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Anaphylaxis risk with IV iron low, but varies with formulation
The results of the new retrospective cohort study were published online March 29 in Annals of Internal Medicine (doi: 10.7326/M21-4009).
“The rates of anaphylaxis were very low with all IV iron products but were three- to eightfold greater for iron dextran and ferumoxytol than for iron sucrose,” wrote Chintan V. Dave, PharmD, PhD, of Rutgers University, New Brunswick, N.J., and colleagues.
Using data from Medicare insurance claims, the researchers evaluated the incidence of anaphylaxis among patients 65 years or older receiving their first dose of one of five different IV iron formulations for the treatment of iron deficiency anemia. Patients were treated between July 2013 and December 2018 and the iron formulations were ferric carboxymaltose, ferumoxytol, ferric gluconate, iron dextran, or iron sucrose.
Overall, 167,925 patients were included and categorized based on the iron supplement they received. Dr. Dave and colleagues found that the adjusted incidence rates (IRs) for anaphylaxis per 10,000 first administrations were 9.8 cases for iron dextran (95% confidence interval [CI], 6.2 to 15.3 cases), 4.0 cases for ferumoxytol (95% CI, 2.5 to 6.6 cases), 1.5 cases for ferric gluconate (95% CI, 0.3 to 6.6 cases), 1.2 cases for iron sucrose (95% CI, 0.6 to 2.5 cases), and 0.8 cases for ferric carboxymaltose (95% CI, 0.3 to 2.6 cases).
Only those patients receiving iron dextran or ferumoxytol had anaphylactic reactions requiring hospitalization.
Using iron sucrose as the referent category, the researchers found that the odds ratios (ORs) for anaphylaxis were 8.3 for iron dextran (95% CI, 3.5-19.8) and 3.4 for ferumoxytol (95% CI, 1.4-8.3).
“Anaphylaxis is just one of many factors one should consider when deciding on the choice of IV iron therapy,” Dr. Dave noted in an interview, when asked whether he feels that these findings will change the use of parenteral iron in practice.
Acknowledging that anaphylaxis is a severe but rare complication, Dr. Dave stated that other factors such as “clinical indication, setting, dose, the number and duration of administrations required to replenish iron reserves, risk of other adverse reactions, and costs,” should also be considered when designing treatment plans using intravenous iron.
In the study, anaphylaxis was defined as reactions that occurred within 24 hours of IV iron administration and was restricted to the following:
- Anaphylaxis resulting in hospitalization.
- An outpatient or emergency department visit due to anaphylactic shock accompanied by codes relating to the administration of cardiopulmonary resuscitation or epinephrine or the occurrence of hypotension.
- Two separate encounters for anaphylactic shock within the same day representing different encounter types, that is, inpatient, outpatient, or emergency department visit.
Dr. Dave and colleagues acknowledged study limitations, such as the fact the anaphylaxis criteria included only the most severe cases and could therefore have missed milder cases of anaphylaxis secondary to IV iron. Further, they noted that these findings may not be applicable to a younger patient population.
Patients were excluded from the study if they had received IV iron between January 2007 and July 2013, had a diagnosis of HIV or end-stage renal disease, had a recent blood transfusion, or had a history of anaphylactic reactions.
The study authors disclosed no relevant financial relationships.
The results of the new retrospective cohort study were published online March 29 in Annals of Internal Medicine (doi: 10.7326/M21-4009).
“The rates of anaphylaxis were very low with all IV iron products but were three- to eightfold greater for iron dextran and ferumoxytol than for iron sucrose,” wrote Chintan V. Dave, PharmD, PhD, of Rutgers University, New Brunswick, N.J., and colleagues.
Using data from Medicare insurance claims, the researchers evaluated the incidence of anaphylaxis among patients 65 years or older receiving their first dose of one of five different IV iron formulations for the treatment of iron deficiency anemia. Patients were treated between July 2013 and December 2018 and the iron formulations were ferric carboxymaltose, ferumoxytol, ferric gluconate, iron dextran, or iron sucrose.
Overall, 167,925 patients were included and categorized based on the iron supplement they received. Dr. Dave and colleagues found that the adjusted incidence rates (IRs) for anaphylaxis per 10,000 first administrations were 9.8 cases for iron dextran (95% confidence interval [CI], 6.2 to 15.3 cases), 4.0 cases for ferumoxytol (95% CI, 2.5 to 6.6 cases), 1.5 cases for ferric gluconate (95% CI, 0.3 to 6.6 cases), 1.2 cases for iron sucrose (95% CI, 0.6 to 2.5 cases), and 0.8 cases for ferric carboxymaltose (95% CI, 0.3 to 2.6 cases).
Only those patients receiving iron dextran or ferumoxytol had anaphylactic reactions requiring hospitalization.
Using iron sucrose as the referent category, the researchers found that the odds ratios (ORs) for anaphylaxis were 8.3 for iron dextran (95% CI, 3.5-19.8) and 3.4 for ferumoxytol (95% CI, 1.4-8.3).
“Anaphylaxis is just one of many factors one should consider when deciding on the choice of IV iron therapy,” Dr. Dave noted in an interview, when asked whether he feels that these findings will change the use of parenteral iron in practice.
Acknowledging that anaphylaxis is a severe but rare complication, Dr. Dave stated that other factors such as “clinical indication, setting, dose, the number and duration of administrations required to replenish iron reserves, risk of other adverse reactions, and costs,” should also be considered when designing treatment plans using intravenous iron.
In the study, anaphylaxis was defined as reactions that occurred within 24 hours of IV iron administration and was restricted to the following:
- Anaphylaxis resulting in hospitalization.
- An outpatient or emergency department visit due to anaphylactic shock accompanied by codes relating to the administration of cardiopulmonary resuscitation or epinephrine or the occurrence of hypotension.
- Two separate encounters for anaphylactic shock within the same day representing different encounter types, that is, inpatient, outpatient, or emergency department visit.
Dr. Dave and colleagues acknowledged study limitations, such as the fact the anaphylaxis criteria included only the most severe cases and could therefore have missed milder cases of anaphylaxis secondary to IV iron. Further, they noted that these findings may not be applicable to a younger patient population.
Patients were excluded from the study if they had received IV iron between January 2007 and July 2013, had a diagnosis of HIV or end-stage renal disease, had a recent blood transfusion, or had a history of anaphylactic reactions.
The study authors disclosed no relevant financial relationships.
The results of the new retrospective cohort study were published online March 29 in Annals of Internal Medicine (doi: 10.7326/M21-4009).
“The rates of anaphylaxis were very low with all IV iron products but were three- to eightfold greater for iron dextran and ferumoxytol than for iron sucrose,” wrote Chintan V. Dave, PharmD, PhD, of Rutgers University, New Brunswick, N.J., and colleagues.
Using data from Medicare insurance claims, the researchers evaluated the incidence of anaphylaxis among patients 65 years or older receiving their first dose of one of five different IV iron formulations for the treatment of iron deficiency anemia. Patients were treated between July 2013 and December 2018 and the iron formulations were ferric carboxymaltose, ferumoxytol, ferric gluconate, iron dextran, or iron sucrose.
Overall, 167,925 patients were included and categorized based on the iron supplement they received. Dr. Dave and colleagues found that the adjusted incidence rates (IRs) for anaphylaxis per 10,000 first administrations were 9.8 cases for iron dextran (95% confidence interval [CI], 6.2 to 15.3 cases), 4.0 cases for ferumoxytol (95% CI, 2.5 to 6.6 cases), 1.5 cases for ferric gluconate (95% CI, 0.3 to 6.6 cases), 1.2 cases for iron sucrose (95% CI, 0.6 to 2.5 cases), and 0.8 cases for ferric carboxymaltose (95% CI, 0.3 to 2.6 cases).
Only those patients receiving iron dextran or ferumoxytol had anaphylactic reactions requiring hospitalization.
Using iron sucrose as the referent category, the researchers found that the odds ratios (ORs) for anaphylaxis were 8.3 for iron dextran (95% CI, 3.5-19.8) and 3.4 for ferumoxytol (95% CI, 1.4-8.3).
“Anaphylaxis is just one of many factors one should consider when deciding on the choice of IV iron therapy,” Dr. Dave noted in an interview, when asked whether he feels that these findings will change the use of parenteral iron in practice.
Acknowledging that anaphylaxis is a severe but rare complication, Dr. Dave stated that other factors such as “clinical indication, setting, dose, the number and duration of administrations required to replenish iron reserves, risk of other adverse reactions, and costs,” should also be considered when designing treatment plans using intravenous iron.
In the study, anaphylaxis was defined as reactions that occurred within 24 hours of IV iron administration and was restricted to the following:
- Anaphylaxis resulting in hospitalization.
- An outpatient or emergency department visit due to anaphylactic shock accompanied by codes relating to the administration of cardiopulmonary resuscitation or epinephrine or the occurrence of hypotension.
- Two separate encounters for anaphylactic shock within the same day representing different encounter types, that is, inpatient, outpatient, or emergency department visit.
Dr. Dave and colleagues acknowledged study limitations, such as the fact the anaphylaxis criteria included only the most severe cases and could therefore have missed milder cases of anaphylaxis secondary to IV iron. Further, they noted that these findings may not be applicable to a younger patient population.
Patients were excluded from the study if they had received IV iron between January 2007 and July 2013, had a diagnosis of HIV or end-stage renal disease, had a recent blood transfusion, or had a history of anaphylactic reactions.
The study authors disclosed no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
Cervical cancer screening rates on the decline in the U.S.
The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.
“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.
Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.
Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
Sociodemographic factors influence on rates and reasons for overdue screening
Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.
Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.
Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).
For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.
Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.
“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.
In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”
Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.
The study authors and commentator disclosed no relevant financial relationships.
The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.
“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.
Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.
Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
Sociodemographic factors influence on rates and reasons for overdue screening
Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.
Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.
Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).
For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.
Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.
“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.
In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”
Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.
The study authors and commentator disclosed no relevant financial relationships.
The number of women screened for cervical cancer in the United States declined between 2005 and 2019 with lack of knowledge about the need for screening being cited as the most common reason for not receiving up-to-date screening. These are the results of a population-based, cross-sectional study conducted by the U.S. Preventive Services Task Force and were published online in JAMA Network Open.
“The fact that this reason increased over time across most sociodemographic groups suggests a need for interventions targeting screening awareness for all women,” lead author Ryan Suk, PhD, MS, from the University of Texas Health Science Center, Houston, and colleagues wrote.
Between 2005 and 2019, the researchers evaluated data from 20,557 women (weighted, 113.1 million women) included in the U.S. National Health Interview Survey. The cohort included women aged 21-65 years without previous hysterectomy and included data on sociodemographic factors such as race, ethnicity, sexual orientation, health insurance type, and rurality of residence.
Dr. Suk and colleagues found that the proportion of women without current screening increased from 2005 to 2019 (from 14.4% to 23.0%; P < .001) and that a higher proportion of those women were in the 21- to 29-year age group (weighted, 29.1%), compared with women in the 30- to 65-year age group (weighted, 21.1%; P < .001). Regardless of age, not knowing that screening was indicated was the most common reason cited for not having up-to-date screening.
Sociodemographic factors influence on rates and reasons for overdue screening
Based on weighted population estimates, 6.1% of women included were Asian, 17.2% were Hispanic, 13.1% were non-Hispanic Black, 61% were non-Hispanic White, and 2.7% were other races and/or ethnicities.
Dr. Suk and colleagues found that Asian women had the highest rates of overdue screening, compared with non-Hispanic White women, who had the lowest rates (weighted, 31.4% vs. 20.1%, respectively). The authors also found that reasons for overdue screening varied by sociodemographic factors. For example, while both Asian and Hispanic women cited lack of knowledge as a barrier to routine screening, Asian women were more likely to also report lack of recommendation from a health care professional as a barrier while Hispanic women were more likely to also report lack of access as a barrier to timely screening.
Over the 14-year study period, higher rates of overdue screening were also noted among those identifying as LGBTQ+ versus heterosexual (32.0% vs. 22.2%; P < .001), those with no insurance versus private insurance (41.7% vs. 18.1%; P < .001), and those living in rural versus urban areas (26.2% vs. 22.6%; P = .04).
For the study, guideline-concordant, up-to-date screening in 2005 was defined as screening every 3 years for women aged 21-65 years based on USPSTF guidelines and clinical recommendations. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou (Pap smear) test alone for women aged 21-29 years and screening every 3 years with a Pap smear alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30-65 years.
Dr. Suk and colleagues suggested that guideline updates over the study period could have led to uncertainty regarding appropriate timing and recommended screening intervals, which in turn, may have played a role in decreased cancer screening recommendations.
“Studies have suggested that changing guidelines may produce an increase in both overscreening and underscreening but those already at higher risk of cervical cancer may be most susceptible to underscreening,” wrote the authors.
In an interview, Ruchi Garg, MD, from Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates, Fairfax, Va., commented: “I think it has been hard to keep up with the guidelines changing so frequently. Furthermore it’s not clearly delineated (or at least there seems to be confusion or extrapolation) that the guidelines are just for Pap smear and that it doesn’t translate into a well woman checkup/pelvic exam; [however], if physicians continue to tell the patients to come in every year, then there won’t be so much underscreening since the physicians/providers will be able to keep track of when the Pap smears need to get done.”
Similar to the study authors, Dr. Garg also suggested that community lectures and public health announcements, particularly when guidelines are updated, will be helpful in enhancing patient education and reducing the rate of this preventable cancer.
The study authors and commentator disclosed no relevant financial relationships.
FROM JAMA NETWORK OPEN
Intent to vaccinate kids against COVID higher among vaccinated parents
“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.
The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.
Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.
The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.
The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.
Hesitance in vaccinated parents
Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.
“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.
In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”
Advice for clinicians from outside expert
“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.
Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.
“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.
The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.
Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.
The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.
The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.
Hesitance in vaccinated parents
Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.
“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.
In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”
Advice for clinicians from outside expert
“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.
Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.
“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.
The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.
Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.
The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.
The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.
Hesitance in vaccinated parents
Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.
“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.
In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”
Advice for clinicians from outside expert
“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.
Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.
FROM JAMA PEDIATRICS
New antimigraine drugs linked with less risk for adverse events
“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
Methods
The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.
The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.
The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
Results
Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.
Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.
With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)
When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.
Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
Balancing efficacy and tolerability
“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.
“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.
With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”
The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”
Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.
Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.
“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
Methods
The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.
The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.
The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
Results
Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.
Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.
With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)
When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.
Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
Balancing efficacy and tolerability
“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.
“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.
With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”
The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”
Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.
Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.
“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
Methods
The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.
The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.
The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
Results
Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.
Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.
With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)
When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.
Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
Balancing efficacy and tolerability
“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.
“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.
With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”
The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”
Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.
Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.
FROM JAMA NETWORK OPEN
Reassuring data on long-term outcomes among kids with MIS-C
Most children who develop multisystemic inflammatory syndrome (MIS-C) after infection with SARS-CoV-2 recover relatively quickly and without significant sequelae, according to a research letter published online in JAMA Pediatrics.
“The results of this research letter offer some reassurance as has been the case with other longitudinal reports, that children with MIS-C largely recover from the illness with minimal sequelae,” said Kanwal M. Farooqi, MD, a pediatric cardiologist from Columbia University Irving Medical Center, New York.
“This is despite the severity of the initial clinical presentation, which can be quite significant with signs of systemic inflammation, hypotension, and need for ICU-level care,” continued Dr. Farooqi, who was not involved in the study.
Given that little is known about the medium- and long-term effects of MIS-C following infection with COVID-19, Patrick Davies, MRCPCH, Nottingham (England) University Hospitals NHS Trust, and colleagues reviewed data from one of the earliest multicenter national cohorts of children in the United Kingdom. The cohort included children admitted to the hospital prior to May 10, 2020, and the analysis was based on data from 68 of 76 (89%) patients of the initial surviving cohort. Information regarding critical care readmissions and outpatient follow-up visits up to April 1, 2021 (1-year post admission), was included in the analysis.
Overall laboratory results appeared normal for most children at 50 days post admission, including neutrophils, platelets, ferritin, creatinine, and alanine transaminase. Just 3% (2/65 test results) of children showed elevated levels of C-reactive protein, 3% (2/59 test results) for D-dimer, and 2% (1/60 test results) for troponin.
Based on echocardiographic data, 14 of the 19 patients who presented with aneurysms had resolution. Nine of 10 patients who presented with “bright” coronary arteries had resolution and only one progressed to having unresolved coronary artery aneurysms with the latest follow-up at 86 days post admission. All of the 38 patients who presented with impaired function without aneurysm had recovered by day 74.
Of the six patients with ongoing echocardiographic abnormalities, all had aneurysmal changes noted on echocardiograms performed between 86 and 336 days post admission. The authors were surprised to find that troponin levels in this group were lower when compared with others in the cohort (0.06 ng/mL [interquartile range, 0.02-0.418 ng/mL] vs. 0.157 ng/mL [0.033-0.81 ng/mL]; P = .02).
These six patients ranged in age from 0 to 13 years (median age, 8.75 years); five were Afro Caribbean boys and one was a White girl.
The researchers acknowledged that, despite coming from a nationwide data set, the interpretation of this data is limited given the small size of the cohort and the lack of standardized follow-up protocol available at the time.
When asked how this data might inform follow-up guidance for children post COVID infection, Dr. Farooqi said, “although it appears from the data that we have seen in the last few months that the patients recover relatively quickly from MIS-C, I believe it is reasonable to evaluate them at 6-month intervals for the second year until we have more information regarding longer-term outcomes.”
The study authors and Dr. Farooqi disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Most children who develop multisystemic inflammatory syndrome (MIS-C) after infection with SARS-CoV-2 recover relatively quickly and without significant sequelae, according to a research letter published online in JAMA Pediatrics.
“The results of this research letter offer some reassurance as has been the case with other longitudinal reports, that children with MIS-C largely recover from the illness with minimal sequelae,” said Kanwal M. Farooqi, MD, a pediatric cardiologist from Columbia University Irving Medical Center, New York.
“This is despite the severity of the initial clinical presentation, which can be quite significant with signs of systemic inflammation, hypotension, and need for ICU-level care,” continued Dr. Farooqi, who was not involved in the study.
Given that little is known about the medium- and long-term effects of MIS-C following infection with COVID-19, Patrick Davies, MRCPCH, Nottingham (England) University Hospitals NHS Trust, and colleagues reviewed data from one of the earliest multicenter national cohorts of children in the United Kingdom. The cohort included children admitted to the hospital prior to May 10, 2020, and the analysis was based on data from 68 of 76 (89%) patients of the initial surviving cohort. Information regarding critical care readmissions and outpatient follow-up visits up to April 1, 2021 (1-year post admission), was included in the analysis.
Overall laboratory results appeared normal for most children at 50 days post admission, including neutrophils, platelets, ferritin, creatinine, and alanine transaminase. Just 3% (2/65 test results) of children showed elevated levels of C-reactive protein, 3% (2/59 test results) for D-dimer, and 2% (1/60 test results) for troponin.
Based on echocardiographic data, 14 of the 19 patients who presented with aneurysms had resolution. Nine of 10 patients who presented with “bright” coronary arteries had resolution and only one progressed to having unresolved coronary artery aneurysms with the latest follow-up at 86 days post admission. All of the 38 patients who presented with impaired function without aneurysm had recovered by day 74.
Of the six patients with ongoing echocardiographic abnormalities, all had aneurysmal changes noted on echocardiograms performed between 86 and 336 days post admission. The authors were surprised to find that troponin levels in this group were lower when compared with others in the cohort (0.06 ng/mL [interquartile range, 0.02-0.418 ng/mL] vs. 0.157 ng/mL [0.033-0.81 ng/mL]; P = .02).
These six patients ranged in age from 0 to 13 years (median age, 8.75 years); five were Afro Caribbean boys and one was a White girl.
The researchers acknowledged that, despite coming from a nationwide data set, the interpretation of this data is limited given the small size of the cohort and the lack of standardized follow-up protocol available at the time.
When asked how this data might inform follow-up guidance for children post COVID infection, Dr. Farooqi said, “although it appears from the data that we have seen in the last few months that the patients recover relatively quickly from MIS-C, I believe it is reasonable to evaluate them at 6-month intervals for the second year until we have more information regarding longer-term outcomes.”
The study authors and Dr. Farooqi disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Most children who develop multisystemic inflammatory syndrome (MIS-C) after infection with SARS-CoV-2 recover relatively quickly and without significant sequelae, according to a research letter published online in JAMA Pediatrics.
“The results of this research letter offer some reassurance as has been the case with other longitudinal reports, that children with MIS-C largely recover from the illness with minimal sequelae,” said Kanwal M. Farooqi, MD, a pediatric cardiologist from Columbia University Irving Medical Center, New York.
“This is despite the severity of the initial clinical presentation, which can be quite significant with signs of systemic inflammation, hypotension, and need for ICU-level care,” continued Dr. Farooqi, who was not involved in the study.
Given that little is known about the medium- and long-term effects of MIS-C following infection with COVID-19, Patrick Davies, MRCPCH, Nottingham (England) University Hospitals NHS Trust, and colleagues reviewed data from one of the earliest multicenter national cohorts of children in the United Kingdom. The cohort included children admitted to the hospital prior to May 10, 2020, and the analysis was based on data from 68 of 76 (89%) patients of the initial surviving cohort. Information regarding critical care readmissions and outpatient follow-up visits up to April 1, 2021 (1-year post admission), was included in the analysis.
Overall laboratory results appeared normal for most children at 50 days post admission, including neutrophils, platelets, ferritin, creatinine, and alanine transaminase. Just 3% (2/65 test results) of children showed elevated levels of C-reactive protein, 3% (2/59 test results) for D-dimer, and 2% (1/60 test results) for troponin.
Based on echocardiographic data, 14 of the 19 patients who presented with aneurysms had resolution. Nine of 10 patients who presented with “bright” coronary arteries had resolution and only one progressed to having unresolved coronary artery aneurysms with the latest follow-up at 86 days post admission. All of the 38 patients who presented with impaired function without aneurysm had recovered by day 74.
Of the six patients with ongoing echocardiographic abnormalities, all had aneurysmal changes noted on echocardiograms performed between 86 and 336 days post admission. The authors were surprised to find that troponin levels in this group were lower when compared with others in the cohort (0.06 ng/mL [interquartile range, 0.02-0.418 ng/mL] vs. 0.157 ng/mL [0.033-0.81 ng/mL]; P = .02).
These six patients ranged in age from 0 to 13 years (median age, 8.75 years); five were Afro Caribbean boys and one was a White girl.
The researchers acknowledged that, despite coming from a nationwide data set, the interpretation of this data is limited given the small size of the cohort and the lack of standardized follow-up protocol available at the time.
When asked how this data might inform follow-up guidance for children post COVID infection, Dr. Farooqi said, “although it appears from the data that we have seen in the last few months that the patients recover relatively quickly from MIS-C, I believe it is reasonable to evaluate them at 6-month intervals for the second year until we have more information regarding longer-term outcomes.”
The study authors and Dr. Farooqi disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Long-term use of prescription sleep meds unsupported by new research
a new study shows.
“While there are good data from [randomized, controlled trials] that these medications improve sleep disturbances in the short term,” few studies have examined whether they provide long-term benefits, stated the authors of the paper, which was published in BMJ Open.
“The current observational study does not support use of sleep medications over the long term, as there were no self-reported differences at 1 or 2 years of follow-up comparing sleep medication users with nonusers,” author Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital, Boston, and colleagues wrote.
Women included in the analysis were drawn from the Study of Women’s Health Across the Nation (SWAN), an ongoing multicenter, longitudinal study examining women during the menopausal transition. The average age of the women included in the cohort was 49.5 years and approximately half were White. All women reported a sleep disturbance on at least 3 nights per week during a 2-week interval. At follow up, women were asked to use a Likert scale to rate three aspects of sleep: difficulty initiating sleep, frequent awakening, and waking up early. On the scale, 1 represented having no difficulties on any nights, 3 represented having difficulties 1-2 nights per week, and 5 represented having difficulty 5-7 nights per week.
Women already using prescription sleep medication at their baseline visit were excluded from the study. Medications used included benzodiazepines, selective BZD receptor agonists, and other hypnotics.
Over the 21 years of follow-up in the SWAN study (1995-2016), Dr. Solomon and colleagues identified 238 women using sleep medication and these were compared with a cohort of 447 propensity score–matched non–sleep medication uses. Overall, the 685 women included were similar in characteristics to each other as well as to the other potentially eligible women not included in the analysis.
Sleep disturbance patterns compared
At baseline, sleep disturbance patterns were similar between the two groups. Among medication users, the mean score for difficulty initiating sleep was 2.7 (95% confidence interval, 2.5-2.9), waking frequently 3.8 (95% CI, 3.6-3.9), and waking early 2.9 (95% CI, 2.7-3.1). Among the nonusers, the baseline scores were 2.6 (95% CI, 2.5-2.7), 3.7 (95% CI, 3.6-3.8), and 2.7 (95% CI, 2.5-2.8), respectively. After 1 year, there was no statistically significant difference in scores between the two groups. The average ratings for medication users were 2.6 (95% CI, 2.3-2.8) for difficulty initiating sleep, 3.8 (95% CI, 3.6-4.0) for waking frequently, and 2.8 (95% CI, 2.6-3.0) for waking early.
Average ratings among nonusers were 2.3 (95% CI, 2.2-2.4), 3.5 (95% CI, 3.3-3.6), and 2.5 (95% CI, 2.3-2.6), respectively.
After 2 years, there were still no statistically significant reductions in sleep disturbances among those taking prescription sleep medications, compared with those not taking medication.
The researchers noted that approximately half of the women in this cohort were current or past tobacco users and that 20% were moderate to heavy alcohol users.
More work-up, not more medication, needed
The study authors acknowledged the limitations of an observational study and noted that, since participants only reported medication use and sleep disturbances at annual visits, they did not know whether patients’ medication use was intermittent or of any interim outcomes. Additionally, the authors pointed out that those classified as “nonusers” may have been using over-the-counter medication.
“Investigations should look at detailed-use patterns, on a daily or weekly basis, with frequent outcomes data,” Dr. Solomon said in an interview. “While our data shed new light on chronic use, we only had data collected on an annual basis; daily or weekly data would provide more granular information.”
Regarding clinician prescribing practices, Dr. Solomon said, “short-term, intermittent use can be helpful, but use these agents sparingly” and “educate patients that chronic regular use of medications for sleep is not associated with improvement in sleep disturbances.”
Commenting on the study, Andrea Matsumura, MD, a sleep specialist at the Oregon Clinic in Portland, echoed this sentiment: “When someone says they are having trouble sleeping this is the tip of the iceberg and it warrants an evaluation to determine if someone has a breathing disorder, a circadian disorder, a life situation, or a type of insomnia that is driving the sleeplessness.”
“I think this study supports what we all should know,” Dr. Matsumura concluded. “Sleep aids are not meant to be used long term” and should not be used for longer than 2 weeks without further work-up.
Funding for this study was provided through a grant from the National Institutes of Health. Dr. Solomon has received salary support from research grants to Brigham and Women’s Hospital for unrelated work from AbbVie, Amgen, Corrona, Genentech and Pfizer. The other authors and Dr. Matsumura have reported no relevant financial relationships.
a new study shows.
“While there are good data from [randomized, controlled trials] that these medications improve sleep disturbances in the short term,” few studies have examined whether they provide long-term benefits, stated the authors of the paper, which was published in BMJ Open.
“The current observational study does not support use of sleep medications over the long term, as there were no self-reported differences at 1 or 2 years of follow-up comparing sleep medication users with nonusers,” author Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital, Boston, and colleagues wrote.
Women included in the analysis were drawn from the Study of Women’s Health Across the Nation (SWAN), an ongoing multicenter, longitudinal study examining women during the menopausal transition. The average age of the women included in the cohort was 49.5 years and approximately half were White. All women reported a sleep disturbance on at least 3 nights per week during a 2-week interval. At follow up, women were asked to use a Likert scale to rate three aspects of sleep: difficulty initiating sleep, frequent awakening, and waking up early. On the scale, 1 represented having no difficulties on any nights, 3 represented having difficulties 1-2 nights per week, and 5 represented having difficulty 5-7 nights per week.
Women already using prescription sleep medication at their baseline visit were excluded from the study. Medications used included benzodiazepines, selective BZD receptor agonists, and other hypnotics.
Over the 21 years of follow-up in the SWAN study (1995-2016), Dr. Solomon and colleagues identified 238 women using sleep medication and these were compared with a cohort of 447 propensity score–matched non–sleep medication uses. Overall, the 685 women included were similar in characteristics to each other as well as to the other potentially eligible women not included in the analysis.
Sleep disturbance patterns compared
At baseline, sleep disturbance patterns were similar between the two groups. Among medication users, the mean score for difficulty initiating sleep was 2.7 (95% confidence interval, 2.5-2.9), waking frequently 3.8 (95% CI, 3.6-3.9), and waking early 2.9 (95% CI, 2.7-3.1). Among the nonusers, the baseline scores were 2.6 (95% CI, 2.5-2.7), 3.7 (95% CI, 3.6-3.8), and 2.7 (95% CI, 2.5-2.8), respectively. After 1 year, there was no statistically significant difference in scores between the two groups. The average ratings for medication users were 2.6 (95% CI, 2.3-2.8) for difficulty initiating sleep, 3.8 (95% CI, 3.6-4.0) for waking frequently, and 2.8 (95% CI, 2.6-3.0) for waking early.
Average ratings among nonusers were 2.3 (95% CI, 2.2-2.4), 3.5 (95% CI, 3.3-3.6), and 2.5 (95% CI, 2.3-2.6), respectively.
After 2 years, there were still no statistically significant reductions in sleep disturbances among those taking prescription sleep medications, compared with those not taking medication.
The researchers noted that approximately half of the women in this cohort were current or past tobacco users and that 20% were moderate to heavy alcohol users.
More work-up, not more medication, needed
The study authors acknowledged the limitations of an observational study and noted that, since participants only reported medication use and sleep disturbances at annual visits, they did not know whether patients’ medication use was intermittent or of any interim outcomes. Additionally, the authors pointed out that those classified as “nonusers” may have been using over-the-counter medication.
“Investigations should look at detailed-use patterns, on a daily or weekly basis, with frequent outcomes data,” Dr. Solomon said in an interview. “While our data shed new light on chronic use, we only had data collected on an annual basis; daily or weekly data would provide more granular information.”
Regarding clinician prescribing practices, Dr. Solomon said, “short-term, intermittent use can be helpful, but use these agents sparingly” and “educate patients that chronic regular use of medications for sleep is not associated with improvement in sleep disturbances.”
Commenting on the study, Andrea Matsumura, MD, a sleep specialist at the Oregon Clinic in Portland, echoed this sentiment: “When someone says they are having trouble sleeping this is the tip of the iceberg and it warrants an evaluation to determine if someone has a breathing disorder, a circadian disorder, a life situation, or a type of insomnia that is driving the sleeplessness.”
“I think this study supports what we all should know,” Dr. Matsumura concluded. “Sleep aids are not meant to be used long term” and should not be used for longer than 2 weeks without further work-up.
Funding for this study was provided through a grant from the National Institutes of Health. Dr. Solomon has received salary support from research grants to Brigham and Women’s Hospital for unrelated work from AbbVie, Amgen, Corrona, Genentech and Pfizer. The other authors and Dr. Matsumura have reported no relevant financial relationships.
a new study shows.
“While there are good data from [randomized, controlled trials] that these medications improve sleep disturbances in the short term,” few studies have examined whether they provide long-term benefits, stated the authors of the paper, which was published in BMJ Open.
“The current observational study does not support use of sleep medications over the long term, as there were no self-reported differences at 1 or 2 years of follow-up comparing sleep medication users with nonusers,” author Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital, Boston, and colleagues wrote.
Women included in the analysis were drawn from the Study of Women’s Health Across the Nation (SWAN), an ongoing multicenter, longitudinal study examining women during the menopausal transition. The average age of the women included in the cohort was 49.5 years and approximately half were White. All women reported a sleep disturbance on at least 3 nights per week during a 2-week interval. At follow up, women were asked to use a Likert scale to rate three aspects of sleep: difficulty initiating sleep, frequent awakening, and waking up early. On the scale, 1 represented having no difficulties on any nights, 3 represented having difficulties 1-2 nights per week, and 5 represented having difficulty 5-7 nights per week.
Women already using prescription sleep medication at their baseline visit were excluded from the study. Medications used included benzodiazepines, selective BZD receptor agonists, and other hypnotics.
Over the 21 years of follow-up in the SWAN study (1995-2016), Dr. Solomon and colleagues identified 238 women using sleep medication and these were compared with a cohort of 447 propensity score–matched non–sleep medication uses. Overall, the 685 women included were similar in characteristics to each other as well as to the other potentially eligible women not included in the analysis.
Sleep disturbance patterns compared
At baseline, sleep disturbance patterns were similar between the two groups. Among medication users, the mean score for difficulty initiating sleep was 2.7 (95% confidence interval, 2.5-2.9), waking frequently 3.8 (95% CI, 3.6-3.9), and waking early 2.9 (95% CI, 2.7-3.1). Among the nonusers, the baseline scores were 2.6 (95% CI, 2.5-2.7), 3.7 (95% CI, 3.6-3.8), and 2.7 (95% CI, 2.5-2.8), respectively. After 1 year, there was no statistically significant difference in scores between the two groups. The average ratings for medication users were 2.6 (95% CI, 2.3-2.8) for difficulty initiating sleep, 3.8 (95% CI, 3.6-4.0) for waking frequently, and 2.8 (95% CI, 2.6-3.0) for waking early.
Average ratings among nonusers were 2.3 (95% CI, 2.2-2.4), 3.5 (95% CI, 3.3-3.6), and 2.5 (95% CI, 2.3-2.6), respectively.
After 2 years, there were still no statistically significant reductions in sleep disturbances among those taking prescription sleep medications, compared with those not taking medication.
The researchers noted that approximately half of the women in this cohort were current or past tobacco users and that 20% were moderate to heavy alcohol users.
More work-up, not more medication, needed
The study authors acknowledged the limitations of an observational study and noted that, since participants only reported medication use and sleep disturbances at annual visits, they did not know whether patients’ medication use was intermittent or of any interim outcomes. Additionally, the authors pointed out that those classified as “nonusers” may have been using over-the-counter medication.
“Investigations should look at detailed-use patterns, on a daily or weekly basis, with frequent outcomes data,” Dr. Solomon said in an interview. “While our data shed new light on chronic use, we only had data collected on an annual basis; daily or weekly data would provide more granular information.”
Regarding clinician prescribing practices, Dr. Solomon said, “short-term, intermittent use can be helpful, but use these agents sparingly” and “educate patients that chronic regular use of medications for sleep is not associated with improvement in sleep disturbances.”
Commenting on the study, Andrea Matsumura, MD, a sleep specialist at the Oregon Clinic in Portland, echoed this sentiment: “When someone says they are having trouble sleeping this is the tip of the iceberg and it warrants an evaluation to determine if someone has a breathing disorder, a circadian disorder, a life situation, or a type of insomnia that is driving the sleeplessness.”
“I think this study supports what we all should know,” Dr. Matsumura concluded. “Sleep aids are not meant to be used long term” and should not be used for longer than 2 weeks without further work-up.
Funding for this study was provided through a grant from the National Institutes of Health. Dr. Solomon has received salary support from research grants to Brigham and Women’s Hospital for unrelated work from AbbVie, Amgen, Corrona, Genentech and Pfizer. The other authors and Dr. Matsumura have reported no relevant financial relationships.
FROM BMJ OPEN
ADHD in preschool kids: Adrenergic agonists may be a better fit
A new study finds that alpha2-adrenergic agonists may be of benefit and have fewer side effects than stimulant medications for the treatment of attention-deficit/hyperactivity disorder in preschool-age children.
The study was published online May 4 in JAMA.
As part of a retrospective analysis, Elizabeth Harstad, MD, MPH, of Boston Children’s Hospital and colleagues evaluated health record data from 497 preschool-age children with ADHD across seven developmental-behavioral pediatric practices in the United States. Children included in the evaluation were younger than 6 years and were treated for ADHD between Jan. 1, 2013, and July 1, 2017, with either an alpha2-adrenergic agonist or a stimulant.
Overall, 175 children (35%) were prescribed an alpha2-adrenergic agonist (most often guanfacine) as first-line ADHD medication, and 322 children (65%) were prescribed a stimulant (most often a methylphenidate-based preparation). Before any medication regimens were initiated, 62% of children received behavioral therapy.
“These findings suggest that for some children there may be a concern about either how well a stimulant will work or how well a stimulant will be tolerated that is leading clinicians to instead prescribe an alpha2-adrenergic agonist as the first medication tried,” Dr. Harstad said in an interview.
Clinical improvement was noted in 66% of children treated with alpha2-adrenergic agonists (95% confidence interval, 57.5%-73.9%) and in 78% of children treated with stimulants (95% CI, 72.4%-83.4%).
Most adverse effects were more common among children who received stimulants than among those who received alpha2-adrenergic agonists. These adverse effects included difficulty falling asleep (21% vs. 11%), decreased appetite (38% vs. 7%), increased stomachaches (13% vs. 5%), and increased skin picking/repetitive behaviors (11% vs. 5%). Only daytime sleepiness was more frequent among children who received an alpha2-adrenergic agonist rather than a stimulant (38% vs. 3%).
“We also found that for the youngest children (<4 years old), those initiated on alpha2-adrenergic agonists stayed on these medications longer than those initiated on stimulants, which may indicate that they are better tolerated, although more research is needed to confirm this,” Dr. Harstad said.
“While our study focused on how well medications work and how well they are tolerated when used to treat preschool-age children with ADHD, it is important to remember that behavioral therapy is recommended as first-line treatment for ADHD in preschool-age children, not medication,” Dr. Harstad added.
Mark Wolraich, MD, of the University of Oklahoma, echoed that sentiment. “The article mentions that behavioral interventions, in the form of parent training in behavior management, is an effective first-line treatment” and, per the American Academy of Pediatrics guidelines, “is the first line of treatment recommended for preschool-age children before medication should be considered.”
Dr. Wolraich also noted that “neither drug has official FDA [U.S. Food and Drug Administration] approval in this age group” but that “methylphenidate comes the closest to having met the FDA requirements for approval in this age group, which is why the AAP guidelines recommended its use if parent training in behavior management is not sufficient.”
Although Dr. Harstad and colleagues note that the study included a large and diverse sample size from across the United States, they acknowledge that “further research, including from randomized clinical trials, is needed to assess comparative effectiveness of alpha2-adrenergic agonists versus stimulants.”
Funding for the study was provided through a cooperative agreement with the Maternal and Child Health Bureau, the Health Resources and Services Administration, and the U.S. Department of Health & Human Services. Dr. Harstad has reported receiving reported receiving compensation for serving as a medical reviewer for Understood.org and grant funding from the Palmer Family Fund for Autism Research to conduct research related to autism spectrum disorder at Boston Children’s Hospital. Disclosures for the other authors are listed in the original article. Dr. Wolraich has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study finds that alpha2-adrenergic agonists may be of benefit and have fewer side effects than stimulant medications for the treatment of attention-deficit/hyperactivity disorder in preschool-age children.
The study was published online May 4 in JAMA.
As part of a retrospective analysis, Elizabeth Harstad, MD, MPH, of Boston Children’s Hospital and colleagues evaluated health record data from 497 preschool-age children with ADHD across seven developmental-behavioral pediatric practices in the United States. Children included in the evaluation were younger than 6 years and were treated for ADHD between Jan. 1, 2013, and July 1, 2017, with either an alpha2-adrenergic agonist or a stimulant.
Overall, 175 children (35%) were prescribed an alpha2-adrenergic agonist (most often guanfacine) as first-line ADHD medication, and 322 children (65%) were prescribed a stimulant (most often a methylphenidate-based preparation). Before any medication regimens were initiated, 62% of children received behavioral therapy.
“These findings suggest that for some children there may be a concern about either how well a stimulant will work or how well a stimulant will be tolerated that is leading clinicians to instead prescribe an alpha2-adrenergic agonist as the first medication tried,” Dr. Harstad said in an interview.
Clinical improvement was noted in 66% of children treated with alpha2-adrenergic agonists (95% confidence interval, 57.5%-73.9%) and in 78% of children treated with stimulants (95% CI, 72.4%-83.4%).
Most adverse effects were more common among children who received stimulants than among those who received alpha2-adrenergic agonists. These adverse effects included difficulty falling asleep (21% vs. 11%), decreased appetite (38% vs. 7%), increased stomachaches (13% vs. 5%), and increased skin picking/repetitive behaviors (11% vs. 5%). Only daytime sleepiness was more frequent among children who received an alpha2-adrenergic agonist rather than a stimulant (38% vs. 3%).
“We also found that for the youngest children (<4 years old), those initiated on alpha2-adrenergic agonists stayed on these medications longer than those initiated on stimulants, which may indicate that they are better tolerated, although more research is needed to confirm this,” Dr. Harstad said.
“While our study focused on how well medications work and how well they are tolerated when used to treat preschool-age children with ADHD, it is important to remember that behavioral therapy is recommended as first-line treatment for ADHD in preschool-age children, not medication,” Dr. Harstad added.
Mark Wolraich, MD, of the University of Oklahoma, echoed that sentiment. “The article mentions that behavioral interventions, in the form of parent training in behavior management, is an effective first-line treatment” and, per the American Academy of Pediatrics guidelines, “is the first line of treatment recommended for preschool-age children before medication should be considered.”
Dr. Wolraich also noted that “neither drug has official FDA [U.S. Food and Drug Administration] approval in this age group” but that “methylphenidate comes the closest to having met the FDA requirements for approval in this age group, which is why the AAP guidelines recommended its use if parent training in behavior management is not sufficient.”
Although Dr. Harstad and colleagues note that the study included a large and diverse sample size from across the United States, they acknowledge that “further research, including from randomized clinical trials, is needed to assess comparative effectiveness of alpha2-adrenergic agonists versus stimulants.”
Funding for the study was provided through a cooperative agreement with the Maternal and Child Health Bureau, the Health Resources and Services Administration, and the U.S. Department of Health & Human Services. Dr. Harstad has reported receiving reported receiving compensation for serving as a medical reviewer for Understood.org and grant funding from the Palmer Family Fund for Autism Research to conduct research related to autism spectrum disorder at Boston Children’s Hospital. Disclosures for the other authors are listed in the original article. Dr. Wolraich has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study finds that alpha2-adrenergic agonists may be of benefit and have fewer side effects than stimulant medications for the treatment of attention-deficit/hyperactivity disorder in preschool-age children.
The study was published online May 4 in JAMA.
As part of a retrospective analysis, Elizabeth Harstad, MD, MPH, of Boston Children’s Hospital and colleagues evaluated health record data from 497 preschool-age children with ADHD across seven developmental-behavioral pediatric practices in the United States. Children included in the evaluation were younger than 6 years and were treated for ADHD between Jan. 1, 2013, and July 1, 2017, with either an alpha2-adrenergic agonist or a stimulant.
Overall, 175 children (35%) were prescribed an alpha2-adrenergic agonist (most often guanfacine) as first-line ADHD medication, and 322 children (65%) were prescribed a stimulant (most often a methylphenidate-based preparation). Before any medication regimens were initiated, 62% of children received behavioral therapy.
“These findings suggest that for some children there may be a concern about either how well a stimulant will work or how well a stimulant will be tolerated that is leading clinicians to instead prescribe an alpha2-adrenergic agonist as the first medication tried,” Dr. Harstad said in an interview.
Clinical improvement was noted in 66% of children treated with alpha2-adrenergic agonists (95% confidence interval, 57.5%-73.9%) and in 78% of children treated with stimulants (95% CI, 72.4%-83.4%).
Most adverse effects were more common among children who received stimulants than among those who received alpha2-adrenergic agonists. These adverse effects included difficulty falling asleep (21% vs. 11%), decreased appetite (38% vs. 7%), increased stomachaches (13% vs. 5%), and increased skin picking/repetitive behaviors (11% vs. 5%). Only daytime sleepiness was more frequent among children who received an alpha2-adrenergic agonist rather than a stimulant (38% vs. 3%).
“We also found that for the youngest children (<4 years old), those initiated on alpha2-adrenergic agonists stayed on these medications longer than those initiated on stimulants, which may indicate that they are better tolerated, although more research is needed to confirm this,” Dr. Harstad said.
“While our study focused on how well medications work and how well they are tolerated when used to treat preschool-age children with ADHD, it is important to remember that behavioral therapy is recommended as first-line treatment for ADHD in preschool-age children, not medication,” Dr. Harstad added.
Mark Wolraich, MD, of the University of Oklahoma, echoed that sentiment. “The article mentions that behavioral interventions, in the form of parent training in behavior management, is an effective first-line treatment” and, per the American Academy of Pediatrics guidelines, “is the first line of treatment recommended for preschool-age children before medication should be considered.”
Dr. Wolraich also noted that “neither drug has official FDA [U.S. Food and Drug Administration] approval in this age group” but that “methylphenidate comes the closest to having met the FDA requirements for approval in this age group, which is why the AAP guidelines recommended its use if parent training in behavior management is not sufficient.”
Although Dr. Harstad and colleagues note that the study included a large and diverse sample size from across the United States, they acknowledge that “further research, including from randomized clinical trials, is needed to assess comparative effectiveness of alpha2-adrenergic agonists versus stimulants.”
Funding for the study was provided through a cooperative agreement with the Maternal and Child Health Bureau, the Health Resources and Services Administration, and the U.S. Department of Health & Human Services. Dr. Harstad has reported receiving reported receiving compensation for serving as a medical reviewer for Understood.org and grant funding from the Palmer Family Fund for Autism Research to conduct research related to autism spectrum disorder at Boston Children’s Hospital. Disclosures for the other authors are listed in the original article. Dr. Wolraich has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID exposure risk outside of work increasing for clinicians
One-third of COVID-19 exposures among health care providers (HCPs) in Minnesota are caused by family or community exposure, not patient care, according to a study conducted by the Minnesota Department of Health and published online Oct. 30 in Morbidity and Mortality Weekly Report. And nonwork exposures were more likely to lead to COVID-19 infections.
Between March 6 and July 11, 2020, researchers with the Minnesota Department of Health evaluated 21,406 incidences of HCP exposure to confirmed COVID-19 cases. Of those, 5,374 (25%) were classified as higher-risk exposures, meaning the provider had close contact for 15 minutes or more, or during an aerosol-generating procedure.
Two-thirds (66%) of the higher-risk exposures occurred during direct patient care and 34% were related to nonpatient care interactions (e.g., coworkers and social and household contacts). Overall, 6.9% (373) of the HCPs with a higher-risk exposure received a positive SARS-CoV-2 test result within 14 days of the exposure. Notably, HCPs with household or social exposure had the highest positivity rate across all exposure types at 13%.
“Since the time period covered in this report, we’ve seen a significant increase in the proportion of HCPs who have had higher-risk exposures outside of work due to household or social contacts,” said lead author Ashley Fell, MPH, from the Minnesota Department of Health.
“HCPs with household or social exposures are also more likely to test positive than HCPs with higher risk exposures within the healthcare setting, which is an important message for both HCPs and the community at large that more COVID-19 spreading in our communities poses a greater risk to our HCPs and health care system,” Ms. Fell said in an interview.
When evaluating personal protective equipment use among exposed HCPs, researchers found that 90% of providers in acute or ambulatory care were wearing a respirator or medical-grade face mask at time of exposure, compared with just 68% of HCPs working in congregate living or long-term care facilities.
Further, investigators found that an HCP with a positive SARS-CoV-2 test working in a congregate living or long-term care facility resulted in exposure of a median of three additional HCPs (interquartile range, 1-6), compared with a median of one additional HCP exposure in acute or ambulatory care (IQR, 1-3).
The researchers also found that, compared with HCPs in acute or ambulatory settings, HCPs working in long-term care or congregate living settings were more likely to return to work following a high-risk exposure (57% vs. 37%) and work while symptomatic (4.8% vs. 1.3%).
When asked whether these findings apply to HCPs in other states, Andrew T. Chan, MD, from Massachusetts General Hospital, Boston, noted: “These data are not surprising and confirm what many of us have been seeing in our own areas.
“Clearly, the risk of contracting COVID-19 is particularly high for frontline health care workers in long-term care facilities and nursing homes,” Dr. Chan said.
“Furthermore, the infection control practices in these care settings are often not as rigorous, and together these factors are probably contributing to higher risks of infection,” he said.
The authors acknowledged potential study limitations including misclassification of HCP risk for exposure or misclassification of community exposure as workplace exposure.
“We also recognize that HCPs, like the rest of the community, are experiencing COVID fatigue and that facilities have to constantly be innovative and vigilant to help HCPs maintain rigorous safety precautions with their patients and around their colleagues,” Ms. Fell concluded.
The authors and Dr. Chan disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
This article first appeared on Medscape.com.
One-third of COVID-19 exposures among health care providers (HCPs) in Minnesota are caused by family or community exposure, not patient care, according to a study conducted by the Minnesota Department of Health and published online Oct. 30 in Morbidity and Mortality Weekly Report. And nonwork exposures were more likely to lead to COVID-19 infections.
Between March 6 and July 11, 2020, researchers with the Minnesota Department of Health evaluated 21,406 incidences of HCP exposure to confirmed COVID-19 cases. Of those, 5,374 (25%) were classified as higher-risk exposures, meaning the provider had close contact for 15 minutes or more, or during an aerosol-generating procedure.
Two-thirds (66%) of the higher-risk exposures occurred during direct patient care and 34% were related to nonpatient care interactions (e.g., coworkers and social and household contacts). Overall, 6.9% (373) of the HCPs with a higher-risk exposure received a positive SARS-CoV-2 test result within 14 days of the exposure. Notably, HCPs with household or social exposure had the highest positivity rate across all exposure types at 13%.
“Since the time period covered in this report, we’ve seen a significant increase in the proportion of HCPs who have had higher-risk exposures outside of work due to household or social contacts,” said lead author Ashley Fell, MPH, from the Minnesota Department of Health.
“HCPs with household or social exposures are also more likely to test positive than HCPs with higher risk exposures within the healthcare setting, which is an important message for both HCPs and the community at large that more COVID-19 spreading in our communities poses a greater risk to our HCPs and health care system,” Ms. Fell said in an interview.
When evaluating personal protective equipment use among exposed HCPs, researchers found that 90% of providers in acute or ambulatory care were wearing a respirator or medical-grade face mask at time of exposure, compared with just 68% of HCPs working in congregate living or long-term care facilities.
Further, investigators found that an HCP with a positive SARS-CoV-2 test working in a congregate living or long-term care facility resulted in exposure of a median of three additional HCPs (interquartile range, 1-6), compared with a median of one additional HCP exposure in acute or ambulatory care (IQR, 1-3).
The researchers also found that, compared with HCPs in acute or ambulatory settings, HCPs working in long-term care or congregate living settings were more likely to return to work following a high-risk exposure (57% vs. 37%) and work while symptomatic (4.8% vs. 1.3%).
When asked whether these findings apply to HCPs in other states, Andrew T. Chan, MD, from Massachusetts General Hospital, Boston, noted: “These data are not surprising and confirm what many of us have been seeing in our own areas.
“Clearly, the risk of contracting COVID-19 is particularly high for frontline health care workers in long-term care facilities and nursing homes,” Dr. Chan said.
“Furthermore, the infection control practices in these care settings are often not as rigorous, and together these factors are probably contributing to higher risks of infection,” he said.
The authors acknowledged potential study limitations including misclassification of HCP risk for exposure or misclassification of community exposure as workplace exposure.
“We also recognize that HCPs, like the rest of the community, are experiencing COVID fatigue and that facilities have to constantly be innovative and vigilant to help HCPs maintain rigorous safety precautions with their patients and around their colleagues,” Ms. Fell concluded.
The authors and Dr. Chan disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
This article first appeared on Medscape.com.
One-third of COVID-19 exposures among health care providers (HCPs) in Minnesota are caused by family or community exposure, not patient care, according to a study conducted by the Minnesota Department of Health and published online Oct. 30 in Morbidity and Mortality Weekly Report. And nonwork exposures were more likely to lead to COVID-19 infections.
Between March 6 and July 11, 2020, researchers with the Minnesota Department of Health evaluated 21,406 incidences of HCP exposure to confirmed COVID-19 cases. Of those, 5,374 (25%) were classified as higher-risk exposures, meaning the provider had close contact for 15 minutes or more, or during an aerosol-generating procedure.
Two-thirds (66%) of the higher-risk exposures occurred during direct patient care and 34% were related to nonpatient care interactions (e.g., coworkers and social and household contacts). Overall, 6.9% (373) of the HCPs with a higher-risk exposure received a positive SARS-CoV-2 test result within 14 days of the exposure. Notably, HCPs with household or social exposure had the highest positivity rate across all exposure types at 13%.
“Since the time period covered in this report, we’ve seen a significant increase in the proportion of HCPs who have had higher-risk exposures outside of work due to household or social contacts,” said lead author Ashley Fell, MPH, from the Minnesota Department of Health.
“HCPs with household or social exposures are also more likely to test positive than HCPs with higher risk exposures within the healthcare setting, which is an important message for both HCPs and the community at large that more COVID-19 spreading in our communities poses a greater risk to our HCPs and health care system,” Ms. Fell said in an interview.
When evaluating personal protective equipment use among exposed HCPs, researchers found that 90% of providers in acute or ambulatory care were wearing a respirator or medical-grade face mask at time of exposure, compared with just 68% of HCPs working in congregate living or long-term care facilities.
Further, investigators found that an HCP with a positive SARS-CoV-2 test working in a congregate living or long-term care facility resulted in exposure of a median of three additional HCPs (interquartile range, 1-6), compared with a median of one additional HCP exposure in acute or ambulatory care (IQR, 1-3).
The researchers also found that, compared with HCPs in acute or ambulatory settings, HCPs working in long-term care or congregate living settings were more likely to return to work following a high-risk exposure (57% vs. 37%) and work while symptomatic (4.8% vs. 1.3%).
When asked whether these findings apply to HCPs in other states, Andrew T. Chan, MD, from Massachusetts General Hospital, Boston, noted: “These data are not surprising and confirm what many of us have been seeing in our own areas.
“Clearly, the risk of contracting COVID-19 is particularly high for frontline health care workers in long-term care facilities and nursing homes,” Dr. Chan said.
“Furthermore, the infection control practices in these care settings are often not as rigorous, and together these factors are probably contributing to higher risks of infection,” he said.
The authors acknowledged potential study limitations including misclassification of HCP risk for exposure or misclassification of community exposure as workplace exposure.
“We also recognize that HCPs, like the rest of the community, are experiencing COVID fatigue and that facilities have to constantly be innovative and vigilant to help HCPs maintain rigorous safety precautions with their patients and around their colleagues,” Ms. Fell concluded.
The authors and Dr. Chan disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
This article first appeared on Medscape.com.
New CDC guidance for health care personnel exposed to HCV
The new guidance was developed in part as a result of an increase in the incidence of acute HCV infection in the United States, which increases the risk for occupational exposure among HCP. “[I]n certain health care settings, HCP might be exposed to source patients with early HCV infection before those patients develop serologic evidence of infection or symptoms indicative of viral hepatitis,” wrote the authors of the report, published online July 24 in the CDC’s Morbidity and Mortality Weekly Report.
The guidelines, which no longer recommend waiting for spontaneous resolution upon initial diagnosis, include recommendations and algorithms for baseline and follow-up testing, appropriate test type, and recommendations for clinical management. The recommendations were developed on the basis of a current literature review, expert opinion from subject matter experts, and recent guidance from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
Baseline testing ASAP
Baseline testing of the source patient and the HCP should be performed as soon as possible, preferably within 48 hours of exposure. The source patient should be tested for HCV RNA using a nucleic acid test. Alternatively, screening anti-HCV serology can be performed in patients at low risk for HCV and a nucleic acid test performed if serology is positive.
Baseline testing for the HCP should include anti-HCV testing and, if positive, HCV RNA testing is recommended. HCPs who test positive for HCV RNA at baseline are considered to have a preexisting HCV infection and should be referred for treatment.
Follow-up testing
For HCPs with exposure to blood or body fluids from a patient who is anti-HCV positive but HCV RNA negative, follow-up testing is not required.
If the source patient is HCV RNA positive, or if status of the source patient is unknown, the authors recommend that exposed HCPs have HCV RNA follow-up testing at 3-6 weeks post exposure, in addition to baseline testing. A final anti-HCV test is recommended at 4-6 months post exposure as there can be potential periods of aviremia during acute HCV infection.
Exposed HCPs who develop signs of illness indicative of HCV infection at any time should be tested for HCV RNA.
HCPs with positive HCV RNA test results should be referred for care and curative antiviral therapy.
Postexposure prophylaxis is not recommended
Recent data have shown that the risk for HCV infection from percutaneous exposure is 0.2% and from mucocutaneous exposure is 0%. On the basis of this information, the CDC guidelines no longer recommend routine postexposure prophylaxis for HCPs with occupational exposure to HCV. Rather, curative antiviral regimens should be reserved for instances of documented HCV transmission.
The authors disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The new guidance was developed in part as a result of an increase in the incidence of acute HCV infection in the United States, which increases the risk for occupational exposure among HCP. “[I]n certain health care settings, HCP might be exposed to source patients with early HCV infection before those patients develop serologic evidence of infection or symptoms indicative of viral hepatitis,” wrote the authors of the report, published online July 24 in the CDC’s Morbidity and Mortality Weekly Report.
The guidelines, which no longer recommend waiting for spontaneous resolution upon initial diagnosis, include recommendations and algorithms for baseline and follow-up testing, appropriate test type, and recommendations for clinical management. The recommendations were developed on the basis of a current literature review, expert opinion from subject matter experts, and recent guidance from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
Baseline testing ASAP
Baseline testing of the source patient and the HCP should be performed as soon as possible, preferably within 48 hours of exposure. The source patient should be tested for HCV RNA using a nucleic acid test. Alternatively, screening anti-HCV serology can be performed in patients at low risk for HCV and a nucleic acid test performed if serology is positive.
Baseline testing for the HCP should include anti-HCV testing and, if positive, HCV RNA testing is recommended. HCPs who test positive for HCV RNA at baseline are considered to have a preexisting HCV infection and should be referred for treatment.
Follow-up testing
For HCPs with exposure to blood or body fluids from a patient who is anti-HCV positive but HCV RNA negative, follow-up testing is not required.
If the source patient is HCV RNA positive, or if status of the source patient is unknown, the authors recommend that exposed HCPs have HCV RNA follow-up testing at 3-6 weeks post exposure, in addition to baseline testing. A final anti-HCV test is recommended at 4-6 months post exposure as there can be potential periods of aviremia during acute HCV infection.
Exposed HCPs who develop signs of illness indicative of HCV infection at any time should be tested for HCV RNA.
HCPs with positive HCV RNA test results should be referred for care and curative antiviral therapy.
Postexposure prophylaxis is not recommended
Recent data have shown that the risk for HCV infection from percutaneous exposure is 0.2% and from mucocutaneous exposure is 0%. On the basis of this information, the CDC guidelines no longer recommend routine postexposure prophylaxis for HCPs with occupational exposure to HCV. Rather, curative antiviral regimens should be reserved for instances of documented HCV transmission.
The authors disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The new guidance was developed in part as a result of an increase in the incidence of acute HCV infection in the United States, which increases the risk for occupational exposure among HCP. “[I]n certain health care settings, HCP might be exposed to source patients with early HCV infection before those patients develop serologic evidence of infection or symptoms indicative of viral hepatitis,” wrote the authors of the report, published online July 24 in the CDC’s Morbidity and Mortality Weekly Report.
The guidelines, which no longer recommend waiting for spontaneous resolution upon initial diagnosis, include recommendations and algorithms for baseline and follow-up testing, appropriate test type, and recommendations for clinical management. The recommendations were developed on the basis of a current literature review, expert opinion from subject matter experts, and recent guidance from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
Baseline testing ASAP
Baseline testing of the source patient and the HCP should be performed as soon as possible, preferably within 48 hours of exposure. The source patient should be tested for HCV RNA using a nucleic acid test. Alternatively, screening anti-HCV serology can be performed in patients at low risk for HCV and a nucleic acid test performed if serology is positive.
Baseline testing for the HCP should include anti-HCV testing and, if positive, HCV RNA testing is recommended. HCPs who test positive for HCV RNA at baseline are considered to have a preexisting HCV infection and should be referred for treatment.
Follow-up testing
For HCPs with exposure to blood or body fluids from a patient who is anti-HCV positive but HCV RNA negative, follow-up testing is not required.
If the source patient is HCV RNA positive, or if status of the source patient is unknown, the authors recommend that exposed HCPs have HCV RNA follow-up testing at 3-6 weeks post exposure, in addition to baseline testing. A final anti-HCV test is recommended at 4-6 months post exposure as there can be potential periods of aviremia during acute HCV infection.
Exposed HCPs who develop signs of illness indicative of HCV infection at any time should be tested for HCV RNA.
HCPs with positive HCV RNA test results should be referred for care and curative antiviral therapy.
Postexposure prophylaxis is not recommended
Recent data have shown that the risk for HCV infection from percutaneous exposure is 0.2% and from mucocutaneous exposure is 0%. On the basis of this information, the CDC guidelines no longer recommend routine postexposure prophylaxis for HCPs with occupational exposure to HCV. Rather, curative antiviral regimens should be reserved for instances of documented HCV transmission.
The authors disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Face mask type matters when sterilizing, study finds
according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.
With plasma vapor hydrogen peroxide (H2O2) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO2) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.
In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.
“The H2O2 treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO2 treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.
The study did not evaluate the effect of repeated sterilizations on face masks.
Five masks of each type were sterilized with either H2O2 or ClO2. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.
Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H2O2 sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H2O2, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO2 sterilization were 95.1%, 76.2%, and 77.9%, respectively.
The researchers note that, although overall filtration efficiency was maintained with ClO2 sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.
The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.
Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.
“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.
The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.
This article first appeared on Medscape.com.
according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.
With plasma vapor hydrogen peroxide (H2O2) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO2) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.
In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.
“The H2O2 treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO2 treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.
The study did not evaluate the effect of repeated sterilizations on face masks.
Five masks of each type were sterilized with either H2O2 or ClO2. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.
Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H2O2 sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H2O2, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO2 sterilization were 95.1%, 76.2%, and 77.9%, respectively.
The researchers note that, although overall filtration efficiency was maintained with ClO2 sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.
The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.
Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.
“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.
The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.
This article first appeared on Medscape.com.
according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.
With plasma vapor hydrogen peroxide (H2O2) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO2) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.
In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.
“The H2O2 treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO2 treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.
The study did not evaluate the effect of repeated sterilizations on face masks.
Five masks of each type were sterilized with either H2O2 or ClO2. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.
Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H2O2 sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H2O2, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO2 sterilization were 95.1%, 76.2%, and 77.9%, respectively.
The researchers note that, although overall filtration efficiency was maintained with ClO2 sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.
The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.
Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.
“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.
The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.
This article first appeared on Medscape.com.