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COVID-19 vaccines in pregnancy may protect baby, too
Women who receive COVID-19 vaccines during pregnancy pass antibodies to their babies, which could protect newborns from the disease, research has shown.
Researchers with New York University Langone Health conducted a study that included pregnant women who had received at least one dose of an mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna) by June 4.
All neonates had antibodies to the spike protein at high titers, the researchers found.
Unlike similar prior studies, the researchers also looked for antibodies to the nucleocapsid protein, which would have indicated the presence of antibodies from natural COVID-19 infection. They did not detect antibodies to the nucleocapsid protein, and the lack of these antibodies suggests that the antibodies to the spike protein resulted from vaccination and not from prior infection, the researchers said.
The participants had a median time from completion of the vaccine series to delivery of 13 weeks. The study was published online in the American Journal of Obstetrics & Gynecology MFM.
“The presence of these anti-spike antibodies in the cord blood should, at least in theory, offer these newborns some degree of protection,” said study investigator Ashley S. Roman, MD, director of the division of maternal-fetal medicine at NYU Langone Health. “While the primary rationale for vaccination during pregnancy is to keep moms healthy and keep moms out of the hospital, the outstanding question to us was whether there is any fetal or neonatal benefit conferred by receiving the vaccine during pregnancy.”
Questions remain about the degree and durability of protection for newborns from these antibodies. An ongoing study, MOMI-VAX, aims to systematically measure antibody levels in mothers who receive COVID-19 vaccines during pregnancy and in their babies over time.
The present study contributes welcome preliminary evidence suggesting a benefit to infants, said Emily Adhikari, MD, of the University of Texas Southwestern Medical Center in Dallas, who was not involved in the study.
Still, “the main concern and our priority as obstetricians is to vaccinate pregnant women to protect them from severe or critical illness,” she said.
Although most individuals infected with SARS-CoV-2 recover, a significant portion of pregnant women get seriously sick, Dr. Adhikari said. “With this recent Delta surge, we are seeing more pregnant patients who are sicker,” said Dr. Adhikari, who has published research from one hospital describing this trend.
When weighing whether patients should receive COVID-19 vaccines in pregnancy, the risks from infection have outweighed any risk from vaccination to such an extent that there is “not a comparison to make,” Dr. Adhikari said. “The risks of the infection are so much higher.
“For me, it is a matter of making sure that my patient understands that we have really good safety data on these vaccines and there is no reason to think that a pregnant person would be harmed by them. On the contrary, the benefit is to protect and maybe even save your life,” Dr. Adhikari said. “And now we have more evidence that the fetus may also benefit.”
The rationale for vaccinations during pregnancy can vary, Dr. Roman said. Flu shots in pregnancy mainly are intended to protect the mother, though they confer protection for newborns as well. With the whooping cough vaccine given in the third trimester, however, the primary aim is to protect the baby from whooping cough in the first months of life, Dr. Roman said.
“I think it is really important for pregnant women to understand that antibodies crossing the placenta is a good thing,” she added.
As patients who already have received COVID-19 vaccines become pregnant and may become eligible for a booster dose, Dr. Adhikari will offer it, she said, though she has confidence in the protection provided by the initial immune response.
Dr. Roman and Dr. Adhikari had no disclosures.
Women who receive COVID-19 vaccines during pregnancy pass antibodies to their babies, which could protect newborns from the disease, research has shown.
Researchers with New York University Langone Health conducted a study that included pregnant women who had received at least one dose of an mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna) by June 4.
All neonates had antibodies to the spike protein at high titers, the researchers found.
Unlike similar prior studies, the researchers also looked for antibodies to the nucleocapsid protein, which would have indicated the presence of antibodies from natural COVID-19 infection. They did not detect antibodies to the nucleocapsid protein, and the lack of these antibodies suggests that the antibodies to the spike protein resulted from vaccination and not from prior infection, the researchers said.
The participants had a median time from completion of the vaccine series to delivery of 13 weeks. The study was published online in the American Journal of Obstetrics & Gynecology MFM.
“The presence of these anti-spike antibodies in the cord blood should, at least in theory, offer these newborns some degree of protection,” said study investigator Ashley S. Roman, MD, director of the division of maternal-fetal medicine at NYU Langone Health. “While the primary rationale for vaccination during pregnancy is to keep moms healthy and keep moms out of the hospital, the outstanding question to us was whether there is any fetal or neonatal benefit conferred by receiving the vaccine during pregnancy.”
Questions remain about the degree and durability of protection for newborns from these antibodies. An ongoing study, MOMI-VAX, aims to systematically measure antibody levels in mothers who receive COVID-19 vaccines during pregnancy and in their babies over time.
The present study contributes welcome preliminary evidence suggesting a benefit to infants, said Emily Adhikari, MD, of the University of Texas Southwestern Medical Center in Dallas, who was not involved in the study.
Still, “the main concern and our priority as obstetricians is to vaccinate pregnant women to protect them from severe or critical illness,” she said.
Although most individuals infected with SARS-CoV-2 recover, a significant portion of pregnant women get seriously sick, Dr. Adhikari said. “With this recent Delta surge, we are seeing more pregnant patients who are sicker,” said Dr. Adhikari, who has published research from one hospital describing this trend.
When weighing whether patients should receive COVID-19 vaccines in pregnancy, the risks from infection have outweighed any risk from vaccination to such an extent that there is “not a comparison to make,” Dr. Adhikari said. “The risks of the infection are so much higher.
“For me, it is a matter of making sure that my patient understands that we have really good safety data on these vaccines and there is no reason to think that a pregnant person would be harmed by them. On the contrary, the benefit is to protect and maybe even save your life,” Dr. Adhikari said. “And now we have more evidence that the fetus may also benefit.”
The rationale for vaccinations during pregnancy can vary, Dr. Roman said. Flu shots in pregnancy mainly are intended to protect the mother, though they confer protection for newborns as well. With the whooping cough vaccine given in the third trimester, however, the primary aim is to protect the baby from whooping cough in the first months of life, Dr. Roman said.
“I think it is really important for pregnant women to understand that antibodies crossing the placenta is a good thing,” she added.
As patients who already have received COVID-19 vaccines become pregnant and may become eligible for a booster dose, Dr. Adhikari will offer it, she said, though she has confidence in the protection provided by the initial immune response.
Dr. Roman and Dr. Adhikari had no disclosures.
Women who receive COVID-19 vaccines during pregnancy pass antibodies to their babies, which could protect newborns from the disease, research has shown.
Researchers with New York University Langone Health conducted a study that included pregnant women who had received at least one dose of an mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna) by June 4.
All neonates had antibodies to the spike protein at high titers, the researchers found.
Unlike similar prior studies, the researchers also looked for antibodies to the nucleocapsid protein, which would have indicated the presence of antibodies from natural COVID-19 infection. They did not detect antibodies to the nucleocapsid protein, and the lack of these antibodies suggests that the antibodies to the spike protein resulted from vaccination and not from prior infection, the researchers said.
The participants had a median time from completion of the vaccine series to delivery of 13 weeks. The study was published online in the American Journal of Obstetrics & Gynecology MFM.
“The presence of these anti-spike antibodies in the cord blood should, at least in theory, offer these newborns some degree of protection,” said study investigator Ashley S. Roman, MD, director of the division of maternal-fetal medicine at NYU Langone Health. “While the primary rationale for vaccination during pregnancy is to keep moms healthy and keep moms out of the hospital, the outstanding question to us was whether there is any fetal or neonatal benefit conferred by receiving the vaccine during pregnancy.”
Questions remain about the degree and durability of protection for newborns from these antibodies. An ongoing study, MOMI-VAX, aims to systematically measure antibody levels in mothers who receive COVID-19 vaccines during pregnancy and in their babies over time.
The present study contributes welcome preliminary evidence suggesting a benefit to infants, said Emily Adhikari, MD, of the University of Texas Southwestern Medical Center in Dallas, who was not involved in the study.
Still, “the main concern and our priority as obstetricians is to vaccinate pregnant women to protect them from severe or critical illness,” she said.
Although most individuals infected with SARS-CoV-2 recover, a significant portion of pregnant women get seriously sick, Dr. Adhikari said. “With this recent Delta surge, we are seeing more pregnant patients who are sicker,” said Dr. Adhikari, who has published research from one hospital describing this trend.
When weighing whether patients should receive COVID-19 vaccines in pregnancy, the risks from infection have outweighed any risk from vaccination to such an extent that there is “not a comparison to make,” Dr. Adhikari said. “The risks of the infection are so much higher.
“For me, it is a matter of making sure that my patient understands that we have really good safety data on these vaccines and there is no reason to think that a pregnant person would be harmed by them. On the contrary, the benefit is to protect and maybe even save your life,” Dr. Adhikari said. “And now we have more evidence that the fetus may also benefit.”
The rationale for vaccinations during pregnancy can vary, Dr. Roman said. Flu shots in pregnancy mainly are intended to protect the mother, though they confer protection for newborns as well. With the whooping cough vaccine given in the third trimester, however, the primary aim is to protect the baby from whooping cough in the first months of life, Dr. Roman said.
“I think it is really important for pregnant women to understand that antibodies crossing the placenta is a good thing,” she added.
As patients who already have received COVID-19 vaccines become pregnant and may become eligible for a booster dose, Dr. Adhikari will offer it, she said, though she has confidence in the protection provided by the initial immune response.
Dr. Roman and Dr. Adhikari had no disclosures.
FROM AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY MFM
Pandemic affected home life of nearly 70% of female physicians with children
The survey, conducted by the Robert Graham Center and the American Board of Family Medicine from May to June 2020, examined the professional and personal experiences of being a mother and a primary care physician during the pandemic.
“The pandemic was hard for everyone, but for women who had children in the home, and it didn’t really matter what age, it seemed like the emotional impact was much harder,” study author Yalda Jabbarpour, MD, said in an interview.
The results of the survey of 89 female physicians who worked in the primary care specialty were published in the Journal of Mother Studies.
Dr. Jabbapour and her colleagues found that 67% of female physicians with children said the pandemic had a great “impact” on their home life compared with 25% of those without children. Furthermore, 41% of physician moms said COVID-19 greatly affected their work life, as opposed to 17% of their counterparts without children.
“Women are going into medicine at much higher rates. In primary care, it’s becoming close to the majority,” said Dr. Jabbarpour, a family physician and medical director of the Robert Graham Center for Policy Studies. “That has important workforce implications. If we’re not supporting our female physicians and they are greater than 50% of the physician workforce and they’re burning out, who’s going to have a doctor anymore?”
Child care challenges
Researchers found that the emotional toll female physicians experienced early on in the pandemic was indicative of the challenges they were facing. Some of those challenges included managing anxiety, increased stress from both work and home, and social isolation from friends and family.
Another challenge physician mothers had to deal with was fulfilling child care and homeschooling needs, as many women didn’t know what to do with their children and didn’t have external support from their employers.
Child care options vanished for many people during the pandemic, Emily Kaye, MD, MPH, who was not involved in the study, said in an interview.
“I think it was incredibly challenging for everyone and uniquely challenging for women who were young mothers, specifically with respect to child care” said Dr. Kaye, assistant professor in the department of oncology at St. Jude Children’s Research Hospital. “Many women were expected to just continue plugging on in the absence of any reasonable or safe form of child care.”
Some of the changes physician-mothers said they were required to make at home or in their personal lives included physical changes related to their family safety, such as decontaminating themselves in their garages before heading home after a shift. Some also reported that they had to find new ways to maintain emotional and mental health because of social isolation from family and friends.
The survey results, which were taken early on in the pandemic, highlight the need for health policies that support physician mothers and families, as women shoulder the burden of parenting and domestic responsibilities in heterosexual relationships, the researchers said.
“I’m hoping that people pay attention and start to implement more family friendly policies within their workplaces,” Dr. Jabbarpour said. “But during a pandemic, it was essential for [female health care workers] to go in, and they had nowhere to put their kids. [Therefore], the choice became leaving young children alone at home, putting them into daycare facilities that did remain open without knowing if they were [safe], or quitting their jobs. None of those choices are good.”
Community support as a potential solution
Dr. Kaye said she believes that there should be a “long overdue investment” in community support, affordable and accessible child care, flexible spending, paid family leave, and other forms of caregiving support.
“In order to keep women physicians in the workforce, we need to have a significant increase in investment in the social safety net in this country,” Dr. Kaye said.
Researchers said more studies should evaluate the role the COVID-19 pandemic had on the primary care workforce in the U.S., “with a specific emphasis on how the pandemic impacted mothers, and should more intentionally consider the further intersections of race and ethnicity in the experiences of physician-mothers.”
“I think people are burning out and then there’s all this anti-science, anti-health sentiment out there, which makes it harder,” Dr. Jabbarpour said. “If we did repeat this study now, I think things would be even more dire in the voices of the women that we heard.”
Dr. Jabbarpour and Dr. Kaye reported no disclosures.
The survey, conducted by the Robert Graham Center and the American Board of Family Medicine from May to June 2020, examined the professional and personal experiences of being a mother and a primary care physician during the pandemic.
“The pandemic was hard for everyone, but for women who had children in the home, and it didn’t really matter what age, it seemed like the emotional impact was much harder,” study author Yalda Jabbarpour, MD, said in an interview.
The results of the survey of 89 female physicians who worked in the primary care specialty were published in the Journal of Mother Studies.
Dr. Jabbapour and her colleagues found that 67% of female physicians with children said the pandemic had a great “impact” on their home life compared with 25% of those without children. Furthermore, 41% of physician moms said COVID-19 greatly affected their work life, as opposed to 17% of their counterparts without children.
“Women are going into medicine at much higher rates. In primary care, it’s becoming close to the majority,” said Dr. Jabbarpour, a family physician and medical director of the Robert Graham Center for Policy Studies. “That has important workforce implications. If we’re not supporting our female physicians and they are greater than 50% of the physician workforce and they’re burning out, who’s going to have a doctor anymore?”
Child care challenges
Researchers found that the emotional toll female physicians experienced early on in the pandemic was indicative of the challenges they were facing. Some of those challenges included managing anxiety, increased stress from both work and home, and social isolation from friends and family.
Another challenge physician mothers had to deal with was fulfilling child care and homeschooling needs, as many women didn’t know what to do with their children and didn’t have external support from their employers.
Child care options vanished for many people during the pandemic, Emily Kaye, MD, MPH, who was not involved in the study, said in an interview.
“I think it was incredibly challenging for everyone and uniquely challenging for women who were young mothers, specifically with respect to child care” said Dr. Kaye, assistant professor in the department of oncology at St. Jude Children’s Research Hospital. “Many women were expected to just continue plugging on in the absence of any reasonable or safe form of child care.”
Some of the changes physician-mothers said they were required to make at home or in their personal lives included physical changes related to their family safety, such as decontaminating themselves in their garages before heading home after a shift. Some also reported that they had to find new ways to maintain emotional and mental health because of social isolation from family and friends.
The survey results, which were taken early on in the pandemic, highlight the need for health policies that support physician mothers and families, as women shoulder the burden of parenting and domestic responsibilities in heterosexual relationships, the researchers said.
“I’m hoping that people pay attention and start to implement more family friendly policies within their workplaces,” Dr. Jabbarpour said. “But during a pandemic, it was essential for [female health care workers] to go in, and they had nowhere to put their kids. [Therefore], the choice became leaving young children alone at home, putting them into daycare facilities that did remain open without knowing if they were [safe], or quitting their jobs. None of those choices are good.”
Community support as a potential solution
Dr. Kaye said she believes that there should be a “long overdue investment” in community support, affordable and accessible child care, flexible spending, paid family leave, and other forms of caregiving support.
“In order to keep women physicians in the workforce, we need to have a significant increase in investment in the social safety net in this country,” Dr. Kaye said.
Researchers said more studies should evaluate the role the COVID-19 pandemic had on the primary care workforce in the U.S., “with a specific emphasis on how the pandemic impacted mothers, and should more intentionally consider the further intersections of race and ethnicity in the experiences of physician-mothers.”
“I think people are burning out and then there’s all this anti-science, anti-health sentiment out there, which makes it harder,” Dr. Jabbarpour said. “If we did repeat this study now, I think things would be even more dire in the voices of the women that we heard.”
Dr. Jabbarpour and Dr. Kaye reported no disclosures.
The survey, conducted by the Robert Graham Center and the American Board of Family Medicine from May to June 2020, examined the professional and personal experiences of being a mother and a primary care physician during the pandemic.
“The pandemic was hard for everyone, but for women who had children in the home, and it didn’t really matter what age, it seemed like the emotional impact was much harder,” study author Yalda Jabbarpour, MD, said in an interview.
The results of the survey of 89 female physicians who worked in the primary care specialty were published in the Journal of Mother Studies.
Dr. Jabbapour and her colleagues found that 67% of female physicians with children said the pandemic had a great “impact” on their home life compared with 25% of those without children. Furthermore, 41% of physician moms said COVID-19 greatly affected their work life, as opposed to 17% of their counterparts without children.
“Women are going into medicine at much higher rates. In primary care, it’s becoming close to the majority,” said Dr. Jabbarpour, a family physician and medical director of the Robert Graham Center for Policy Studies. “That has important workforce implications. If we’re not supporting our female physicians and they are greater than 50% of the physician workforce and they’re burning out, who’s going to have a doctor anymore?”
Child care challenges
Researchers found that the emotional toll female physicians experienced early on in the pandemic was indicative of the challenges they were facing. Some of those challenges included managing anxiety, increased stress from both work and home, and social isolation from friends and family.
Another challenge physician mothers had to deal with was fulfilling child care and homeschooling needs, as many women didn’t know what to do with their children and didn’t have external support from their employers.
Child care options vanished for many people during the pandemic, Emily Kaye, MD, MPH, who was not involved in the study, said in an interview.
“I think it was incredibly challenging for everyone and uniquely challenging for women who were young mothers, specifically with respect to child care” said Dr. Kaye, assistant professor in the department of oncology at St. Jude Children’s Research Hospital. “Many women were expected to just continue plugging on in the absence of any reasonable or safe form of child care.”
Some of the changes physician-mothers said they were required to make at home or in their personal lives included physical changes related to their family safety, such as decontaminating themselves in their garages before heading home after a shift. Some also reported that they had to find new ways to maintain emotional and mental health because of social isolation from family and friends.
The survey results, which were taken early on in the pandemic, highlight the need for health policies that support physician mothers and families, as women shoulder the burden of parenting and domestic responsibilities in heterosexual relationships, the researchers said.
“I’m hoping that people pay attention and start to implement more family friendly policies within their workplaces,” Dr. Jabbarpour said. “But during a pandemic, it was essential for [female health care workers] to go in, and they had nowhere to put their kids. [Therefore], the choice became leaving young children alone at home, putting them into daycare facilities that did remain open without knowing if they were [safe], or quitting their jobs. None of those choices are good.”
Community support as a potential solution
Dr. Kaye said she believes that there should be a “long overdue investment” in community support, affordable and accessible child care, flexible spending, paid family leave, and other forms of caregiving support.
“In order to keep women physicians in the workforce, we need to have a significant increase in investment in the social safety net in this country,” Dr. Kaye said.
Researchers said more studies should evaluate the role the COVID-19 pandemic had on the primary care workforce in the U.S., “with a specific emphasis on how the pandemic impacted mothers, and should more intentionally consider the further intersections of race and ethnicity in the experiences of physician-mothers.”
“I think people are burning out and then there’s all this anti-science, anti-health sentiment out there, which makes it harder,” Dr. Jabbarpour said. “If we did repeat this study now, I think things would be even more dire in the voices of the women that we heard.”
Dr. Jabbarpour and Dr. Kaye reported no disclosures.
FROM JOURNAL OF MOTHER STUDIES
When children and teens with cancer get COVID-19
Although most children and adolescents with cancer have mild illness from COVID-19 infection, some do experience severe disease and a small percentage even die, according to a recent analysis.
The findings, published online in Lancet Oncology, represent the first global registry data spanning different income groups to report COVID-19 outcomes in pediatric oncology patients.
“We wanted to create a global pool of evidence to answer the question: Do we see severe [COVID-19] infection [in children with cancer]?” corresponding author Sheena Mukkada, MD, St. Jude Children’s Research Hospital, Memphis, said in an interview.
In a cohort of 1,319 pediatric patients followed for 30 days, Dr. Mukkada and colleagues reported that 80% of these patients had asymptomatic to moderate disease from COVID-19, while 1 in 5 experienced severe or critical illness and almost 4% died – four times the mortality rate observed in published cohorts of general pediatric patients.
The results highlight that “children and adolescents with cancer generally recover without incident from COVID-19, but can have a severe course of infection,” the authors concluded.
And knowing that some children can get very sick, investigators wanted “to identify who these patients are so that we can prioritize and protect that group,” she added.
Echoing that sentiment, Kathy Pritchard-Jones, MD, president of the International Society of Paediatric Oncology and coauthor on the study, noted in a press release that, “by working together to create this global registry, we have enabled hospitals around the world to rapidly share and learn how COVID-19 is affecting children with cancer.”
Dr. Pritchard-Jones commented that overall these results provide reassurance that “many children can continue their cancer treatment safely, but they also highlight important clinical features that may predict a more severe clinical course and the need for greater vigilance for some patients.”
Inside the Global Registry data
The Global Registry of COVID-19 in Childhood Cancer, created jointly by St. Jude Children’s Research Hospital and SIOP, included data from 131 institutions in 45 countries. Children recruited into the registry between April 2020 and February 2021 ranged in age from infancy to 18 years old.
Most patients remained asymptomatic (35%) or experienced mild to moderate illness (45%), though 20% did develop severe or critical illness.
The investigators highlighted several factors associated with a greater risk of developing more severe illness from COVID-19, which included cancer type, intensity of therapy, age, absolute lymphocyte count, and presence of comorbidities or COVID-19 symptoms.
Notably, more than 80% of either severe or critical infections occurred in patients with hematologic malignancies – with 56% of cases in patients with acute lymphoblastic lymphoma or acute lymphoblastic leukemia – followed by extracranial solid tumors (15.8%), and central nervous system tumors (2.7%).
In patients with acute lymphoblastic leukemia or acute lymphoblastic lymphoma, severe or critical disease was most common in those receiving induction therapy (30%), relapse or refractory therapy (30%), and those in the maintenance or continuation phase of therapy (19%).
Older age was associated with a higher likelihood of having severe disease – with the lowest risk in infants (9.7%) and the highest in the 15- to 18-year-old cohort (27.3%).
Patients with lymphopenia who had an absolute lymphocyte count of 300 cells per mm3 or less and an absolute neutrophil count of 500 cells per mm3 or more also had an elevated risk of severe illness from COVID-19.
Regarding whether the presence of lymphopenia or neutropenia should change the treatment approach, Dr. Mukkada noted that, when possible, these patients should receive antiviral treatment, such as remdesivir, if the center has antivirals, or be prioritized for hospital admission.
Modifying cancer treatment might be recommended if patients are highly lymphopenic or have very low neutrophil counts, but a more effective strategy is simply to ensure that age-eligible children and adolescents with cancer or who have had a hematopoietic stem-cell transplantation have been fully vaccinated against COVID-19. For children who are not yet age-eligible, everyone around them should be vaccinated.
Pediatric patients in low- and middle-income countries were also more likely to have severe or critical outcomes from COVID-19 (41.7%), compared with patients in other income groups (23.9%).
The impact of COVID-19 “has been felt in every corner of the world, but particularly in low- and middle-income countries, compared to high-income countries,” senior author Carlos Rodriguez-Galindo, MD, global director at St. Jude, said in a statement.
In terms of the intersection of cancer treatment and COVID diagnosis, almost 83% of pediatric patients were receiving treatment for their cancer. Chemotherapy was withheld in about 45% of these patients and some modification to the treatment regimen occurred in almost 56% of participants on active therapy.
“Treatment modifications were least common in patients from upper-middle–income countries, compared with other income groups,” the authors wrote.
Although an interesting observation, Dr. Mukkada noted that the registry data could not explain why treatment modifications occurred less frequently in upper-middle income countries as opposed to high-income and lower-income countries.
U.K. Monitoring Project
Not all studies, however, have found that COVID-19 infection is significantly more severe in children with cancer. In a 2020 report from the U.K. Paediatric Coronavirus Cancer Monitoring Project, researchers evaluated all children in the United Kingdom under the age of 16 diagnosed with COVID and cancer.
“[Given that] we had complete coverage of every center in the U.K. that cares for children with cancer, we are confident that we picked up at least all the severe or critical cases,” lead author Gerard Millen, MD, honorary clinical research fellow, University of Birmingham (England), said in an interview.
Between March 2020 and July 2020, Dr. Millen and colleagues identified 54 positive cases of COVID-19, 15 (28%) of which were asymptomatic, 34 (63%) mild, and 4 (7.4%) severe or critical – more in line with the incidence of severe illness reported in the general pediatric population.
“Thankfully, we had no children with cancer in the U.K. who died from COVID-19,” Dr. Millen noted. “Overall, in the U.K., we have taken the approach that the majority of children with cancer in this country are at very low risk from COVID-19 and that we do not have good evidence to modify their treatment.”
Dr. Millen pointed out that the data in the U.K. study were “remarkably similar” to those from the high-income countries in the global St. Jude/SIOP cohort, where 7.4% of patients in that cohort had severe or critical disease, compared with 7.4% of patients from their own U.K. cohort.
“I think many of the key differences between the two cohorts reflect the fact that access to treatment in many low- to middle-income countries is more challenging with many factors contributing to overall poorer outcomes for both cancer and noncancer metrics,” Dr. Millen said.
Both the U.K. and registry studies were performed prior to vaccinations becoming available to older children, and before the emergence of certain variants, including the Delta variant, which is responsible for the most recent surge of COVID-19 infections around the world.
Data on COVID-19 vaccination in children with cancer are limited but promising so far.
As for whether the Delta variant might affect outcomes for children with cancer and COVID-19, Dr. Mukkada could only speculate, but she noted that “what we are hearing anecdotally about the [Delta] disease being more severe, even in patients who don’t have cancer, is leading us to say that we can’t close the registry yet. We are still actively enrolling children.”
The study was funded by the American Lebanese Syrian Associated Charities and the National Cancer Institute. The study authors and Dr. Millen disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although most children and adolescents with cancer have mild illness from COVID-19 infection, some do experience severe disease and a small percentage even die, according to a recent analysis.
The findings, published online in Lancet Oncology, represent the first global registry data spanning different income groups to report COVID-19 outcomes in pediatric oncology patients.
“We wanted to create a global pool of evidence to answer the question: Do we see severe [COVID-19] infection [in children with cancer]?” corresponding author Sheena Mukkada, MD, St. Jude Children’s Research Hospital, Memphis, said in an interview.
In a cohort of 1,319 pediatric patients followed for 30 days, Dr. Mukkada and colleagues reported that 80% of these patients had asymptomatic to moderate disease from COVID-19, while 1 in 5 experienced severe or critical illness and almost 4% died – four times the mortality rate observed in published cohorts of general pediatric patients.
The results highlight that “children and adolescents with cancer generally recover without incident from COVID-19, but can have a severe course of infection,” the authors concluded.
And knowing that some children can get very sick, investigators wanted “to identify who these patients are so that we can prioritize and protect that group,” she added.
Echoing that sentiment, Kathy Pritchard-Jones, MD, president of the International Society of Paediatric Oncology and coauthor on the study, noted in a press release that, “by working together to create this global registry, we have enabled hospitals around the world to rapidly share and learn how COVID-19 is affecting children with cancer.”
Dr. Pritchard-Jones commented that overall these results provide reassurance that “many children can continue their cancer treatment safely, but they also highlight important clinical features that may predict a more severe clinical course and the need for greater vigilance for some patients.”
Inside the Global Registry data
The Global Registry of COVID-19 in Childhood Cancer, created jointly by St. Jude Children’s Research Hospital and SIOP, included data from 131 institutions in 45 countries. Children recruited into the registry between April 2020 and February 2021 ranged in age from infancy to 18 years old.
Most patients remained asymptomatic (35%) or experienced mild to moderate illness (45%), though 20% did develop severe or critical illness.
The investigators highlighted several factors associated with a greater risk of developing more severe illness from COVID-19, which included cancer type, intensity of therapy, age, absolute lymphocyte count, and presence of comorbidities or COVID-19 symptoms.
Notably, more than 80% of either severe or critical infections occurred in patients with hematologic malignancies – with 56% of cases in patients with acute lymphoblastic lymphoma or acute lymphoblastic leukemia – followed by extracranial solid tumors (15.8%), and central nervous system tumors (2.7%).
In patients with acute lymphoblastic leukemia or acute lymphoblastic lymphoma, severe or critical disease was most common in those receiving induction therapy (30%), relapse or refractory therapy (30%), and those in the maintenance or continuation phase of therapy (19%).
Older age was associated with a higher likelihood of having severe disease – with the lowest risk in infants (9.7%) and the highest in the 15- to 18-year-old cohort (27.3%).
Patients with lymphopenia who had an absolute lymphocyte count of 300 cells per mm3 or less and an absolute neutrophil count of 500 cells per mm3 or more also had an elevated risk of severe illness from COVID-19.
Regarding whether the presence of lymphopenia or neutropenia should change the treatment approach, Dr. Mukkada noted that, when possible, these patients should receive antiviral treatment, such as remdesivir, if the center has antivirals, or be prioritized for hospital admission.
Modifying cancer treatment might be recommended if patients are highly lymphopenic or have very low neutrophil counts, but a more effective strategy is simply to ensure that age-eligible children and adolescents with cancer or who have had a hematopoietic stem-cell transplantation have been fully vaccinated against COVID-19. For children who are not yet age-eligible, everyone around them should be vaccinated.
Pediatric patients in low- and middle-income countries were also more likely to have severe or critical outcomes from COVID-19 (41.7%), compared with patients in other income groups (23.9%).
The impact of COVID-19 “has been felt in every corner of the world, but particularly in low- and middle-income countries, compared to high-income countries,” senior author Carlos Rodriguez-Galindo, MD, global director at St. Jude, said in a statement.
In terms of the intersection of cancer treatment and COVID diagnosis, almost 83% of pediatric patients were receiving treatment for their cancer. Chemotherapy was withheld in about 45% of these patients and some modification to the treatment regimen occurred in almost 56% of participants on active therapy.
“Treatment modifications were least common in patients from upper-middle–income countries, compared with other income groups,” the authors wrote.
Although an interesting observation, Dr. Mukkada noted that the registry data could not explain why treatment modifications occurred less frequently in upper-middle income countries as opposed to high-income and lower-income countries.
U.K. Monitoring Project
Not all studies, however, have found that COVID-19 infection is significantly more severe in children with cancer. In a 2020 report from the U.K. Paediatric Coronavirus Cancer Monitoring Project, researchers evaluated all children in the United Kingdom under the age of 16 diagnosed with COVID and cancer.
“[Given that] we had complete coverage of every center in the U.K. that cares for children with cancer, we are confident that we picked up at least all the severe or critical cases,” lead author Gerard Millen, MD, honorary clinical research fellow, University of Birmingham (England), said in an interview.
Between March 2020 and July 2020, Dr. Millen and colleagues identified 54 positive cases of COVID-19, 15 (28%) of which were asymptomatic, 34 (63%) mild, and 4 (7.4%) severe or critical – more in line with the incidence of severe illness reported in the general pediatric population.
“Thankfully, we had no children with cancer in the U.K. who died from COVID-19,” Dr. Millen noted. “Overall, in the U.K., we have taken the approach that the majority of children with cancer in this country are at very low risk from COVID-19 and that we do not have good evidence to modify their treatment.”
Dr. Millen pointed out that the data in the U.K. study were “remarkably similar” to those from the high-income countries in the global St. Jude/SIOP cohort, where 7.4% of patients in that cohort had severe or critical disease, compared with 7.4% of patients from their own U.K. cohort.
“I think many of the key differences between the two cohorts reflect the fact that access to treatment in many low- to middle-income countries is more challenging with many factors contributing to overall poorer outcomes for both cancer and noncancer metrics,” Dr. Millen said.
Both the U.K. and registry studies were performed prior to vaccinations becoming available to older children, and before the emergence of certain variants, including the Delta variant, which is responsible for the most recent surge of COVID-19 infections around the world.
Data on COVID-19 vaccination in children with cancer are limited but promising so far.
As for whether the Delta variant might affect outcomes for children with cancer and COVID-19, Dr. Mukkada could only speculate, but she noted that “what we are hearing anecdotally about the [Delta] disease being more severe, even in patients who don’t have cancer, is leading us to say that we can’t close the registry yet. We are still actively enrolling children.”
The study was funded by the American Lebanese Syrian Associated Charities and the National Cancer Institute. The study authors and Dr. Millen disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although most children and adolescents with cancer have mild illness from COVID-19 infection, some do experience severe disease and a small percentage even die, according to a recent analysis.
The findings, published online in Lancet Oncology, represent the first global registry data spanning different income groups to report COVID-19 outcomes in pediatric oncology patients.
“We wanted to create a global pool of evidence to answer the question: Do we see severe [COVID-19] infection [in children with cancer]?” corresponding author Sheena Mukkada, MD, St. Jude Children’s Research Hospital, Memphis, said in an interview.
In a cohort of 1,319 pediatric patients followed for 30 days, Dr. Mukkada and colleagues reported that 80% of these patients had asymptomatic to moderate disease from COVID-19, while 1 in 5 experienced severe or critical illness and almost 4% died – four times the mortality rate observed in published cohorts of general pediatric patients.
The results highlight that “children and adolescents with cancer generally recover without incident from COVID-19, but can have a severe course of infection,” the authors concluded.
And knowing that some children can get very sick, investigators wanted “to identify who these patients are so that we can prioritize and protect that group,” she added.
Echoing that sentiment, Kathy Pritchard-Jones, MD, president of the International Society of Paediatric Oncology and coauthor on the study, noted in a press release that, “by working together to create this global registry, we have enabled hospitals around the world to rapidly share and learn how COVID-19 is affecting children with cancer.”
Dr. Pritchard-Jones commented that overall these results provide reassurance that “many children can continue their cancer treatment safely, but they also highlight important clinical features that may predict a more severe clinical course and the need for greater vigilance for some patients.”
Inside the Global Registry data
The Global Registry of COVID-19 in Childhood Cancer, created jointly by St. Jude Children’s Research Hospital and SIOP, included data from 131 institutions in 45 countries. Children recruited into the registry between April 2020 and February 2021 ranged in age from infancy to 18 years old.
Most patients remained asymptomatic (35%) or experienced mild to moderate illness (45%), though 20% did develop severe or critical illness.
The investigators highlighted several factors associated with a greater risk of developing more severe illness from COVID-19, which included cancer type, intensity of therapy, age, absolute lymphocyte count, and presence of comorbidities or COVID-19 symptoms.
Notably, more than 80% of either severe or critical infections occurred in patients with hematologic malignancies – with 56% of cases in patients with acute lymphoblastic lymphoma or acute lymphoblastic leukemia – followed by extracranial solid tumors (15.8%), and central nervous system tumors (2.7%).
In patients with acute lymphoblastic leukemia or acute lymphoblastic lymphoma, severe or critical disease was most common in those receiving induction therapy (30%), relapse or refractory therapy (30%), and those in the maintenance or continuation phase of therapy (19%).
Older age was associated with a higher likelihood of having severe disease – with the lowest risk in infants (9.7%) and the highest in the 15- to 18-year-old cohort (27.3%).
Patients with lymphopenia who had an absolute lymphocyte count of 300 cells per mm3 or less and an absolute neutrophil count of 500 cells per mm3 or more also had an elevated risk of severe illness from COVID-19.
Regarding whether the presence of lymphopenia or neutropenia should change the treatment approach, Dr. Mukkada noted that, when possible, these patients should receive antiviral treatment, such as remdesivir, if the center has antivirals, or be prioritized for hospital admission.
Modifying cancer treatment might be recommended if patients are highly lymphopenic or have very low neutrophil counts, but a more effective strategy is simply to ensure that age-eligible children and adolescents with cancer or who have had a hematopoietic stem-cell transplantation have been fully vaccinated against COVID-19. For children who are not yet age-eligible, everyone around them should be vaccinated.
Pediatric patients in low- and middle-income countries were also more likely to have severe or critical outcomes from COVID-19 (41.7%), compared with patients in other income groups (23.9%).
The impact of COVID-19 “has been felt in every corner of the world, but particularly in low- and middle-income countries, compared to high-income countries,” senior author Carlos Rodriguez-Galindo, MD, global director at St. Jude, said in a statement.
In terms of the intersection of cancer treatment and COVID diagnosis, almost 83% of pediatric patients were receiving treatment for their cancer. Chemotherapy was withheld in about 45% of these patients and some modification to the treatment regimen occurred in almost 56% of participants on active therapy.
“Treatment modifications were least common in patients from upper-middle–income countries, compared with other income groups,” the authors wrote.
Although an interesting observation, Dr. Mukkada noted that the registry data could not explain why treatment modifications occurred less frequently in upper-middle income countries as opposed to high-income and lower-income countries.
U.K. Monitoring Project
Not all studies, however, have found that COVID-19 infection is significantly more severe in children with cancer. In a 2020 report from the U.K. Paediatric Coronavirus Cancer Monitoring Project, researchers evaluated all children in the United Kingdom under the age of 16 diagnosed with COVID and cancer.
“[Given that] we had complete coverage of every center in the U.K. that cares for children with cancer, we are confident that we picked up at least all the severe or critical cases,” lead author Gerard Millen, MD, honorary clinical research fellow, University of Birmingham (England), said in an interview.
Between March 2020 and July 2020, Dr. Millen and colleagues identified 54 positive cases of COVID-19, 15 (28%) of which were asymptomatic, 34 (63%) mild, and 4 (7.4%) severe or critical – more in line with the incidence of severe illness reported in the general pediatric population.
“Thankfully, we had no children with cancer in the U.K. who died from COVID-19,” Dr. Millen noted. “Overall, in the U.K., we have taken the approach that the majority of children with cancer in this country are at very low risk from COVID-19 and that we do not have good evidence to modify their treatment.”
Dr. Millen pointed out that the data in the U.K. study were “remarkably similar” to those from the high-income countries in the global St. Jude/SIOP cohort, where 7.4% of patients in that cohort had severe or critical disease, compared with 7.4% of patients from their own U.K. cohort.
“I think many of the key differences between the two cohorts reflect the fact that access to treatment in many low- to middle-income countries is more challenging with many factors contributing to overall poorer outcomes for both cancer and noncancer metrics,” Dr. Millen said.
Both the U.K. and registry studies were performed prior to vaccinations becoming available to older children, and before the emergence of certain variants, including the Delta variant, which is responsible for the most recent surge of COVID-19 infections around the world.
Data on COVID-19 vaccination in children with cancer are limited but promising so far.
As for whether the Delta variant might affect outcomes for children with cancer and COVID-19, Dr. Mukkada could only speculate, but she noted that “what we are hearing anecdotally about the [Delta] disease being more severe, even in patients who don’t have cancer, is leading us to say that we can’t close the registry yet. We are still actively enrolling children.”
The study was funded by the American Lebanese Syrian Associated Charities and the National Cancer Institute. The study authors and Dr. Millen disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Youth e-cigarette use: Assessing for, and halting, the hidden habit
THE CASE
Joe, an 18-year-old, has been your patient for many years and has an uncomplicated medical history. He presents for his preparticipation sports examination for the upcoming high school baseball season. Joe’s mother, who arrives at the office with him, tells you she’s worried because she found an e-cigarette in his backpack last week. Joe says that many of the kids at his school vape and he tried it a while back and now vapes “a lot.”
After talking further with Joe, you realize that he is vaping every day, using a 5% nicotine pod. Based on previous consults with the behavioral health counselor in your clinic, you know that this level of vaping is about the same as smoking 1 pack of cigarettes per day in terms of nicotine exposure. Joe states that he often vapes in the bathroom at school because he cannot concentrate in class if he doesn’t vape. He also reports that he had previously used 1 pod per week but had recently started vaping more to help with his cravings.
You assess his withdrawal symptoms and learn that he feels on edge when he is not able to vape and that he vapes heavily before going into school because he knows he will not be able to vape again until his third passing period.
●
Electronic cigarettes (e-cigarettes; also called “vapes”) are electronic nicotine delivery systems that heat and aerosolize e-liquid or “e-juice” that is inhaled by the user. The e-liquid is made up primarily of propylene glycol, vegetable glycerin, and flavorings, and often includes nicotine. Nicotine levels in e-cigarettes can range from 0 mg/mL to 60 mg/mL (regular cigarettes contain ~12 mg of nicotine). The nicotine level of the pod available from e-cigarette company JUUL (50 mg/mL e-liquid) is equivalent to about 1 pack of cigarettes.1 E-cigarette devices are relatively affordable; popular brands cost $10 to $20, while the replacement pods or e-liquid are typically about $4 each.
The e-cigarette market is quickly evolving and diversifying. Originally, e-cigarettes looked similar to cigarettes (cig-a-likes) but did not efficiently deliver nicotine to the user.2 E-cigarettes have evolved and some now deliver cigarette-like levels of nicotine to the user.3,4 Youth and young adults primarily use pod-mod e-cigarettes, which have a sleek design and produce less vapor than older e-cigarettes, making them easier to conceal. They can look like a USB flash-drive or have a teardrop shape. Pod-mod e-cigarettes dominate the current market, led by companies such as JUUL, NJOY, and Vuse.5
E-cigarette use is proliferating in the United States, particularly among young people and facilitated by the introduction of pod-based e-cigarettes in appealing flavors.6,7 While rates of current e-cigarette use by US adults is around 5.5%,8 recent data show that 32.7% of US high school students say they’ve used an e-cigarette in the past 30 days.9
Continue to: A double-edged sword
A double-edged sword. E-cigarettes are less harmful than traditional cigarettes in the short term and likely benefit adult smokers who completely substitute e-cigarettes for their tobacco cigarettes.10 In randomized trials of adult smokers, e-cigarette use resulted in moderate combustible-cigarette cessation rates that rival or exceed rates achieved with traditional nicotine replacement therapy (NRT).11-13 However, most e-cigarettes contain addictive nicotine, can facilitate transitions to more harmful forms of tobacco use,10,14,15 and have unknown long-term health effects. Therefore, youth, young adults, and those who are otherwise tobacco naïve should not initiate e-cigarette use.
Moreover, cases of e-cigarette or vaping product use–associated lung injury (EVALI)—a disease linked to vaping that causes cough, fever, shortness of breath, and death—were first identified in August 2019 and peaked in September 2019 before new cases decreased dramatically through January 2020.16 Since the initial cases of EVALI arose, product testing has shown that tetrahydrocannabinol (THC) and vitamin E acetate are the main ingredients linked to EVALI cases.17 For this reason, the Centers for Disease Control and Prevention and others strongly recommend against use of THC-containing e-cigarettes.18
Given the high rates of e-cigarette use among youth and young adults and its potential health harms, it is critical to inquire about e-cigarette use at primary care visits, and, as appropriate, to assess frequency and quantity of use. Patients who require intervention will be more likely to succeed in quitting if they are connected with behavioral health counseling and prescribed medication. This article offers evidence-based guidance to assess and advise teens and young adults regarding the potential health impact of e-cigarettes.
A NEW ICD-10-CM CODE AND A BRIEF ASSESSMENT TOOL
According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)19 and the International Classification of Diseases, 10th Revision (ICD-10-CM),20 a tobacco use disorder is a problematic pattern of use leading to clinically significant impairment or distress. Associated features and behavioral markers of frequency and quantity include use within 30 minutes of waking, daily use, and increasing use. However, with youth, consider intervention for use of any nicotine or tobacco product, including e-cigarettes, regardless of whether it meets the threshold for diagnosis.21
The new code.
Continue to: As with other tobacco use...
As with other tobacco use, assess e-cigarette use patterns by asking questions about the frequency, duration, and quantity of use. Additionally, determine the level of nicotine in the e-liquid (discussed earlier) and evaluate whether the individual displays signs of physiologic dependence (eg, failed attempts to reduce or quit e-cigarette use, increased use, nicotine withdrawal symptoms).
A useful assessment tool. While e-cigarette use is not often included on current substance use screening measures, the above questions can be added to the end of measures such as the CRAFFT (Car-Relax-Alone-Forget-Family and Friends-Trouble) test.22 Additionally, if an adolescent reports vaping, the American Academy of Pediatrics (AAP) recommends using a brief screening tool such as the Hooked on Nicotine Checklist (HONC) to establish his or her level of dependence (TABLE 1).23
The HONC is ideal for a primary care setting because it is brief and has a high level of sensitivity, minimizing false-negative reports24; a patient’s acknowledgement of any item indicates a loss of autonomy over nicotine. Establishing the level of nicotine dependence is particularly pertinent when making decisions regarding the course of treatment and whether to prescribe NRT (eg, nicotine patch, gum, lozenge). Alternatively, you can quickly assess level of dependence by determining the time to first e-cigarette use in the morning. Tobacco guidelines suggest that if time to first use is > 30 minutes, the individual is “moderately dependent”; if time to first use is < 30 minutes after waking, the individual is “severely dependent.”25
COMBINATION TREATMENT IS MOST SUCCESSFUL
Studies have shown that the most effective treatment for tobacco cessation is pairing behavioral treatment with combination NRT (eg, nicotine gum + patch).25,26 The literature on e-cigarette cessation remains in its infancy, but techniques from traditional smoking cessation can be applied because the behaviors differ only in their mode of nicotine delivery.
Behavioral treatment. There are several options for behavioral treatment for tobacco cessation—and thus, e-cigarette cessation. The first step will depend on the patient’s level of motivation. If the patient is not yet ready to quit, consider using brief motivational interviewing. Once the patient is willing to engage in treatment, options include setting a mutually agreed upon quit date or planning for a reduction in the frequency and duration of vaping.
Continue to: Referrals to the Quitline...
Referrals to the Quitline (800-QUIT-NOW) have long been standard practice and can be used to extend primary care treatment.25 Studies show that it is more effective to connect patients directly to the Quitline at their primary care appointment27 than asking them to call after the visit.28,29 We suggest providing direct assistance in the office to patients as they initiate treatment with the Quitline.
Finally, if the level of dependence is severe or the patient is not motivated to quit, connect them with a behavioral health provider in your clinic or with an outside therapist skilled in cognitive behavioral techniques related to tobacco cessation. Discuss with the patient that quitting nicotine use is difficult for many people and that the best option for success is the combination of counseling and medication.25
Nicotine replacement therapy for e-cigarette use. While over-the-counter NRT (nicotine gum, patches, lozenges) is approved by the US Food and Drug Administration only for sale to adults ≥ 18 years, the AAP issued guidance on prescribing NRT for those < 18 years who use e-cigarettes.30 While the AAP does not suggest a lower age limit for prescribing NRT, national data show that < 6% of middle schoolers report e-cigarette use and that e-cigarette use does not become common (~20% current use) until high school.31 It is therefore unlikely that a child < 14 years would require pharmacotherapy. On their fact sheet, the AAP includes the following guidance:
“Patients who are motivated to quit should use as much safe, FDA-approved NRT as needed to avoid smoking or vaping. When assessing a patient’s current level of nicotine use, it may be helpful to understand that using one JUUL pod per day is equivalent to one pack of cigarettes per day …. Pediatricians and other healthcare providers should work with each patient to determine a starting dosage of NRT that is most likely to help them quit successfully. Dosing is based on the patient’s level of nicotine dependence, which can be measured using a screening tool” (TABLE 123).32
The AAP NRT dosing guidelines can be found at downloads.aap.org/RCE/NRT_and_Adolescents_Pediatrician_Guidance_factsheet.pdf.32 Of note, the dosing guidelines for adolescents are the same as those for adults and are based on level of use and dependence. Moreover, the clinician and patient should work together to choose the initial dose and the plan for weaning NRT over time.
Continue to: THE CASE
Based on your conversation with Joe, you administer the HONC screening tool. He scores 9 out of 10, indicating significant loss of autonomy over nicotine. You consult with a behavioral health counselor, who believes that Joe would benefit from counseling and NRT. You discuss this treatment plan with Joe, who says he is ready to quit because he does not like feeling as if he depends on vaping. Your shared decision is to start the 21-mg patch and 4-mg gum with plans to step down from there.
Joe agrees to set a quit date in the following week. The behavioral health counselor then meets with Joe and they develop a quit plan, which is shared with you so you can follow up at the next visit. Joe also agrees to talk with his parents, who are unaware of his level of use and dependence. Everyone agrees on the quit plan, and a follow-up visit is scheduled.
At the follow-up visit 1 month later, Joe and his parents report that he has quit vaping but is still using the patch and gum. You instruct Joe to reduce his NRT use to the 14-mg patch and 2-mg gum and to stop using them over the next 2 to 3 weeks. Everyone is in agreement with the treatment plan. You also re-administer the HONC screening tool and see that Joe’s score has reduced by 7 points to just 2 out of 10. You recommend that Joe continue to see the behavioral health counselor and follow up as needed. (A noted benefit of having a behavioral health counselor in your clinic is the opportunity for informal briefings on patient progress.33,34)
Following each visit with Joe, you make sure to complete documentation on (1) tobacco/e-cigarette use assessment, (2) diagnoses, (3) discussion of benefits of quitting,(4) assessment of readiness to quit, (5) creation and support of a quit plan, and (6) connection with a behavioral health counselor and planned follow-up. (See TABLE 235 for details onbilling codes.)
CORRESPONDENCE
Eleanor L. S. Leavens, PhD, 3901 Rainbow Boulevard, Mail Stop 1008, Kansas City, KS 66160; [email protected]
1. Prochaska JJ, Vogel EA, Benowitz N. Nicotine delivery and cigarette equivalents from vaping a JUULpod. Tob Control. Published online March 24, 2021. doi: 10.1136/tobaccocontrol- 2020-056367
2. Rüther T, Hagedorn D, Schiela K, et al. Nicotine delivery efficiency of first-and second-generation e-cigarettes and its impact on relief of craving during the acute phase of use. Int J Hyg Environ Health. 2018;221:191-198. doi: 10.1016/j.ijheh.2017.10.012
3. Hajek P, Pittaccio K, Pesola F, et al. Nicotine delivery and users’ reactions to Juul compared with cigarettes and other e‐cigarette products. Addiction. 2020;115:1141-1148. doi: 10.1111/add.14936
4. Wagener TL, Floyd EL, Stepanov I, et al. Have combustible cigarettes met their match? The nicotine delivery profiles and harmful constituent exposures of second-generation and third-generation electronic cigarette users. Tob control. 2017;26:e23-e28. doi: 10.1136/tobaccocontrol-2016-053041
5. Herzog B, Kanada P. Nielsen: Tobacco all channel data thru 8/11 - cig vol decelerates. Published August 21, 2018. Accessed August 19, 2021. https://athra.org.au/wp-content/uploads/2018/09/Wells-Fargo-Nielsen-Tobacco-All-Channel-Report-Period-Ending-8.11.18.pdf
6. Harrell MB, Weaver SR, Loukas A, et al. Flavored e-cigarette use: characterizing youth, young adult, and adult users. Prev Med Rep. 2017;5:33-40. doi: 10.1016/j.pmedr.2016.11.001
7. Morean ME, Butler ER, Bold KW, et al. Preferring more e-cigarette flavors is associated with e-cigarette use frequency among adolescents but not adults. PloS One. 2018;13:e0189015. doi: 10.1371/journal.pone.0189015
8. Obisesan OH, Osei AD, Iftekhar Uddin SM, et al. Trends in e-cigarette use in adults in the United States, 2016-2018. JAMA Intern Med. 2020;180:1394-1398. doi: 10.1001/jamainternmed.2020.2817
9. Creamer MR, Wang TW, Babb S, et al. Tobacco product use and cessation indicators among adults—United States, 2018. MMWR Morb Mortal Wkly Rep. 2019;68:1013-1019. doi: 10.15585/mmwr.mm6845a2
10. NASEM. Public health consequences of e-cigarettes. National Academies Press; 2018. Accessed August 19, 2021. www.ncbi.nlm.nih.gov/books/NBK507171/
11. Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. 2019;380:629-637. doi: 10.1056/NEJMoa1808779
12. Pulvers K, Nollen NL, Rice M, et al. Effect of pod e-cigarettes vs cigarettes on carcinogen exposure among African American and Latinx smokers: a randomized clinical trial. JAMA Netw Open. 2020;3:e2026324. doi: 10.1001/jamanetworkopen.2020.26324
13. Wang RJ, Bhadriraju S, Glantz SA. E-cigarette use and adult cigarette smoking cessation: a meta-analysis. Am J Public Health. 2021;111:230-246. doi: 10.2105/AJPH.2020.305999
14. Barrington-Trimis JL, Urman R, Berhane K, et al. E-cigarettes and future cigarette use. Pediatrics. 2016;138:e20160379. doi: 10.1542/peds.2016-0379
15. Soneji S, Barrington-Trimis JL, Wills TA, et al. Association between initial use of e-cigarettes and subsequent cigarette smoking among adolescents and young adults: a systematic review and meta-analysis. JAMA Pediatr. 2017;171:788-797. doi: 10.1001/jamapediatrics.2017.1488
16. Krishnasamy VP, Hallowell BD, Ko JY, et al. Update: characteristics of a nationwide outbreak of e-cigarette, or vaping, product use–associated lung injury—United States, August 2019–January 2020. MMWR Morb Mortal Wkly Rep. 2020;69:90-94. doi: 10.15585/mmwr.mm6903e2
17. Blount BC, Karwowski MP, Shields PG, et al. Vitamin E acetate in bronchoalveolar-lavage fluid associated with EVALI. N Engl J Med. 2020;382:697-705. doi: 10.1056/NEJMoa1916433
18. CDC. Outbreak of lung injury associated with use of e-cigarette, or vaping, products. Updated February 25, 2020. Accessed August 19, 2021. www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html
19. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th edition (DSM-5). American Psychiatric Publishing; 2013.
20. CDC. International Classification of Diseases, 10th Revision. Updated July 30, 2021. Accessed August 31, 2021. www.cdc.gov/nchs/icd/icd10cm.htm
21. CDC. Surgeon General’s advisory on e-cigarette use among youth. Reviewed April 9, 2019. Accessed August 19, 2021. www.cdc.gov/tobacco/basic_information/e-cigarettes/surgeon-general-advisory/index.html
22. Knight JR, Sherritt L, Shrier LA, et al. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002;156:607-614. doi: 10.1001/archpedi.156.6.607
23. DiFranza JR, Savageau JA, Fletcher K, et al. Measuring the loss of autonomy over nicotine use in adolescents: the DANDY (Development and Assessment of Nicotine Dependence in Youths) study. Arch Pediatr Adolesc Med. 2002;156:397-403. doi: 10.1001/archpedi.156.4.397
24. Wellman RJ, Savageau JA, Godiwala S, et al. A comparison of the Hooked on Nicotine Checklist and the Fagerström Test for Nicotine Dependence in adult smokers. Nicotine Tob Res. 2006;8:575-580. doi: 10.1080/14622200600789965
25. Fiore MC, Jaén CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Published May 2008. Accessed August 19, 2021. www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/TreatingTobaccoUseandDependence-2008Update.pdf
26. Shah SD, Wilken LA, Winkler SR, et al. Systematic review and meta-analysis of combination therapy for smoking cessation. J Am Pharm Assoc. 2008;48:659-665. doi: 10.1331/JAPhA.2008.07063
27. Vidrine JI, Shete S, Cao Y, et al. Ask-Advise-Connect: a new approach to smoking treatment delivery in health care settings. JAMA Intern Med. 2013;173:458-464. doi: 10.1001/jamainternmed.2013.3751
28. Bentz CJ, Bayley KB, Bonin KE, et al. The feasibility of connecting physician offices to a state-level tobacco quit line. Am J Prev Med. 2006;30:31-37. doi: 10.1016/j.amepre.2005.08.043
29. Borland R, Segan CJ. The potential of quitlines to increase smoking cessation. Drug Alcohol Rev. 2006;25:73-78. doi: 10.1080/09595230500459537
30. Farber HJ, Walley SC, Groner JA, et al. Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke. Pediatrics. 2015;136:1008-1017. doi: 10.1542/peds.2015-3108
31. Gentzke AS, Wang TW, Jamal A, et al. Tobacco product use among middle and high school students—United States, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1881-1888. doi: 10.15585/mmwr.mm6950a1
32. AAP. Nicotine replacement therapy and adolescent patients: information for pediatricians. Updated November 2019. Accessed August 19, 2021. https://downloads.aap.org/RCE/NRT_and_Adolescents_Pediatrician_Guidance_factsheet.pdf
33. Blasi PR, Cromp D, McDonald S, et al. Approaches to behavioral health integration at high performing primary care practices. J Am Board Fam Med. 2018;31:691-701. doi: 10.3122/jabfm.2018.05.170468
34. Jacobs C, Brieler JA, Salas J, et al. Integrated behavioral health care in family medicine residencies a CERA survey. Fam Med. 2018;50:380-384. doi: 10.22454/FamMed.2018.639260
35. Oliverez M. Quick guide: billing for smoking cessation services. Capture Billing. Accessed August 26, 2021. https://capturebilling.com/how-bill-smoking-cessation-counseling-99406-99407/
THE CASE
Joe, an 18-year-old, has been your patient for many years and has an uncomplicated medical history. He presents for his preparticipation sports examination for the upcoming high school baseball season. Joe’s mother, who arrives at the office with him, tells you she’s worried because she found an e-cigarette in his backpack last week. Joe says that many of the kids at his school vape and he tried it a while back and now vapes “a lot.”
After talking further with Joe, you realize that he is vaping every day, using a 5% nicotine pod. Based on previous consults with the behavioral health counselor in your clinic, you know that this level of vaping is about the same as smoking 1 pack of cigarettes per day in terms of nicotine exposure. Joe states that he often vapes in the bathroom at school because he cannot concentrate in class if he doesn’t vape. He also reports that he had previously used 1 pod per week but had recently started vaping more to help with his cravings.
You assess his withdrawal symptoms and learn that he feels on edge when he is not able to vape and that he vapes heavily before going into school because he knows he will not be able to vape again until his third passing period.
●
Electronic cigarettes (e-cigarettes; also called “vapes”) are electronic nicotine delivery systems that heat and aerosolize e-liquid or “e-juice” that is inhaled by the user. The e-liquid is made up primarily of propylene glycol, vegetable glycerin, and flavorings, and often includes nicotine. Nicotine levels in e-cigarettes can range from 0 mg/mL to 60 mg/mL (regular cigarettes contain ~12 mg of nicotine). The nicotine level of the pod available from e-cigarette company JUUL (50 mg/mL e-liquid) is equivalent to about 1 pack of cigarettes.1 E-cigarette devices are relatively affordable; popular brands cost $10 to $20, while the replacement pods or e-liquid are typically about $4 each.
The e-cigarette market is quickly evolving and diversifying. Originally, e-cigarettes looked similar to cigarettes (cig-a-likes) but did not efficiently deliver nicotine to the user.2 E-cigarettes have evolved and some now deliver cigarette-like levels of nicotine to the user.3,4 Youth and young adults primarily use pod-mod e-cigarettes, which have a sleek design and produce less vapor than older e-cigarettes, making them easier to conceal. They can look like a USB flash-drive or have a teardrop shape. Pod-mod e-cigarettes dominate the current market, led by companies such as JUUL, NJOY, and Vuse.5
E-cigarette use is proliferating in the United States, particularly among young people and facilitated by the introduction of pod-based e-cigarettes in appealing flavors.6,7 While rates of current e-cigarette use by US adults is around 5.5%,8 recent data show that 32.7% of US high school students say they’ve used an e-cigarette in the past 30 days.9
Continue to: A double-edged sword
A double-edged sword. E-cigarettes are less harmful than traditional cigarettes in the short term and likely benefit adult smokers who completely substitute e-cigarettes for their tobacco cigarettes.10 In randomized trials of adult smokers, e-cigarette use resulted in moderate combustible-cigarette cessation rates that rival or exceed rates achieved with traditional nicotine replacement therapy (NRT).11-13 However, most e-cigarettes contain addictive nicotine, can facilitate transitions to more harmful forms of tobacco use,10,14,15 and have unknown long-term health effects. Therefore, youth, young adults, and those who are otherwise tobacco naïve should not initiate e-cigarette use.
Moreover, cases of e-cigarette or vaping product use–associated lung injury (EVALI)—a disease linked to vaping that causes cough, fever, shortness of breath, and death—were first identified in August 2019 and peaked in September 2019 before new cases decreased dramatically through January 2020.16 Since the initial cases of EVALI arose, product testing has shown that tetrahydrocannabinol (THC) and vitamin E acetate are the main ingredients linked to EVALI cases.17 For this reason, the Centers for Disease Control and Prevention and others strongly recommend against use of THC-containing e-cigarettes.18
Given the high rates of e-cigarette use among youth and young adults and its potential health harms, it is critical to inquire about e-cigarette use at primary care visits, and, as appropriate, to assess frequency and quantity of use. Patients who require intervention will be more likely to succeed in quitting if they are connected with behavioral health counseling and prescribed medication. This article offers evidence-based guidance to assess and advise teens and young adults regarding the potential health impact of e-cigarettes.
A NEW ICD-10-CM CODE AND A BRIEF ASSESSMENT TOOL
According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)19 and the International Classification of Diseases, 10th Revision (ICD-10-CM),20 a tobacco use disorder is a problematic pattern of use leading to clinically significant impairment or distress. Associated features and behavioral markers of frequency and quantity include use within 30 minutes of waking, daily use, and increasing use. However, with youth, consider intervention for use of any nicotine or tobacco product, including e-cigarettes, regardless of whether it meets the threshold for diagnosis.21
The new code.
Continue to: As with other tobacco use...
As with other tobacco use, assess e-cigarette use patterns by asking questions about the frequency, duration, and quantity of use. Additionally, determine the level of nicotine in the e-liquid (discussed earlier) and evaluate whether the individual displays signs of physiologic dependence (eg, failed attempts to reduce or quit e-cigarette use, increased use, nicotine withdrawal symptoms).
A useful assessment tool. While e-cigarette use is not often included on current substance use screening measures, the above questions can be added to the end of measures such as the CRAFFT (Car-Relax-Alone-Forget-Family and Friends-Trouble) test.22 Additionally, if an adolescent reports vaping, the American Academy of Pediatrics (AAP) recommends using a brief screening tool such as the Hooked on Nicotine Checklist (HONC) to establish his or her level of dependence (TABLE 1).23
The HONC is ideal for a primary care setting because it is brief and has a high level of sensitivity, minimizing false-negative reports24; a patient’s acknowledgement of any item indicates a loss of autonomy over nicotine. Establishing the level of nicotine dependence is particularly pertinent when making decisions regarding the course of treatment and whether to prescribe NRT (eg, nicotine patch, gum, lozenge). Alternatively, you can quickly assess level of dependence by determining the time to first e-cigarette use in the morning. Tobacco guidelines suggest that if time to first use is > 30 minutes, the individual is “moderately dependent”; if time to first use is < 30 minutes after waking, the individual is “severely dependent.”25
COMBINATION TREATMENT IS MOST SUCCESSFUL
Studies have shown that the most effective treatment for tobacco cessation is pairing behavioral treatment with combination NRT (eg, nicotine gum + patch).25,26 The literature on e-cigarette cessation remains in its infancy, but techniques from traditional smoking cessation can be applied because the behaviors differ only in their mode of nicotine delivery.
Behavioral treatment. There are several options for behavioral treatment for tobacco cessation—and thus, e-cigarette cessation. The first step will depend on the patient’s level of motivation. If the patient is not yet ready to quit, consider using brief motivational interviewing. Once the patient is willing to engage in treatment, options include setting a mutually agreed upon quit date or planning for a reduction in the frequency and duration of vaping.
Continue to: Referrals to the Quitline...
Referrals to the Quitline (800-QUIT-NOW) have long been standard practice and can be used to extend primary care treatment.25 Studies show that it is more effective to connect patients directly to the Quitline at their primary care appointment27 than asking them to call after the visit.28,29 We suggest providing direct assistance in the office to patients as they initiate treatment with the Quitline.
Finally, if the level of dependence is severe or the patient is not motivated to quit, connect them with a behavioral health provider in your clinic or with an outside therapist skilled in cognitive behavioral techniques related to tobacco cessation. Discuss with the patient that quitting nicotine use is difficult for many people and that the best option for success is the combination of counseling and medication.25
Nicotine replacement therapy for e-cigarette use. While over-the-counter NRT (nicotine gum, patches, lozenges) is approved by the US Food and Drug Administration only for sale to adults ≥ 18 years, the AAP issued guidance on prescribing NRT for those < 18 years who use e-cigarettes.30 While the AAP does not suggest a lower age limit for prescribing NRT, national data show that < 6% of middle schoolers report e-cigarette use and that e-cigarette use does not become common (~20% current use) until high school.31 It is therefore unlikely that a child < 14 years would require pharmacotherapy. On their fact sheet, the AAP includes the following guidance:
“Patients who are motivated to quit should use as much safe, FDA-approved NRT as needed to avoid smoking or vaping. When assessing a patient’s current level of nicotine use, it may be helpful to understand that using one JUUL pod per day is equivalent to one pack of cigarettes per day …. Pediatricians and other healthcare providers should work with each patient to determine a starting dosage of NRT that is most likely to help them quit successfully. Dosing is based on the patient’s level of nicotine dependence, which can be measured using a screening tool” (TABLE 123).32
The AAP NRT dosing guidelines can be found at downloads.aap.org/RCE/NRT_and_Adolescents_Pediatrician_Guidance_factsheet.pdf.32 Of note, the dosing guidelines for adolescents are the same as those for adults and are based on level of use and dependence. Moreover, the clinician and patient should work together to choose the initial dose and the plan for weaning NRT over time.
Continue to: THE CASE
Based on your conversation with Joe, you administer the HONC screening tool. He scores 9 out of 10, indicating significant loss of autonomy over nicotine. You consult with a behavioral health counselor, who believes that Joe would benefit from counseling and NRT. You discuss this treatment plan with Joe, who says he is ready to quit because he does not like feeling as if he depends on vaping. Your shared decision is to start the 21-mg patch and 4-mg gum with plans to step down from there.
Joe agrees to set a quit date in the following week. The behavioral health counselor then meets with Joe and they develop a quit plan, which is shared with you so you can follow up at the next visit. Joe also agrees to talk with his parents, who are unaware of his level of use and dependence. Everyone agrees on the quit plan, and a follow-up visit is scheduled.
At the follow-up visit 1 month later, Joe and his parents report that he has quit vaping but is still using the patch and gum. You instruct Joe to reduce his NRT use to the 14-mg patch and 2-mg gum and to stop using them over the next 2 to 3 weeks. Everyone is in agreement with the treatment plan. You also re-administer the HONC screening tool and see that Joe’s score has reduced by 7 points to just 2 out of 10. You recommend that Joe continue to see the behavioral health counselor and follow up as needed. (A noted benefit of having a behavioral health counselor in your clinic is the opportunity for informal briefings on patient progress.33,34)
Following each visit with Joe, you make sure to complete documentation on (1) tobacco/e-cigarette use assessment, (2) diagnoses, (3) discussion of benefits of quitting,(4) assessment of readiness to quit, (5) creation and support of a quit plan, and (6) connection with a behavioral health counselor and planned follow-up. (See TABLE 235 for details onbilling codes.)
CORRESPONDENCE
Eleanor L. S. Leavens, PhD, 3901 Rainbow Boulevard, Mail Stop 1008, Kansas City, KS 66160; [email protected]
THE CASE
Joe, an 18-year-old, has been your patient for many years and has an uncomplicated medical history. He presents for his preparticipation sports examination for the upcoming high school baseball season. Joe’s mother, who arrives at the office with him, tells you she’s worried because she found an e-cigarette in his backpack last week. Joe says that many of the kids at his school vape and he tried it a while back and now vapes “a lot.”
After talking further with Joe, you realize that he is vaping every day, using a 5% nicotine pod. Based on previous consults with the behavioral health counselor in your clinic, you know that this level of vaping is about the same as smoking 1 pack of cigarettes per day in terms of nicotine exposure. Joe states that he often vapes in the bathroom at school because he cannot concentrate in class if he doesn’t vape. He also reports that he had previously used 1 pod per week but had recently started vaping more to help with his cravings.
You assess his withdrawal symptoms and learn that he feels on edge when he is not able to vape and that he vapes heavily before going into school because he knows he will not be able to vape again until his third passing period.
●
Electronic cigarettes (e-cigarettes; also called “vapes”) are electronic nicotine delivery systems that heat and aerosolize e-liquid or “e-juice” that is inhaled by the user. The e-liquid is made up primarily of propylene glycol, vegetable glycerin, and flavorings, and often includes nicotine. Nicotine levels in e-cigarettes can range from 0 mg/mL to 60 mg/mL (regular cigarettes contain ~12 mg of nicotine). The nicotine level of the pod available from e-cigarette company JUUL (50 mg/mL e-liquid) is equivalent to about 1 pack of cigarettes.1 E-cigarette devices are relatively affordable; popular brands cost $10 to $20, while the replacement pods or e-liquid are typically about $4 each.
The e-cigarette market is quickly evolving and diversifying. Originally, e-cigarettes looked similar to cigarettes (cig-a-likes) but did not efficiently deliver nicotine to the user.2 E-cigarettes have evolved and some now deliver cigarette-like levels of nicotine to the user.3,4 Youth and young adults primarily use pod-mod e-cigarettes, which have a sleek design and produce less vapor than older e-cigarettes, making them easier to conceal. They can look like a USB flash-drive or have a teardrop shape. Pod-mod e-cigarettes dominate the current market, led by companies such as JUUL, NJOY, and Vuse.5
E-cigarette use is proliferating in the United States, particularly among young people and facilitated by the introduction of pod-based e-cigarettes in appealing flavors.6,7 While rates of current e-cigarette use by US adults is around 5.5%,8 recent data show that 32.7% of US high school students say they’ve used an e-cigarette in the past 30 days.9
Continue to: A double-edged sword
A double-edged sword. E-cigarettes are less harmful than traditional cigarettes in the short term and likely benefit adult smokers who completely substitute e-cigarettes for their tobacco cigarettes.10 In randomized trials of adult smokers, e-cigarette use resulted in moderate combustible-cigarette cessation rates that rival or exceed rates achieved with traditional nicotine replacement therapy (NRT).11-13 However, most e-cigarettes contain addictive nicotine, can facilitate transitions to more harmful forms of tobacco use,10,14,15 and have unknown long-term health effects. Therefore, youth, young adults, and those who are otherwise tobacco naïve should not initiate e-cigarette use.
Moreover, cases of e-cigarette or vaping product use–associated lung injury (EVALI)—a disease linked to vaping that causes cough, fever, shortness of breath, and death—were first identified in August 2019 and peaked in September 2019 before new cases decreased dramatically through January 2020.16 Since the initial cases of EVALI arose, product testing has shown that tetrahydrocannabinol (THC) and vitamin E acetate are the main ingredients linked to EVALI cases.17 For this reason, the Centers for Disease Control and Prevention and others strongly recommend against use of THC-containing e-cigarettes.18
Given the high rates of e-cigarette use among youth and young adults and its potential health harms, it is critical to inquire about e-cigarette use at primary care visits, and, as appropriate, to assess frequency and quantity of use. Patients who require intervention will be more likely to succeed in quitting if they are connected with behavioral health counseling and prescribed medication. This article offers evidence-based guidance to assess and advise teens and young adults regarding the potential health impact of e-cigarettes.
A NEW ICD-10-CM CODE AND A BRIEF ASSESSMENT TOOL
According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)19 and the International Classification of Diseases, 10th Revision (ICD-10-CM),20 a tobacco use disorder is a problematic pattern of use leading to clinically significant impairment or distress. Associated features and behavioral markers of frequency and quantity include use within 30 minutes of waking, daily use, and increasing use. However, with youth, consider intervention for use of any nicotine or tobacco product, including e-cigarettes, regardless of whether it meets the threshold for diagnosis.21
The new code.
Continue to: As with other tobacco use...
As with other tobacco use, assess e-cigarette use patterns by asking questions about the frequency, duration, and quantity of use. Additionally, determine the level of nicotine in the e-liquid (discussed earlier) and evaluate whether the individual displays signs of physiologic dependence (eg, failed attempts to reduce or quit e-cigarette use, increased use, nicotine withdrawal symptoms).
A useful assessment tool. While e-cigarette use is not often included on current substance use screening measures, the above questions can be added to the end of measures such as the CRAFFT (Car-Relax-Alone-Forget-Family and Friends-Trouble) test.22 Additionally, if an adolescent reports vaping, the American Academy of Pediatrics (AAP) recommends using a brief screening tool such as the Hooked on Nicotine Checklist (HONC) to establish his or her level of dependence (TABLE 1).23
The HONC is ideal for a primary care setting because it is brief and has a high level of sensitivity, minimizing false-negative reports24; a patient’s acknowledgement of any item indicates a loss of autonomy over nicotine. Establishing the level of nicotine dependence is particularly pertinent when making decisions regarding the course of treatment and whether to prescribe NRT (eg, nicotine patch, gum, lozenge). Alternatively, you can quickly assess level of dependence by determining the time to first e-cigarette use in the morning. Tobacco guidelines suggest that if time to first use is > 30 minutes, the individual is “moderately dependent”; if time to first use is < 30 minutes after waking, the individual is “severely dependent.”25
COMBINATION TREATMENT IS MOST SUCCESSFUL
Studies have shown that the most effective treatment for tobacco cessation is pairing behavioral treatment with combination NRT (eg, nicotine gum + patch).25,26 The literature on e-cigarette cessation remains in its infancy, but techniques from traditional smoking cessation can be applied because the behaviors differ only in their mode of nicotine delivery.
Behavioral treatment. There are several options for behavioral treatment for tobacco cessation—and thus, e-cigarette cessation. The first step will depend on the patient’s level of motivation. If the patient is not yet ready to quit, consider using brief motivational interviewing. Once the patient is willing to engage in treatment, options include setting a mutually agreed upon quit date or planning for a reduction in the frequency and duration of vaping.
Continue to: Referrals to the Quitline...
Referrals to the Quitline (800-QUIT-NOW) have long been standard practice and can be used to extend primary care treatment.25 Studies show that it is more effective to connect patients directly to the Quitline at their primary care appointment27 than asking them to call after the visit.28,29 We suggest providing direct assistance in the office to patients as they initiate treatment with the Quitline.
Finally, if the level of dependence is severe or the patient is not motivated to quit, connect them with a behavioral health provider in your clinic or with an outside therapist skilled in cognitive behavioral techniques related to tobacco cessation. Discuss with the patient that quitting nicotine use is difficult for many people and that the best option for success is the combination of counseling and medication.25
Nicotine replacement therapy for e-cigarette use. While over-the-counter NRT (nicotine gum, patches, lozenges) is approved by the US Food and Drug Administration only for sale to adults ≥ 18 years, the AAP issued guidance on prescribing NRT for those < 18 years who use e-cigarettes.30 While the AAP does not suggest a lower age limit for prescribing NRT, national data show that < 6% of middle schoolers report e-cigarette use and that e-cigarette use does not become common (~20% current use) until high school.31 It is therefore unlikely that a child < 14 years would require pharmacotherapy. On their fact sheet, the AAP includes the following guidance:
“Patients who are motivated to quit should use as much safe, FDA-approved NRT as needed to avoid smoking or vaping. When assessing a patient’s current level of nicotine use, it may be helpful to understand that using one JUUL pod per day is equivalent to one pack of cigarettes per day …. Pediatricians and other healthcare providers should work with each patient to determine a starting dosage of NRT that is most likely to help them quit successfully. Dosing is based on the patient’s level of nicotine dependence, which can be measured using a screening tool” (TABLE 123).32
The AAP NRT dosing guidelines can be found at downloads.aap.org/RCE/NRT_and_Adolescents_Pediatrician_Guidance_factsheet.pdf.32 Of note, the dosing guidelines for adolescents are the same as those for adults and are based on level of use and dependence. Moreover, the clinician and patient should work together to choose the initial dose and the plan for weaning NRT over time.
Continue to: THE CASE
Based on your conversation with Joe, you administer the HONC screening tool. He scores 9 out of 10, indicating significant loss of autonomy over nicotine. You consult with a behavioral health counselor, who believes that Joe would benefit from counseling and NRT. You discuss this treatment plan with Joe, who says he is ready to quit because he does not like feeling as if he depends on vaping. Your shared decision is to start the 21-mg patch and 4-mg gum with plans to step down from there.
Joe agrees to set a quit date in the following week. The behavioral health counselor then meets with Joe and they develop a quit plan, which is shared with you so you can follow up at the next visit. Joe also agrees to talk with his parents, who are unaware of his level of use and dependence. Everyone agrees on the quit plan, and a follow-up visit is scheduled.
At the follow-up visit 1 month later, Joe and his parents report that he has quit vaping but is still using the patch and gum. You instruct Joe to reduce his NRT use to the 14-mg patch and 2-mg gum and to stop using them over the next 2 to 3 weeks. Everyone is in agreement with the treatment plan. You also re-administer the HONC screening tool and see that Joe’s score has reduced by 7 points to just 2 out of 10. You recommend that Joe continue to see the behavioral health counselor and follow up as needed. (A noted benefit of having a behavioral health counselor in your clinic is the opportunity for informal briefings on patient progress.33,34)
Following each visit with Joe, you make sure to complete documentation on (1) tobacco/e-cigarette use assessment, (2) diagnoses, (3) discussion of benefits of quitting,(4) assessment of readiness to quit, (5) creation and support of a quit plan, and (6) connection with a behavioral health counselor and planned follow-up. (See TABLE 235 for details onbilling codes.)
CORRESPONDENCE
Eleanor L. S. Leavens, PhD, 3901 Rainbow Boulevard, Mail Stop 1008, Kansas City, KS 66160; [email protected]
1. Prochaska JJ, Vogel EA, Benowitz N. Nicotine delivery and cigarette equivalents from vaping a JUULpod. Tob Control. Published online March 24, 2021. doi: 10.1136/tobaccocontrol- 2020-056367
2. Rüther T, Hagedorn D, Schiela K, et al. Nicotine delivery efficiency of first-and second-generation e-cigarettes and its impact on relief of craving during the acute phase of use. Int J Hyg Environ Health. 2018;221:191-198. doi: 10.1016/j.ijheh.2017.10.012
3. Hajek P, Pittaccio K, Pesola F, et al. Nicotine delivery and users’ reactions to Juul compared with cigarettes and other e‐cigarette products. Addiction. 2020;115:1141-1148. doi: 10.1111/add.14936
4. Wagener TL, Floyd EL, Stepanov I, et al. Have combustible cigarettes met their match? The nicotine delivery profiles and harmful constituent exposures of second-generation and third-generation electronic cigarette users. Tob control. 2017;26:e23-e28. doi: 10.1136/tobaccocontrol-2016-053041
5. Herzog B, Kanada P. Nielsen: Tobacco all channel data thru 8/11 - cig vol decelerates. Published August 21, 2018. Accessed August 19, 2021. https://athra.org.au/wp-content/uploads/2018/09/Wells-Fargo-Nielsen-Tobacco-All-Channel-Report-Period-Ending-8.11.18.pdf
6. Harrell MB, Weaver SR, Loukas A, et al. Flavored e-cigarette use: characterizing youth, young adult, and adult users. Prev Med Rep. 2017;5:33-40. doi: 10.1016/j.pmedr.2016.11.001
7. Morean ME, Butler ER, Bold KW, et al. Preferring more e-cigarette flavors is associated with e-cigarette use frequency among adolescents but not adults. PloS One. 2018;13:e0189015. doi: 10.1371/journal.pone.0189015
8. Obisesan OH, Osei AD, Iftekhar Uddin SM, et al. Trends in e-cigarette use in adults in the United States, 2016-2018. JAMA Intern Med. 2020;180:1394-1398. doi: 10.1001/jamainternmed.2020.2817
9. Creamer MR, Wang TW, Babb S, et al. Tobacco product use and cessation indicators among adults—United States, 2018. MMWR Morb Mortal Wkly Rep. 2019;68:1013-1019. doi: 10.15585/mmwr.mm6845a2
10. NASEM. Public health consequences of e-cigarettes. National Academies Press; 2018. Accessed August 19, 2021. www.ncbi.nlm.nih.gov/books/NBK507171/
11. Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. 2019;380:629-637. doi: 10.1056/NEJMoa1808779
12. Pulvers K, Nollen NL, Rice M, et al. Effect of pod e-cigarettes vs cigarettes on carcinogen exposure among African American and Latinx smokers: a randomized clinical trial. JAMA Netw Open. 2020;3:e2026324. doi: 10.1001/jamanetworkopen.2020.26324
13. Wang RJ, Bhadriraju S, Glantz SA. E-cigarette use and adult cigarette smoking cessation: a meta-analysis. Am J Public Health. 2021;111:230-246. doi: 10.2105/AJPH.2020.305999
14. Barrington-Trimis JL, Urman R, Berhane K, et al. E-cigarettes and future cigarette use. Pediatrics. 2016;138:e20160379. doi: 10.1542/peds.2016-0379
15. Soneji S, Barrington-Trimis JL, Wills TA, et al. Association between initial use of e-cigarettes and subsequent cigarette smoking among adolescents and young adults: a systematic review and meta-analysis. JAMA Pediatr. 2017;171:788-797. doi: 10.1001/jamapediatrics.2017.1488
16. Krishnasamy VP, Hallowell BD, Ko JY, et al. Update: characteristics of a nationwide outbreak of e-cigarette, or vaping, product use–associated lung injury—United States, August 2019–January 2020. MMWR Morb Mortal Wkly Rep. 2020;69:90-94. doi: 10.15585/mmwr.mm6903e2
17. Blount BC, Karwowski MP, Shields PG, et al. Vitamin E acetate in bronchoalveolar-lavage fluid associated with EVALI. N Engl J Med. 2020;382:697-705. doi: 10.1056/NEJMoa1916433
18. CDC. Outbreak of lung injury associated with use of e-cigarette, or vaping, products. Updated February 25, 2020. Accessed August 19, 2021. www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html
19. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th edition (DSM-5). American Psychiatric Publishing; 2013.
20. CDC. International Classification of Diseases, 10th Revision. Updated July 30, 2021. Accessed August 31, 2021. www.cdc.gov/nchs/icd/icd10cm.htm
21. CDC. Surgeon General’s advisory on e-cigarette use among youth. Reviewed April 9, 2019. Accessed August 19, 2021. www.cdc.gov/tobacco/basic_information/e-cigarettes/surgeon-general-advisory/index.html
22. Knight JR, Sherritt L, Shrier LA, et al. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002;156:607-614. doi: 10.1001/archpedi.156.6.607
23. DiFranza JR, Savageau JA, Fletcher K, et al. Measuring the loss of autonomy over nicotine use in adolescents: the DANDY (Development and Assessment of Nicotine Dependence in Youths) study. Arch Pediatr Adolesc Med. 2002;156:397-403. doi: 10.1001/archpedi.156.4.397
24. Wellman RJ, Savageau JA, Godiwala S, et al. A comparison of the Hooked on Nicotine Checklist and the Fagerström Test for Nicotine Dependence in adult smokers. Nicotine Tob Res. 2006;8:575-580. doi: 10.1080/14622200600789965
25. Fiore MC, Jaén CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Published May 2008. Accessed August 19, 2021. www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/TreatingTobaccoUseandDependence-2008Update.pdf
26. Shah SD, Wilken LA, Winkler SR, et al. Systematic review and meta-analysis of combination therapy for smoking cessation. J Am Pharm Assoc. 2008;48:659-665. doi: 10.1331/JAPhA.2008.07063
27. Vidrine JI, Shete S, Cao Y, et al. Ask-Advise-Connect: a new approach to smoking treatment delivery in health care settings. JAMA Intern Med. 2013;173:458-464. doi: 10.1001/jamainternmed.2013.3751
28. Bentz CJ, Bayley KB, Bonin KE, et al. The feasibility of connecting physician offices to a state-level tobacco quit line. Am J Prev Med. 2006;30:31-37. doi: 10.1016/j.amepre.2005.08.043
29. Borland R, Segan CJ. The potential of quitlines to increase smoking cessation. Drug Alcohol Rev. 2006;25:73-78. doi: 10.1080/09595230500459537
30. Farber HJ, Walley SC, Groner JA, et al. Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke. Pediatrics. 2015;136:1008-1017. doi: 10.1542/peds.2015-3108
31. Gentzke AS, Wang TW, Jamal A, et al. Tobacco product use among middle and high school students—United States, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1881-1888. doi: 10.15585/mmwr.mm6950a1
32. AAP. Nicotine replacement therapy and adolescent patients: information for pediatricians. Updated November 2019. Accessed August 19, 2021. https://downloads.aap.org/RCE/NRT_and_Adolescents_Pediatrician_Guidance_factsheet.pdf
33. Blasi PR, Cromp D, McDonald S, et al. Approaches to behavioral health integration at high performing primary care practices. J Am Board Fam Med. 2018;31:691-701. doi: 10.3122/jabfm.2018.05.170468
34. Jacobs C, Brieler JA, Salas J, et al. Integrated behavioral health care in family medicine residencies a CERA survey. Fam Med. 2018;50:380-384. doi: 10.22454/FamMed.2018.639260
35. Oliverez M. Quick guide: billing for smoking cessation services. Capture Billing. Accessed August 26, 2021. https://capturebilling.com/how-bill-smoking-cessation-counseling-99406-99407/
1. Prochaska JJ, Vogel EA, Benowitz N. Nicotine delivery and cigarette equivalents from vaping a JUULpod. Tob Control. Published online March 24, 2021. doi: 10.1136/tobaccocontrol- 2020-056367
2. Rüther T, Hagedorn D, Schiela K, et al. Nicotine delivery efficiency of first-and second-generation e-cigarettes and its impact on relief of craving during the acute phase of use. Int J Hyg Environ Health. 2018;221:191-198. doi: 10.1016/j.ijheh.2017.10.012
3. Hajek P, Pittaccio K, Pesola F, et al. Nicotine delivery and users’ reactions to Juul compared with cigarettes and other e‐cigarette products. Addiction. 2020;115:1141-1148. doi: 10.1111/add.14936
4. Wagener TL, Floyd EL, Stepanov I, et al. Have combustible cigarettes met their match? The nicotine delivery profiles and harmful constituent exposures of second-generation and third-generation electronic cigarette users. Tob control. 2017;26:e23-e28. doi: 10.1136/tobaccocontrol-2016-053041
5. Herzog B, Kanada P. Nielsen: Tobacco all channel data thru 8/11 - cig vol decelerates. Published August 21, 2018. Accessed August 19, 2021. https://athra.org.au/wp-content/uploads/2018/09/Wells-Fargo-Nielsen-Tobacco-All-Channel-Report-Period-Ending-8.11.18.pdf
6. Harrell MB, Weaver SR, Loukas A, et al. Flavored e-cigarette use: characterizing youth, young adult, and adult users. Prev Med Rep. 2017;5:33-40. doi: 10.1016/j.pmedr.2016.11.001
7. Morean ME, Butler ER, Bold KW, et al. Preferring more e-cigarette flavors is associated with e-cigarette use frequency among adolescents but not adults. PloS One. 2018;13:e0189015. doi: 10.1371/journal.pone.0189015
8. Obisesan OH, Osei AD, Iftekhar Uddin SM, et al. Trends in e-cigarette use in adults in the United States, 2016-2018. JAMA Intern Med. 2020;180:1394-1398. doi: 10.1001/jamainternmed.2020.2817
9. Creamer MR, Wang TW, Babb S, et al. Tobacco product use and cessation indicators among adults—United States, 2018. MMWR Morb Mortal Wkly Rep. 2019;68:1013-1019. doi: 10.15585/mmwr.mm6845a2
10. NASEM. Public health consequences of e-cigarettes. National Academies Press; 2018. Accessed August 19, 2021. www.ncbi.nlm.nih.gov/books/NBK507171/
11. Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. 2019;380:629-637. doi: 10.1056/NEJMoa1808779
12. Pulvers K, Nollen NL, Rice M, et al. Effect of pod e-cigarettes vs cigarettes on carcinogen exposure among African American and Latinx smokers: a randomized clinical trial. JAMA Netw Open. 2020;3:e2026324. doi: 10.1001/jamanetworkopen.2020.26324
13. Wang RJ, Bhadriraju S, Glantz SA. E-cigarette use and adult cigarette smoking cessation: a meta-analysis. Am J Public Health. 2021;111:230-246. doi: 10.2105/AJPH.2020.305999
14. Barrington-Trimis JL, Urman R, Berhane K, et al. E-cigarettes and future cigarette use. Pediatrics. 2016;138:e20160379. doi: 10.1542/peds.2016-0379
15. Soneji S, Barrington-Trimis JL, Wills TA, et al. Association between initial use of e-cigarettes and subsequent cigarette smoking among adolescents and young adults: a systematic review and meta-analysis. JAMA Pediatr. 2017;171:788-797. doi: 10.1001/jamapediatrics.2017.1488
16. Krishnasamy VP, Hallowell BD, Ko JY, et al. Update: characteristics of a nationwide outbreak of e-cigarette, or vaping, product use–associated lung injury—United States, August 2019–January 2020. MMWR Morb Mortal Wkly Rep. 2020;69:90-94. doi: 10.15585/mmwr.mm6903e2
17. Blount BC, Karwowski MP, Shields PG, et al. Vitamin E acetate in bronchoalveolar-lavage fluid associated with EVALI. N Engl J Med. 2020;382:697-705. doi: 10.1056/NEJMoa1916433
18. CDC. Outbreak of lung injury associated with use of e-cigarette, or vaping, products. Updated February 25, 2020. Accessed August 19, 2021. www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html
19. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th edition (DSM-5). American Psychiatric Publishing; 2013.
20. CDC. International Classification of Diseases, 10th Revision. Updated July 30, 2021. Accessed August 31, 2021. www.cdc.gov/nchs/icd/icd10cm.htm
21. CDC. Surgeon General’s advisory on e-cigarette use among youth. Reviewed April 9, 2019. Accessed August 19, 2021. www.cdc.gov/tobacco/basic_information/e-cigarettes/surgeon-general-advisory/index.html
22. Knight JR, Sherritt L, Shrier LA, et al. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002;156:607-614. doi: 10.1001/archpedi.156.6.607
23. DiFranza JR, Savageau JA, Fletcher K, et al. Measuring the loss of autonomy over nicotine use in adolescents: the DANDY (Development and Assessment of Nicotine Dependence in Youths) study. Arch Pediatr Adolesc Med. 2002;156:397-403. doi: 10.1001/archpedi.156.4.397
24. Wellman RJ, Savageau JA, Godiwala S, et al. A comparison of the Hooked on Nicotine Checklist and the Fagerström Test for Nicotine Dependence in adult smokers. Nicotine Tob Res. 2006;8:575-580. doi: 10.1080/14622200600789965
25. Fiore MC, Jaén CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Published May 2008. Accessed August 19, 2021. www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/TreatingTobaccoUseandDependence-2008Update.pdf
26. Shah SD, Wilken LA, Winkler SR, et al. Systematic review and meta-analysis of combination therapy for smoking cessation. J Am Pharm Assoc. 2008;48:659-665. doi: 10.1331/JAPhA.2008.07063
27. Vidrine JI, Shete S, Cao Y, et al. Ask-Advise-Connect: a new approach to smoking treatment delivery in health care settings. JAMA Intern Med. 2013;173:458-464. doi: 10.1001/jamainternmed.2013.3751
28. Bentz CJ, Bayley KB, Bonin KE, et al. The feasibility of connecting physician offices to a state-level tobacco quit line. Am J Prev Med. 2006;30:31-37. doi: 10.1016/j.amepre.2005.08.043
29. Borland R, Segan CJ. The potential of quitlines to increase smoking cessation. Drug Alcohol Rev. 2006;25:73-78. doi: 10.1080/09595230500459537
30. Farber HJ, Walley SC, Groner JA, et al. Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke. Pediatrics. 2015;136:1008-1017. doi: 10.1542/peds.2015-3108
31. Gentzke AS, Wang TW, Jamal A, et al. Tobacco product use among middle and high school students—United States, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1881-1888. doi: 10.15585/mmwr.mm6950a1
32. AAP. Nicotine replacement therapy and adolescent patients: information for pediatricians. Updated November 2019. Accessed August 19, 2021. https://downloads.aap.org/RCE/NRT_and_Adolescents_Pediatrician_Guidance_factsheet.pdf
33. Blasi PR, Cromp D, McDonald S, et al. Approaches to behavioral health integration at high performing primary care practices. J Am Board Fam Med. 2018;31:691-701. doi: 10.3122/jabfm.2018.05.170468
34. Jacobs C, Brieler JA, Salas J, et al. Integrated behavioral health care in family medicine residencies a CERA survey. Fam Med. 2018;50:380-384. doi: 10.22454/FamMed.2018.639260
35. Oliverez M. Quick guide: billing for smoking cessation services. Capture Billing. Accessed August 26, 2021. https://capturebilling.com/how-bill-smoking-cessation-counseling-99406-99407/
Decline in child COVID may signal end of latest surge
A second consecutive week of falling COVID-19 cases in children, along with continued declines in new admissions, may indicate that the latest surge has peaked.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
New hospitalizations in children aged 0-17 years peaked on Sept. 4 – when the rate reached 0.51 per 100,000 population – and were down to 0.47 as of Sept. 11, the latest date for which data should be considered reliable, the Centers for Disease Control and Prevention said.
The CDC’s data largely agree with the AAP/CHA report, showing that cases peaked during the week of Aug. 22-28. Cases per 100,000 for children that week looked like this: 154.7 (age 0-4 years), 276.6 (5-11 years), 320.0 (12-15), and 334.1 (16-17). The highest rates that week among adults were 288.6 per 100,000 in 30- to 39-year-olds and 286.5 for those aged 18-29, the CDC said on its COVID Data Tracker.
By the week of Sept. 5-11 – reporting delays can affect more recent data – the rates in children were down more than 20% in each of the four age groups, according to the CDC.
Vaccinations among children, unfortunately, continue to decline. Vaccine initiations for 12- to 15-year-olds slipped from 199,000 (Sept. 7-13) to 179,000 during the week of Sept. 14-20, while the 16- to 17-year-olds went from almost 83,000 down to 75,000. Initiations have dropped for 6 straight weeks in both age groups, based on the CDC data.
Despite those declines, however, the 16- and 17-year-olds just passed a couple of vaccination milestones. More than 60% – 60.9%, to be exact – have now received at least one dose of COVID vaccine, and 50.3% can be considered fully vaccinated. For those aged 12-15, the corresponding figures are 53.1% and 42.0%, the CDC reported.
When children under age 12 years are included – through clinical trial involvement or incorrect birth dates – the CDC data put the total count of Americans under age 18 who have received at least one dose of vaccine at almost 12.8 million, with vaccination complete in 10.3 million.
Total cases, as calculated by the APA and CHA, are now over 5.5 million, although that figure includes cases in individuals as old as 20 years, since many states differ from the CDC on the age range for a child. The CDC’s COVID Data Tracker put the total for children aged 0-17 at nearly 4.6 million.
The total number of COVID-related deaths in children is 480 as of Sept. 16, the AAP and CHA said, based on data from 45 states, New York, City, Puerto Rico, and Guam, but the CDC provides a higher number, 548, since the pandemic began. Children aged 0-4 years represent the largest share (32.3%) of those 548 deaths, followed by the 12- to 15-year-olds (26.5%), based on the CDC data.
A second consecutive week of falling COVID-19 cases in children, along with continued declines in new admissions, may indicate that the latest surge has peaked.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
New hospitalizations in children aged 0-17 years peaked on Sept. 4 – when the rate reached 0.51 per 100,000 population – and were down to 0.47 as of Sept. 11, the latest date for which data should be considered reliable, the Centers for Disease Control and Prevention said.
The CDC’s data largely agree with the AAP/CHA report, showing that cases peaked during the week of Aug. 22-28. Cases per 100,000 for children that week looked like this: 154.7 (age 0-4 years), 276.6 (5-11 years), 320.0 (12-15), and 334.1 (16-17). The highest rates that week among adults were 288.6 per 100,000 in 30- to 39-year-olds and 286.5 for those aged 18-29, the CDC said on its COVID Data Tracker.
By the week of Sept. 5-11 – reporting delays can affect more recent data – the rates in children were down more than 20% in each of the four age groups, according to the CDC.
Vaccinations among children, unfortunately, continue to decline. Vaccine initiations for 12- to 15-year-olds slipped from 199,000 (Sept. 7-13) to 179,000 during the week of Sept. 14-20, while the 16- to 17-year-olds went from almost 83,000 down to 75,000. Initiations have dropped for 6 straight weeks in both age groups, based on the CDC data.
Despite those declines, however, the 16- and 17-year-olds just passed a couple of vaccination milestones. More than 60% – 60.9%, to be exact – have now received at least one dose of COVID vaccine, and 50.3% can be considered fully vaccinated. For those aged 12-15, the corresponding figures are 53.1% and 42.0%, the CDC reported.
When children under age 12 years are included – through clinical trial involvement or incorrect birth dates – the CDC data put the total count of Americans under age 18 who have received at least one dose of vaccine at almost 12.8 million, with vaccination complete in 10.3 million.
Total cases, as calculated by the APA and CHA, are now over 5.5 million, although that figure includes cases in individuals as old as 20 years, since many states differ from the CDC on the age range for a child. The CDC’s COVID Data Tracker put the total for children aged 0-17 at nearly 4.6 million.
The total number of COVID-related deaths in children is 480 as of Sept. 16, the AAP and CHA said, based on data from 45 states, New York, City, Puerto Rico, and Guam, but the CDC provides a higher number, 548, since the pandemic began. Children aged 0-4 years represent the largest share (32.3%) of those 548 deaths, followed by the 12- to 15-year-olds (26.5%), based on the CDC data.
A second consecutive week of falling COVID-19 cases in children, along with continued declines in new admissions, may indicate that the latest surge has peaked.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
New hospitalizations in children aged 0-17 years peaked on Sept. 4 – when the rate reached 0.51 per 100,000 population – and were down to 0.47 as of Sept. 11, the latest date for which data should be considered reliable, the Centers for Disease Control and Prevention said.
The CDC’s data largely agree with the AAP/CHA report, showing that cases peaked during the week of Aug. 22-28. Cases per 100,000 for children that week looked like this: 154.7 (age 0-4 years), 276.6 (5-11 years), 320.0 (12-15), and 334.1 (16-17). The highest rates that week among adults were 288.6 per 100,000 in 30- to 39-year-olds and 286.5 for those aged 18-29, the CDC said on its COVID Data Tracker.
By the week of Sept. 5-11 – reporting delays can affect more recent data – the rates in children were down more than 20% in each of the four age groups, according to the CDC.
Vaccinations among children, unfortunately, continue to decline. Vaccine initiations for 12- to 15-year-olds slipped from 199,000 (Sept. 7-13) to 179,000 during the week of Sept. 14-20, while the 16- to 17-year-olds went from almost 83,000 down to 75,000. Initiations have dropped for 6 straight weeks in both age groups, based on the CDC data.
Despite those declines, however, the 16- and 17-year-olds just passed a couple of vaccination milestones. More than 60% – 60.9%, to be exact – have now received at least one dose of COVID vaccine, and 50.3% can be considered fully vaccinated. For those aged 12-15, the corresponding figures are 53.1% and 42.0%, the CDC reported.
When children under age 12 years are included – through clinical trial involvement or incorrect birth dates – the CDC data put the total count of Americans under age 18 who have received at least one dose of vaccine at almost 12.8 million, with vaccination complete in 10.3 million.
Total cases, as calculated by the APA and CHA, are now over 5.5 million, although that figure includes cases in individuals as old as 20 years, since many states differ from the CDC on the age range for a child. The CDC’s COVID Data Tracker put the total for children aged 0-17 at nearly 4.6 million.
The total number of COVID-related deaths in children is 480 as of Sept. 16, the AAP and CHA said, based on data from 45 states, New York, City, Puerto Rico, and Guam, but the CDC provides a higher number, 548, since the pandemic began. Children aged 0-4 years represent the largest share (32.3%) of those 548 deaths, followed by the 12- to 15-year-olds (26.5%), based on the CDC data.
HPV vaccine safety concerns up 80% from 2015 to 2018
Despite a decrease in reported adverse events after receiving the human papillomavirus (HPV) vaccine, among parents of unvaccinated adolescents, concerns about the vaccine’s safety rose 80% from 2015 to 2018, according to research published September 17 in JAMA Network Open.
Since its approval in 2006 by the U.S. Food and Drug Administration, uptake of the HPV vaccine has consistently lagged behind that of other routine vaccinations. According to the most recent data from the Centers for Disease Control and Prevention, released September 3, 58.6% of adolescents were considered up to date with their HPV vaccinations in 2020.
Trials prior to the vaccine’s FDA approval as well as an abundance of clinical and observational evidence after it hit the market demonstrate the vaccine’s efficacy and safety, said lead author Kalyani Sonawane, PhD, an assistant professor of management, policy, and community health at the UTHealth School of Public Health, in Houston, Texas, in an interview. Still, recent research suggests that safety concerns are a main reason why parents are hesitant to have their children vaccinated, she noted.
In the study, Dr. Sonawane and colleagues analyzed data from National Immunization Survey-Teen (NIS-Teen) from 2015 through 2018. NIS-Teen is a random-digit-dialed telephone survey conducted annually by the CDC to monitor routine vaccination coverage among adolescents aged 13 to 17. The researchers identified 39,364 adolescents who had not received any HPV shots and reviewed the caregivers’ reasons for vaccine hesitancy. The research team also reviewed the Vaccine Adverse Event Reporting System (VAERS). They identified 16,621 reports that listed the HPV vaccine from 2015 through 2018.
The top five reasons caregivers cited for avoiding the HPV vaccine were the following:
- not needed or necessary
- safety concerns
- not recommended
- lack of knowledge
- not sexually active
Of these, safety concerns were the only factor that increased during the study period. They increased from 13.0% in 2015 to 23.4% in 2018. Concerns over vaccine safety rose in 30 states, with increases of over 200% in California, Hawaii, South Dakota, and Mississippi.
The proportion of unvaccinated adolescents whose caregivers thought the HPV vaccine was not needed or necessary remained steady at around 25%. Those whose caregivers listed “not recommended,” “lack of knowledge,” and “not sexually active” as reasons for avoiding vaccination decreased over the study period.
The reporting rate for adverse events following HPV vaccination decreased from 44.7 per 100,000 doses in 2015 to 29.4 per 100,000 doses in 2018. Of the reported 16,621 adverse events following HPV vaccination that occurred over the study period, 4.6% were serious, resulting in hospitalizations, disability, life-threatening events, or death. From 2015 through 2018, reporting rates for serious adverse events remained level at around 0.3 events per 100,000 doses.
This mismatch between increasing vaccine safety concerns and decreasing adverse events suggests that disinformation may be driving these concerns more than scientific fact, Nosayaba Osazuwa-Peters, PhD, MPH, an assistant professor in head and neck surgery and communication sciences at the Duke University School of Medicine, in Durham, North Carolina, told this news organization. He co-wrote an invited commentary on the study and was not involved with the research. Although there have always been people who are hesitant to receive vaccinations, he said, social media and the internet have undoubtedly played a role in spreading concern.
Dr. Sonawane agreed. Online, “there are a lot of antivaccine groups that are making unwarranted claims about the vaccine’s safety,” such as that the HPV vaccine causes autism or fertility problems in women, she said. “We believe that this growing antivaccine movement in the U.S. and across the globe – which the World Health Organization has declared as one of the biggest threats right now – is also contributing to safety concerns among U.S. parents, particularly HPV vaccine safety.”
Although the study did not address strategies to combat this misinformation, Dr. Osazuwa-Peters said clinicians need to improve their communication with parents and patients. One way to do that, he said, is by bolstering an online presence and by countering vaccine disinformation with evidence-based responses on the internet. Most people get their medical information online. “Many people are just afraid because they don’t trust the messages coming from health care,” he said. “So, we need to a better job of not just providing the facts but providing the facts in a way that the end users can understand and appreciate.”
Dr. Sonawane and Dr. Osazuwa-Peters report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Despite a decrease in reported adverse events after receiving the human papillomavirus (HPV) vaccine, among parents of unvaccinated adolescents, concerns about the vaccine’s safety rose 80% from 2015 to 2018, according to research published September 17 in JAMA Network Open.
Since its approval in 2006 by the U.S. Food and Drug Administration, uptake of the HPV vaccine has consistently lagged behind that of other routine vaccinations. According to the most recent data from the Centers for Disease Control and Prevention, released September 3, 58.6% of adolescents were considered up to date with their HPV vaccinations in 2020.
Trials prior to the vaccine’s FDA approval as well as an abundance of clinical and observational evidence after it hit the market demonstrate the vaccine’s efficacy and safety, said lead author Kalyani Sonawane, PhD, an assistant professor of management, policy, and community health at the UTHealth School of Public Health, in Houston, Texas, in an interview. Still, recent research suggests that safety concerns are a main reason why parents are hesitant to have their children vaccinated, she noted.
In the study, Dr. Sonawane and colleagues analyzed data from National Immunization Survey-Teen (NIS-Teen) from 2015 through 2018. NIS-Teen is a random-digit-dialed telephone survey conducted annually by the CDC to monitor routine vaccination coverage among adolescents aged 13 to 17. The researchers identified 39,364 adolescents who had not received any HPV shots and reviewed the caregivers’ reasons for vaccine hesitancy. The research team also reviewed the Vaccine Adverse Event Reporting System (VAERS). They identified 16,621 reports that listed the HPV vaccine from 2015 through 2018.
The top five reasons caregivers cited for avoiding the HPV vaccine were the following:
- not needed or necessary
- safety concerns
- not recommended
- lack of knowledge
- not sexually active
Of these, safety concerns were the only factor that increased during the study period. They increased from 13.0% in 2015 to 23.4% in 2018. Concerns over vaccine safety rose in 30 states, with increases of over 200% in California, Hawaii, South Dakota, and Mississippi.
The proportion of unvaccinated adolescents whose caregivers thought the HPV vaccine was not needed or necessary remained steady at around 25%. Those whose caregivers listed “not recommended,” “lack of knowledge,” and “not sexually active” as reasons for avoiding vaccination decreased over the study period.
The reporting rate for adverse events following HPV vaccination decreased from 44.7 per 100,000 doses in 2015 to 29.4 per 100,000 doses in 2018. Of the reported 16,621 adverse events following HPV vaccination that occurred over the study period, 4.6% were serious, resulting in hospitalizations, disability, life-threatening events, or death. From 2015 through 2018, reporting rates for serious adverse events remained level at around 0.3 events per 100,000 doses.
This mismatch between increasing vaccine safety concerns and decreasing adverse events suggests that disinformation may be driving these concerns more than scientific fact, Nosayaba Osazuwa-Peters, PhD, MPH, an assistant professor in head and neck surgery and communication sciences at the Duke University School of Medicine, in Durham, North Carolina, told this news organization. He co-wrote an invited commentary on the study and was not involved with the research. Although there have always been people who are hesitant to receive vaccinations, he said, social media and the internet have undoubtedly played a role in spreading concern.
Dr. Sonawane agreed. Online, “there are a lot of antivaccine groups that are making unwarranted claims about the vaccine’s safety,” such as that the HPV vaccine causes autism or fertility problems in women, she said. “We believe that this growing antivaccine movement in the U.S. and across the globe – which the World Health Organization has declared as one of the biggest threats right now – is also contributing to safety concerns among U.S. parents, particularly HPV vaccine safety.”
Although the study did not address strategies to combat this misinformation, Dr. Osazuwa-Peters said clinicians need to improve their communication with parents and patients. One way to do that, he said, is by bolstering an online presence and by countering vaccine disinformation with evidence-based responses on the internet. Most people get their medical information online. “Many people are just afraid because they don’t trust the messages coming from health care,” he said. “So, we need to a better job of not just providing the facts but providing the facts in a way that the end users can understand and appreciate.”
Dr. Sonawane and Dr. Osazuwa-Peters report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Despite a decrease in reported adverse events after receiving the human papillomavirus (HPV) vaccine, among parents of unvaccinated adolescents, concerns about the vaccine’s safety rose 80% from 2015 to 2018, according to research published September 17 in JAMA Network Open.
Since its approval in 2006 by the U.S. Food and Drug Administration, uptake of the HPV vaccine has consistently lagged behind that of other routine vaccinations. According to the most recent data from the Centers for Disease Control and Prevention, released September 3, 58.6% of adolescents were considered up to date with their HPV vaccinations in 2020.
Trials prior to the vaccine’s FDA approval as well as an abundance of clinical and observational evidence after it hit the market demonstrate the vaccine’s efficacy and safety, said lead author Kalyani Sonawane, PhD, an assistant professor of management, policy, and community health at the UTHealth School of Public Health, in Houston, Texas, in an interview. Still, recent research suggests that safety concerns are a main reason why parents are hesitant to have their children vaccinated, she noted.
In the study, Dr. Sonawane and colleagues analyzed data from National Immunization Survey-Teen (NIS-Teen) from 2015 through 2018. NIS-Teen is a random-digit-dialed telephone survey conducted annually by the CDC to monitor routine vaccination coverage among adolescents aged 13 to 17. The researchers identified 39,364 adolescents who had not received any HPV shots and reviewed the caregivers’ reasons for vaccine hesitancy. The research team also reviewed the Vaccine Adverse Event Reporting System (VAERS). They identified 16,621 reports that listed the HPV vaccine from 2015 through 2018.
The top five reasons caregivers cited for avoiding the HPV vaccine were the following:
- not needed or necessary
- safety concerns
- not recommended
- lack of knowledge
- not sexually active
Of these, safety concerns were the only factor that increased during the study period. They increased from 13.0% in 2015 to 23.4% in 2018. Concerns over vaccine safety rose in 30 states, with increases of over 200% in California, Hawaii, South Dakota, and Mississippi.
The proportion of unvaccinated adolescents whose caregivers thought the HPV vaccine was not needed or necessary remained steady at around 25%. Those whose caregivers listed “not recommended,” “lack of knowledge,” and “not sexually active” as reasons for avoiding vaccination decreased over the study period.
The reporting rate for adverse events following HPV vaccination decreased from 44.7 per 100,000 doses in 2015 to 29.4 per 100,000 doses in 2018. Of the reported 16,621 adverse events following HPV vaccination that occurred over the study period, 4.6% were serious, resulting in hospitalizations, disability, life-threatening events, or death. From 2015 through 2018, reporting rates for serious adverse events remained level at around 0.3 events per 100,000 doses.
This mismatch between increasing vaccine safety concerns and decreasing adverse events suggests that disinformation may be driving these concerns more than scientific fact, Nosayaba Osazuwa-Peters, PhD, MPH, an assistant professor in head and neck surgery and communication sciences at the Duke University School of Medicine, in Durham, North Carolina, told this news organization. He co-wrote an invited commentary on the study and was not involved with the research. Although there have always been people who are hesitant to receive vaccinations, he said, social media and the internet have undoubtedly played a role in spreading concern.
Dr. Sonawane agreed. Online, “there are a lot of antivaccine groups that are making unwarranted claims about the vaccine’s safety,” such as that the HPV vaccine causes autism or fertility problems in women, she said. “We believe that this growing antivaccine movement in the U.S. and across the globe – which the World Health Organization has declared as one of the biggest threats right now – is also contributing to safety concerns among U.S. parents, particularly HPV vaccine safety.”
Although the study did not address strategies to combat this misinformation, Dr. Osazuwa-Peters said clinicians need to improve their communication with parents and patients. One way to do that, he said, is by bolstering an online presence and by countering vaccine disinformation with evidence-based responses on the internet. Most people get their medical information online. “Many people are just afraid because they don’t trust the messages coming from health care,” he said. “So, we need to a better job of not just providing the facts but providing the facts in a way that the end users can understand and appreciate.”
Dr. Sonawane and Dr. Osazuwa-Peters report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adolescent immunizations and protecting our children from COVID-19
I began thinking of a topic for this column weeks ago determined to discuss anything except COVID-19. Yet, news reports from all sources blasted daily reminders of rising COVID-19 cases overall and specifically in children.
In August, school resumed for many of our patients and the battle over mandating masks for school attendance was in full swing. The fact that it is a Centers for Disease Control and Prevention recommendation supported by both the American Academy of Pediatrics and the Pediatric Infectious Disease Society fell on deaf ears. One day, I heard a report that over 25,000 students attending Texas public schools were diagnosed with COVID-19 between Aug. 23 and Aug. 29. This peak in activity occurred just 2 weeks after the start of school and led to the closure of 45 school districts. Texas does not have a monopoly on these rising cases. Delta, a more contagious variant, began circulating in June 2021 and by July it was the most predominant. Emergency department visits and hospitalizations have increased nationwide. During the latter 2 weeks of August 2021, COVID-19–related ED visits and hospitalizations for persons aged 0-17 years were 3.4 and 3.7 times higher in states with the lowest vaccination coverage, compared with states with high vaccination coverage (MMWR Morb Mortal Wkly Rep. 2021;70:1249-54). Specifically, the rates of hospitalization the week ending Aug. 14, 2021, were nearly 5 times the rates for the week ending June 26, 2021, for 0- to 17-year-olds and nearly 10 times the rates for children 0-4 years of age. Hospitalization rates were 10.1 times higher for unimmunized adolescents than for fully vaccinated ones (MMWR Morb Mortal Wkly Rep. 2021;70:1255-60).
Multiple elected state leaders have opposed interventions such as mandating masks in school, and our children are paying for it. These leaders have relinquished their responsibility to local school boards. Several have reinforced the no-mask mandate while others have had the courage and insight to ignore state government leaders and have established mask mandates.
How is this lack of enforcement of national recommendations affecting our patients? Let’s look at two neighboring school districts in Texas. School districts have COVID-19 dashboards that are updated daily and accessible to the general public. School District A requires masks for school entry. It serves 196,171 students and has 27,195 teachers and staff. Since school opened in August, 1,606 cumulative cases of COVID-19 in students (0.8%) and 282 in staff (1%) have been reported. Fifty-five percent of the student cases occurred in elementary schools. In contrast, School District B located in the adjacent county serves 64,517 students and has 3,906 teachers and staff with no mask mandate. Since August, there have been 4,506 cumulative COVID-19 cases in students (6.9%) and 578 (14.7%) in staff. Information regarding the specific school type was not provided; however, the dashboard indicates that 2,924 cases (64.8%) occurred in children younger than 11 years of age. County data indicate 62% of those older than 12 years of age were fully vaccinated in District A, compared with 54% of persons older than 12 years in District B. The county COVID-19 positivity rate in District A is 17.6% and in District B it is 20%. Both counties are experiencing increased COVID-19 activity yet have had strikingly different outcomes in the student/staff population. While supporting the case for wearing masks to prevent disease transmission, one can’t ignore the adolescents who were infected and vaccine eligible (District A: 706; District B: 1,582). Their vaccination status could not be determined.
As pediatricians we have played an integral part in the elimination of diseases through educating and administering vaccinations. Adolescents are relatively healthy, thus limiting the number of encounters with them. The majority complete the 11-year visit; however, many fail to return for the 16- to 18-year visit.
So how are we doing? CDC data from 10 U.S. jurisdictions demonstrated a substantial decrease in vaccine administration between March and May of 2020, compared with the same period in 2018 and 2019. A decline was anticipated because of the nationwide lockdown. Doses of HPV administered declined almost 64% and 71% for 9- to 12-year-olds and 13- to 17-year-olds, respectively. Tdap administration declined 66% and 61% for the same respective age groups. Although administered doses increased between June and September of 2020, it was not sufficient to achieve catch-up coverage. Compared to the same period in 2018-2019, administration of the HPV vaccine declined 12.8% and 28% (ages 9-12 and ages 13-17) and for Tdap it was 21% and 30% lower (ages 9-12 and ages 13-17) (MMWR Morb Mortal Wkly Rep. 2021;70:840-5).
Now, we have another adolescent vaccine to discuss and encourage our patients to receive. We also need to address their concerns and/or to at least direct them to a reliable source to obtain accurate information. For the first time, a recommended vaccine may not be available at their medical home. Many don’t know where to go to receive it (http://www.vaccines.gov). Results of a Kaiser Family Foundation COVID-19 survey (August 2021) indicated that parents trusted their pediatricians most often (78%) for vaccine advice. The respondents voiced concern about trusting the location where the child would be immunized and long-term effects especially related to fertility. Parents who received communications regarding the benefits of vaccination were twice as likely to have their adolescents immunized. Finally, remember: Like parent, like child. An immunized parent is more likely to immunize the adolescent. (See Fig. 1.)
It is beyond the scope of this column to discuss the psychosocial aspects of this disease: children experiencing the death of teachers, classmates, family members, and those viewing the vitriol between pro- and antimask proponents often exhibited on school premises. And let’s not forget the child who wants to wear a mask but may be ostracized or bullied for doing so.
Our job is to do our very best to advocate for and to protect our patients by promoting mandatory masks at schools and encouraging vaccination of adolescents as we patiently wait for vaccines to become available for all of our children.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures.
I began thinking of a topic for this column weeks ago determined to discuss anything except COVID-19. Yet, news reports from all sources blasted daily reminders of rising COVID-19 cases overall and specifically in children.
In August, school resumed for many of our patients and the battle over mandating masks for school attendance was in full swing. The fact that it is a Centers for Disease Control and Prevention recommendation supported by both the American Academy of Pediatrics and the Pediatric Infectious Disease Society fell on deaf ears. One day, I heard a report that over 25,000 students attending Texas public schools were diagnosed with COVID-19 between Aug. 23 and Aug. 29. This peak in activity occurred just 2 weeks after the start of school and led to the closure of 45 school districts. Texas does not have a monopoly on these rising cases. Delta, a more contagious variant, began circulating in June 2021 and by July it was the most predominant. Emergency department visits and hospitalizations have increased nationwide. During the latter 2 weeks of August 2021, COVID-19–related ED visits and hospitalizations for persons aged 0-17 years were 3.4 and 3.7 times higher in states with the lowest vaccination coverage, compared with states with high vaccination coverage (MMWR Morb Mortal Wkly Rep. 2021;70:1249-54). Specifically, the rates of hospitalization the week ending Aug. 14, 2021, were nearly 5 times the rates for the week ending June 26, 2021, for 0- to 17-year-olds and nearly 10 times the rates for children 0-4 years of age. Hospitalization rates were 10.1 times higher for unimmunized adolescents than for fully vaccinated ones (MMWR Morb Mortal Wkly Rep. 2021;70:1255-60).
Multiple elected state leaders have opposed interventions such as mandating masks in school, and our children are paying for it. These leaders have relinquished their responsibility to local school boards. Several have reinforced the no-mask mandate while others have had the courage and insight to ignore state government leaders and have established mask mandates.
How is this lack of enforcement of national recommendations affecting our patients? Let’s look at two neighboring school districts in Texas. School districts have COVID-19 dashboards that are updated daily and accessible to the general public. School District A requires masks for school entry. It serves 196,171 students and has 27,195 teachers and staff. Since school opened in August, 1,606 cumulative cases of COVID-19 in students (0.8%) and 282 in staff (1%) have been reported. Fifty-five percent of the student cases occurred in elementary schools. In contrast, School District B located in the adjacent county serves 64,517 students and has 3,906 teachers and staff with no mask mandate. Since August, there have been 4,506 cumulative COVID-19 cases in students (6.9%) and 578 (14.7%) in staff. Information regarding the specific school type was not provided; however, the dashboard indicates that 2,924 cases (64.8%) occurred in children younger than 11 years of age. County data indicate 62% of those older than 12 years of age were fully vaccinated in District A, compared with 54% of persons older than 12 years in District B. The county COVID-19 positivity rate in District A is 17.6% and in District B it is 20%. Both counties are experiencing increased COVID-19 activity yet have had strikingly different outcomes in the student/staff population. While supporting the case for wearing masks to prevent disease transmission, one can’t ignore the adolescents who were infected and vaccine eligible (District A: 706; District B: 1,582). Their vaccination status could not be determined.
As pediatricians we have played an integral part in the elimination of diseases through educating and administering vaccinations. Adolescents are relatively healthy, thus limiting the number of encounters with them. The majority complete the 11-year visit; however, many fail to return for the 16- to 18-year visit.
So how are we doing? CDC data from 10 U.S. jurisdictions demonstrated a substantial decrease in vaccine administration between March and May of 2020, compared with the same period in 2018 and 2019. A decline was anticipated because of the nationwide lockdown. Doses of HPV administered declined almost 64% and 71% for 9- to 12-year-olds and 13- to 17-year-olds, respectively. Tdap administration declined 66% and 61% for the same respective age groups. Although administered doses increased between June and September of 2020, it was not sufficient to achieve catch-up coverage. Compared to the same period in 2018-2019, administration of the HPV vaccine declined 12.8% and 28% (ages 9-12 and ages 13-17) and for Tdap it was 21% and 30% lower (ages 9-12 and ages 13-17) (MMWR Morb Mortal Wkly Rep. 2021;70:840-5).
Now, we have another adolescent vaccine to discuss and encourage our patients to receive. We also need to address their concerns and/or to at least direct them to a reliable source to obtain accurate information. For the first time, a recommended vaccine may not be available at their medical home. Many don’t know where to go to receive it (http://www.vaccines.gov). Results of a Kaiser Family Foundation COVID-19 survey (August 2021) indicated that parents trusted their pediatricians most often (78%) for vaccine advice. The respondents voiced concern about trusting the location where the child would be immunized and long-term effects especially related to fertility. Parents who received communications regarding the benefits of vaccination were twice as likely to have their adolescents immunized. Finally, remember: Like parent, like child. An immunized parent is more likely to immunize the adolescent. (See Fig. 1.)
It is beyond the scope of this column to discuss the psychosocial aspects of this disease: children experiencing the death of teachers, classmates, family members, and those viewing the vitriol between pro- and antimask proponents often exhibited on school premises. And let’s not forget the child who wants to wear a mask but may be ostracized or bullied for doing so.
Our job is to do our very best to advocate for and to protect our patients by promoting mandatory masks at schools and encouraging vaccination of adolescents as we patiently wait for vaccines to become available for all of our children.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures.
I began thinking of a topic for this column weeks ago determined to discuss anything except COVID-19. Yet, news reports from all sources blasted daily reminders of rising COVID-19 cases overall and specifically in children.
In August, school resumed for many of our patients and the battle over mandating masks for school attendance was in full swing. The fact that it is a Centers for Disease Control and Prevention recommendation supported by both the American Academy of Pediatrics and the Pediatric Infectious Disease Society fell on deaf ears. One day, I heard a report that over 25,000 students attending Texas public schools were diagnosed with COVID-19 between Aug. 23 and Aug. 29. This peak in activity occurred just 2 weeks after the start of school and led to the closure of 45 school districts. Texas does not have a monopoly on these rising cases. Delta, a more contagious variant, began circulating in June 2021 and by July it was the most predominant. Emergency department visits and hospitalizations have increased nationwide. During the latter 2 weeks of August 2021, COVID-19–related ED visits and hospitalizations for persons aged 0-17 years were 3.4 and 3.7 times higher in states with the lowest vaccination coverage, compared with states with high vaccination coverage (MMWR Morb Mortal Wkly Rep. 2021;70:1249-54). Specifically, the rates of hospitalization the week ending Aug. 14, 2021, were nearly 5 times the rates for the week ending June 26, 2021, for 0- to 17-year-olds and nearly 10 times the rates for children 0-4 years of age. Hospitalization rates were 10.1 times higher for unimmunized adolescents than for fully vaccinated ones (MMWR Morb Mortal Wkly Rep. 2021;70:1255-60).
Multiple elected state leaders have opposed interventions such as mandating masks in school, and our children are paying for it. These leaders have relinquished their responsibility to local school boards. Several have reinforced the no-mask mandate while others have had the courage and insight to ignore state government leaders and have established mask mandates.
How is this lack of enforcement of national recommendations affecting our patients? Let’s look at two neighboring school districts in Texas. School districts have COVID-19 dashboards that are updated daily and accessible to the general public. School District A requires masks for school entry. It serves 196,171 students and has 27,195 teachers and staff. Since school opened in August, 1,606 cumulative cases of COVID-19 in students (0.8%) and 282 in staff (1%) have been reported. Fifty-five percent of the student cases occurred in elementary schools. In contrast, School District B located in the adjacent county serves 64,517 students and has 3,906 teachers and staff with no mask mandate. Since August, there have been 4,506 cumulative COVID-19 cases in students (6.9%) and 578 (14.7%) in staff. Information regarding the specific school type was not provided; however, the dashboard indicates that 2,924 cases (64.8%) occurred in children younger than 11 years of age. County data indicate 62% of those older than 12 years of age were fully vaccinated in District A, compared with 54% of persons older than 12 years in District B. The county COVID-19 positivity rate in District A is 17.6% and in District B it is 20%. Both counties are experiencing increased COVID-19 activity yet have had strikingly different outcomes in the student/staff population. While supporting the case for wearing masks to prevent disease transmission, one can’t ignore the adolescents who were infected and vaccine eligible (District A: 706; District B: 1,582). Their vaccination status could not be determined.
As pediatricians we have played an integral part in the elimination of diseases through educating and administering vaccinations. Adolescents are relatively healthy, thus limiting the number of encounters with them. The majority complete the 11-year visit; however, many fail to return for the 16- to 18-year visit.
So how are we doing? CDC data from 10 U.S. jurisdictions demonstrated a substantial decrease in vaccine administration between March and May of 2020, compared with the same period in 2018 and 2019. A decline was anticipated because of the nationwide lockdown. Doses of HPV administered declined almost 64% and 71% for 9- to 12-year-olds and 13- to 17-year-olds, respectively. Tdap administration declined 66% and 61% for the same respective age groups. Although administered doses increased between June and September of 2020, it was not sufficient to achieve catch-up coverage. Compared to the same period in 2018-2019, administration of the HPV vaccine declined 12.8% and 28% (ages 9-12 and ages 13-17) and for Tdap it was 21% and 30% lower (ages 9-12 and ages 13-17) (MMWR Morb Mortal Wkly Rep. 2021;70:840-5).
Now, we have another adolescent vaccine to discuss and encourage our patients to receive. We also need to address their concerns and/or to at least direct them to a reliable source to obtain accurate information. For the first time, a recommended vaccine may not be available at their medical home. Many don’t know where to go to receive it (http://www.vaccines.gov). Results of a Kaiser Family Foundation COVID-19 survey (August 2021) indicated that parents trusted their pediatricians most often (78%) for vaccine advice. The respondents voiced concern about trusting the location where the child would be immunized and long-term effects especially related to fertility. Parents who received communications regarding the benefits of vaccination were twice as likely to have their adolescents immunized. Finally, remember: Like parent, like child. An immunized parent is more likely to immunize the adolescent. (See Fig. 1.)
It is beyond the scope of this column to discuss the psychosocial aspects of this disease: children experiencing the death of teachers, classmates, family members, and those viewing the vitriol between pro- and antimask proponents often exhibited on school premises. And let’s not forget the child who wants to wear a mask but may be ostracized or bullied for doing so.
Our job is to do our very best to advocate for and to protect our patients by promoting mandatory masks at schools and encouraging vaccination of adolescents as we patiently wait for vaccines to become available for all of our children.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures.
Navigating parenthood as pediatricians
PHM 2021 session
The Baby at Work or the Baby at Home: Navigating Parenthood as Pediatricians
Presenters
Jessica Gold, MD; Dana Foradori, MD, MEd; Nivedita Srinivas, MD; Honora Burnett, MD; Julie Pantaleoni, MD; and Barrett Fromme, MD, MHPE
Session summary
A group of physician-mothers from multiple academic children’s hospitals came together in a storytelling format to discuss topics relating to being a parent and pediatric hospitalist. Through short and poignant stories, the presenters shared their experiences and reviewed recent literature and policy changes relating to the topic. This mini-plenary focused on three themes:
1. Easing the transition back to work after the birth of a child.
2. Coping with the tension between being a parent and pediatrician.
3. The role that divisions, departments, and institutions can play in supporting parents and promoting workplace engagement.
The session concluded with a robust question-and-answer portion where participants built upon the themes above and shared their own experiences as pediatric hospitalist parents.
Key takeaways
- “Use your voice.” Physicians who are parents must continue having conversations about the challenging aspects of being a parent and hospitalist and advocate for the changes they would like to see.
- There will always be tension as a physician parent, but we can learn to embrace it while also learning how to ask for help, set boundaries, and share when we are struggling.
- There are numerous challenges for hospitalists who are parents because of poor parental leave policies in the United States, but this is slowly changing. For example, starting in July 2021, the ACGME mandated 6 weeks of parental leave during training without having to extend training.
- “You are not alone.” The presenters emphasized that their reason for hosting this session was to shed light on this topic and let all pediatric hospitalist parents know that they are not alone in this experience.
Dr. Scott is a second-year pediatric hospital medicine fellow at New York–Presbyterian Columbia/Cornell. Her academic interests are in curriculum development and evaluation in medical education with a focus on telemedicine.
PHM 2021 session
The Baby at Work or the Baby at Home: Navigating Parenthood as Pediatricians
Presenters
Jessica Gold, MD; Dana Foradori, MD, MEd; Nivedita Srinivas, MD; Honora Burnett, MD; Julie Pantaleoni, MD; and Barrett Fromme, MD, MHPE
Session summary
A group of physician-mothers from multiple academic children’s hospitals came together in a storytelling format to discuss topics relating to being a parent and pediatric hospitalist. Through short and poignant stories, the presenters shared their experiences and reviewed recent literature and policy changes relating to the topic. This mini-plenary focused on three themes:
1. Easing the transition back to work after the birth of a child.
2. Coping with the tension between being a parent and pediatrician.
3. The role that divisions, departments, and institutions can play in supporting parents and promoting workplace engagement.
The session concluded with a robust question-and-answer portion where participants built upon the themes above and shared their own experiences as pediatric hospitalist parents.
Key takeaways
- “Use your voice.” Physicians who are parents must continue having conversations about the challenging aspects of being a parent and hospitalist and advocate for the changes they would like to see.
- There will always be tension as a physician parent, but we can learn to embrace it while also learning how to ask for help, set boundaries, and share when we are struggling.
- There are numerous challenges for hospitalists who are parents because of poor parental leave policies in the United States, but this is slowly changing. For example, starting in July 2021, the ACGME mandated 6 weeks of parental leave during training without having to extend training.
- “You are not alone.” The presenters emphasized that their reason for hosting this session was to shed light on this topic and let all pediatric hospitalist parents know that they are not alone in this experience.
Dr. Scott is a second-year pediatric hospital medicine fellow at New York–Presbyterian Columbia/Cornell. Her academic interests are in curriculum development and evaluation in medical education with a focus on telemedicine.
PHM 2021 session
The Baby at Work or the Baby at Home: Navigating Parenthood as Pediatricians
Presenters
Jessica Gold, MD; Dana Foradori, MD, MEd; Nivedita Srinivas, MD; Honora Burnett, MD; Julie Pantaleoni, MD; and Barrett Fromme, MD, MHPE
Session summary
A group of physician-mothers from multiple academic children’s hospitals came together in a storytelling format to discuss topics relating to being a parent and pediatric hospitalist. Through short and poignant stories, the presenters shared their experiences and reviewed recent literature and policy changes relating to the topic. This mini-plenary focused on three themes:
1. Easing the transition back to work after the birth of a child.
2. Coping with the tension between being a parent and pediatrician.
3. The role that divisions, departments, and institutions can play in supporting parents and promoting workplace engagement.
The session concluded with a robust question-and-answer portion where participants built upon the themes above and shared their own experiences as pediatric hospitalist parents.
Key takeaways
- “Use your voice.” Physicians who are parents must continue having conversations about the challenging aspects of being a parent and hospitalist and advocate for the changes they would like to see.
- There will always be tension as a physician parent, but we can learn to embrace it while also learning how to ask for help, set boundaries, and share when we are struggling.
- There are numerous challenges for hospitalists who are parents because of poor parental leave policies in the United States, but this is slowly changing. For example, starting in July 2021, the ACGME mandated 6 weeks of parental leave during training without having to extend training.
- “You are not alone.” The presenters emphasized that their reason for hosting this session was to shed light on this topic and let all pediatric hospitalist parents know that they are not alone in this experience.
Dr. Scott is a second-year pediatric hospital medicine fellow at New York–Presbyterian Columbia/Cornell. Her academic interests are in curriculum development and evaluation in medical education with a focus on telemedicine.
COVID vaccine is safe, effective for children aged 5-11, Pfizer says
With record numbers of COVID-19 cases being reported in kids, Pfizer and its partner BioNTech have announced that their mRNA vaccine for COVID-19 is safe and appears to generate a protective immune response in children as young as 5.
The companies have been testing a lower dose of the vaccine -- just 10 milligrams -- in children between the ages of 5 and 11. That’s one-third the dose given to adults.
In a clinical trial that included more than 2,200 children, Pfizer says two doses of the vaccines given 3 weeks apart generated a high level of neutralizing antibodies, comparable to the level seen in older children who get a higher dose of the vaccine.
On the advice of its vaccine advisory committee, the Food and Drug Administration asked vaccine makers to include more children in these studies earlier this year.
Rather than testing whether the vaccines are preventing COVID-19 illness in children, as they did in adults, the pharmaceutical companies that make the COVID-19 vaccines are looking at the antibody levels generated by the vaccines instead. The FDA has approved the approach in hopes of speeding vaccines to children, who are now back in school full time in most parts of the United States.
With that in mind, Evan Anderson, MD, a doctor with Children’s Healthcare of Atlanta who is an investigator for the trial — and is therefore kept in the dark about its results — said it’s important to keep in mind that the company didn’t share any efficacy data today.
“We don’t know whether there were cases of COVID-19 among children that were enrolled in the study and how those compared in those who received placebo versus those that received vaccine,” he said.
The company says side effects seen in the trial are comparable to those seen in older children. The company said there were no cases of heart inflammation called myocarditis observed. Pfizer says they plan to send their data to the FDA as soon as possible.
The company says side effects seen in the trial are comparable to those seen in older children. Pfizer says they plan to send their data to the FDA as soon as possible.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in a news release. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
When asked how soon the FDA might act on Pfizer’s application, Anderson said others had speculated about timelines of 4 to 6 weeks, but he also noted that the FDA could still exercise its authority to ask the company for more information, which could slow the process down.
“As a parent myself, I would love to see that timeline occurring quickly. However, I do want the FDA to fully review the data and ask the necessary questions,” he said. “It’s a little speculative to get too definitive with timelines.”
A version of this article first appeared on WebMD.com.
With record numbers of COVID-19 cases being reported in kids, Pfizer and its partner BioNTech have announced that their mRNA vaccine for COVID-19 is safe and appears to generate a protective immune response in children as young as 5.
The companies have been testing a lower dose of the vaccine -- just 10 milligrams -- in children between the ages of 5 and 11. That’s one-third the dose given to adults.
In a clinical trial that included more than 2,200 children, Pfizer says two doses of the vaccines given 3 weeks apart generated a high level of neutralizing antibodies, comparable to the level seen in older children who get a higher dose of the vaccine.
On the advice of its vaccine advisory committee, the Food and Drug Administration asked vaccine makers to include more children in these studies earlier this year.
Rather than testing whether the vaccines are preventing COVID-19 illness in children, as they did in adults, the pharmaceutical companies that make the COVID-19 vaccines are looking at the antibody levels generated by the vaccines instead. The FDA has approved the approach in hopes of speeding vaccines to children, who are now back in school full time in most parts of the United States.
With that in mind, Evan Anderson, MD, a doctor with Children’s Healthcare of Atlanta who is an investigator for the trial — and is therefore kept in the dark about its results — said it’s important to keep in mind that the company didn’t share any efficacy data today.
“We don’t know whether there were cases of COVID-19 among children that were enrolled in the study and how those compared in those who received placebo versus those that received vaccine,” he said.
The company says side effects seen in the trial are comparable to those seen in older children. The company said there were no cases of heart inflammation called myocarditis observed. Pfizer says they plan to send their data to the FDA as soon as possible.
The company says side effects seen in the trial are comparable to those seen in older children. Pfizer says they plan to send their data to the FDA as soon as possible.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in a news release. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
When asked how soon the FDA might act on Pfizer’s application, Anderson said others had speculated about timelines of 4 to 6 weeks, but he also noted that the FDA could still exercise its authority to ask the company for more information, which could slow the process down.
“As a parent myself, I would love to see that timeline occurring quickly. However, I do want the FDA to fully review the data and ask the necessary questions,” he said. “It’s a little speculative to get too definitive with timelines.”
A version of this article first appeared on WebMD.com.
With record numbers of COVID-19 cases being reported in kids, Pfizer and its partner BioNTech have announced that their mRNA vaccine for COVID-19 is safe and appears to generate a protective immune response in children as young as 5.
The companies have been testing a lower dose of the vaccine -- just 10 milligrams -- in children between the ages of 5 and 11. That’s one-third the dose given to adults.
In a clinical trial that included more than 2,200 children, Pfizer says two doses of the vaccines given 3 weeks apart generated a high level of neutralizing antibodies, comparable to the level seen in older children who get a higher dose of the vaccine.
On the advice of its vaccine advisory committee, the Food and Drug Administration asked vaccine makers to include more children in these studies earlier this year.
Rather than testing whether the vaccines are preventing COVID-19 illness in children, as they did in adults, the pharmaceutical companies that make the COVID-19 vaccines are looking at the antibody levels generated by the vaccines instead. The FDA has approved the approach in hopes of speeding vaccines to children, who are now back in school full time in most parts of the United States.
With that in mind, Evan Anderson, MD, a doctor with Children’s Healthcare of Atlanta who is an investigator for the trial — and is therefore kept in the dark about its results — said it’s important to keep in mind that the company didn’t share any efficacy data today.
“We don’t know whether there were cases of COVID-19 among children that were enrolled in the study and how those compared in those who received placebo versus those that received vaccine,” he said.
The company says side effects seen in the trial are comparable to those seen in older children. The company said there were no cases of heart inflammation called myocarditis observed. Pfizer says they plan to send their data to the FDA as soon as possible.
The company says side effects seen in the trial are comparable to those seen in older children. Pfizer says they plan to send their data to the FDA as soon as possible.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in a news release. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
When asked how soon the FDA might act on Pfizer’s application, Anderson said others had speculated about timelines of 4 to 6 weeks, but he also noted that the FDA could still exercise its authority to ask the company for more information, which could slow the process down.
“As a parent myself, I would love to see that timeline occurring quickly. However, I do want the FDA to fully review the data and ask the necessary questions,” he said. “It’s a little speculative to get too definitive with timelines.”
A version of this article first appeared on WebMD.com.
Parent-led intervention linked with decreased autism symptoms in at-risk infants
These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.
“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
Study intervention is a nontraditonal approach
Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”
Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.
“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”
“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.
Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).
The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
Other research has shown benefits of new study approach
This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.
Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”
The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
New study shows value of parent-mediated interventions
Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.
“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”
“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.
“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”
What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”
This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.
These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.
“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
Study intervention is a nontraditonal approach
Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”
Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.
“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”
“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.
Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).
The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
Other research has shown benefits of new study approach
This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.
Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”
The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
New study shows value of parent-mediated interventions
Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.
“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”
“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.
“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”
What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”
This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.
These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.
“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
Study intervention is a nontraditonal approach
Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”
Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.
“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”
“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.
Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).
The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
Other research has shown benefits of new study approach
This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.
Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”
The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
New study shows value of parent-mediated interventions
Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.
“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”
“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.
“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”
What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”
This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.
FROM JAMA PEDIATRICS