User login
Measles complications in the U.S. unchanged in posteradication era
CHICAGO – An evaluation of the measles threat in the modern era gives no indication that the risk of complications or death is any different than it was before a vaccine became available, according to an analysis of inpatient complications between 2002 and 2013.
In 2000, measles was declared eliminated in the United States, but for those who have been infected since that time, the risk of serious complications and death has not diminished, noted Raj Chovatiya, MD, PhD, in a session at the annual meeting of the Society for Investigative Dermatology.
By eliminated, the Centers of Disease Control and Prevention – which reported 86 confirmed cases of measles in 2000 – was referring to a technical definition of no new endemic or continuous transmissions in the previous 12 months. It was expected that a modest number of cases of this reportable disease would continue to accrue for an infection that remains common elsewhere in the world.
“Worldwide there are about 20 million cases of measles annually with an estimated 100,000 deaths attributed to this cause,” said Dr. Chovatiya, who is a dermatology resident at Northwestern University, Chicago.
In the United States, posteradication infection rates remained at low levels for several years but were already rising from 2002 to 2013, when Dr. Chovatiya and his coinvestigators sought to describe the incidence, associations, comorbidities, and outcomes of hospitalizations for measles. Toward the end of the period the researchers were examining the incidence rates climbed more steeply.
“So far this year, 764 CDC cases of measles [were] reported. That is the most we have seen in the U.S. since 1994,” Dr. Chovatiya said.
Based on his analysis of hospitalizations from 2002 to 2013, the threat of these outbreaks is no different then that before the disease was declared eliminated or before a vaccine became available.
The cross-sectional study was conducted with data from the Nationwide Inpatient Sample, an all-payer database that is considered to be a representative of national trends.
Characteristic of measles, the majority of the 582 hospitalizations evaluated over this period occurred in children aged between 1 and 9 years. The proportion of patients with preexisting chronic comorbid conditions was low. Rather, “most were pretty healthy” prior to admission, according to Dr. Chovatiya, who said that the majority of admissions were from an emergency department.
Measles, which targets epithelial cells and depresses the immune system, is a potentially serious disease because of its ability to produce complications in essentially every organ of the body, including the lungs, kidneys, blood, and central nervous system. Consistent with past studies, the most common complication in this series was pneumonia, observed in 20% of patients. The list of other serious complications identified in this study period, including encephalitis and acute renal failure, was long.
“We observed death in 4.3% of our 582 cases, or about 25 cases,” reported Dr. Chovatiya. He indicated that this is a high percentage among a population composed largely of children who were well before hospitalization.
The mortality rate from measles was numerically but not statistically higher than that of overall hospital admissions during this period, but an admission for measles was associated with significantly longer average length of stay (3.7 vs. 3.5 days) and slightly but significantly higher direct costs ($18,907 vs. $18,474).
“I want to point out that these are just direct inpatient costs,” Dr. Chovatiya said. Extrapolating from published data about indirect expenses, he said that the total health cost burden “is absolutely staggering.”
Previous studies have suggested that about 25% of patients with measles require hospitalization and 1 in every 1,000 patients will die. The data collected by Dr. Chovatiya support these often-cited figures, indicating that they remain unchanged in the modern era.
particularly insufficient penetration of vaccination in many communities.
The vaccine “is inexpensive, extremely effective, and lifesaving,” said Dr. Chovatiya, making the point that all of the morbidity, mortality, and costs he described are largely avoidable.
Attempting to provide perspective of the measles threat and the impact of the vaccine, Dr. Chovatiya cited a hypothetical calculation that 732,000 deaths from measles would have been expected in the United States among the pool of children born between 1994 and 2013 had no vaccine been offered. Again, most of these deaths would have occurred in otherwise healthy children.
Dr. Chovatiya reported no potential conflicts of interest.
CHICAGO – An evaluation of the measles threat in the modern era gives no indication that the risk of complications or death is any different than it was before a vaccine became available, according to an analysis of inpatient complications between 2002 and 2013.
In 2000, measles was declared eliminated in the United States, but for those who have been infected since that time, the risk of serious complications and death has not diminished, noted Raj Chovatiya, MD, PhD, in a session at the annual meeting of the Society for Investigative Dermatology.
By eliminated, the Centers of Disease Control and Prevention – which reported 86 confirmed cases of measles in 2000 – was referring to a technical definition of no new endemic or continuous transmissions in the previous 12 months. It was expected that a modest number of cases of this reportable disease would continue to accrue for an infection that remains common elsewhere in the world.
“Worldwide there are about 20 million cases of measles annually with an estimated 100,000 deaths attributed to this cause,” said Dr. Chovatiya, who is a dermatology resident at Northwestern University, Chicago.
In the United States, posteradication infection rates remained at low levels for several years but were already rising from 2002 to 2013, when Dr. Chovatiya and his coinvestigators sought to describe the incidence, associations, comorbidities, and outcomes of hospitalizations for measles. Toward the end of the period the researchers were examining the incidence rates climbed more steeply.
“So far this year, 764 CDC cases of measles [were] reported. That is the most we have seen in the U.S. since 1994,” Dr. Chovatiya said.
Based on his analysis of hospitalizations from 2002 to 2013, the threat of these outbreaks is no different then that before the disease was declared eliminated or before a vaccine became available.
The cross-sectional study was conducted with data from the Nationwide Inpatient Sample, an all-payer database that is considered to be a representative of national trends.
Characteristic of measles, the majority of the 582 hospitalizations evaluated over this period occurred in children aged between 1 and 9 years. The proportion of patients with preexisting chronic comorbid conditions was low. Rather, “most were pretty healthy” prior to admission, according to Dr. Chovatiya, who said that the majority of admissions were from an emergency department.
Measles, which targets epithelial cells and depresses the immune system, is a potentially serious disease because of its ability to produce complications in essentially every organ of the body, including the lungs, kidneys, blood, and central nervous system. Consistent with past studies, the most common complication in this series was pneumonia, observed in 20% of patients. The list of other serious complications identified in this study period, including encephalitis and acute renal failure, was long.
“We observed death in 4.3% of our 582 cases, or about 25 cases,” reported Dr. Chovatiya. He indicated that this is a high percentage among a population composed largely of children who were well before hospitalization.
The mortality rate from measles was numerically but not statistically higher than that of overall hospital admissions during this period, but an admission for measles was associated with significantly longer average length of stay (3.7 vs. 3.5 days) and slightly but significantly higher direct costs ($18,907 vs. $18,474).
“I want to point out that these are just direct inpatient costs,” Dr. Chovatiya said. Extrapolating from published data about indirect expenses, he said that the total health cost burden “is absolutely staggering.”
Previous studies have suggested that about 25% of patients with measles require hospitalization and 1 in every 1,000 patients will die. The data collected by Dr. Chovatiya support these often-cited figures, indicating that they remain unchanged in the modern era.
particularly insufficient penetration of vaccination in many communities.
The vaccine “is inexpensive, extremely effective, and lifesaving,” said Dr. Chovatiya, making the point that all of the morbidity, mortality, and costs he described are largely avoidable.
Attempting to provide perspective of the measles threat and the impact of the vaccine, Dr. Chovatiya cited a hypothetical calculation that 732,000 deaths from measles would have been expected in the United States among the pool of children born between 1994 and 2013 had no vaccine been offered. Again, most of these deaths would have occurred in otherwise healthy children.
Dr. Chovatiya reported no potential conflicts of interest.
CHICAGO – An evaluation of the measles threat in the modern era gives no indication that the risk of complications or death is any different than it was before a vaccine became available, according to an analysis of inpatient complications between 2002 and 2013.
In 2000, measles was declared eliminated in the United States, but for those who have been infected since that time, the risk of serious complications and death has not diminished, noted Raj Chovatiya, MD, PhD, in a session at the annual meeting of the Society for Investigative Dermatology.
By eliminated, the Centers of Disease Control and Prevention – which reported 86 confirmed cases of measles in 2000 – was referring to a technical definition of no new endemic or continuous transmissions in the previous 12 months. It was expected that a modest number of cases of this reportable disease would continue to accrue for an infection that remains common elsewhere in the world.
“Worldwide there are about 20 million cases of measles annually with an estimated 100,000 deaths attributed to this cause,” said Dr. Chovatiya, who is a dermatology resident at Northwestern University, Chicago.
In the United States, posteradication infection rates remained at low levels for several years but were already rising from 2002 to 2013, when Dr. Chovatiya and his coinvestigators sought to describe the incidence, associations, comorbidities, and outcomes of hospitalizations for measles. Toward the end of the period the researchers were examining the incidence rates climbed more steeply.
“So far this year, 764 CDC cases of measles [were] reported. That is the most we have seen in the U.S. since 1994,” Dr. Chovatiya said.
Based on his analysis of hospitalizations from 2002 to 2013, the threat of these outbreaks is no different then that before the disease was declared eliminated or before a vaccine became available.
The cross-sectional study was conducted with data from the Nationwide Inpatient Sample, an all-payer database that is considered to be a representative of national trends.
Characteristic of measles, the majority of the 582 hospitalizations evaluated over this period occurred in children aged between 1 and 9 years. The proportion of patients with preexisting chronic comorbid conditions was low. Rather, “most were pretty healthy” prior to admission, according to Dr. Chovatiya, who said that the majority of admissions were from an emergency department.
Measles, which targets epithelial cells and depresses the immune system, is a potentially serious disease because of its ability to produce complications in essentially every organ of the body, including the lungs, kidneys, blood, and central nervous system. Consistent with past studies, the most common complication in this series was pneumonia, observed in 20% of patients. The list of other serious complications identified in this study period, including encephalitis and acute renal failure, was long.
“We observed death in 4.3% of our 582 cases, or about 25 cases,” reported Dr. Chovatiya. He indicated that this is a high percentage among a population composed largely of children who were well before hospitalization.
The mortality rate from measles was numerically but not statistically higher than that of overall hospital admissions during this period, but an admission for measles was associated with significantly longer average length of stay (3.7 vs. 3.5 days) and slightly but significantly higher direct costs ($18,907 vs. $18,474).
“I want to point out that these are just direct inpatient costs,” Dr. Chovatiya said. Extrapolating from published data about indirect expenses, he said that the total health cost burden “is absolutely staggering.”
Previous studies have suggested that about 25% of patients with measles require hospitalization and 1 in every 1,000 patients will die. The data collected by Dr. Chovatiya support these often-cited figures, indicating that they remain unchanged in the modern era.
particularly insufficient penetration of vaccination in many communities.
The vaccine “is inexpensive, extremely effective, and lifesaving,” said Dr. Chovatiya, making the point that all of the morbidity, mortality, and costs he described are largely avoidable.
Attempting to provide perspective of the measles threat and the impact of the vaccine, Dr. Chovatiya cited a hypothetical calculation that 732,000 deaths from measles would have been expected in the United States among the pool of children born between 1994 and 2013 had no vaccine been offered. Again, most of these deaths would have occurred in otherwise healthy children.
Dr. Chovatiya reported no potential conflicts of interest.
REPORTING FROM SID 2019
Maternal immunization protects against serious RSV infection in infancy
LJUBLJANA, SLOVENIA – Passive protection of infants from severe respiratory syncytial virus lower respiratory tract infection during the first 6 months of life has convincingly been achieved through maternal immunization using a novel nanoparticle vaccine in the landmark PREPARE trial.
“I think it’s important for everyone, especially people like myself who’ve been working on maternal immunization for about 20 years, to realize that this is a historic study,” Flor M. Munoz, MD, declared in reporting the study results at the annual meeting of the European Society for Paediatric Infectious Diseases.
“We have here for the first time a phase-3, global, randomized, placebo-controlled, observer-blinded clinical trial looking at an experimental vaccine in pregnant women for the protection of infants from a disease for which we really don’t have other potential solutions quite yet, and in a period of high vulnerability,” said Dr. Munoz, a pediatric infectious disease specialist at Baylor College of Medicine, Houston.
Indeed, respiratory syncytial virus (RSV) is the No. 2 cause of mortality worldwide during the first year of life. Moreover, most cases of severe RSV lower respiratory tract infection occur in otherwise healthy infants aged less than 5 months, when active immunization presents daunting challenges.
“While certainly mortality is uncommon in high-income countries, we do see significant hospitalization there due to severe RSV lower respiratory tract infection in the first year of life, sometimes more than other common diseases, like influenza,” she noted.
PREPARE included 4,636 women with low-risk pregnancies who were randomized 2:1 to a single intramuscular injection of the investigational RSV vaccine or placebo during gestational weeks 28-36, with efficacy assessed through the first 180 days of life. The study took place at 87 sites in 11 countries during 4 years worth of RSV seasons. Roughly half of participants were South African, one-quarter were in the United States, and the rest were drawn from nine other low-, middle-, or high-income countries in the Northern and Southern Hemispheres. The median gestational age at vaccination was 32 weeks.
The primary efficacy endpoint specified by the Food and Drug Administration – but not other regulatory agencies – was the placebo-subtracted rate of RSV lower respiratory tract infection as defined by RSV detected by reverse transcription polymerase chain reaction, along with at least one clinical manifestation of lower respiratory tract infection, oxygen saturation below 95%, and/or tachypnea. The risk of this outcome was reduced by 39% during the first 90 days of life and by 27% through 180 days in infants in the maternal immunization group, a difference which didn’t achieve statistical significance.
However, prespecified major secondary endpoints arguably of greater clinical relevance were consistently positive. Notably, when levels of transplacentally transferred neutralizing antibodies against RSV A and B were highest, with events occurring in 57 of 2,765 evaluable infants in the active treatment arm and in 53 of 1,430 controls. Similarly, there was a 40% reduction through day 180. Moreover, rates of another key secondary endpoint – RSV lower respiratory tract infection plus severe hypoxemia with an oxygen saturation below 92% – were reduced by 48% and 42% through days 90 and 180, respectively. Thus, the vaccine’s protective effect was greatest against the most severe outcomes of RSV infection in infancy, according to Dr. Munoz.
No safety signals related to this immunization strategy were seen during 1 year of follow-up of infants and 6 months for the mothers. Side effects were essentially limited to mild, self-limited injection site reactions, with zero impact on pregnancy and delivery.
An intriguing finding in an exploratory analysis was that the vaccine appeared to have ancillary benefits beyond prevention of medically significant RSV disease in the young infants. For example, the rate of all lower respiratory tract infections with severe hypoxemia – with no requirement for demonstration of RSV infection – was reduced by 46% during the first 90 days of life in the immunized group. Similarly, the rate of all-cause lower respiratory tract infection resulting in hospitalization was reduced by 28%.
“This is actually quite interesting, because these are unexpected benefits in terms of all-cause effects,” the pediatrician commented, adding that she and her coinvestigators are delving into this phenomenon in order to gain better understanding.
Additional analyses of the recently completed PREPARE study are ongoing but already have yielded some important findings. For example, women immunized before 33 weeks’ gestation had significantly greater transplacental antibody transfer than those immunized later in pregnancy, with resultant markedly greater vaccine efficacy in their offspring as well: A placebo-subtracted 70% reduction in RSV lower respiratory tract infection with severe hypoxemia through 90 days, compared with a 44% reduction associated with immunization at gestational week 33 or later. And when the interval between immunization and delivery was at least 30 days, the risk of this endpoint was reduced by 65%; in contrast, there was no significant difference between vaccine and placebo groups when time from immunization to delivery was less than 30 days.
Also noteworthy was that maternal immunization afforded no infant protection in the United States. This unanticipated finding is still under investigation, although suspicion centers around the fact that RSV seasons were generally milder there, and American women were vaccinated at a later gestational age, with a corresponding shorter interval to delivery.
The novel recombinant nanoparticle vaccine tested in PREPARE contains a nearly full-length RSV fusion protein produced in insect cells. The nanoparticles express both prefusion epitopes and epitopes common to pre- and postfusion conformations. Aluminum phosphate is employed as the adjuvant.
Novavax’s stock price has been kicked to the curb since the company earlier reported that a large phase 3 trial of the vaccine failed to meet its primary endpoint for prevention of RSV lower respiratory tract infection in older adults. Now the vaccine’s failure to meet its prespecified FDA-mandated primary endpoint in the maternal immunization study will doubtless spawn further financially dismissive headlines in the business press as well.
But pediatricians are famously advocates for children, and PREPARE received a warm welcome from the pediatric infectious disease community, regardless of investor response. Indeed, PREPARE was the only clinical trial deemed of sufficient import to be featured in the opening plenary session of ESPID 2019.
Ulrich Heininger, MD, professor of pediatrics at the University of Basel (Switzerland), who cochaired the session, jointly sponsored by ESPID and the Pediatric Infectious Diseases Society, declared, “These findings, I think, are a great step forward.”
Dr. Munoz reported receiving research grants from Janssen, the National Institutes of Health, the Centers for Disease Control and Prevention, and Novavax, which sponsored the PREPARE trial, assisted by an $89 million grant from the Bill and Melinda Gates Foundation.
LJUBLJANA, SLOVENIA – Passive protection of infants from severe respiratory syncytial virus lower respiratory tract infection during the first 6 months of life has convincingly been achieved through maternal immunization using a novel nanoparticle vaccine in the landmark PREPARE trial.
“I think it’s important for everyone, especially people like myself who’ve been working on maternal immunization for about 20 years, to realize that this is a historic study,” Flor M. Munoz, MD, declared in reporting the study results at the annual meeting of the European Society for Paediatric Infectious Diseases.
“We have here for the first time a phase-3, global, randomized, placebo-controlled, observer-blinded clinical trial looking at an experimental vaccine in pregnant women for the protection of infants from a disease for which we really don’t have other potential solutions quite yet, and in a period of high vulnerability,” said Dr. Munoz, a pediatric infectious disease specialist at Baylor College of Medicine, Houston.
Indeed, respiratory syncytial virus (RSV) is the No. 2 cause of mortality worldwide during the first year of life. Moreover, most cases of severe RSV lower respiratory tract infection occur in otherwise healthy infants aged less than 5 months, when active immunization presents daunting challenges.
“While certainly mortality is uncommon in high-income countries, we do see significant hospitalization there due to severe RSV lower respiratory tract infection in the first year of life, sometimes more than other common diseases, like influenza,” she noted.
PREPARE included 4,636 women with low-risk pregnancies who were randomized 2:1 to a single intramuscular injection of the investigational RSV vaccine or placebo during gestational weeks 28-36, with efficacy assessed through the first 180 days of life. The study took place at 87 sites in 11 countries during 4 years worth of RSV seasons. Roughly half of participants were South African, one-quarter were in the United States, and the rest were drawn from nine other low-, middle-, or high-income countries in the Northern and Southern Hemispheres. The median gestational age at vaccination was 32 weeks.
The primary efficacy endpoint specified by the Food and Drug Administration – but not other regulatory agencies – was the placebo-subtracted rate of RSV lower respiratory tract infection as defined by RSV detected by reverse transcription polymerase chain reaction, along with at least one clinical manifestation of lower respiratory tract infection, oxygen saturation below 95%, and/or tachypnea. The risk of this outcome was reduced by 39% during the first 90 days of life and by 27% through 180 days in infants in the maternal immunization group, a difference which didn’t achieve statistical significance.
However, prespecified major secondary endpoints arguably of greater clinical relevance were consistently positive. Notably, when levels of transplacentally transferred neutralizing antibodies against RSV A and B were highest, with events occurring in 57 of 2,765 evaluable infants in the active treatment arm and in 53 of 1,430 controls. Similarly, there was a 40% reduction through day 180. Moreover, rates of another key secondary endpoint – RSV lower respiratory tract infection plus severe hypoxemia with an oxygen saturation below 92% – were reduced by 48% and 42% through days 90 and 180, respectively. Thus, the vaccine’s protective effect was greatest against the most severe outcomes of RSV infection in infancy, according to Dr. Munoz.
No safety signals related to this immunization strategy were seen during 1 year of follow-up of infants and 6 months for the mothers. Side effects were essentially limited to mild, self-limited injection site reactions, with zero impact on pregnancy and delivery.
An intriguing finding in an exploratory analysis was that the vaccine appeared to have ancillary benefits beyond prevention of medically significant RSV disease in the young infants. For example, the rate of all lower respiratory tract infections with severe hypoxemia – with no requirement for demonstration of RSV infection – was reduced by 46% during the first 90 days of life in the immunized group. Similarly, the rate of all-cause lower respiratory tract infection resulting in hospitalization was reduced by 28%.
“This is actually quite interesting, because these are unexpected benefits in terms of all-cause effects,” the pediatrician commented, adding that she and her coinvestigators are delving into this phenomenon in order to gain better understanding.
Additional analyses of the recently completed PREPARE study are ongoing but already have yielded some important findings. For example, women immunized before 33 weeks’ gestation had significantly greater transplacental antibody transfer than those immunized later in pregnancy, with resultant markedly greater vaccine efficacy in their offspring as well: A placebo-subtracted 70% reduction in RSV lower respiratory tract infection with severe hypoxemia through 90 days, compared with a 44% reduction associated with immunization at gestational week 33 or later. And when the interval between immunization and delivery was at least 30 days, the risk of this endpoint was reduced by 65%; in contrast, there was no significant difference between vaccine and placebo groups when time from immunization to delivery was less than 30 days.
Also noteworthy was that maternal immunization afforded no infant protection in the United States. This unanticipated finding is still under investigation, although suspicion centers around the fact that RSV seasons were generally milder there, and American women were vaccinated at a later gestational age, with a corresponding shorter interval to delivery.
The novel recombinant nanoparticle vaccine tested in PREPARE contains a nearly full-length RSV fusion protein produced in insect cells. The nanoparticles express both prefusion epitopes and epitopes common to pre- and postfusion conformations. Aluminum phosphate is employed as the adjuvant.
Novavax’s stock price has been kicked to the curb since the company earlier reported that a large phase 3 trial of the vaccine failed to meet its primary endpoint for prevention of RSV lower respiratory tract infection in older adults. Now the vaccine’s failure to meet its prespecified FDA-mandated primary endpoint in the maternal immunization study will doubtless spawn further financially dismissive headlines in the business press as well.
But pediatricians are famously advocates for children, and PREPARE received a warm welcome from the pediatric infectious disease community, regardless of investor response. Indeed, PREPARE was the only clinical trial deemed of sufficient import to be featured in the opening plenary session of ESPID 2019.
Ulrich Heininger, MD, professor of pediatrics at the University of Basel (Switzerland), who cochaired the session, jointly sponsored by ESPID and the Pediatric Infectious Diseases Society, declared, “These findings, I think, are a great step forward.”
Dr. Munoz reported receiving research grants from Janssen, the National Institutes of Health, the Centers for Disease Control and Prevention, and Novavax, which sponsored the PREPARE trial, assisted by an $89 million grant from the Bill and Melinda Gates Foundation.
LJUBLJANA, SLOVENIA – Passive protection of infants from severe respiratory syncytial virus lower respiratory tract infection during the first 6 months of life has convincingly been achieved through maternal immunization using a novel nanoparticle vaccine in the landmark PREPARE trial.
“I think it’s important for everyone, especially people like myself who’ve been working on maternal immunization for about 20 years, to realize that this is a historic study,” Flor M. Munoz, MD, declared in reporting the study results at the annual meeting of the European Society for Paediatric Infectious Diseases.
“We have here for the first time a phase-3, global, randomized, placebo-controlled, observer-blinded clinical trial looking at an experimental vaccine in pregnant women for the protection of infants from a disease for which we really don’t have other potential solutions quite yet, and in a period of high vulnerability,” said Dr. Munoz, a pediatric infectious disease specialist at Baylor College of Medicine, Houston.
Indeed, respiratory syncytial virus (RSV) is the No. 2 cause of mortality worldwide during the first year of life. Moreover, most cases of severe RSV lower respiratory tract infection occur in otherwise healthy infants aged less than 5 months, when active immunization presents daunting challenges.
“While certainly mortality is uncommon in high-income countries, we do see significant hospitalization there due to severe RSV lower respiratory tract infection in the first year of life, sometimes more than other common diseases, like influenza,” she noted.
PREPARE included 4,636 women with low-risk pregnancies who were randomized 2:1 to a single intramuscular injection of the investigational RSV vaccine or placebo during gestational weeks 28-36, with efficacy assessed through the first 180 days of life. The study took place at 87 sites in 11 countries during 4 years worth of RSV seasons. Roughly half of participants were South African, one-quarter were in the United States, and the rest were drawn from nine other low-, middle-, or high-income countries in the Northern and Southern Hemispheres. The median gestational age at vaccination was 32 weeks.
The primary efficacy endpoint specified by the Food and Drug Administration – but not other regulatory agencies – was the placebo-subtracted rate of RSV lower respiratory tract infection as defined by RSV detected by reverse transcription polymerase chain reaction, along with at least one clinical manifestation of lower respiratory tract infection, oxygen saturation below 95%, and/or tachypnea. The risk of this outcome was reduced by 39% during the first 90 days of life and by 27% through 180 days in infants in the maternal immunization group, a difference which didn’t achieve statistical significance.
However, prespecified major secondary endpoints arguably of greater clinical relevance were consistently positive. Notably, when levels of transplacentally transferred neutralizing antibodies against RSV A and B were highest, with events occurring in 57 of 2,765 evaluable infants in the active treatment arm and in 53 of 1,430 controls. Similarly, there was a 40% reduction through day 180. Moreover, rates of another key secondary endpoint – RSV lower respiratory tract infection plus severe hypoxemia with an oxygen saturation below 92% – were reduced by 48% and 42% through days 90 and 180, respectively. Thus, the vaccine’s protective effect was greatest against the most severe outcomes of RSV infection in infancy, according to Dr. Munoz.
No safety signals related to this immunization strategy were seen during 1 year of follow-up of infants and 6 months for the mothers. Side effects were essentially limited to mild, self-limited injection site reactions, with zero impact on pregnancy and delivery.
An intriguing finding in an exploratory analysis was that the vaccine appeared to have ancillary benefits beyond prevention of medically significant RSV disease in the young infants. For example, the rate of all lower respiratory tract infections with severe hypoxemia – with no requirement for demonstration of RSV infection – was reduced by 46% during the first 90 days of life in the immunized group. Similarly, the rate of all-cause lower respiratory tract infection resulting in hospitalization was reduced by 28%.
“This is actually quite interesting, because these are unexpected benefits in terms of all-cause effects,” the pediatrician commented, adding that she and her coinvestigators are delving into this phenomenon in order to gain better understanding.
Additional analyses of the recently completed PREPARE study are ongoing but already have yielded some important findings. For example, women immunized before 33 weeks’ gestation had significantly greater transplacental antibody transfer than those immunized later in pregnancy, with resultant markedly greater vaccine efficacy in their offspring as well: A placebo-subtracted 70% reduction in RSV lower respiratory tract infection with severe hypoxemia through 90 days, compared with a 44% reduction associated with immunization at gestational week 33 or later. And when the interval between immunization and delivery was at least 30 days, the risk of this endpoint was reduced by 65%; in contrast, there was no significant difference between vaccine and placebo groups when time from immunization to delivery was less than 30 days.
Also noteworthy was that maternal immunization afforded no infant protection in the United States. This unanticipated finding is still under investigation, although suspicion centers around the fact that RSV seasons were generally milder there, and American women were vaccinated at a later gestational age, with a corresponding shorter interval to delivery.
The novel recombinant nanoparticle vaccine tested in PREPARE contains a nearly full-length RSV fusion protein produced in insect cells. The nanoparticles express both prefusion epitopes and epitopes common to pre- and postfusion conformations. Aluminum phosphate is employed as the adjuvant.
Novavax’s stock price has been kicked to the curb since the company earlier reported that a large phase 3 trial of the vaccine failed to meet its primary endpoint for prevention of RSV lower respiratory tract infection in older adults. Now the vaccine’s failure to meet its prespecified FDA-mandated primary endpoint in the maternal immunization study will doubtless spawn further financially dismissive headlines in the business press as well.
But pediatricians are famously advocates for children, and PREPARE received a warm welcome from the pediatric infectious disease community, regardless of investor response. Indeed, PREPARE was the only clinical trial deemed of sufficient import to be featured in the opening plenary session of ESPID 2019.
Ulrich Heininger, MD, professor of pediatrics at the University of Basel (Switzerland), who cochaired the session, jointly sponsored by ESPID and the Pediatric Infectious Diseases Society, declared, “These findings, I think, are a great step forward.”
Dr. Munoz reported receiving research grants from Janssen, the National Institutes of Health, the Centers for Disease Control and Prevention, and Novavax, which sponsored the PREPARE trial, assisted by an $89 million grant from the Bill and Melinda Gates Foundation.
REPORTING FROM ESPID 2019
Is it measles? – Diagnosis and management for the pediatric provider
The mother of an 8-month-old calls your office and is hysterical. Her daughter has had cough for a few days with high fevers and now has developed a full body rash. She is worried about measles and is on her way to your office.
We are in the middle of a measles epidemic, there’s no denying it. Measles was declared eliminated in 2000, but reported cases in the United States have been on the rise, and are now at the highest number since 2014. Five months into 2019, there have been 839 reported cases as of May 13). Measles outbreaks (defined by the Centers for Disease Control and Prevention as three or more cases) have been reported in California, Georgia, Maryland, Michigan, New Jersey, New York, and Pennsylvania. When vaccination rates fall, it is easy for measles to spread. The virus is highly contagious in nonimmune people, because of its airborne spread and its persistence in the environment for hours.
First – is it really measles?
It can be difficult to distinguish the maculopapular rash of measles from similar rashes that occur with more benign viral illnesses. Adding to the challenge, the last major measles outbreak in the United States was over 2 decades ago, and many practicing pediatricians have never seen a single case. So, what clinical features can help distinguish measles from other febrile illnesses?
The prodromal phase of measles lasts approximately 2-4 days and children have high fevers (103°-105° F), anorexia, and malaise. Conjunctivitis, coryza, and cough develop during this phase, and precede any rash. Koplik spots appear during the prodromal phase, but are not seen in all cases. These spots are 1- to 3-mm blue-white lesions on an erythematous base on the buccal mucosa, classically opposite the first molar. The spots often slough once the rash appears. The rash appears 2-4 days after the onset of fever, and is initially maculopapular and blanching. The first lesions appear on the face and neck, and the rash spreads cranial to caudal, typically sparing palms and soles. After days 3-4, the rash will no longer blanch. High fevers persist for 2-4 more days with rash, ongoing respiratory symptoms, conjunctivitis, and pharyngitis. Note that the fever will persist even with development of the rash, unlike in roseola.
It is not only important to diagnosis measles from a public health standpoint, but also because measles can have severe complications, especially in infants and children under 5 years. During the 1989-1991 outbreak, the mortality rate was 2.2 deaths per 1,000 cases (J Infect Dis. 2004 May 1. doi: 10.1086/377694).
Six percent of patients develop pneumonia, which in infants and toddlers can lead to respiratory distress or failure requiring hospitalization. Pneumonia is responsible for 60% of measles deaths, according to the CDC “Pink Book,” Epidemiology and Prevention of Vaccine-Preventable Diseases, chapter 13 on measles, 13th Ed., 2015. Ocular complications include keratitis and corneal ulceration. Measles also can cause serious neurologic complications. Encephalitis, seen in 1 per 1,000 cases, usually arises several days after the rash and may present with seizure or encephalopathy. Acute disseminated encephalomyelitis (ADEM), an inflammatory demyelinating disease of the central nervous system, occurs in approximately 1 per 1,000 cases, typically presents during the recovery phase (1-2 weeks after rash), and can have long-term sequelae. Subacute sclerosing panencephalitis (SSPE) is a progressive and fatal neurodegenerative disorder, and presents 7-10 years after measles infection.
Should you transfer the patient to a hospital?
Unless there is a medical need for the child to be admitted, sending a patient with potential measles to the hospital is not necessary, and can cause exposure to a large group of medical personnel, and patients who cannot be vaccinated (such as infants, immunocompromised patients, and pregnant women). However, if there is concern for complications such as seizures, encephalitis, or pneumonia, then transfer is indicated. Call the accepting hospital in advance so the staff can prepare for the patient. During transfer, place a standard face mask on the patient and instruct the patient not to remove it.
For hospitals accepting a suspected measles case, meet the patient outside of the facility and ensure that the patient is wearing a standard face mask. All staff interacting with the patient should practice contact and airborne precautions (N95 respirator mask). Take the patient directly to an isolation room with negative airflow. Caution pregnant staff that they should not have contact with the patient.
Which diagnostic tests should you use?
Diagnosis can be made based on serum antibody tests (measles IgM and IgG), throat or urine viral cultures, and nasopharyngeal and throat specimen polymerase chain reaction (PCR) testing. The CDC recommends obtaining a serum sample for measles IgM testing and a throat swab for PCR in all suspected cases, but local health departments vary in their specific testing recommendations. Familiarize yourself with the tests recommended by your local department of health, and where they prefer testing on outpatients to be done. Confirmed measles should be reported to your department of health.
What are considerations for community pediatric offices?
Update families in emails to call ahead if they suspect measles. This way the office can prepare a room for the family, and have the family immediately brought back without exposing staff and other families in the waiting area. It may be more prudent to examine these children at the end of the clinic day as the virus can persist for up to 2 hours on fomites and in the air. Therefore, all waiting areas and shared air spaces (including those with shared air ducts) should be cleared for 2 hours after the patient leaves.
When should you provide prophylaxis after exposure?
A patient with suspected measles does not require immediate vaccination. If it is measles, it is already too late to vaccinate. If measles is ruled out, the child should follow the standard measles vaccination guidelines.
Individuals are contagious from 4 days before to 4 days after the rash appears.
If measles is confirmed, all people who are unvaccinated or undervaccinated and were exposed to the confirmed case during the contagious period should be vaccinated within 72 hours of exposure. Infants 6 months or older may safely receive the MMR vaccine. However, infants vaccinated with MMR before their first birthday must be vaccinated again at age 12-15 months (greater than 28 days after prior vaccine) and at 4-6 years. Immunoglobulin prophylaxis should be given intramuscularly in exposed infants ages birth to less than 6 months, and in those ages 6-12 months who present beyond the 72-hour window. Unvaccinated or undervaccinated, exposed individuals at high risk for complications from measles (immunocompromised, pregnant) also should receive immunoglobulin.
What should you tell traveling families?
Several countries have large, ongoing measles outbreaks, including Israel, Ukraine, and the Philippines. Before international travel, infants 6-11 months should receive one dose of MMR vaccine, and children 12 months and older need two doses separated by at least 28 days. For unvaccinated or undervaccinated children, consider advising families to hold off travel to high-risk countries, or understand the indications to vaccinate a child upon return.
Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Medical Center in Washington. She said she has no relevant financial disclosures. Dr. Emily Willner is a pediatric emergency medicine attending at Children’s National Medical Center, and an assistant professor of pediatrics and emergency medicine at George Washington University, Washington. She has no relevant financial disclosures.
The mother of an 8-month-old calls your office and is hysterical. Her daughter has had cough for a few days with high fevers and now has developed a full body rash. She is worried about measles and is on her way to your office.
We are in the middle of a measles epidemic, there’s no denying it. Measles was declared eliminated in 2000, but reported cases in the United States have been on the rise, and are now at the highest number since 2014. Five months into 2019, there have been 839 reported cases as of May 13). Measles outbreaks (defined by the Centers for Disease Control and Prevention as three or more cases) have been reported in California, Georgia, Maryland, Michigan, New Jersey, New York, and Pennsylvania. When vaccination rates fall, it is easy for measles to spread. The virus is highly contagious in nonimmune people, because of its airborne spread and its persistence in the environment for hours.
First – is it really measles?
It can be difficult to distinguish the maculopapular rash of measles from similar rashes that occur with more benign viral illnesses. Adding to the challenge, the last major measles outbreak in the United States was over 2 decades ago, and many practicing pediatricians have never seen a single case. So, what clinical features can help distinguish measles from other febrile illnesses?
The prodromal phase of measles lasts approximately 2-4 days and children have high fevers (103°-105° F), anorexia, and malaise. Conjunctivitis, coryza, and cough develop during this phase, and precede any rash. Koplik spots appear during the prodromal phase, but are not seen in all cases. These spots are 1- to 3-mm blue-white lesions on an erythematous base on the buccal mucosa, classically opposite the first molar. The spots often slough once the rash appears. The rash appears 2-4 days after the onset of fever, and is initially maculopapular and blanching. The first lesions appear on the face and neck, and the rash spreads cranial to caudal, typically sparing palms and soles. After days 3-4, the rash will no longer blanch. High fevers persist for 2-4 more days with rash, ongoing respiratory symptoms, conjunctivitis, and pharyngitis. Note that the fever will persist even with development of the rash, unlike in roseola.
It is not only important to diagnosis measles from a public health standpoint, but also because measles can have severe complications, especially in infants and children under 5 years. During the 1989-1991 outbreak, the mortality rate was 2.2 deaths per 1,000 cases (J Infect Dis. 2004 May 1. doi: 10.1086/377694).
Six percent of patients develop pneumonia, which in infants and toddlers can lead to respiratory distress or failure requiring hospitalization. Pneumonia is responsible for 60% of measles deaths, according to the CDC “Pink Book,” Epidemiology and Prevention of Vaccine-Preventable Diseases, chapter 13 on measles, 13th Ed., 2015. Ocular complications include keratitis and corneal ulceration. Measles also can cause serious neurologic complications. Encephalitis, seen in 1 per 1,000 cases, usually arises several days after the rash and may present with seizure or encephalopathy. Acute disseminated encephalomyelitis (ADEM), an inflammatory demyelinating disease of the central nervous system, occurs in approximately 1 per 1,000 cases, typically presents during the recovery phase (1-2 weeks after rash), and can have long-term sequelae. Subacute sclerosing panencephalitis (SSPE) is a progressive and fatal neurodegenerative disorder, and presents 7-10 years after measles infection.
Should you transfer the patient to a hospital?
Unless there is a medical need for the child to be admitted, sending a patient with potential measles to the hospital is not necessary, and can cause exposure to a large group of medical personnel, and patients who cannot be vaccinated (such as infants, immunocompromised patients, and pregnant women). However, if there is concern for complications such as seizures, encephalitis, or pneumonia, then transfer is indicated. Call the accepting hospital in advance so the staff can prepare for the patient. During transfer, place a standard face mask on the patient and instruct the patient not to remove it.
For hospitals accepting a suspected measles case, meet the patient outside of the facility and ensure that the patient is wearing a standard face mask. All staff interacting with the patient should practice contact and airborne precautions (N95 respirator mask). Take the patient directly to an isolation room with negative airflow. Caution pregnant staff that they should not have contact with the patient.
Which diagnostic tests should you use?
Diagnosis can be made based on serum antibody tests (measles IgM and IgG), throat or urine viral cultures, and nasopharyngeal and throat specimen polymerase chain reaction (PCR) testing. The CDC recommends obtaining a serum sample for measles IgM testing and a throat swab for PCR in all suspected cases, but local health departments vary in their specific testing recommendations. Familiarize yourself with the tests recommended by your local department of health, and where they prefer testing on outpatients to be done. Confirmed measles should be reported to your department of health.
What are considerations for community pediatric offices?
Update families in emails to call ahead if they suspect measles. This way the office can prepare a room for the family, and have the family immediately brought back without exposing staff and other families in the waiting area. It may be more prudent to examine these children at the end of the clinic day as the virus can persist for up to 2 hours on fomites and in the air. Therefore, all waiting areas and shared air spaces (including those with shared air ducts) should be cleared for 2 hours after the patient leaves.
When should you provide prophylaxis after exposure?
A patient with suspected measles does not require immediate vaccination. If it is measles, it is already too late to vaccinate. If measles is ruled out, the child should follow the standard measles vaccination guidelines.
Individuals are contagious from 4 days before to 4 days after the rash appears.
If measles is confirmed, all people who are unvaccinated or undervaccinated and were exposed to the confirmed case during the contagious period should be vaccinated within 72 hours of exposure. Infants 6 months or older may safely receive the MMR vaccine. However, infants vaccinated with MMR before their first birthday must be vaccinated again at age 12-15 months (greater than 28 days after prior vaccine) and at 4-6 years. Immunoglobulin prophylaxis should be given intramuscularly in exposed infants ages birth to less than 6 months, and in those ages 6-12 months who present beyond the 72-hour window. Unvaccinated or undervaccinated, exposed individuals at high risk for complications from measles (immunocompromised, pregnant) also should receive immunoglobulin.
What should you tell traveling families?
Several countries have large, ongoing measles outbreaks, including Israel, Ukraine, and the Philippines. Before international travel, infants 6-11 months should receive one dose of MMR vaccine, and children 12 months and older need two doses separated by at least 28 days. For unvaccinated or undervaccinated children, consider advising families to hold off travel to high-risk countries, or understand the indications to vaccinate a child upon return.
Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Medical Center in Washington. She said she has no relevant financial disclosures. Dr. Emily Willner is a pediatric emergency medicine attending at Children’s National Medical Center, and an assistant professor of pediatrics and emergency medicine at George Washington University, Washington. She has no relevant financial disclosures.
The mother of an 8-month-old calls your office and is hysterical. Her daughter has had cough for a few days with high fevers and now has developed a full body rash. She is worried about measles and is on her way to your office.
We are in the middle of a measles epidemic, there’s no denying it. Measles was declared eliminated in 2000, but reported cases in the United States have been on the rise, and are now at the highest number since 2014. Five months into 2019, there have been 839 reported cases as of May 13). Measles outbreaks (defined by the Centers for Disease Control and Prevention as three or more cases) have been reported in California, Georgia, Maryland, Michigan, New Jersey, New York, and Pennsylvania. When vaccination rates fall, it is easy for measles to spread. The virus is highly contagious in nonimmune people, because of its airborne spread and its persistence in the environment for hours.
First – is it really measles?
It can be difficult to distinguish the maculopapular rash of measles from similar rashes that occur with more benign viral illnesses. Adding to the challenge, the last major measles outbreak in the United States was over 2 decades ago, and many practicing pediatricians have never seen a single case. So, what clinical features can help distinguish measles from other febrile illnesses?
The prodromal phase of measles lasts approximately 2-4 days and children have high fevers (103°-105° F), anorexia, and malaise. Conjunctivitis, coryza, and cough develop during this phase, and precede any rash. Koplik spots appear during the prodromal phase, but are not seen in all cases. These spots are 1- to 3-mm blue-white lesions on an erythematous base on the buccal mucosa, classically opposite the first molar. The spots often slough once the rash appears. The rash appears 2-4 days after the onset of fever, and is initially maculopapular and blanching. The first lesions appear on the face and neck, and the rash spreads cranial to caudal, typically sparing palms and soles. After days 3-4, the rash will no longer blanch. High fevers persist for 2-4 more days with rash, ongoing respiratory symptoms, conjunctivitis, and pharyngitis. Note that the fever will persist even with development of the rash, unlike in roseola.
It is not only important to diagnosis measles from a public health standpoint, but also because measles can have severe complications, especially in infants and children under 5 years. During the 1989-1991 outbreak, the mortality rate was 2.2 deaths per 1,000 cases (J Infect Dis. 2004 May 1. doi: 10.1086/377694).
Six percent of patients develop pneumonia, which in infants and toddlers can lead to respiratory distress or failure requiring hospitalization. Pneumonia is responsible for 60% of measles deaths, according to the CDC “Pink Book,” Epidemiology and Prevention of Vaccine-Preventable Diseases, chapter 13 on measles, 13th Ed., 2015. Ocular complications include keratitis and corneal ulceration. Measles also can cause serious neurologic complications. Encephalitis, seen in 1 per 1,000 cases, usually arises several days after the rash and may present with seizure or encephalopathy. Acute disseminated encephalomyelitis (ADEM), an inflammatory demyelinating disease of the central nervous system, occurs in approximately 1 per 1,000 cases, typically presents during the recovery phase (1-2 weeks after rash), and can have long-term sequelae. Subacute sclerosing panencephalitis (SSPE) is a progressive and fatal neurodegenerative disorder, and presents 7-10 years after measles infection.
Should you transfer the patient to a hospital?
Unless there is a medical need for the child to be admitted, sending a patient with potential measles to the hospital is not necessary, and can cause exposure to a large group of medical personnel, and patients who cannot be vaccinated (such as infants, immunocompromised patients, and pregnant women). However, if there is concern for complications such as seizures, encephalitis, or pneumonia, then transfer is indicated. Call the accepting hospital in advance so the staff can prepare for the patient. During transfer, place a standard face mask on the patient and instruct the patient not to remove it.
For hospitals accepting a suspected measles case, meet the patient outside of the facility and ensure that the patient is wearing a standard face mask. All staff interacting with the patient should practice contact and airborne precautions (N95 respirator mask). Take the patient directly to an isolation room with negative airflow. Caution pregnant staff that they should not have contact with the patient.
Which diagnostic tests should you use?
Diagnosis can be made based on serum antibody tests (measles IgM and IgG), throat or urine viral cultures, and nasopharyngeal and throat specimen polymerase chain reaction (PCR) testing. The CDC recommends obtaining a serum sample for measles IgM testing and a throat swab for PCR in all suspected cases, but local health departments vary in their specific testing recommendations. Familiarize yourself with the tests recommended by your local department of health, and where they prefer testing on outpatients to be done. Confirmed measles should be reported to your department of health.
What are considerations for community pediatric offices?
Update families in emails to call ahead if they suspect measles. This way the office can prepare a room for the family, and have the family immediately brought back without exposing staff and other families in the waiting area. It may be more prudent to examine these children at the end of the clinic day as the virus can persist for up to 2 hours on fomites and in the air. Therefore, all waiting areas and shared air spaces (including those with shared air ducts) should be cleared for 2 hours after the patient leaves.
When should you provide prophylaxis after exposure?
A patient with suspected measles does not require immediate vaccination. If it is measles, it is already too late to vaccinate. If measles is ruled out, the child should follow the standard measles vaccination guidelines.
Individuals are contagious from 4 days before to 4 days after the rash appears.
If measles is confirmed, all people who are unvaccinated or undervaccinated and were exposed to the confirmed case during the contagious period should be vaccinated within 72 hours of exposure. Infants 6 months or older may safely receive the MMR vaccine. However, infants vaccinated with MMR before their first birthday must be vaccinated again at age 12-15 months (greater than 28 days after prior vaccine) and at 4-6 years. Immunoglobulin prophylaxis should be given intramuscularly in exposed infants ages birth to less than 6 months, and in those ages 6-12 months who present beyond the 72-hour window. Unvaccinated or undervaccinated, exposed individuals at high risk for complications from measles (immunocompromised, pregnant) also should receive immunoglobulin.
What should you tell traveling families?
Several countries have large, ongoing measles outbreaks, including Israel, Ukraine, and the Philippines. Before international travel, infants 6-11 months should receive one dose of MMR vaccine, and children 12 months and older need two doses separated by at least 28 days. For unvaccinated or undervaccinated children, consider advising families to hold off travel to high-risk countries, or understand the indications to vaccinate a child upon return.
Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Medical Center in Washington. She said she has no relevant financial disclosures. Dr. Emily Willner is a pediatric emergency medicine attending at Children’s National Medical Center, and an assistant professor of pediatrics and emergency medicine at George Washington University, Washington. She has no relevant financial disclosures.
Infections within first year of life predicted IBD
according to the findings of a large population-based study.
It remains unclear whether the risk reflects infections in themselves or the use of antibiotic therapy, wrote Charles N. Bernstein, MD, of the University of Manitoba, Winnipeg, and associates. Infections did not appear to be a proxy for immunodeficiency disorders, which were similarly infrequent among cases and controls, they noted. Limiting antibiotic usage, while desirable, would be difficult to do for infections as serious as many in the study. Hence, they suggested research to determine “exactly what antibiotic intake does to infant gut microflora or intestinal or systemic immune responses,” and whether giving probiotics or prebiotics after antibiotic therapy helps attenuate the risk of inflammatory bowel disease (IBD) and other autoimmune disorders. The findings were published in Gastroenterology.
IBD is probably multifactorial, but specific causal factors remain unclear. Based on mounting evidence for the role of gut dysbiosis, the researchers explored whether IBD is associated with higher rates of infections and other critical events during the neonatal period and the first year of life by comparing 825 patients with IBD and 5,999 controls matched by age, sex, and area of residence. The data source was the University of Manitoba IBD Epidemiology Database, which includes all Manitobans diagnosed with IBD from 1984 to 2010. The researchers also compared patients with 1,740 unaffected siblings.
Gastrointestinal infections, gastrointestinal disease, and abdominal pain during the first year of life did not predict subsequent IBD. Maternal IBD was the strongest risk factor (odds ratio, 4.5; 95% confidence interval, 3.1-6.7). Among neonatal events, the only significant risk factor was being in the highest versus the lowest socioeconomic quintile (OR, 1.35; 95% CI, 1.01-1.79). This association persisted during the first year of life.
Infections during the first year of life were a significant risk factor for IBD before age 10 (OR, 3.1; 95% CI, 1.1-8.8) and age 20 years (OR, 1.6; 95% CI, 1.2-2.2) in the population-based analysis. In contrast, patients and their unaffected siblings had similar rates of infection during early life. The study may have missed differences in exposures between these groups, or perhaps patients lack certain protective genes possessed by healthy siblings, the researchers wrote.
Numbers of antibiotic prescriptions during the first year and the first decade of life did not significantly differ between 33 cases and 270 controls with available data. However, there was a trend toward more antibiotics prescribed to patients versus controls.
“Together with our past reports that neither cesarean section birth nor antenatal or perinatal maternal use of antibiotics predict ultimate development of IBD, it seems that neonatal changes to the microbiome are subsumed by those occurring in the first year of life,” the investigators concluded. They recommended studying the infant gut microbiome before and for several months after infections and antibiotic exposure to determine which shifts in microbiota predict IBD onset.
The Manitoba Centre for Health Policy provided access to the Population Health Research Data Repository. Dr. Bernstein is supported by the Bingham Chair in Gastroenterology. He reported ties to AbbVie Canada, Ferring Canada, Janssen Canada, Shire Canada, Takeda Canada, Pfizer Canada, Napo Pharmaceuticals, 4D Pharma, and Mylan.
SOURCE: Bernstein CN et al. Gastroenterology. 2019 Feb 14. doi: 10.1053/j.gastro.2019.02.004.
Understanding and exploring factors that could impact inflammatory bowel disease (IBD) development is imperative. This study by Bernstein et al. evaluated whether environmental factors in the first year of life may impact subsequent diagnosis of IBD using population-based cohort data with robust and detailed health information. Maternal history of IBD was the most predictive factor in development of IBD, further evidence of a genetic component to disease pathogenesis. However, environmental factors such as high socioeconomic status within the first year of life were predictive of diagnosis of IBD later in life, possibly lending further support to the “hygiene hypothesis.”
Also, significant infections identified in the clinical setting or requiring hospitalization were predictive of subsequent IBD diagnosis. This is particularly interesting as gut microbiome perturbations increasingly take the stage as a possible pathway of significance in IBD. Could infection within the first year of life or the subsequent antibiotic use required affect the gut microbiome so significantly and perhaps permanently to affect development of later childhood or adult IBD?
Sara Horst, MD, MPH, is an associate professor of medicine in the department of gastroenterology, hepatology, and medicine at Vanderbilt University, Nashville, Tenn. She has consulted for Janssen, UCB, and Boehringer Ingelheim.
Understanding and exploring factors that could impact inflammatory bowel disease (IBD) development is imperative. This study by Bernstein et al. evaluated whether environmental factors in the first year of life may impact subsequent diagnosis of IBD using population-based cohort data with robust and detailed health information. Maternal history of IBD was the most predictive factor in development of IBD, further evidence of a genetic component to disease pathogenesis. However, environmental factors such as high socioeconomic status within the first year of life were predictive of diagnosis of IBD later in life, possibly lending further support to the “hygiene hypothesis.”
Also, significant infections identified in the clinical setting or requiring hospitalization were predictive of subsequent IBD diagnosis. This is particularly interesting as gut microbiome perturbations increasingly take the stage as a possible pathway of significance in IBD. Could infection within the first year of life or the subsequent antibiotic use required affect the gut microbiome so significantly and perhaps permanently to affect development of later childhood or adult IBD?
Sara Horst, MD, MPH, is an associate professor of medicine in the department of gastroenterology, hepatology, and medicine at Vanderbilt University, Nashville, Tenn. She has consulted for Janssen, UCB, and Boehringer Ingelheim.
Understanding and exploring factors that could impact inflammatory bowel disease (IBD) development is imperative. This study by Bernstein et al. evaluated whether environmental factors in the first year of life may impact subsequent diagnosis of IBD using population-based cohort data with robust and detailed health information. Maternal history of IBD was the most predictive factor in development of IBD, further evidence of a genetic component to disease pathogenesis. However, environmental factors such as high socioeconomic status within the first year of life were predictive of diagnosis of IBD later in life, possibly lending further support to the “hygiene hypothesis.”
Also, significant infections identified in the clinical setting or requiring hospitalization were predictive of subsequent IBD diagnosis. This is particularly interesting as gut microbiome perturbations increasingly take the stage as a possible pathway of significance in IBD. Could infection within the first year of life or the subsequent antibiotic use required affect the gut microbiome so significantly and perhaps permanently to affect development of later childhood or adult IBD?
Sara Horst, MD, MPH, is an associate professor of medicine in the department of gastroenterology, hepatology, and medicine at Vanderbilt University, Nashville, Tenn. She has consulted for Janssen, UCB, and Boehringer Ingelheim.
according to the findings of a large population-based study.
It remains unclear whether the risk reflects infections in themselves or the use of antibiotic therapy, wrote Charles N. Bernstein, MD, of the University of Manitoba, Winnipeg, and associates. Infections did not appear to be a proxy for immunodeficiency disorders, which were similarly infrequent among cases and controls, they noted. Limiting antibiotic usage, while desirable, would be difficult to do for infections as serious as many in the study. Hence, they suggested research to determine “exactly what antibiotic intake does to infant gut microflora or intestinal or systemic immune responses,” and whether giving probiotics or prebiotics after antibiotic therapy helps attenuate the risk of inflammatory bowel disease (IBD) and other autoimmune disorders. The findings were published in Gastroenterology.
IBD is probably multifactorial, but specific causal factors remain unclear. Based on mounting evidence for the role of gut dysbiosis, the researchers explored whether IBD is associated with higher rates of infections and other critical events during the neonatal period and the first year of life by comparing 825 patients with IBD and 5,999 controls matched by age, sex, and area of residence. The data source was the University of Manitoba IBD Epidemiology Database, which includes all Manitobans diagnosed with IBD from 1984 to 2010. The researchers also compared patients with 1,740 unaffected siblings.
Gastrointestinal infections, gastrointestinal disease, and abdominal pain during the first year of life did not predict subsequent IBD. Maternal IBD was the strongest risk factor (odds ratio, 4.5; 95% confidence interval, 3.1-6.7). Among neonatal events, the only significant risk factor was being in the highest versus the lowest socioeconomic quintile (OR, 1.35; 95% CI, 1.01-1.79). This association persisted during the first year of life.
Infections during the first year of life were a significant risk factor for IBD before age 10 (OR, 3.1; 95% CI, 1.1-8.8) and age 20 years (OR, 1.6; 95% CI, 1.2-2.2) in the population-based analysis. In contrast, patients and their unaffected siblings had similar rates of infection during early life. The study may have missed differences in exposures between these groups, or perhaps patients lack certain protective genes possessed by healthy siblings, the researchers wrote.
Numbers of antibiotic prescriptions during the first year and the first decade of life did not significantly differ between 33 cases and 270 controls with available data. However, there was a trend toward more antibiotics prescribed to patients versus controls.
“Together with our past reports that neither cesarean section birth nor antenatal or perinatal maternal use of antibiotics predict ultimate development of IBD, it seems that neonatal changes to the microbiome are subsumed by those occurring in the first year of life,” the investigators concluded. They recommended studying the infant gut microbiome before and for several months after infections and antibiotic exposure to determine which shifts in microbiota predict IBD onset.
The Manitoba Centre for Health Policy provided access to the Population Health Research Data Repository. Dr. Bernstein is supported by the Bingham Chair in Gastroenterology. He reported ties to AbbVie Canada, Ferring Canada, Janssen Canada, Shire Canada, Takeda Canada, Pfizer Canada, Napo Pharmaceuticals, 4D Pharma, and Mylan.
SOURCE: Bernstein CN et al. Gastroenterology. 2019 Feb 14. doi: 10.1053/j.gastro.2019.02.004.
according to the findings of a large population-based study.
It remains unclear whether the risk reflects infections in themselves or the use of antibiotic therapy, wrote Charles N. Bernstein, MD, of the University of Manitoba, Winnipeg, and associates. Infections did not appear to be a proxy for immunodeficiency disorders, which were similarly infrequent among cases and controls, they noted. Limiting antibiotic usage, while desirable, would be difficult to do for infections as serious as many in the study. Hence, they suggested research to determine “exactly what antibiotic intake does to infant gut microflora or intestinal or systemic immune responses,” and whether giving probiotics or prebiotics after antibiotic therapy helps attenuate the risk of inflammatory bowel disease (IBD) and other autoimmune disorders. The findings were published in Gastroenterology.
IBD is probably multifactorial, but specific causal factors remain unclear. Based on mounting evidence for the role of gut dysbiosis, the researchers explored whether IBD is associated with higher rates of infections and other critical events during the neonatal period and the first year of life by comparing 825 patients with IBD and 5,999 controls matched by age, sex, and area of residence. The data source was the University of Manitoba IBD Epidemiology Database, which includes all Manitobans diagnosed with IBD from 1984 to 2010. The researchers also compared patients with 1,740 unaffected siblings.
Gastrointestinal infections, gastrointestinal disease, and abdominal pain during the first year of life did not predict subsequent IBD. Maternal IBD was the strongest risk factor (odds ratio, 4.5; 95% confidence interval, 3.1-6.7). Among neonatal events, the only significant risk factor was being in the highest versus the lowest socioeconomic quintile (OR, 1.35; 95% CI, 1.01-1.79). This association persisted during the first year of life.
Infections during the first year of life were a significant risk factor for IBD before age 10 (OR, 3.1; 95% CI, 1.1-8.8) and age 20 years (OR, 1.6; 95% CI, 1.2-2.2) in the population-based analysis. In contrast, patients and their unaffected siblings had similar rates of infection during early life. The study may have missed differences in exposures between these groups, or perhaps patients lack certain protective genes possessed by healthy siblings, the researchers wrote.
Numbers of antibiotic prescriptions during the first year and the first decade of life did not significantly differ between 33 cases and 270 controls with available data. However, there was a trend toward more antibiotics prescribed to patients versus controls.
“Together with our past reports that neither cesarean section birth nor antenatal or perinatal maternal use of antibiotics predict ultimate development of IBD, it seems that neonatal changes to the microbiome are subsumed by those occurring in the first year of life,” the investigators concluded. They recommended studying the infant gut microbiome before and for several months after infections and antibiotic exposure to determine which shifts in microbiota predict IBD onset.
The Manitoba Centre for Health Policy provided access to the Population Health Research Data Repository. Dr. Bernstein is supported by the Bingham Chair in Gastroenterology. He reported ties to AbbVie Canada, Ferring Canada, Janssen Canada, Shire Canada, Takeda Canada, Pfizer Canada, Napo Pharmaceuticals, 4D Pharma, and Mylan.
SOURCE: Bernstein CN et al. Gastroenterology. 2019 Feb 14. doi: 10.1053/j.gastro.2019.02.004.
FROM GASTROENTEROLOGY
High-deductible plans do not raise out-of-pocket costs for autism care
In states that mandate coverage for autism spectrum disorder (ASD) health services, families in high-deductible health plans (HDHPs) access ASD-related services without paying more out-of-pocket expenses than traditional plan enrollees, an analysis found.
Lead author Colleen L. Barry, PhD, of Johns Hopkins University, Baltimore, and colleagues examined insurance claims between 2008 and 2012 for children covered by three large U.S. insurers (United Healthcare, Aetna, and Humana) to compare the effects of ASD-related coverage mandates on health spending. At least 47 states and Washington, D.C., have enacted mandates that require insurers to cover ASD-related health services, such as diagnostic and assessment services and behavioral and functional therapies. The final study sample included 98,639 children aged 0-21 years with at least two ASD-related service claims on different days during the study period.
The investigators found that, among HDHP enrollees, coverage mandates were associated with marked increases in average monthly spending across all service categories, but not among traditional plan enrollees. Specifically for HDHP patients, ASD coverage mandates were linked to a $98 greater increase in average monthly spending for insurers on ASD-specific outpatient services, a $142 greater increase in average monthly insurer spending on all outpatient services, and a $142 greater increase in average monthly insurer spending on all health services, according to the study published in Pediatrics. Out-of-pocket spending by patients however, was not significantly different between HDHP and traditional plan enrollees in states that mandate ASD-related coverage, the study found.
Dr. Barry and associates concluded that patients in both HDHP and traditional insurance plans spend large sums on ASD-related care in coverage mandate states, but because costs likely exceed HDHP deductibles, insurers absorb any increases. They suggested that families with regularly high health care expenditures related to ASD services consider high-deductible plans in the context of mandate laws.
“Future research is needed to better understand how features of HDHPs, such as deductible size and health savings account structure, influence the ability of families to make wise choices in obtaining care, and to examine plan premiums and financial strain associated with these plans, particularly for families with children with ASD and high expenditures,” Dr. Barry and associates wrote.
The authors reported no relevant financial disclosures. The study was supported by a National Institute of Mental Health grant and funded by the National Institutes of Health.
SOURCE: Barry CL et al. Pediatrics. 2019 May 13. doi: 10.1542/peds.2018-2391.
The analysis by Barry et al. takes a deep dive into the impact of different payment models on a family’s access to autism spectrum disorder–related services, commented David Keller, MD, and Ann Reynolds, MD.
The work emphasizes the reason that “we must continue to study how interventions in behavioral economics, such as mandates and high-deductible health plans, impact access to care for our most vulnerable children,” they wrote.
These data were from 2008 to 2012, before the Affordable Care Act was implemented. As the definition of “high deductible” has changed from $3,000 annually to $10,000 annually, “have families made different choices regarding care?” they asked.
“With the implementation of value-based payments, we will be creating competing forces through the application of behavioral economics. We need to understand how the interplay of economic forces affects families and their access to essential services,” Dr. Keller and Dr. Reynolds continued.
“We need to understand how to help families make informed decisions that balance the needs of their children with the financial realities of our complex care system so that we can support them in that process,” they wrote. “Understanding the impact of behavioral economics on consumer behavior is essential to assuring that children get the right care at the right time for the right diagnosis.”
Dr. Keller is a professor and Dr. Reynolds is an associate professor at the University of Colorado at Denver, Aurora. This is an excerpt of their editorial that accompanies the study by Barry et al. (Pediatrics. 2019 May 13. doi: 10.1542/peds.2019-0926). Dr. Keller reported no relevant financial disclosures. Dr. Reynolds reported providing consultation to Ovid Therapeutics regarding evaluation of sleep severity and improvement in clinical trials.
The analysis by Barry et al. takes a deep dive into the impact of different payment models on a family’s access to autism spectrum disorder–related services, commented David Keller, MD, and Ann Reynolds, MD.
The work emphasizes the reason that “we must continue to study how interventions in behavioral economics, such as mandates and high-deductible health plans, impact access to care for our most vulnerable children,” they wrote.
These data were from 2008 to 2012, before the Affordable Care Act was implemented. As the definition of “high deductible” has changed from $3,000 annually to $10,000 annually, “have families made different choices regarding care?” they asked.
“With the implementation of value-based payments, we will be creating competing forces through the application of behavioral economics. We need to understand how the interplay of economic forces affects families and their access to essential services,” Dr. Keller and Dr. Reynolds continued.
“We need to understand how to help families make informed decisions that balance the needs of their children with the financial realities of our complex care system so that we can support them in that process,” they wrote. “Understanding the impact of behavioral economics on consumer behavior is essential to assuring that children get the right care at the right time for the right diagnosis.”
Dr. Keller is a professor and Dr. Reynolds is an associate professor at the University of Colorado at Denver, Aurora. This is an excerpt of their editorial that accompanies the study by Barry et al. (Pediatrics. 2019 May 13. doi: 10.1542/peds.2019-0926). Dr. Keller reported no relevant financial disclosures. Dr. Reynolds reported providing consultation to Ovid Therapeutics regarding evaluation of sleep severity and improvement in clinical trials.
The analysis by Barry et al. takes a deep dive into the impact of different payment models on a family’s access to autism spectrum disorder–related services, commented David Keller, MD, and Ann Reynolds, MD.
The work emphasizes the reason that “we must continue to study how interventions in behavioral economics, such as mandates and high-deductible health plans, impact access to care for our most vulnerable children,” they wrote.
These data were from 2008 to 2012, before the Affordable Care Act was implemented. As the definition of “high deductible” has changed from $3,000 annually to $10,000 annually, “have families made different choices regarding care?” they asked.
“With the implementation of value-based payments, we will be creating competing forces through the application of behavioral economics. We need to understand how the interplay of economic forces affects families and their access to essential services,” Dr. Keller and Dr. Reynolds continued.
“We need to understand how to help families make informed decisions that balance the needs of their children with the financial realities of our complex care system so that we can support them in that process,” they wrote. “Understanding the impact of behavioral economics on consumer behavior is essential to assuring that children get the right care at the right time for the right diagnosis.”
Dr. Keller is a professor and Dr. Reynolds is an associate professor at the University of Colorado at Denver, Aurora. This is an excerpt of their editorial that accompanies the study by Barry et al. (Pediatrics. 2019 May 13. doi: 10.1542/peds.2019-0926). Dr. Keller reported no relevant financial disclosures. Dr. Reynolds reported providing consultation to Ovid Therapeutics regarding evaluation of sleep severity and improvement in clinical trials.
In states that mandate coverage for autism spectrum disorder (ASD) health services, families in high-deductible health plans (HDHPs) access ASD-related services without paying more out-of-pocket expenses than traditional plan enrollees, an analysis found.
Lead author Colleen L. Barry, PhD, of Johns Hopkins University, Baltimore, and colleagues examined insurance claims between 2008 and 2012 for children covered by three large U.S. insurers (United Healthcare, Aetna, and Humana) to compare the effects of ASD-related coverage mandates on health spending. At least 47 states and Washington, D.C., have enacted mandates that require insurers to cover ASD-related health services, such as diagnostic and assessment services and behavioral and functional therapies. The final study sample included 98,639 children aged 0-21 years with at least two ASD-related service claims on different days during the study period.
The investigators found that, among HDHP enrollees, coverage mandates were associated with marked increases in average monthly spending across all service categories, but not among traditional plan enrollees. Specifically for HDHP patients, ASD coverage mandates were linked to a $98 greater increase in average monthly spending for insurers on ASD-specific outpatient services, a $142 greater increase in average monthly insurer spending on all outpatient services, and a $142 greater increase in average monthly insurer spending on all health services, according to the study published in Pediatrics. Out-of-pocket spending by patients however, was not significantly different between HDHP and traditional plan enrollees in states that mandate ASD-related coverage, the study found.
Dr. Barry and associates concluded that patients in both HDHP and traditional insurance plans spend large sums on ASD-related care in coverage mandate states, but because costs likely exceed HDHP deductibles, insurers absorb any increases. They suggested that families with regularly high health care expenditures related to ASD services consider high-deductible plans in the context of mandate laws.
“Future research is needed to better understand how features of HDHPs, such as deductible size and health savings account structure, influence the ability of families to make wise choices in obtaining care, and to examine plan premiums and financial strain associated with these plans, particularly for families with children with ASD and high expenditures,” Dr. Barry and associates wrote.
The authors reported no relevant financial disclosures. The study was supported by a National Institute of Mental Health grant and funded by the National Institutes of Health.
SOURCE: Barry CL et al. Pediatrics. 2019 May 13. doi: 10.1542/peds.2018-2391.
In states that mandate coverage for autism spectrum disorder (ASD) health services, families in high-deductible health plans (HDHPs) access ASD-related services without paying more out-of-pocket expenses than traditional plan enrollees, an analysis found.
Lead author Colleen L. Barry, PhD, of Johns Hopkins University, Baltimore, and colleagues examined insurance claims between 2008 and 2012 for children covered by three large U.S. insurers (United Healthcare, Aetna, and Humana) to compare the effects of ASD-related coverage mandates on health spending. At least 47 states and Washington, D.C., have enacted mandates that require insurers to cover ASD-related health services, such as diagnostic and assessment services and behavioral and functional therapies. The final study sample included 98,639 children aged 0-21 years with at least two ASD-related service claims on different days during the study period.
The investigators found that, among HDHP enrollees, coverage mandates were associated with marked increases in average monthly spending across all service categories, but not among traditional plan enrollees. Specifically for HDHP patients, ASD coverage mandates were linked to a $98 greater increase in average monthly spending for insurers on ASD-specific outpatient services, a $142 greater increase in average monthly insurer spending on all outpatient services, and a $142 greater increase in average monthly insurer spending on all health services, according to the study published in Pediatrics. Out-of-pocket spending by patients however, was not significantly different between HDHP and traditional plan enrollees in states that mandate ASD-related coverage, the study found.
Dr. Barry and associates concluded that patients in both HDHP and traditional insurance plans spend large sums on ASD-related care in coverage mandate states, but because costs likely exceed HDHP deductibles, insurers absorb any increases. They suggested that families with regularly high health care expenditures related to ASD services consider high-deductible plans in the context of mandate laws.
“Future research is needed to better understand how features of HDHPs, such as deductible size and health savings account structure, influence the ability of families to make wise choices in obtaining care, and to examine plan premiums and financial strain associated with these plans, particularly for families with children with ASD and high expenditures,” Dr. Barry and associates wrote.
The authors reported no relevant financial disclosures. The study was supported by a National Institute of Mental Health grant and funded by the National Institutes of Health.
SOURCE: Barry CL et al. Pediatrics. 2019 May 13. doi: 10.1542/peds.2018-2391.
FROM PEDIATRICS
Comorbid depression worsens many pediatric hospital outcomes
according to a study in the Journal of Affective Disorders.
The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.
This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.
One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.
The study did not receive funding, and the authors declared there are no conflicts of interest.
SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.
according to a study in the Journal of Affective Disorders.
The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.
This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.
One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.
The study did not receive funding, and the authors declared there are no conflicts of interest.
SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.
according to a study in the Journal of Affective Disorders.
The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.
This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.
One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.
The study did not receive funding, and the authors declared there are no conflicts of interest.
SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
QOL concerns prompt second-line therapy in children with ITP
NEW ORLEANS – In a survey of pediatric hematologists, quality of life was the most frequently cited reason for starting second-line therapy in children with immune thrombocytopenia.
Quality of life (QOL) was an indication for second-line treatment in nearly three-quarters of patients studied, and it ranked among the top three indications – along with bleeding frequency and bleeding severity – for treatment in more than half of patients.
Kristin A. Shimano, MD, of the department of pediatrics at the University of California, San Francisco, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.
Dr. Shimano and colleagues surveyed hematologists treating children in the ICON1 study (Am J Hematol. 2019 Apr 3. doi: 10.1002/ajh.25479).
The study enrolled 120 children receiving second-line immune thrombocytopenia (ITP) treatment at 21 centers. The median age at enrollment was 11.7 years (range, 1.2-17.8 years). About half of patients (53%) had chronic ITP, 31% had persistent ITP, and 16% had newly diagnosed ITP. The median number of prior treatments was three (range, zero to eight).
At study entry, the hematologists were asked to provide reasons that patients required second-line treatment. The list of 12 possible reasons included patient or parent QOL; bleeding severity; bleeding frequency; severity of thrombocytopenia; chronicity of ITP; high baseline activity level; involvement in sports; patient age; distance from medical center; and parent, patient, or physician anxiety. The hematologists were asked to choose all reasons that applied and to rank the top three reasons.
QOL was chosen as a reason to treat in 73% of patients (n = 88). QOL was among the top three reasons in 57% of patients (n = 68) and was the most important reason in 27% of patients (n = 32).
The severity and frequency of bleeding were ranked among the top three indications as well. Bleeding severity was a top indication in 29% of cases (n = 35), and bleeding frequency was a top indication in 40% of cases (n = 48).
Reasons for starting second-line treatment varied depending on patients’ phase of disease.
Bleeding severity was significantly more likely to be an indication for treatment among patients who had newly diagnosed or persistent ITP (69%), rather than chronic ITP (31%; P = .0025). Bleeding frequency was also significantly more likely to be an indication among patients with newly diagnosed or persistent ITP (63% vs. 37%; P = .0054).
Conversely, QOL was significantly more likely to be an indication for patients with chronic ITP (65%) rather than newly diagnosed or persistent ITP (35%, P = .0056). Sports participation was a more likely indication among patients with chronic ITP as well (75% vs. 26%, P = .017).
Indications for treatment also varied according to baseline platelet counts. For example, QOL was an indication for treatment in 42% of patients with baseline platelet counts less than 10 x 109/L and 78% of patients with platelet counts of 20 x 109/L or greater. So the higher the baseline platelet count, the more likely QOL was an indication for treatment (P = .006).
On the other hand, the importance hematologists placed on QOL did not appear to correlate with actual health-related QOL as assessed by the Kids ITP Tool. There was no difference reported in baseline health-related QOL, according to the tool, in children for whom QOL was ranked versus unranked by hematologists.
This finding suggests physicians may not be adequately assessing the impact of ITP on QOL, Dr. Shimano said.
“Better clinical measures of the impact of ITP on patient quality of life are needed to assess both need for treatment and treatment response,” she said. “Understanding the effects of individual second-line treatments on quality of life is critical for this patient population in order to best tailor therapy for each patient.”
Dr. Shimano reported involvement in an investigator-initiated trial for eltrombopag in children with ITP. The study, which has not yet opened, is funded by Novartis.
SOURCE: Shimano KA et al. ASPHO 2019, Abstract 2012.
NEW ORLEANS – In a survey of pediatric hematologists, quality of life was the most frequently cited reason for starting second-line therapy in children with immune thrombocytopenia.
Quality of life (QOL) was an indication for second-line treatment in nearly three-quarters of patients studied, and it ranked among the top three indications – along with bleeding frequency and bleeding severity – for treatment in more than half of patients.
Kristin A. Shimano, MD, of the department of pediatrics at the University of California, San Francisco, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.
Dr. Shimano and colleagues surveyed hematologists treating children in the ICON1 study (Am J Hematol. 2019 Apr 3. doi: 10.1002/ajh.25479).
The study enrolled 120 children receiving second-line immune thrombocytopenia (ITP) treatment at 21 centers. The median age at enrollment was 11.7 years (range, 1.2-17.8 years). About half of patients (53%) had chronic ITP, 31% had persistent ITP, and 16% had newly diagnosed ITP. The median number of prior treatments was three (range, zero to eight).
At study entry, the hematologists were asked to provide reasons that patients required second-line treatment. The list of 12 possible reasons included patient or parent QOL; bleeding severity; bleeding frequency; severity of thrombocytopenia; chronicity of ITP; high baseline activity level; involvement in sports; patient age; distance from medical center; and parent, patient, or physician anxiety. The hematologists were asked to choose all reasons that applied and to rank the top three reasons.
QOL was chosen as a reason to treat in 73% of patients (n = 88). QOL was among the top three reasons in 57% of patients (n = 68) and was the most important reason in 27% of patients (n = 32).
The severity and frequency of bleeding were ranked among the top three indications as well. Bleeding severity was a top indication in 29% of cases (n = 35), and bleeding frequency was a top indication in 40% of cases (n = 48).
Reasons for starting second-line treatment varied depending on patients’ phase of disease.
Bleeding severity was significantly more likely to be an indication for treatment among patients who had newly diagnosed or persistent ITP (69%), rather than chronic ITP (31%; P = .0025). Bleeding frequency was also significantly more likely to be an indication among patients with newly diagnosed or persistent ITP (63% vs. 37%; P = .0054).
Conversely, QOL was significantly more likely to be an indication for patients with chronic ITP (65%) rather than newly diagnosed or persistent ITP (35%, P = .0056). Sports participation was a more likely indication among patients with chronic ITP as well (75% vs. 26%, P = .017).
Indications for treatment also varied according to baseline platelet counts. For example, QOL was an indication for treatment in 42% of patients with baseline platelet counts less than 10 x 109/L and 78% of patients with platelet counts of 20 x 109/L or greater. So the higher the baseline platelet count, the more likely QOL was an indication for treatment (P = .006).
On the other hand, the importance hematologists placed on QOL did not appear to correlate with actual health-related QOL as assessed by the Kids ITP Tool. There was no difference reported in baseline health-related QOL, according to the tool, in children for whom QOL was ranked versus unranked by hematologists.
This finding suggests physicians may not be adequately assessing the impact of ITP on QOL, Dr. Shimano said.
“Better clinical measures of the impact of ITP on patient quality of life are needed to assess both need for treatment and treatment response,” she said. “Understanding the effects of individual second-line treatments on quality of life is critical for this patient population in order to best tailor therapy for each patient.”
Dr. Shimano reported involvement in an investigator-initiated trial for eltrombopag in children with ITP. The study, which has not yet opened, is funded by Novartis.
SOURCE: Shimano KA et al. ASPHO 2019, Abstract 2012.
NEW ORLEANS – In a survey of pediatric hematologists, quality of life was the most frequently cited reason for starting second-line therapy in children with immune thrombocytopenia.
Quality of life (QOL) was an indication for second-line treatment in nearly three-quarters of patients studied, and it ranked among the top three indications – along with bleeding frequency and bleeding severity – for treatment in more than half of patients.
Kristin A. Shimano, MD, of the department of pediatrics at the University of California, San Francisco, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.
Dr. Shimano and colleagues surveyed hematologists treating children in the ICON1 study (Am J Hematol. 2019 Apr 3. doi: 10.1002/ajh.25479).
The study enrolled 120 children receiving second-line immune thrombocytopenia (ITP) treatment at 21 centers. The median age at enrollment was 11.7 years (range, 1.2-17.8 years). About half of patients (53%) had chronic ITP, 31% had persistent ITP, and 16% had newly diagnosed ITP. The median number of prior treatments was three (range, zero to eight).
At study entry, the hematologists were asked to provide reasons that patients required second-line treatment. The list of 12 possible reasons included patient or parent QOL; bleeding severity; bleeding frequency; severity of thrombocytopenia; chronicity of ITP; high baseline activity level; involvement in sports; patient age; distance from medical center; and parent, patient, or physician anxiety. The hematologists were asked to choose all reasons that applied and to rank the top three reasons.
QOL was chosen as a reason to treat in 73% of patients (n = 88). QOL was among the top three reasons in 57% of patients (n = 68) and was the most important reason in 27% of patients (n = 32).
The severity and frequency of bleeding were ranked among the top three indications as well. Bleeding severity was a top indication in 29% of cases (n = 35), and bleeding frequency was a top indication in 40% of cases (n = 48).
Reasons for starting second-line treatment varied depending on patients’ phase of disease.
Bleeding severity was significantly more likely to be an indication for treatment among patients who had newly diagnosed or persistent ITP (69%), rather than chronic ITP (31%; P = .0025). Bleeding frequency was also significantly more likely to be an indication among patients with newly diagnosed or persistent ITP (63% vs. 37%; P = .0054).
Conversely, QOL was significantly more likely to be an indication for patients with chronic ITP (65%) rather than newly diagnosed or persistent ITP (35%, P = .0056). Sports participation was a more likely indication among patients with chronic ITP as well (75% vs. 26%, P = .017).
Indications for treatment also varied according to baseline platelet counts. For example, QOL was an indication for treatment in 42% of patients with baseline platelet counts less than 10 x 109/L and 78% of patients with platelet counts of 20 x 109/L or greater. So the higher the baseline platelet count, the more likely QOL was an indication for treatment (P = .006).
On the other hand, the importance hematologists placed on QOL did not appear to correlate with actual health-related QOL as assessed by the Kids ITP Tool. There was no difference reported in baseline health-related QOL, according to the tool, in children for whom QOL was ranked versus unranked by hematologists.
This finding suggests physicians may not be adequately assessing the impact of ITP on QOL, Dr. Shimano said.
“Better clinical measures of the impact of ITP on patient quality of life are needed to assess both need for treatment and treatment response,” she said. “Understanding the effects of individual second-line treatments on quality of life is critical for this patient population in order to best tailor therapy for each patient.”
Dr. Shimano reported involvement in an investigator-initiated trial for eltrombopag in children with ITP. The study, which has not yet opened, is funded by Novartis.
SOURCE: Shimano KA et al. ASPHO 2019, Abstract 2012.
REPORTING FROM THE 2019 ASPHO CONFERENCE
Key clinical point: Quality of life was the most frequently cited reason for starting second-line therapy in children with immune thrombocytopenia.
Major finding: Quality of life was chosen as a reason to treat in 73% of patients, it was among the top three reasons in 57% of patients, and it was the most important reason in 27%.
Study details: A survey of hematologists treating 120 children in an observational study.
Disclosures: The speaker reported involvement in an investigator-initiated trial for eltrombopag in children with ITP. The study, which has not yet opened, is funded by Novartis.
Source: Shimano KA et al. ASPHO 2019, Abstract 2012.
Evaluation, treatment of anxiety in children and adolescents with autism spectrum disorder
1 As ASD by definition involves deficits in communication and interaction, as well as restricted, repetitive patterns of behavior, interests, or activities, diagnosis and treatment of anxiety disorders in this population can present a significant challenge.
martinedoucet/E+/Getty Images
Clinical vignette
Sean is a 9-year-old boy in the fourth grade diagnosed with ASD. He is in a regular education classroom setting. Until this year, his grades have been above average. This year his mother has been getting calls from the teachers reporting that he is disruptive in class, and is having difficulty paying attention unless the subject relates to a specific interest of his. At home, his mother has been struggling to get him to do chores and homework, and even sitting at the dinner table is now a battle. He is significantly more irritable than usual. While he always preferred routines and familiar activities, deviations from them now trigger strong reactions and sometimes tantrums. He has started to insist on staying up late, and refuses to go to bed without his mother present. Notably his mother reports that she and Sean’s father recently separated, and that she believes he is very upset by this, although he refuses to talk about it.
Discussion
This case highlights the diagnostic complexity with which children with ASD may present. With the overlap between some of the core symptoms of ASD and anxiety, as well as the potential for other co-occurring disorders, a number of factors need to be explored before arriving at a treatment plan.
In evaluating behavior changes in children with ASD, I find it most helpful to start by looking for any medical or environmental factors. Medical problems such as illness or gastrointestinal difficulties may contribute to behavioral challenges and anxiety. Also, be sure to inquire if there are any precipitating events or change in the environment which might correlate with the change in behavior. In this case, we do have a situation – namely Sean’s parents separating – that may be contributing. While addressing Sean’s thoughts and feelings about this remains challenging, awareness of this factor certainly is important.
Understanding the educational setting and supports of a child with ASD is of significant importance. Academic challenges may result from learning or language difficulties, which can result in significant stress. While the vignette mentions that Sean’s grades had previously been above average, it is possible that increased complexity of material is contributing to his school struggles.
Next, it is worth looking at the question of whether Sean meets criteria for ADHD, which is estimated to occur in 30%-61% of people with ASD. In the case vignette, the mention of disruptions and attentional difficulties in the classroom warrant further investigation.
Finally, the question of whether insistence on routine, strong reactions to unfamiliar circumstances, disruptive behavior, and irritability meet criteria for an anxiety disorder is a complex one. Children with ASD may have difficulty communicating that they are anxious, making the behavioral observations of those around them especially important. An advantage pediatric primary care providers have in this circumstance is longitudinal experience with the child and family, which can help confirm whether the problem perceived as anxiety is a manifestation of core autism symptoms, or newer-onset phenomena. Assessing the severity and settings of the behavior also is necessary to guide treatment decisions. In the vignette, Sean’s irritability, acting out, and bedtime difficulties all are of relatively new onset, and occurring across multiple settings with significant functional consequences, making a diagnosis of an anxiety disorder the likely explanation.
As for treatment, cognitive behavioral therapy has been shown to be effective for anxiety in children with high functioning ASD.2 If a clinician with experience with this population is available, that certainly is preferred. If medication is being considered, there are no randomized controlled trials that have demonstrated efficacy of medication for anxiety specifically in children with co-occurring ASD. Treatment recommendations are taken from studies in typically developing children,3 where the SSRIs fluoxetine and sertraline have demonstrated efficacy in treatment of anxiety. When opting for pharmacotherapy in children with ASD, starting low, going slow, and carefully monitoring for side effects is recommended. Regardless of the method of treatment, a clear definition of the target symptoms ahead of time is critical for monitoring response and evaluating treatment effect.
Dr. Hoffnung is a pediatric psychiatrist at the University of Vermont Children’s Hospital and an assistant professor of psychiatry at the Robert Larner, M.D. College of Medicine at the University of Vermont, both in Burlington. He said he had no relevant financial disclosures. Email him at [email protected].
References
1. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17.
2. Child Psychiatry Hum Dev. 2015 Aug;46(4):533-47.
3. Pediatrics. 2016 Feb;137 Suppl 2:S115-23.
1 As ASD by definition involves deficits in communication and interaction, as well as restricted, repetitive patterns of behavior, interests, or activities, diagnosis and treatment of anxiety disorders in this population can present a significant challenge.
martinedoucet/E+/Getty Images
Clinical vignette
Sean is a 9-year-old boy in the fourth grade diagnosed with ASD. He is in a regular education classroom setting. Until this year, his grades have been above average. This year his mother has been getting calls from the teachers reporting that he is disruptive in class, and is having difficulty paying attention unless the subject relates to a specific interest of his. At home, his mother has been struggling to get him to do chores and homework, and even sitting at the dinner table is now a battle. He is significantly more irritable than usual. While he always preferred routines and familiar activities, deviations from them now trigger strong reactions and sometimes tantrums. He has started to insist on staying up late, and refuses to go to bed without his mother present. Notably his mother reports that she and Sean’s father recently separated, and that she believes he is very upset by this, although he refuses to talk about it.
Discussion
This case highlights the diagnostic complexity with which children with ASD may present. With the overlap between some of the core symptoms of ASD and anxiety, as well as the potential for other co-occurring disorders, a number of factors need to be explored before arriving at a treatment plan.
In evaluating behavior changes in children with ASD, I find it most helpful to start by looking for any medical or environmental factors. Medical problems such as illness or gastrointestinal difficulties may contribute to behavioral challenges and anxiety. Also, be sure to inquire if there are any precipitating events or change in the environment which might correlate with the change in behavior. In this case, we do have a situation – namely Sean’s parents separating – that may be contributing. While addressing Sean’s thoughts and feelings about this remains challenging, awareness of this factor certainly is important.
Understanding the educational setting and supports of a child with ASD is of significant importance. Academic challenges may result from learning or language difficulties, which can result in significant stress. While the vignette mentions that Sean’s grades had previously been above average, it is possible that increased complexity of material is contributing to his school struggles.
Next, it is worth looking at the question of whether Sean meets criteria for ADHD, which is estimated to occur in 30%-61% of people with ASD. In the case vignette, the mention of disruptions and attentional difficulties in the classroom warrant further investigation.
Finally, the question of whether insistence on routine, strong reactions to unfamiliar circumstances, disruptive behavior, and irritability meet criteria for an anxiety disorder is a complex one. Children with ASD may have difficulty communicating that they are anxious, making the behavioral observations of those around them especially important. An advantage pediatric primary care providers have in this circumstance is longitudinal experience with the child and family, which can help confirm whether the problem perceived as anxiety is a manifestation of core autism symptoms, or newer-onset phenomena. Assessing the severity and settings of the behavior also is necessary to guide treatment decisions. In the vignette, Sean’s irritability, acting out, and bedtime difficulties all are of relatively new onset, and occurring across multiple settings with significant functional consequences, making a diagnosis of an anxiety disorder the likely explanation.
As for treatment, cognitive behavioral therapy has been shown to be effective for anxiety in children with high functioning ASD.2 If a clinician with experience with this population is available, that certainly is preferred. If medication is being considered, there are no randomized controlled trials that have demonstrated efficacy of medication for anxiety specifically in children with co-occurring ASD. Treatment recommendations are taken from studies in typically developing children,3 where the SSRIs fluoxetine and sertraline have demonstrated efficacy in treatment of anxiety. When opting for pharmacotherapy in children with ASD, starting low, going slow, and carefully monitoring for side effects is recommended. Regardless of the method of treatment, a clear definition of the target symptoms ahead of time is critical for monitoring response and evaluating treatment effect.
Dr. Hoffnung is a pediatric psychiatrist at the University of Vermont Children’s Hospital and an assistant professor of psychiatry at the Robert Larner, M.D. College of Medicine at the University of Vermont, both in Burlington. He said he had no relevant financial disclosures. Email him at [email protected].
References
1. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17.
2. Child Psychiatry Hum Dev. 2015 Aug;46(4):533-47.
3. Pediatrics. 2016 Feb;137 Suppl 2:S115-23.
1 As ASD by definition involves deficits in communication and interaction, as well as restricted, repetitive patterns of behavior, interests, or activities, diagnosis and treatment of anxiety disorders in this population can present a significant challenge.
martinedoucet/E+/Getty Images
Clinical vignette
Sean is a 9-year-old boy in the fourth grade diagnosed with ASD. He is in a regular education classroom setting. Until this year, his grades have been above average. This year his mother has been getting calls from the teachers reporting that he is disruptive in class, and is having difficulty paying attention unless the subject relates to a specific interest of his. At home, his mother has been struggling to get him to do chores and homework, and even sitting at the dinner table is now a battle. He is significantly more irritable than usual. While he always preferred routines and familiar activities, deviations from them now trigger strong reactions and sometimes tantrums. He has started to insist on staying up late, and refuses to go to bed without his mother present. Notably his mother reports that she and Sean’s father recently separated, and that she believes he is very upset by this, although he refuses to talk about it.
Discussion
This case highlights the diagnostic complexity with which children with ASD may present. With the overlap between some of the core symptoms of ASD and anxiety, as well as the potential for other co-occurring disorders, a number of factors need to be explored before arriving at a treatment plan.
In evaluating behavior changes in children with ASD, I find it most helpful to start by looking for any medical or environmental factors. Medical problems such as illness or gastrointestinal difficulties may contribute to behavioral challenges and anxiety. Also, be sure to inquire if there are any precipitating events or change in the environment which might correlate with the change in behavior. In this case, we do have a situation – namely Sean’s parents separating – that may be contributing. While addressing Sean’s thoughts and feelings about this remains challenging, awareness of this factor certainly is important.
Understanding the educational setting and supports of a child with ASD is of significant importance. Academic challenges may result from learning or language difficulties, which can result in significant stress. While the vignette mentions that Sean’s grades had previously been above average, it is possible that increased complexity of material is contributing to his school struggles.
Next, it is worth looking at the question of whether Sean meets criteria for ADHD, which is estimated to occur in 30%-61% of people with ASD. In the case vignette, the mention of disruptions and attentional difficulties in the classroom warrant further investigation.
Finally, the question of whether insistence on routine, strong reactions to unfamiliar circumstances, disruptive behavior, and irritability meet criteria for an anxiety disorder is a complex one. Children with ASD may have difficulty communicating that they are anxious, making the behavioral observations of those around them especially important. An advantage pediatric primary care providers have in this circumstance is longitudinal experience with the child and family, which can help confirm whether the problem perceived as anxiety is a manifestation of core autism symptoms, or newer-onset phenomena. Assessing the severity and settings of the behavior also is necessary to guide treatment decisions. In the vignette, Sean’s irritability, acting out, and bedtime difficulties all are of relatively new onset, and occurring across multiple settings with significant functional consequences, making a diagnosis of an anxiety disorder the likely explanation.
As for treatment, cognitive behavioral therapy has been shown to be effective for anxiety in children with high functioning ASD.2 If a clinician with experience with this population is available, that certainly is preferred. If medication is being considered, there are no randomized controlled trials that have demonstrated efficacy of medication for anxiety specifically in children with co-occurring ASD. Treatment recommendations are taken from studies in typically developing children,3 where the SSRIs fluoxetine and sertraline have demonstrated efficacy in treatment of anxiety. When opting for pharmacotherapy in children with ASD, starting low, going slow, and carefully monitoring for side effects is recommended. Regardless of the method of treatment, a clear definition of the target symptoms ahead of time is critical for monitoring response and evaluating treatment effect.
Dr. Hoffnung is a pediatric psychiatrist at the University of Vermont Children’s Hospital and an assistant professor of psychiatry at the Robert Larner, M.D. College of Medicine at the University of Vermont, both in Burlington. He said he had no relevant financial disclosures. Email him at [email protected].
References
1. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17.
2. Child Psychiatry Hum Dev. 2015 Aug;46(4):533-47.
3. Pediatrics. 2016 Feb;137 Suppl 2:S115-23.
Is there an epidemic of anxiety and depression among today’s adolescents?
It seems that every week there are fresh headlines about a mental health crisis in children and adolescents, reporting exploding rates of severe anxiety and depression in youth. These reports raise the question of whether or not there has been a significant change in their incidence: Are more children developing depressive and anxiety disorders? Are they having greater difficulty accessing care? Are the disorders more severe than they were in the past? Or are young people failing to develop appropriate skills to manage anxiety, sadness, and other forms of distress that are a normal (if unpleasant) part of life? These are important questions, as they will help us to advocate for the proper services to address the public health challenge that underlies this “epidemic.”
What do the data show?
It is important to start by noting that epidemiologic data on child psychiatry in the United States are not as robust as we might like. It was only in 1999 that the Surgeon General’s Report on Mental Health articulated that there was a need for a more systematic approach to collecting epidemiologic data on psychiatric illness in children and adolescents. At that time, the consensus was that approximately one in five children would develop a psychiatric illness by the age of 18 and that approximately 5% of all children would experience a severe or persistent mental illness.1 In the 2 decades since then there have been expanded efforts to collect data, including the addition of an adolescent supplement to the National Comorbidity Survey sponsored by the National Institute of Mental Health, although our current estimates still are based on representative surveys of thousands of U.S. children and teenagers, often with questionnaires filled out by their parents. Thus, we may have overestimates of some behavioral disorders that are obvious and of concern to parents or underestimates of certain internalizing disorders such as depression that can remain unstated and contained in the mind of the adolescent. And even with accurate current estimates, our ability to make statements about trends or changes in rates of disease is limited by the very short period of time in which we have been studying these disease rates in U.S. youth, some changes in definitions, and the unknown impact of increasing recognition rather than true change in incidence.
What is unequivocally clear is that psychiatric illnesses usually present in youth and that these illnesses are among the most common illnesses of youth. Current estimates are that nearly one in four young people will have a psychiatric illness (by The Diagnostic and Statistical Manual of Mental Disorders [DSM], Fifth Edition criteria) by the time they turn 18,2 although only 10% of youth will experience an illness that meets the Substance Abuse and Mental Health Services Administration criteria for a serious emotional disturbance, or one that has a substantial impact on a child’s ability to function socially, emotionally, and academically.3
While it once was believed that children did not experience psychiatric illness, we now know that the majority of psychiatric illnesses present during childhood, adolescence, and young adulthood. The Centers for Disease Control and Prevention estimates that 50% of lifetime psychiatric illness has presented by the age of 15 years and 75% by the age of 24. Only one-quarter of all lifetime psychiatric illnesses emerge in full adulthood, or after the age of 24. Early diagnosis and treatment can make a significant difference in the overall impact of serious illnesses such as schizophrenia and bipolar disorder. We also can state with confidence that anxiety disorders are the most common psychiatric illnesses of youth, making up over 30% of all diagnoses, followed by disorders of behavior (19%), mood (14%), and then substance use (11%).4 Even compared with asthma (with a prevalence of approximately 11%), widely considered to be among the most common disease of childhood, psychiatric illnesses are the most common in youth.
The question then is whether these numbers are changing. The National Comorbidity Survey conducted in 2014 found that the incidence of major depressive episodes in adolescents had increased significantly between 2005 and 2014, from 9% to 11%.5 This is a survey of nearly 200,000 youth across the United States, interviewed by phone with a structured questionnaire assessing their (self-reported) DSM criteria for a major depressive episode, along with other illnesses. During this time frame, access to specialty mental health providers increased among adolescents, alongside their rate of use of psychiatric medications and inpatient hospitalization.
In Europe, where they have more robust epidemiological data, there also has been a public perception of an increase in depression in adolescents. Studies there have suggested that prevalence rates have not changed significantly, and that the problem actually may be a function of a growing population, greater public awareness, and higher rates of psychological distress.6
In the United States, it is difficult to place the prevalence rates in a meaningful context, given the shorter time frame during which we have been following these rates in young people. It is worth highlighting that although the rates at which young people are gaining access to mental health clinicians, being prescribed medications, and being admitted to psychiatric hospitals all have increased, there has not been an associated decrease in the rate of illness or in the severity of symptoms. It certainly is possible that the increase in use of services by youth is being driven by the increased prevalence of this diagnosis, or it may be that other factors, such as those detailed in international studies, are driving this increase in the incidence of depression.
What about the suicide rate?
Another statistic that addressed the question of whether there may be an epidemic of anxiety and depression in adolescents is the recent increase in the suicide rate. While the rate of completed suicide in 15- to 24-year-olds has been trending upward over the last decade, it is worth noting that this phenomenon appears to be occurring across age groups and is not isolated to adolescents. While adolescents may have a unique underlying set of issues driving the increase, it also may be that factors affecting the entire population (access to firearms, the epidemic of opioid addiction) may be at the core of this worrisome trend.
What about the role of stress?
It is worth noting that there is evidence of an increased rate of psychological distress in adolescents and young adults separate from any increase in the rate of psychiatric illness. Surveys of adolescents in high school and entering college demonstrate higher self-reported rates of severe stress and anxiety. One survey from the American Psychological Association from August 2018 found teenagers reporting higher levels of stress and related sadness and anxiety than the levels among the adults who were surveyed. So more young people are struggling with feelings of anxiety and sadness, without necessarily meeting criteria for a psychiatric illness. This suggests that levels of external stressors may have increased, or that the establishment of healthy coping skills has somehow been compromised in young people, or both.
What can you do as a clinician?
While the broader question of whether actual incidence rates of depression are on the rise will not be settled any time soon, when a patient of yours complains of high levels of stress, anxiety, or feelings of depression, it is very possible that the individual has a psychiatric diagnosis. A quick screening evaluation, using a questionnaire such as the Pediatric Symptom Checklist and/or a brief interview, can indicate if the patient may benefit from a referral.
In addition, all children, including those who have a psychiatric diagnosis, will benefit from a calm, patient, supportive adult who is interested in their distress. It would be very helpful if you are ready to talk about healthy coping skills, and how they are developed over time and only in the setting of actually struggling with some adversity. Help them frame their source of stress as a challenge rather than a threat. Help them identify their meaningful supports, particularly adults who know them well, and offer concrete and practical advice and motivation. And remind them about how self-care is essential to managing the normal stress of adolescence. Have handouts (or virtual ones) ready on good sleep hygiene, the value of exercise, and fact-based nutritional guidance. Offer strategies to manage screen time so that it is a recharging break and not a time sink. Support their identification of other strategies to decompress and manage stress: Are they recharged by time with friends? Exercise? Playing music? Listening to music? Playing video games? They should be building their personalized list, and it should include more active as well as passive strategies. Educate them about the risks of using drugs and alcohol “to relax,” or only having one way of unwinding. Educate your patients and parents about the special value of a mindfulness practice, whether meditation, yoga, or any activity in which they practice a nonjudgmental observation and acceptance of strong emotions.
Accurate prevalence rates can help us consider the statistical probability of a psychiatric diagnosis. By talking with your patients about stressful feelings, you can consider the individual need for a fuller psychiatric evaluation while also helping them reframe their approach to stress to one that is more empowering, adaptive, and healthy.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Mental Health: A Report of the Surgeon General, National Institutes of Mental Health (1999).
2. Prevalence of psychiatric disorders in childhood and adolescence, in “Mental Health Services: A Public Health Perspective,” 2nd ed. (Oxford, UK: Oxford University Press; 2004, pp. 111-28).
3. Public Health Rep. 2006 May-Jun;121(3):303-10.
4. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9.
5. Pediatrics. 2016 Dec;138(6):e20161878.
6. Depress Anxiety. 2014 Jun;31(6):506-16.
It seems that every week there are fresh headlines about a mental health crisis in children and adolescents, reporting exploding rates of severe anxiety and depression in youth. These reports raise the question of whether or not there has been a significant change in their incidence: Are more children developing depressive and anxiety disorders? Are they having greater difficulty accessing care? Are the disorders more severe than they were in the past? Or are young people failing to develop appropriate skills to manage anxiety, sadness, and other forms of distress that are a normal (if unpleasant) part of life? These are important questions, as they will help us to advocate for the proper services to address the public health challenge that underlies this “epidemic.”
What do the data show?
It is important to start by noting that epidemiologic data on child psychiatry in the United States are not as robust as we might like. It was only in 1999 that the Surgeon General’s Report on Mental Health articulated that there was a need for a more systematic approach to collecting epidemiologic data on psychiatric illness in children and adolescents. At that time, the consensus was that approximately one in five children would develop a psychiatric illness by the age of 18 and that approximately 5% of all children would experience a severe or persistent mental illness.1 In the 2 decades since then there have been expanded efforts to collect data, including the addition of an adolescent supplement to the National Comorbidity Survey sponsored by the National Institute of Mental Health, although our current estimates still are based on representative surveys of thousands of U.S. children and teenagers, often with questionnaires filled out by their parents. Thus, we may have overestimates of some behavioral disorders that are obvious and of concern to parents or underestimates of certain internalizing disorders such as depression that can remain unstated and contained in the mind of the adolescent. And even with accurate current estimates, our ability to make statements about trends or changes in rates of disease is limited by the very short period of time in which we have been studying these disease rates in U.S. youth, some changes in definitions, and the unknown impact of increasing recognition rather than true change in incidence.
What is unequivocally clear is that psychiatric illnesses usually present in youth and that these illnesses are among the most common illnesses of youth. Current estimates are that nearly one in four young people will have a psychiatric illness (by The Diagnostic and Statistical Manual of Mental Disorders [DSM], Fifth Edition criteria) by the time they turn 18,2 although only 10% of youth will experience an illness that meets the Substance Abuse and Mental Health Services Administration criteria for a serious emotional disturbance, or one that has a substantial impact on a child’s ability to function socially, emotionally, and academically.3
While it once was believed that children did not experience psychiatric illness, we now know that the majority of psychiatric illnesses present during childhood, adolescence, and young adulthood. The Centers for Disease Control and Prevention estimates that 50% of lifetime psychiatric illness has presented by the age of 15 years and 75% by the age of 24. Only one-quarter of all lifetime psychiatric illnesses emerge in full adulthood, or after the age of 24. Early diagnosis and treatment can make a significant difference in the overall impact of serious illnesses such as schizophrenia and bipolar disorder. We also can state with confidence that anxiety disorders are the most common psychiatric illnesses of youth, making up over 30% of all diagnoses, followed by disorders of behavior (19%), mood (14%), and then substance use (11%).4 Even compared with asthma (with a prevalence of approximately 11%), widely considered to be among the most common disease of childhood, psychiatric illnesses are the most common in youth.
The question then is whether these numbers are changing. The National Comorbidity Survey conducted in 2014 found that the incidence of major depressive episodes in adolescents had increased significantly between 2005 and 2014, from 9% to 11%.5 This is a survey of nearly 200,000 youth across the United States, interviewed by phone with a structured questionnaire assessing their (self-reported) DSM criteria for a major depressive episode, along with other illnesses. During this time frame, access to specialty mental health providers increased among adolescents, alongside their rate of use of psychiatric medications and inpatient hospitalization.
In Europe, where they have more robust epidemiological data, there also has been a public perception of an increase in depression in adolescents. Studies there have suggested that prevalence rates have not changed significantly, and that the problem actually may be a function of a growing population, greater public awareness, and higher rates of psychological distress.6
In the United States, it is difficult to place the prevalence rates in a meaningful context, given the shorter time frame during which we have been following these rates in young people. It is worth highlighting that although the rates at which young people are gaining access to mental health clinicians, being prescribed medications, and being admitted to psychiatric hospitals all have increased, there has not been an associated decrease in the rate of illness or in the severity of symptoms. It certainly is possible that the increase in use of services by youth is being driven by the increased prevalence of this diagnosis, or it may be that other factors, such as those detailed in international studies, are driving this increase in the incidence of depression.
What about the suicide rate?
Another statistic that addressed the question of whether there may be an epidemic of anxiety and depression in adolescents is the recent increase in the suicide rate. While the rate of completed suicide in 15- to 24-year-olds has been trending upward over the last decade, it is worth noting that this phenomenon appears to be occurring across age groups and is not isolated to adolescents. While adolescents may have a unique underlying set of issues driving the increase, it also may be that factors affecting the entire population (access to firearms, the epidemic of opioid addiction) may be at the core of this worrisome trend.
What about the role of stress?
It is worth noting that there is evidence of an increased rate of psychological distress in adolescents and young adults separate from any increase in the rate of psychiatric illness. Surveys of adolescents in high school and entering college demonstrate higher self-reported rates of severe stress and anxiety. One survey from the American Psychological Association from August 2018 found teenagers reporting higher levels of stress and related sadness and anxiety than the levels among the adults who were surveyed. So more young people are struggling with feelings of anxiety and sadness, without necessarily meeting criteria for a psychiatric illness. This suggests that levels of external stressors may have increased, or that the establishment of healthy coping skills has somehow been compromised in young people, or both.
What can you do as a clinician?
While the broader question of whether actual incidence rates of depression are on the rise will not be settled any time soon, when a patient of yours complains of high levels of stress, anxiety, or feelings of depression, it is very possible that the individual has a psychiatric diagnosis. A quick screening evaluation, using a questionnaire such as the Pediatric Symptom Checklist and/or a brief interview, can indicate if the patient may benefit from a referral.
In addition, all children, including those who have a psychiatric diagnosis, will benefit from a calm, patient, supportive adult who is interested in their distress. It would be very helpful if you are ready to talk about healthy coping skills, and how they are developed over time and only in the setting of actually struggling with some adversity. Help them frame their source of stress as a challenge rather than a threat. Help them identify their meaningful supports, particularly adults who know them well, and offer concrete and practical advice and motivation. And remind them about how self-care is essential to managing the normal stress of adolescence. Have handouts (or virtual ones) ready on good sleep hygiene, the value of exercise, and fact-based nutritional guidance. Offer strategies to manage screen time so that it is a recharging break and not a time sink. Support their identification of other strategies to decompress and manage stress: Are they recharged by time with friends? Exercise? Playing music? Listening to music? Playing video games? They should be building their personalized list, and it should include more active as well as passive strategies. Educate them about the risks of using drugs and alcohol “to relax,” or only having one way of unwinding. Educate your patients and parents about the special value of a mindfulness practice, whether meditation, yoga, or any activity in which they practice a nonjudgmental observation and acceptance of strong emotions.
Accurate prevalence rates can help us consider the statistical probability of a psychiatric diagnosis. By talking with your patients about stressful feelings, you can consider the individual need for a fuller psychiatric evaluation while also helping them reframe their approach to stress to one that is more empowering, adaptive, and healthy.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Mental Health: A Report of the Surgeon General, National Institutes of Mental Health (1999).
2. Prevalence of psychiatric disorders in childhood and adolescence, in “Mental Health Services: A Public Health Perspective,” 2nd ed. (Oxford, UK: Oxford University Press; 2004, pp. 111-28).
3. Public Health Rep. 2006 May-Jun;121(3):303-10.
4. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9.
5. Pediatrics. 2016 Dec;138(6):e20161878.
6. Depress Anxiety. 2014 Jun;31(6):506-16.
It seems that every week there are fresh headlines about a mental health crisis in children and adolescents, reporting exploding rates of severe anxiety and depression in youth. These reports raise the question of whether or not there has been a significant change in their incidence: Are more children developing depressive and anxiety disorders? Are they having greater difficulty accessing care? Are the disorders more severe than they were in the past? Or are young people failing to develop appropriate skills to manage anxiety, sadness, and other forms of distress that are a normal (if unpleasant) part of life? These are important questions, as they will help us to advocate for the proper services to address the public health challenge that underlies this “epidemic.”
What do the data show?
It is important to start by noting that epidemiologic data on child psychiatry in the United States are not as robust as we might like. It was only in 1999 that the Surgeon General’s Report on Mental Health articulated that there was a need for a more systematic approach to collecting epidemiologic data on psychiatric illness in children and adolescents. At that time, the consensus was that approximately one in five children would develop a psychiatric illness by the age of 18 and that approximately 5% of all children would experience a severe or persistent mental illness.1 In the 2 decades since then there have been expanded efforts to collect data, including the addition of an adolescent supplement to the National Comorbidity Survey sponsored by the National Institute of Mental Health, although our current estimates still are based on representative surveys of thousands of U.S. children and teenagers, often with questionnaires filled out by their parents. Thus, we may have overestimates of some behavioral disorders that are obvious and of concern to parents or underestimates of certain internalizing disorders such as depression that can remain unstated and contained in the mind of the adolescent. And even with accurate current estimates, our ability to make statements about trends or changes in rates of disease is limited by the very short period of time in which we have been studying these disease rates in U.S. youth, some changes in definitions, and the unknown impact of increasing recognition rather than true change in incidence.
What is unequivocally clear is that psychiatric illnesses usually present in youth and that these illnesses are among the most common illnesses of youth. Current estimates are that nearly one in four young people will have a psychiatric illness (by The Diagnostic and Statistical Manual of Mental Disorders [DSM], Fifth Edition criteria) by the time they turn 18,2 although only 10% of youth will experience an illness that meets the Substance Abuse and Mental Health Services Administration criteria for a serious emotional disturbance, or one that has a substantial impact on a child’s ability to function socially, emotionally, and academically.3
While it once was believed that children did not experience psychiatric illness, we now know that the majority of psychiatric illnesses present during childhood, adolescence, and young adulthood. The Centers for Disease Control and Prevention estimates that 50% of lifetime psychiatric illness has presented by the age of 15 years and 75% by the age of 24. Only one-quarter of all lifetime psychiatric illnesses emerge in full adulthood, or after the age of 24. Early diagnosis and treatment can make a significant difference in the overall impact of serious illnesses such as schizophrenia and bipolar disorder. We also can state with confidence that anxiety disorders are the most common psychiatric illnesses of youth, making up over 30% of all diagnoses, followed by disorders of behavior (19%), mood (14%), and then substance use (11%).4 Even compared with asthma (with a prevalence of approximately 11%), widely considered to be among the most common disease of childhood, psychiatric illnesses are the most common in youth.
The question then is whether these numbers are changing. The National Comorbidity Survey conducted in 2014 found that the incidence of major depressive episodes in adolescents had increased significantly between 2005 and 2014, from 9% to 11%.5 This is a survey of nearly 200,000 youth across the United States, interviewed by phone with a structured questionnaire assessing their (self-reported) DSM criteria for a major depressive episode, along with other illnesses. During this time frame, access to specialty mental health providers increased among adolescents, alongside their rate of use of psychiatric medications and inpatient hospitalization.
In Europe, where they have more robust epidemiological data, there also has been a public perception of an increase in depression in adolescents. Studies there have suggested that prevalence rates have not changed significantly, and that the problem actually may be a function of a growing population, greater public awareness, and higher rates of psychological distress.6
In the United States, it is difficult to place the prevalence rates in a meaningful context, given the shorter time frame during which we have been following these rates in young people. It is worth highlighting that although the rates at which young people are gaining access to mental health clinicians, being prescribed medications, and being admitted to psychiatric hospitals all have increased, there has not been an associated decrease in the rate of illness or in the severity of symptoms. It certainly is possible that the increase in use of services by youth is being driven by the increased prevalence of this diagnosis, or it may be that other factors, such as those detailed in international studies, are driving this increase in the incidence of depression.
What about the suicide rate?
Another statistic that addressed the question of whether there may be an epidemic of anxiety and depression in adolescents is the recent increase in the suicide rate. While the rate of completed suicide in 15- to 24-year-olds has been trending upward over the last decade, it is worth noting that this phenomenon appears to be occurring across age groups and is not isolated to adolescents. While adolescents may have a unique underlying set of issues driving the increase, it also may be that factors affecting the entire population (access to firearms, the epidemic of opioid addiction) may be at the core of this worrisome trend.
What about the role of stress?
It is worth noting that there is evidence of an increased rate of psychological distress in adolescents and young adults separate from any increase in the rate of psychiatric illness. Surveys of adolescents in high school and entering college demonstrate higher self-reported rates of severe stress and anxiety. One survey from the American Psychological Association from August 2018 found teenagers reporting higher levels of stress and related sadness and anxiety than the levels among the adults who were surveyed. So more young people are struggling with feelings of anxiety and sadness, without necessarily meeting criteria for a psychiatric illness. This suggests that levels of external stressors may have increased, or that the establishment of healthy coping skills has somehow been compromised in young people, or both.
What can you do as a clinician?
While the broader question of whether actual incidence rates of depression are on the rise will not be settled any time soon, when a patient of yours complains of high levels of stress, anxiety, or feelings of depression, it is very possible that the individual has a psychiatric diagnosis. A quick screening evaluation, using a questionnaire such as the Pediatric Symptom Checklist and/or a brief interview, can indicate if the patient may benefit from a referral.
In addition, all children, including those who have a psychiatric diagnosis, will benefit from a calm, patient, supportive adult who is interested in their distress. It would be very helpful if you are ready to talk about healthy coping skills, and how they are developed over time and only in the setting of actually struggling with some adversity. Help them frame their source of stress as a challenge rather than a threat. Help them identify their meaningful supports, particularly adults who know them well, and offer concrete and practical advice and motivation. And remind them about how self-care is essential to managing the normal stress of adolescence. Have handouts (or virtual ones) ready on good sleep hygiene, the value of exercise, and fact-based nutritional guidance. Offer strategies to manage screen time so that it is a recharging break and not a time sink. Support their identification of other strategies to decompress and manage stress: Are they recharged by time with friends? Exercise? Playing music? Listening to music? Playing video games? They should be building their personalized list, and it should include more active as well as passive strategies. Educate them about the risks of using drugs and alcohol “to relax,” or only having one way of unwinding. Educate your patients and parents about the special value of a mindfulness practice, whether meditation, yoga, or any activity in which they practice a nonjudgmental observation and acceptance of strong emotions.
Accurate prevalence rates can help us consider the statistical probability of a psychiatric diagnosis. By talking with your patients about stressful feelings, you can consider the individual need for a fuller psychiatric evaluation while also helping them reframe their approach to stress to one that is more empowering, adaptive, and healthy.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Mental Health: A Report of the Surgeon General, National Institutes of Mental Health (1999).
2. Prevalence of psychiatric disorders in childhood and adolescence, in “Mental Health Services: A Public Health Perspective,” 2nd ed. (Oxford, UK: Oxford University Press; 2004, pp. 111-28).
3. Public Health Rep. 2006 May-Jun;121(3):303-10.
4. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9.
5. Pediatrics. 2016 Dec;138(6):e20161878.
6. Depress Anxiety. 2014 Jun;31(6):506-16.
Flu vaccine visits reveal missed opportunities for HPV vaccination
BALTIMORE – according to a study.
“Overall in preventive visits, missed opportunities were much higher for HPV, compared to the other two vaccines” recommended for adolescents, MenACWY (meningococcal conjugate vaccine) and Tdap, Mary Kate Kelly, MPH, of Children’s Hospital of Philadelphia, told attendees at the Pediatric Academic Societies annual meeting. “In order to increase vaccination rates, it’s essential to implement efforts to reduce missed opportunities.”
According to 2018 Centers for Disease Control and Prevention data, Ms. Kelly said, vaccine coverage for the HPV vaccine is approximately 66%, compared with 85% for the MenACWY vaccine and 89% for the Tdap vaccine.
Ms. Kelly and her colleagues investigated how often children or adolescents missed an opportunity to get an HPV vaccine when they received an influenza vaccine during an office visit. This study was part of the larger STOP HPV trial funded by the National Institutes of Health and aimed at implementing evidence-based interventions to reduce missed opportunities for HPV vaccination in primary care.
The researchers retrospectively reviewed EHRs from 2015 to 2018 for 48 pediatric practices across 19 states. All practices were part of the American Academy of Pediatrics’ Pediatric Research in Office Settings (PROS) national pediatric primary care network. The researchers isolated all visits for patients aged 11-17 years who received their flu vaccine and were eligible to receive the HPV vaccine.
The investigators defined a missed opportunity as one in which a patient was due for the HPV vaccine but did not receive one at the visit when they received their flu vaccine.
The study involved 40,129 patients who received the flu vaccine at 52,818 visits when they also were eligible to receive the HPV vaccine. The median age of patients was 12 years old, and 47% were female.
In 68% of visits, the patient could have received an HPV vaccine but did not – even though they were due and eligible for one. The rate was the same for boys and for girls. By contrast, only 38% of visits involved a missed opportunity for the MenACWY vaccines and 39% for the Tdap vaccine.
Rates of missed opportunities for HPV vaccination ranged among individual practices from 22% to 81% of overall visits. Patients were more than twice as likely to miss the opportunity for an HPV vaccine dose if it would have been their first dose – 70% of missed opportunities – versus being a second or third dose, which comprised 30% of missed opportunities (adjusted relative risk, 2.48; P less than .001)).
“However, missed opportunities were also common for subsequent HPV doses when vaccine hesitancy is less likely to be an issue,” Ms. Kelly added.
It also was much more likely that missed opportunities occurred during nurse visits or visits for an acute or chronic condition rather than preventive visits, which made up about half (51%) of all visits analyzed. While 48% of preventive visits involved a missed opportunity, 93% of nurse visits (aRR compared with preventive, 2.18; P less than.001) and 89% of acute or chronic visits (aRR, 2.11; P less than .001) did.
Percentages of missed opportunities were similarly high for the MenACWY and Tdap vaccines at nurse visits and acute/chronic visits, but much lower at preventive visits for the MenACWY (12%) and Tdap (15%) vaccines.
“Increasing simultaneous administration of HPV and other adolescent vaccines with the influenza vaccine may help to improve coverage,” Ms. Kelly concluded.
The study was limited by its use of a convenience sample from practices that were interested in participating and willing to stock the HPV vaccine. Additionally, the researchers could not detect or adjust for EHR errors or inaccurate or incomplete vaccine histories, and they were unable to look at vaccine hesitancy or refusal with the EHRs.
The research was funded by the National Institutes of Health, the U.S. Department of Health & Human Services, and the National Research Network to Improve Children’s Health. The authors reported no relevant financial disclosures.
BALTIMORE – according to a study.
“Overall in preventive visits, missed opportunities were much higher for HPV, compared to the other two vaccines” recommended for adolescents, MenACWY (meningococcal conjugate vaccine) and Tdap, Mary Kate Kelly, MPH, of Children’s Hospital of Philadelphia, told attendees at the Pediatric Academic Societies annual meeting. “In order to increase vaccination rates, it’s essential to implement efforts to reduce missed opportunities.”
According to 2018 Centers for Disease Control and Prevention data, Ms. Kelly said, vaccine coverage for the HPV vaccine is approximately 66%, compared with 85% for the MenACWY vaccine and 89% for the Tdap vaccine.
Ms. Kelly and her colleagues investigated how often children or adolescents missed an opportunity to get an HPV vaccine when they received an influenza vaccine during an office visit. This study was part of the larger STOP HPV trial funded by the National Institutes of Health and aimed at implementing evidence-based interventions to reduce missed opportunities for HPV vaccination in primary care.
The researchers retrospectively reviewed EHRs from 2015 to 2018 for 48 pediatric practices across 19 states. All practices were part of the American Academy of Pediatrics’ Pediatric Research in Office Settings (PROS) national pediatric primary care network. The researchers isolated all visits for patients aged 11-17 years who received their flu vaccine and were eligible to receive the HPV vaccine.
The investigators defined a missed opportunity as one in which a patient was due for the HPV vaccine but did not receive one at the visit when they received their flu vaccine.
The study involved 40,129 patients who received the flu vaccine at 52,818 visits when they also were eligible to receive the HPV vaccine. The median age of patients was 12 years old, and 47% were female.
In 68% of visits, the patient could have received an HPV vaccine but did not – even though they were due and eligible for one. The rate was the same for boys and for girls. By contrast, only 38% of visits involved a missed opportunity for the MenACWY vaccines and 39% for the Tdap vaccine.
Rates of missed opportunities for HPV vaccination ranged among individual practices from 22% to 81% of overall visits. Patients were more than twice as likely to miss the opportunity for an HPV vaccine dose if it would have been their first dose – 70% of missed opportunities – versus being a second or third dose, which comprised 30% of missed opportunities (adjusted relative risk, 2.48; P less than .001)).
“However, missed opportunities were also common for subsequent HPV doses when vaccine hesitancy is less likely to be an issue,” Ms. Kelly added.
It also was much more likely that missed opportunities occurred during nurse visits or visits for an acute or chronic condition rather than preventive visits, which made up about half (51%) of all visits analyzed. While 48% of preventive visits involved a missed opportunity, 93% of nurse visits (aRR compared with preventive, 2.18; P less than.001) and 89% of acute or chronic visits (aRR, 2.11; P less than .001) did.
Percentages of missed opportunities were similarly high for the MenACWY and Tdap vaccines at nurse visits and acute/chronic visits, but much lower at preventive visits for the MenACWY (12%) and Tdap (15%) vaccines.
“Increasing simultaneous administration of HPV and other adolescent vaccines with the influenza vaccine may help to improve coverage,” Ms. Kelly concluded.
The study was limited by its use of a convenience sample from practices that were interested in participating and willing to stock the HPV vaccine. Additionally, the researchers could not detect or adjust for EHR errors or inaccurate or incomplete vaccine histories, and they were unable to look at vaccine hesitancy or refusal with the EHRs.
The research was funded by the National Institutes of Health, the U.S. Department of Health & Human Services, and the National Research Network to Improve Children’s Health. The authors reported no relevant financial disclosures.
BALTIMORE – according to a study.
“Overall in preventive visits, missed opportunities were much higher for HPV, compared to the other two vaccines” recommended for adolescents, MenACWY (meningococcal conjugate vaccine) and Tdap, Mary Kate Kelly, MPH, of Children’s Hospital of Philadelphia, told attendees at the Pediatric Academic Societies annual meeting. “In order to increase vaccination rates, it’s essential to implement efforts to reduce missed opportunities.”
According to 2018 Centers for Disease Control and Prevention data, Ms. Kelly said, vaccine coverage for the HPV vaccine is approximately 66%, compared with 85% for the MenACWY vaccine and 89% for the Tdap vaccine.
Ms. Kelly and her colleagues investigated how often children or adolescents missed an opportunity to get an HPV vaccine when they received an influenza vaccine during an office visit. This study was part of the larger STOP HPV trial funded by the National Institutes of Health and aimed at implementing evidence-based interventions to reduce missed opportunities for HPV vaccination in primary care.
The researchers retrospectively reviewed EHRs from 2015 to 2018 for 48 pediatric practices across 19 states. All practices were part of the American Academy of Pediatrics’ Pediatric Research in Office Settings (PROS) national pediatric primary care network. The researchers isolated all visits for patients aged 11-17 years who received their flu vaccine and were eligible to receive the HPV vaccine.
The investigators defined a missed opportunity as one in which a patient was due for the HPV vaccine but did not receive one at the visit when they received their flu vaccine.
The study involved 40,129 patients who received the flu vaccine at 52,818 visits when they also were eligible to receive the HPV vaccine. The median age of patients was 12 years old, and 47% were female.
In 68% of visits, the patient could have received an HPV vaccine but did not – even though they were due and eligible for one. The rate was the same for boys and for girls. By contrast, only 38% of visits involved a missed opportunity for the MenACWY vaccines and 39% for the Tdap vaccine.
Rates of missed opportunities for HPV vaccination ranged among individual practices from 22% to 81% of overall visits. Patients were more than twice as likely to miss the opportunity for an HPV vaccine dose if it would have been their first dose – 70% of missed opportunities – versus being a second or third dose, which comprised 30% of missed opportunities (adjusted relative risk, 2.48; P less than .001)).
“However, missed opportunities were also common for subsequent HPV doses when vaccine hesitancy is less likely to be an issue,” Ms. Kelly added.
It also was much more likely that missed opportunities occurred during nurse visits or visits for an acute or chronic condition rather than preventive visits, which made up about half (51%) of all visits analyzed. While 48% of preventive visits involved a missed opportunity, 93% of nurse visits (aRR compared with preventive, 2.18; P less than.001) and 89% of acute or chronic visits (aRR, 2.11; P less than .001) did.
Percentages of missed opportunities were similarly high for the MenACWY and Tdap vaccines at nurse visits and acute/chronic visits, but much lower at preventive visits for the MenACWY (12%) and Tdap (15%) vaccines.
“Increasing simultaneous administration of HPV and other adolescent vaccines with the influenza vaccine may help to improve coverage,” Ms. Kelly concluded.
The study was limited by its use of a convenience sample from practices that were interested in participating and willing to stock the HPV vaccine. Additionally, the researchers could not detect or adjust for EHR errors or inaccurate or incomplete vaccine histories, and they were unable to look at vaccine hesitancy or refusal with the EHRs.
The research was funded by the National Institutes of Health, the U.S. Department of Health & Human Services, and the National Research Network to Improve Children’s Health. The authors reported no relevant financial disclosures.
REPORTING FROM PAS 2019