Heidi Splete

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.

Policies increasing access to immediate postpartum long-acting reversible contraception (LARC) were associated with reductions in preterm birth and low birth weight, based on data from South Carolina’s Medicaid program.

Preterm birth and low birth weight represent the second-leading cause of infant mortality in the United States, wrote Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues. Previous policy interventions to reduce preterm birth and low birth weight have focused on services before and during pregnancy, they said. LARC is a safe and effective postpartum intervention, but cost has been a limiting factor, they noted.

In 2012, the Medicaid program in South Carolina began reimbursing hospitals for immediate postpartum LARC independent of global maternity payments. In a previous study, the researchers found that the implementation of this policy had reduced the number of short-interval births among adolescents.

The goal of the current study, published in JAMA Pediatrics, was to analyze the association between South Carolina’s policy change and rates of preterm birth and low birth weight among individuals with Medicaid coverage during childbirth. The researchers analyzed data from 186,953 Medicaid-paid births between January 2009 and December 2015 in South Carolina. Of these, 46,414 births (24.8%) occurred in hospitals that provided immediate postpartum LARC in response to the policy change. Overall, the implementing hospitals had more annual births paid for by Medicaid compared to nonimplementing hospitals (1,105 vs. 511) and were less likely to be rural (33.3% vs. 46.8%) and had a greater share of preterm births (15.5% vs. 9.5%). Prior to the policy change, the probability of a preterm birth in the next 4 years was 4.4% for patients at implementing hospitals and 3.5% for those in nonimplementing hospitals, and the probability of a low-birth-weight birth was 3.6% and 2.9%, respectively.

The policy change was associated with a decrease of 0.4 percentage points for preterm birth and 0.3 percentage points for subsequent low-birth-weight birth.

When the results were stratified based on race and ethnicity, the policy change was associated with a decrease of 0.5 percentage points in the probability of preterm birth in both non-Hispanic Blacks and non-Hispanic Whites. No significant differences appeared in the association between the policy change and rates of preterm birth or low-birth-weight birth between non-Hispanic Black and non-Hispanic White individuals.

However, the policy was associated with a significant decrease of 0.6 percentage points in the probability of short-interval birth among non-Hispanic Blacks, and a decrease of 1.6 percentage points in the probability of another birth within 4 years overall. The policy change also was associated with a significant increase of 27 days between births among non-Hispanic Blacks, but not with any significant change among non-Hispanic Whites or the study population overall.

“In addition, although our data cannot speak to this, the policy may have affected the intendedness of subsequent pregnancies, leading to healthier behaviors before and during pregnancy, such as early initiation of prenatal care,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on pregnancy intention or abortion, and the lack of data on patient-reported outcomes, notably the provision of patient-centered counseling and whether such counseling was biased, the researchers noted. Other limitations included a lack of data on infant mortality and potential confounding from risk profiles of patients in implementing vs. nonimplementing hospitals, they wrote.

Also, the study provides population-level data, which does not guide clinical decision-making about intervals between childbirth and subsequent pregnancy, the researchers emphasized.

Although the data support the value of postpartum contraception in improving birth outcomes, “it is imperative that efforts to expand access focus on assuring comprehensive access to all forms of contraception without coercion,” the researchers concluded. “Additional policy solutions are needed to improve infant health, including those that directly address structural and interpersonal racism to reduce racial disparities in infant health,” they said.

The study is important because, although immediate postpartum LARC policies were first implemented almost a decade ago in the United States, population-level evidence on the effects of these policies remains scarce, Dr. Steenland said in an interview.  

Existing barriers to improving access to immediate postpartum LARC include health professional training and logistics within hospitals, as well as ensuring correct billing and timely reimbursements, Dr. Steenland said. “Simple and clear billing procedures, and advanced reimbursement so that hospitals can have devices stocked would make it easier to provide this service,” she noted.

“This service has gone from being almost completely unavailable, to available in some hospitals, mainly those that are urban, teaching, and high volume,” said Dr. Steenland. “Additional research is needed to determine how health systems can make this service available to all birthing persons,” she said. “Also, critically, additional research is needed to identify strategies to ensure that counseling for immediate postpartum LARC, and family planning more generally, is patient-centered, so that the availability of immediate postpartum LARC increases, rather than restricts, choice,” she added. “Finally, additional research is needed to determine whether postpartum people have affordable and accessible access to LARC removal services,” Dr. Steenland emphasized.
 

Immediate post partum is critical period

The immediate postpartum period is a critical time for access to contraception because many women do not return for postpartum visits after hospital discharge, Tracey A. Wilkinson, MD, and Jeffrey F. Peipert, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. “The focus on contraception access during the postpartum period prior to hospital discharge is important because of the potential sequelae of a subsequent unintended pregnancy or short interpregnancy intervals,” they noted. These issues may be more acute in marginalized communities, and policies to expand immediate postpartum LARC are in place in a majority of states, the editorialists said.

However, they agreed with the authors’ statements that implementation of LARC must be done in a manner that supports patient choice and avoids coercion. Given the baseline disparities of the infant outcomes studied, increased access to immediate postpartum LARC must be provided in a way that does not exacerbate these disparities, they said. “This ultimately means that plans to increase access to contraception should emphasize availability while avoiding coercion, and if a patient ultimately decides to discontinue a method, enable that to occur easily and seamlessly, including LARC device removal,” they explained.

“Future studies examining patient centeredness of these postpartum LARC implementation efforts would be an important element to augment these data and show the impact in additional spheres beyond infant outcomes,” they added.
 

Overcome trust barriers and offer options

“In a time of restrictive access to abortion and contraception in many states, any additional increase in access can potentially be meaningful,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Additionally, given the significantly higher rates of infant and maternal morbidity and mortality among the non-Hispanic Black population, seeing an intervention that can improve outcomes for both mothers and babies is also potentially very positive,” she said.

Dr. Prager said she was not surprised by the study findings, as immediate LARC is much more common in other countries and has shown similar outcomes. “Additionally, I am reassured by the fact that the increased number of days until the next pregnancy is not higher, as this indirectly indicates that patients were able to get their LARC removed when they desired another pregnancy,” she noted.

Barriers to improving access to immediate postpartum LARC in the Medicaid population may include mistrust for any long-acting contraception, “especially if they perceive that cessation of the method will be difficult to achieve,” Dr. Prager noted. “Certainly, counseling about LARC removal should be an element of counseling prior to any initiation, and lack of access to removal of an IUD or implant can be categorized as a form of reproductive coercion,” she said. Dr. Prager said that such counseling might be more effective if it occurred during prenatal visits, “so if providers are not talking about this during routine OB visits and patients only hear about immediate postpartum LARC when they are in the hospital for delivery, they may be less likely to accept the practice,” she said. “Finally, although Medicaid will cover the cost of immediate postpartum LARC, private insurers do not do so consistently in all states, so some hospitals may find this process too difficult to navigate and therefore not offer immediate postpartum LARC,” Dr. Prager emphasized.

As for additional research, Dr. Prager said she would like to see more studies in an overall United States population of pregnant people, both Medicaid patients and others, on whether the immediate postpartum timing of LARC is desired.

“I would like to couple that with patients’ impressions or experiences of their ability to access contraception outside of the immediate postpartum time period, and also their impressions or experience with ability to have LARC removed, since they are the only contraceptives not necessarily within personal control for initiation or cessation,” Dr. Prager said.

The study was supported by the National Institute for Child Health and Development, and lead author Dr. Steenland received support from other National Institutes of Health grants. The researchers had no financial conflicts to disclose. The editorial was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Peipert disclosed serving on advisory boards for Bayer and CooperSurgical, and receiving research support from Merck, Bayer, and CooperSurgical/Teva. Dr. Wilkinson had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Policies increasing access to immediate postpartum long-acting reversible contraception (LARC) were associated with reductions in preterm birth and low birth weight, based on data from South Carolina’s Medicaid program.

Preterm birth and low birth weight represent the second-leading cause of infant mortality in the United States, wrote Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues. Previous policy interventions to reduce preterm birth and low birth weight have focused on services before and during pregnancy, they said. LARC is a safe and effective postpartum intervention, but cost has been a limiting factor, they noted.

In 2012, the Medicaid program in South Carolina began reimbursing hospitals for immediate postpartum LARC independent of global maternity payments. In a previous study, the researchers found that the implementation of this policy had reduced the number of short-interval births among adolescents.

The goal of the current study, published in JAMA Pediatrics, was to analyze the association between South Carolina’s policy change and rates of preterm birth and low birth weight among individuals with Medicaid coverage during childbirth. The researchers analyzed data from 186,953 Medicaid-paid births between January 2009 and December 2015 in South Carolina. Of these, 46,414 births (24.8%) occurred in hospitals that provided immediate postpartum LARC in response to the policy change. Overall, the implementing hospitals had more annual births paid for by Medicaid compared to nonimplementing hospitals (1,105 vs. 511) and were less likely to be rural (33.3% vs. 46.8%) and had a greater share of preterm births (15.5% vs. 9.5%). Prior to the policy change, the probability of a preterm birth in the next 4 years was 4.4% for patients at implementing hospitals and 3.5% for those in nonimplementing hospitals, and the probability of a low-birth-weight birth was 3.6% and 2.9%, respectively.

The policy change was associated with a decrease of 0.4 percentage points for preterm birth and 0.3 percentage points for subsequent low-birth-weight birth.

When the results were stratified based on race and ethnicity, the policy change was associated with a decrease of 0.5 percentage points in the probability of preterm birth in both non-Hispanic Blacks and non-Hispanic Whites. No significant differences appeared in the association between the policy change and rates of preterm birth or low-birth-weight birth between non-Hispanic Black and non-Hispanic White individuals.

However, the policy was associated with a significant decrease of 0.6 percentage points in the probability of short-interval birth among non-Hispanic Blacks, and a decrease of 1.6 percentage points in the probability of another birth within 4 years overall. The policy change also was associated with a significant increase of 27 days between births among non-Hispanic Blacks, but not with any significant change among non-Hispanic Whites or the study population overall.

“In addition, although our data cannot speak to this, the policy may have affected the intendedness of subsequent pregnancies, leading to healthier behaviors before and during pregnancy, such as early initiation of prenatal care,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on pregnancy intention or abortion, and the lack of data on patient-reported outcomes, notably the provision of patient-centered counseling and whether such counseling was biased, the researchers noted. Other limitations included a lack of data on infant mortality and potential confounding from risk profiles of patients in implementing vs. nonimplementing hospitals, they wrote.

Also, the study provides population-level data, which does not guide clinical decision-making about intervals between childbirth and subsequent pregnancy, the researchers emphasized.

Although the data support the value of postpartum contraception in improving birth outcomes, “it is imperative that efforts to expand access focus on assuring comprehensive access to all forms of contraception without coercion,” the researchers concluded. “Additional policy solutions are needed to improve infant health, including those that directly address structural and interpersonal racism to reduce racial disparities in infant health,” they said.

The study is important because, although immediate postpartum LARC policies were first implemented almost a decade ago in the United States, population-level evidence on the effects of these policies remains scarce, Dr. Steenland said in an interview.  

Existing barriers to improving access to immediate postpartum LARC include health professional training and logistics within hospitals, as well as ensuring correct billing and timely reimbursements, Dr. Steenland said. “Simple and clear billing procedures, and advanced reimbursement so that hospitals can have devices stocked would make it easier to provide this service,” she noted.

“This service has gone from being almost completely unavailable, to available in some hospitals, mainly those that are urban, teaching, and high volume,” said Dr. Steenland. “Additional research is needed to determine how health systems can make this service available to all birthing persons,” she said. “Also, critically, additional research is needed to identify strategies to ensure that counseling for immediate postpartum LARC, and family planning more generally, is patient-centered, so that the availability of immediate postpartum LARC increases, rather than restricts, choice,” she added. “Finally, additional research is needed to determine whether postpartum people have affordable and accessible access to LARC removal services,” Dr. Steenland emphasized.
 

Immediate post partum is critical period

The immediate postpartum period is a critical time for access to contraception because many women do not return for postpartum visits after hospital discharge, Tracey A. Wilkinson, MD, and Jeffrey F. Peipert, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. “The focus on contraception access during the postpartum period prior to hospital discharge is important because of the potential sequelae of a subsequent unintended pregnancy or short interpregnancy intervals,” they noted. These issues may be more acute in marginalized communities, and policies to expand immediate postpartum LARC are in place in a majority of states, the editorialists said.

However, they agreed with the authors’ statements that implementation of LARC must be done in a manner that supports patient choice and avoids coercion. Given the baseline disparities of the infant outcomes studied, increased access to immediate postpartum LARC must be provided in a way that does not exacerbate these disparities, they said. “This ultimately means that plans to increase access to contraception should emphasize availability while avoiding coercion, and if a patient ultimately decides to discontinue a method, enable that to occur easily and seamlessly, including LARC device removal,” they explained.

“Future studies examining patient centeredness of these postpartum LARC implementation efforts would be an important element to augment these data and show the impact in additional spheres beyond infant outcomes,” they added.
 

Overcome trust barriers and offer options

“In a time of restrictive access to abortion and contraception in many states, any additional increase in access can potentially be meaningful,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Additionally, given the significantly higher rates of infant and maternal morbidity and mortality among the non-Hispanic Black population, seeing an intervention that can improve outcomes for both mothers and babies is also potentially very positive,” she said.

Dr. Prager said she was not surprised by the study findings, as immediate LARC is much more common in other countries and has shown similar outcomes. “Additionally, I am reassured by the fact that the increased number of days until the next pregnancy is not higher, as this indirectly indicates that patients were able to get their LARC removed when they desired another pregnancy,” she noted.

Barriers to improving access to immediate postpartum LARC in the Medicaid population may include mistrust for any long-acting contraception, “especially if they perceive that cessation of the method will be difficult to achieve,” Dr. Prager noted. “Certainly, counseling about LARC removal should be an element of counseling prior to any initiation, and lack of access to removal of an IUD or implant can be categorized as a form of reproductive coercion,” she said. Dr. Prager said that such counseling might be more effective if it occurred during prenatal visits, “so if providers are not talking about this during routine OB visits and patients only hear about immediate postpartum LARC when they are in the hospital for delivery, they may be less likely to accept the practice,” she said. “Finally, although Medicaid will cover the cost of immediate postpartum LARC, private insurers do not do so consistently in all states, so some hospitals may find this process too difficult to navigate and therefore not offer immediate postpartum LARC,” Dr. Prager emphasized.

As for additional research, Dr. Prager said she would like to see more studies in an overall United States population of pregnant people, both Medicaid patients and others, on whether the immediate postpartum timing of LARC is desired.

“I would like to couple that with patients’ impressions or experiences of their ability to access contraception outside of the immediate postpartum time period, and also their impressions or experience with ability to have LARC removed, since they are the only contraceptives not necessarily within personal control for initiation or cessation,” Dr. Prager said.

The study was supported by the National Institute for Child Health and Development, and lead author Dr. Steenland received support from other National Institutes of Health grants. The researchers had no financial conflicts to disclose. The editorial was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Peipert disclosed serving on advisory boards for Bayer and CooperSurgical, and receiving research support from Merck, Bayer, and CooperSurgical/Teva. Dr. Wilkinson had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Policies increasing access to immediate postpartum long-acting reversible contraception (LARC) were associated with reductions in preterm birth and low birth weight, based on data from South Carolina’s Medicaid program.

Preterm birth and low birth weight represent the second-leading cause of infant mortality in the United States, wrote Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues. Previous policy interventions to reduce preterm birth and low birth weight have focused on services before and during pregnancy, they said. LARC is a safe and effective postpartum intervention, but cost has been a limiting factor, they noted.

In 2012, the Medicaid program in South Carolina began reimbursing hospitals for immediate postpartum LARC independent of global maternity payments. In a previous study, the researchers found that the implementation of this policy had reduced the number of short-interval births among adolescents.

The goal of the current study, published in JAMA Pediatrics, was to analyze the association between South Carolina’s policy change and rates of preterm birth and low birth weight among individuals with Medicaid coverage during childbirth. The researchers analyzed data from 186,953 Medicaid-paid births between January 2009 and December 2015 in South Carolina. Of these, 46,414 births (24.8%) occurred in hospitals that provided immediate postpartum LARC in response to the policy change. Overall, the implementing hospitals had more annual births paid for by Medicaid compared to nonimplementing hospitals (1,105 vs. 511) and were less likely to be rural (33.3% vs. 46.8%) and had a greater share of preterm births (15.5% vs. 9.5%). Prior to the policy change, the probability of a preterm birth in the next 4 years was 4.4% for patients at implementing hospitals and 3.5% for those in nonimplementing hospitals, and the probability of a low-birth-weight birth was 3.6% and 2.9%, respectively.

The policy change was associated with a decrease of 0.4 percentage points for preterm birth and 0.3 percentage points for subsequent low-birth-weight birth.

When the results were stratified based on race and ethnicity, the policy change was associated with a decrease of 0.5 percentage points in the probability of preterm birth in both non-Hispanic Blacks and non-Hispanic Whites. No significant differences appeared in the association between the policy change and rates of preterm birth or low-birth-weight birth between non-Hispanic Black and non-Hispanic White individuals.

However, the policy was associated with a significant decrease of 0.6 percentage points in the probability of short-interval birth among non-Hispanic Blacks, and a decrease of 1.6 percentage points in the probability of another birth within 4 years overall. The policy change also was associated with a significant increase of 27 days between births among non-Hispanic Blacks, but not with any significant change among non-Hispanic Whites or the study population overall.

“In addition, although our data cannot speak to this, the policy may have affected the intendedness of subsequent pregnancies, leading to healthier behaviors before and during pregnancy, such as early initiation of prenatal care,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on pregnancy intention or abortion, and the lack of data on patient-reported outcomes, notably the provision of patient-centered counseling and whether such counseling was biased, the researchers noted. Other limitations included a lack of data on infant mortality and potential confounding from risk profiles of patients in implementing vs. nonimplementing hospitals, they wrote.

Also, the study provides population-level data, which does not guide clinical decision-making about intervals between childbirth and subsequent pregnancy, the researchers emphasized.

Although the data support the value of postpartum contraception in improving birth outcomes, “it is imperative that efforts to expand access focus on assuring comprehensive access to all forms of contraception without coercion,” the researchers concluded. “Additional policy solutions are needed to improve infant health, including those that directly address structural and interpersonal racism to reduce racial disparities in infant health,” they said.

The study is important because, although immediate postpartum LARC policies were first implemented almost a decade ago in the United States, population-level evidence on the effects of these policies remains scarce, Dr. Steenland said in an interview.  

Existing barriers to improving access to immediate postpartum LARC include health professional training and logistics within hospitals, as well as ensuring correct billing and timely reimbursements, Dr. Steenland said. “Simple and clear billing procedures, and advanced reimbursement so that hospitals can have devices stocked would make it easier to provide this service,” she noted.

“This service has gone from being almost completely unavailable, to available in some hospitals, mainly those that are urban, teaching, and high volume,” said Dr. Steenland. “Additional research is needed to determine how health systems can make this service available to all birthing persons,” she said. “Also, critically, additional research is needed to identify strategies to ensure that counseling for immediate postpartum LARC, and family planning more generally, is patient-centered, so that the availability of immediate postpartum LARC increases, rather than restricts, choice,” she added. “Finally, additional research is needed to determine whether postpartum people have affordable and accessible access to LARC removal services,” Dr. Steenland emphasized.
 

Immediate post partum is critical period

The immediate postpartum period is a critical time for access to contraception because many women do not return for postpartum visits after hospital discharge, Tracey A. Wilkinson, MD, and Jeffrey F. Peipert, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. “The focus on contraception access during the postpartum period prior to hospital discharge is important because of the potential sequelae of a subsequent unintended pregnancy or short interpregnancy intervals,” they noted. These issues may be more acute in marginalized communities, and policies to expand immediate postpartum LARC are in place in a majority of states, the editorialists said.

However, they agreed with the authors’ statements that implementation of LARC must be done in a manner that supports patient choice and avoids coercion. Given the baseline disparities of the infant outcomes studied, increased access to immediate postpartum LARC must be provided in a way that does not exacerbate these disparities, they said. “This ultimately means that plans to increase access to contraception should emphasize availability while avoiding coercion, and if a patient ultimately decides to discontinue a method, enable that to occur easily and seamlessly, including LARC device removal,” they explained.

“Future studies examining patient centeredness of these postpartum LARC implementation efforts would be an important element to augment these data and show the impact in additional spheres beyond infant outcomes,” they added.
 

Overcome trust barriers and offer options

“In a time of restrictive access to abortion and contraception in many states, any additional increase in access can potentially be meaningful,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Additionally, given the significantly higher rates of infant and maternal morbidity and mortality among the non-Hispanic Black population, seeing an intervention that can improve outcomes for both mothers and babies is also potentially very positive,” she said.

Dr. Prager said she was not surprised by the study findings, as immediate LARC is much more common in other countries and has shown similar outcomes. “Additionally, I am reassured by the fact that the increased number of days until the next pregnancy is not higher, as this indirectly indicates that patients were able to get their LARC removed when they desired another pregnancy,” she noted.

Barriers to improving access to immediate postpartum LARC in the Medicaid population may include mistrust for any long-acting contraception, “especially if they perceive that cessation of the method will be difficult to achieve,” Dr. Prager noted. “Certainly, counseling about LARC removal should be an element of counseling prior to any initiation, and lack of access to removal of an IUD or implant can be categorized as a form of reproductive coercion,” she said. Dr. Prager said that such counseling might be more effective if it occurred during prenatal visits, “so if providers are not talking about this during routine OB visits and patients only hear about immediate postpartum LARC when they are in the hospital for delivery, they may be less likely to accept the practice,” she said. “Finally, although Medicaid will cover the cost of immediate postpartum LARC, private insurers do not do so consistently in all states, so some hospitals may find this process too difficult to navigate and therefore not offer immediate postpartum LARC,” Dr. Prager emphasized.

As for additional research, Dr. Prager said she would like to see more studies in an overall United States population of pregnant people, both Medicaid patients and others, on whether the immediate postpartum timing of LARC is desired.

“I would like to couple that with patients’ impressions or experiences of their ability to access contraception outside of the immediate postpartum time period, and also their impressions or experience with ability to have LARC removed, since they are the only contraceptives not necessarily within personal control for initiation or cessation,” Dr. Prager said.

The study was supported by the National Institute for Child Health and Development, and lead author Dr. Steenland received support from other National Institutes of Health grants. The researchers had no financial conflicts to disclose. The editorial was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Peipert disclosed serving on advisory boards for Bayer and CooperSurgical, and receiving research support from Merck, Bayer, and CooperSurgical/Teva. Dr. Wilkinson had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Field cancerization and subsequent second cancer in squamous cell carcinoma (SCC) patients was significantly associated with cigarette and alcohol use, based on data from more than 300 individuals.

Cigarette and alcohol use are established risk factors for SCCs of the esophagus, head, and neck, Manabu Moto, MD, of Kyoto University and colleagues wrote. “In addition, squamous cell carcinoma and squamous dysplastic epithelium develop multifocally in these organs,” in a phenomenon known as field cancerization, but the interaction of multiple dysplastic epithelium with other factors, notably whether cessation of cigarette and alcohol use would reduce risk of SCC, has not been well studied.

In a study published in Gastro Hep Advances, the researchers identified 331 adults with newly diagnosed superficial esophageal SCC who underwent endoscopic resection, and 1,022 healthy controls. Field cancerization was based on the number of Lugol-voiding lesions (LVLs) per endoscopic view according to three groups: grade A, 0 LVLs; grade B, 1-9; or grade C, at least 10. The primary study outcome was a measure of risk factors for the development of LVLs.

“Multiple LVLs are closely associated with inactive aldehyde dehydrogenase 2 (ALDH2) and field cancerization,” the researchers wrote. Before assessing their human subjects, they used a mouse model to investigate whether alcohol intake and abstinence would affect acetaldehyde-induced DNA damage to the esophageal epithelium among individuals with ALDH2 dysfunction.

The researchers found that DNA damage, measured by acetaldehyde-derived DNA adduct levels (via N²-ethylidene-dG), accumulated with alcohol consumption over time, but decreased with alcohol cessation in the mouse model.

For the human part of the study, participants completed a lifestyle survey at entry, with questions about alcohol consumption history, alcohol flushing response, smoking, consumption of high-temperature foods, and consumption of green and yellow vegetables and fruit. Drinking status was divided into five groups: never/rarely (of less than 1 unit/week), light (1-8.9 units/week), moderate (9-17.9 units/week), heavy (18 or more units/week), and ex-drinker, with 1 unit defined as 22 g of ethanol. Smoking was divided into three groups: never (0 pack-years), light (less than 30 pack-years), and heavy (30 or more pack-years). Patients were given educational materials at study entry about the importance of alcohol and smoking cessation, as well as verbal advice to cease these behaviors.

Participants underwent endoscopic surveillance at 3-month intervals for up to 6 months following endoscopic resection.

Overall, increased alcohol consumption was associated with increased risk in development of LVL across all LVL grades; higher grades of LVLs were positively associated with high-intensity alcohol consumption, smoking, flushing, and high-temperature foods, and negatively associated with eating vegetables and fruit.

The risk of LVL grade progression was most strongly associated with increased alcohol consumption and with reported flushing. “The greatest risk was observed in the patients with flushing reactions who consumed an average of 30 units per week in grade C LVL,” with an odds ratio of 534, compared with healthy controls. “Since flushing reaction is caused by accumulation of acetaldehyde due to ALDH2 deficient, our result also means that acetaldehyde is a strong carcinogen in field cancerization.”

Secondary outcomes included the incidence of second primary esophageal SCC and head/neck SCC; these were significantly more prevalent in patients with grade C LVL (cumulative 5-year incidence of 47.1% for ESCC and 13.3% for head and neck SCC). However, alcohol and smoking cessation significantly reduced the development of second primary esophageal SCC (adjusted hazard ratios, 0.47 for alcohol and 0.49 for smoking).

The study findings were limited by several factors including the lack of randomization to noncessation and cessation groups and the inclusion of cancer patients, but not long-term cancer survivors, the researchers noted.

“We believe that our data will be useful to establish a prevention and surveillance strategy for cancer survivors, because the overall prognosis of esophageal cancer and head and neck cancer is still poor,” with a 5-year survival rate of less than 20%, and the results highlight the need to educate cancer survivors on the value of smoking and alcohol cessation, they added.

The study was supported by the National Cancer Center Research and Development Fund 36 by the Ministry of Health, Labour, and Welfare of Japan. The researchers had no financial conflicts to disclose.

Field cancerization and subsequent second cancer in squamous cell carcinoma (SCC) patients was significantly associated with cigarette and alcohol use, based on data from more than 300 individuals.

Cigarette and alcohol use are established risk factors for SCCs of the esophagus, head, and neck, Manabu Moto, MD, of Kyoto University and colleagues wrote. “In addition, squamous cell carcinoma and squamous dysplastic epithelium develop multifocally in these organs,” in a phenomenon known as field cancerization, but the interaction of multiple dysplastic epithelium with other factors, notably whether cessation of cigarette and alcohol use would reduce risk of SCC, has not been well studied.

In a study published in Gastro Hep Advances, the researchers identified 331 adults with newly diagnosed superficial esophageal SCC who underwent endoscopic resection, and 1,022 healthy controls. Field cancerization was based on the number of Lugol-voiding lesions (LVLs) per endoscopic view according to three groups: grade A, 0 LVLs; grade B, 1-9; or grade C, at least 10. The primary study outcome was a measure of risk factors for the development of LVLs.

“Multiple LVLs are closely associated with inactive aldehyde dehydrogenase 2 (ALDH2) and field cancerization,” the researchers wrote. Before assessing their human subjects, they used a mouse model to investigate whether alcohol intake and abstinence would affect acetaldehyde-induced DNA damage to the esophageal epithelium among individuals with ALDH2 dysfunction.

The researchers found that DNA damage, measured by acetaldehyde-derived DNA adduct levels (via N²-ethylidene-dG), accumulated with alcohol consumption over time, but decreased with alcohol cessation in the mouse model.

For the human part of the study, participants completed a lifestyle survey at entry, with questions about alcohol consumption history, alcohol flushing response, smoking, consumption of high-temperature foods, and consumption of green and yellow vegetables and fruit. Drinking status was divided into five groups: never/rarely (of less than 1 unit/week), light (1-8.9 units/week), moderate (9-17.9 units/week), heavy (18 or more units/week), and ex-drinker, with 1 unit defined as 22 g of ethanol. Smoking was divided into three groups: never (0 pack-years), light (less than 30 pack-years), and heavy (30 or more pack-years). Patients were given educational materials at study entry about the importance of alcohol and smoking cessation, as well as verbal advice to cease these behaviors.

Participants underwent endoscopic surveillance at 3-month intervals for up to 6 months following endoscopic resection.

Overall, increased alcohol consumption was associated with increased risk in development of LVL across all LVL grades; higher grades of LVLs were positively associated with high-intensity alcohol consumption, smoking, flushing, and high-temperature foods, and negatively associated with eating vegetables and fruit.

The risk of LVL grade progression was most strongly associated with increased alcohol consumption and with reported flushing. “The greatest risk was observed in the patients with flushing reactions who consumed an average of 30 units per week in grade C LVL,” with an odds ratio of 534, compared with healthy controls. “Since flushing reaction is caused by accumulation of acetaldehyde due to ALDH2 deficient, our result also means that acetaldehyde is a strong carcinogen in field cancerization.”

Secondary outcomes included the incidence of second primary esophageal SCC and head/neck SCC; these were significantly more prevalent in patients with grade C LVL (cumulative 5-year incidence of 47.1% for ESCC and 13.3% for head and neck SCC). However, alcohol and smoking cessation significantly reduced the development of second primary esophageal SCC (adjusted hazard ratios, 0.47 for alcohol and 0.49 for smoking).

The study findings were limited by several factors including the lack of randomization to noncessation and cessation groups and the inclusion of cancer patients, but not long-term cancer survivors, the researchers noted.

“We believe that our data will be useful to establish a prevention and surveillance strategy for cancer survivors, because the overall prognosis of esophageal cancer and head and neck cancer is still poor,” with a 5-year survival rate of less than 20%, and the results highlight the need to educate cancer survivors on the value of smoking and alcohol cessation, they added.

The study was supported by the National Cancer Center Research and Development Fund 36 by the Ministry of Health, Labour, and Welfare of Japan. The researchers had no financial conflicts to disclose.

Field cancerization and subsequent second cancer in squamous cell carcinoma (SCC) patients was significantly associated with cigarette and alcohol use, based on data from more than 300 individuals.

Cigarette and alcohol use are established risk factors for SCCs of the esophagus, head, and neck, Manabu Moto, MD, of Kyoto University and colleagues wrote. “In addition, squamous cell carcinoma and squamous dysplastic epithelium develop multifocally in these organs,” in a phenomenon known as field cancerization, but the interaction of multiple dysplastic epithelium with other factors, notably whether cessation of cigarette and alcohol use would reduce risk of SCC, has not been well studied.

In a study published in Gastro Hep Advances, the researchers identified 331 adults with newly diagnosed superficial esophageal SCC who underwent endoscopic resection, and 1,022 healthy controls. Field cancerization was based on the number of Lugol-voiding lesions (LVLs) per endoscopic view according to three groups: grade A, 0 LVLs; grade B, 1-9; or grade C, at least 10. The primary study outcome was a measure of risk factors for the development of LVLs.

“Multiple LVLs are closely associated with inactive aldehyde dehydrogenase 2 (ALDH2) and field cancerization,” the researchers wrote. Before assessing their human subjects, they used a mouse model to investigate whether alcohol intake and abstinence would affect acetaldehyde-induced DNA damage to the esophageal epithelium among individuals with ALDH2 dysfunction.

The researchers found that DNA damage, measured by acetaldehyde-derived DNA adduct levels (via N²-ethylidene-dG), accumulated with alcohol consumption over time, but decreased with alcohol cessation in the mouse model.

For the human part of the study, participants completed a lifestyle survey at entry, with questions about alcohol consumption history, alcohol flushing response, smoking, consumption of high-temperature foods, and consumption of green and yellow vegetables and fruit. Drinking status was divided into five groups: never/rarely (of less than 1 unit/week), light (1-8.9 units/week), moderate (9-17.9 units/week), heavy (18 or more units/week), and ex-drinker, with 1 unit defined as 22 g of ethanol. Smoking was divided into three groups: never (0 pack-years), light (less than 30 pack-years), and heavy (30 or more pack-years). Patients were given educational materials at study entry about the importance of alcohol and smoking cessation, as well as verbal advice to cease these behaviors.

Participants underwent endoscopic surveillance at 3-month intervals for up to 6 months following endoscopic resection.

Overall, increased alcohol consumption was associated with increased risk in development of LVL across all LVL grades; higher grades of LVLs were positively associated with high-intensity alcohol consumption, smoking, flushing, and high-temperature foods, and negatively associated with eating vegetables and fruit.

The risk of LVL grade progression was most strongly associated with increased alcohol consumption and with reported flushing. “The greatest risk was observed in the patients with flushing reactions who consumed an average of 30 units per week in grade C LVL,” with an odds ratio of 534, compared with healthy controls. “Since flushing reaction is caused by accumulation of acetaldehyde due to ALDH2 deficient, our result also means that acetaldehyde is a strong carcinogen in field cancerization.”

Secondary outcomes included the incidence of second primary esophageal SCC and head/neck SCC; these were significantly more prevalent in patients with grade C LVL (cumulative 5-year incidence of 47.1% for ESCC and 13.3% for head and neck SCC). However, alcohol and smoking cessation significantly reduced the development of second primary esophageal SCC (adjusted hazard ratios, 0.47 for alcohol and 0.49 for smoking).

The study findings were limited by several factors including the lack of randomization to noncessation and cessation groups and the inclusion of cancer patients, but not long-term cancer survivors, the researchers noted.

“We believe that our data will be useful to establish a prevention and surveillance strategy for cancer survivors, because the overall prognosis of esophageal cancer and head and neck cancer is still poor,” with a 5-year survival rate of less than 20%, and the results highlight the need to educate cancer survivors on the value of smoking and alcohol cessation, they added.

The study was supported by the National Cancer Center Research and Development Fund 36 by the Ministry of Health, Labour, and Welfare of Japan. The researchers had no financial conflicts to disclose.

Older adults who avoided hospital admission with at-home geriatric assessment and home-based care incurred significantly lower costs compared with those hospitalized, in a new study.

The comprehensive geriatric assessment (CGA) is an established strategy for guiding care of older adults in a hospital setting, but its use in other settings has not been well studied, Surya Singh, PhD, of the University of Oxford (England), and colleagues wrote in their paper published in Age and Ageing. Hospital at home is active treatment by health care professionals in the patient’s home for a condition that otherwise would require acute hospital inpatient care, for a limited time period.

Interest in providing health care in the home as an alternative to hospitalization is on the rise as a way to improve patient outcomes and reduce costs, but actual cost-effectiveness data on HAH interventions are limited, the authors said. “Wide scale implementation of such services has also been constrained by the practical difficulties of designing and delivering services that cut across primary and secondary care, might involve social care and require different workforce and funding arrangements.”

In this study, the researchers conducted a cost-effectiveness analysis alongside a randomized trial of an admission avoidance CGA hospital at home (CGAHAH) service as an alternative to hospital admission. They identified individuals aged 65 years and older who were living in the community but being considered for an unplanned hospital admission in the United Kingdom. A total of 700 individuals were randomized to CGAHAH and 355 to hospital care using a 2:1 ratio. Patients were assessed at baseline in the community or in an acute care setting before being transferred to CGAHAH service. These services included access to social workers, home care, district nursing, community rehabilitation, community mental health services and acute hospital services, such as diagnostic tests and transfer to hospital. The core workforce usually included consultant geriatricians, junior doctors, nurse practitioners, health care assistants or support workers, physiotherapists, occupational therapists, and community pharmacists. There were at least daily virtual ward rounds
 

Comparison between HAH and in-hospital groups

Patients in the CGAHAH group had a mean of 7.17 days of care, and those in hospital had a mean of 4.92 hospital days. At 6 months’ follow-up, the mean number of care days was 9.47 in the CGAHAH group and 10.58 in the hospital group, which was a nonsignificant difference.

“For complete cases, we found that allocation to CGAHAH resulted in 3 fewer days in hospital, a difference that was reduced to 1 day at 6 months follow-up,” the researchers wrote.

Overall, after adjusting for baseline variables, the health and social care costs after 6 months were less for CGAHAH than admission to hospital. The average cost differences between the two were approximately $3,000 or 2,265 pounds. The cost difference remained and increased to a mean difference of 2,840 pounds in favor of HAH after adding informal care/societal costs.

In addition, patients randomized to CGAHAH were less likely to have been admitted to long-term residential care at 6 months follow-up, compared with the hospital group; the mean days in residential care at 6 months were 3.43 and 6.14, respectively.

Both groups showed an approximate 15% decrease in measures of quality of life from baseline to 6 months, and no differences were noted in quality-adjusted survival between the groups.
 

Pandemic ‘has accelerated interest’ in HAH

“Health systems around the world are exploring alternatives to hospital admission, such as hospital at home, to act as a buffer to the increasing demand for hospital care,” corresponding author Sasha Shepperd, MSc, DPhil, said in an interview. “This is partly due to a growing older population with increased health needs, but also an emphasis on providing health care that limits a decline in capacity for the older population. Inevitably, the COVID-19 pandemic has accelerated interest in hospital at home to create additional acute health care capacity.”

The take home-message supports the home service option. “If you can access a hospital-at-home service, consider this as an option for older people who would otherwise be admitted to hospital and are eligible for hospital at home care. However, is important that the provision of hospital at home is adequately resourced, and that families and caregivers are supported,” she said.

“Barriers include delivering a different type of service that requires easy access to hospital services, including admission if required; a trained workforce to provide multidisciplinary care in a patient’s home; and ensuring a good fit with existing health and social care services,” Dr. Shepperd said.

Future research areas include the demands placed on caregivers from hospital-at-home services, and how the provision of hospital at home impacts hospital and community services, she added.

Findings support use of HAH

The data from the current study support the use of a hospital at home concept, especially in the geriatric age population, for acute health conditions that could be managed at home rather than acutely in a hospital-based environment,” Noel Deep, MD, emphasized in an interview.

Dr. Deep, who is a general internist in group practice in Antigo, Wisc., said he was not surprised by the study findings.

“I am a big proponent of the hospital at home approach to taking care of patients who can be safely and appropriately managed in the familiarity and comfort of their own home environment with help from physicians, nurses, and other home health care services,” he said. “It is a valuable option for appropriately screened and selected patients to be provided this approach to management of their acute health care situations.”

Primary care physicians should explore using HAH when faced with the decision of admitting an elderly individual to the hospital for management of an acute worsening of a chronic medical condition or a reversible acute illness, said Dr. Deep, who serves on the editorial advisory board of Internal Medicine News.

The current study reinforces previous studies and data showing the benefits of managing acute health problems of elderly individuals in their home environment. These benefits include “an opportunity to free up the emergency rooms and hospitals for providing care to those individuals who truly would be best served by being admitted to the hospital,” Dr. Deep explained. Home care for the elderly “would also lead to decreased utilization of the personal protective equipment and limit exposure of the vulnerable elderly individuals to the coronavirus. Primary care physicians should always explore this possibility of providing care to the patients in their homes if it is a viable option.

“While our practice environment [in the United States] is slightly different than that referenced in this article, many, if not almost all, of our primary care physicians provide care to the geriatric age population and provide assessment and management which would be comparable to this comprehensive geriatric assessment that is discussed in the article,” and many primary care physicians have seen similar results in outcomes that the study shows, said Dr. Deep. The available research and expert opinions are quite similar and agree upon the positive outcomes in terms of providing the CGAHAH approach.
 

Study is important but raises questions

The study is important because patient-centered, effective care should be the goal of any health system, William Golden, MD, of the University of Arkansas for Medical Sciences, Little Rock, said in an interview. 

Dr. Golden also noted that the study raised a number of questions. How each patient entered the treatment protocol was not clear. “Similarly, it is not clear whether admission criteria and resource costs in England cross to the United States experience.”

“Having close follow up of patients at home as opposed to an ‘observation status’ could be a nice innovation, but more details are needed to consider implementation in a specific community setting,” he emphasized.

As for the clinical value of the study for primary care, “primary care professionals should welcome well-staffed alternatives to inpatient care for select patient presentations,” said Dr. Golden, who is also a member of the editorial advisory board of Internal Medicine News.

The current study does not identify the conditions that were treated at home and the logistics of delivering such services, which limits comparison with what experts have seen in practice in terms of outcomes using the CGAHAH, he said. “Interested practitioners would benefit from literature detailing the staffing and decision support tools that form the core framework of this innovation.”
 

Limitations and strengths of study, according to authors

The study findings were limited by several factors including the calculation of CGAHAH based on service budgets, rather than from collecting information on the actual resources used; potential errors in patients’ estimation of their informal care; and lack of data on a differential impact of CGAHAH for underserved communities, the researchers noted.

However, the results were strengthened by the large study population and randomized design, and support the value of CGAHAH, which addresses the need for management of multiple long-term conditions and the potential decline in functional and cognitive ability in older adults, they said. Providing CGAHAH as an alternative to admission to hospital for older people, with a focus on multidimensional assessment, is one option that might reduce reliance on hospitalization and residential care and at a lower cost.

The study was supported by the National Institute for Health Research, and several coauthors received individual grants from the NIHR, with no other financial conflicts to disclose. Dr. Golden and Dr. Deep had no financial conflicts to disclose.

Older adults who avoided hospital admission with at-home geriatric assessment and home-based care incurred significantly lower costs compared with those hospitalized, in a new study.

The comprehensive geriatric assessment (CGA) is an established strategy for guiding care of older adults in a hospital setting, but its use in other settings has not been well studied, Surya Singh, PhD, of the University of Oxford (England), and colleagues wrote in their paper published in Age and Ageing. Hospital at home is active treatment by health care professionals in the patient’s home for a condition that otherwise would require acute hospital inpatient care, for a limited time period.

Interest in providing health care in the home as an alternative to hospitalization is on the rise as a way to improve patient outcomes and reduce costs, but actual cost-effectiveness data on HAH interventions are limited, the authors said. “Wide scale implementation of such services has also been constrained by the practical difficulties of designing and delivering services that cut across primary and secondary care, might involve social care and require different workforce and funding arrangements.”

In this study, the researchers conducted a cost-effectiveness analysis alongside a randomized trial of an admission avoidance CGA hospital at home (CGAHAH) service as an alternative to hospital admission. They identified individuals aged 65 years and older who were living in the community but being considered for an unplanned hospital admission in the United Kingdom. A total of 700 individuals were randomized to CGAHAH and 355 to hospital care using a 2:1 ratio. Patients were assessed at baseline in the community or in an acute care setting before being transferred to CGAHAH service. These services included access to social workers, home care, district nursing, community rehabilitation, community mental health services and acute hospital services, such as diagnostic tests and transfer to hospital. The core workforce usually included consultant geriatricians, junior doctors, nurse practitioners, health care assistants or support workers, physiotherapists, occupational therapists, and community pharmacists. There were at least daily virtual ward rounds
 

Comparison between HAH and in-hospital groups

Patients in the CGAHAH group had a mean of 7.17 days of care, and those in hospital had a mean of 4.92 hospital days. At 6 months’ follow-up, the mean number of care days was 9.47 in the CGAHAH group and 10.58 in the hospital group, which was a nonsignificant difference.

“For complete cases, we found that allocation to CGAHAH resulted in 3 fewer days in hospital, a difference that was reduced to 1 day at 6 months follow-up,” the researchers wrote.

Overall, after adjusting for baseline variables, the health and social care costs after 6 months were less for CGAHAH than admission to hospital. The average cost differences between the two were approximately $3,000 or 2,265 pounds. The cost difference remained and increased to a mean difference of 2,840 pounds in favor of HAH after adding informal care/societal costs.

In addition, patients randomized to CGAHAH were less likely to have been admitted to long-term residential care at 6 months follow-up, compared with the hospital group; the mean days in residential care at 6 months were 3.43 and 6.14, respectively.

Both groups showed an approximate 15% decrease in measures of quality of life from baseline to 6 months, and no differences were noted in quality-adjusted survival between the groups.
 

Pandemic ‘has accelerated interest’ in HAH

“Health systems around the world are exploring alternatives to hospital admission, such as hospital at home, to act as a buffer to the increasing demand for hospital care,” corresponding author Sasha Shepperd, MSc, DPhil, said in an interview. “This is partly due to a growing older population with increased health needs, but also an emphasis on providing health care that limits a decline in capacity for the older population. Inevitably, the COVID-19 pandemic has accelerated interest in hospital at home to create additional acute health care capacity.”

The take home-message supports the home service option. “If you can access a hospital-at-home service, consider this as an option for older people who would otherwise be admitted to hospital and are eligible for hospital at home care. However, is important that the provision of hospital at home is adequately resourced, and that families and caregivers are supported,” she said.

“Barriers include delivering a different type of service that requires easy access to hospital services, including admission if required; a trained workforce to provide multidisciplinary care in a patient’s home; and ensuring a good fit with existing health and social care services,” Dr. Shepperd said.

Future research areas include the demands placed on caregivers from hospital-at-home services, and how the provision of hospital at home impacts hospital and community services, she added.

Findings support use of HAH

The data from the current study support the use of a hospital at home concept, especially in the geriatric age population, for acute health conditions that could be managed at home rather than acutely in a hospital-based environment,” Noel Deep, MD, emphasized in an interview.

Dr. Deep, who is a general internist in group practice in Antigo, Wisc., said he was not surprised by the study findings.

“I am a big proponent of the hospital at home approach to taking care of patients who can be safely and appropriately managed in the familiarity and comfort of their own home environment with help from physicians, nurses, and other home health care services,” he said. “It is a valuable option for appropriately screened and selected patients to be provided this approach to management of their acute health care situations.”

Primary care physicians should explore using HAH when faced with the decision of admitting an elderly individual to the hospital for management of an acute worsening of a chronic medical condition or a reversible acute illness, said Dr. Deep, who serves on the editorial advisory board of Internal Medicine News.

The current study reinforces previous studies and data showing the benefits of managing acute health problems of elderly individuals in their home environment. These benefits include “an opportunity to free up the emergency rooms and hospitals for providing care to those individuals who truly would be best served by being admitted to the hospital,” Dr. Deep explained. Home care for the elderly “would also lead to decreased utilization of the personal protective equipment and limit exposure of the vulnerable elderly individuals to the coronavirus. Primary care physicians should always explore this possibility of providing care to the patients in their homes if it is a viable option.

“While our practice environment [in the United States] is slightly different than that referenced in this article, many, if not almost all, of our primary care physicians provide care to the geriatric age population and provide assessment and management which would be comparable to this comprehensive geriatric assessment that is discussed in the article,” and many primary care physicians have seen similar results in outcomes that the study shows, said Dr. Deep. The available research and expert opinions are quite similar and agree upon the positive outcomes in terms of providing the CGAHAH approach.
 

Study is important but raises questions

The study is important because patient-centered, effective care should be the goal of any health system, William Golden, MD, of the University of Arkansas for Medical Sciences, Little Rock, said in an interview. 

Dr. Golden also noted that the study raised a number of questions. How each patient entered the treatment protocol was not clear. “Similarly, it is not clear whether admission criteria and resource costs in England cross to the United States experience.”

“Having close follow up of patients at home as opposed to an ‘observation status’ could be a nice innovation, but more details are needed to consider implementation in a specific community setting,” he emphasized.

As for the clinical value of the study for primary care, “primary care professionals should welcome well-staffed alternatives to inpatient care for select patient presentations,” said Dr. Golden, who is also a member of the editorial advisory board of Internal Medicine News.

The current study does not identify the conditions that were treated at home and the logistics of delivering such services, which limits comparison with what experts have seen in practice in terms of outcomes using the CGAHAH, he said. “Interested practitioners would benefit from literature detailing the staffing and decision support tools that form the core framework of this innovation.”
 

Limitations and strengths of study, according to authors

The study findings were limited by several factors including the calculation of CGAHAH based on service budgets, rather than from collecting information on the actual resources used; potential errors in patients’ estimation of their informal care; and lack of data on a differential impact of CGAHAH for underserved communities, the researchers noted.

However, the results were strengthened by the large study population and randomized design, and support the value of CGAHAH, which addresses the need for management of multiple long-term conditions and the potential decline in functional and cognitive ability in older adults, they said. Providing CGAHAH as an alternative to admission to hospital for older people, with a focus on multidimensional assessment, is one option that might reduce reliance on hospitalization and residential care and at a lower cost.

The study was supported by the National Institute for Health Research, and several coauthors received individual grants from the NIHR, with no other financial conflicts to disclose. Dr. Golden and Dr. Deep had no financial conflicts to disclose.

Older adults who avoided hospital admission with at-home geriatric assessment and home-based care incurred significantly lower costs compared with those hospitalized, in a new study.

The comprehensive geriatric assessment (CGA) is an established strategy for guiding care of older adults in a hospital setting, but its use in other settings has not been well studied, Surya Singh, PhD, of the University of Oxford (England), and colleagues wrote in their paper published in Age and Ageing. Hospital at home is active treatment by health care professionals in the patient’s home for a condition that otherwise would require acute hospital inpatient care, for a limited time period.

Interest in providing health care in the home as an alternative to hospitalization is on the rise as a way to improve patient outcomes and reduce costs, but actual cost-effectiveness data on HAH interventions are limited, the authors said. “Wide scale implementation of such services has also been constrained by the practical difficulties of designing and delivering services that cut across primary and secondary care, might involve social care and require different workforce and funding arrangements.”

In this study, the researchers conducted a cost-effectiveness analysis alongside a randomized trial of an admission avoidance CGA hospital at home (CGAHAH) service as an alternative to hospital admission. They identified individuals aged 65 years and older who were living in the community but being considered for an unplanned hospital admission in the United Kingdom. A total of 700 individuals were randomized to CGAHAH and 355 to hospital care using a 2:1 ratio. Patients were assessed at baseline in the community or in an acute care setting before being transferred to CGAHAH service. These services included access to social workers, home care, district nursing, community rehabilitation, community mental health services and acute hospital services, such as diagnostic tests and transfer to hospital. The core workforce usually included consultant geriatricians, junior doctors, nurse practitioners, health care assistants or support workers, physiotherapists, occupational therapists, and community pharmacists. There were at least daily virtual ward rounds
 

Comparison between HAH and in-hospital groups

Patients in the CGAHAH group had a mean of 7.17 days of care, and those in hospital had a mean of 4.92 hospital days. At 6 months’ follow-up, the mean number of care days was 9.47 in the CGAHAH group and 10.58 in the hospital group, which was a nonsignificant difference.

“For complete cases, we found that allocation to CGAHAH resulted in 3 fewer days in hospital, a difference that was reduced to 1 day at 6 months follow-up,” the researchers wrote.

Overall, after adjusting for baseline variables, the health and social care costs after 6 months were less for CGAHAH than admission to hospital. The average cost differences between the two were approximately $3,000 or 2,265 pounds. The cost difference remained and increased to a mean difference of 2,840 pounds in favor of HAH after adding informal care/societal costs.

In addition, patients randomized to CGAHAH were less likely to have been admitted to long-term residential care at 6 months follow-up, compared with the hospital group; the mean days in residential care at 6 months were 3.43 and 6.14, respectively.

Both groups showed an approximate 15% decrease in measures of quality of life from baseline to 6 months, and no differences were noted in quality-adjusted survival between the groups.
 

Pandemic ‘has accelerated interest’ in HAH

“Health systems around the world are exploring alternatives to hospital admission, such as hospital at home, to act as a buffer to the increasing demand for hospital care,” corresponding author Sasha Shepperd, MSc, DPhil, said in an interview. “This is partly due to a growing older population with increased health needs, but also an emphasis on providing health care that limits a decline in capacity for the older population. Inevitably, the COVID-19 pandemic has accelerated interest in hospital at home to create additional acute health care capacity.”

The take home-message supports the home service option. “If you can access a hospital-at-home service, consider this as an option for older people who would otherwise be admitted to hospital and are eligible for hospital at home care. However, is important that the provision of hospital at home is adequately resourced, and that families and caregivers are supported,” she said.

“Barriers include delivering a different type of service that requires easy access to hospital services, including admission if required; a trained workforce to provide multidisciplinary care in a patient’s home; and ensuring a good fit with existing health and social care services,” Dr. Shepperd said.

Future research areas include the demands placed on caregivers from hospital-at-home services, and how the provision of hospital at home impacts hospital and community services, she added.

Findings support use of HAH

The data from the current study support the use of a hospital at home concept, especially in the geriatric age population, for acute health conditions that could be managed at home rather than acutely in a hospital-based environment,” Noel Deep, MD, emphasized in an interview.

Dr. Deep, who is a general internist in group practice in Antigo, Wisc., said he was not surprised by the study findings.

“I am a big proponent of the hospital at home approach to taking care of patients who can be safely and appropriately managed in the familiarity and comfort of their own home environment with help from physicians, nurses, and other home health care services,” he said. “It is a valuable option for appropriately screened and selected patients to be provided this approach to management of their acute health care situations.”

Primary care physicians should explore using HAH when faced with the decision of admitting an elderly individual to the hospital for management of an acute worsening of a chronic medical condition or a reversible acute illness, said Dr. Deep, who serves on the editorial advisory board of Internal Medicine News.

The current study reinforces previous studies and data showing the benefits of managing acute health problems of elderly individuals in their home environment. These benefits include “an opportunity to free up the emergency rooms and hospitals for providing care to those individuals who truly would be best served by being admitted to the hospital,” Dr. Deep explained. Home care for the elderly “would also lead to decreased utilization of the personal protective equipment and limit exposure of the vulnerable elderly individuals to the coronavirus. Primary care physicians should always explore this possibility of providing care to the patients in their homes if it is a viable option.

“While our practice environment [in the United States] is slightly different than that referenced in this article, many, if not almost all, of our primary care physicians provide care to the geriatric age population and provide assessment and management which would be comparable to this comprehensive geriatric assessment that is discussed in the article,” and many primary care physicians have seen similar results in outcomes that the study shows, said Dr. Deep. The available research and expert opinions are quite similar and agree upon the positive outcomes in terms of providing the CGAHAH approach.
 

Study is important but raises questions

The study is important because patient-centered, effective care should be the goal of any health system, William Golden, MD, of the University of Arkansas for Medical Sciences, Little Rock, said in an interview. 

Dr. Golden also noted that the study raised a number of questions. How each patient entered the treatment protocol was not clear. “Similarly, it is not clear whether admission criteria and resource costs in England cross to the United States experience.”

“Having close follow up of patients at home as opposed to an ‘observation status’ could be a nice innovation, but more details are needed to consider implementation in a specific community setting,” he emphasized.

As for the clinical value of the study for primary care, “primary care professionals should welcome well-staffed alternatives to inpatient care for select patient presentations,” said Dr. Golden, who is also a member of the editorial advisory board of Internal Medicine News.

The current study does not identify the conditions that were treated at home and the logistics of delivering such services, which limits comparison with what experts have seen in practice in terms of outcomes using the CGAHAH, he said. “Interested practitioners would benefit from literature detailing the staffing and decision support tools that form the core framework of this innovation.”
 

Limitations and strengths of study, according to authors

The study findings were limited by several factors including the calculation of CGAHAH based on service budgets, rather than from collecting information on the actual resources used; potential errors in patients’ estimation of their informal care; and lack of data on a differential impact of CGAHAH for underserved communities, the researchers noted.

However, the results were strengthened by the large study population and randomized design, and support the value of CGAHAH, which addresses the need for management of multiple long-term conditions and the potential decline in functional and cognitive ability in older adults, they said. Providing CGAHAH as an alternative to admission to hospital for older people, with a focus on multidimensional assessment, is one option that might reduce reliance on hospitalization and residential care and at a lower cost.

The study was supported by the National Institute for Health Research, and several coauthors received individual grants from the NIHR, with no other financial conflicts to disclose. Dr. Golden and Dr. Deep had no financial conflicts to disclose.

Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

A steroid-free clinical response had no impact on multiple components of Crohn’s disease progression, based on data from 95 adults.

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.

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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 immunosuppressants. 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.

A steroid-free clinical response had no impact on multiple components of Crohn’s disease progression, based on data from 95 adults.

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 immunosuppressants. 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.

A steroid-free clinical response had no impact on multiple components of Crohn’s disease progression, based on data from 95 adults.

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 immunosuppressants. 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.