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Abortion laws link to state-level mortality
States that have moderate state abortion laws had lower rates of maternal, fetal, and infant mortality, but not lower all-cause mortality, in reproductive-aged females compared with states that have restrictive laws, new research using 2000-2019 data indicates.
Additionally, having a higher number of laws that restrict abortion in a state was linked with higher maternal and infant mortality in the state, the study states.
Mortality increases with number of laws
“Each additional abortion regulation was associated with an increase in maternal mortality (1.09/100,000 live births; 95% confidence interval, 0.36-1.82) and infant mortality (0.20/1,000 live births; 95% CI, 0.12-0.26),” the authors write.
Lorie M. Harper, MD, MSCI, with the department of women’s health, University of Texas at Austin, led a team that simultaneously studied four categories of mortality: all-cause mortality in females ages 15-49 years; maternal mortality; infant mortality; and fetal mortality.
Her team did a retrospective cohort study using the Centers for Disease Control and Prevention’s WONDER (Wide-ranging ONline Data for Epidemiologic Research) database. WONDER collects publicly available data with information on mortality by state.
Data were available from 2000 to 2019 for all-cause, maternal, and infant mortality. Fetal mortality data were available from 2005 to 2019.
Findings were published ahead of print in February’s Obstetrics & Gynecology.
Though the study was done before the Supreme Court decision overturning Roe v. Wade in June 2022, its findings may shed light on potential trends depending on states’ decisions.
In the wake of the Dobbs v. Jackson Women’s Health Organization, an estimated 33 million U.S. women will live in states without available abortion services, the authors note.
State abortion laws changed dramatically in the study period
The authors chose the 2-decade time frame because data could be accessed for both maternal and infant mortality for all the years and because state level abortion laws changed dramatically in that time.
The Guttmacher Institute has analyzed each state’s abortion policy landscape and scored states as restrictive, moderate, or supportive. Certain types of abortion laws were associated with higher rates of all-cause mortality in reproductive-age females.
Those laws included trigger laws (the laws that automatically outlaw abortion in a state when federal law is overturned), laws that limit access to medication abortion, and parental consent laws, according to the paper.
Additionally, states that restrict access to abortion have higher rates of maternal and infant death, even after accounting for the general health of the population.
Trigger-law states have strong mortality association
Blair G. Darney, PhD, MPH, with the department of obstetrics and gynecology, Oregon Health & Science University and the OHSU-PSU School of Public Health in Portland, and two OHSU coauthors note in an accompanying editorial that having a trigger law in place was associated with elevations in all four mortality measures. However, trigger laws had not yet been enacted during the study.
The existence of trigger laws is likely a proxy for other factors, they write.
“[T]he relationship between trigger laws and increased mortality may more likely be explained by other factors that were not considered in the analysis than by laws that were not enacted at the time of the study,” the editorialists write.
Those factors may include lack of Medicaid expansion, socioeconomic inequities, and other policies.
The editorialists also caution that just because some types of abortion restrictions don’t appear to increase mortality, it doesn’t mean they aren’t harmful.
“For example, laws prohibiting private or Medicaid insurance coverage for abortions were not associated with maternal mortality, but these laws may simply shift the burden of payment to the individual seeking an abortion or be mitigated by funds that support an individual’s out-of-pocket cost for care. The lack of an association may therefore reflect women’s resilience and their ability to obtain needed health care in the face of financial challenges,” they write.
They point out that, conversely, Targeted Regulation of Abortion Providers (TRAP) laws, which supporters say protect women, have been associated instead with increases in maternal mortality.
Dr. Harper and study coauthors, noting that the relationship between abortion laws and mortality is complex, urge states with restrictive abortion laws to consider proven countermeasures to offset the rates, including Medicaid expansion.
One coauthor served on a medical advisory board, was a site primary investigator for several clinical trials, and received royalties from UpToDate for two topics related to trial of labor after cesarean. The other authors did not report any potential conflicts of interest. Dr. Darney’s institution receives research funding from Organon and the Office of Population Affairs on which she is the primary investigator, and she is a member of the board of directors of the Society of Family Planning and a deputy editor at Contraception. She has received an honorarium from ACOG for committee work. The other editorialists did not report any potential conflicts of interest.
States that have moderate state abortion laws had lower rates of maternal, fetal, and infant mortality, but not lower all-cause mortality, in reproductive-aged females compared with states that have restrictive laws, new research using 2000-2019 data indicates.
Additionally, having a higher number of laws that restrict abortion in a state was linked with higher maternal and infant mortality in the state, the study states.
Mortality increases with number of laws
“Each additional abortion regulation was associated with an increase in maternal mortality (1.09/100,000 live births; 95% confidence interval, 0.36-1.82) and infant mortality (0.20/1,000 live births; 95% CI, 0.12-0.26),” the authors write.
Lorie M. Harper, MD, MSCI, with the department of women’s health, University of Texas at Austin, led a team that simultaneously studied four categories of mortality: all-cause mortality in females ages 15-49 years; maternal mortality; infant mortality; and fetal mortality.
Her team did a retrospective cohort study using the Centers for Disease Control and Prevention’s WONDER (Wide-ranging ONline Data for Epidemiologic Research) database. WONDER collects publicly available data with information on mortality by state.
Data were available from 2000 to 2019 for all-cause, maternal, and infant mortality. Fetal mortality data were available from 2005 to 2019.
Findings were published ahead of print in February’s Obstetrics & Gynecology.
Though the study was done before the Supreme Court decision overturning Roe v. Wade in June 2022, its findings may shed light on potential trends depending on states’ decisions.
In the wake of the Dobbs v. Jackson Women’s Health Organization, an estimated 33 million U.S. women will live in states without available abortion services, the authors note.
State abortion laws changed dramatically in the study period
The authors chose the 2-decade time frame because data could be accessed for both maternal and infant mortality for all the years and because state level abortion laws changed dramatically in that time.
The Guttmacher Institute has analyzed each state’s abortion policy landscape and scored states as restrictive, moderate, or supportive. Certain types of abortion laws were associated with higher rates of all-cause mortality in reproductive-age females.
Those laws included trigger laws (the laws that automatically outlaw abortion in a state when federal law is overturned), laws that limit access to medication abortion, and parental consent laws, according to the paper.
Additionally, states that restrict access to abortion have higher rates of maternal and infant death, even after accounting for the general health of the population.
Trigger-law states have strong mortality association
Blair G. Darney, PhD, MPH, with the department of obstetrics and gynecology, Oregon Health & Science University and the OHSU-PSU School of Public Health in Portland, and two OHSU coauthors note in an accompanying editorial that having a trigger law in place was associated with elevations in all four mortality measures. However, trigger laws had not yet been enacted during the study.
The existence of trigger laws is likely a proxy for other factors, they write.
“[T]he relationship between trigger laws and increased mortality may more likely be explained by other factors that were not considered in the analysis than by laws that were not enacted at the time of the study,” the editorialists write.
Those factors may include lack of Medicaid expansion, socioeconomic inequities, and other policies.
The editorialists also caution that just because some types of abortion restrictions don’t appear to increase mortality, it doesn’t mean they aren’t harmful.
“For example, laws prohibiting private or Medicaid insurance coverage for abortions were not associated with maternal mortality, but these laws may simply shift the burden of payment to the individual seeking an abortion or be mitigated by funds that support an individual’s out-of-pocket cost for care. The lack of an association may therefore reflect women’s resilience and their ability to obtain needed health care in the face of financial challenges,” they write.
They point out that, conversely, Targeted Regulation of Abortion Providers (TRAP) laws, which supporters say protect women, have been associated instead with increases in maternal mortality.
Dr. Harper and study coauthors, noting that the relationship between abortion laws and mortality is complex, urge states with restrictive abortion laws to consider proven countermeasures to offset the rates, including Medicaid expansion.
One coauthor served on a medical advisory board, was a site primary investigator for several clinical trials, and received royalties from UpToDate for two topics related to trial of labor after cesarean. The other authors did not report any potential conflicts of interest. Dr. Darney’s institution receives research funding from Organon and the Office of Population Affairs on which she is the primary investigator, and she is a member of the board of directors of the Society of Family Planning and a deputy editor at Contraception. She has received an honorarium from ACOG for committee work. The other editorialists did not report any potential conflicts of interest.
States that have moderate state abortion laws had lower rates of maternal, fetal, and infant mortality, but not lower all-cause mortality, in reproductive-aged females compared with states that have restrictive laws, new research using 2000-2019 data indicates.
Additionally, having a higher number of laws that restrict abortion in a state was linked with higher maternal and infant mortality in the state, the study states.
Mortality increases with number of laws
“Each additional abortion regulation was associated with an increase in maternal mortality (1.09/100,000 live births; 95% confidence interval, 0.36-1.82) and infant mortality (0.20/1,000 live births; 95% CI, 0.12-0.26),” the authors write.
Lorie M. Harper, MD, MSCI, with the department of women’s health, University of Texas at Austin, led a team that simultaneously studied four categories of mortality: all-cause mortality in females ages 15-49 years; maternal mortality; infant mortality; and fetal mortality.
Her team did a retrospective cohort study using the Centers for Disease Control and Prevention’s WONDER (Wide-ranging ONline Data for Epidemiologic Research) database. WONDER collects publicly available data with information on mortality by state.
Data were available from 2000 to 2019 for all-cause, maternal, and infant mortality. Fetal mortality data were available from 2005 to 2019.
Findings were published ahead of print in February’s Obstetrics & Gynecology.
Though the study was done before the Supreme Court decision overturning Roe v. Wade in June 2022, its findings may shed light on potential trends depending on states’ decisions.
In the wake of the Dobbs v. Jackson Women’s Health Organization, an estimated 33 million U.S. women will live in states without available abortion services, the authors note.
State abortion laws changed dramatically in the study period
The authors chose the 2-decade time frame because data could be accessed for both maternal and infant mortality for all the years and because state level abortion laws changed dramatically in that time.
The Guttmacher Institute has analyzed each state’s abortion policy landscape and scored states as restrictive, moderate, or supportive. Certain types of abortion laws were associated with higher rates of all-cause mortality in reproductive-age females.
Those laws included trigger laws (the laws that automatically outlaw abortion in a state when federal law is overturned), laws that limit access to medication abortion, and parental consent laws, according to the paper.
Additionally, states that restrict access to abortion have higher rates of maternal and infant death, even after accounting for the general health of the population.
Trigger-law states have strong mortality association
Blair G. Darney, PhD, MPH, with the department of obstetrics and gynecology, Oregon Health & Science University and the OHSU-PSU School of Public Health in Portland, and two OHSU coauthors note in an accompanying editorial that having a trigger law in place was associated with elevations in all four mortality measures. However, trigger laws had not yet been enacted during the study.
The existence of trigger laws is likely a proxy for other factors, they write.
“[T]he relationship between trigger laws and increased mortality may more likely be explained by other factors that were not considered in the analysis than by laws that were not enacted at the time of the study,” the editorialists write.
Those factors may include lack of Medicaid expansion, socioeconomic inequities, and other policies.
The editorialists also caution that just because some types of abortion restrictions don’t appear to increase mortality, it doesn’t mean they aren’t harmful.
“For example, laws prohibiting private or Medicaid insurance coverage for abortions were not associated with maternal mortality, but these laws may simply shift the burden of payment to the individual seeking an abortion or be mitigated by funds that support an individual’s out-of-pocket cost for care. The lack of an association may therefore reflect women’s resilience and their ability to obtain needed health care in the face of financial challenges,” they write.
They point out that, conversely, Targeted Regulation of Abortion Providers (TRAP) laws, which supporters say protect women, have been associated instead with increases in maternal mortality.
Dr. Harper and study coauthors, noting that the relationship between abortion laws and mortality is complex, urge states with restrictive abortion laws to consider proven countermeasures to offset the rates, including Medicaid expansion.
One coauthor served on a medical advisory board, was a site primary investigator for several clinical trials, and received royalties from UpToDate for two topics related to trial of labor after cesarean. The other authors did not report any potential conflicts of interest. Dr. Darney’s institution receives research funding from Organon and the Office of Population Affairs on which she is the primary investigator, and she is a member of the board of directors of the Society of Family Planning and a deputy editor at Contraception. She has received an honorarium from ACOG for committee work. The other editorialists did not report any potential conflicts of interest.
FROM OBSTETRICS & GYNECOLOGY
Mediterranean diet linked with fewer pregnancy complications
Women in the United States who followed a Mediterranean-style diet – heavy on fresh foods, fish, and olive oil – around the time of conception had lower risk of developing a pregnancy complication, results of a large new study suggest.
The study included 7,798 women who had not given birth before. The group was geographically, racially, and ethnically diverse.
Researchers led by Nour Makarem, PhD, MS, with the department of epidemiology, Columbia University, New York, published their results in JAMA Network Open.
“Generally, higher intakes of vegetables, fruits, legumes, fish, and whole grains and lower intakes of red and processed meat were associated with lower risk of APOs [adverse pregnancy outcomes],” the authors wrote.
21% lower risk of complications
The investigators found that women in the study – who were part of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which enrolled 10,038 women between Oct. 1, 2010, and Sept. 30, 2013, and scored high on adherence to a Mediterranean diet – had a 21% lower risk of developing any adverse pregnancy outcome (APO) than those who had low adherence. And the better the adherence, the lower the risk of adverse outcomes, especially preeclampsia or eclampsia and gestational diabetes, the researchers wrote.
The research team also studied how following the diet correlated with gestational high blood pressure, preterm birth, delivery of a small-for-gestational-age infant, and stillbirth.
Women were scored on consumption of nine components: vegetables (excluding potatoes), fruits, nuts, whole grains, legumes, fish, monounsaturated to saturated fat ratio, red and processed meats, and alcohol.
No differences by race, ethnicity, or BMI
There were no differences in adverse pregnancy outcomes by race, ethnicity, or the woman’s body mass index before pregnancy, but associations were stronger in the women who were 35 years or older, according to the paper.
The authors pointed out that the women in the study had access to prenatal care at a large academic medical center during their first 3 months of pregnancy so the study may actually underestimate the importance of the diet in the pregnancy outcomes.
Christina Han, MD, division director of maternal-fetal medicine at University of California, Los Angeles, who was not part of the study, said that the results make sense as the researchers looked at the time of conception, which is a time that reflects the way a person chooses to live their life.
“We know that your health state as you enter pregnancy can significantly affect your outcomes for that pregnancy,” she said. “We’ve known for decades now that a Mediterranean diet is good for just about everybody.”
Unequal access to foods on diet
Dr. Han said that, while it’s great the researchers were able to confirm the benefit of the Mediterranean diet, it highlights inequity as lower income people are not as likely to be able to afford fresh fruits and vegetables and fish.
“This is a call to arms for our food distribution system to even out the big divide in what patients have access to,” Dr. Han said.
She noted that most of the women in this study were married, non-Hispanic White, and had higher levels of education which may make it hard to generalize these results to the general population.
A limitation of the study is that the women were asked to report what they ate themselves, which can be less accurate than when researchers record what is eaten in a controlled setting.
The researchers suggested a next step: “Long-term intervention studies are needed to assess whether promoting a Mediterranean-style diet around the time of conception and throughout pregnancy can prevent APOs.”
Dr. Makarem reported receiving grants from the National Institutes of Health and the American Heart Association outside the submitted work. One coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the study. One coauthor reported receiving personal fees for serving on the board of directors for iRhythm and from fees paid through Cedars-Sinai Medical Center from Abbott Diagnostics and Sanofi outside the submitted work, and one coauthor reported serving as a clinical end point committee member for GlaxoSmithKline outside the submitted work. No other disclosures were reported. Dr. Han reported no relevant financial relationships.
Women in the United States who followed a Mediterranean-style diet – heavy on fresh foods, fish, and olive oil – around the time of conception had lower risk of developing a pregnancy complication, results of a large new study suggest.
The study included 7,798 women who had not given birth before. The group was geographically, racially, and ethnically diverse.
Researchers led by Nour Makarem, PhD, MS, with the department of epidemiology, Columbia University, New York, published their results in JAMA Network Open.
“Generally, higher intakes of vegetables, fruits, legumes, fish, and whole grains and lower intakes of red and processed meat were associated with lower risk of APOs [adverse pregnancy outcomes],” the authors wrote.
21% lower risk of complications
The investigators found that women in the study – who were part of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which enrolled 10,038 women between Oct. 1, 2010, and Sept. 30, 2013, and scored high on adherence to a Mediterranean diet – had a 21% lower risk of developing any adverse pregnancy outcome (APO) than those who had low adherence. And the better the adherence, the lower the risk of adverse outcomes, especially preeclampsia or eclampsia and gestational diabetes, the researchers wrote.
The research team also studied how following the diet correlated with gestational high blood pressure, preterm birth, delivery of a small-for-gestational-age infant, and stillbirth.
Women were scored on consumption of nine components: vegetables (excluding potatoes), fruits, nuts, whole grains, legumes, fish, monounsaturated to saturated fat ratio, red and processed meats, and alcohol.
No differences by race, ethnicity, or BMI
There were no differences in adverse pregnancy outcomes by race, ethnicity, or the woman’s body mass index before pregnancy, but associations were stronger in the women who were 35 years or older, according to the paper.
The authors pointed out that the women in the study had access to prenatal care at a large academic medical center during their first 3 months of pregnancy so the study may actually underestimate the importance of the diet in the pregnancy outcomes.
Christina Han, MD, division director of maternal-fetal medicine at University of California, Los Angeles, who was not part of the study, said that the results make sense as the researchers looked at the time of conception, which is a time that reflects the way a person chooses to live their life.
“We know that your health state as you enter pregnancy can significantly affect your outcomes for that pregnancy,” she said. “We’ve known for decades now that a Mediterranean diet is good for just about everybody.”
Unequal access to foods on diet
Dr. Han said that, while it’s great the researchers were able to confirm the benefit of the Mediterranean diet, it highlights inequity as lower income people are not as likely to be able to afford fresh fruits and vegetables and fish.
“This is a call to arms for our food distribution system to even out the big divide in what patients have access to,” Dr. Han said.
She noted that most of the women in this study were married, non-Hispanic White, and had higher levels of education which may make it hard to generalize these results to the general population.
A limitation of the study is that the women were asked to report what they ate themselves, which can be less accurate than when researchers record what is eaten in a controlled setting.
The researchers suggested a next step: “Long-term intervention studies are needed to assess whether promoting a Mediterranean-style diet around the time of conception and throughout pregnancy can prevent APOs.”
Dr. Makarem reported receiving grants from the National Institutes of Health and the American Heart Association outside the submitted work. One coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the study. One coauthor reported receiving personal fees for serving on the board of directors for iRhythm and from fees paid through Cedars-Sinai Medical Center from Abbott Diagnostics and Sanofi outside the submitted work, and one coauthor reported serving as a clinical end point committee member for GlaxoSmithKline outside the submitted work. No other disclosures were reported. Dr. Han reported no relevant financial relationships.
Women in the United States who followed a Mediterranean-style diet – heavy on fresh foods, fish, and olive oil – around the time of conception had lower risk of developing a pregnancy complication, results of a large new study suggest.
The study included 7,798 women who had not given birth before. The group was geographically, racially, and ethnically diverse.
Researchers led by Nour Makarem, PhD, MS, with the department of epidemiology, Columbia University, New York, published their results in JAMA Network Open.
“Generally, higher intakes of vegetables, fruits, legumes, fish, and whole grains and lower intakes of red and processed meat were associated with lower risk of APOs [adverse pregnancy outcomes],” the authors wrote.
21% lower risk of complications
The investigators found that women in the study – who were part of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which enrolled 10,038 women between Oct. 1, 2010, and Sept. 30, 2013, and scored high on adherence to a Mediterranean diet – had a 21% lower risk of developing any adverse pregnancy outcome (APO) than those who had low adherence. And the better the adherence, the lower the risk of adverse outcomes, especially preeclampsia or eclampsia and gestational diabetes, the researchers wrote.
The research team also studied how following the diet correlated with gestational high blood pressure, preterm birth, delivery of a small-for-gestational-age infant, and stillbirth.
Women were scored on consumption of nine components: vegetables (excluding potatoes), fruits, nuts, whole grains, legumes, fish, monounsaturated to saturated fat ratio, red and processed meats, and alcohol.
No differences by race, ethnicity, or BMI
There were no differences in adverse pregnancy outcomes by race, ethnicity, or the woman’s body mass index before pregnancy, but associations were stronger in the women who were 35 years or older, according to the paper.
The authors pointed out that the women in the study had access to prenatal care at a large academic medical center during their first 3 months of pregnancy so the study may actually underestimate the importance of the diet in the pregnancy outcomes.
Christina Han, MD, division director of maternal-fetal medicine at University of California, Los Angeles, who was not part of the study, said that the results make sense as the researchers looked at the time of conception, which is a time that reflects the way a person chooses to live their life.
“We know that your health state as you enter pregnancy can significantly affect your outcomes for that pregnancy,” she said. “We’ve known for decades now that a Mediterranean diet is good for just about everybody.”
Unequal access to foods on diet
Dr. Han said that, while it’s great the researchers were able to confirm the benefit of the Mediterranean diet, it highlights inequity as lower income people are not as likely to be able to afford fresh fruits and vegetables and fish.
“This is a call to arms for our food distribution system to even out the big divide in what patients have access to,” Dr. Han said.
She noted that most of the women in this study were married, non-Hispanic White, and had higher levels of education which may make it hard to generalize these results to the general population.
A limitation of the study is that the women were asked to report what they ate themselves, which can be less accurate than when researchers record what is eaten in a controlled setting.
The researchers suggested a next step: “Long-term intervention studies are needed to assess whether promoting a Mediterranean-style diet around the time of conception and throughout pregnancy can prevent APOs.”
Dr. Makarem reported receiving grants from the National Institutes of Health and the American Heart Association outside the submitted work. One coauthor reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the study. One coauthor reported receiving personal fees for serving on the board of directors for iRhythm and from fees paid through Cedars-Sinai Medical Center from Abbott Diagnostics and Sanofi outside the submitted work, and one coauthor reported serving as a clinical end point committee member for GlaxoSmithKline outside the submitted work. No other disclosures were reported. Dr. Han reported no relevant financial relationships.
FROM JAMA NETWORK OPEN
Guidance updated for congenital hypothyroidism screening, management
Congenital hypothyroidism is one of the most common preventable causes of intellectual disabilities worldwide, but newborn screening has not been established in all countries.
Additionally, screening alone is not enough to prevent adverse outcomes in children, write authors of a technical report published online in Pediatrics (Jan. 2023;151[1]:e2022060420).
Susan R. Rose, MD, with the division of endocrinology at Cincinnati Children’s Hospital Medical Center in Ohio, led the work group that updated guidance for screening and management of congenital hypothyroidism. The group worked in conjunction with the American Academy of Pediatrics Section on Endocrinology, the AAP Council on Genetics, the Pediatric Endocrine Society, and the American Thyroid Association.
In addition to screening, timely diagnosis, effective treatment, and follow-up are important.
Tests don’t always tell the full story with congenital hypothyroidism.
“Physicians need to consider hypothyroidism in the face of clinical symptoms, even if newborn screening thyroid test results are normal,” the authors write.
They add that newborn screening for congenital hypothyroidism followed by prompt levothyroxine therapy can prevent severe intellectual disability, psychomotor dysfunction, and impaired growth.
Incidence of congenital hypothyroidism ranges from approximately 1 in 2,000 to 1 in 4,000 newborn infants in countries that have newborn screening data, according to the report.
Following are highlights of the guidance:
Clinical signs
Symptoms and signs include large posterior fontanelle, lethargy, large tongue, prolonged jaundice, umbilical hernia, constipation, and/or hypothermia. With these signs, measuring serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) is indicated, regardless of screening results.
Newborn screening in first days
Population screening is cost effective when performed by state or other public health laboratories working with hospitals or birthing centers in their area, the authors write.
Multidisciplinary teams are best able to conduct comprehensive care when cases are detected.
The screening includes a dried blood spot from a heel stick on an approved paper card using appropriate collection methods. The blood spots are then sent to the laboratory. The preferred age for collecting the specimen is 48-72 hours of age.
That timing may be difficult, the authors note, as 90% of infants in the United States and Europe are discharged before 48 hours, but taking the specimen before discharge is important to avoid missing the early diagnosis.
“However, collection of the NBS [newborn screening] specimen before 48 hours of age, and particularly before 24 hours of age, necessitates the use of age-specific TSH reference ranges or repeat screening, particularly to avoid false-positive results,” the authors note.
If a newborn infant is transferred to another hospital, communication about the screening is critical.
Testing strategies
Three test strategies are used for screening: a primary TSH – reflex T4 measurement; primary T4 – reflex TSH measurement; and combined T4 and TSH measurement.
“All three test strategies detect moderate to severe primary congenital hypothyroidism with similar accuracy,” the authors write.
Most newborn screening programs in the United States and worldwide use a primary TSH test strategy.
Multiple births, same-sex twins
The incidence of congenital hypothyroidism appears to be higher with multiple births (1:876 in twin births and 1:575 in higher-order multiple births in one study). Another study showed the incidence of congenital hypothyroidism in same-sex twins to be 1 in 593, compared with 1 in 3,060 in different-sex twins.
“Most twin pairs (> 95%) are discordant for congenital hypothyroidism,” the authors write. “However, in monozygotic twins who share placental circulation, blood from a euthyroid fetal twin with normal thyroid hormone levels may cross to a fetal twin with congenital hypothyroidism, temporarily correcting the hypothyroidism and preventing its detection by newborn screening at 24-72 hours of life. Thus, all monozygotic twins, or same-sex twins for whom zygosity is unknown, should undergo repeat newborn screening around 2 weeks of age.”
Down syndrome
Congenital hypothyroidism incidence in infants with trisomy 21 (Down syndrome) is high and ranges from 1% to 12% in various reports. The infants tend to have lower T4 concentrations and higher TSH concentrations than do infants without trisomy. Down syndrome is associated with other comorbidities, including congenital heart disease, “that may further increase the risk of abnormal newborn screening results because of acute illness or excess iodine exposure,” the authors write.
Even infants with Down syndrome who don’t have congenital hypothyroidism are still at significant risk of developing primary hypothyroidism in their first year (approximately 7% in one prospective study).
“Therefore, in these infants, a second newborn screening should be performed at 2-4 weeks of life and serum TSH should be measured at 6 and 12 months of life,” the authors say.
Communication with primary care provider
Direct communication between the newborn screening program and the primary care physician is important for appropriate follow-up. Consulting a pediatric endocrinologist can speed diagnosis and management.
Serum confirmation after abnormal screening
The next step if any child’s screening results suggest congenital hypothyroidism is to perform a physical exam (for goiter, lingual thyroid gland, and/or physical signs of hypothyroidism) and to measure the concentrations of TSH and FT4 (or total T4) in the blood.
For confirmation of abnormal screening results, the authors say, measurement of FT4 is preferred over measuring total T4.
Interpreting serum confirmation
Some interpretations are clear cut: “Elevated TSH with low FT4 on the confirmatory serum testing indicates overt primary hypothyroidism,” the authors write.
But there are various other outcomes with more controversy.
Elevated TSH and normal FT4, for instance, is known as hyperthyrotropinemia or subclinical hypothyroidism and represents a mild primary thyroid abnormality.
In this scenario, there is controversy regarding the need for L-T4 therapy because there are few and conflicting studies regarding how mild congenital hypothyroidism affects cognitive development.
“[E]xpert opinion suggests that persistent TSH elevation > 10 mIU/L is an indication to initiate L-T4 treatment,” the authors write.
Normal TSH and low T4 is seen in patients with central hypothyroidism, prematurity, low birth weight, acute illness, or thyroxine-binding globulin deficiency.
“The concept that central hypothyroidism is usually mild appears unfounded: A study from the Netherlands found that mean pretreatment serum FT4 levels in central congenital hypothyroidism were similar to those of patients with moderately severe primary congenital hypothyroidism. Therefore, L-T4 treatment of central congenital hypothyroidism is indicated.”
Imaging
Routine thyroid imaging is controversial for patients with congenital hypothyroidism. In most cases, it won’t alter clinical management before age 3 years.
Thyroid ultrasonography can find thyroid tissue without radiation exposure and can be performed at any time after a congenital hypothyroidism diagnosis.
“Ultrasonography has lower sensitivity than scintigraphy for detecting ectopic thyroid tissue, the most common cause of congenital hypothyroidism, although its sensitivity is improved by the use of color Doppler,” the authors write.
Infants with normal thyroid imaging at birth may have transient hypothyroidism. In these patients, reevaluation of thyroid hormone therapy after 3 years of age to assess for persistent hypothyroidism may be beneficial.
Treatment
Congenital hypothyroidism is treated with enteral L-T4 at a starting dose of 10-15 mcg/kg per day, given once a day.
L-T4 tablets are the treatment of choice and generic tablets are fine for most children, the authors write, adding that a brand name formulation may be more consistent and better for children with severe congenital hypothyroidism.
An oral solution of L-T4 has been approved by the U.S. Food and Drug Administration for use in children.
“[H]owever, limited experience with its use showed that dosing may not be equivalent to dosing with tablet formulations,” the guidance states.
The goal of initial L-T4 therapy is to normalize serum FT4 and TSH levels as quickly as possible. The outlook is poorer for infants whose hypothyroidism is detected later in life, who receive inadequate doses of L-T4, or who have more severe forms.
Age-specific TSH reference ranges vary by laboratory, but recent studies indicate the top limit of normal TSH in infants in the first 3 months of life is 4.1-4.8 mIU/L.
“[T]herefore, TSH values above 5 mIU/L generally are abnormal if observed after 3 months of age. Whether overtreatment (defined by elevated serum FT4) is harmful remains unclear and evidence is conflicting,” the authors write.
Monitoring
In the near-term follow-up, close laboratory monitoring is necessary during L-T4 treatment to maintain blood TSH and FT4 in the target ranges. Studies support measuring those levels every 1-2 months in the first 6 months of life for children with congenital hypothyroidism, every 2-3 months in the second 6 months, and then every 3-4 months between 1 and 3 years of age.
In long-term follow-up, attention to behavioral and cognitive development is important, because children with congenital hypothyroidism may be at higher risk for neurocognitive and socioemotional dysfunction compared with their peers, even with adequate treatment of congenital hypothyroidism. Hearing deficits are reported in about 10% of children with congenital hypothyroidism.
Developmental outcomes
When L-T4 therapy is maintained and TSH and FT4 are within target range, growth and adult height are generally normal in children with congenital hypothyroidism.
In contrast, the neurodevelopmental prognosis is less certain when treatment starts late.
“[I]nfants with severe congenital hypothyroidism and intrauterine hypothyroidism (as indicated by retarded skeletal maturation at birth) may have low-to-normal intelligence,” the report states. “Similarly, although more than 80% of infants given L-T4 replacement therapy before 3 months of age have an intelligence [quotient] greater than 85, 77% of these infants show signs of cognitive impairment in arithmetic ability, speech, or fine motor coordination later in life.”
If a child is properly treated for congenital hypothyroidism but growth or development is abnormal, testing for other illness, hearing deficit, or other hormone deficiency is needed, the report states.
The authors report no relevant financial relationships.
Congenital hypothyroidism is one of the most common preventable causes of intellectual disabilities worldwide, but newborn screening has not been established in all countries.
Additionally, screening alone is not enough to prevent adverse outcomes in children, write authors of a technical report published online in Pediatrics (Jan. 2023;151[1]:e2022060420).
Susan R. Rose, MD, with the division of endocrinology at Cincinnati Children’s Hospital Medical Center in Ohio, led the work group that updated guidance for screening and management of congenital hypothyroidism. The group worked in conjunction with the American Academy of Pediatrics Section on Endocrinology, the AAP Council on Genetics, the Pediatric Endocrine Society, and the American Thyroid Association.
In addition to screening, timely diagnosis, effective treatment, and follow-up are important.
Tests don’t always tell the full story with congenital hypothyroidism.
“Physicians need to consider hypothyroidism in the face of clinical symptoms, even if newborn screening thyroid test results are normal,” the authors write.
They add that newborn screening for congenital hypothyroidism followed by prompt levothyroxine therapy can prevent severe intellectual disability, psychomotor dysfunction, and impaired growth.
Incidence of congenital hypothyroidism ranges from approximately 1 in 2,000 to 1 in 4,000 newborn infants in countries that have newborn screening data, according to the report.
Following are highlights of the guidance:
Clinical signs
Symptoms and signs include large posterior fontanelle, lethargy, large tongue, prolonged jaundice, umbilical hernia, constipation, and/or hypothermia. With these signs, measuring serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) is indicated, regardless of screening results.
Newborn screening in first days
Population screening is cost effective when performed by state or other public health laboratories working with hospitals or birthing centers in their area, the authors write.
Multidisciplinary teams are best able to conduct comprehensive care when cases are detected.
The screening includes a dried blood spot from a heel stick on an approved paper card using appropriate collection methods. The blood spots are then sent to the laboratory. The preferred age for collecting the specimen is 48-72 hours of age.
That timing may be difficult, the authors note, as 90% of infants in the United States and Europe are discharged before 48 hours, but taking the specimen before discharge is important to avoid missing the early diagnosis.
“However, collection of the NBS [newborn screening] specimen before 48 hours of age, and particularly before 24 hours of age, necessitates the use of age-specific TSH reference ranges or repeat screening, particularly to avoid false-positive results,” the authors note.
If a newborn infant is transferred to another hospital, communication about the screening is critical.
Testing strategies
Three test strategies are used for screening: a primary TSH – reflex T4 measurement; primary T4 – reflex TSH measurement; and combined T4 and TSH measurement.
“All three test strategies detect moderate to severe primary congenital hypothyroidism with similar accuracy,” the authors write.
Most newborn screening programs in the United States and worldwide use a primary TSH test strategy.
Multiple births, same-sex twins
The incidence of congenital hypothyroidism appears to be higher with multiple births (1:876 in twin births and 1:575 in higher-order multiple births in one study). Another study showed the incidence of congenital hypothyroidism in same-sex twins to be 1 in 593, compared with 1 in 3,060 in different-sex twins.
“Most twin pairs (> 95%) are discordant for congenital hypothyroidism,” the authors write. “However, in monozygotic twins who share placental circulation, blood from a euthyroid fetal twin with normal thyroid hormone levels may cross to a fetal twin with congenital hypothyroidism, temporarily correcting the hypothyroidism and preventing its detection by newborn screening at 24-72 hours of life. Thus, all monozygotic twins, or same-sex twins for whom zygosity is unknown, should undergo repeat newborn screening around 2 weeks of age.”
Down syndrome
Congenital hypothyroidism incidence in infants with trisomy 21 (Down syndrome) is high and ranges from 1% to 12% in various reports. The infants tend to have lower T4 concentrations and higher TSH concentrations than do infants without trisomy. Down syndrome is associated with other comorbidities, including congenital heart disease, “that may further increase the risk of abnormal newborn screening results because of acute illness or excess iodine exposure,” the authors write.
Even infants with Down syndrome who don’t have congenital hypothyroidism are still at significant risk of developing primary hypothyroidism in their first year (approximately 7% in one prospective study).
“Therefore, in these infants, a second newborn screening should be performed at 2-4 weeks of life and serum TSH should be measured at 6 and 12 months of life,” the authors say.
Communication with primary care provider
Direct communication between the newborn screening program and the primary care physician is important for appropriate follow-up. Consulting a pediatric endocrinologist can speed diagnosis and management.
Serum confirmation after abnormal screening
The next step if any child’s screening results suggest congenital hypothyroidism is to perform a physical exam (for goiter, lingual thyroid gland, and/or physical signs of hypothyroidism) and to measure the concentrations of TSH and FT4 (or total T4) in the blood.
For confirmation of abnormal screening results, the authors say, measurement of FT4 is preferred over measuring total T4.
Interpreting serum confirmation
Some interpretations are clear cut: “Elevated TSH with low FT4 on the confirmatory serum testing indicates overt primary hypothyroidism,” the authors write.
But there are various other outcomes with more controversy.
Elevated TSH and normal FT4, for instance, is known as hyperthyrotropinemia or subclinical hypothyroidism and represents a mild primary thyroid abnormality.
In this scenario, there is controversy regarding the need for L-T4 therapy because there are few and conflicting studies regarding how mild congenital hypothyroidism affects cognitive development.
“[E]xpert opinion suggests that persistent TSH elevation > 10 mIU/L is an indication to initiate L-T4 treatment,” the authors write.
Normal TSH and low T4 is seen in patients with central hypothyroidism, prematurity, low birth weight, acute illness, or thyroxine-binding globulin deficiency.
“The concept that central hypothyroidism is usually mild appears unfounded: A study from the Netherlands found that mean pretreatment serum FT4 levels in central congenital hypothyroidism were similar to those of patients with moderately severe primary congenital hypothyroidism. Therefore, L-T4 treatment of central congenital hypothyroidism is indicated.”
Imaging
Routine thyroid imaging is controversial for patients with congenital hypothyroidism. In most cases, it won’t alter clinical management before age 3 years.
Thyroid ultrasonography can find thyroid tissue without radiation exposure and can be performed at any time after a congenital hypothyroidism diagnosis.
“Ultrasonography has lower sensitivity than scintigraphy for detecting ectopic thyroid tissue, the most common cause of congenital hypothyroidism, although its sensitivity is improved by the use of color Doppler,” the authors write.
Infants with normal thyroid imaging at birth may have transient hypothyroidism. In these patients, reevaluation of thyroid hormone therapy after 3 years of age to assess for persistent hypothyroidism may be beneficial.
Treatment
Congenital hypothyroidism is treated with enteral L-T4 at a starting dose of 10-15 mcg/kg per day, given once a day.
L-T4 tablets are the treatment of choice and generic tablets are fine for most children, the authors write, adding that a brand name formulation may be more consistent and better for children with severe congenital hypothyroidism.
An oral solution of L-T4 has been approved by the U.S. Food and Drug Administration for use in children.
“[H]owever, limited experience with its use showed that dosing may not be equivalent to dosing with tablet formulations,” the guidance states.
The goal of initial L-T4 therapy is to normalize serum FT4 and TSH levels as quickly as possible. The outlook is poorer for infants whose hypothyroidism is detected later in life, who receive inadequate doses of L-T4, or who have more severe forms.
Age-specific TSH reference ranges vary by laboratory, but recent studies indicate the top limit of normal TSH in infants in the first 3 months of life is 4.1-4.8 mIU/L.
“[T]herefore, TSH values above 5 mIU/L generally are abnormal if observed after 3 months of age. Whether overtreatment (defined by elevated serum FT4) is harmful remains unclear and evidence is conflicting,” the authors write.
Monitoring
In the near-term follow-up, close laboratory monitoring is necessary during L-T4 treatment to maintain blood TSH and FT4 in the target ranges. Studies support measuring those levels every 1-2 months in the first 6 months of life for children with congenital hypothyroidism, every 2-3 months in the second 6 months, and then every 3-4 months between 1 and 3 years of age.
In long-term follow-up, attention to behavioral and cognitive development is important, because children with congenital hypothyroidism may be at higher risk for neurocognitive and socioemotional dysfunction compared with their peers, even with adequate treatment of congenital hypothyroidism. Hearing deficits are reported in about 10% of children with congenital hypothyroidism.
Developmental outcomes
When L-T4 therapy is maintained and TSH and FT4 are within target range, growth and adult height are generally normal in children with congenital hypothyroidism.
In contrast, the neurodevelopmental prognosis is less certain when treatment starts late.
“[I]nfants with severe congenital hypothyroidism and intrauterine hypothyroidism (as indicated by retarded skeletal maturation at birth) may have low-to-normal intelligence,” the report states. “Similarly, although more than 80% of infants given L-T4 replacement therapy before 3 months of age have an intelligence [quotient] greater than 85, 77% of these infants show signs of cognitive impairment in arithmetic ability, speech, or fine motor coordination later in life.”
If a child is properly treated for congenital hypothyroidism but growth or development is abnormal, testing for other illness, hearing deficit, or other hormone deficiency is needed, the report states.
The authors report no relevant financial relationships.
Congenital hypothyroidism is one of the most common preventable causes of intellectual disabilities worldwide, but newborn screening has not been established in all countries.
Additionally, screening alone is not enough to prevent adverse outcomes in children, write authors of a technical report published online in Pediatrics (Jan. 2023;151[1]:e2022060420).
Susan R. Rose, MD, with the division of endocrinology at Cincinnati Children’s Hospital Medical Center in Ohio, led the work group that updated guidance for screening and management of congenital hypothyroidism. The group worked in conjunction with the American Academy of Pediatrics Section on Endocrinology, the AAP Council on Genetics, the Pediatric Endocrine Society, and the American Thyroid Association.
In addition to screening, timely diagnosis, effective treatment, and follow-up are important.
Tests don’t always tell the full story with congenital hypothyroidism.
“Physicians need to consider hypothyroidism in the face of clinical symptoms, even if newborn screening thyroid test results are normal,” the authors write.
They add that newborn screening for congenital hypothyroidism followed by prompt levothyroxine therapy can prevent severe intellectual disability, psychomotor dysfunction, and impaired growth.
Incidence of congenital hypothyroidism ranges from approximately 1 in 2,000 to 1 in 4,000 newborn infants in countries that have newborn screening data, according to the report.
Following are highlights of the guidance:
Clinical signs
Symptoms and signs include large posterior fontanelle, lethargy, large tongue, prolonged jaundice, umbilical hernia, constipation, and/or hypothermia. With these signs, measuring serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) is indicated, regardless of screening results.
Newborn screening in first days
Population screening is cost effective when performed by state or other public health laboratories working with hospitals or birthing centers in their area, the authors write.
Multidisciplinary teams are best able to conduct comprehensive care when cases are detected.
The screening includes a dried blood spot from a heel stick on an approved paper card using appropriate collection methods. The blood spots are then sent to the laboratory. The preferred age for collecting the specimen is 48-72 hours of age.
That timing may be difficult, the authors note, as 90% of infants in the United States and Europe are discharged before 48 hours, but taking the specimen before discharge is important to avoid missing the early diagnosis.
“However, collection of the NBS [newborn screening] specimen before 48 hours of age, and particularly before 24 hours of age, necessitates the use of age-specific TSH reference ranges or repeat screening, particularly to avoid false-positive results,” the authors note.
If a newborn infant is transferred to another hospital, communication about the screening is critical.
Testing strategies
Three test strategies are used for screening: a primary TSH – reflex T4 measurement; primary T4 – reflex TSH measurement; and combined T4 and TSH measurement.
“All three test strategies detect moderate to severe primary congenital hypothyroidism with similar accuracy,” the authors write.
Most newborn screening programs in the United States and worldwide use a primary TSH test strategy.
Multiple births, same-sex twins
The incidence of congenital hypothyroidism appears to be higher with multiple births (1:876 in twin births and 1:575 in higher-order multiple births in one study). Another study showed the incidence of congenital hypothyroidism in same-sex twins to be 1 in 593, compared with 1 in 3,060 in different-sex twins.
“Most twin pairs (> 95%) are discordant for congenital hypothyroidism,” the authors write. “However, in monozygotic twins who share placental circulation, blood from a euthyroid fetal twin with normal thyroid hormone levels may cross to a fetal twin with congenital hypothyroidism, temporarily correcting the hypothyroidism and preventing its detection by newborn screening at 24-72 hours of life. Thus, all monozygotic twins, or same-sex twins for whom zygosity is unknown, should undergo repeat newborn screening around 2 weeks of age.”
Down syndrome
Congenital hypothyroidism incidence in infants with trisomy 21 (Down syndrome) is high and ranges from 1% to 12% in various reports. The infants tend to have lower T4 concentrations and higher TSH concentrations than do infants without trisomy. Down syndrome is associated with other comorbidities, including congenital heart disease, “that may further increase the risk of abnormal newborn screening results because of acute illness or excess iodine exposure,” the authors write.
Even infants with Down syndrome who don’t have congenital hypothyroidism are still at significant risk of developing primary hypothyroidism in their first year (approximately 7% in one prospective study).
“Therefore, in these infants, a second newborn screening should be performed at 2-4 weeks of life and serum TSH should be measured at 6 and 12 months of life,” the authors say.
Communication with primary care provider
Direct communication between the newborn screening program and the primary care physician is important for appropriate follow-up. Consulting a pediatric endocrinologist can speed diagnosis and management.
Serum confirmation after abnormal screening
The next step if any child’s screening results suggest congenital hypothyroidism is to perform a physical exam (for goiter, lingual thyroid gland, and/or physical signs of hypothyroidism) and to measure the concentrations of TSH and FT4 (or total T4) in the blood.
For confirmation of abnormal screening results, the authors say, measurement of FT4 is preferred over measuring total T4.
Interpreting serum confirmation
Some interpretations are clear cut: “Elevated TSH with low FT4 on the confirmatory serum testing indicates overt primary hypothyroidism,” the authors write.
But there are various other outcomes with more controversy.
Elevated TSH and normal FT4, for instance, is known as hyperthyrotropinemia or subclinical hypothyroidism and represents a mild primary thyroid abnormality.
In this scenario, there is controversy regarding the need for L-T4 therapy because there are few and conflicting studies regarding how mild congenital hypothyroidism affects cognitive development.
“[E]xpert opinion suggests that persistent TSH elevation > 10 mIU/L is an indication to initiate L-T4 treatment,” the authors write.
Normal TSH and low T4 is seen in patients with central hypothyroidism, prematurity, low birth weight, acute illness, or thyroxine-binding globulin deficiency.
“The concept that central hypothyroidism is usually mild appears unfounded: A study from the Netherlands found that mean pretreatment serum FT4 levels in central congenital hypothyroidism were similar to those of patients with moderately severe primary congenital hypothyroidism. Therefore, L-T4 treatment of central congenital hypothyroidism is indicated.”
Imaging
Routine thyroid imaging is controversial for patients with congenital hypothyroidism. In most cases, it won’t alter clinical management before age 3 years.
Thyroid ultrasonography can find thyroid tissue without radiation exposure and can be performed at any time after a congenital hypothyroidism diagnosis.
“Ultrasonography has lower sensitivity than scintigraphy for detecting ectopic thyroid tissue, the most common cause of congenital hypothyroidism, although its sensitivity is improved by the use of color Doppler,” the authors write.
Infants with normal thyroid imaging at birth may have transient hypothyroidism. In these patients, reevaluation of thyroid hormone therapy after 3 years of age to assess for persistent hypothyroidism may be beneficial.
Treatment
Congenital hypothyroidism is treated with enteral L-T4 at a starting dose of 10-15 mcg/kg per day, given once a day.
L-T4 tablets are the treatment of choice and generic tablets are fine for most children, the authors write, adding that a brand name formulation may be more consistent and better for children with severe congenital hypothyroidism.
An oral solution of L-T4 has been approved by the U.S. Food and Drug Administration for use in children.
“[H]owever, limited experience with its use showed that dosing may not be equivalent to dosing with tablet formulations,” the guidance states.
The goal of initial L-T4 therapy is to normalize serum FT4 and TSH levels as quickly as possible. The outlook is poorer for infants whose hypothyroidism is detected later in life, who receive inadequate doses of L-T4, or who have more severe forms.
Age-specific TSH reference ranges vary by laboratory, but recent studies indicate the top limit of normal TSH in infants in the first 3 months of life is 4.1-4.8 mIU/L.
“[T]herefore, TSH values above 5 mIU/L generally are abnormal if observed after 3 months of age. Whether overtreatment (defined by elevated serum FT4) is harmful remains unclear and evidence is conflicting,” the authors write.
Monitoring
In the near-term follow-up, close laboratory monitoring is necessary during L-T4 treatment to maintain blood TSH and FT4 in the target ranges. Studies support measuring those levels every 1-2 months in the first 6 months of life for children with congenital hypothyroidism, every 2-3 months in the second 6 months, and then every 3-4 months between 1 and 3 years of age.
In long-term follow-up, attention to behavioral and cognitive development is important, because children with congenital hypothyroidism may be at higher risk for neurocognitive and socioemotional dysfunction compared with their peers, even with adequate treatment of congenital hypothyroidism. Hearing deficits are reported in about 10% of children with congenital hypothyroidism.
Developmental outcomes
When L-T4 therapy is maintained and TSH and FT4 are within target range, growth and adult height are generally normal in children with congenital hypothyroidism.
In contrast, the neurodevelopmental prognosis is less certain when treatment starts late.
“[I]nfants with severe congenital hypothyroidism and intrauterine hypothyroidism (as indicated by retarded skeletal maturation at birth) may have low-to-normal intelligence,” the report states. “Similarly, although more than 80% of infants given L-T4 replacement therapy before 3 months of age have an intelligence [quotient] greater than 85, 77% of these infants show signs of cognitive impairment in arithmetic ability, speech, or fine motor coordination later in life.”
If a child is properly treated for congenital hypothyroidism but growth or development is abnormal, testing for other illness, hearing deficit, or other hormone deficiency is needed, the report states.
The authors report no relevant financial relationships.
FROM PEDIATRICS
CAB-LA’s full potential for HIV prevention hits snags
, say authors of a new review article.
CAB-LA “represents the most important breakthrough in HIV prevention in recent years,” write Geoffroy Liegeon, MD, and Jade Ghosn, MD, PhD, with Université Paris Cité, in this month’s HIV Medicine.
It has been found to be safe, and more effective in phase 3 trials than oral PrEP, and is well-accepted in men who have sex with men, and transgender and cisgender women.
Reductions in stigma
Surveys show patients at high risk for HIV – especially those who see PrEP as burdensome – are highly interested in long-acting injectable drugs. Reduced stigma with the injections also appears to steer the choice toward a long-acting agent and may attract more people to HIV prevention programs.
The first two injections are given 4 weeks apart, followed by an injection every 8 weeks.
Models designed to increase uptake, adherence, and persistence when on and after discontinuing CAB-LA will be important for wider rollout, as will better patient education and demonstrated efficacy and safety in populations not included in clinical trials, Dr. Liegeon and Dr. Ghosn note.
Still, they point out that its broader integration into clinical routine is held back by factors including breakthrough infections despite timely injections, complexity of follow-up, logistical considerations, and its cost-effectiveness compared with oral PrEP.
A hefty price tag
“[T]he cost effectiveness compared with TDF-FTC [tenofovir/emtricitabine] generics may not support its use at the current price in many settings,” the authors write.
For low- and middle-income countries, the TDF/FTC price is about $55, according to the World Health Organization’s Global Price Reporting, while the current price of CAB-LA in the United States is about $22,000, according to Dr. Ghosn. He said in an interview that because the cost of generics can reach $400-$500 per year in the United States, depending on the pharmaceutical companies, the price for CAB-LA is almost 60 times higher than TDF/FTC in the Untied States.
The biggest hope for the price reduction, at least in lower-income countries, he said, is a new licensing agreement.
ViiV Healthcare signed a new voluntary licensing agreement with the Medicines Patent Pool in July to help access in low-income, lower-middle-income, and sub-Saharan African countries, he explained.
The authors summarize: “[E]stablishing the effectiveness of CAB-LA does not guarantee its uptake into clinical routine.”
Because of the combined issues, the WHO recommended CAB-LA as an additional prevention choice for PrEP in its recent guidelines, pending further studies.
Barriers frustrate providers
Lauren Fontana, DO, assistant professor at the University of Minnesota, Minneapolis, and infectious disease physician at M Health Fairview, said in an interview that “as a health care provider, cost and insurance barriers can be frustrating, especially when CAB-LA is identified as the best option for a patient.”
Lack of nonphysician-led initiatives, such as nurse- or pharmacy-led services for CAB-LA, may limit availability to marginalized and at-risk populations, she said.
“If a clinic can acquire CAB-LA, clinic protocols need to be developed and considerations of missed visits and doses must be thought about when implementing a program,” Dr. Fontana said.
Clinics need resources to engage with patients to promote retention in the program with case management and pharmacy support, she added.
“Simplification processes need to be developed to make CAB-LA an option for more clinics and patients,” she continued. “We are still learning about the incidence of breakthrough HIV infections, patterns of HIV seroconversion, and how to optimize testing so that HIV infections are detected early.”
Dr. Liegeon, Dr. Ghosn, and Dr. Fontana report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, say authors of a new review article.
CAB-LA “represents the most important breakthrough in HIV prevention in recent years,” write Geoffroy Liegeon, MD, and Jade Ghosn, MD, PhD, with Université Paris Cité, in this month’s HIV Medicine.
It has been found to be safe, and more effective in phase 3 trials than oral PrEP, and is well-accepted in men who have sex with men, and transgender and cisgender women.
Reductions in stigma
Surveys show patients at high risk for HIV – especially those who see PrEP as burdensome – are highly interested in long-acting injectable drugs. Reduced stigma with the injections also appears to steer the choice toward a long-acting agent and may attract more people to HIV prevention programs.
The first two injections are given 4 weeks apart, followed by an injection every 8 weeks.
Models designed to increase uptake, adherence, and persistence when on and after discontinuing CAB-LA will be important for wider rollout, as will better patient education and demonstrated efficacy and safety in populations not included in clinical trials, Dr. Liegeon and Dr. Ghosn note.
Still, they point out that its broader integration into clinical routine is held back by factors including breakthrough infections despite timely injections, complexity of follow-up, logistical considerations, and its cost-effectiveness compared with oral PrEP.
A hefty price tag
“[T]he cost effectiveness compared with TDF-FTC [tenofovir/emtricitabine] generics may not support its use at the current price in many settings,” the authors write.
For low- and middle-income countries, the TDF/FTC price is about $55, according to the World Health Organization’s Global Price Reporting, while the current price of CAB-LA in the United States is about $22,000, according to Dr. Ghosn. He said in an interview that because the cost of generics can reach $400-$500 per year in the United States, depending on the pharmaceutical companies, the price for CAB-LA is almost 60 times higher than TDF/FTC in the Untied States.
The biggest hope for the price reduction, at least in lower-income countries, he said, is a new licensing agreement.
ViiV Healthcare signed a new voluntary licensing agreement with the Medicines Patent Pool in July to help access in low-income, lower-middle-income, and sub-Saharan African countries, he explained.
The authors summarize: “[E]stablishing the effectiveness of CAB-LA does not guarantee its uptake into clinical routine.”
Because of the combined issues, the WHO recommended CAB-LA as an additional prevention choice for PrEP in its recent guidelines, pending further studies.
Barriers frustrate providers
Lauren Fontana, DO, assistant professor at the University of Minnesota, Minneapolis, and infectious disease physician at M Health Fairview, said in an interview that “as a health care provider, cost and insurance barriers can be frustrating, especially when CAB-LA is identified as the best option for a patient.”
Lack of nonphysician-led initiatives, such as nurse- or pharmacy-led services for CAB-LA, may limit availability to marginalized and at-risk populations, she said.
“If a clinic can acquire CAB-LA, clinic protocols need to be developed and considerations of missed visits and doses must be thought about when implementing a program,” Dr. Fontana said.
Clinics need resources to engage with patients to promote retention in the program with case management and pharmacy support, she added.
“Simplification processes need to be developed to make CAB-LA an option for more clinics and patients,” she continued. “We are still learning about the incidence of breakthrough HIV infections, patterns of HIV seroconversion, and how to optimize testing so that HIV infections are detected early.”
Dr. Liegeon, Dr. Ghosn, and Dr. Fontana report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, say authors of a new review article.
CAB-LA “represents the most important breakthrough in HIV prevention in recent years,” write Geoffroy Liegeon, MD, and Jade Ghosn, MD, PhD, with Université Paris Cité, in this month’s HIV Medicine.
It has been found to be safe, and more effective in phase 3 trials than oral PrEP, and is well-accepted in men who have sex with men, and transgender and cisgender women.
Reductions in stigma
Surveys show patients at high risk for HIV – especially those who see PrEP as burdensome – are highly interested in long-acting injectable drugs. Reduced stigma with the injections also appears to steer the choice toward a long-acting agent and may attract more people to HIV prevention programs.
The first two injections are given 4 weeks apart, followed by an injection every 8 weeks.
Models designed to increase uptake, adherence, and persistence when on and after discontinuing CAB-LA will be important for wider rollout, as will better patient education and demonstrated efficacy and safety in populations not included in clinical trials, Dr. Liegeon and Dr. Ghosn note.
Still, they point out that its broader integration into clinical routine is held back by factors including breakthrough infections despite timely injections, complexity of follow-up, logistical considerations, and its cost-effectiveness compared with oral PrEP.
A hefty price tag
“[T]he cost effectiveness compared with TDF-FTC [tenofovir/emtricitabine] generics may not support its use at the current price in many settings,” the authors write.
For low- and middle-income countries, the TDF/FTC price is about $55, according to the World Health Organization’s Global Price Reporting, while the current price of CAB-LA in the United States is about $22,000, according to Dr. Ghosn. He said in an interview that because the cost of generics can reach $400-$500 per year in the United States, depending on the pharmaceutical companies, the price for CAB-LA is almost 60 times higher than TDF/FTC in the Untied States.
The biggest hope for the price reduction, at least in lower-income countries, he said, is a new licensing agreement.
ViiV Healthcare signed a new voluntary licensing agreement with the Medicines Patent Pool in July to help access in low-income, lower-middle-income, and sub-Saharan African countries, he explained.
The authors summarize: “[E]stablishing the effectiveness of CAB-LA does not guarantee its uptake into clinical routine.”
Because of the combined issues, the WHO recommended CAB-LA as an additional prevention choice for PrEP in its recent guidelines, pending further studies.
Barriers frustrate providers
Lauren Fontana, DO, assistant professor at the University of Minnesota, Minneapolis, and infectious disease physician at M Health Fairview, said in an interview that “as a health care provider, cost and insurance barriers can be frustrating, especially when CAB-LA is identified as the best option for a patient.”
Lack of nonphysician-led initiatives, such as nurse- or pharmacy-led services for CAB-LA, may limit availability to marginalized and at-risk populations, she said.
“If a clinic can acquire CAB-LA, clinic protocols need to be developed and considerations of missed visits and doses must be thought about when implementing a program,” Dr. Fontana said.
Clinics need resources to engage with patients to promote retention in the program with case management and pharmacy support, she added.
“Simplification processes need to be developed to make CAB-LA an option for more clinics and patients,” she continued. “We are still learning about the incidence of breakthrough HIV infections, patterns of HIV seroconversion, and how to optimize testing so that HIV infections are detected early.”
Dr. Liegeon, Dr. Ghosn, and Dr. Fontana report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HIV MEDICINE
Direct-acting antivirals tied to better outcomes in chronic Hep C
Eiichi Ogawa, MD, PhD, with the department of general internal medicine, Kyushu University Hospital in Fukuoka, Japan, led the retrospective study of 245,596 adults with CHC. In the new research, which was published in JAMA Internal Medicine, the authors analyzed data from the Optum Clinformatics Data Mart (CDM) database, 2010-2021.
It was important to do the study because of limited and conflicting information – mostly from case reports – on safety of the DAAs when they were approved for CHC in 2014, said coauthor Mindie H. Nguyen, MD, in an interview.
‘DAA treatment is safe’
“The main message is that DAA treatment is safe,” said Dr. Nguyen, of the division of gastroenterology and hepatology at Stanford (Calif.) University Medical Center in Palo Alto. In the early days of treatment, physicians were treating the sickest patients with the DAAs, which may have introduced patient selection bias and caused lasting misperceptions about poor safety, she noted.
“I really hope to dispel this myth,” she said, adding that this study also shows improved liver and nonliver outcomes.
Of the total cohort in this study, 40,654 patients had one or more prescriptions for a DAA (without interferon) and 204,942 patients had not been treated.
All-cause mortality reduced by 57%
DAA treatment, vs. no treatment, was linked with a large and significant reduction (57%) in all-cause mortality. That finding was particularly notable, because it was seen regardless of age, sex, race and ethnicity, comorbidities, alcohol use, and presence of hepatocellular carcinoma or cirrhosis.
The authors noted that patients without cirrhosis are a population previously considered to receive less benefit from an HCV cure than patients with cirrhosis.
DAAs were associated with lower risk of hepatocellular carcinoma and decompensation as well as risk of nonliver outcomes, including diabetes, cardiovascular disease (CVD), and chronic kidney disease (CKD).
Lower risk of poor nonliver outcomes
The researchers found that when they compared DAA-treated patients with untreated patients, the incidences per 1,000 person-years of having diabetes were 30.2 vs. 37.2 (P less than .001), and of having kidney disease was 31.1 vs. 34.1 (P less than .001), respectively.
“This retrospective cohort study provides valuable information to physicians,” Noel Deep, MD, chief medical officer at Aspirus Langlade Hospital in Antigo, Wis., said, in an interview.
The study’s size helps confirm DAAs’ safety and benefit, and previously unknown added benefits, in treating CHC, he continued.
Large study confirms, introduces DAA benefits
Dr. Deep, who was not part of the study, noted that DAAs now show much promise in efficacy and tolerability in most people with chronic hepatitis C, including those with concomitant conditions such as CKD.
“Previous studies did not have such large-scale nationwide data. [The findings of the new study] greatly enhance our knowledge of DAA treatment for chronic hepatitis C patients across the spectrum from noncirrhotic to compensated cirrhotic to decompensated cirrhotic,” Dr. Deep said. “The added benefit of improved outcomes for diabetes, CVD, CKD, and nonliver cancers truly surprised me.”
Dr. Deep pointed out some limitations of the study, including that, as the authors acknowledge, only privately insured patients were included so results may not be generalizable to the underinsured/uninsured “who might have other risk factors, poorer health, and fewer resources.”
He added: “The data also may not be reflective of the outcomes in Asians who were, in my opinion, also underrepresented in this study.”
The authors cited the insurance claims database they used as a strength of the study, due to it containing information on 61 million people from across all regions of the United States.
Dr. Ogawa reports grants from Gilead Sciences outside the submitted work. Coauthor Dr. Nguyen reports institutional grants and advisory board fees from Gilead Sciences outside the submitted work. Another coauthor reports speaking/consulting fees from Gilead and Merck Sharp & Dohme outside the submitted work. No other disclosures were reported.
The Stanford Center for Population Health Sciences (PHS) supported this study by providing access to the PHS Data Core.
Dr. Deep reports no relevant financial relationships. He serves on the editorial advisory board of Internal Medicine News.
Eiichi Ogawa, MD, PhD, with the department of general internal medicine, Kyushu University Hospital in Fukuoka, Japan, led the retrospective study of 245,596 adults with CHC. In the new research, which was published in JAMA Internal Medicine, the authors analyzed data from the Optum Clinformatics Data Mart (CDM) database, 2010-2021.
It was important to do the study because of limited and conflicting information – mostly from case reports – on safety of the DAAs when they were approved for CHC in 2014, said coauthor Mindie H. Nguyen, MD, in an interview.
‘DAA treatment is safe’
“The main message is that DAA treatment is safe,” said Dr. Nguyen, of the division of gastroenterology and hepatology at Stanford (Calif.) University Medical Center in Palo Alto. In the early days of treatment, physicians were treating the sickest patients with the DAAs, which may have introduced patient selection bias and caused lasting misperceptions about poor safety, she noted.
“I really hope to dispel this myth,” she said, adding that this study also shows improved liver and nonliver outcomes.
Of the total cohort in this study, 40,654 patients had one or more prescriptions for a DAA (without interferon) and 204,942 patients had not been treated.
All-cause mortality reduced by 57%
DAA treatment, vs. no treatment, was linked with a large and significant reduction (57%) in all-cause mortality. That finding was particularly notable, because it was seen regardless of age, sex, race and ethnicity, comorbidities, alcohol use, and presence of hepatocellular carcinoma or cirrhosis.
The authors noted that patients without cirrhosis are a population previously considered to receive less benefit from an HCV cure than patients with cirrhosis.
DAAs were associated with lower risk of hepatocellular carcinoma and decompensation as well as risk of nonliver outcomes, including diabetes, cardiovascular disease (CVD), and chronic kidney disease (CKD).
Lower risk of poor nonliver outcomes
The researchers found that when they compared DAA-treated patients with untreated patients, the incidences per 1,000 person-years of having diabetes were 30.2 vs. 37.2 (P less than .001), and of having kidney disease was 31.1 vs. 34.1 (P less than .001), respectively.
“This retrospective cohort study provides valuable information to physicians,” Noel Deep, MD, chief medical officer at Aspirus Langlade Hospital in Antigo, Wis., said, in an interview.
The study’s size helps confirm DAAs’ safety and benefit, and previously unknown added benefits, in treating CHC, he continued.
Large study confirms, introduces DAA benefits
Dr. Deep, who was not part of the study, noted that DAAs now show much promise in efficacy and tolerability in most people with chronic hepatitis C, including those with concomitant conditions such as CKD.
“Previous studies did not have such large-scale nationwide data. [The findings of the new study] greatly enhance our knowledge of DAA treatment for chronic hepatitis C patients across the spectrum from noncirrhotic to compensated cirrhotic to decompensated cirrhotic,” Dr. Deep said. “The added benefit of improved outcomes for diabetes, CVD, CKD, and nonliver cancers truly surprised me.”
Dr. Deep pointed out some limitations of the study, including that, as the authors acknowledge, only privately insured patients were included so results may not be generalizable to the underinsured/uninsured “who might have other risk factors, poorer health, and fewer resources.”
He added: “The data also may not be reflective of the outcomes in Asians who were, in my opinion, also underrepresented in this study.”
The authors cited the insurance claims database they used as a strength of the study, due to it containing information on 61 million people from across all regions of the United States.
Dr. Ogawa reports grants from Gilead Sciences outside the submitted work. Coauthor Dr. Nguyen reports institutional grants and advisory board fees from Gilead Sciences outside the submitted work. Another coauthor reports speaking/consulting fees from Gilead and Merck Sharp & Dohme outside the submitted work. No other disclosures were reported.
The Stanford Center for Population Health Sciences (PHS) supported this study by providing access to the PHS Data Core.
Dr. Deep reports no relevant financial relationships. He serves on the editorial advisory board of Internal Medicine News.
Eiichi Ogawa, MD, PhD, with the department of general internal medicine, Kyushu University Hospital in Fukuoka, Japan, led the retrospective study of 245,596 adults with CHC. In the new research, which was published in JAMA Internal Medicine, the authors analyzed data from the Optum Clinformatics Data Mart (CDM) database, 2010-2021.
It was important to do the study because of limited and conflicting information – mostly from case reports – on safety of the DAAs when they were approved for CHC in 2014, said coauthor Mindie H. Nguyen, MD, in an interview.
‘DAA treatment is safe’
“The main message is that DAA treatment is safe,” said Dr. Nguyen, of the division of gastroenterology and hepatology at Stanford (Calif.) University Medical Center in Palo Alto. In the early days of treatment, physicians were treating the sickest patients with the DAAs, which may have introduced patient selection bias and caused lasting misperceptions about poor safety, she noted.
“I really hope to dispel this myth,” she said, adding that this study also shows improved liver and nonliver outcomes.
Of the total cohort in this study, 40,654 patients had one or more prescriptions for a DAA (without interferon) and 204,942 patients had not been treated.
All-cause mortality reduced by 57%
DAA treatment, vs. no treatment, was linked with a large and significant reduction (57%) in all-cause mortality. That finding was particularly notable, because it was seen regardless of age, sex, race and ethnicity, comorbidities, alcohol use, and presence of hepatocellular carcinoma or cirrhosis.
The authors noted that patients without cirrhosis are a population previously considered to receive less benefit from an HCV cure than patients with cirrhosis.
DAAs were associated with lower risk of hepatocellular carcinoma and decompensation as well as risk of nonliver outcomes, including diabetes, cardiovascular disease (CVD), and chronic kidney disease (CKD).
Lower risk of poor nonliver outcomes
The researchers found that when they compared DAA-treated patients with untreated patients, the incidences per 1,000 person-years of having diabetes were 30.2 vs. 37.2 (P less than .001), and of having kidney disease was 31.1 vs. 34.1 (P less than .001), respectively.
“This retrospective cohort study provides valuable information to physicians,” Noel Deep, MD, chief medical officer at Aspirus Langlade Hospital in Antigo, Wis., said, in an interview.
The study’s size helps confirm DAAs’ safety and benefit, and previously unknown added benefits, in treating CHC, he continued.
Large study confirms, introduces DAA benefits
Dr. Deep, who was not part of the study, noted that DAAs now show much promise in efficacy and tolerability in most people with chronic hepatitis C, including those with concomitant conditions such as CKD.
“Previous studies did not have such large-scale nationwide data. [The findings of the new study] greatly enhance our knowledge of DAA treatment for chronic hepatitis C patients across the spectrum from noncirrhotic to compensated cirrhotic to decompensated cirrhotic,” Dr. Deep said. “The added benefit of improved outcomes for diabetes, CVD, CKD, and nonliver cancers truly surprised me.”
Dr. Deep pointed out some limitations of the study, including that, as the authors acknowledge, only privately insured patients were included so results may not be generalizable to the underinsured/uninsured “who might have other risk factors, poorer health, and fewer resources.”
He added: “The data also may not be reflective of the outcomes in Asians who were, in my opinion, also underrepresented in this study.”
The authors cited the insurance claims database they used as a strength of the study, due to it containing information on 61 million people from across all regions of the United States.
Dr. Ogawa reports grants from Gilead Sciences outside the submitted work. Coauthor Dr. Nguyen reports institutional grants and advisory board fees from Gilead Sciences outside the submitted work. Another coauthor reports speaking/consulting fees from Gilead and Merck Sharp & Dohme outside the submitted work. No other disclosures were reported.
The Stanford Center for Population Health Sciences (PHS) supported this study by providing access to the PHS Data Core.
Dr. Deep reports no relevant financial relationships. He serves on the editorial advisory board of Internal Medicine News.
FROM JAMA INTERNAL MEDICINE
Overdose deaths up 81% in pregnant, postpartum women
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
FROM JAMA
Deductibles a threat to more imaging after abnormal mammogram
CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.
“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.
However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.
Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.
Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
Groups most likely to forgo further tests
The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).
Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.
“It caught a lot of women by surprise,” she told this news organization.
The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.
However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
Reducing false-positive recalls
The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”
Physicians who order additional tests must also consider the financial burden for patients, she said.
Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.
Further compounding the problem is that not every insurer is subject to state law, she said.
Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.
“It would be great to have a federal law that is inclusive,” she said.
Education efforts may help
Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”
He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”
Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.
“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.
However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.
Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.
Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
Groups most likely to forgo further tests
The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).
Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.
“It caught a lot of women by surprise,” she told this news organization.
The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.
However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
Reducing false-positive recalls
The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”
Physicians who order additional tests must also consider the financial burden for patients, she said.
Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.
Further compounding the problem is that not every insurer is subject to state law, she said.
Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.
“It would be great to have a federal law that is inclusive,” she said.
Education efforts may help
Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”
He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”
Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.
“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.
However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.
Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.
Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
Groups most likely to forgo further tests
The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).
Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.
“It caught a lot of women by surprise,” she told this news organization.
The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.
However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
Reducing false-positive recalls
The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”
Physicians who order additional tests must also consider the financial burden for patients, she said.
Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.
Further compounding the problem is that not every insurer is subject to state law, she said.
Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.
“It would be great to have a federal law that is inclusive,” she said.
Education efforts may help
Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”
He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”
Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT RSNA 2022
Single chest x-ray could predict 10-year CVD risk
who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.
Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.
The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
Not all data points available in EHR
But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.
Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.
The researchers trained a deep-learning model with single chest x-rays only.
They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.
Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.
They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.
“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
Tested against independent group
They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.
Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.
There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).
Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.
They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).
Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.
“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.
“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.
David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.
“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”
He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.
Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.
A version of this article first appeared on Medscape.com.
who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.
Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.
The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
Not all data points available in EHR
But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.
Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.
The researchers trained a deep-learning model with single chest x-rays only.
They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.
Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.
They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.
“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
Tested against independent group
They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.
Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.
There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).
Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.
They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).
Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.
“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.
“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.
David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.
“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”
He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.
Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.
A version of this article first appeared on Medscape.com.
who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.
Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.
The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
Not all data points available in EHR
But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.
Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.
The researchers trained a deep-learning model with single chest x-rays only.
They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.
Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.
They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.
“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
Tested against independent group
They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.
Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.
There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).
Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.
They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).
Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.
“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.
“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.
David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.
“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”
He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.
Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.
A version of this article first appeared on Medscape.com.
AT RSNA 2022
Lung cancer screening pushes 20-year survival rate to 80%
CHICAGO – , findings from a 20-year international study indicate.
Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.
The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.
Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
Participants’ 20-year survival rate 80%
Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.
Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.
For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).
No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.
These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.
At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.
Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.
When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.
“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.
“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
Findings “very promising”
Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.
“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.
“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.
Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.
So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.
“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.
Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.
Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – , findings from a 20-year international study indicate.
Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.
The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.
Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
Participants’ 20-year survival rate 80%
Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.
Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.
For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).
No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.
These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.
At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.
Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.
When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.
“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.
“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
Findings “very promising”
Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.
“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.
“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.
Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.
So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.
“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.
Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.
Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – , findings from a 20-year international study indicate.
Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.
The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.
Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
Participants’ 20-year survival rate 80%
Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.
Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.
For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).
No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.
These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.
At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.
Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.
When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.
“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.
“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
Findings “very promising”
Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.
“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.
“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.
Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.
So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.
“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.
Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.
Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT RSNA 2022
Obesity tied to worse brain health in children
CHICAGO – Higher weight and body mass index (BMI) in preadolescents are linked with poor brain health, new research suggests.
Poor brain health has been linked with obesity in adults, but little has been known about the link in children.
Lead author Simone Kaltenhauser, a postgraduate research fellow in radiology and biomedical imaging at the Yale School of Medicine, New Haven, Conn., presented her findings at the annual meeting of the Radiological Society of North America.
To represent the national sociodemographic makeup, the researchers used baseline information from the Adolescent Brain Cognitive Development (ABCD) study, which included 11,878 children aged 9 and 10 years from 21 centers across the United States.
This study included 5,169 children (51.9% girls). Children who had had traumatic brain injury, eating disorders, neurodevelopmental problems, and psychiatric diseases were excluded from the final analysis.
The researchers analyzed information from structural MRI and resting-state functional MRI, which allowed them to measure brain activity by detecting changes in blood flow.
“We analyzed the average fractional anisotropy (FA), mean (MD), axial (AD) and radial diffusivity (RD), and neurite density (ND) of 35 white matter (WM) tracts; cortical thickness and surface of 68 regions; and functional connectivity of 91 predefined network correlations,” the authors explained.
They adjusted for age, sex, race/ethnicity, handedness, and socioeconomic status. They used linear models to determine associations between weight and BMI z-scores and the imaging metrics.
Loss of white matter integrity
Among children with obesity, there was pervasive loss of white matter integrity and neurite density, cortical gray matter thinning, and decreased connectivity within and between networks that have been associated with impulse control and reward-based decision-making.
“These changes persisted in a similar pattern also 2 years later,” she said.
A member of the audience asked whether a reverse relationship might be at work – that poor brain health might drive obesity rather than the other way around.
Ms. Kaltenhauser agreed that other factors could be driving the link and acknowledged as a limitation that they did not have access to genetic information on the children.
Information on the effects of overweight and obesity is critical, especially in the United States, where an estimated 1 in 5 children are obese.
Ms. Kaltenhauser said she hopes her study raises awareness of potential brain health consequences as well as the physical consequences of childhood obesity.
Senior author Sam Payabvash, MD, a neuroradiologist and assistant professor of radiology and biomedical imaging at the Yale School of Medicine, said in a press release that the study may help explain the findings from previous studies that show an association between higher BMI in children and poor cognitive functioning and academic performance.
“The longitudinal ABCD study gives us the opportunity to observe any changes that occur in children with higher weight and BMI z-scores,” Dr. Payabvash said. “We’ll need to watch over the next 6-10 years.”
Avenues for future research
Amit B. Desai, MD, a neuroradiologist with Mayo Clinic in Jacksonville, Fla., who was not part of the study, said that while the research demonstrates an association between brain structure and BMI and obesity, “there may be other lurking variables.”
“What’s happening at an earlier stage in life could be causing both,” he said.
He noted that he would like to see future studies involving children at even earlier ages, along with investigations of the role of genetics or socioeconomic factors.
Including older children would be interesting as well, he said.
“Myelination doesn’t complete until you’re in your late teens or early 20s, so there are structural changes happening in the brain much later on into adolescence and early adulthood,” Dr. Desai said.
It would be premature, he said, to conclude from these findings that if children have obesity, there must be something wrong with their brain.
He would like to see whether there are changes in this link if a child is obese early on and later has normal weight or if a child has normal weight early and then becomes obese.
“It’s definitely an eye-opening study, but [it] needs additional work to expand upon it,” he said.
Ms. Kaltenhauser and Dr. Desai report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – Higher weight and body mass index (BMI) in preadolescents are linked with poor brain health, new research suggests.
Poor brain health has been linked with obesity in adults, but little has been known about the link in children.
Lead author Simone Kaltenhauser, a postgraduate research fellow in radiology and biomedical imaging at the Yale School of Medicine, New Haven, Conn., presented her findings at the annual meeting of the Radiological Society of North America.
To represent the national sociodemographic makeup, the researchers used baseline information from the Adolescent Brain Cognitive Development (ABCD) study, which included 11,878 children aged 9 and 10 years from 21 centers across the United States.
This study included 5,169 children (51.9% girls). Children who had had traumatic brain injury, eating disorders, neurodevelopmental problems, and psychiatric diseases were excluded from the final analysis.
The researchers analyzed information from structural MRI and resting-state functional MRI, which allowed them to measure brain activity by detecting changes in blood flow.
“We analyzed the average fractional anisotropy (FA), mean (MD), axial (AD) and radial diffusivity (RD), and neurite density (ND) of 35 white matter (WM) tracts; cortical thickness and surface of 68 regions; and functional connectivity of 91 predefined network correlations,” the authors explained.
They adjusted for age, sex, race/ethnicity, handedness, and socioeconomic status. They used linear models to determine associations between weight and BMI z-scores and the imaging metrics.
Loss of white matter integrity
Among children with obesity, there was pervasive loss of white matter integrity and neurite density, cortical gray matter thinning, and decreased connectivity within and between networks that have been associated with impulse control and reward-based decision-making.
“These changes persisted in a similar pattern also 2 years later,” she said.
A member of the audience asked whether a reverse relationship might be at work – that poor brain health might drive obesity rather than the other way around.
Ms. Kaltenhauser agreed that other factors could be driving the link and acknowledged as a limitation that they did not have access to genetic information on the children.
Information on the effects of overweight and obesity is critical, especially in the United States, where an estimated 1 in 5 children are obese.
Ms. Kaltenhauser said she hopes her study raises awareness of potential brain health consequences as well as the physical consequences of childhood obesity.
Senior author Sam Payabvash, MD, a neuroradiologist and assistant professor of radiology and biomedical imaging at the Yale School of Medicine, said in a press release that the study may help explain the findings from previous studies that show an association between higher BMI in children and poor cognitive functioning and academic performance.
“The longitudinal ABCD study gives us the opportunity to observe any changes that occur in children with higher weight and BMI z-scores,” Dr. Payabvash said. “We’ll need to watch over the next 6-10 years.”
Avenues for future research
Amit B. Desai, MD, a neuroradiologist with Mayo Clinic in Jacksonville, Fla., who was not part of the study, said that while the research demonstrates an association between brain structure and BMI and obesity, “there may be other lurking variables.”
“What’s happening at an earlier stage in life could be causing both,” he said.
He noted that he would like to see future studies involving children at even earlier ages, along with investigations of the role of genetics or socioeconomic factors.
Including older children would be interesting as well, he said.
“Myelination doesn’t complete until you’re in your late teens or early 20s, so there are structural changes happening in the brain much later on into adolescence and early adulthood,” Dr. Desai said.
It would be premature, he said, to conclude from these findings that if children have obesity, there must be something wrong with their brain.
He would like to see whether there are changes in this link if a child is obese early on and later has normal weight or if a child has normal weight early and then becomes obese.
“It’s definitely an eye-opening study, but [it] needs additional work to expand upon it,” he said.
Ms. Kaltenhauser and Dr. Desai report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – Higher weight and body mass index (BMI) in preadolescents are linked with poor brain health, new research suggests.
Poor brain health has been linked with obesity in adults, but little has been known about the link in children.
Lead author Simone Kaltenhauser, a postgraduate research fellow in radiology and biomedical imaging at the Yale School of Medicine, New Haven, Conn., presented her findings at the annual meeting of the Radiological Society of North America.
To represent the national sociodemographic makeup, the researchers used baseline information from the Adolescent Brain Cognitive Development (ABCD) study, which included 11,878 children aged 9 and 10 years from 21 centers across the United States.
This study included 5,169 children (51.9% girls). Children who had had traumatic brain injury, eating disorders, neurodevelopmental problems, and psychiatric diseases were excluded from the final analysis.
The researchers analyzed information from structural MRI and resting-state functional MRI, which allowed them to measure brain activity by detecting changes in blood flow.
“We analyzed the average fractional anisotropy (FA), mean (MD), axial (AD) and radial diffusivity (RD), and neurite density (ND) of 35 white matter (WM) tracts; cortical thickness and surface of 68 regions; and functional connectivity of 91 predefined network correlations,” the authors explained.
They adjusted for age, sex, race/ethnicity, handedness, and socioeconomic status. They used linear models to determine associations between weight and BMI z-scores and the imaging metrics.
Loss of white matter integrity
Among children with obesity, there was pervasive loss of white matter integrity and neurite density, cortical gray matter thinning, and decreased connectivity within and between networks that have been associated with impulse control and reward-based decision-making.
“These changes persisted in a similar pattern also 2 years later,” she said.
A member of the audience asked whether a reverse relationship might be at work – that poor brain health might drive obesity rather than the other way around.
Ms. Kaltenhauser agreed that other factors could be driving the link and acknowledged as a limitation that they did not have access to genetic information on the children.
Information on the effects of overweight and obesity is critical, especially in the United States, where an estimated 1 in 5 children are obese.
Ms. Kaltenhauser said she hopes her study raises awareness of potential brain health consequences as well as the physical consequences of childhood obesity.
Senior author Sam Payabvash, MD, a neuroradiologist and assistant professor of radiology and biomedical imaging at the Yale School of Medicine, said in a press release that the study may help explain the findings from previous studies that show an association between higher BMI in children and poor cognitive functioning and academic performance.
“The longitudinal ABCD study gives us the opportunity to observe any changes that occur in children with higher weight and BMI z-scores,” Dr. Payabvash said. “We’ll need to watch over the next 6-10 years.”
Avenues for future research
Amit B. Desai, MD, a neuroradiologist with Mayo Clinic in Jacksonville, Fla., who was not part of the study, said that while the research demonstrates an association between brain structure and BMI and obesity, “there may be other lurking variables.”
“What’s happening at an earlier stage in life could be causing both,” he said.
He noted that he would like to see future studies involving children at even earlier ages, along with investigations of the role of genetics or socioeconomic factors.
Including older children would be interesting as well, he said.
“Myelination doesn’t complete until you’re in your late teens or early 20s, so there are structural changes happening in the brain much later on into adolescence and early adulthood,” Dr. Desai said.
It would be premature, he said, to conclude from these findings that if children have obesity, there must be something wrong with their brain.
He would like to see whether there are changes in this link if a child is obese early on and later has normal weight or if a child has normal weight early and then becomes obese.
“It’s definitely an eye-opening study, but [it] needs additional work to expand upon it,” he said.
Ms. Kaltenhauser and Dr. Desai report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT RSNA 2022