of patients with anti-MDA5 autoantibodies also had anti-Ro52, as did 64% of those with anti-Jo-1. After controlling for the presence of these other myositis-specific autoantibodies, auto-Ro52 autoantibodies were independently associated with ILD, which was present in 36% of those with and just 4% of those without anti-Ro52 autoantibodies.
Importantly, if a patient with JDM or another form of juvenile myositis had both anti-Ro52 and another myositis-specific autoantibody, the risk for ILD rose dramatically, climbing to 70% in patients with anti-Ro52 and anti-MDA5 autoantibodies, and to 100% in those who were both anti-Ro52- and anti-Jo-1 positive.
Patients with anti-Ro52 autoantibodies had a worse prognosis, with more severe and chronic disease, Dr. Stevens noted.
Novel potential treatment for ILD in JDM: JAK inhibitors
Standard treatment of ILD in JDM in all cases includes high-dose pulsed corticosteroids, intravenous immunoglobulin (IVIG), and either methotrexate or mycophenolate mofetil. Consideration should be given to adding cyclosporine, particularly when a macrophage activation syndrome component is present. In addition, several exciting recent lines of evidence suggest a potential role for Janus kinase (JAK) inhibitors in the subset of JDM patients with anti-MDA5 autoantibody-positive disease, according to Dr. Stevens.
For one, Dr. Sabbagh and colleagues have reported impressive success with the use of the JAK 1/3 inhibitor tofacitinib (Xeljanz) in two patients with anti-MDA5 autoantibody-positive refractory JDM with ILD. Both patients experienced moderate clinical improvement in disease activity in their skin, muscles, and other target organs. But particularly striking was what the investigators termed the “remarkable” improvement in ILD, including near-resolution of abnormal findings on high-resolution CT imaging and a more robust performance on pulmonary function testing.
Both of these hitherto treatment-refractory patients were able to wean or discontinue their immunosuppressive medications. The patients’ elevated blood interferon-response gene signature improved significantly in response to tofacitinib, and their problematic upregulation of STAT1 phosphorylation of CD4+ T cells and monocytes stimulated with interferon-gamma was tamed, dropping to levels typically seen in healthy individuals.
Also, French pediatric rheumatologists have identified key phenotypic and cytokine differences between 13 patients with JDM or juvenile overlap myositis who were anti-MDA5 autoantibody positive at presentation and 51 others who were not. The anti-MDA5 autoantibody–positive group had a higher frequency of ILD, arthritis, skin ulcerations, and lupus features, but milder muscle involvement than did the anti-MDA5 autoantibody–negative group. The anti-MDA5 autoantibody–positive patients demonstrated enhanced interferon-alpha signaling based upon their significantly higher serum interferon-alpha levels, compared with the anti-MDA5-negative group, and those levels decreased following treatment with improvement in symptoms.
The French investigators proposed that interferon-alpha may constitute a novel therapeutic target in the subgroup of patients with severe, refractory juvenile myositis and anti-MDA5 autoantibodies – and, as it happens, it’s known that JAK inhibitors modulate the interferon pathway.
Risk factors for ILD in SJIA
In the past half-dozen years or so, pediatric rheumatologists have become increasingly aware of and concerned about a new development in SJIA: the occurrence of comorbid ILD. This is a poor-prognosis disease: In a cohort from the United Kingdom, 5-year mortality from the time of diagnosis was 41%, fully 40-fold higher than in patients with SJIA only.
Patient cohorts with SJIA and ILD have unusual clinical and laboratory features that aren’t part of the typical picture in SJIA. These include acute clubbing, lymphopenia, a fixed pruritic rash, unexplained abdominal pain, peripheral eosinophilia, facial swelling, and an increased ferritin level, a hallmark of acute macrophage activation syndrome. Onset of SJIA before 2 years of age is another red flag associated with increased risk for ILD. So is trisomy 21, which is up to 50 times more prevalent in patients with SJIA and ILD than in the general population or in patients with SJIA only. Another clue is an adverse reaction to tocilizumab (Actemra).
Any of these findings warrant hypervigilance: “Be on high alert and monitor these patients for ILD much more closely,” Dr. Stevens advised.
This means ordering a CT scan, prescribing PCP prophylaxis, and regularly measuring pulmonary function, admittedly a challenge in children under 7 years old. In these younger kids, practical solutions include measuring their oxygen saturation before and after running around the room to see if it drops. A 6-minute walk test and sleep oximetry are other options.
The explanation for the abrupt arrival of ILD as part of the picture in SJIA during the past decade remains unclear. The timing coincides with a major advance in the treatment of SJIA: the arrival of biologic agents blocking interleukin-1 and -6. Could this be a serious treatment side effect?
“It’s all association so far, and we’re not really sure why we’re seeing this association. Is it because we’re using a lot [fewer] corticosteroids now, and maybe those were preventing lung disease in the past?” Dr. Stevens speculated.
At this point, she and her fellow pediatric rheumatologists are awaiting further evidence before discussing a curb in their use of IL-1 or -6 inhibitors in patients with SJIA.
“These drugs have turned around the lives of kids with SJIA. They used to suffer through all our ineffective treatments for years, with terrible joint destruction and a pretty high mortality rate. These are great drugs for this disease, and we certainly don’t want to limit them,” she said.
Dr. Stevens reported research collaborations with Kineta and Seattle Genetics in addition to her employment at Janssen Pharmaceuticals.
MAUI, HAWAII – Anti-Ro52 autoantibodies are the latest and most potent of the autoantibody predictors of interstitial lung disease (ILD) discovered in patients with juvenile dermatomyositis, Anne M. Stevens, MD, PhD, said at the 2020 Rheumatology Winter Clinical Symposium.
In addition to detailing the autoantibody red flags for ILD in juvenile dermatomyositis (JDM), she called for “hypervigilance” in patients with systemic juvenile idiopathic arthritis (SJIA) who exhibit any of a series of risk factors for ILD.
“Most of the lung disease in kids with systemic JIA is asymptomatic until very late, but it can be reversible if we treat it. So it’s worth finding and monitoring and giving everyone PCP [pneumocystis pneumonia] prophylaxis, because they have a high incidence of PCP if they have any of those risk factors,” observed Dr. Stevens, a pediatric rheumatologist at the University of Washington, Seattle, and senior director for the adaptive immunity research program at Janssen Pharmaceuticals.
Autoantibodies predict ILD in JDM
Dr. Stevens highlighted recent work by Sara Sabbagh, DO, of the National Institute of Arthritis and Musculoskeletal and Skin Diseases and coinvestigators in the Childhood Myositis Heterogeneity Collaborative Study Group. They reported the presence of anti-Ro52 autoantibodies in 14% of a cohort of 302 patients with JDM as well as in 12% of 25 patients with juvenile polymyositis and in 18% of 44 youths with an overlap of juvenile connective tissue disease and myositis. In addition, 13% of patients were positive for autoantibodies previously identified as being associated with ILD in these forms of juvenile myositis: Namely, 9% of the cohort were positive for antimelanoma differentiation–associated protein 5 (anti-MDA5) autoantibodies, and antiaminoacyl tRNA synthestase (anti-Jo-1) autoantibodies were present in 4%.
A total of 33 of the 371 juvenile myositis patients had ILD based upon CT imaging, chest X-ray, dyspnea on exertion, and/or biopsy. Most patients with anti-Ro52 also had other autoantibodies associated with ILD. Indeed, 31% of patients with anti-MDA5 autoantibodies also had anti-Ro52, as did 64% of those with anti-Jo-1. After controlling for the presence of these other myositis-specific autoantibodies, auto-Ro52 autoantibodies were independently associated with ILD, which was present in 36% of those with and just 4% of those without anti-Ro52 autoantibodies.
Importantly, if a patient with JDM or another form of juvenile myositis had both anti-Ro52 and another myositis-specific autoantibody, the risk for ILD rose dramatically, climbing to 70% in patients with anti-Ro52 and anti-MDA5 autoantibodies, and to 100% in those who were both anti-Ro52- and anti-Jo-1 positive.
Patients with anti-Ro52 autoantibodies had a worse prognosis, with more severe and chronic disease, Dr. Stevens noted.
Novel potential treatment for ILD in JDM: JAK inhibitors
Standard treatment of ILD in JDM in all cases includes high-dose pulsed corticosteroids, intravenous immunoglobulin (IVIG), and either methotrexate or mycophenolate mofetil. Consideration should be given to adding cyclosporine, particularly when a macrophage activation syndrome component is present. In addition, several exciting recent lines of evidence suggest a potential role for Janus kinase (JAK) inhibitors in the subset of JDM patients with anti-MDA5 autoantibody-positive disease, according to Dr. Stevens.
For one, Dr. Sabbagh and colleagues have reported impressive success with the use of the JAK 1/3 inhibitor tofacitinib (Xeljanz) in two patients with anti-MDA5 autoantibody-positive refractory JDM with ILD. Both patients experienced moderate clinical improvement in disease activity in their skin, muscles, and other target organs. But particularly striking was what the investigators termed the “remarkable” improvement in ILD, including near-resolution of abnormal findings on high-resolution CT imaging and a more robust performance on pulmonary function testing.
Both of these hitherto treatment-refractory patients were able to wean or discontinue their immunosuppressive medications. The patients’ elevated blood interferon-response gene signature improved significantly in response to tofacitinib, and their problematic upregulation of STAT1 phosphorylation of CD4+ T cells and monocytes stimulated with interferon-gamma was tamed, dropping to levels typically seen in healthy individuals.
Also, French pediatric rheumatologists have identified key phenotypic and cytokine differences between 13 patients with JDM or juvenile overlap myositis who were anti-MDA5 autoantibody positive at presentation and 51 others who were not. The anti-MDA5 autoantibody–positive group had a higher frequency of ILD, arthritis, skin ulcerations, and lupus features, but milder muscle involvement than did the anti-MDA5 autoantibody–negative group. The anti-MDA5 autoantibody–positive patients demonstrated enhanced interferon-alpha signaling based upon their significantly higher serum interferon-alpha levels, compared with the anti-MDA5-negative group, and those levels decreased following treatment with improvement in symptoms.
The French investigators proposed that interferon-alpha may constitute a novel therapeutic target in the subgroup of patients with severe, refractory juvenile myositis and anti-MDA5 autoantibodies – and, as it happens, it’s known that JAK inhibitors modulate the interferon pathway.
Risk factors for ILD in SJIA
In the past half-dozen years or so, pediatric rheumatologists have become increasingly aware of and concerned about a new development in SJIA: the occurrence of comorbid ILD. This is a poor-prognosis disease: In a cohort from the United Kingdom, 5-year mortality from the time of diagnosis was 41%, fully 40-fold higher than in patients with SJIA only.
Patient cohorts with SJIA and ILD have unusual clinical and laboratory features that aren’t part of the typical picture in SJIA. These include acute clubbing, lymphopenia, a fixed pruritic rash, unexplained abdominal pain, peripheral eosinophilia, facial swelling, and an increased ferritin level, a hallmark of acute macrophage activation syndrome. Onset of SJIA before 2 years of age is another red flag associated with increased risk for ILD. So is trisomy 21, which is up to 50 times more prevalent in patients with SJIA and ILD than in the general population or in patients with SJIA only. Another clue is an adverse reaction to tocilizumab (Actemra).
Any of these findings warrant hypervigilance: “Be on high alert and monitor these patients for ILD much more closely,” Dr. Stevens advised.
This means ordering a CT scan, prescribing PCP prophylaxis, and regularly measuring pulmonary function, admittedly a challenge in children under 7 years old. In these younger kids, practical solutions include measuring their oxygen saturation before and after running around the room to see if it drops. A 6-minute walk test and sleep oximetry are other options.
The explanation for the abrupt arrival of ILD as part of the picture in SJIA during the past decade remains unclear. The timing coincides with a major advance in the treatment of SJIA: the arrival of biologic agents blocking interleukin-1 and -6. Could this be a serious treatment side effect?
“It’s all association so far, and we’re not really sure why we’re seeing this association. Is it because we’re using a lot [fewer] corticosteroids now, and maybe those were preventing lung disease in the past?” Dr. Stevens speculated.
At this point, she and her fellow pediatric rheumatologists are awaiting further evidence before discussing a curb in their use of IL-1 or -6 inhibitors in patients with SJIA.
“These drugs have turned around the lives of kids with SJIA. They used to suffer through all our ineffective treatments for years, with terrible joint destruction and a pretty high mortality rate. These are great drugs for this disease, and we certainly don’t want to limit them,” she said.
Dr. Stevens reported research collaborations with Kineta and Seattle Genetics in addition to her employment at Janssen Pharmaceuticals.
MAUI, HAWAII – Anti-Ro52 autoantibodies are the latest and most potent of the autoantibody predictors of interstitial lung disease (ILD) discovered in patients with juvenile dermatomyositis, Anne M. Stevens, MD, PhD, said at the 2020 Rheumatology Winter Clinical Symposium.
In addition to detailing the autoantibody red flags for ILD in juvenile dermatomyositis (JDM), she called for “hypervigilance” in patients with systemic juvenile idiopathic arthritis (SJIA) who exhibit any of a series of risk factors for ILD.
“Most of the lung disease in kids with systemic JIA is asymptomatic until very late, but it can be reversible if we treat it. So it’s worth finding and monitoring and giving everyone PCP [pneumocystis pneumonia] prophylaxis, because they have a high incidence of PCP if they have any of those risk factors,” observed Dr. Stevens, a pediatric rheumatologist at the University of Washington, Seattle, and senior director for the adaptive immunity research program at Janssen Pharmaceuticals.
Autoantibodies predict ILD in JDM
Dr. Stevens highlighted recent work by Sara Sabbagh, DO, of the National Institute of Arthritis and Musculoskeletal and Skin Diseases and coinvestigators in the Childhood Myositis Heterogeneity Collaborative Study Group. They reported the presence of anti-Ro52 autoantibodies in 14% of a cohort of 302 patients with JDM as well as in 12% of 25 patients with juvenile polymyositis and in 18% of 44 youths with an overlap of juvenile connective tissue disease and myositis. In addition, 13% of patients were positive for autoantibodies previously identified as being associated with ILD in these forms of juvenile myositis: Namely, 9% of the cohort were positive for antimelanoma differentiation–associated protein 5 (anti-MDA5) autoantibodies, and antiaminoacyl tRNA synthestase (anti-Jo-1) autoantibodies were present in 4%.
A total of 33 of the 371 juvenile myositis patients had ILD based upon CT imaging, chest X-ray, dyspnea on exertion, and/or biopsy. Most patients with anti-Ro52 also had other autoantibodies associated with ILD. Indeed, 31% of patients with anti-MDA5 autoantibodies also had anti-Ro52, as did 64% of those with anti-Jo-1. After controlling for the presence of these other myositis-specific autoantibodies, auto-Ro52 autoantibodies were independently associated with ILD, which was present in 36% of those with and just 4% of those without anti-Ro52 autoantibodies.
Importantly, if a patient with JDM or another form of juvenile myositis had both anti-Ro52 and another myositis-specific autoantibody, the risk for ILD rose dramatically, climbing to 70% in patients with anti-Ro52 and anti-MDA5 autoantibodies, and to 100% in those who were both anti-Ro52- and anti-Jo-1 positive.
Patients with anti-Ro52 autoantibodies had a worse prognosis, with more severe and chronic disease, Dr. Stevens noted.
Novel potential treatment for ILD in JDM: JAK inhibitors
Standard treatment of ILD in JDM in all cases includes high-dose pulsed corticosteroids, intravenous immunoglobulin (IVIG), and either methotrexate or mycophenolate mofetil. Consideration should be given to adding cyclosporine, particularly when a macrophage activation syndrome component is present. In addition, several exciting recent lines of evidence suggest a potential role for Janus kinase (JAK) inhibitors in the subset of JDM patients with anti-MDA5 autoantibody-positive disease, according to Dr. Stevens.
For one, Dr. Sabbagh and colleagues have reported impressive success with the use of the JAK 1/3 inhibitor tofacitinib (Xeljanz) in two patients with anti-MDA5 autoantibody-positive refractory JDM with ILD. Both patients experienced moderate clinical improvement in disease activity in their skin, muscles, and other target organs. But particularly striking was what the investigators termed the “remarkable” improvement in ILD, including near-resolution of abnormal findings on high-resolution CT imaging and a more robust performance on pulmonary function testing.
Both of these hitherto treatment-refractory patients were able to wean or discontinue their immunosuppressive medications. The patients’ elevated blood interferon-response gene signature improved significantly in response to tofacitinib, and their problematic upregulation of STAT1 phosphorylation of CD4+ T cells and monocytes stimulated with interferon-gamma was tamed, dropping to levels typically seen in healthy individuals.
Also, French pediatric rheumatologists have identified key phenotypic and cytokine differences between 13 patients with JDM or juvenile overlap myositis who were anti-MDA5 autoantibody positive at presentation and 51 others who were not. The anti-MDA5 autoantibody–positive group had a higher frequency of ILD, arthritis, skin ulcerations, and lupus features, but milder muscle involvement than did the anti-MDA5 autoantibody–negative group. The anti-MDA5 autoantibody–positive patients demonstrated enhanced interferon-alpha signaling based upon their significantly higher serum interferon-alpha levels, compared with the anti-MDA5-negative group, and those levels decreased following treatment with improvement in symptoms.
The French investigators proposed that interferon-alpha may constitute a novel therapeutic target in the subgroup of patients with severe, refractory juvenile myositis and anti-MDA5 autoantibodies – and, as it happens, it’s known that JAK inhibitors modulate the interferon pathway.
Risk factors for ILD in SJIA
In the past half-dozen years or so, pediatric rheumatologists have become increasingly aware of and concerned about a new development in SJIA: the occurrence of comorbid ILD. This is a poor-prognosis disease: In a cohort from the United Kingdom, 5-year mortality from the time of diagnosis was 41%, fully 40-fold higher than in patients with SJIA only.
Patient cohorts with SJIA and ILD have unusual clinical and laboratory features that aren’t part of the typical picture in SJIA. These include acute clubbing, lymphopenia, a fixed pruritic rash, unexplained abdominal pain, peripheral eosinophilia, facial swelling, and an increased ferritin level, a hallmark of acute macrophage activation syndrome. Onset of SJIA before 2 years of age is another red flag associated with increased risk for ILD. So is trisomy 21, which is up to 50 times more prevalent in patients with SJIA and ILD than in the general population or in patients with SJIA only. Another clue is an adverse reaction to tocilizumab (Actemra).
Any of these findings warrant hypervigilance: “Be on high alert and monitor these patients for ILD much more closely,” Dr. Stevens advised.
This means ordering a CT scan, prescribing PCP prophylaxis, and regularly measuring pulmonary function, admittedly a challenge in children under 7 years old. In these younger kids, practical solutions include measuring their oxygen saturation before and after running around the room to see if it drops. A 6-minute walk test and sleep oximetry are other options.
The explanation for the abrupt arrival of ILD as part of the picture in SJIA during the past decade remains unclear. The timing coincides with a major advance in the treatment of SJIA: the arrival of biologic agents blocking interleukin-1 and -6. Could this be a serious treatment side effect?
“It’s all association so far, and we’re not really sure why we’re seeing this association. Is it because we’re using a lot [fewer] corticosteroids now, and maybe those were preventing lung disease in the past?” Dr. Stevens speculated.
At this point, she and her fellow pediatric rheumatologists are awaiting further evidence before discussing a curb in their use of IL-1 or -6 inhibitors in patients with SJIA.
“These drugs have turned around the lives of kids with SJIA. They used to suffer through all our ineffective treatments for years, with terrible joint destruction and a pretty high mortality rate. These are great drugs for this disease, and we certainly don’t want to limit them,” she said.
Dr. Stevens reported research collaborations with Kineta and Seattle Genetics in addition to her employment at Janssen Pharmaceuticals.
REPORTING FROM RWCS 2020
COVID-19 death rate was twice as high in cancer patients in NYC study
COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.
with COVID-19 treated during the same time period in the same hospital system.
Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.
“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.
They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.
In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.
Deaths by cancer type
Among the 164 patients with solid tumors, case fatality rates were as follows:
- Pancreatic – 67% (2/3)
- Lung – 55% (6/11)
- Colorectal – 38% (8/21)
- Upper gastrointestinal – 38% (3/8)
- Gynecologic – 38% (5/13)
- Skin – 33% (1/3)
- Hepatobiliary – 29% (2/7)
- Bone/soft tissue – 20% (1/5)
- Genitourinary – 15% (7/46)
- Breast – 14% (4/28)
- Neurologic – 13% (1/8)
- Head and neck – 13% (1/8).
None of the three patients with neuroendocrine tumors died.
Among the 54 patients with hematologic malignancies, case fatality rates were as follows:
- Chronic myeloid leukemia – 100% (1/1)
- Hodgkin lymphoma – 60% (3/5)
- Myelodysplastic syndromes – 60% (3/5)
- Multiple myeloma – 38% (5/13)
- Non-Hodgkin lymphoma – 33% (5/15)
- Chronic lymphocytic leukemia – 33% (1/3)
- Myeloproliferative neoplasms – 29% (2/7).
None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.
Factors associated with increased mortality
The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.
Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.
“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.
Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.
Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
Proactive strategies moving forward
“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.
The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.
“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”
The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.
SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.
COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.
with COVID-19 treated during the same time period in the same hospital system.
Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.
“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.
They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.
In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.
Deaths by cancer type
Among the 164 patients with solid tumors, case fatality rates were as follows:
- Pancreatic – 67% (2/3)
- Lung – 55% (6/11)
- Colorectal – 38% (8/21)
- Upper gastrointestinal – 38% (3/8)
- Gynecologic – 38% (5/13)
- Skin – 33% (1/3)
- Hepatobiliary – 29% (2/7)
- Bone/soft tissue – 20% (1/5)
- Genitourinary – 15% (7/46)
- Breast – 14% (4/28)
- Neurologic – 13% (1/8)
- Head and neck – 13% (1/8).
None of the three patients with neuroendocrine tumors died.
Among the 54 patients with hematologic malignancies, case fatality rates were as follows:
- Chronic myeloid leukemia – 100% (1/1)
- Hodgkin lymphoma – 60% (3/5)
- Myelodysplastic syndromes – 60% (3/5)
- Multiple myeloma – 38% (5/13)
- Non-Hodgkin lymphoma – 33% (5/15)
- Chronic lymphocytic leukemia – 33% (1/3)
- Myeloproliferative neoplasms – 29% (2/7).
None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.
Factors associated with increased mortality
The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.
Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.
“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.
Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.
Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
Proactive strategies moving forward
“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.
The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.
“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”
The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.
SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.
COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.
with COVID-19 treated during the same time period in the same hospital system.
Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.
“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.
They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.
In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.
Deaths by cancer type
Among the 164 patients with solid tumors, case fatality rates were as follows:
- Pancreatic – 67% (2/3)
- Lung – 55% (6/11)
- Colorectal – 38% (8/21)
- Upper gastrointestinal – 38% (3/8)
- Gynecologic – 38% (5/13)
- Skin – 33% (1/3)
- Hepatobiliary – 29% (2/7)
- Bone/soft tissue – 20% (1/5)
- Genitourinary – 15% (7/46)
- Breast – 14% (4/28)
- Neurologic – 13% (1/8)
- Head and neck – 13% (1/8).
None of the three patients with neuroendocrine tumors died.
Among the 54 patients with hematologic malignancies, case fatality rates were as follows:
- Chronic myeloid leukemia – 100% (1/1)
- Hodgkin lymphoma – 60% (3/5)
- Myelodysplastic syndromes – 60% (3/5)
- Multiple myeloma – 38% (5/13)
- Non-Hodgkin lymphoma – 33% (5/15)
- Chronic lymphocytic leukemia – 33% (1/3)
- Myeloproliferative neoplasms – 29% (2/7).
None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.
Factors associated with increased mortality
The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.
Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.
“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.
Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.
Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
Proactive strategies moving forward
“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.
The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.
“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”
The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.
SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.
FROM CANCER DISCOVERY
Sensitizer prevalent in many hypoallergenic products for children
(AD) and allergic contact dermatitis, according to a research letter in the Journal of the American Academy of Dermatology.
In the letter, the authors, Reid W. Collis, of Washington University in St. Louis, and David M. Sheinbein, MD, of the division of dermatology at the university, referred to a previous study showing an association between contact sensitivity with CAPB and people with a history of AD. This was supported by the results of their own recent study in pediatric patients, they wrote, which found that reactions to CAPB were “exclusively” in patients with AD.
In the survey, they looked at children’s shampoo and soap products available on online databases of six of the biggest retailers, and analyzed the top 20 best-selling products for each retailer in 2018. Of the unique products, CAPB was found to be an ingredient in 52% (39 of 75) of the shampoos and 44% (29 of 66) of the soap products. But each of these products “contained the term ‘hypoallergenic; on the product itself or in the product’s description,” they noted.
“CAPB is a prevalent sensitizer in pediatric patients and should be avoided in patients with AD,” the investigators wrote. That said, it’s not included among the 35 prevalent allergens in the T.R.U.E. test, and they recommended that pediatricians and dermatologists “be aware of common products containing CAPB when counseling patients about their product choices,” considering that CAPB sensitivity is more likely in patients with AD.
The study had no funding source, and the authors had no disclosures.
cpalmer@mdedge.com
SOURCE: Cho SI et al. J Am Acad Dermatol. 2020 May. doi: 10.1016/j.jaad.2019.12.036.
(AD) and allergic contact dermatitis, according to a research letter in the Journal of the American Academy of Dermatology.
In the letter, the authors, Reid W. Collis, of Washington University in St. Louis, and David M. Sheinbein, MD, of the division of dermatology at the university, referred to a previous study showing an association between contact sensitivity with CAPB and people with a history of AD. This was supported by the results of their own recent study in pediatric patients, they wrote, which found that reactions to CAPB were “exclusively” in patients with AD.
In the survey, they looked at children’s shampoo and soap products available on online databases of six of the biggest retailers, and analyzed the top 20 best-selling products for each retailer in 2018. Of the unique products, CAPB was found to be an ingredient in 52% (39 of 75) of the shampoos and 44% (29 of 66) of the soap products. But each of these products “contained the term ‘hypoallergenic; on the product itself or in the product’s description,” they noted.
“CAPB is a prevalent sensitizer in pediatric patients and should be avoided in patients with AD,” the investigators wrote. That said, it’s not included among the 35 prevalent allergens in the T.R.U.E. test, and they recommended that pediatricians and dermatologists “be aware of common products containing CAPB when counseling patients about their product choices,” considering that CAPB sensitivity is more likely in patients with AD.
The study had no funding source, and the authors had no disclosures.
cpalmer@mdedge.com
SOURCE: Cho SI et al. J Am Acad Dermatol. 2020 May. doi: 10.1016/j.jaad.2019.12.036.
(AD) and allergic contact dermatitis, according to a research letter in the Journal of the American Academy of Dermatology.
In the letter, the authors, Reid W. Collis, of Washington University in St. Louis, and David M. Sheinbein, MD, of the division of dermatology at the university, referred to a previous study showing an association between contact sensitivity with CAPB and people with a history of AD. This was supported by the results of their own recent study in pediatric patients, they wrote, which found that reactions to CAPB were “exclusively” in patients with AD.
In the survey, they looked at children’s shampoo and soap products available on online databases of six of the biggest retailers, and analyzed the top 20 best-selling products for each retailer in 2018. Of the unique products, CAPB was found to be an ingredient in 52% (39 of 75) of the shampoos and 44% (29 of 66) of the soap products. But each of these products “contained the term ‘hypoallergenic; on the product itself or in the product’s description,” they noted.
“CAPB is a prevalent sensitizer in pediatric patients and should be avoided in patients with AD,” the investigators wrote. That said, it’s not included among the 35 prevalent allergens in the T.R.U.E. test, and they recommended that pediatricians and dermatologists “be aware of common products containing CAPB when counseling patients about their product choices,” considering that CAPB sensitivity is more likely in patients with AD.
The study had no funding source, and the authors had no disclosures.
cpalmer@mdedge.com
SOURCE: Cho SI et al. J Am Acad Dermatol. 2020 May. doi: 10.1016/j.jaad.2019.12.036.