Heidi Splete

Women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes, based on data from a meta-analysis of nearly 60,000 individuals.

Marijuana misuse remains a top substance use disorder and studies of prenatal use show a prevalence as high as 22% worldwide, wrote Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., and colleagues.

“The prevalence of marijuana use during pregnancy may continue to increase, given that there is a suggested association between legalized recreational marijuana and increased use in prenatal and postpartum periods,” they wrote. “Remarkably, 34%-60% of individuals who use marijuana keep using it during pregnancy,” and many women cite a belief that marijuana is safe to use while pregnant, they noted.

Cannabinoid receptors are present in the developing fetus by the start of the second trimester, and exposure to exogenous cannabinoids may be associated with changes in the prefrontal cortex, including development and function, the researchers said. However, previous studies of an association between maternal marijuana use and poor neonatal outcomes have been inconsistent, they added.

In a study published in JAMA Network Open, the researchers identified 16 interventional and observational studies including 59,138 patients; each study included pregnant women who were exposed to marijuana, compared with those not exposed to marijuana, along with neonatal outcomes. The data selection included studies published until Aug. 16, 2021, and 10 studies were published in 2015 or later.

Overall, the risk for seven adverse neonatal outcomes was significantly increased among women who were exposed to marijuana during pregnancy, compared with those not exposed. The researchers identified increased risk for birth weight less than 2,500 g (relative risk, 2.06; P = .005), small for gestational age (RR, 1.61; P < .001), preterm delivery (RR, 1.28; P < .001), and NICU admission (RR, 1.38; P < .001). In addition, they found significant differences in mean birth weight (mean difference, −112.30 g; P < .001), Apgar score at 1 minute (mean difference, −0.26; P = .002), and infant head circumference (mean difference, −0.34cm; P = .02) between women who used marijuana during pregnancy and those who did not.

The study findings were limited by several factors, including the assessment of only cohort studies, which might suffer from bias given their retrospective designs, the researchers noted. Other limitations included the reliance on self-reports, the inability to adjust for tobacco/marijuana coexposure, and the lack of differentiation between levels of use and between different types of marijuana ingestion, they added.

However, the results support an association between marijuana use and adverse neonatal outcomes, and the researchers recommended additional studies of both maternal and neonatal outcomes associated with marijuana exposure. “Given increasing marijuana legalization and use worldwide, raising awareness and educating patients about these adverse outcomes may help to improve neonatal health,” they concluded.

New research prompted new review

The motivation to conduct this analysis at this time was prompted by the publication of several new, high-quality studies on the use of marijuana in pregnancy, according to Dr. Marchand. “It’s been a few years since a full analysis of all of the available data had been done, so we decided it was time to see if the old conclusions still held,” he said in an interview.

Dr. Marchand said he was surprised to see such a clear connection to preterm deliveries and lower birth weights. “When we perform a meta-analysis, we use all of the available data, and some important studies performed as recently as the past few years provided the depth of evidence behind these connections,” he said. “We didn’t have that level of evidence the last time this topic was studied only a few years ago,” he added.

The study is the largest meta-analysis on this topic to date, so the message to clinicians is highly significant, Dr. Marchand said. That message is “that we now have a very high level of evidence to say that smoking marijuana during pregnancy is harmful, and we (physicians especially) can no longer state that we just don’t know,” he said. “This is going to mean that deciding to smoke marijuana during your pregnancy is also deciding to do something that can harm your baby,” he emphasized. “This paper also will force some difficult decisions for mothers who use marijuana to treat medical problems, and there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety,” Dr. Marchand noted. “This will set up a difficult risk-versus-benefits situation, where these mothers, ideally with the help of their physicians, will have to decide if the risks of stopping marijuana outweigh the possible harm to the unborn baby,” he said.

As for additional research, long-term studies to assess behavioral changes as exposed children grow up would be beneficial, Dr. Marchand said. Such studies “could really help us balance the risk of marijuana exposure in pregnancy, especially if it is being used to treat serious medical conditions,” he noted.

Findings are a call to action

The view among many women that prenatal cannabis use is safe and without consequence “is a false narrative perpetuated by a combination of outdated evidence and recent changes to state-level cannabis policies,” wrote Kara R. Skelton, PhD, of Towson (Md.) University, and Sara E. Benjamin-Neelon, PhD, of Johns Hopkins University, Baltimore, in an accompanying editorial.

The findings from the current study add to the growing evidence that prenatal cannabis use is associated with adverse birth outcomes, they wrote. “Clinician-directed communication about cannabis has been criticized by pregnant women, with recent findings supporting a need for increased cannabis communication by clinicians,” and not only clinicians, but all health professionals who encounter women who are pregnant or attempting pregnancy should not miss the opportunity to communicate the risks of prenatal cannabis use, they emphasized.

The authors highlighted some of the current study’s limitations, including the inability to determine a dose-response association, the reliance on self-reports, and the lack of adjustment for tobacco/marijuana coexposure. However, they noted that the inclusion of recent studies (10 published in 2015 or later) strengthens the results because of the significant increase in the potency of Δ-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, in recent decades.

“We urge clinicians, public health professionals, and policy makers to carefully consider the consequences of in utero cannabis exposure identified by Marchand et al. and partner to ensure prioritization of infant and child health during this time of precipitous cannabis legalization and commercialization,” the authors emphasized. “Without necessary safeguards to protect neonatal health, prenatal cannabis use poses a substantial threat to current and future generations of children,” they wrote.

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

Women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes, based on data from a meta-analysis of nearly 60,000 individuals.

Marijuana misuse remains a top substance use disorder and studies of prenatal use show a prevalence as high as 22% worldwide, wrote Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., and colleagues.

“The prevalence of marijuana use during pregnancy may continue to increase, given that there is a suggested association between legalized recreational marijuana and increased use in prenatal and postpartum periods,” they wrote. “Remarkably, 34%-60% of individuals who use marijuana keep using it during pregnancy,” and many women cite a belief that marijuana is safe to use while pregnant, they noted.

Cannabinoid receptors are present in the developing fetus by the start of the second trimester, and exposure to exogenous cannabinoids may be associated with changes in the prefrontal cortex, including development and function, the researchers said. However, previous studies of an association between maternal marijuana use and poor neonatal outcomes have been inconsistent, they added.

In a study published in JAMA Network Open, the researchers identified 16 interventional and observational studies including 59,138 patients; each study included pregnant women who were exposed to marijuana, compared with those not exposed to marijuana, along with neonatal outcomes. The data selection included studies published until Aug. 16, 2021, and 10 studies were published in 2015 or later.

Overall, the risk for seven adverse neonatal outcomes was significantly increased among women who were exposed to marijuana during pregnancy, compared with those not exposed. The researchers identified increased risk for birth weight less than 2,500 g (relative risk, 2.06; P = .005), small for gestational age (RR, 1.61; P < .001), preterm delivery (RR, 1.28; P < .001), and NICU admission (RR, 1.38; P < .001). In addition, they found significant differences in mean birth weight (mean difference, −112.30 g; P < .001), Apgar score at 1 minute (mean difference, −0.26; P = .002), and infant head circumference (mean difference, −0.34cm; P = .02) between women who used marijuana during pregnancy and those who did not.

The study findings were limited by several factors, including the assessment of only cohort studies, which might suffer from bias given their retrospective designs, the researchers noted. Other limitations included the reliance on self-reports, the inability to adjust for tobacco/marijuana coexposure, and the lack of differentiation between levels of use and between different types of marijuana ingestion, they added.

However, the results support an association between marijuana use and adverse neonatal outcomes, and the researchers recommended additional studies of both maternal and neonatal outcomes associated with marijuana exposure. “Given increasing marijuana legalization and use worldwide, raising awareness and educating patients about these adverse outcomes may help to improve neonatal health,” they concluded.

New research prompted new review

The motivation to conduct this analysis at this time was prompted by the publication of several new, high-quality studies on the use of marijuana in pregnancy, according to Dr. Marchand. “It’s been a few years since a full analysis of all of the available data had been done, so we decided it was time to see if the old conclusions still held,” he said in an interview.

Dr. Marchand said he was surprised to see such a clear connection to preterm deliveries and lower birth weights. “When we perform a meta-analysis, we use all of the available data, and some important studies performed as recently as the past few years provided the depth of evidence behind these connections,” he said. “We didn’t have that level of evidence the last time this topic was studied only a few years ago,” he added.

The study is the largest meta-analysis on this topic to date, so the message to clinicians is highly significant, Dr. Marchand said. That message is “that we now have a very high level of evidence to say that smoking marijuana during pregnancy is harmful, and we (physicians especially) can no longer state that we just don’t know,” he said. “This is going to mean that deciding to smoke marijuana during your pregnancy is also deciding to do something that can harm your baby,” he emphasized. “This paper also will force some difficult decisions for mothers who use marijuana to treat medical problems, and there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety,” Dr. Marchand noted. “This will set up a difficult risk-versus-benefits situation, where these mothers, ideally with the help of their physicians, will have to decide if the risks of stopping marijuana outweigh the possible harm to the unborn baby,” he said.

As for additional research, long-term studies to assess behavioral changes as exposed children grow up would be beneficial, Dr. Marchand said. Such studies “could really help us balance the risk of marijuana exposure in pregnancy, especially if it is being used to treat serious medical conditions,” he noted.

Findings are a call to action

The view among many women that prenatal cannabis use is safe and without consequence “is a false narrative perpetuated by a combination of outdated evidence and recent changes to state-level cannabis policies,” wrote Kara R. Skelton, PhD, of Towson (Md.) University, and Sara E. Benjamin-Neelon, PhD, of Johns Hopkins University, Baltimore, in an accompanying editorial.

The findings from the current study add to the growing evidence that prenatal cannabis use is associated with adverse birth outcomes, they wrote. “Clinician-directed communication about cannabis has been criticized by pregnant women, with recent findings supporting a need for increased cannabis communication by clinicians,” and not only clinicians, but all health professionals who encounter women who are pregnant or attempting pregnancy should not miss the opportunity to communicate the risks of prenatal cannabis use, they emphasized.

The authors highlighted some of the current study’s limitations, including the inability to determine a dose-response association, the reliance on self-reports, and the lack of adjustment for tobacco/marijuana coexposure. However, they noted that the inclusion of recent studies (10 published in 2015 or later) strengthens the results because of the significant increase in the potency of Δ-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, in recent decades.

“We urge clinicians, public health professionals, and policy makers to carefully consider the consequences of in utero cannabis exposure identified by Marchand et al. and partner to ensure prioritization of infant and child health during this time of precipitous cannabis legalization and commercialization,” the authors emphasized. “Without necessary safeguards to protect neonatal health, prenatal cannabis use poses a substantial threat to current and future generations of children,” they wrote.

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

Women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes, based on data from a meta-analysis of nearly 60,000 individuals.

Marijuana misuse remains a top substance use disorder and studies of prenatal use show a prevalence as high as 22% worldwide, wrote Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., and colleagues.

“The prevalence of marijuana use during pregnancy may continue to increase, given that there is a suggested association between legalized recreational marijuana and increased use in prenatal and postpartum periods,” they wrote. “Remarkably, 34%-60% of individuals who use marijuana keep using it during pregnancy,” and many women cite a belief that marijuana is safe to use while pregnant, they noted.

Cannabinoid receptors are present in the developing fetus by the start of the second trimester, and exposure to exogenous cannabinoids may be associated with changes in the prefrontal cortex, including development and function, the researchers said. However, previous studies of an association between maternal marijuana use and poor neonatal outcomes have been inconsistent, they added.

In a study published in JAMA Network Open, the researchers identified 16 interventional and observational studies including 59,138 patients; each study included pregnant women who were exposed to marijuana, compared with those not exposed to marijuana, along with neonatal outcomes. The data selection included studies published until Aug. 16, 2021, and 10 studies were published in 2015 or later.

Overall, the risk for seven adverse neonatal outcomes was significantly increased among women who were exposed to marijuana during pregnancy, compared with those not exposed. The researchers identified increased risk for birth weight less than 2,500 g (relative risk, 2.06; P = .005), small for gestational age (RR, 1.61; P < .001), preterm delivery (RR, 1.28; P < .001), and NICU admission (RR, 1.38; P < .001). In addition, they found significant differences in mean birth weight (mean difference, −112.30 g; P < .001), Apgar score at 1 minute (mean difference, −0.26; P = .002), and infant head circumference (mean difference, −0.34cm; P = .02) between women who used marijuana during pregnancy and those who did not.

The study findings were limited by several factors, including the assessment of only cohort studies, which might suffer from bias given their retrospective designs, the researchers noted. Other limitations included the reliance on self-reports, the inability to adjust for tobacco/marijuana coexposure, and the lack of differentiation between levels of use and between different types of marijuana ingestion, they added.

However, the results support an association between marijuana use and adverse neonatal outcomes, and the researchers recommended additional studies of both maternal and neonatal outcomes associated with marijuana exposure. “Given increasing marijuana legalization and use worldwide, raising awareness and educating patients about these adverse outcomes may help to improve neonatal health,” they concluded.

New research prompted new review

The motivation to conduct this analysis at this time was prompted by the publication of several new, high-quality studies on the use of marijuana in pregnancy, according to Dr. Marchand. “It’s been a few years since a full analysis of all of the available data had been done, so we decided it was time to see if the old conclusions still held,” he said in an interview.

Dr. Marchand said he was surprised to see such a clear connection to preterm deliveries and lower birth weights. “When we perform a meta-analysis, we use all of the available data, and some important studies performed as recently as the past few years provided the depth of evidence behind these connections,” he said. “We didn’t have that level of evidence the last time this topic was studied only a few years ago,” he added.

The study is the largest meta-analysis on this topic to date, so the message to clinicians is highly significant, Dr. Marchand said. That message is “that we now have a very high level of evidence to say that smoking marijuana during pregnancy is harmful, and we (physicians especially) can no longer state that we just don’t know,” he said. “This is going to mean that deciding to smoke marijuana during your pregnancy is also deciding to do something that can harm your baby,” he emphasized. “This paper also will force some difficult decisions for mothers who use marijuana to treat medical problems, and there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety,” Dr. Marchand noted. “This will set up a difficult risk-versus-benefits situation, where these mothers, ideally with the help of their physicians, will have to decide if the risks of stopping marijuana outweigh the possible harm to the unborn baby,” he said.

As for additional research, long-term studies to assess behavioral changes as exposed children grow up would be beneficial, Dr. Marchand said. Such studies “could really help us balance the risk of marijuana exposure in pregnancy, especially if it is being used to treat serious medical conditions,” he noted.

Findings are a call to action

The view among many women that prenatal cannabis use is safe and without consequence “is a false narrative perpetuated by a combination of outdated evidence and recent changes to state-level cannabis policies,” wrote Kara R. Skelton, PhD, of Towson (Md.) University, and Sara E. Benjamin-Neelon, PhD, of Johns Hopkins University, Baltimore, in an accompanying editorial.

The findings from the current study add to the growing evidence that prenatal cannabis use is associated with adverse birth outcomes, they wrote. “Clinician-directed communication about cannabis has been criticized by pregnant women, with recent findings supporting a need for increased cannabis communication by clinicians,” and not only clinicians, but all health professionals who encounter women who are pregnant or attempting pregnancy should not miss the opportunity to communicate the risks of prenatal cannabis use, they emphasized.

The authors highlighted some of the current study’s limitations, including the inability to determine a dose-response association, the reliance on self-reports, and the lack of adjustment for tobacco/marijuana coexposure. However, they noted that the inclusion of recent studies (10 published in 2015 or later) strengthens the results because of the significant increase in the potency of Δ-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, in recent decades.

“We urge clinicians, public health professionals, and policy makers to carefully consider the consequences of in utero cannabis exposure identified by Marchand et al. and partner to ensure prioritization of infant and child health during this time of precipitous cannabis legalization and commercialization,” the authors emphasized. “Without necessary safeguards to protect neonatal health, prenatal cannabis use poses a substantial threat to current and future generations of children,” they wrote.

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

Achieving steroid-free clinical and endoscopic remission does not decrease the risk of Crohn’s disease progression measured by surgery, hospitalization, or initiation of new treatments, according to a post hoc analysis of data from a prospective RCT.

The therapeutic goals of Crohn’s disease have evolved from controlling symptoms to blocking disease progression and reducing complications, wrote David Laharie, MD, of Hôpital Haut-Lévêque, Pessac, France, and colleagues. The goal of steroid-free remission has been used as an endpoint of treatment, but data on the impact of such remission on long-term disease are limited, the researchers noted in a retrospective study published in Clinical Gastroenterology and Hepatology.

undefined undefined/iStock/Getty Images

In the study, the researchers reviewed data from 95 adults with early Crohn’s disease (CD) who participated in the TAILORIX trial involving treatment with infliximab and immunomodulators. The primary endpoint of the TAILORIX trial was sustained corticosteroid-free remission from week 22 to 54. In the current study, the primary endpoint was progression-free survival at 1, 3, and 5 years in patients who did or did not meet the TAILORIX primary endpoint. The median disease duration was 4.5 months, and the median follow-up was 64.2 months.

Progression-free survival was defined as a composite of luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment during the follow-up period.

In the study population, 45 patients achieved corticosteroid-free remission and 50 did not. At 54 weeks, 17 patients with corticosteroid-free remission (38%) and 28 patients without remission (56%) achieved complete mucosal healing, and progression-free survival rates were similar between these groups.

Overall, the rates of progression-free survival at 1, 3, and 5 years were not significantly different between the remission and nonremission groups: 86% versus 91%, respectively, at 1 year; 70% for both groups at 3 years; and 64% and 61%, respectively, at 5 years.

The researchers also compared individual components of the primary endpoint (luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment), and found no significant differences in survival rates in patients who had and had not achieved steroid-free remission.

Survival rates without luminal surgery at 1, 3, and 5 years were 97% versus 96%, 93% versus 90%, and 87% versus 82%, respectively, for remission and nonremission groups. Similarly, survival rates without anal surgery were 93%, 86%, and 86% versus 96%, 88%, and 85%, respectively, for the two groups. Rates of hospitalization-free survival at 1, 3, and 5 years were 90% versus 92%, 81% versus 81%, and 78% versus 69%, respectively, in the remission and nonremission groups. Survival rates without a new systemic CD treatment also were similar at 1, 3, and 5 years: 93% versus 95%, 71% versus 93%, and 60% versus 51%, respectively, for the remission and nonremission groups.

CD progression was not associated with not achieving corticosteroid-free remission (hazard ratio, 0.861). Other factors that were not associated with disease progression in this study included CRP greater than 5 mg/L, age older than 30 years, active smoking, and B1 phenotype.

The researchers noted that, although endoscopic and clinical remission is currently recommended for CD, “there is no validated or standardized definition of this endoscopic goal.” The high rates of survival without major abdominal surgery, regardless of remission status, suggest a significant impact of early combination therapy for CD patients who were biologic naive. Other studies have shown similar improved outcomes for CD patients with early treatment.

The study findings were limited by several factors including the retrospective design and lack of power to compare long-term progression-free survival, the researchers noted. However, the results were strengthened by the robust data on hospitalizations and surgeries from the TAILORIX trial.

The results support a more flexible strategy for CD, “recommending endoscopic and clinical remission in early diagnosed patients and less stringent objectives in those with more refractory or advanced disease,” they concluded.
 

Findings may guide patient management

The current study is important to help clinicians know whether CD patients who achieve a short-term, steroid-free clinical and endoscopic remission go on to experience better long-term disease outcomes than those who do not achieve this short-term remission, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

Dr. Sakuraba said that he was surprised by the study findings. “Achieving a clinical remission off steroids with complete endoscopic remission, i.e., deep remission, is considered a treatment goal, but the fact that it did not result in less disease progression was surprising.”

The take-home message for clinicians from the study is that CD patients may still experience disease progression after achieving a single time of clinical and endoscopic remission “mainly due to loss of response to infliximab, so continued long-term disease monitoring and control are required,” Dr. Sakuraba said.

The current study was a post hoc follow-up analysis of a previous trial, Dr. Sakuraba noted. Therefore, studies primarily focused on changing the disease progression and natural course of CD are warranted.

Dr. Laharie disclosed counseling, boards, transportation, or fees from AbbVie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, and Tillots. Dr. Sakuraba had no relevant financial conflicts to disclose.

This article was updated Feb. 10, 2022.

Achieving steroid-free clinical and endoscopic remission does not decrease the risk of Crohn’s disease progression measured by surgery, hospitalization, or initiation of new treatments, according to a post hoc analysis of data from a prospective RCT.

The therapeutic goals of Crohn’s disease have evolved from controlling symptoms to blocking disease progression and reducing complications, wrote David Laharie, MD, of Hôpital Haut-Lévêque, Pessac, France, and colleagues. The goal of steroid-free remission has been used as an endpoint of treatment, but data on the impact of such remission on long-term disease are limited, the researchers noted in a retrospective study published in Clinical Gastroenterology and Hepatology.

undefined undefined/iStock/Getty Images

In the study, the researchers reviewed data from 95 adults with early Crohn’s disease (CD) who participated in the TAILORIX trial involving treatment with infliximab and immunomodulators. The primary endpoint of the TAILORIX trial was sustained corticosteroid-free remission from week 22 to 54. In the current study, the primary endpoint was progression-free survival at 1, 3, and 5 years in patients who did or did not meet the TAILORIX primary endpoint. The median disease duration was 4.5 months, and the median follow-up was 64.2 months.

Progression-free survival was defined as a composite of luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment during the follow-up period.

In the study population, 45 patients achieved corticosteroid-free remission and 50 did not. At 54 weeks, 17 patients with corticosteroid-free remission (38%) and 28 patients without remission (56%) achieved complete mucosal healing, and progression-free survival rates were similar between these groups.

Overall, the rates of progression-free survival at 1, 3, and 5 years were not significantly different between the remission and nonremission groups: 86% versus 91%, respectively, at 1 year; 70% for both groups at 3 years; and 64% and 61%, respectively, at 5 years.

The researchers also compared individual components of the primary endpoint (luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment), and found no significant differences in survival rates in patients who had and had not achieved steroid-free remission.

Survival rates without luminal surgery at 1, 3, and 5 years were 97% versus 96%, 93% versus 90%, and 87% versus 82%, respectively, for remission and nonremission groups. Similarly, survival rates without anal surgery were 93%, 86%, and 86% versus 96%, 88%, and 85%, respectively, for the two groups. Rates of hospitalization-free survival at 1, 3, and 5 years were 90% versus 92%, 81% versus 81%, and 78% versus 69%, respectively, in the remission and nonremission groups. Survival rates without a new systemic CD treatment also were similar at 1, 3, and 5 years: 93% versus 95%, 71% versus 93%, and 60% versus 51%, respectively, for the remission and nonremission groups.

CD progression was not associated with not achieving corticosteroid-free remission (hazard ratio, 0.861). Other factors that were not associated with disease progression in this study included CRP greater than 5 mg/L, age older than 30 years, active smoking, and B1 phenotype.

The researchers noted that, although endoscopic and clinical remission is currently recommended for CD, “there is no validated or standardized definition of this endoscopic goal.” The high rates of survival without major abdominal surgery, regardless of remission status, suggest a significant impact of early combination therapy for CD patients who were biologic naive. Other studies have shown similar improved outcomes for CD patients with early treatment.

The study findings were limited by several factors including the retrospective design and lack of power to compare long-term progression-free survival, the researchers noted. However, the results were strengthened by the robust data on hospitalizations and surgeries from the TAILORIX trial.

The results support a more flexible strategy for CD, “recommending endoscopic and clinical remission in early diagnosed patients and less stringent objectives in those with more refractory or advanced disease,” they concluded.
 

Findings may guide patient management

The current study is important to help clinicians know whether CD patients who achieve a short-term, steroid-free clinical and endoscopic remission go on to experience better long-term disease outcomes than those who do not achieve this short-term remission, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

Dr. Sakuraba said that he was surprised by the study findings. “Achieving a clinical remission off steroids with complete endoscopic remission, i.e., deep remission, is considered a treatment goal, but the fact that it did not result in less disease progression was surprising.”

The take-home message for clinicians from the study is that CD patients may still experience disease progression after achieving a single time of clinical and endoscopic remission “mainly due to loss of response to infliximab, so continued long-term disease monitoring and control are required,” Dr. Sakuraba said.

The current study was a post hoc follow-up analysis of a previous trial, Dr. Sakuraba noted. Therefore, studies primarily focused on changing the disease progression and natural course of CD are warranted.

Dr. Laharie disclosed counseling, boards, transportation, or fees from AbbVie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, and Tillots. Dr. Sakuraba had no relevant financial conflicts to disclose.

This article was updated Feb. 10, 2022.

Achieving steroid-free clinical and endoscopic remission does not decrease the risk of Crohn’s disease progression measured by surgery, hospitalization, or initiation of new treatments, according to a post hoc analysis of data from a prospective RCT.

The therapeutic goals of Crohn’s disease have evolved from controlling symptoms to blocking disease progression and reducing complications, wrote David Laharie, MD, of Hôpital Haut-Lévêque, Pessac, France, and colleagues. The goal of steroid-free remission has been used as an endpoint of treatment, but data on the impact of such remission on long-term disease are limited, the researchers noted in a retrospective study published in Clinical Gastroenterology and Hepatology.

undefined undefined/iStock/Getty Images

In the study, the researchers reviewed data from 95 adults with early Crohn’s disease (CD) who participated in the TAILORIX trial involving treatment with infliximab and immunomodulators. The primary endpoint of the TAILORIX trial was sustained corticosteroid-free remission from week 22 to 54. In the current study, the primary endpoint was progression-free survival at 1, 3, and 5 years in patients who did or did not meet the TAILORIX primary endpoint. The median disease duration was 4.5 months, and the median follow-up was 64.2 months.

Progression-free survival was defined as a composite of luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment during the follow-up period.

In the study population, 45 patients achieved corticosteroid-free remission and 50 did not. At 54 weeks, 17 patients with corticosteroid-free remission (38%) and 28 patients without remission (56%) achieved complete mucosal healing, and progression-free survival rates were similar between these groups.

Overall, the rates of progression-free survival at 1, 3, and 5 years were not significantly different between the remission and nonremission groups: 86% versus 91%, respectively, at 1 year; 70% for both groups at 3 years; and 64% and 61%, respectively, at 5 years.

The researchers also compared individual components of the primary endpoint (luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment), and found no significant differences in survival rates in patients who had and had not achieved steroid-free remission.

Survival rates without luminal surgery at 1, 3, and 5 years were 97% versus 96%, 93% versus 90%, and 87% versus 82%, respectively, for remission and nonremission groups. Similarly, survival rates without anal surgery were 93%, 86%, and 86% versus 96%, 88%, and 85%, respectively, for the two groups. Rates of hospitalization-free survival at 1, 3, and 5 years were 90% versus 92%, 81% versus 81%, and 78% versus 69%, respectively, in the remission and nonremission groups. Survival rates without a new systemic CD treatment also were similar at 1, 3, and 5 years: 93% versus 95%, 71% versus 93%, and 60% versus 51%, respectively, for the remission and nonremission groups.

CD progression was not associated with not achieving corticosteroid-free remission (hazard ratio, 0.861). Other factors that were not associated with disease progression in this study included CRP greater than 5 mg/L, age older than 30 years, active smoking, and B1 phenotype.

The researchers noted that, although endoscopic and clinical remission is currently recommended for CD, “there is no validated or standardized definition of this endoscopic goal.” The high rates of survival without major abdominal surgery, regardless of remission status, suggest a significant impact of early combination therapy for CD patients who were biologic naive. Other studies have shown similar improved outcomes for CD patients with early treatment.

The study findings were limited by several factors including the retrospective design and lack of power to compare long-term progression-free survival, the researchers noted. However, the results were strengthened by the robust data on hospitalizations and surgeries from the TAILORIX trial.

The results support a more flexible strategy for CD, “recommending endoscopic and clinical remission in early diagnosed patients and less stringent objectives in those with more refractory or advanced disease,” they concluded.
 

Findings may guide patient management

The current study is important to help clinicians know whether CD patients who achieve a short-term, steroid-free clinical and endoscopic remission go on to experience better long-term disease outcomes than those who do not achieve this short-term remission, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

Dr. Sakuraba said that he was surprised by the study findings. “Achieving a clinical remission off steroids with complete endoscopic remission, i.e., deep remission, is considered a treatment goal, but the fact that it did not result in less disease progression was surprising.”

The take-home message for clinicians from the study is that CD patients may still experience disease progression after achieving a single time of clinical and endoscopic remission “mainly due to loss of response to infliximab, so continued long-term disease monitoring and control are required,” Dr. Sakuraba said.

The current study was a post hoc follow-up analysis of a previous trial, Dr. Sakuraba noted. Therefore, studies primarily focused on changing the disease progression and natural course of CD are warranted.

Dr. Laharie disclosed counseling, boards, transportation, or fees from AbbVie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, and Tillots. Dr. Sakuraba had no relevant financial conflicts to disclose.

This article was updated Feb. 10, 2022.

Recalls and false-positives for breast imaging patients were significantly more likely when the results were read by less-experienced radiologists who had worked more hours that day, based on data from more than 97,000 screening mammograms.

Psychology literature has shown the impact of fatigue on performance in a range of settings, and previous studies have shown that radiologists’ performances are more accurate earlier in their shifts compared to later-shift performance, write Michael H. Bernstein, PhD, and colleagues at Brown University, Providence, R.I., in a study published online Jan. 11 in Radiology.

The effect of time of day on performance may be greater for more detailed imaging modalities that are more “cognitively taxing,” and the effect may be greater in less-experienced radiologists, but the impact of time and experience on overall patient recall and false-positive rates has not been well-studied, the researchers said.

In the retrospective review, the researchers identified 97,671 screening mammograms read by 18 radiologists at one of 12 community sites between Jan. 2018 and Dec. 2019. The researchers analyzed the results by type of image, either standard digital mammography (DM) or the more complex digital breast tomosynthesis (DBT). The researchers separated radiologists into two groups: those with at least 5 post-training years of experience and those with less than 5 post-training years of experience. A total of nine radiologists fell into each category.

Overall, the recall rates were significantly different and higher for DM versus DBT (10.2% vs. 9.0%; P = .006). The false-positive (FP) rate also differed significantly and was higher for DM versus DBT (9.8% vs. 8.6%; P = .004).

The odds of recall increased by 11.5% with each hour of reading time for radiologists with less than 5 post-training years of experience for both DBT (odds ratio, 1.12) and DM (OR, 1.09). For the more experienced radiologists, the odds of recall increased by 1.6% for each hour of reading time for DBT but decreased by 0.1% for DM, with no significant difference.

Similarly, the odds of an FP result increased by 12.1% for DBT and 9% for DM per hour of reading time for radiologists with less experience. For more experienced radiologists, the odds of an FP increased by 1.6% for DBT but decreased by 1.1% for DM per hour of reading time.

Cancer detection (defined as true-positive, or TP) was not higher for DM across time, the researchers note. However, “DBT achieved a higher TP rate than DM regardless of the time of day; this shows that for DBT to maintain a constant and superior TP rate relative to DM, radiologists’ FP rates had to go up as the day went on,” they write. “That is, although DBT achieves a superior TP rate, more junior radiologists appeared to compensate for their fatigue later in the day when using DBT by recalling a broader range of mammograms, more of which were FP findings.”

The researchers caution that their findings were limited by several factors, including the study’s retrospective design and the lack of randomization of the imaging technology, patients, and time of day, which prohibit conclusions regarding causality. Other limitations included the consideration of time of day without the ability to use hours since the start of a clinical shift and the use of a 5-year mark to indicate experience without accounting for work volume.

However, the stronger impact of a time-of-day effect for more junior radiologists agrees with findings from other studies, the researchers add. More empirical research is needed, and the researchers propose a longitudinal study of how time of day affects radiologists as they gain experience, as well as experimental studies to test strategies for mitigating the time-of-day effect observed in the current study.
 

Scheduled breaks may reduce impact of fatigue

“Digital breast tomosynthesis is increasingly used in clinical practice and takes significantly longer to interpret compared with digital mammography,” said corresponding author Ana P. Lourenco, MD, in an interview. “Radiologists interpret hundreds of images for each screening digital breast tomosynthesis exam, compared with four images for each screening digital mammogram exam; this may certainly contribute to radiologist fatigue.”

“I found it interesting that there was a difference based on years of experience of the radiologist, but I was not surprised that recall rate increased later in the day, as some of us had anecdotally noted this in our clinical practice,” Dr. Lourenco said. In fact, the idea to conduct the study was prompted by a conversation with her statistician colleagues “about how I subjectively felt like my own recall rate increased at the end of the day.”

Ways to counteract the impact of fatigue could include intermittent breaks to refocus attention, said Dr. Lourenco. “Potential barriers would include imaging volumes and attending to patients in the breast imaging center,” she said. “If we can show that decreasing fatigue improves mammography performance metrics, then this may encourage practices to support such interventions.”

However, “more research that includes a larger number of radiologists, wider range of imaging interpretation experience, perhaps even experimental studies comparing metrics for radiologists reading with scheduled breaks versus without such breaks would be of interest,” Dr. Lourenco said.
 

Fatigue in health care goes beyond radiology

“Due primarily to staffing shortages and increased volume and complexity of patients, burnout and fatigue of all medical personnel, not just physicians, have become hallmarks of modern health care delivery in the United States, and this has been exacerbated by COVID-19 and other societal factors,” said Jeffrey C. Weinreb, MD, professor of radiology and biomedical imaging at Yale University, New Haven, Conn., in an interview.

Previous studies have documented the fact that radiologists are among the specialists most affected by burnout and fatigue, and it has an impact on their performance, Dr. Weinreb said. The current study is important because it tries to pinpoint the key variables that are responsible for fatigue, so resources can be directed to effect change, he said.

Dr. Weinreb said he was not particularly surprised by the study findings. “Diagnostic mammography is a high-volume repetitive enterprise, so it would have been surprising if radiologist experience and time of day had no effect on performance and recall rate,” he said. “As most radiologists will attest based on personal experience, human beings get tired and lose some level of cognition over the course of a long, intense workday,” he added.

“I am a bit surprised that less experienced radiologists were more likely to recommend additional imaging at a higher rate when interpreting DBT but not for DM and only later in the day,” Dr. Weinreb noted. “The authors suggest that this could be due to the increased number of images that are viewed with DBT and the different ways experienced and less experienced radiologists process the information. However, there could be other explanations, such as differences in volumes or differences in ages.”

“Reducing the study volumes per radiologist is one obvious solution to reducing fatigue, but it will not be practical in many practices,” said Dr. Weinreb. “The important work of interpreting diagnostic mammograms needs to continue and grow. Without an increase in radiologist mammographers in the labor pool, this is not going to happen any time soon.”

Instead, “more immediate obvious solutions to radiologist fatigue in clinical practice include more frequent breaks during the workday, which would include walking around and not looking at a computer or cell phone screen, fewer images per study, report templates, streamlined workflow, more variety in daily work, and AI assistance for interpretation and reporting,” said Dr. Weinreb. Using nonradiologists when possible to relieve some of the burden could be considered, “but this is a complex and politically charged issue,” he noted.

Radiology is a well-compensated specialty, but further increasing compensation would help to mitigate burnout, said Dr. Weinreb. However, “perhaps even more important is making certain that the efforts of individual radiologists are appreciated and recognized,” he said.

As for additional research needs, “mammographers are not the only radiologists experiencing fatigue, but the most critical contributing factors for other types of imaging exams and subspecialities may not be identical,” Dr. Weinreb emphasized. “Data for other radiologists, similar to that provided by this study for diagnostic mammography, could be useful.

“An additional area of research could address the issue of individual radiologist circadian rhythms,” said Dr. Weinreb. “Perhaps we could rigorously determine whom amongst us is a ‘morning person’ versus one who performs equally well or better later in the day and use this information for radiologist scheduling,” he said. “Finally, once we know the key factors affecting performance for each type of exam and subspecialty, studies of possible incremental and combined benefits of various interventions would be needed.”

The study received no outside funding. The researchers and Dr. Weinreb have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recalls and false-positives for breast imaging patients were significantly more likely when the results were read by less-experienced radiologists who had worked more hours that day, based on data from more than 97,000 screening mammograms.

Psychology literature has shown the impact of fatigue on performance in a range of settings, and previous studies have shown that radiologists’ performances are more accurate earlier in their shifts compared to later-shift performance, write Michael H. Bernstein, PhD, and colleagues at Brown University, Providence, R.I., in a study published online Jan. 11 in Radiology.

The effect of time of day on performance may be greater for more detailed imaging modalities that are more “cognitively taxing,” and the effect may be greater in less-experienced radiologists, but the impact of time and experience on overall patient recall and false-positive rates has not been well-studied, the researchers said.

In the retrospective review, the researchers identified 97,671 screening mammograms read by 18 radiologists at one of 12 community sites between Jan. 2018 and Dec. 2019. The researchers analyzed the results by type of image, either standard digital mammography (DM) or the more complex digital breast tomosynthesis (DBT). The researchers separated radiologists into two groups: those with at least 5 post-training years of experience and those with less than 5 post-training years of experience. A total of nine radiologists fell into each category.

Overall, the recall rates were significantly different and higher for DM versus DBT (10.2% vs. 9.0%; P = .006). The false-positive (FP) rate also differed significantly and was higher for DM versus DBT (9.8% vs. 8.6%; P = .004).

The odds of recall increased by 11.5% with each hour of reading time for radiologists with less than 5 post-training years of experience for both DBT (odds ratio, 1.12) and DM (OR, 1.09). For the more experienced radiologists, the odds of recall increased by 1.6% for each hour of reading time for DBT but decreased by 0.1% for DM, with no significant difference.

Similarly, the odds of an FP result increased by 12.1% for DBT and 9% for DM per hour of reading time for radiologists with less experience. For more experienced radiologists, the odds of an FP increased by 1.6% for DBT but decreased by 1.1% for DM per hour of reading time.

Cancer detection (defined as true-positive, or TP) was not higher for DM across time, the researchers note. However, “DBT achieved a higher TP rate than DM regardless of the time of day; this shows that for DBT to maintain a constant and superior TP rate relative to DM, radiologists’ FP rates had to go up as the day went on,” they write. “That is, although DBT achieves a superior TP rate, more junior radiologists appeared to compensate for their fatigue later in the day when using DBT by recalling a broader range of mammograms, more of which were FP findings.”

The researchers caution that their findings were limited by several factors, including the study’s retrospective design and the lack of randomization of the imaging technology, patients, and time of day, which prohibit conclusions regarding causality. Other limitations included the consideration of time of day without the ability to use hours since the start of a clinical shift and the use of a 5-year mark to indicate experience without accounting for work volume.

However, the stronger impact of a time-of-day effect for more junior radiologists agrees with findings from other studies, the researchers add. More empirical research is needed, and the researchers propose a longitudinal study of how time of day affects radiologists as they gain experience, as well as experimental studies to test strategies for mitigating the time-of-day effect observed in the current study.
 

Scheduled breaks may reduce impact of fatigue

“Digital breast tomosynthesis is increasingly used in clinical practice and takes significantly longer to interpret compared with digital mammography,” said corresponding author Ana P. Lourenco, MD, in an interview. “Radiologists interpret hundreds of images for each screening digital breast tomosynthesis exam, compared with four images for each screening digital mammogram exam; this may certainly contribute to radiologist fatigue.”

“I found it interesting that there was a difference based on years of experience of the radiologist, but I was not surprised that recall rate increased later in the day, as some of us had anecdotally noted this in our clinical practice,” Dr. Lourenco said. In fact, the idea to conduct the study was prompted by a conversation with her statistician colleagues “about how I subjectively felt like my own recall rate increased at the end of the day.”

Ways to counteract the impact of fatigue could include intermittent breaks to refocus attention, said Dr. Lourenco. “Potential barriers would include imaging volumes and attending to patients in the breast imaging center,” she said. “If we can show that decreasing fatigue improves mammography performance metrics, then this may encourage practices to support such interventions.”

However, “more research that includes a larger number of radiologists, wider range of imaging interpretation experience, perhaps even experimental studies comparing metrics for radiologists reading with scheduled breaks versus without such breaks would be of interest,” Dr. Lourenco said.
 

Fatigue in health care goes beyond radiology

“Due primarily to staffing shortages and increased volume and complexity of patients, burnout and fatigue of all medical personnel, not just physicians, have become hallmarks of modern health care delivery in the United States, and this has been exacerbated by COVID-19 and other societal factors,” said Jeffrey C. Weinreb, MD, professor of radiology and biomedical imaging at Yale University, New Haven, Conn., in an interview.

Previous studies have documented the fact that radiologists are among the specialists most affected by burnout and fatigue, and it has an impact on their performance, Dr. Weinreb said. The current study is important because it tries to pinpoint the key variables that are responsible for fatigue, so resources can be directed to effect change, he said.

Dr. Weinreb said he was not particularly surprised by the study findings. “Diagnostic mammography is a high-volume repetitive enterprise, so it would have been surprising if radiologist experience and time of day had no effect on performance and recall rate,” he said. “As most radiologists will attest based on personal experience, human beings get tired and lose some level of cognition over the course of a long, intense workday,” he added.

“I am a bit surprised that less experienced radiologists were more likely to recommend additional imaging at a higher rate when interpreting DBT but not for DM and only later in the day,” Dr. Weinreb noted. “The authors suggest that this could be due to the increased number of images that are viewed with DBT and the different ways experienced and less experienced radiologists process the information. However, there could be other explanations, such as differences in volumes or differences in ages.”

“Reducing the study volumes per radiologist is one obvious solution to reducing fatigue, but it will not be practical in many practices,” said Dr. Weinreb. “The important work of interpreting diagnostic mammograms needs to continue and grow. Without an increase in radiologist mammographers in the labor pool, this is not going to happen any time soon.”

Instead, “more immediate obvious solutions to radiologist fatigue in clinical practice include more frequent breaks during the workday, which would include walking around and not looking at a computer or cell phone screen, fewer images per study, report templates, streamlined workflow, more variety in daily work, and AI assistance for interpretation and reporting,” said Dr. Weinreb. Using nonradiologists when possible to relieve some of the burden could be considered, “but this is a complex and politically charged issue,” he noted.

Radiology is a well-compensated specialty, but further increasing compensation would help to mitigate burnout, said Dr. Weinreb. However, “perhaps even more important is making certain that the efforts of individual radiologists are appreciated and recognized,” he said.

As for additional research needs, “mammographers are not the only radiologists experiencing fatigue, but the most critical contributing factors for other types of imaging exams and subspecialities may not be identical,” Dr. Weinreb emphasized. “Data for other radiologists, similar to that provided by this study for diagnostic mammography, could be useful.

“An additional area of research could address the issue of individual radiologist circadian rhythms,” said Dr. Weinreb. “Perhaps we could rigorously determine whom amongst us is a ‘morning person’ versus one who performs equally well or better later in the day and use this information for radiologist scheduling,” he said. “Finally, once we know the key factors affecting performance for each type of exam and subspecialty, studies of possible incremental and combined benefits of various interventions would be needed.”

The study received no outside funding. The researchers and Dr. Weinreb have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recalls and false-positives for breast imaging patients were significantly more likely when the results were read by less-experienced radiologists who had worked more hours that day, based on data from more than 97,000 screening mammograms.

Psychology literature has shown the impact of fatigue on performance in a range of settings, and previous studies have shown that radiologists’ performances are more accurate earlier in their shifts compared to later-shift performance, write Michael H. Bernstein, PhD, and colleagues at Brown University, Providence, R.I., in a study published online Jan. 11 in Radiology.

The effect of time of day on performance may be greater for more detailed imaging modalities that are more “cognitively taxing,” and the effect may be greater in less-experienced radiologists, but the impact of time and experience on overall patient recall and false-positive rates has not been well-studied, the researchers said.

In the retrospective review, the researchers identified 97,671 screening mammograms read by 18 radiologists at one of 12 community sites between Jan. 2018 and Dec. 2019. The researchers analyzed the results by type of image, either standard digital mammography (DM) or the more complex digital breast tomosynthesis (DBT). The researchers separated radiologists into two groups: those with at least 5 post-training years of experience and those with less than 5 post-training years of experience. A total of nine radiologists fell into each category.

Overall, the recall rates were significantly different and higher for DM versus DBT (10.2% vs. 9.0%; P = .006). The false-positive (FP) rate also differed significantly and was higher for DM versus DBT (9.8% vs. 8.6%; P = .004).

The odds of recall increased by 11.5% with each hour of reading time for radiologists with less than 5 post-training years of experience for both DBT (odds ratio, 1.12) and DM (OR, 1.09). For the more experienced radiologists, the odds of recall increased by 1.6% for each hour of reading time for DBT but decreased by 0.1% for DM, with no significant difference.

Similarly, the odds of an FP result increased by 12.1% for DBT and 9% for DM per hour of reading time for radiologists with less experience. For more experienced radiologists, the odds of an FP increased by 1.6% for DBT but decreased by 1.1% for DM per hour of reading time.

Cancer detection (defined as true-positive, or TP) was not higher for DM across time, the researchers note. However, “DBT achieved a higher TP rate than DM regardless of the time of day; this shows that for DBT to maintain a constant and superior TP rate relative to DM, radiologists’ FP rates had to go up as the day went on,” they write. “That is, although DBT achieves a superior TP rate, more junior radiologists appeared to compensate for their fatigue later in the day when using DBT by recalling a broader range of mammograms, more of which were FP findings.”

The researchers caution that their findings were limited by several factors, including the study’s retrospective design and the lack of randomization of the imaging technology, patients, and time of day, which prohibit conclusions regarding causality. Other limitations included the consideration of time of day without the ability to use hours since the start of a clinical shift and the use of a 5-year mark to indicate experience without accounting for work volume.

However, the stronger impact of a time-of-day effect for more junior radiologists agrees with findings from other studies, the researchers add. More empirical research is needed, and the researchers propose a longitudinal study of how time of day affects radiologists as they gain experience, as well as experimental studies to test strategies for mitigating the time-of-day effect observed in the current study.
 

Scheduled breaks may reduce impact of fatigue

“Digital breast tomosynthesis is increasingly used in clinical practice and takes significantly longer to interpret compared with digital mammography,” said corresponding author Ana P. Lourenco, MD, in an interview. “Radiologists interpret hundreds of images for each screening digital breast tomosynthesis exam, compared with four images for each screening digital mammogram exam; this may certainly contribute to radiologist fatigue.”

“I found it interesting that there was a difference based on years of experience of the radiologist, but I was not surprised that recall rate increased later in the day, as some of us had anecdotally noted this in our clinical practice,” Dr. Lourenco said. In fact, the idea to conduct the study was prompted by a conversation with her statistician colleagues “about how I subjectively felt like my own recall rate increased at the end of the day.”

Ways to counteract the impact of fatigue could include intermittent breaks to refocus attention, said Dr. Lourenco. “Potential barriers would include imaging volumes and attending to patients in the breast imaging center,” she said. “If we can show that decreasing fatigue improves mammography performance metrics, then this may encourage practices to support such interventions.”

However, “more research that includes a larger number of radiologists, wider range of imaging interpretation experience, perhaps even experimental studies comparing metrics for radiologists reading with scheduled breaks versus without such breaks would be of interest,” Dr. Lourenco said.
 

Fatigue in health care goes beyond radiology

“Due primarily to staffing shortages and increased volume and complexity of patients, burnout and fatigue of all medical personnel, not just physicians, have become hallmarks of modern health care delivery in the United States, and this has been exacerbated by COVID-19 and other societal factors,” said Jeffrey C. Weinreb, MD, professor of radiology and biomedical imaging at Yale University, New Haven, Conn., in an interview.

Previous studies have documented the fact that radiologists are among the specialists most affected by burnout and fatigue, and it has an impact on their performance, Dr. Weinreb said. The current study is important because it tries to pinpoint the key variables that are responsible for fatigue, so resources can be directed to effect change, he said.

Dr. Weinreb said he was not particularly surprised by the study findings. “Diagnostic mammography is a high-volume repetitive enterprise, so it would have been surprising if radiologist experience and time of day had no effect on performance and recall rate,” he said. “As most radiologists will attest based on personal experience, human beings get tired and lose some level of cognition over the course of a long, intense workday,” he added.

“I am a bit surprised that less experienced radiologists were more likely to recommend additional imaging at a higher rate when interpreting DBT but not for DM and only later in the day,” Dr. Weinreb noted. “The authors suggest that this could be due to the increased number of images that are viewed with DBT and the different ways experienced and less experienced radiologists process the information. However, there could be other explanations, such as differences in volumes or differences in ages.”

“Reducing the study volumes per radiologist is one obvious solution to reducing fatigue, but it will not be practical in many practices,” said Dr. Weinreb. “The important work of interpreting diagnostic mammograms needs to continue and grow. Without an increase in radiologist mammographers in the labor pool, this is not going to happen any time soon.”

Instead, “more immediate obvious solutions to radiologist fatigue in clinical practice include more frequent breaks during the workday, which would include walking around and not looking at a computer or cell phone screen, fewer images per study, report templates, streamlined workflow, more variety in daily work, and AI assistance for interpretation and reporting,” said Dr. Weinreb. Using nonradiologists when possible to relieve some of the burden could be considered, “but this is a complex and politically charged issue,” he noted.

Radiology is a well-compensated specialty, but further increasing compensation would help to mitigate burnout, said Dr. Weinreb. However, “perhaps even more important is making certain that the efforts of individual radiologists are appreciated and recognized,” he said.

As for additional research needs, “mammographers are not the only radiologists experiencing fatigue, but the most critical contributing factors for other types of imaging exams and subspecialities may not be identical,” Dr. Weinreb emphasized. “Data for other radiologists, similar to that provided by this study for diagnostic mammography, could be useful.

“An additional area of research could address the issue of individual radiologist circadian rhythms,” said Dr. Weinreb. “Perhaps we could rigorously determine whom amongst us is a ‘morning person’ versus one who performs equally well or better later in the day and use this information for radiologist scheduling,” he said. “Finally, once we know the key factors affecting performance for each type of exam and subspecialty, studies of possible incremental and combined benefits of various interventions would be needed.”

The study received no outside funding. The researchers and Dr. Weinreb have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

Approximately 3% of youth who tested positive for COVID-19 in an emergency department setting had severe outcomes after 2 weeks, but this risk was 0.5% among those not admitted to the hospital, based on data from more than 3,000 individuals aged 18 and younger.

In the early stages of the COVID-19 pandemic, youth younger than 18 years accounted for fewer than 5% of reported cases, but now account for approximately 25% of positive cases, wrote Anna L. Funk, PhD, of the University of Calgary, Alberta, Canada, and colleagues.

However, the risk of severe outcomes of youth with COVID-19 remains poorly understood and data from large studies are lacking, they noted.

In a prospective cohort study published in JAMA Network Open, the researchers reviewed data from 3,221 children and adolescents who were tested for COVID-19 at one of 41 emergency departments in 10 countries including Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States between March 2020 and June 2021. Positive infections were confirmed by polymerase chain reaction (PCR) testing. At 14 days’ follow-up after a positive test, 735 patients (22.8%), were hospitalized, 107 (3.3%) had severe outcomes, and 4 (0.12%) had died. Severe outcomes were significantly more likely in children aged 5-10 years and 10-18 years vs. less than 1 year (odds ratios, 1.60 and 2.39, respectively), and in children with a self-reported chronic illness (OR, 2.34) or a prior episode of pneumonia (OR, 3.15).

Severe outcomes were more likely in patients who presented with symptoms that started 4-7 days before seeking care, compared with those whose symptoms started 0-3 days before seeking care (OR, 2.22).

The researchers also reviewed data from a subgroup of 2,510 individuals who were discharged home from the ED after initial testing. At 14 days’ follow-up, 50 of these patients (2.0%) were hospitalized and 12 (0.5%) had severe outcomes. In addition, the researchers found that the risk of severe outcomes among hospitalized COVID-19–positive youth was nearly four times higher, compared with hospitalized youth who tested negative for COVID-19 (risk difference, 3.9%).

Previous retrospective studies of severe outcomes in children and adolescents with COVID-19 have yielded varying results, in part because of the variation in study populations, the researchers noted in their discussion of the findings. “Our study population provides a risk estimate for youths brought for ED care.” Therefore, “Our lower estimate of severe disease likely reflects our stringent definition, which required the occurrence of complications or specific invasive interventions,” they said.

The study limitations included the potential overestimation of the risk of severe outcomes because patients were recruited in the ED, the researchers noted. Other limitations included variation in regional case definitions, screening criteria, and testing capacity among different sites and time periods. “Thus, 5% of our SARS-CoV-2–positive participants were asymptomatic – most of whom were tested as they were positive contacts of known cases or as part of routine screening procedures,” they said. The findings also are not generalizable to all community EDs and did not account for variants, they added.

However, the results were strengthened by the ability to compare outcomes for children with positive tests to similar children with negative tests, and add to the literature showing an increased risk of severe outcomes for those hospitalized with positive tests, the researchers concluded.
 

Data may inform clinical decisions

“The data [in the current study] are concerning for severe outcomes for children even prior to the Omicron strain,” said Margaret Thew, DNP, FP-BC, of Children’s Wisconsin-Milwaukee Hospital, in an interview. “Presently, the number of children infected with the Omicron strain is much higher and hospitalizations among children are at their highest since COVID-19 began,” she said. “For medical providers caring for this population, the study sheds light on pediatric patients who may be at higher risk of severe illness when they become infected with COVID-19,” she added.

“I was surprised by how high the number of pediatric patients hospitalized (22%) and the percentage (3%) with severe disease were during this time,” given that the timeline for these data preceded the spread of the Omicron strain, said Ms. Thew. “The risk of prior pneumonia was quite surprising. I do not recall seeing prior pneumonia as a risk factor for more severe COVID-19 with children or adults,” she added.

The take-home messaging for clinicians caring for children and adolescents is the added knowledge of the risk factors for severe outcomes from COVID-19, including the 10-18 age range, chronic illness, prior pneumonia, and longer symptom duration before seeking care in the ED, Ms. Thew emphasized.

However, additional research is needed on the impact of the new strains of COVID-19 on pediatric and adolescent hospitalizations, Ms. Thew said. Research also is needed on the other illnesses that have resulted from COVID-19, including illness requiring antibiotic use or medical interventions or treatments, and on the risk of combined COVID-19 and influenza viruses, she noted.

The study was supported by the Canadian Institutes of Health Research, Alberta Innovates, the Alberta Health Services University of Calgary Clinical Research Fund, the Alberta Children’s Hospital Research Institute, the COVID-19 Research Accelerator Funding Track (CRAFT) Program at the University of California, Davis, and the Cincinnati Children’s Hospital Medical Center Division of Emergency Medicine Small Grants Program. Lead author Dr. Funk was supported by the University of Calgary Eyes-High Post-Doctoral Research Fund, but had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Approximately 3% of youth who tested positive for COVID-19 in an emergency department setting had severe outcomes after 2 weeks, but this risk was 0.5% among those not admitted to the hospital, based on data from more than 3,000 individuals aged 18 and younger.

In the early stages of the COVID-19 pandemic, youth younger than 18 years accounted for fewer than 5% of reported cases, but now account for approximately 25% of positive cases, wrote Anna L. Funk, PhD, of the University of Calgary, Alberta, Canada, and colleagues.

However, the risk of severe outcomes of youth with COVID-19 remains poorly understood and data from large studies are lacking, they noted.

In a prospective cohort study published in JAMA Network Open, the researchers reviewed data from 3,221 children and adolescents who were tested for COVID-19 at one of 41 emergency departments in 10 countries including Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States between March 2020 and June 2021. Positive infections were confirmed by polymerase chain reaction (PCR) testing. At 14 days’ follow-up after a positive test, 735 patients (22.8%), were hospitalized, 107 (3.3%) had severe outcomes, and 4 (0.12%) had died. Severe outcomes were significantly more likely in children aged 5-10 years and 10-18 years vs. less than 1 year (odds ratios, 1.60 and 2.39, respectively), and in children with a self-reported chronic illness (OR, 2.34) or a prior episode of pneumonia (OR, 3.15).

Severe outcomes were more likely in patients who presented with symptoms that started 4-7 days before seeking care, compared with those whose symptoms started 0-3 days before seeking care (OR, 2.22).

The researchers also reviewed data from a subgroup of 2,510 individuals who were discharged home from the ED after initial testing. At 14 days’ follow-up, 50 of these patients (2.0%) were hospitalized and 12 (0.5%) had severe outcomes. In addition, the researchers found that the risk of severe outcomes among hospitalized COVID-19–positive youth was nearly four times higher, compared with hospitalized youth who tested negative for COVID-19 (risk difference, 3.9%).

Previous retrospective studies of severe outcomes in children and adolescents with COVID-19 have yielded varying results, in part because of the variation in study populations, the researchers noted in their discussion of the findings. “Our study population provides a risk estimate for youths brought for ED care.” Therefore, “Our lower estimate of severe disease likely reflects our stringent definition, which required the occurrence of complications or specific invasive interventions,” they said.

The study limitations included the potential overestimation of the risk of severe outcomes because patients were recruited in the ED, the researchers noted. Other limitations included variation in regional case definitions, screening criteria, and testing capacity among different sites and time periods. “Thus, 5% of our SARS-CoV-2–positive participants were asymptomatic – most of whom were tested as they were positive contacts of known cases or as part of routine screening procedures,” they said. The findings also are not generalizable to all community EDs and did not account for variants, they added.

However, the results were strengthened by the ability to compare outcomes for children with positive tests to similar children with negative tests, and add to the literature showing an increased risk of severe outcomes for those hospitalized with positive tests, the researchers concluded.
 

Data may inform clinical decisions

“The data [in the current study] are concerning for severe outcomes for children even prior to the Omicron strain,” said Margaret Thew, DNP, FP-BC, of Children’s Wisconsin-Milwaukee Hospital, in an interview. “Presently, the number of children infected with the Omicron strain is much higher and hospitalizations among children are at their highest since COVID-19 began,” she said. “For medical providers caring for this population, the study sheds light on pediatric patients who may be at higher risk of severe illness when they become infected with COVID-19,” she added.

“I was surprised by how high the number of pediatric patients hospitalized (22%) and the percentage (3%) with severe disease were during this time,” given that the timeline for these data preceded the spread of the Omicron strain, said Ms. Thew. “The risk of prior pneumonia was quite surprising. I do not recall seeing prior pneumonia as a risk factor for more severe COVID-19 with children or adults,” she added.

The take-home messaging for clinicians caring for children and adolescents is the added knowledge of the risk factors for severe outcomes from COVID-19, including the 10-18 age range, chronic illness, prior pneumonia, and longer symptom duration before seeking care in the ED, Ms. Thew emphasized.

However, additional research is needed on the impact of the new strains of COVID-19 on pediatric and adolescent hospitalizations, Ms. Thew said. Research also is needed on the other illnesses that have resulted from COVID-19, including illness requiring antibiotic use or medical interventions or treatments, and on the risk of combined COVID-19 and influenza viruses, she noted.

The study was supported by the Canadian Institutes of Health Research, Alberta Innovates, the Alberta Health Services University of Calgary Clinical Research Fund, the Alberta Children’s Hospital Research Institute, the COVID-19 Research Accelerator Funding Track (CRAFT) Program at the University of California, Davis, and the Cincinnati Children’s Hospital Medical Center Division of Emergency Medicine Small Grants Program. Lead author Dr. Funk was supported by the University of Calgary Eyes-High Post-Doctoral Research Fund, but had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Approximately 3% of youth who tested positive for COVID-19 in an emergency department setting had severe outcomes after 2 weeks, but this risk was 0.5% among those not admitted to the hospital, based on data from more than 3,000 individuals aged 18 and younger.

In the early stages of the COVID-19 pandemic, youth younger than 18 years accounted for fewer than 5% of reported cases, but now account for approximately 25% of positive cases, wrote Anna L. Funk, PhD, of the University of Calgary, Alberta, Canada, and colleagues.

However, the risk of severe outcomes of youth with COVID-19 remains poorly understood and data from large studies are lacking, they noted.

In a prospective cohort study published in JAMA Network Open, the researchers reviewed data from 3,221 children and adolescents who were tested for COVID-19 at one of 41 emergency departments in 10 countries including Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States between March 2020 and June 2021. Positive infections were confirmed by polymerase chain reaction (PCR) testing. At 14 days’ follow-up after a positive test, 735 patients (22.8%), were hospitalized, 107 (3.3%) had severe outcomes, and 4 (0.12%) had died. Severe outcomes were significantly more likely in children aged 5-10 years and 10-18 years vs. less than 1 year (odds ratios, 1.60 and 2.39, respectively), and in children with a self-reported chronic illness (OR, 2.34) or a prior episode of pneumonia (OR, 3.15).

Severe outcomes were more likely in patients who presented with symptoms that started 4-7 days before seeking care, compared with those whose symptoms started 0-3 days before seeking care (OR, 2.22).

The researchers also reviewed data from a subgroup of 2,510 individuals who were discharged home from the ED after initial testing. At 14 days’ follow-up, 50 of these patients (2.0%) were hospitalized and 12 (0.5%) had severe outcomes. In addition, the researchers found that the risk of severe outcomes among hospitalized COVID-19–positive youth was nearly four times higher, compared with hospitalized youth who tested negative for COVID-19 (risk difference, 3.9%).

Previous retrospective studies of severe outcomes in children and adolescents with COVID-19 have yielded varying results, in part because of the variation in study populations, the researchers noted in their discussion of the findings. “Our study population provides a risk estimate for youths brought for ED care.” Therefore, “Our lower estimate of severe disease likely reflects our stringent definition, which required the occurrence of complications or specific invasive interventions,” they said.

The study limitations included the potential overestimation of the risk of severe outcomes because patients were recruited in the ED, the researchers noted. Other limitations included variation in regional case definitions, screening criteria, and testing capacity among different sites and time periods. “Thus, 5% of our SARS-CoV-2–positive participants were asymptomatic – most of whom were tested as they were positive contacts of known cases or as part of routine screening procedures,” they said. The findings also are not generalizable to all community EDs and did not account for variants, they added.

However, the results were strengthened by the ability to compare outcomes for children with positive tests to similar children with negative tests, and add to the literature showing an increased risk of severe outcomes for those hospitalized with positive tests, the researchers concluded.
 

Data may inform clinical decisions

“The data [in the current study] are concerning for severe outcomes for children even prior to the Omicron strain,” said Margaret Thew, DNP, FP-BC, of Children’s Wisconsin-Milwaukee Hospital, in an interview. “Presently, the number of children infected with the Omicron strain is much higher and hospitalizations among children are at their highest since COVID-19 began,” she said. “For medical providers caring for this population, the study sheds light on pediatric patients who may be at higher risk of severe illness when they become infected with COVID-19,” she added.

“I was surprised by how high the number of pediatric patients hospitalized (22%) and the percentage (3%) with severe disease were during this time,” given that the timeline for these data preceded the spread of the Omicron strain, said Ms. Thew. “The risk of prior pneumonia was quite surprising. I do not recall seeing prior pneumonia as a risk factor for more severe COVID-19 with children or adults,” she added.

The take-home messaging for clinicians caring for children and adolescents is the added knowledge of the risk factors for severe outcomes from COVID-19, including the 10-18 age range, chronic illness, prior pneumonia, and longer symptom duration before seeking care in the ED, Ms. Thew emphasized.

However, additional research is needed on the impact of the new strains of COVID-19 on pediatric and adolescent hospitalizations, Ms. Thew said. Research also is needed on the other illnesses that have resulted from COVID-19, including illness requiring antibiotic use or medical interventions or treatments, and on the risk of combined COVID-19 and influenza viruses, she noted.

The study was supported by the Canadian Institutes of Health Research, Alberta Innovates, the Alberta Health Services University of Calgary Clinical Research Fund, the Alberta Children’s Hospital Research Institute, the COVID-19 Research Accelerator Funding Track (CRAFT) Program at the University of California, Davis, and the Cincinnati Children’s Hospital Medical Center Division of Emergency Medicine Small Grants Program. Lead author Dr. Funk was supported by the University of Calgary Eyes-High Post-Doctoral Research Fund, but had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Behavior problems, anxiety, and depression in youths were associated with these individuals participating in remote schooling during broader social lockdowns in a new study.

The systematic review, which was published in JAMA Pediatrics on Jan. 18, 2022, was based on data from 36 studies from 11 countries on mental health, physical health, and well-being in children and adolescents aged 0-18 years. The total population included 79,781 children and 18,028 parents or caregivers. The studies reflected the first wave of pandemic school closures and lockdowns from February to July 2020, with the duration of school closure ranging from 1 week to 3 months.

“There are strong theoretical reasons to suggest that school closures may have contributed to a considerable proportion of the harms identified here, particularly mental health harms, through reduction in social contacts with peers and teachers,” Russell Viner, PhD, of UCL Great Ormond St Institute of Child Health, London, and colleagues wrote in their paper.

The researchers included 9 longitudinal pre-post studies, 5 cohort studies, 21 cross-sectional studies, and 1 modeling study in their analysis. Overall, approximately one-third of the studies (36%) were considered high quality, and approximately two-thirds (64%) of the studies were published in journals. Twenty-five of the reports analyzed focused on mental health and well-being.

Schools provide not only education, but also services including meals, health care, and health supplies. Schools also serve as a safety net and source of social support for children, the researchers noted.

The losses children may have experienced during school closures occurred during a time when more than 167,000 children younger than 18 years lost a parent or caregiver to COVID-19, according to a recent report titled “Hidden Pain” by researchers at the University of Pennsylvania, Nemours Children’s Health, and the COVID Collaborative. Although not addressed in the current study, school closures would prevent bereaved children from receiving social-emotional support from friends and teachers. This crisis of loss also prompted the American Academy of Pediatrics to issue a National State of Emergency in Children’s Mental Health in October 2021.
 

New study results

These studies identified associations between school closures during broader lockdowns and increased emotional and behavioral problems, as well as increased restlessness and inattention. Across these studies, 18%-60% of children and adolescents scored higher than the risk thresholds for diagnoses of distress, especially depressive symptoms and anxiety.

Although two studies showed no significant association with suicide in response to school closures during lockdowns, three studies suggested increased use of screen time, two studies reported increased social media use, and six studies reported lower levels of physical activity.

Three studies of child abuse showed decreases in notifications during lockdowns, likely driven by lack of referrals from schools, the authors noted. A total of 10 studies on sleep and 5 studies on diet showed inconsistent evidence of harm during the specific period of school closures and social lockdowns.

“The contrast of rises in distress with decreases in presentations suggests that there was an escalation of unmet mental health need during lockdowns in already vulnerable children and adolescents,” the researchers wrote. “More troubling still is evidence of a reduction in the ability of the health and social care systems to protect children in many countries, as shown by the large falls in child protection referrals seen in high-quality cohort studies.”
 

‘Study presents concrete assessments rather than speculation’

“Concerns have been widely expressed in the lay media and beyond that school closures could negatively impact the mental and physical health of children and adolescents,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “The authors presented a narrative synthesis summarizing available evidence for the first wave of COVID-19 on school closures during the broader social lockdown occurring during this period.”

The “importance” of this research is that “it is not a single convenience sample study, but a systematic review from 11 countries including the United States, United Kingdom, China, and Turkey, among others, and that the quality of the information was graded,” Dr. Jay said. “Although not a meta-analysis, the study presents concrete assessments rather than speculation and overviews its limitations so that the clinician can weigh this information. Importantly, the authors excluded closure of schools with transmission of infection.

“Clearly, school lockdowns as a measure of controlling infectious disease needs balance with potential of negative health behaviors in children and adolescents. Ongoing prospective longitudinal studies are needed as sequential waves of the pandemic continue,” she emphasized.

“Clinically, this study highlights the need for clinicians to consider [asking] about the impact of school closures and remote versus hybrid versus in-person education [as part of their] patients and families question inventory,” Dr. Jay said. “Also, the use of depression inventories can be offered to youth to assess their mental health state at a visit, either via telemedicine or in person, and ideally at sequential visits for a more in-depth assessment.”
 

Schools play key role in social and emotional development

“It was important to conduct this study now, because this current time is unprecedented,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “We know based on evolutionary biology, anthropology, and developmental psychology, among other disciplines, that meaningful interpersonal interactions embedded in the context of community are vital to supporting human well-being.

“In our current time, the primary framework of community for our children is the school setting; it is the predominant space where they engage in the interpersonal interactions necessary for developing resilience, their sense of purpose, belonging, and fidelity,” he emphasized.

“Rarely in the course of human existence have kids been removed from the broader context of community to this extent and for this duration,” Dr. Loper said. “This study capitalizes on this unprecedented moment to begin to further understand how compromises in our sociocultural infrastructure of community, like school closures and lockdowns, may manifest as mental health problems in children and adolescents. More importantly, it contributes to the exploration of potential unintended consequences of our current infection control measures so we can adapt to support the overall well-being of our children in this ‘new normal.’ ”

Dr. Loper added that he was not surprised by the new study’s findings.

“We were already seeing a decline in pediatric mental health and overall well-being in the years preceding COVID-19 because of the ‘isolation epidemic’ involving many of the factors that this study explored,” he said. “I think this review further illustrates the vital necessity of community to support the health and well-being of humans, and specifically children and adolescents.”

From a clinical standpoint, “we need to be intentional and consistent in balancing infection control measures with our kids’ fundamental psychosocial needs,” Dr. Loper said.

“We need to recognize that, when children and adolescents are isolated from community, their fundamental psychosocial needs go unmet,” he emphasized. “If children and adolescents cannot access the meaningful interpersonal interactions necessary for resilience, then they cannot overcome or navigate distress. They will exhibit the avoidance and withdrawal behaviors that accumulate to manifest as adverse mental health symptoms like anxiety and depression.

“Additional research is needed to further explore how compromises in the psychosocial infrastructure of community manifest as downstream symptom indicators such as anxiety and depression,” which are often manifestations of unmet needs, Dr. Loper said.
 

Limitations and strengths, according to authors

The findings were limited by several factors, including a lack of examination of school closures’ effects on mental health independent of broader social lockdowns, according to the researchers. Other limitations included the authors potentially having missed studies, inclusion of cross-sectional studies with relatively weak evidence, potential bias from studies using parent reports, and a focus on the first COVID-19 wave, during which many school closures were of limited duration. Also, the researchers said they did not include studies focused on particular groups, such as children with learning difficulties or autism.

The use of large databases from education as well as health care in studies analyzed were strengths of the new research, they said. The investigators received no outside funding for their study. The researchers, Dr. Jay, and Dr. Loper had no financial conflicts to disclose. Dr. Jay serves on the editorial advisory board of Pediatric News.

Behavior problems, anxiety, and depression in youths were associated with these individuals participating in remote schooling during broader social lockdowns in a new study.

The systematic review, which was published in JAMA Pediatrics on Jan. 18, 2022, was based on data from 36 studies from 11 countries on mental health, physical health, and well-being in children and adolescents aged 0-18 years. The total population included 79,781 children and 18,028 parents or caregivers. The studies reflected the first wave of pandemic school closures and lockdowns from February to July 2020, with the duration of school closure ranging from 1 week to 3 months.

“There are strong theoretical reasons to suggest that school closures may have contributed to a considerable proportion of the harms identified here, particularly mental health harms, through reduction in social contacts with peers and teachers,” Russell Viner, PhD, of UCL Great Ormond St Institute of Child Health, London, and colleagues wrote in their paper.

The researchers included 9 longitudinal pre-post studies, 5 cohort studies, 21 cross-sectional studies, and 1 modeling study in their analysis. Overall, approximately one-third of the studies (36%) were considered high quality, and approximately two-thirds (64%) of the studies were published in journals. Twenty-five of the reports analyzed focused on mental health and well-being.

Schools provide not only education, but also services including meals, health care, and health supplies. Schools also serve as a safety net and source of social support for children, the researchers noted.

The losses children may have experienced during school closures occurred during a time when more than 167,000 children younger than 18 years lost a parent or caregiver to COVID-19, according to a recent report titled “Hidden Pain” by researchers at the University of Pennsylvania, Nemours Children’s Health, and the COVID Collaborative. Although not addressed in the current study, school closures would prevent bereaved children from receiving social-emotional support from friends and teachers. This crisis of loss also prompted the American Academy of Pediatrics to issue a National State of Emergency in Children’s Mental Health in October 2021.
 

New study results

These studies identified associations between school closures during broader lockdowns and increased emotional and behavioral problems, as well as increased restlessness and inattention. Across these studies, 18%-60% of children and adolescents scored higher than the risk thresholds for diagnoses of distress, especially depressive symptoms and anxiety.

Although two studies showed no significant association with suicide in response to school closures during lockdowns, three studies suggested increased use of screen time, two studies reported increased social media use, and six studies reported lower levels of physical activity.

Three studies of child abuse showed decreases in notifications during lockdowns, likely driven by lack of referrals from schools, the authors noted. A total of 10 studies on sleep and 5 studies on diet showed inconsistent evidence of harm during the specific period of school closures and social lockdowns.

“The contrast of rises in distress with decreases in presentations suggests that there was an escalation of unmet mental health need during lockdowns in already vulnerable children and adolescents,” the researchers wrote. “More troubling still is evidence of a reduction in the ability of the health and social care systems to protect children in many countries, as shown by the large falls in child protection referrals seen in high-quality cohort studies.”
 

‘Study presents concrete assessments rather than speculation’

“Concerns have been widely expressed in the lay media and beyond that school closures could negatively impact the mental and physical health of children and adolescents,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “The authors presented a narrative synthesis summarizing available evidence for the first wave of COVID-19 on school closures during the broader social lockdown occurring during this period.”

The “importance” of this research is that “it is not a single convenience sample study, but a systematic review from 11 countries including the United States, United Kingdom, China, and Turkey, among others, and that the quality of the information was graded,” Dr. Jay said. “Although not a meta-analysis, the study presents concrete assessments rather than speculation and overviews its limitations so that the clinician can weigh this information. Importantly, the authors excluded closure of schools with transmission of infection.

“Clearly, school lockdowns as a measure of controlling infectious disease needs balance with potential of negative health behaviors in children and adolescents. Ongoing prospective longitudinal studies are needed as sequential waves of the pandemic continue,” she emphasized.

“Clinically, this study highlights the need for clinicians to consider [asking] about the impact of school closures and remote versus hybrid versus in-person education [as part of their] patients and families question inventory,” Dr. Jay said. “Also, the use of depression inventories can be offered to youth to assess their mental health state at a visit, either via telemedicine or in person, and ideally at sequential visits for a more in-depth assessment.”
 

Schools play key role in social and emotional development

“It was important to conduct this study now, because this current time is unprecedented,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “We know based on evolutionary biology, anthropology, and developmental psychology, among other disciplines, that meaningful interpersonal interactions embedded in the context of community are vital to supporting human well-being.

“In our current time, the primary framework of community for our children is the school setting; it is the predominant space where they engage in the interpersonal interactions necessary for developing resilience, their sense of purpose, belonging, and fidelity,” he emphasized.

“Rarely in the course of human existence have kids been removed from the broader context of community to this extent and for this duration,” Dr. Loper said. “This study capitalizes on this unprecedented moment to begin to further understand how compromises in our sociocultural infrastructure of community, like school closures and lockdowns, may manifest as mental health problems in children and adolescents. More importantly, it contributes to the exploration of potential unintended consequences of our current infection control measures so we can adapt to support the overall well-being of our children in this ‘new normal.’ ”

Dr. Loper added that he was not surprised by the new study’s findings.

“We were already seeing a decline in pediatric mental health and overall well-being in the years preceding COVID-19 because of the ‘isolation epidemic’ involving many of the factors that this study explored,” he said. “I think this review further illustrates the vital necessity of community to support the health and well-being of humans, and specifically children and adolescents.”

From a clinical standpoint, “we need to be intentional and consistent in balancing infection control measures with our kids’ fundamental psychosocial needs,” Dr. Loper said.

“We need to recognize that, when children and adolescents are isolated from community, their fundamental psychosocial needs go unmet,” he emphasized. “If children and adolescents cannot access the meaningful interpersonal interactions necessary for resilience, then they cannot overcome or navigate distress. They will exhibit the avoidance and withdrawal behaviors that accumulate to manifest as adverse mental health symptoms like anxiety and depression.

“Additional research is needed to further explore how compromises in the psychosocial infrastructure of community manifest as downstream symptom indicators such as anxiety and depression,” which are often manifestations of unmet needs, Dr. Loper said.
 

Limitations and strengths, according to authors

The findings were limited by several factors, including a lack of examination of school closures’ effects on mental health independent of broader social lockdowns, according to the researchers. Other limitations included the authors potentially having missed studies, inclusion of cross-sectional studies with relatively weak evidence, potential bias from studies using parent reports, and a focus on the first COVID-19 wave, during which many school closures were of limited duration. Also, the researchers said they did not include studies focused on particular groups, such as children with learning difficulties or autism.

The use of large databases from education as well as health care in studies analyzed were strengths of the new research, they said. The investigators received no outside funding for their study. The researchers, Dr. Jay, and Dr. Loper had no financial conflicts to disclose. Dr. Jay serves on the editorial advisory board of Pediatric News.

Behavior problems, anxiety, and depression in youths were associated with these individuals participating in remote schooling during broader social lockdowns in a new study.

The systematic review, which was published in JAMA Pediatrics on Jan. 18, 2022, was based on data from 36 studies from 11 countries on mental health, physical health, and well-being in children and adolescents aged 0-18 years. The total population included 79,781 children and 18,028 parents or caregivers. The studies reflected the first wave of pandemic school closures and lockdowns from February to July 2020, with the duration of school closure ranging from 1 week to 3 months.

“There are strong theoretical reasons to suggest that school closures may have contributed to a considerable proportion of the harms identified here, particularly mental health harms, through reduction in social contacts with peers and teachers,” Russell Viner, PhD, of UCL Great Ormond St Institute of Child Health, London, and colleagues wrote in their paper.

The researchers included 9 longitudinal pre-post studies, 5 cohort studies, 21 cross-sectional studies, and 1 modeling study in their analysis. Overall, approximately one-third of the studies (36%) were considered high quality, and approximately two-thirds (64%) of the studies were published in journals. Twenty-five of the reports analyzed focused on mental health and well-being.

Schools provide not only education, but also services including meals, health care, and health supplies. Schools also serve as a safety net and source of social support for children, the researchers noted.

The losses children may have experienced during school closures occurred during a time when more than 167,000 children younger than 18 years lost a parent or caregiver to COVID-19, according to a recent report titled “Hidden Pain” by researchers at the University of Pennsylvania, Nemours Children’s Health, and the COVID Collaborative. Although not addressed in the current study, school closures would prevent bereaved children from receiving social-emotional support from friends and teachers. This crisis of loss also prompted the American Academy of Pediatrics to issue a National State of Emergency in Children’s Mental Health in October 2021.
 

New study results

These studies identified associations between school closures during broader lockdowns and increased emotional and behavioral problems, as well as increased restlessness and inattention. Across these studies, 18%-60% of children and adolescents scored higher than the risk thresholds for diagnoses of distress, especially depressive symptoms and anxiety.

Although two studies showed no significant association with suicide in response to school closures during lockdowns, three studies suggested increased use of screen time, two studies reported increased social media use, and six studies reported lower levels of physical activity.

Three studies of child abuse showed decreases in notifications during lockdowns, likely driven by lack of referrals from schools, the authors noted. A total of 10 studies on sleep and 5 studies on diet showed inconsistent evidence of harm during the specific period of school closures and social lockdowns.

“The contrast of rises in distress with decreases in presentations suggests that there was an escalation of unmet mental health need during lockdowns in already vulnerable children and adolescents,” the researchers wrote. “More troubling still is evidence of a reduction in the ability of the health and social care systems to protect children in many countries, as shown by the large falls in child protection referrals seen in high-quality cohort studies.”
 

‘Study presents concrete assessments rather than speculation’

“Concerns have been widely expressed in the lay media and beyond that school closures could negatively impact the mental and physical health of children and adolescents,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “The authors presented a narrative synthesis summarizing available evidence for the first wave of COVID-19 on school closures during the broader social lockdown occurring during this period.”

The “importance” of this research is that “it is not a single convenience sample study, but a systematic review from 11 countries including the United States, United Kingdom, China, and Turkey, among others, and that the quality of the information was graded,” Dr. Jay said. “Although not a meta-analysis, the study presents concrete assessments rather than speculation and overviews its limitations so that the clinician can weigh this information. Importantly, the authors excluded closure of schools with transmission of infection.

“Clearly, school lockdowns as a measure of controlling infectious disease needs balance with potential of negative health behaviors in children and adolescents. Ongoing prospective longitudinal studies are needed as sequential waves of the pandemic continue,” she emphasized.

“Clinically, this study highlights the need for clinicians to consider [asking] about the impact of school closures and remote versus hybrid versus in-person education [as part of their] patients and families question inventory,” Dr. Jay said. “Also, the use of depression inventories can be offered to youth to assess their mental health state at a visit, either via telemedicine or in person, and ideally at sequential visits for a more in-depth assessment.”
 

Schools play key role in social and emotional development

“It was important to conduct this study now, because this current time is unprecedented,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “We know based on evolutionary biology, anthropology, and developmental psychology, among other disciplines, that meaningful interpersonal interactions embedded in the context of community are vital to supporting human well-being.

“In our current time, the primary framework of community for our children is the school setting; it is the predominant space where they engage in the interpersonal interactions necessary for developing resilience, their sense of purpose, belonging, and fidelity,” he emphasized.

“Rarely in the course of human existence have kids been removed from the broader context of community to this extent and for this duration,” Dr. Loper said. “This study capitalizes on this unprecedented moment to begin to further understand how compromises in our sociocultural infrastructure of community, like school closures and lockdowns, may manifest as mental health problems in children and adolescents. More importantly, it contributes to the exploration of potential unintended consequences of our current infection control measures so we can adapt to support the overall well-being of our children in this ‘new normal.’ ”

Dr. Loper added that he was not surprised by the new study’s findings.

“We were already seeing a decline in pediatric mental health and overall well-being in the years preceding COVID-19 because of the ‘isolation epidemic’ involving many of the factors that this study explored,” he said. “I think this review further illustrates the vital necessity of community to support the health and well-being of humans, and specifically children and adolescents.”

From a clinical standpoint, “we need to be intentional and consistent in balancing infection control measures with our kids’ fundamental psychosocial needs,” Dr. Loper said.

“We need to recognize that, when children and adolescents are isolated from community, their fundamental psychosocial needs go unmet,” he emphasized. “If children and adolescents cannot access the meaningful interpersonal interactions necessary for resilience, then they cannot overcome or navigate distress. They will exhibit the avoidance and withdrawal behaviors that accumulate to manifest as adverse mental health symptoms like anxiety and depression.

“Additional research is needed to further explore how compromises in the psychosocial infrastructure of community manifest as downstream symptom indicators such as anxiety and depression,” which are often manifestations of unmet needs, Dr. Loper said.
 

Limitations and strengths, according to authors

The findings were limited by several factors, including a lack of examination of school closures’ effects on mental health independent of broader social lockdowns, according to the researchers. Other limitations included the authors potentially having missed studies, inclusion of cross-sectional studies with relatively weak evidence, potential bias from studies using parent reports, and a focus on the first COVID-19 wave, during which many school closures were of limited duration. Also, the researchers said they did not include studies focused on particular groups, such as children with learning difficulties or autism.

The use of large databases from education as well as health care in studies analyzed were strengths of the new research, they said. The investigators received no outside funding for their study. The researchers, Dr. Jay, and Dr. Loper had no financial conflicts to disclose. Dr. Jay serves on the editorial advisory board of Pediatric News.

Antibiotics were administered to newborns at low risk for early-onset sepsis as frequently as to newborns with EOS risk factors, based on data from approximately 7,500 infants.

EOS remains a significant cause of morbidity and mortality, and predicting which newborns are at risk remains a challenge for neonatal care that often drives high rates of antibiotic use, Dustin D. Flannery, DO, of Children’s Hospital of Philadelphia and colleagues wrote.

Antibiotic exposures are associated with short- and long-term adverse effects in both preterm and term infants, which highlights the need for improved risk assessment in this population, the researchers said.

“A robust estimate of EOS risk in relation to delivery characteristics among infants of all gestational ages at birth could significantly contribute to newborn clinical management by identifying newborns unlikely to benefit from empirical antibiotic therapy,” they emphasized.

In a study published in Pediatrics, the researchers identified 7,540 infants born between Jan. 1, 2009, and Dec. 31, 2014, at two high-risk perinatal units in Philadelphia. Gestational age ranged from 22 to 43 weeks. Criteria for low risk of EOS were determined via an algorithm that included cesarean delivery (with or without labor or membrane rupture), and no antepartum concerns for intra-amniotic infection or nonreassuring fetal status.

A total of 6,428 infants did not meet the low-risk criteria; another 1,121 infants met the low-risk criteria. The primary outcome of EOS was defined as growth of a pathogen in at least 1 blood and/or cerebrospinal fluid culture obtained at 72 hours or less after birth. Overall, 41 infants who did not meet the low-risk criteria developed EOS; none of the infants who met the low-risk criteria developed EOS. Secondary outcomes included initiation of empirical antibiotics at 72 hours or less after birth and the duration of antibiotic use.

Although fewer low-risk infants received antibiotics, compared with infants with EOS (80.4% vs. 91.0%, P < .001), the duration of antibiotic use was not significantly different between the groups, with an adjusted difference of 0.6 hours.

Among infants who did not meet low-risk criteria, 157 were started on antibiotics for each case of EOS, the researchers noted in their discussion of the findings. “Because no cases of EOS were identified in the low-risk group, this proportion could not be calculated but suggests that antibiotic exposure in this group was disproportionately higher for incidence of EOS.”

The study findings were limited by several factors including the possible lack of generalizability to other centers and the use of data from a period before more refined EOS strategies, the researchers noted. Other limitations include the inability to assess the effect of lab results on antibiotic use, a lack of data on the exact indication for delivery, and potential misclassification bias.

Risk assessment tools should not be used alone, but should be used to inform clinical decision-making, the researchers emphasized. However, the results were strengthened by the inclusion of moderately preterm infants, who are rarely studied, and the clinical utility of the risk algorithm used in the study. “The implications of our study include potential adjustments to sepsis risk assessment in term infants, and confirmation and enhancement of previous studies that identify a subset of lower-risk preterm infants,” who may be spared empirical or prolonged antibiotic exposure, they concluded.
 

Data inform intelligent antibiotic use

“Early-onset sepsis is predominantly caused by exposure of the fetus or neonate to ascending maternal colonization or infection by gastrointestinal or genitourinary bacteria,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “Scenarios where there is limited neonatal exposure to these organisms would decrease the risk of development of EOS, therefore it is not surprising that delivery characteristics of low-risk deliveries as defined by investigators – the absence of labor, absence of intra-amniotic infection, rupture of membranes at time of delivery, and cesarean delivery – would have resulted in decreased likelihood of EOS.”

Inappropriate antibiotic use contributes to the development of resistant and more virulent strains of bacteria. A growing body of literature also suggests that early antibiotic usage in newborns may affect the neonatal gut microbiome, which is important for development of the neonatal immune system. Early alterations of the microbiome may have long-term implications,” Dr. Krishna said.

“Understanding the delivery characteristics that increase the risk of EOS are crucial to optimizing the use of antibiotics and thereby minimize potential harm to newborns,” she said. “Studies such as the current study are needed develop EOS prediction tools to improve antibiotic utilization.” More research is needed not only to adequately predict EOS, but to explore how antibiotics affect the neonatal microbiome, and how clinicians can circumvent potential adverse implications with antibiotic use to improve long-term health, Dr. Krishna concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Antibiotics were administered to newborns at low risk for early-onset sepsis as frequently as to newborns with EOS risk factors, based on data from approximately 7,500 infants.

EOS remains a significant cause of morbidity and mortality, and predicting which newborns are at risk remains a challenge for neonatal care that often drives high rates of antibiotic use, Dustin D. Flannery, DO, of Children’s Hospital of Philadelphia and colleagues wrote.

Antibiotic exposures are associated with short- and long-term adverse effects in both preterm and term infants, which highlights the need for improved risk assessment in this population, the researchers said.

“A robust estimate of EOS risk in relation to delivery characteristics among infants of all gestational ages at birth could significantly contribute to newborn clinical management by identifying newborns unlikely to benefit from empirical antibiotic therapy,” they emphasized.

In a study published in Pediatrics, the researchers identified 7,540 infants born between Jan. 1, 2009, and Dec. 31, 2014, at two high-risk perinatal units in Philadelphia. Gestational age ranged from 22 to 43 weeks. Criteria for low risk of EOS were determined via an algorithm that included cesarean delivery (with or without labor or membrane rupture), and no antepartum concerns for intra-amniotic infection or nonreassuring fetal status.

A total of 6,428 infants did not meet the low-risk criteria; another 1,121 infants met the low-risk criteria. The primary outcome of EOS was defined as growth of a pathogen in at least 1 blood and/or cerebrospinal fluid culture obtained at 72 hours or less after birth. Overall, 41 infants who did not meet the low-risk criteria developed EOS; none of the infants who met the low-risk criteria developed EOS. Secondary outcomes included initiation of empirical antibiotics at 72 hours or less after birth and the duration of antibiotic use.

Although fewer low-risk infants received antibiotics, compared with infants with EOS (80.4% vs. 91.0%, P < .001), the duration of antibiotic use was not significantly different between the groups, with an adjusted difference of 0.6 hours.

Among infants who did not meet low-risk criteria, 157 were started on antibiotics for each case of EOS, the researchers noted in their discussion of the findings. “Because no cases of EOS were identified in the low-risk group, this proportion could not be calculated but suggests that antibiotic exposure in this group was disproportionately higher for incidence of EOS.”

The study findings were limited by several factors including the possible lack of generalizability to other centers and the use of data from a period before more refined EOS strategies, the researchers noted. Other limitations include the inability to assess the effect of lab results on antibiotic use, a lack of data on the exact indication for delivery, and potential misclassification bias.

Risk assessment tools should not be used alone, but should be used to inform clinical decision-making, the researchers emphasized. However, the results were strengthened by the inclusion of moderately preterm infants, who are rarely studied, and the clinical utility of the risk algorithm used in the study. “The implications of our study include potential adjustments to sepsis risk assessment in term infants, and confirmation and enhancement of previous studies that identify a subset of lower-risk preterm infants,” who may be spared empirical or prolonged antibiotic exposure, they concluded.
 

Data inform intelligent antibiotic use

“Early-onset sepsis is predominantly caused by exposure of the fetus or neonate to ascending maternal colonization or infection by gastrointestinal or genitourinary bacteria,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “Scenarios where there is limited neonatal exposure to these organisms would decrease the risk of development of EOS, therefore it is not surprising that delivery characteristics of low-risk deliveries as defined by investigators – the absence of labor, absence of intra-amniotic infection, rupture of membranes at time of delivery, and cesarean delivery – would have resulted in decreased likelihood of EOS.”

Inappropriate antibiotic use contributes to the development of resistant and more virulent strains of bacteria. A growing body of literature also suggests that early antibiotic usage in newborns may affect the neonatal gut microbiome, which is important for development of the neonatal immune system. Early alterations of the microbiome may have long-term implications,” Dr. Krishna said.

“Understanding the delivery characteristics that increase the risk of EOS are crucial to optimizing the use of antibiotics and thereby minimize potential harm to newborns,” she said. “Studies such as the current study are needed develop EOS prediction tools to improve antibiotic utilization.” More research is needed not only to adequately predict EOS, but to explore how antibiotics affect the neonatal microbiome, and how clinicians can circumvent potential adverse implications with antibiotic use to improve long-term health, Dr. Krishna concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Antibiotics were administered to newborns at low risk for early-onset sepsis as frequently as to newborns with EOS risk factors, based on data from approximately 7,500 infants.

EOS remains a significant cause of morbidity and mortality, and predicting which newborns are at risk remains a challenge for neonatal care that often drives high rates of antibiotic use, Dustin D. Flannery, DO, of Children’s Hospital of Philadelphia and colleagues wrote.

Antibiotic exposures are associated with short- and long-term adverse effects in both preterm and term infants, which highlights the need for improved risk assessment in this population, the researchers said.

“A robust estimate of EOS risk in relation to delivery characteristics among infants of all gestational ages at birth could significantly contribute to newborn clinical management by identifying newborns unlikely to benefit from empirical antibiotic therapy,” they emphasized.

In a study published in Pediatrics, the researchers identified 7,540 infants born between Jan. 1, 2009, and Dec. 31, 2014, at two high-risk perinatal units in Philadelphia. Gestational age ranged from 22 to 43 weeks. Criteria for low risk of EOS were determined via an algorithm that included cesarean delivery (with or without labor or membrane rupture), and no antepartum concerns for intra-amniotic infection or nonreassuring fetal status.

A total of 6,428 infants did not meet the low-risk criteria; another 1,121 infants met the low-risk criteria. The primary outcome of EOS was defined as growth of a pathogen in at least 1 blood and/or cerebrospinal fluid culture obtained at 72 hours or less after birth. Overall, 41 infants who did not meet the low-risk criteria developed EOS; none of the infants who met the low-risk criteria developed EOS. Secondary outcomes included initiation of empirical antibiotics at 72 hours or less after birth and the duration of antibiotic use.

Although fewer low-risk infants received antibiotics, compared with infants with EOS (80.4% vs. 91.0%, P < .001), the duration of antibiotic use was not significantly different between the groups, with an adjusted difference of 0.6 hours.

Among infants who did not meet low-risk criteria, 157 were started on antibiotics for each case of EOS, the researchers noted in their discussion of the findings. “Because no cases of EOS were identified in the low-risk group, this proportion could not be calculated but suggests that antibiotic exposure in this group was disproportionately higher for incidence of EOS.”

The study findings were limited by several factors including the possible lack of generalizability to other centers and the use of data from a period before more refined EOS strategies, the researchers noted. Other limitations include the inability to assess the effect of lab results on antibiotic use, a lack of data on the exact indication for delivery, and potential misclassification bias.

Risk assessment tools should not be used alone, but should be used to inform clinical decision-making, the researchers emphasized. However, the results were strengthened by the inclusion of moderately preterm infants, who are rarely studied, and the clinical utility of the risk algorithm used in the study. “The implications of our study include potential adjustments to sepsis risk assessment in term infants, and confirmation and enhancement of previous studies that identify a subset of lower-risk preterm infants,” who may be spared empirical or prolonged antibiotic exposure, they concluded.
 

Data inform intelligent antibiotic use

“Early-onset sepsis is predominantly caused by exposure of the fetus or neonate to ascending maternal colonization or infection by gastrointestinal or genitourinary bacteria,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “Scenarios where there is limited neonatal exposure to these organisms would decrease the risk of development of EOS, therefore it is not surprising that delivery characteristics of low-risk deliveries as defined by investigators – the absence of labor, absence of intra-amniotic infection, rupture of membranes at time of delivery, and cesarean delivery – would have resulted in decreased likelihood of EOS.”

Inappropriate antibiotic use contributes to the development of resistant and more virulent strains of bacteria. A growing body of literature also suggests that early antibiotic usage in newborns may affect the neonatal gut microbiome, which is important for development of the neonatal immune system. Early alterations of the microbiome may have long-term implications,” Dr. Krishna said.

“Understanding the delivery characteristics that increase the risk of EOS are crucial to optimizing the use of antibiotics and thereby minimize potential harm to newborns,” she said. “Studies such as the current study are needed develop EOS prediction tools to improve antibiotic utilization.” More research is needed not only to adequately predict EOS, but to explore how antibiotics affect the neonatal microbiome, and how clinicians can circumvent potential adverse implications with antibiotic use to improve long-term health, Dr. Krishna concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

A pair of updated clinical guidelines from the American College of Physicians on the diagnosis and management of diverticulitis emphasized reduced use of antibiotics, outpatient management, and informed decision-making prior to elective surgery.

The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”

Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.

The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.

In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
 

Guidance on diagnosis and management

In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.

Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.

The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.

All three recommendations are conditional, with low-certainty evidence, according to the authors.
 

Colonoscopy for diagnostic evaluation and interventions

In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.

Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.

A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.

The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.

The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.

This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
 

Update confirms best practices

“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”

Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.

Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.

Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
 

Curbing antibiotic use

It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.

“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”

“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”

As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”

The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.

A pair of updated clinical guidelines from the American College of Physicians on the diagnosis and management of diverticulitis emphasized reduced use of antibiotics, outpatient management, and informed decision-making prior to elective surgery.

The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”

Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.

The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.

In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
 

Guidance on diagnosis and management

In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.

Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.

The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.

All three recommendations are conditional, with low-certainty evidence, according to the authors.
 

Colonoscopy for diagnostic evaluation and interventions

In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.

Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.

A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.

The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.

The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.

This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
 

Update confirms best practices

“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”

Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.

Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.

Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
 

Curbing antibiotic use

It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.

“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”

“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”

As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”

The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.

A pair of updated clinical guidelines from the American College of Physicians on the diagnosis and management of diverticulitis emphasized reduced use of antibiotics, outpatient management, and informed decision-making prior to elective surgery.

The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”

Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.

The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.

In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
 

Guidance on diagnosis and management

In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.

Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.

The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.

All three recommendations are conditional, with low-certainty evidence, according to the authors.
 

Colonoscopy for diagnostic evaluation and interventions

In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.

Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.

A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.

The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.

The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.

This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
 

Update confirms best practices

“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”

Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.

Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.

Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
 

Curbing antibiotic use

It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.

“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”

“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”

As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”

The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.

Approximately one-third of registered randomized, controlled trials for connective tissue diseases are incomplete or unpublished, based on data from 175 studies.

“The failure to complete a trial is a waste of time and money, and a missed opportunity to contribute to patient’s health,” Alejandro Brigante, MD, of the Internal Medicine–Rheumatology service at Güemes Sanitorium in Buenos Aires, and colleagues wrote.

Patients with connective tissue diseases (CTDs) experience high levels of disability, poor quality of life, and poor survival, and more randomized, controlled trials are needed to explore treatment options, they said.

In a study published in Arthritis Care & Research, the researchers examined factors leading to the failure of CTD studies. They identified 175 studies of CTDs registered at clinicaltrials.gov since 2000. Most of the studies were phase 3, placebo-controlled trials involving pharmacologic treatments; 117 (67%) were identified as completed, 58 (33%) were identified as discontinued. Approximately half (51%) of the studies involved systemic lupus erythematosus, and half were funded by industry. The median sample size planned for the studies was 101 patients, and 83 studies stated a plan to recruit less than 100 patients.

Of the 58 discontinued trials, 12 were withdrawn, 33 were terminated, and 13 had an unknown status. These trials represented a potential enrollment of 11,389 patients, 31% of the estimated number of patients across all 175 studies.

The researchers found identified reasons for discontinuation for 39 of the 58 discontinued trials. The main reasons included insufficient patient accrual in 11 trials, interim results showing futility (8 trials), safety concerns (5 trials), funding issues (5 trials), conduct problems (4 trials), company decisions (2 trials), administrative reasons (2 trials), and departure of the principal investigator (1 trial); the reason for discontinuation was unclear in 1 trial. Discontinuation rates were not significantly different across disease types.

“By subtracting from the 58 discontinued trials the 13 studies for which early termination was justified (e.g., discontinuation for futility or safety concerns), we considered 45 (26%) trials prematurely terminated,” the researchers wrote. Overall, completed studies were less likely than discontinued studies to have a placebo group, and they had longer treatment periods to evaluate primary outcomes. A sample size of less than 100 patients was the only factor significantly associated with early study termination (odds ratio, 2.1), after controlling for multiple variables.

The researchers checked the publication status of 130 studies, including 94 completed and 36 discontinued randomized, controlled trials. Of these, 44 were unpublished and 86 were published in a peer-reviewed journal at a median of 24 months after study completion. The publication rate was significantly higher for completed studies, compared with discontinued studies (81% vs. 22%), and the rates were not significantly different among diseases. The main reasons for nonpublication included poor recruitment, study rejection and preparation for resubmission, lack of time, low priority, and the fact that the study was ongoing. A sample size of less than 100 patients was the main barrier to publication for completed studies.

The study findings were limited by several factors including selection bias and inability to study factors, such as study complexity or the nature of interventions that might have affected trial completion, the researchers noted. Other limitations include a lack of data on negative results and the possible missed publication of some of the studies.

However, the results illustrate the waste of resources in CTD trials, which are needed to identify effective treatments for these patients, the researchers said. “A better understanding of the factors leading to waste will guide future allocation of resources and could help to maximize the successful conduct of RCTs.”

More research is needed to determine the most effective interventions and reduce the risk of trial noncompletion and nonpublication, they concluded.

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

Approximately one-third of registered randomized, controlled trials for connective tissue diseases are incomplete or unpublished, based on data from 175 studies.

“The failure to complete a trial is a waste of time and money, and a missed opportunity to contribute to patient’s health,” Alejandro Brigante, MD, of the Internal Medicine–Rheumatology service at Güemes Sanitorium in Buenos Aires, and colleagues wrote.

Patients with connective tissue diseases (CTDs) experience high levels of disability, poor quality of life, and poor survival, and more randomized, controlled trials are needed to explore treatment options, they said.

In a study published in Arthritis Care & Research, the researchers examined factors leading to the failure of CTD studies. They identified 175 studies of CTDs registered at clinicaltrials.gov since 2000. Most of the studies were phase 3, placebo-controlled trials involving pharmacologic treatments; 117 (67%) were identified as completed, 58 (33%) were identified as discontinued. Approximately half (51%) of the studies involved systemic lupus erythematosus, and half were funded by industry. The median sample size planned for the studies was 101 patients, and 83 studies stated a plan to recruit less than 100 patients.

Of the 58 discontinued trials, 12 were withdrawn, 33 were terminated, and 13 had an unknown status. These trials represented a potential enrollment of 11,389 patients, 31% of the estimated number of patients across all 175 studies.

The researchers found identified reasons for discontinuation for 39 of the 58 discontinued trials. The main reasons included insufficient patient accrual in 11 trials, interim results showing futility (8 trials), safety concerns (5 trials), funding issues (5 trials), conduct problems (4 trials), company decisions (2 trials), administrative reasons (2 trials), and departure of the principal investigator (1 trial); the reason for discontinuation was unclear in 1 trial. Discontinuation rates were not significantly different across disease types.

“By subtracting from the 58 discontinued trials the 13 studies for which early termination was justified (e.g., discontinuation for futility or safety concerns), we considered 45 (26%) trials prematurely terminated,” the researchers wrote. Overall, completed studies were less likely than discontinued studies to have a placebo group, and they had longer treatment periods to evaluate primary outcomes. A sample size of less than 100 patients was the only factor significantly associated with early study termination (odds ratio, 2.1), after controlling for multiple variables.

The researchers checked the publication status of 130 studies, including 94 completed and 36 discontinued randomized, controlled trials. Of these, 44 were unpublished and 86 were published in a peer-reviewed journal at a median of 24 months after study completion. The publication rate was significantly higher for completed studies, compared with discontinued studies (81% vs. 22%), and the rates were not significantly different among diseases. The main reasons for nonpublication included poor recruitment, study rejection and preparation for resubmission, lack of time, low priority, and the fact that the study was ongoing. A sample size of less than 100 patients was the main barrier to publication for completed studies.

The study findings were limited by several factors including selection bias and inability to study factors, such as study complexity or the nature of interventions that might have affected trial completion, the researchers noted. Other limitations include a lack of data on negative results and the possible missed publication of some of the studies.

However, the results illustrate the waste of resources in CTD trials, which are needed to identify effective treatments for these patients, the researchers said. “A better understanding of the factors leading to waste will guide future allocation of resources and could help to maximize the successful conduct of RCTs.”

More research is needed to determine the most effective interventions and reduce the risk of trial noncompletion and nonpublication, they concluded.

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

Approximately one-third of registered randomized, controlled trials for connective tissue diseases are incomplete or unpublished, based on data from 175 studies.

“The failure to complete a trial is a waste of time and money, and a missed opportunity to contribute to patient’s health,” Alejandro Brigante, MD, of the Internal Medicine–Rheumatology service at Güemes Sanitorium in Buenos Aires, and colleagues wrote.

Patients with connective tissue diseases (CTDs) experience high levels of disability, poor quality of life, and poor survival, and more randomized, controlled trials are needed to explore treatment options, they said.

In a study published in Arthritis Care & Research, the researchers examined factors leading to the failure of CTD studies. They identified 175 studies of CTDs registered at clinicaltrials.gov since 2000. Most of the studies were phase 3, placebo-controlled trials involving pharmacologic treatments; 117 (67%) were identified as completed, 58 (33%) were identified as discontinued. Approximately half (51%) of the studies involved systemic lupus erythematosus, and half were funded by industry. The median sample size planned for the studies was 101 patients, and 83 studies stated a plan to recruit less than 100 patients.

Of the 58 discontinued trials, 12 were withdrawn, 33 were terminated, and 13 had an unknown status. These trials represented a potential enrollment of 11,389 patients, 31% of the estimated number of patients across all 175 studies.

The researchers found identified reasons for discontinuation for 39 of the 58 discontinued trials. The main reasons included insufficient patient accrual in 11 trials, interim results showing futility (8 trials), safety concerns (5 trials), funding issues (5 trials), conduct problems (4 trials), company decisions (2 trials), administrative reasons (2 trials), and departure of the principal investigator (1 trial); the reason for discontinuation was unclear in 1 trial. Discontinuation rates were not significantly different across disease types.

“By subtracting from the 58 discontinued trials the 13 studies for which early termination was justified (e.g., discontinuation for futility or safety concerns), we considered 45 (26%) trials prematurely terminated,” the researchers wrote. Overall, completed studies were less likely than discontinued studies to have a placebo group, and they had longer treatment periods to evaluate primary outcomes. A sample size of less than 100 patients was the only factor significantly associated with early study termination (odds ratio, 2.1), after controlling for multiple variables.

The researchers checked the publication status of 130 studies, including 94 completed and 36 discontinued randomized, controlled trials. Of these, 44 were unpublished and 86 were published in a peer-reviewed journal at a median of 24 months after study completion. The publication rate was significantly higher for completed studies, compared with discontinued studies (81% vs. 22%), and the rates were not significantly different among diseases. The main reasons for nonpublication included poor recruitment, study rejection and preparation for resubmission, lack of time, low priority, and the fact that the study was ongoing. A sample size of less than 100 patients was the main barrier to publication for completed studies.

The study findings were limited by several factors including selection bias and inability to study factors, such as study complexity or the nature of interventions that might have affected trial completion, the researchers noted. Other limitations include a lack of data on negative results and the possible missed publication of some of the studies.

However, the results illustrate the waste of resources in CTD trials, which are needed to identify effective treatments for these patients, the researchers said. “A better understanding of the factors leading to waste will guide future allocation of resources and could help to maximize the successful conduct of RCTs.”

More research is needed to determine the most effective interventions and reduce the risk of trial noncompletion and nonpublication, they concluded.

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

Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.

“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.

The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.

In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.

In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.

Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.

The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.

Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.

Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.

Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.

The full Jan. 10 FAQ is available here.

This article was updated Jan. 14, 2022.

Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.

“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.

The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.

In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.

In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.

Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.

The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.

Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.

Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.

Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.

The full Jan. 10 FAQ is available here.

This article was updated Jan. 14, 2022.

Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.

“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.

The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.

In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.

In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.

Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.

The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.

Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.

Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.

Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.

The full Jan. 10 FAQ is available here.

This article was updated Jan. 14, 2022.