Heidi Splete

The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.

The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.

Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.

Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.

The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.

Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.

The guideline also includes a visual algorithm for each age group.

Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.

The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
 

Infants aged 8-21 days

The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.

For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.

Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
 

Infants aged 22-28 days

In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.

As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
 

Infants aged 29-60 days

For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.

Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.

During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”

Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”

The guideline received no outside funding. The authors had no financial conflicts to disclose.

The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.

The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.

Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.

Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.

The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.

Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.

The guideline also includes a visual algorithm for each age group.

Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.

The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
 

Infants aged 8-21 days

The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.

For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.

Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
 

Infants aged 22-28 days

In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.

As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
 

Infants aged 29-60 days

For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.

Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.

During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”

Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”

The guideline received no outside funding. The authors had no financial conflicts to disclose.

The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.

The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.

Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.

Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.

The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.

Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.

The guideline also includes a visual algorithm for each age group.

Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.

The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
 

Infants aged 8-21 days

The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.

For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.

Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
 

Infants aged 22-28 days

In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.

As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
 

Infants aged 29-60 days

For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.

Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.

During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”

Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”

The guideline received no outside funding. The authors had no financial conflicts to disclose.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

“From a public health standpoint, I think we have an evolving situation,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a moderated session with Lee Beers, MD, president of the American Academy of Pediatrics, at the virtual Pediatric Hospital Medicine annual conference.

“From a public health standpoint, I think we have an evolving situation,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a moderated session with Lee Beers, MD, president of the American Academy of Pediatrics, at the virtual Pediatric Hospital Medicine annual conference.

“From a public health standpoint, I think we have an evolving situation,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a moderated session with Lee Beers, MD, president of the American Academy of Pediatrics, at the virtual Pediatric Hospital Medicine annual conference.

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

Androgenetic alopecia significantly impairs patients’ overall quality of life and emotional health, but does not have a notable impact on the incidence of depression, according a systematic review and meta-analysis of 41 studies.

“Hair loss affects self-image, causes trichodynia, and plays a role in emotions and social activity, which may be associated with psychiatric problems and impaired health-related quality of life,” wrote Chun-Hsien Huang, MD, of Chang Gung Memorial Hospital, Linkou, Taiwan, and colleagues. However, systematic reviews of the associations between androgenetic alopecia (AGA) and health-related quality of life (HRQOL) are lacking, they said.

In a study published in JAMA Dermatology, the researchers reviewed data from a total of 7,995 AGA patients in 41 studies. The studies included 11 tools for HRQOL assessment and 29 tools for psychological assessment. Of these, the Dermatology Life Quality Index (DLQI) and the Hair-Specific Skindex-29 were used to assess quality of life, and the Center for Epidemiologic Studies Depression Scale (CES-D) was used for psychological assessment in the meta-analysis.

Overall, 27 studies identified 18 factors associated with HRQOL; those with an inverse effect were higher self-rated hair loss severity, lower VAS score, and higher educational level. Of note, neither physician-rated hair loss severity nor treatment response were factors in HRQOL, the researchers said.

The pooled DLQI score across studies was 8.16, and subgroup analysis showed no differences in HRQOL between men and women or between patients from European vs. Asian countries. However, five studies showed significant differences in HRQOL between men and women when different assessment tools were used, which emphasized the need for more studies to examine the association of AGA with HRQOL by sex, the researchers said.

The meta-analysis of the Hair-Specific Skindex-29 scores showed pooled averages of 21.95 for symptom dimension, 18.52 in function dimension, and 29.22 in emotion dimension. Of these, the emotion dimension scores indicated moderate emotional impairment.

The average pooled score on the CES-D in the meta-analysis was 14.98, indicating no association between AGA and depression, the researchers said. However, “depression accounts for only a part of the emotion dimension,” they said. “Therefore, emotion dimension could be impaired even if no depressive symptoms were noted.”

The pooled DLQI scores for AGA (8.16) were higher than scores for other skin conditions including alopecia areata (6.3), contact dermatitis (7.35), and acne vulgaris (7.45), but lower than the pooled scores for vitiligo (9.11), urticaria (9.8), psoriasis (10.53), and atopic dermatitis (11.2), the researchers noted. “However, additional head-to-head studies are needed for direct comparisons of HRQOL in patients with various dermatoses,” they said.

The study findings were limited by the cross-sectional design of many of the included studies, and the limited number of assessment tools included in the analysis, the researchers noted. Other limitations were the lack of specific domain scores and the inclusion of only three studies from China, they said.

However, the results are consistent with findings from previous studies, and suggest that patients with AGA may benefit from psychological and psychosocial support, the researchers said.

Quality of life issues deserve attention

“Studies of the quality-of-life impact of various conditions are becoming more common in the medical literature,” Jamie B. MacKelfresh, MD, associate professor of dermatology, Emory University, Atlanta, said in an interview.

“Androgenetic alopecia is the most common type of hair loss in men and women,” she noted. “Hair loss can be labeled as a cosmetic concern, so it is important that providers understand the significant quality-of-life impact androgenetic alopecia has on the many people with this diagnosis,” she emphasized.

Dr. MacKelfresh, who was asked to comment on the study, said she was surprised that the subgroup analysis of the DLQI showed no significant difference between men and women. “This surprised me because a number of past studies have highlighted the relatively greater quality-of-life impact of hair loss on women compared to men,” she noted.

However, she added, “I was not surprised to see that androgenetic alopecia has a significant quality-of-life impact on many patients, and that physician objective assessments of the hair loss do not always correlate with the amount of quality-of-life impact,” said Dr. MacKelfresh. “In the patients I see, I find hair loss very often has a significant quality-of-life impact on patients, regardless of gender, and the amount of quality-of-life impact definitely does not always correlate with the objective amount of hair loss,” she noted.

A takeaway message for clinicians is to be aware that androgenetic alopecia frequently has a significant impact on patients, “particularly in the emotional dimension,” and can affect both men and women, Dr. MacKelfresh said. “Objective assessments of hair loss severity by providers may not accurately predict the degree of quality-of-life impact a patient may experience; therefore providers should include quality-of-life questions as part of their standard evaluation of patients with androgenetic alopecia,” she said. In addition to treating the hair loss, providers can help these patients by guiding them to psychological support resources, she emphasized.

More research is needed to assess the impact of androgenetic alopecia on “men, women, and the non-binary gender population,” as well as the relationship between self-esteem and hair loss, she said. “Finally, it would be helpful to understand what interventions can best help improve androgenetic alopecia patients’ quality of life,” she noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. MacKelfresh had no financial conflicts to disclose.

Androgenetic alopecia significantly impairs patients’ overall quality of life and emotional health, but does not have a notable impact on the incidence of depression, according a systematic review and meta-analysis of 41 studies.

“Hair loss affects self-image, causes trichodynia, and plays a role in emotions and social activity, which may be associated with psychiatric problems and impaired health-related quality of life,” wrote Chun-Hsien Huang, MD, of Chang Gung Memorial Hospital, Linkou, Taiwan, and colleagues. However, systematic reviews of the associations between androgenetic alopecia (AGA) and health-related quality of life (HRQOL) are lacking, they said.

In a study published in JAMA Dermatology, the researchers reviewed data from a total of 7,995 AGA patients in 41 studies. The studies included 11 tools for HRQOL assessment and 29 tools for psychological assessment. Of these, the Dermatology Life Quality Index (DLQI) and the Hair-Specific Skindex-29 were used to assess quality of life, and the Center for Epidemiologic Studies Depression Scale (CES-D) was used for psychological assessment in the meta-analysis.

Overall, 27 studies identified 18 factors associated with HRQOL; those with an inverse effect were higher self-rated hair loss severity, lower VAS score, and higher educational level. Of note, neither physician-rated hair loss severity nor treatment response were factors in HRQOL, the researchers said.

The pooled DLQI score across studies was 8.16, and subgroup analysis showed no differences in HRQOL between men and women or between patients from European vs. Asian countries. However, five studies showed significant differences in HRQOL between men and women when different assessment tools were used, which emphasized the need for more studies to examine the association of AGA with HRQOL by sex, the researchers said.

The meta-analysis of the Hair-Specific Skindex-29 scores showed pooled averages of 21.95 for symptom dimension, 18.52 in function dimension, and 29.22 in emotion dimension. Of these, the emotion dimension scores indicated moderate emotional impairment.

The average pooled score on the CES-D in the meta-analysis was 14.98, indicating no association between AGA and depression, the researchers said. However, “depression accounts for only a part of the emotion dimension,” they said. “Therefore, emotion dimension could be impaired even if no depressive symptoms were noted.”

The pooled DLQI scores for AGA (8.16) were higher than scores for other skin conditions including alopecia areata (6.3), contact dermatitis (7.35), and acne vulgaris (7.45), but lower than the pooled scores for vitiligo (9.11), urticaria (9.8), psoriasis (10.53), and atopic dermatitis (11.2), the researchers noted. “However, additional head-to-head studies are needed for direct comparisons of HRQOL in patients with various dermatoses,” they said.

The study findings were limited by the cross-sectional design of many of the included studies, and the limited number of assessment tools included in the analysis, the researchers noted. Other limitations were the lack of specific domain scores and the inclusion of only three studies from China, they said.

However, the results are consistent with findings from previous studies, and suggest that patients with AGA may benefit from psychological and psychosocial support, the researchers said.

Quality of life issues deserve attention

“Studies of the quality-of-life impact of various conditions are becoming more common in the medical literature,” Jamie B. MacKelfresh, MD, associate professor of dermatology, Emory University, Atlanta, said in an interview.

“Androgenetic alopecia is the most common type of hair loss in men and women,” she noted. “Hair loss can be labeled as a cosmetic concern, so it is important that providers understand the significant quality-of-life impact androgenetic alopecia has on the many people with this diagnosis,” she emphasized.

Dr. MacKelfresh, who was asked to comment on the study, said she was surprised that the subgroup analysis of the DLQI showed no significant difference between men and women. “This surprised me because a number of past studies have highlighted the relatively greater quality-of-life impact of hair loss on women compared to men,” she noted.

However, she added, “I was not surprised to see that androgenetic alopecia has a significant quality-of-life impact on many patients, and that physician objective assessments of the hair loss do not always correlate with the amount of quality-of-life impact,” said Dr. MacKelfresh. “In the patients I see, I find hair loss very often has a significant quality-of-life impact on patients, regardless of gender, and the amount of quality-of-life impact definitely does not always correlate with the objective amount of hair loss,” she noted.

A takeaway message for clinicians is to be aware that androgenetic alopecia frequently has a significant impact on patients, “particularly in the emotional dimension,” and can affect both men and women, Dr. MacKelfresh said. “Objective assessments of hair loss severity by providers may not accurately predict the degree of quality-of-life impact a patient may experience; therefore providers should include quality-of-life questions as part of their standard evaluation of patients with androgenetic alopecia,” she said. In addition to treating the hair loss, providers can help these patients by guiding them to psychological support resources, she emphasized.

More research is needed to assess the impact of androgenetic alopecia on “men, women, and the non-binary gender population,” as well as the relationship between self-esteem and hair loss, she said. “Finally, it would be helpful to understand what interventions can best help improve androgenetic alopecia patients’ quality of life,” she noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. MacKelfresh had no financial conflicts to disclose.

Androgenetic alopecia significantly impairs patients’ overall quality of life and emotional health, but does not have a notable impact on the incidence of depression, according a systematic review and meta-analysis of 41 studies.

“Hair loss affects self-image, causes trichodynia, and plays a role in emotions and social activity, which may be associated with psychiatric problems and impaired health-related quality of life,” wrote Chun-Hsien Huang, MD, of Chang Gung Memorial Hospital, Linkou, Taiwan, and colleagues. However, systematic reviews of the associations between androgenetic alopecia (AGA) and health-related quality of life (HRQOL) are lacking, they said.

In a study published in JAMA Dermatology, the researchers reviewed data from a total of 7,995 AGA patients in 41 studies. The studies included 11 tools for HRQOL assessment and 29 tools for psychological assessment. Of these, the Dermatology Life Quality Index (DLQI) and the Hair-Specific Skindex-29 were used to assess quality of life, and the Center for Epidemiologic Studies Depression Scale (CES-D) was used for psychological assessment in the meta-analysis.

Overall, 27 studies identified 18 factors associated with HRQOL; those with an inverse effect were higher self-rated hair loss severity, lower VAS score, and higher educational level. Of note, neither physician-rated hair loss severity nor treatment response were factors in HRQOL, the researchers said.

The pooled DLQI score across studies was 8.16, and subgroup analysis showed no differences in HRQOL between men and women or between patients from European vs. Asian countries. However, five studies showed significant differences in HRQOL between men and women when different assessment tools were used, which emphasized the need for more studies to examine the association of AGA with HRQOL by sex, the researchers said.

The meta-analysis of the Hair-Specific Skindex-29 scores showed pooled averages of 21.95 for symptom dimension, 18.52 in function dimension, and 29.22 in emotion dimension. Of these, the emotion dimension scores indicated moderate emotional impairment.

The average pooled score on the CES-D in the meta-analysis was 14.98, indicating no association between AGA and depression, the researchers said. However, “depression accounts for only a part of the emotion dimension,” they said. “Therefore, emotion dimension could be impaired even if no depressive symptoms were noted.”

The pooled DLQI scores for AGA (8.16) were higher than scores for other skin conditions including alopecia areata (6.3), contact dermatitis (7.35), and acne vulgaris (7.45), but lower than the pooled scores for vitiligo (9.11), urticaria (9.8), psoriasis (10.53), and atopic dermatitis (11.2), the researchers noted. “However, additional head-to-head studies are needed for direct comparisons of HRQOL in patients with various dermatoses,” they said.

The study findings were limited by the cross-sectional design of many of the included studies, and the limited number of assessment tools included in the analysis, the researchers noted. Other limitations were the lack of specific domain scores and the inclusion of only three studies from China, they said.

However, the results are consistent with findings from previous studies, and suggest that patients with AGA may benefit from psychological and psychosocial support, the researchers said.

Quality of life issues deserve attention

“Studies of the quality-of-life impact of various conditions are becoming more common in the medical literature,” Jamie B. MacKelfresh, MD, associate professor of dermatology, Emory University, Atlanta, said in an interview.

“Androgenetic alopecia is the most common type of hair loss in men and women,” she noted. “Hair loss can be labeled as a cosmetic concern, so it is important that providers understand the significant quality-of-life impact androgenetic alopecia has on the many people with this diagnosis,” she emphasized.

Dr. MacKelfresh, who was asked to comment on the study, said she was surprised that the subgroup analysis of the DLQI showed no significant difference between men and women. “This surprised me because a number of past studies have highlighted the relatively greater quality-of-life impact of hair loss on women compared to men,” she noted.

However, she added, “I was not surprised to see that androgenetic alopecia has a significant quality-of-life impact on many patients, and that physician objective assessments of the hair loss do not always correlate with the amount of quality-of-life impact,” said Dr. MacKelfresh. “In the patients I see, I find hair loss very often has a significant quality-of-life impact on patients, regardless of gender, and the amount of quality-of-life impact definitely does not always correlate with the objective amount of hair loss,” she noted.

A takeaway message for clinicians is to be aware that androgenetic alopecia frequently has a significant impact on patients, “particularly in the emotional dimension,” and can affect both men and women, Dr. MacKelfresh said. “Objective assessments of hair loss severity by providers may not accurately predict the degree of quality-of-life impact a patient may experience; therefore providers should include quality-of-life questions as part of their standard evaluation of patients with androgenetic alopecia,” she said. In addition to treating the hair loss, providers can help these patients by guiding them to psychological support resources, she emphasized.

More research is needed to assess the impact of androgenetic alopecia on “men, women, and the non-binary gender population,” as well as the relationship between self-esteem and hair loss, she said. “Finally, it would be helpful to understand what interventions can best help improve androgenetic alopecia patients’ quality of life,” she noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. MacKelfresh had no financial conflicts to disclose.

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

Digital Vision/Thinkstock

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

Digital Vision/Thinkstock

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

Digital Vision/Thinkstock

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Ultrasonography screening intervals of less than 6-12 months were associated with early detection of hepatocellular carcinoma, as well as increased life expectancy and quality of life, according to data from a nationwide comparative effectiveness study of nearly 60,000 patients in Taiwan.

Many international societies, including the American Association for the Study of Liver Diseases, the Asian Pacific Association for the Study of the Liver, and the European Association for the Study of the Liver, recommend abdominal ultrasonography screening for hepatocellular carcinoma (HCC) with or without alpha-fetoprotein every 6 months for patients at increased risk for HCC, wrote Shih-Chiang Kuo, MD, of National Cheng Kung University, Tainan, Taiwan, and colleagues.

However, some studies do not support this recommendation, and data suggest that “adherence to regular screenings by high-risk patients has been inadequate, leading to reduced overall benefits of ultrasonography screening in real-world practice,” and the impact of screening schedules on quality of life has not been assessed, they said.

In a study published in JAMA Network Open, the researchers identified adults with newly diagnosed HCC from 2002 through 2015 using data from the Taiwan National Cancer Registry. Barcelona Clinic Liver Cancer (BCLC) staging information was available for 42,081 men and 17,113 women; the average age was 62 years for men and 69 years for women. The patients were divided into five cohorts based on the time between their last ultrasonography screening and an index date of 90 days before their HCC diagnosis. These groups were 6 months (0-6 months), 12 months (7-12 months), 24 months (13-24 months), 36 months (25-36 months), and longer than 36 months.

“For both sexes, the proportions of patients with HCC classified as being in earlier stages (stage 0 and A) were higher in subcohorts with shorter screening intervals since the most recent ultrasonography,” the researchers wrote.

The researchers also assessed quality of life measures using the European Quality of Life Five-Dimensions in 807 men (3,370 repeated assessments) and 252 women (1,044 repeated assessments). Among men, the loss of quality of life expectancy in terms of quality of life years (QALYs) was 10.0, 11.1, 12.1, 13.1, and 14.6 for screening intervals of 6 months, 12 months, 24 months, 36 months, and beyond 36 months, respectively. The corresponding QALYs for women at the same screening intervals were 9.0, 9.7, 10.3, 10.7, and 11.4, respectively.

In a subgroup analysis according to underlying liver disease, patients with underlying hepatitis B virus infection or cirrhosis showed the greatest benefits from shorter screening intervals. For those with hepatitis B virus infection, abdominal ultrasonography screening 6 months or less prior to diagnosis of HCC was associated with an additional 4.8 QALYs for men and 2.8 QALYs for women, compared with screening longer than 36 months prior to diagnosis. The corresponding savings in QALY for men and women with underlying cirrhosis was 4.8 QALYs and 2.4 QALYs. Patients with no underlying liver disease also benefited from shorter intervals, with potential savings of 3.2 QALYs for men and 1.6 QALYs for women in the 6-month screening groups, compared with the longer than 36 months groups.

However, less than half of the men overall underwent screening withing 6 months or 12 months before diagnosis (31.4% and 39.3%, respectively); for women, 42.2% received screening within 6 months of diagnosis and 51.9% received screening within 12 months.

The study findings were limited by several factors including the use of only the last screening before diagnosis, which allows the possibility that patients in the 6- or 12-month groups did not have regular screening, the researchers noted. In addition, the lack of data on quality of life for women with BCLC stage D might have caused an underestimation of quality of life loss, they said. However, the results were strengthened by the use of a national database and long follow-up period, they said.

The results support intervals of 6-12 months or less for regular ultrasonography screening as a way to improve early detection of HCC, “and may save lives and improve utility for patients with HCC from a lifetime perspective,” the researchers emphasized. “Because people with underlying risk factors (including hepatitis B virus or hepatitis C virus infection, cirrhosis, and alcoholic liver disease) showed only slightly more frequent ultrasonography screening than those without underlying risk factors, we recommend improving this clinical practice,” they concluded.
 

Impact of identifying risk

“This study is important because HCC remains the third leading cause of cancer deaths, and the 5-year survival rate is low,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr. Sakuraba said that he was not surprised by any of the study findings. “Earlier diagnosis of cancer is often associated with improved outcome in many cancers,” he noted.

However, “Overutilization of resources may lead to increased health care costs, so correct identification of high-risk populations is needed,” Dr. Sakuraba said.

Additional research is warranted in several areas in order to make an impact on clinical practice, Dr. Sakuraba said, notably, “confirmation in other countries and ethnicities where the incidence of viral hepatitis varies.” Comparison to other tests, such as tumor markers, CT, and MRI, is needed as well, he concluded.

The study was supported by the Taiwan Ministry of Science and Technology. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Ultrasonography screening intervals of less than 6-12 months were associated with early detection of hepatocellular carcinoma, as well as increased life expectancy and quality of life, according to data from a nationwide comparative effectiveness study of nearly 60,000 patients in Taiwan.

Many international societies, including the American Association for the Study of Liver Diseases, the Asian Pacific Association for the Study of the Liver, and the European Association for the Study of the Liver, recommend abdominal ultrasonography screening for hepatocellular carcinoma (HCC) with or without alpha-fetoprotein every 6 months for patients at increased risk for HCC, wrote Shih-Chiang Kuo, MD, of National Cheng Kung University, Tainan, Taiwan, and colleagues.

However, some studies do not support this recommendation, and data suggest that “adherence to regular screenings by high-risk patients has been inadequate, leading to reduced overall benefits of ultrasonography screening in real-world practice,” and the impact of screening schedules on quality of life has not been assessed, they said.

In a study published in JAMA Network Open, the researchers identified adults with newly diagnosed HCC from 2002 through 2015 using data from the Taiwan National Cancer Registry. Barcelona Clinic Liver Cancer (BCLC) staging information was available for 42,081 men and 17,113 women; the average age was 62 years for men and 69 years for women. The patients were divided into five cohorts based on the time between their last ultrasonography screening and an index date of 90 days before their HCC diagnosis. These groups were 6 months (0-6 months), 12 months (7-12 months), 24 months (13-24 months), 36 months (25-36 months), and longer than 36 months.

“For both sexes, the proportions of patients with HCC classified as being in earlier stages (stage 0 and A) were higher in subcohorts with shorter screening intervals since the most recent ultrasonography,” the researchers wrote.

The researchers also assessed quality of life measures using the European Quality of Life Five-Dimensions in 807 men (3,370 repeated assessments) and 252 women (1,044 repeated assessments). Among men, the loss of quality of life expectancy in terms of quality of life years (QALYs) was 10.0, 11.1, 12.1, 13.1, and 14.6 for screening intervals of 6 months, 12 months, 24 months, 36 months, and beyond 36 months, respectively. The corresponding QALYs for women at the same screening intervals were 9.0, 9.7, 10.3, 10.7, and 11.4, respectively.

In a subgroup analysis according to underlying liver disease, patients with underlying hepatitis B virus infection or cirrhosis showed the greatest benefits from shorter screening intervals. For those with hepatitis B virus infection, abdominal ultrasonography screening 6 months or less prior to diagnosis of HCC was associated with an additional 4.8 QALYs for men and 2.8 QALYs for women, compared with screening longer than 36 months prior to diagnosis. The corresponding savings in QALY for men and women with underlying cirrhosis was 4.8 QALYs and 2.4 QALYs. Patients with no underlying liver disease also benefited from shorter intervals, with potential savings of 3.2 QALYs for men and 1.6 QALYs for women in the 6-month screening groups, compared with the longer than 36 months groups.

However, less than half of the men overall underwent screening withing 6 months or 12 months before diagnosis (31.4% and 39.3%, respectively); for women, 42.2% received screening within 6 months of diagnosis and 51.9% received screening within 12 months.

The study findings were limited by several factors including the use of only the last screening before diagnosis, which allows the possibility that patients in the 6- or 12-month groups did not have regular screening, the researchers noted. In addition, the lack of data on quality of life for women with BCLC stage D might have caused an underestimation of quality of life loss, they said. However, the results were strengthened by the use of a national database and long follow-up period, they said.

The results support intervals of 6-12 months or less for regular ultrasonography screening as a way to improve early detection of HCC, “and may save lives and improve utility for patients with HCC from a lifetime perspective,” the researchers emphasized. “Because people with underlying risk factors (including hepatitis B virus or hepatitis C virus infection, cirrhosis, and alcoholic liver disease) showed only slightly more frequent ultrasonography screening than those without underlying risk factors, we recommend improving this clinical practice,” they concluded.
 

Impact of identifying risk

“This study is important because HCC remains the third leading cause of cancer deaths, and the 5-year survival rate is low,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr. Sakuraba said that he was not surprised by any of the study findings. “Earlier diagnosis of cancer is often associated with improved outcome in many cancers,” he noted.

However, “Overutilization of resources may lead to increased health care costs, so correct identification of high-risk populations is needed,” Dr. Sakuraba said.

Additional research is warranted in several areas in order to make an impact on clinical practice, Dr. Sakuraba said, notably, “confirmation in other countries and ethnicities where the incidence of viral hepatitis varies.” Comparison to other tests, such as tumor markers, CT, and MRI, is needed as well, he concluded.

The study was supported by the Taiwan Ministry of Science and Technology. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Ultrasonography screening intervals of less than 6-12 months were associated with early detection of hepatocellular carcinoma, as well as increased life expectancy and quality of life, according to data from a nationwide comparative effectiveness study of nearly 60,000 patients in Taiwan.

Many international societies, including the American Association for the Study of Liver Diseases, the Asian Pacific Association for the Study of the Liver, and the European Association for the Study of the Liver, recommend abdominal ultrasonography screening for hepatocellular carcinoma (HCC) with or without alpha-fetoprotein every 6 months for patients at increased risk for HCC, wrote Shih-Chiang Kuo, MD, of National Cheng Kung University, Tainan, Taiwan, and colleagues.

However, some studies do not support this recommendation, and data suggest that “adherence to regular screenings by high-risk patients has been inadequate, leading to reduced overall benefits of ultrasonography screening in real-world practice,” and the impact of screening schedules on quality of life has not been assessed, they said.

In a study published in JAMA Network Open, the researchers identified adults with newly diagnosed HCC from 2002 through 2015 using data from the Taiwan National Cancer Registry. Barcelona Clinic Liver Cancer (BCLC) staging information was available for 42,081 men and 17,113 women; the average age was 62 years for men and 69 years for women. The patients were divided into five cohorts based on the time between their last ultrasonography screening and an index date of 90 days before their HCC diagnosis. These groups were 6 months (0-6 months), 12 months (7-12 months), 24 months (13-24 months), 36 months (25-36 months), and longer than 36 months.

“For both sexes, the proportions of patients with HCC classified as being in earlier stages (stage 0 and A) were higher in subcohorts with shorter screening intervals since the most recent ultrasonography,” the researchers wrote.

The researchers also assessed quality of life measures using the European Quality of Life Five-Dimensions in 807 men (3,370 repeated assessments) and 252 women (1,044 repeated assessments). Among men, the loss of quality of life expectancy in terms of quality of life years (QALYs) was 10.0, 11.1, 12.1, 13.1, and 14.6 for screening intervals of 6 months, 12 months, 24 months, 36 months, and beyond 36 months, respectively. The corresponding QALYs for women at the same screening intervals were 9.0, 9.7, 10.3, 10.7, and 11.4, respectively.

In a subgroup analysis according to underlying liver disease, patients with underlying hepatitis B virus infection or cirrhosis showed the greatest benefits from shorter screening intervals. For those with hepatitis B virus infection, abdominal ultrasonography screening 6 months or less prior to diagnosis of HCC was associated with an additional 4.8 QALYs for men and 2.8 QALYs for women, compared with screening longer than 36 months prior to diagnosis. The corresponding savings in QALY for men and women with underlying cirrhosis was 4.8 QALYs and 2.4 QALYs. Patients with no underlying liver disease also benefited from shorter intervals, with potential savings of 3.2 QALYs for men and 1.6 QALYs for women in the 6-month screening groups, compared with the longer than 36 months groups.

However, less than half of the men overall underwent screening withing 6 months or 12 months before diagnosis (31.4% and 39.3%, respectively); for women, 42.2% received screening within 6 months of diagnosis and 51.9% received screening within 12 months.

The study findings were limited by several factors including the use of only the last screening before diagnosis, which allows the possibility that patients in the 6- or 12-month groups did not have regular screening, the researchers noted. In addition, the lack of data on quality of life for women with BCLC stage D might have caused an underestimation of quality of life loss, they said. However, the results were strengthened by the use of a national database and long follow-up period, they said.

The results support intervals of 6-12 months or less for regular ultrasonography screening as a way to improve early detection of HCC, “and may save lives and improve utility for patients with HCC from a lifetime perspective,” the researchers emphasized. “Because people with underlying risk factors (including hepatitis B virus or hepatitis C virus infection, cirrhosis, and alcoholic liver disease) showed only slightly more frequent ultrasonography screening than those without underlying risk factors, we recommend improving this clinical practice,” they concluded.
 

Impact of identifying risk

“This study is important because HCC remains the third leading cause of cancer deaths, and the 5-year survival rate is low,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr. Sakuraba said that he was not surprised by any of the study findings. “Earlier diagnosis of cancer is often associated with improved outcome in many cancers,” he noted.

However, “Overutilization of resources may lead to increased health care costs, so correct identification of high-risk populations is needed,” Dr. Sakuraba said.

Additional research is warranted in several areas in order to make an impact on clinical practice, Dr. Sakuraba said, notably, “confirmation in other countries and ethnicities where the incidence of viral hepatitis varies.” Comparison to other tests, such as tumor markers, CT, and MRI, is needed as well, he concluded.

The study was supported by the Taiwan Ministry of Science and Technology. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.