Kate Johnson

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

Unless pneumonia is suspected, clinicians should not prescribe antibiotics for most children with chest infections, according to findings of the ARTIC-PC randomized controlled trial, published in The Lancet.

“Prescribing for children with uncomplicated chest infections is still common in most countries,” said lead author Paul Little, MD, professor of primary care research at the University of Southampton, England, in an interview.

But there are barriers to stopping this practice, he said. “If you prescribe an antibiotic and the child gets better, even if the antibiotic was not doing that much, the parents then think that it was the antibiotic that was responsible for the recovery and so expect antibiotics the next time. So, physician prescribing of antibiotics in effect medicalizes illness and keeps the cycle of expectations, reconsultations, and prescriptions going.”

The study included 432 children aged 6 months to 12 years (median age, 3.2 years) who presented at 56 general practices in England with acute, uncomplicated lower respiratory tract infection (LRTI) of less than 21 days’ duration and in whom pneumonia was not suspected clinically. The children were randomly assigned to undergo 7 days of treatment with either amoxicillin 50 mg/kg or placebo. The primary outcome was duration of symptoms rated moderately bad or worse.

For up to 4 weeks, parents scored symptoms – including cough, phlegm, shortness of breath, wheeze, blocked or runny nose, disturbed sleep, feeling generally unwell, fever, and interference with normal activities – in a daily diary. The secondary outcome was symptom severity. Prespecified analyses were made for key clinical subgroups of patients for whom clinicians commonly prescribe (those with chest signs, fever, physician rating of unwell, sputum or chest rattle, and shortness of breath).

There was no significant difference in outcome between children treated with antibiotics and those treated with placebo. The median duration of moderately bad or worse symptoms was similar between the antibiotics group and the placebo group (5 vs. 6 days; hazard ratio, 1.13), as was the median time until symptoms were rated absent or as causing very little problem (7 vs. 8 days; HR, 1.09). There was a small significant difference between the groups in symptom severity score on days 2-4 after seeing the doctor (1.8 in the antibiotics group vs. 2.1 in the placebo group), “which was equivalent to less than one child in three rating symptoms a slight problem rather than very little problem,” the study authors report. “The treatment effects for all outcomes were similar for most subgroups ... but the effect of antibiotics was slightly, but not significantly, greater among those with fever or those who were unwell,” they add.

The investigators conclude that “similar to adults, antibiotics are unlikely to make a clinically important difference to the symptom burden for uncomplicated lower respiratory tract infections in children – both overall, and for the key clinical subgroups where antibiotic prescribing is most common.” They recommend that clinicians provide “safety-netting advice” to parents, such as explaining what illness course to expect and when a return visit would be necessary.

The findings provide “more evidence to do less,” wrote Rianne Oostenbrink, MD, PhD, from Erasmus MC-Sophia, in Rotterdam, the Netherlands, and Lina Jankauskaite, MD, PhD, from Lithuanian University of Health Sciences, Kaunas, in an accompanying comment.

“Overtesting and overtreatment of children are especially prominent in infectious diseases, when fever or other symptoms such as cough can be unspecific and can be of viral or bacterial origin,” they write.

The commenters note that despite antibiotics, most children did have moderately bad or worse symptoms on day 3, and symptoms had improved in about 75% of children in both groups at day 14. “A notable finding of this study is that only a few children had moderately bad or worse symptoms by day 14, and antibiotics did not alleviate the symptoms compared with placebo. Additionally, this trial aligns with other studies that have shown that reducing antibiotic treatment for LRTI is not associated with prolonged morbidity or higher incidence of complications.”

The study was funded by the UK National Institute for Health Research. Dr. Little, Dr. Jankauskaite, and Dr. Oostenbrink have disclosed no relevant financial relationships.

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

Unless pneumonia is suspected, clinicians should not prescribe antibiotics for most children with chest infections, according to findings of the ARTIC-PC randomized controlled trial, published in The Lancet.

“Prescribing for children with uncomplicated chest infections is still common in most countries,” said lead author Paul Little, MD, professor of primary care research at the University of Southampton, England, in an interview.

But there are barriers to stopping this practice, he said. “If you prescribe an antibiotic and the child gets better, even if the antibiotic was not doing that much, the parents then think that it was the antibiotic that was responsible for the recovery and so expect antibiotics the next time. So, physician prescribing of antibiotics in effect medicalizes illness and keeps the cycle of expectations, reconsultations, and prescriptions going.”

The study included 432 children aged 6 months to 12 years (median age, 3.2 years) who presented at 56 general practices in England with acute, uncomplicated lower respiratory tract infection (LRTI) of less than 21 days’ duration and in whom pneumonia was not suspected clinically. The children were randomly assigned to undergo 7 days of treatment with either amoxicillin 50 mg/kg or placebo. The primary outcome was duration of symptoms rated moderately bad or worse.

For up to 4 weeks, parents scored symptoms – including cough, phlegm, shortness of breath, wheeze, blocked or runny nose, disturbed sleep, feeling generally unwell, fever, and interference with normal activities – in a daily diary. The secondary outcome was symptom severity. Prespecified analyses were made for key clinical subgroups of patients for whom clinicians commonly prescribe (those with chest signs, fever, physician rating of unwell, sputum or chest rattle, and shortness of breath).

There was no significant difference in outcome between children treated with antibiotics and those treated with placebo. The median duration of moderately bad or worse symptoms was similar between the antibiotics group and the placebo group (5 vs. 6 days; hazard ratio, 1.13), as was the median time until symptoms were rated absent or as causing very little problem (7 vs. 8 days; HR, 1.09). There was a small significant difference between the groups in symptom severity score on days 2-4 after seeing the doctor (1.8 in the antibiotics group vs. 2.1 in the placebo group), “which was equivalent to less than one child in three rating symptoms a slight problem rather than very little problem,” the study authors report. “The treatment effects for all outcomes were similar for most subgroups ... but the effect of antibiotics was slightly, but not significantly, greater among those with fever or those who were unwell,” they add.

The investigators conclude that “similar to adults, antibiotics are unlikely to make a clinically important difference to the symptom burden for uncomplicated lower respiratory tract infections in children – both overall, and for the key clinical subgroups where antibiotic prescribing is most common.” They recommend that clinicians provide “safety-netting advice” to parents, such as explaining what illness course to expect and when a return visit would be necessary.

The findings provide “more evidence to do less,” wrote Rianne Oostenbrink, MD, PhD, from Erasmus MC-Sophia, in Rotterdam, the Netherlands, and Lina Jankauskaite, MD, PhD, from Lithuanian University of Health Sciences, Kaunas, in an accompanying comment.

“Overtesting and overtreatment of children are especially prominent in infectious diseases, when fever or other symptoms such as cough can be unspecific and can be of viral or bacterial origin,” they write.

The commenters note that despite antibiotics, most children did have moderately bad or worse symptoms on day 3, and symptoms had improved in about 75% of children in both groups at day 14. “A notable finding of this study is that only a few children had moderately bad or worse symptoms by day 14, and antibiotics did not alleviate the symptoms compared with placebo. Additionally, this trial aligns with other studies that have shown that reducing antibiotic treatment for LRTI is not associated with prolonged morbidity or higher incidence of complications.”

The study was funded by the UK National Institute for Health Research. Dr. Little, Dr. Jankauskaite, and Dr. Oostenbrink have disclosed no relevant financial relationships.

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

Unless pneumonia is suspected, clinicians should not prescribe antibiotics for most children with chest infections, according to findings of the ARTIC-PC randomized controlled trial, published in The Lancet.

“Prescribing for children with uncomplicated chest infections is still common in most countries,” said lead author Paul Little, MD, professor of primary care research at the University of Southampton, England, in an interview.

But there are barriers to stopping this practice, he said. “If you prescribe an antibiotic and the child gets better, even if the antibiotic was not doing that much, the parents then think that it was the antibiotic that was responsible for the recovery and so expect antibiotics the next time. So, physician prescribing of antibiotics in effect medicalizes illness and keeps the cycle of expectations, reconsultations, and prescriptions going.”

The study included 432 children aged 6 months to 12 years (median age, 3.2 years) who presented at 56 general practices in England with acute, uncomplicated lower respiratory tract infection (LRTI) of less than 21 days’ duration and in whom pneumonia was not suspected clinically. The children were randomly assigned to undergo 7 days of treatment with either amoxicillin 50 mg/kg or placebo. The primary outcome was duration of symptoms rated moderately bad or worse.

For up to 4 weeks, parents scored symptoms – including cough, phlegm, shortness of breath, wheeze, blocked or runny nose, disturbed sleep, feeling generally unwell, fever, and interference with normal activities – in a daily diary. The secondary outcome was symptom severity. Prespecified analyses were made for key clinical subgroups of patients for whom clinicians commonly prescribe (those with chest signs, fever, physician rating of unwell, sputum or chest rattle, and shortness of breath).

There was no significant difference in outcome between children treated with antibiotics and those treated with placebo. The median duration of moderately bad or worse symptoms was similar between the antibiotics group and the placebo group (5 vs. 6 days; hazard ratio, 1.13), as was the median time until symptoms were rated absent or as causing very little problem (7 vs. 8 days; HR, 1.09). There was a small significant difference between the groups in symptom severity score on days 2-4 after seeing the doctor (1.8 in the antibiotics group vs. 2.1 in the placebo group), “which was equivalent to less than one child in three rating symptoms a slight problem rather than very little problem,” the study authors report. “The treatment effects for all outcomes were similar for most subgroups ... but the effect of antibiotics was slightly, but not significantly, greater among those with fever or those who were unwell,” they add.

The investigators conclude that “similar to adults, antibiotics are unlikely to make a clinically important difference to the symptom burden for uncomplicated lower respiratory tract infections in children – both overall, and for the key clinical subgroups where antibiotic prescribing is most common.” They recommend that clinicians provide “safety-netting advice” to parents, such as explaining what illness course to expect and when a return visit would be necessary.

The findings provide “more evidence to do less,” wrote Rianne Oostenbrink, MD, PhD, from Erasmus MC-Sophia, in Rotterdam, the Netherlands, and Lina Jankauskaite, MD, PhD, from Lithuanian University of Health Sciences, Kaunas, in an accompanying comment.

“Overtesting and overtreatment of children are especially prominent in infectious diseases, when fever or other symptoms such as cough can be unspecific and can be of viral or bacterial origin,” they write.

The commenters note that despite antibiotics, most children did have moderately bad or worse symptoms on day 3, and symptoms had improved in about 75% of children in both groups at day 14. “A notable finding of this study is that only a few children had moderately bad or worse symptoms by day 14, and antibiotics did not alleviate the symptoms compared with placebo. Additionally, this trial aligns with other studies that have shown that reducing antibiotic treatment for LRTI is not associated with prolonged morbidity or higher incidence of complications.”

The study was funded by the UK National Institute for Health Research. Dr. Little, Dr. Jankauskaite, and Dr. Oostenbrink have disclosed no relevant financial relationships.

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

For primary care patients feeling well enough to discontinue antidepressant medication, there was a higher rate of depressive relapse among those who discontinued therapy, compared with those who did not, a new study shows.

The results of the Antidepressants to Prevent Relapse in Depression (ANTLER) trial also suggest that “many patients can discontinue their antidepressants safely in primary care without relapsing, when there is a tapering regime,” said lead investigator Gemma Lewis, PhD, from University College London, in an interview.

The multicenter, randomized, double-blind trial, which was published in the New England Journal of Medicine (2021;385:1257-67), included 478 patients, from 150 primary care practices in the United Kingdom.

The participants (73% female, average age 54 years) had a history of at least two depressive episodes or had been taking antidepressants (citalopram, fluoxetine, sertraline, or mirtazapine) for at least 2 years. The vast majority of patients – 70% – had been using the drugs for more than 3 years, the researchers wrote.

Study participants were randomized to either maintain their antidepressant regimen or to taper off for up to 2 months before switching to a placebo.

Over a follow-up of 52 weeks, relapse occurred in 56% of those who discontinued, compared with 39% of those who maintained their regimen (hazard ratio, 2.06; P < .001). Relapse also occurred sooner in the discontinuation group (13 weeks vs. 19 weeks).

The definition of relapse was answering yes to either of the following two questions:

• Have you had a spell of feeling sad, miserable, or depressed?
• Have you been unable to enjoy or take an interest in things as much as you usually do?

Patients also had to report that one of these experiences had lasted for 2 weeks or more, and having had at least one of the following symptoms: depressive thoughts, fatigue, loss of concentration, or sleep disturbance.

By the end of the trial, 39% of patients in the group who discontinued taking an antidepressant had returned to taking that type of drug.

“We found that remaining on antidepressants long-term does effectively reduce the risk of relapse. However, we also found that 44% of those who discontinued their antidepressants did not relapse after a full year,” Dr. Lewis said.

Who can stop medications without relapsing is unknown

“Many people can stop their medication without relapsing, though at present we cannot identify who those people are,” noted Dr. Lewis.

“Our study did not investigate who is at higher risk of relapse … but this is something we will focus on in the future,” she said.

For primary care clinicians whose patients are considering discontinuation of antidepressant medication, “current best practice is to engage with patients’ priorities and collaborate in coming to a decision,” she noted.

“For the individual patient, it is only possible to know about the average likelihood of relapse – and the severity of potential relapses will also be unpredictable. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants to inform shared decision-making in primary care.”

Findings are ‘important’ but ‘disappointing’

In an editorial published alongside the study (N Engl J Med. 2021;385:1327-8), Jeffrey L. Jackson, MD, MPH, from the Zablocki VA Medical Center and the Medical College of Wisconsin in Milwaukee characterized the findings as “important but disappointing.”

“They confirm what most primary care physicians already knew or intuited. The frequency of relapse after the discontinuation of treatment is high, particularly among patients with several previous depressive episodes,” he explained.

Dr. Jackson also pointed out some unknowns about the trial, including the length trial participants had been in remission for depression.

“It is unclear whether the trial results are generalizable to primary care patients with a first episode of depression,” he said, and noted that participants with three or more previous depressive episodes were more than twice as likely to relapse, compared with participants with fewer episodes.

“I encourage patients with a single bout of depression, especially episodes that are triggered by a life event, such as loss of a loved one, to consider weaning antidepressant treatment after at least 6 months of remission,” he wrote. “For those with three or more previous bouts of depression, my practice has been to recommend that they anticipate medical treatment for life or, if they wish to stop taking medication, explore nonpharmacologic approaches, such as cognitive-behavior therapy.”

Protective effect of antidepressants was clear

“This is an important paper providing an evidence base to the often-cited recommendation that after two or more episodes of depression, antidepressant medication should be continued indefinitely,” said Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia, who was not involved in the study.

“The protective effect of antidepressant medication here was clear – those who discontinued antidepressant medication had a clinically and significantly higher rate of relapse at the end of a year.”

Side effects can be significant

“It is important to note, though, that in the discontinuation group, 44% of patients did not experience a relapse,” Dr. Skolnik said. “While antidepressants work without significant side effects for many patients, for others there are significant side effects that include adverse sexual side effects, effects on appetite and weight, nighttime sweats, and other side effects.”

“So, this study should not be confused to mean that all patients who have had recurrent depression should remain on antidepressants long term. The decision about whether to continue an antidepressant is influenced by many things and should be a shared decision-making process between clinician and patient, informed by the important results of this study, the current situation of the patient, and most importantly, the patient’s informed decision of what they would like to do,” he said.

The study was funded by the U.K. National Institute for Health Research

Dr. Lewis, Dr. Jackson, and Dr. Skolnik reported no conflicts of interest.

For primary care patients feeling well enough to discontinue antidepressant medication, there was a higher rate of depressive relapse among those who discontinued therapy, compared with those who did not, a new study shows.

The results of the Antidepressants to Prevent Relapse in Depression (ANTLER) trial also suggest that “many patients can discontinue their antidepressants safely in primary care without relapsing, when there is a tapering regime,” said lead investigator Gemma Lewis, PhD, from University College London, in an interview.

The multicenter, randomized, double-blind trial, which was published in the New England Journal of Medicine (2021;385:1257-67), included 478 patients, from 150 primary care practices in the United Kingdom.

The participants (73% female, average age 54 years) had a history of at least two depressive episodes or had been taking antidepressants (citalopram, fluoxetine, sertraline, or mirtazapine) for at least 2 years. The vast majority of patients – 70% – had been using the drugs for more than 3 years, the researchers wrote.

Study participants were randomized to either maintain their antidepressant regimen or to taper off for up to 2 months before switching to a placebo.

Over a follow-up of 52 weeks, relapse occurred in 56% of those who discontinued, compared with 39% of those who maintained their regimen (hazard ratio, 2.06; P < .001). Relapse also occurred sooner in the discontinuation group (13 weeks vs. 19 weeks).

The definition of relapse was answering yes to either of the following two questions:

• Have you had a spell of feeling sad, miserable, or depressed?
• Have you been unable to enjoy or take an interest in things as much as you usually do?

Patients also had to report that one of these experiences had lasted for 2 weeks or more, and having had at least one of the following symptoms: depressive thoughts, fatigue, loss of concentration, or sleep disturbance.

By the end of the trial, 39% of patients in the group who discontinued taking an antidepressant had returned to taking that type of drug.

“We found that remaining on antidepressants long-term does effectively reduce the risk of relapse. However, we also found that 44% of those who discontinued their antidepressants did not relapse after a full year,” Dr. Lewis said.

Who can stop medications without relapsing is unknown

“Many people can stop their medication without relapsing, though at present we cannot identify who those people are,” noted Dr. Lewis.

“Our study did not investigate who is at higher risk of relapse … but this is something we will focus on in the future,” she said.

For primary care clinicians whose patients are considering discontinuation of antidepressant medication, “current best practice is to engage with patients’ priorities and collaborate in coming to a decision,” she noted.

“For the individual patient, it is only possible to know about the average likelihood of relapse – and the severity of potential relapses will also be unpredictable. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants to inform shared decision-making in primary care.”

Findings are ‘important’ but ‘disappointing’

In an editorial published alongside the study (N Engl J Med. 2021;385:1327-8), Jeffrey L. Jackson, MD, MPH, from the Zablocki VA Medical Center and the Medical College of Wisconsin in Milwaukee characterized the findings as “important but disappointing.”

“They confirm what most primary care physicians already knew or intuited. The frequency of relapse after the discontinuation of treatment is high, particularly among patients with several previous depressive episodes,” he explained.

Dr. Jackson also pointed out some unknowns about the trial, including the length trial participants had been in remission for depression.

“It is unclear whether the trial results are generalizable to primary care patients with a first episode of depression,” he said, and noted that participants with three or more previous depressive episodes were more than twice as likely to relapse, compared with participants with fewer episodes.

“I encourage patients with a single bout of depression, especially episodes that are triggered by a life event, such as loss of a loved one, to consider weaning antidepressant treatment after at least 6 months of remission,” he wrote. “For those with three or more previous bouts of depression, my practice has been to recommend that they anticipate medical treatment for life or, if they wish to stop taking medication, explore nonpharmacologic approaches, such as cognitive-behavior therapy.”

Protective effect of antidepressants was clear

“This is an important paper providing an evidence base to the often-cited recommendation that after two or more episodes of depression, antidepressant medication should be continued indefinitely,” said Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia, who was not involved in the study.

“The protective effect of antidepressant medication here was clear – those who discontinued antidepressant medication had a clinically and significantly higher rate of relapse at the end of a year.”

Side effects can be significant

“It is important to note, though, that in the discontinuation group, 44% of patients did not experience a relapse,” Dr. Skolnik said. “While antidepressants work without significant side effects for many patients, for others there are significant side effects that include adverse sexual side effects, effects on appetite and weight, nighttime sweats, and other side effects.”

“So, this study should not be confused to mean that all patients who have had recurrent depression should remain on antidepressants long term. The decision about whether to continue an antidepressant is influenced by many things and should be a shared decision-making process between clinician and patient, informed by the important results of this study, the current situation of the patient, and most importantly, the patient’s informed decision of what they would like to do,” he said.

The study was funded by the U.K. National Institute for Health Research

Dr. Lewis, Dr. Jackson, and Dr. Skolnik reported no conflicts of interest.

For primary care patients feeling well enough to discontinue antidepressant medication, there was a higher rate of depressive relapse among those who discontinued therapy, compared with those who did not, a new study shows.

The results of the Antidepressants to Prevent Relapse in Depression (ANTLER) trial also suggest that “many patients can discontinue their antidepressants safely in primary care without relapsing, when there is a tapering regime,” said lead investigator Gemma Lewis, PhD, from University College London, in an interview.

The multicenter, randomized, double-blind trial, which was published in the New England Journal of Medicine (2021;385:1257-67), included 478 patients, from 150 primary care practices in the United Kingdom.

The participants (73% female, average age 54 years) had a history of at least two depressive episodes or had been taking antidepressants (citalopram, fluoxetine, sertraline, or mirtazapine) for at least 2 years. The vast majority of patients – 70% – had been using the drugs for more than 3 years, the researchers wrote.

Study participants were randomized to either maintain their antidepressant regimen or to taper off for up to 2 months before switching to a placebo.

Over a follow-up of 52 weeks, relapse occurred in 56% of those who discontinued, compared with 39% of those who maintained their regimen (hazard ratio, 2.06; P < .001). Relapse also occurred sooner in the discontinuation group (13 weeks vs. 19 weeks).

The definition of relapse was answering yes to either of the following two questions:

• Have you had a spell of feeling sad, miserable, or depressed?
• Have you been unable to enjoy or take an interest in things as much as you usually do?

Patients also had to report that one of these experiences had lasted for 2 weeks or more, and having had at least one of the following symptoms: depressive thoughts, fatigue, loss of concentration, or sleep disturbance.

By the end of the trial, 39% of patients in the group who discontinued taking an antidepressant had returned to taking that type of drug.

“We found that remaining on antidepressants long-term does effectively reduce the risk of relapse. However, we also found that 44% of those who discontinued their antidepressants did not relapse after a full year,” Dr. Lewis said.

Who can stop medications without relapsing is unknown

“Many people can stop their medication without relapsing, though at present we cannot identify who those people are,” noted Dr. Lewis.

“Our study did not investigate who is at higher risk of relapse … but this is something we will focus on in the future,” she said.

For primary care clinicians whose patients are considering discontinuation of antidepressant medication, “current best practice is to engage with patients’ priorities and collaborate in coming to a decision,” she noted.

“For the individual patient, it is only possible to know about the average likelihood of relapse – and the severity of potential relapses will also be unpredictable. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants to inform shared decision-making in primary care.”

Findings are ‘important’ but ‘disappointing’

In an editorial published alongside the study (N Engl J Med. 2021;385:1327-8), Jeffrey L. Jackson, MD, MPH, from the Zablocki VA Medical Center and the Medical College of Wisconsin in Milwaukee characterized the findings as “important but disappointing.”

“They confirm what most primary care physicians already knew or intuited. The frequency of relapse after the discontinuation of treatment is high, particularly among patients with several previous depressive episodes,” he explained.

Dr. Jackson also pointed out some unknowns about the trial, including the length trial participants had been in remission for depression.

“It is unclear whether the trial results are generalizable to primary care patients with a first episode of depression,” he said, and noted that participants with three or more previous depressive episodes were more than twice as likely to relapse, compared with participants with fewer episodes.

“I encourage patients with a single bout of depression, especially episodes that are triggered by a life event, such as loss of a loved one, to consider weaning antidepressant treatment after at least 6 months of remission,” he wrote. “For those with three or more previous bouts of depression, my practice has been to recommend that they anticipate medical treatment for life or, if they wish to stop taking medication, explore nonpharmacologic approaches, such as cognitive-behavior therapy.”

Protective effect of antidepressants was clear

“This is an important paper providing an evidence base to the often-cited recommendation that after two or more episodes of depression, antidepressant medication should be continued indefinitely,” said Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia, who was not involved in the study.

“The protective effect of antidepressant medication here was clear – those who discontinued antidepressant medication had a clinically and significantly higher rate of relapse at the end of a year.”

Side effects can be significant

“It is important to note, though, that in the discontinuation group, 44% of patients did not experience a relapse,” Dr. Skolnik said. “While antidepressants work without significant side effects for many patients, for others there are significant side effects that include adverse sexual side effects, effects on appetite and weight, nighttime sweats, and other side effects.”

“So, this study should not be confused to mean that all patients who have had recurrent depression should remain on antidepressants long term. The decision about whether to continue an antidepressant is influenced by many things and should be a shared decision-making process between clinician and patient, informed by the important results of this study, the current situation of the patient, and most importantly, the patient’s informed decision of what they would like to do,” he said.

The study was funded by the U.K. National Institute for Health Research

Dr. Lewis, Dr. Jackson, and Dr. Skolnik reported no conflicts of interest.

One-year-olds who received a parent-led intervention targeting early signs of autism spectrum disorder (ASD) had significantly reduced symptoms and chances of an autism diagnosis at age 3 years, in a new study.

These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.

“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
 

Study intervention is a nontraditonal approach

Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”

Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.

“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”

“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.

Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).

The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
 

Other research has shown benefits of new study approach

This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.

Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”

The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
 

New study shows value of parent-mediated interventions

Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.

“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”

“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.

“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”

What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”

This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.

One-year-olds who received a parent-led intervention targeting early signs of autism spectrum disorder (ASD) had significantly reduced symptoms and chances of an autism diagnosis at age 3 years, in a new study.

These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.

“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
 

Study intervention is a nontraditonal approach

Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”

Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.

“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”

“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.

Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).

The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
 

Other research has shown benefits of new study approach

This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.

Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”

The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
 

New study shows value of parent-mediated interventions

Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.

“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”

“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.

“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”

What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”

This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.

One-year-olds who received a parent-led intervention targeting early signs of autism spectrum disorder (ASD) had significantly reduced symptoms and chances of an autism diagnosis at age 3 years, in a new study.

These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.

“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
 

Study intervention is a nontraditonal approach

Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”

Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.

“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”

“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.

Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).

The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
 

Other research has shown benefits of new study approach

This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.

Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”

The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
 

New study shows value of parent-mediated interventions

Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.

“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”

“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.

“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”

What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”

This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.

Pediatric urine sampling should be used more frequently than current guidelines suggest for ruling out urinary tract infection (UTI), according to a systematic review and meta-analysis of diagnostic test accuracy studies in ambulatory care (Ann Fam Med 2021;19:437-46).

“Urine sampling is often restricted to children with clinical features such as pain while urinating, frequent urination or children presenting with fever without any abnormalities found on clinical examination,” said lead author Jan Y. Verbakel, MD, PhD, from the University of Leuven (Belgium) in an interview. “Our study findings suggest that, in children, pain while urinating or frequent urination are less accurate than in adults and increase the probability of UTI only moderately.”

Urine sampling “should be applied more broadly in ambulatory care, given that appropriate sampling techniques are available,” he and his coauthors advised in the paper.

Methods and results

The analysis included 35 studies, involving a total of 78,427 patients, which provided information on 58 clinical features and 6 prediction rules of UTI, compared with urine culture. For urine sampling, most studies used catheterization (n = 23), suprapubic aspiration (n = 17), or midstream catch (n = 14), and fewer studies used clean catch (n = 7), bag specimens (n = 5), or diaper pads (n = 2).

The study showed that only three features substantially decreased the likelihood of UTI: being circumcised, the presence of stridor, and the presence of diaper rash. “In febrile children, finding an apparent source of infection decreased the probability of UTI; however, this was not useful for ruling out UTI by itself,” the authors noted.

Additionally, they found that red flags for UTI were cloudy or malodorous urine, hematuria, no fluid intake, suprapubic tenderness, and loin tenderness.

Study implications

“We recommend to sample urine in children that have one or more features that increase the probability of UTI … and less so pain while urinating, frequent urination, urgency, bed wetting, or previous UTI history,” said Dr. Verbakel, who is also a researcher at the University of Oxford (England).

In terms of prediction rules, the analysis showed the Diagnosis of Urinary Tract Infection in Young Children (DUTY) score, Gorelick Scale score, and UTIcalc might be useful to identify which children should have urine sampling, the authors stated in the paper.

Specifically, a DUTY clean-catch score of less than one point was useful for ruling out UTI in children aged less than 5 years, and in girls aged less than 3 years with unexplained fever. The Gorelick Scale score was useful for ruling out UTI when less than two of five variables were present.

“The present meta-analyses confirm that few clinical features are useful for diagnosing or ruling out UTI without further urine analysis. Signs and symptoms combined in a clinical prediction rule, such as with the DUTY or UTIcalc score, might increase accuracy for ruling out UTI; however, these should be validated externally,” Dr. Verbakel said in an interview.

Is urine sampling guideline too broad?

Commenting on the new paper, Martin Koyle, MD, former division chief of urology at the Hospital for Sick Children and professor of surgery at the University of Toronto, expressed concern that unexplained fever is not included as a “differentiating” red flag.

“Many contemporary guidelines define fever as an important diagnostic symptom, as the goal truly is to differentiate lower urinary tract from actual kidney infection, the latter thought to be more important for severity of illness, and potential for developing kidney damage,” he said in an interview. “It begs the question as to which nonfebrile patients who don’t have symptoms related to the respiratory tract for instance [for example, stridor], should be under suspicion for an afebrile urinary tract infection, and have their urine sampled. This paper does not answer that question.”

Dr. Koyle added that an overly broad guideline for urine sampling could come at a cost, and he raised the following questions.

“Will there be an overdiagnosis based on urines alone? Will this lead to overtreatment, often unnecessary, just because there is a positive urine specimen or asymptomatic bacteriuria? Will overtreatment lead to resistant bacteria and side effects related to antibiotics? Will such treatment actually prevent clinical illness and/or renal damage?”

The study authors and Dr. Koyle reported no conflicts of interest.

Pediatric urine sampling should be used more frequently than current guidelines suggest for ruling out urinary tract infection (UTI), according to a systematic review and meta-analysis of diagnostic test accuracy studies in ambulatory care (Ann Fam Med 2021;19:437-46).

“Urine sampling is often restricted to children with clinical features such as pain while urinating, frequent urination or children presenting with fever without any abnormalities found on clinical examination,” said lead author Jan Y. Verbakel, MD, PhD, from the University of Leuven (Belgium) in an interview. “Our study findings suggest that, in children, pain while urinating or frequent urination are less accurate than in adults and increase the probability of UTI only moderately.”

Urine sampling “should be applied more broadly in ambulatory care, given that appropriate sampling techniques are available,” he and his coauthors advised in the paper.

Methods and results

The analysis included 35 studies, involving a total of 78,427 patients, which provided information on 58 clinical features and 6 prediction rules of UTI, compared with urine culture. For urine sampling, most studies used catheterization (n = 23), suprapubic aspiration (n = 17), or midstream catch (n = 14), and fewer studies used clean catch (n = 7), bag specimens (n = 5), or diaper pads (n = 2).

The study showed that only three features substantially decreased the likelihood of UTI: being circumcised, the presence of stridor, and the presence of diaper rash. “In febrile children, finding an apparent source of infection decreased the probability of UTI; however, this was not useful for ruling out UTI by itself,” the authors noted.

Additionally, they found that red flags for UTI were cloudy or malodorous urine, hematuria, no fluid intake, suprapubic tenderness, and loin tenderness.

Study implications

“We recommend to sample urine in children that have one or more features that increase the probability of UTI … and less so pain while urinating, frequent urination, urgency, bed wetting, or previous UTI history,” said Dr. Verbakel, who is also a researcher at the University of Oxford (England).

In terms of prediction rules, the analysis showed the Diagnosis of Urinary Tract Infection in Young Children (DUTY) score, Gorelick Scale score, and UTIcalc might be useful to identify which children should have urine sampling, the authors stated in the paper.

Specifically, a DUTY clean-catch score of less than one point was useful for ruling out UTI in children aged less than 5 years, and in girls aged less than 3 years with unexplained fever. The Gorelick Scale score was useful for ruling out UTI when less than two of five variables were present.

“The present meta-analyses confirm that few clinical features are useful for diagnosing or ruling out UTI without further urine analysis. Signs and symptoms combined in a clinical prediction rule, such as with the DUTY or UTIcalc score, might increase accuracy for ruling out UTI; however, these should be validated externally,” Dr. Verbakel said in an interview.

Is urine sampling guideline too broad?

Commenting on the new paper, Martin Koyle, MD, former division chief of urology at the Hospital for Sick Children and professor of surgery at the University of Toronto, expressed concern that unexplained fever is not included as a “differentiating” red flag.

“Many contemporary guidelines define fever as an important diagnostic symptom, as the goal truly is to differentiate lower urinary tract from actual kidney infection, the latter thought to be more important for severity of illness, and potential for developing kidney damage,” he said in an interview. “It begs the question as to which nonfebrile patients who don’t have symptoms related to the respiratory tract for instance [for example, stridor], should be under suspicion for an afebrile urinary tract infection, and have their urine sampled. This paper does not answer that question.”

Dr. Koyle added that an overly broad guideline for urine sampling could come at a cost, and he raised the following questions.

“Will there be an overdiagnosis based on urines alone? Will this lead to overtreatment, often unnecessary, just because there is a positive urine specimen or asymptomatic bacteriuria? Will overtreatment lead to resistant bacteria and side effects related to antibiotics? Will such treatment actually prevent clinical illness and/or renal damage?”

The study authors and Dr. Koyle reported no conflicts of interest.

Pediatric urine sampling should be used more frequently than current guidelines suggest for ruling out urinary tract infection (UTI), according to a systematic review and meta-analysis of diagnostic test accuracy studies in ambulatory care (Ann Fam Med 2021;19:437-46).

“Urine sampling is often restricted to children with clinical features such as pain while urinating, frequent urination or children presenting with fever without any abnormalities found on clinical examination,” said lead author Jan Y. Verbakel, MD, PhD, from the University of Leuven (Belgium) in an interview. “Our study findings suggest that, in children, pain while urinating or frequent urination are less accurate than in adults and increase the probability of UTI only moderately.”

Urine sampling “should be applied more broadly in ambulatory care, given that appropriate sampling techniques are available,” he and his coauthors advised in the paper.

Methods and results

The analysis included 35 studies, involving a total of 78,427 patients, which provided information on 58 clinical features and 6 prediction rules of UTI, compared with urine culture. For urine sampling, most studies used catheterization (n = 23), suprapubic aspiration (n = 17), or midstream catch (n = 14), and fewer studies used clean catch (n = 7), bag specimens (n = 5), or diaper pads (n = 2).

The study showed that only three features substantially decreased the likelihood of UTI: being circumcised, the presence of stridor, and the presence of diaper rash. “In febrile children, finding an apparent source of infection decreased the probability of UTI; however, this was not useful for ruling out UTI by itself,” the authors noted.

Additionally, they found that red flags for UTI were cloudy or malodorous urine, hematuria, no fluid intake, suprapubic tenderness, and loin tenderness.

Study implications

“We recommend to sample urine in children that have one or more features that increase the probability of UTI … and less so pain while urinating, frequent urination, urgency, bed wetting, or previous UTI history,” said Dr. Verbakel, who is also a researcher at the University of Oxford (England).

In terms of prediction rules, the analysis showed the Diagnosis of Urinary Tract Infection in Young Children (DUTY) score, Gorelick Scale score, and UTIcalc might be useful to identify which children should have urine sampling, the authors stated in the paper.

Specifically, a DUTY clean-catch score of less than one point was useful for ruling out UTI in children aged less than 5 years, and in girls aged less than 3 years with unexplained fever. The Gorelick Scale score was useful for ruling out UTI when less than two of five variables were present.

“The present meta-analyses confirm that few clinical features are useful for diagnosing or ruling out UTI without further urine analysis. Signs and symptoms combined in a clinical prediction rule, such as with the DUTY or UTIcalc score, might increase accuracy for ruling out UTI; however, these should be validated externally,” Dr. Verbakel said in an interview.

Is urine sampling guideline too broad?

Commenting on the new paper, Martin Koyle, MD, former division chief of urology at the Hospital for Sick Children and professor of surgery at the University of Toronto, expressed concern that unexplained fever is not included as a “differentiating” red flag.

“Many contemporary guidelines define fever as an important diagnostic symptom, as the goal truly is to differentiate lower urinary tract from actual kidney infection, the latter thought to be more important for severity of illness, and potential for developing kidney damage,” he said in an interview. “It begs the question as to which nonfebrile patients who don’t have symptoms related to the respiratory tract for instance [for example, stridor], should be under suspicion for an afebrile urinary tract infection, and have their urine sampled. This paper does not answer that question.”

Dr. Koyle added that an overly broad guideline for urine sampling could come at a cost, and he raised the following questions.

“Will there be an overdiagnosis based on urines alone? Will this lead to overtreatment, often unnecessary, just because there is a positive urine specimen or asymptomatic bacteriuria? Will overtreatment lead to resistant bacteria and side effects related to antibiotics? Will such treatment actually prevent clinical illness and/or renal damage?”

The study authors and Dr. Koyle reported no conflicts of interest.

Back-to-school jitters are heightened this year, as children head back to the risk of COVID transmission in class, but one upside to the return of in-person school may be better mental health for students.

Courtesy Dr. Matt Hawrilenko

New research shows that virtual schooling, which dominated in many districts last year, was associated with worse mental health outcomes for students – especially older ones – and youth from Black, Hispanic, or lower-income families were hit hardest because they experienced the most closures.

“Schools with lower funding may have had more difficulty meeting guidelines for safe reopening, including updates to ventilation systems and finding the physical space to create safe distancing between children,” explained lead author Matt Hawrilenko, PhD, of the department of psychiatry and behavioral sciences at the University of Washington, Seattle, in an interview.

“In the context of complex school reopening decisions that balance competing risks and benefits, these findings suggest that allocating funding to support safe in-person instruction may reduce mental health inequities associated with race/ethnicity and income,” he and his coauthors noted in the study, published in JAMA Network Open. “Ensuring that all students have access to additional educational and mental health resources must be an important public health priority, met with appropriate funding and work force augmentation, during and beyond the COVID-19 pandemic.”

The study used a cross-sectional population-based survey of 2,324 parents of school-age children in the United States. It was administered in English and Spanish via web and telephone between Dec. 2 and Dec. 21, 2020, and used the parent-report version of the Strengths and Difficulties Questionnaire (SDQ) to assess mental health difficulties of one child per family in four domains: emotional problems, peer problems, conduct, and hyperactivity. Parents were also asked about what kind of schooling their child had received in the last year (remote, in-person, or hybrid) and about demographic information such as child age, gender, household income, parent race and ethnicity, and parent education.

The results showed that, during the 2020 school year, 58.0% of children attended school remotely, 24% attended fully in person, and 18.0% attended in a hybrid format. “Fully remote schooling was strongly patterned along lines of parent race and ethnicity as well as income,” the authors noted. “Parents of 336 children attending school in person (65.8%) but of 597 children attending school fully remotely (44.5%) were White, whereas all other racial/ethnic groups had larger proportions of children attending school fully remotely (P < .001).”

In terms of mental health, the findings showed that older children who attended school remotely had more difficulties, compared with those who attended in-person – but among younger children, remote learning was comparable or slightly better for mental health.

Specifically, “a child aged 17 years attending school remotely would be expected to have a total difficulty score 2.4 points higher than a child of the same age attending school in person, corresponding to a small effect size in favor of in-person schooling,” the authors wrote. “Conversely, a child aged 4 years attending school remotely would be expected to have a total difficulty score 0.5 points lower than a child of the same age attending school in person, corresponding to a very small effect size in favor of remote schooling.”

Age of child proves critical

“Our best estimate is that remote schooling was associated with no difference in mental health difficulties at age 6, and with slightly more difficulties with each year of age after that, with differences most clearly apparent for high school–aged kids,” explained Dr. Hawrilenko, adding the finding suggests that school reopenings should prioritize older children.

However, “what kids are doing at home matters,” he added. “In the youngest age group, the biggest work kids are doing in school and childcare settings is social and emotional development. … Finding opportunities for regular, safe social interactions with peers – perhaps during outdoor playdates – can help them build those skills.”

He emphasized with the anticipated starts and stutters of the new school year there is an important role that doctors can play.

“First, they can help families assess their own risk profile, and whether it makes sense for their children to attend school in person or remotely [to the extent that is an option]. Second, they can help families think through how school closures might impact their child specifically. For those kids who wind up with long chunks of remote schooling, scheduling in regular interactions with other kids in safe ways could make a big difference. Another driver of child anxiety might be learning loss, and this is a good place to reinforce that not every mental health problem needs a mental health solution.

“A lot of kids might be rightfully anxious about having fallen behind over the pandemic. These kids are preparing to transition to college or to the workforce and may be feeling increasingly behind while approaching these moments of transition. Pointing families toward the resources to help them navigate these issues could go a long way to helping quell child anxiety.”

Research helps fill vacuum

Elizabeth A. Stuart, PhD, who was not involved in the study, said in an interview that this research is particularly valuable because there have been very few data on this topic, especially on a large-scale national sample.

Courtesy Dr. Elizabeth A. Stuart

“Sadly, many of the results are not surprising,” said Dr. Stuart, a statistician and professor of mental health at Johns Hopkins University, Baltimore. “Data have shown significant mental health challenges for adults during the pandemic, and it is not surprising that children and youth would experience that as well, especially for those whose daily routines and structures changed dramatically and who were not able to be interacting in-person with teachers, staff, and classmates. This is an important reminder that schools provide not just academic instruction for students, but that the social interactions and other services (such as behavioral health supports, meals, and connections with other social services) students might receive in school are crucial.

“It has been heartening to see a stronger commitment to getting students safely back into school this fall across the country, and that the Centers for Disease Control and Prevention highlighted the benefits of in-person schooling in their COVID-19–related guidance for schools.”

Dr. Stuart added that, as students return to classes, it will be important for schools to tackle ongoing mental health challenges.

“Some students may be struggling in obvious ways; for others it may be harder to identify. It will also be important to continue to monitor children’s and youth mental health … as returning to in-person school may bring its own challenges. For some individuals and communities, the mental health impacts of the pandemic may last even after the physical health risks resolve.”

Dr. Hawrilenko agreed.

“From a policy perspective, I am quite frankly terrified about how these inequities – in particular, learning loss – might play out long after school closures are a distant memory,” he said. “It is critical to provide schools the resources not just to minimize risk when reopening, but additional funding for workforce augmentation – both for mental health staffing and for additional educational support – to help students navigate the months and years over which they transition back into the classroom.”

Dr. Hawrilenko and Dr. Stuart had no disclosures.

Back-to-school jitters are heightened this year, as children head back to the risk of COVID transmission in class, but one upside to the return of in-person school may be better mental health for students.

Courtesy Dr. Matt Hawrilenko

New research shows that virtual schooling, which dominated in many districts last year, was associated with worse mental health outcomes for students – especially older ones – and youth from Black, Hispanic, or lower-income families were hit hardest because they experienced the most closures.

“Schools with lower funding may have had more difficulty meeting guidelines for safe reopening, including updates to ventilation systems and finding the physical space to create safe distancing between children,” explained lead author Matt Hawrilenko, PhD, of the department of psychiatry and behavioral sciences at the University of Washington, Seattle, in an interview.

“In the context of complex school reopening decisions that balance competing risks and benefits, these findings suggest that allocating funding to support safe in-person instruction may reduce mental health inequities associated with race/ethnicity and income,” he and his coauthors noted in the study, published in JAMA Network Open. “Ensuring that all students have access to additional educational and mental health resources must be an important public health priority, met with appropriate funding and work force augmentation, during and beyond the COVID-19 pandemic.”

The study used a cross-sectional population-based survey of 2,324 parents of school-age children in the United States. It was administered in English and Spanish via web and telephone between Dec. 2 and Dec. 21, 2020, and used the parent-report version of the Strengths and Difficulties Questionnaire (SDQ) to assess mental health difficulties of one child per family in four domains: emotional problems, peer problems, conduct, and hyperactivity. Parents were also asked about what kind of schooling their child had received in the last year (remote, in-person, or hybrid) and about demographic information such as child age, gender, household income, parent race and ethnicity, and parent education.

The results showed that, during the 2020 school year, 58.0% of children attended school remotely, 24% attended fully in person, and 18.0% attended in a hybrid format. “Fully remote schooling was strongly patterned along lines of parent race and ethnicity as well as income,” the authors noted. “Parents of 336 children attending school in person (65.8%) but of 597 children attending school fully remotely (44.5%) were White, whereas all other racial/ethnic groups had larger proportions of children attending school fully remotely (P < .001).”

In terms of mental health, the findings showed that older children who attended school remotely had more difficulties, compared with those who attended in-person – but among younger children, remote learning was comparable or slightly better for mental health.

Specifically, “a child aged 17 years attending school remotely would be expected to have a total difficulty score 2.4 points higher than a child of the same age attending school in person, corresponding to a small effect size in favor of in-person schooling,” the authors wrote. “Conversely, a child aged 4 years attending school remotely would be expected to have a total difficulty score 0.5 points lower than a child of the same age attending school in person, corresponding to a very small effect size in favor of remote schooling.”

Age of child proves critical

“Our best estimate is that remote schooling was associated with no difference in mental health difficulties at age 6, and with slightly more difficulties with each year of age after that, with differences most clearly apparent for high school–aged kids,” explained Dr. Hawrilenko, adding the finding suggests that school reopenings should prioritize older children.

However, “what kids are doing at home matters,” he added. “In the youngest age group, the biggest work kids are doing in school and childcare settings is social and emotional development. … Finding opportunities for regular, safe social interactions with peers – perhaps during outdoor playdates – can help them build those skills.”

He emphasized with the anticipated starts and stutters of the new school year there is an important role that doctors can play.

“First, they can help families assess their own risk profile, and whether it makes sense for their children to attend school in person or remotely [to the extent that is an option]. Second, they can help families think through how school closures might impact their child specifically. For those kids who wind up with long chunks of remote schooling, scheduling in regular interactions with other kids in safe ways could make a big difference. Another driver of child anxiety might be learning loss, and this is a good place to reinforce that not every mental health problem needs a mental health solution.

“A lot of kids might be rightfully anxious about having fallen behind over the pandemic. These kids are preparing to transition to college or to the workforce and may be feeling increasingly behind while approaching these moments of transition. Pointing families toward the resources to help them navigate these issues could go a long way to helping quell child anxiety.”

Research helps fill vacuum

Elizabeth A. Stuart, PhD, who was not involved in the study, said in an interview that this research is particularly valuable because there have been very few data on this topic, especially on a large-scale national sample.

Courtesy Dr. Elizabeth A. Stuart

“Sadly, many of the results are not surprising,” said Dr. Stuart, a statistician and professor of mental health at Johns Hopkins University, Baltimore. “Data have shown significant mental health challenges for adults during the pandemic, and it is not surprising that children and youth would experience that as well, especially for those whose daily routines and structures changed dramatically and who were not able to be interacting in-person with teachers, staff, and classmates. This is an important reminder that schools provide not just academic instruction for students, but that the social interactions and other services (such as behavioral health supports, meals, and connections with other social services) students might receive in school are crucial.

“It has been heartening to see a stronger commitment to getting students safely back into school this fall across the country, and that the Centers for Disease Control and Prevention highlighted the benefits of in-person schooling in their COVID-19–related guidance for schools.”

Dr. Stuart added that, as students return to classes, it will be important for schools to tackle ongoing mental health challenges.

“Some students may be struggling in obvious ways; for others it may be harder to identify. It will also be important to continue to monitor children’s and youth mental health … as returning to in-person school may bring its own challenges. For some individuals and communities, the mental health impacts of the pandemic may last even after the physical health risks resolve.”

Dr. Hawrilenko agreed.

“From a policy perspective, I am quite frankly terrified about how these inequities – in particular, learning loss – might play out long after school closures are a distant memory,” he said. “It is critical to provide schools the resources not just to minimize risk when reopening, but additional funding for workforce augmentation – both for mental health staffing and for additional educational support – to help students navigate the months and years over which they transition back into the classroom.”

Dr. Hawrilenko and Dr. Stuart had no disclosures.

Back-to-school jitters are heightened this year, as children head back to the risk of COVID transmission in class, but one upside to the return of in-person school may be better mental health for students.

Courtesy Dr. Matt Hawrilenko

New research shows that virtual schooling, which dominated in many districts last year, was associated with worse mental health outcomes for students – especially older ones – and youth from Black, Hispanic, or lower-income families were hit hardest because they experienced the most closures.

“Schools with lower funding may have had more difficulty meeting guidelines for safe reopening, including updates to ventilation systems and finding the physical space to create safe distancing between children,” explained lead author Matt Hawrilenko, PhD, of the department of psychiatry and behavioral sciences at the University of Washington, Seattle, in an interview.

“In the context of complex school reopening decisions that balance competing risks and benefits, these findings suggest that allocating funding to support safe in-person instruction may reduce mental health inequities associated with race/ethnicity and income,” he and his coauthors noted in the study, published in JAMA Network Open. “Ensuring that all students have access to additional educational and mental health resources must be an important public health priority, met with appropriate funding and work force augmentation, during and beyond the COVID-19 pandemic.”

The study used a cross-sectional population-based survey of 2,324 parents of school-age children in the United States. It was administered in English and Spanish via web and telephone between Dec. 2 and Dec. 21, 2020, and used the parent-report version of the Strengths and Difficulties Questionnaire (SDQ) to assess mental health difficulties of one child per family in four domains: emotional problems, peer problems, conduct, and hyperactivity. Parents were also asked about what kind of schooling their child had received in the last year (remote, in-person, or hybrid) and about demographic information such as child age, gender, household income, parent race and ethnicity, and parent education.

The results showed that, during the 2020 school year, 58.0% of children attended school remotely, 24% attended fully in person, and 18.0% attended in a hybrid format. “Fully remote schooling was strongly patterned along lines of parent race and ethnicity as well as income,” the authors noted. “Parents of 336 children attending school in person (65.8%) but of 597 children attending school fully remotely (44.5%) were White, whereas all other racial/ethnic groups had larger proportions of children attending school fully remotely (P < .001).”

In terms of mental health, the findings showed that older children who attended school remotely had more difficulties, compared with those who attended in-person – but among younger children, remote learning was comparable or slightly better for mental health.

Specifically, “a child aged 17 years attending school remotely would be expected to have a total difficulty score 2.4 points higher than a child of the same age attending school in person, corresponding to a small effect size in favor of in-person schooling,” the authors wrote. “Conversely, a child aged 4 years attending school remotely would be expected to have a total difficulty score 0.5 points lower than a child of the same age attending school in person, corresponding to a very small effect size in favor of remote schooling.”

Age of child proves critical

“Our best estimate is that remote schooling was associated with no difference in mental health difficulties at age 6, and with slightly more difficulties with each year of age after that, with differences most clearly apparent for high school–aged kids,” explained Dr. Hawrilenko, adding the finding suggests that school reopenings should prioritize older children.

However, “what kids are doing at home matters,” he added. “In the youngest age group, the biggest work kids are doing in school and childcare settings is social and emotional development. … Finding opportunities for regular, safe social interactions with peers – perhaps during outdoor playdates – can help them build those skills.”

He emphasized with the anticipated starts and stutters of the new school year there is an important role that doctors can play.

“First, they can help families assess their own risk profile, and whether it makes sense for their children to attend school in person or remotely [to the extent that is an option]. Second, they can help families think through how school closures might impact their child specifically. For those kids who wind up with long chunks of remote schooling, scheduling in regular interactions with other kids in safe ways could make a big difference. Another driver of child anxiety might be learning loss, and this is a good place to reinforce that not every mental health problem needs a mental health solution.

“A lot of kids might be rightfully anxious about having fallen behind over the pandemic. These kids are preparing to transition to college or to the workforce and may be feeling increasingly behind while approaching these moments of transition. Pointing families toward the resources to help them navigate these issues could go a long way to helping quell child anxiety.”

Research helps fill vacuum

Elizabeth A. Stuart, PhD, who was not involved in the study, said in an interview that this research is particularly valuable because there have been very few data on this topic, especially on a large-scale national sample.

Courtesy Dr. Elizabeth A. Stuart

“Sadly, many of the results are not surprising,” said Dr. Stuart, a statistician and professor of mental health at Johns Hopkins University, Baltimore. “Data have shown significant mental health challenges for adults during the pandemic, and it is not surprising that children and youth would experience that as well, especially for those whose daily routines and structures changed dramatically and who were not able to be interacting in-person with teachers, staff, and classmates. This is an important reminder that schools provide not just academic instruction for students, but that the social interactions and other services (such as behavioral health supports, meals, and connections with other social services) students might receive in school are crucial.

“It has been heartening to see a stronger commitment to getting students safely back into school this fall across the country, and that the Centers for Disease Control and Prevention highlighted the benefits of in-person schooling in their COVID-19–related guidance for schools.”

Dr. Stuart added that, as students return to classes, it will be important for schools to tackle ongoing mental health challenges.

“Some students may be struggling in obvious ways; for others it may be harder to identify. It will also be important to continue to monitor children’s and youth mental health … as returning to in-person school may bring its own challenges. For some individuals and communities, the mental health impacts of the pandemic may last even after the physical health risks resolve.”

Dr. Hawrilenko agreed.

“From a policy perspective, I am quite frankly terrified about how these inequities – in particular, learning loss – might play out long after school closures are a distant memory,” he said. “It is critical to provide schools the resources not just to minimize risk when reopening, but additional funding for workforce augmentation – both for mental health staffing and for additional educational support – to help students navigate the months and years over which they transition back into the classroom.”

Dr. Hawrilenko and Dr. Stuart had no disclosures.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

The improved Los Angeles medical dispatch system prompted more callers with limited English proficiency to initiate telecommunicator-assisted cardiopulmonary resuscitation (T-CPR), compared with the previous system, a new study shows.

Chalabala/iStock/Getty Images Plus

The Los Angeles Tiered Dispatch System (LA-TDS), adopted in late 2014, used simplified questions aimed at identifying cardiac arrest, compared with the city’s earlier Medical Priority Dispatch System (MPDS).

The result was substantially decreased call processing times, decreased “undertriage” of out-of-hospital cardiac arrest (OHCA), and improved overall T-CPR rates (Resuscitation. 2020 Oct;155:74-81).

But now, a secondary analysis of the data shows there was a much higher jump in T-CPR rates among a small subset of callers with limited English proficiency, compared with those proficient in English (JAMA Network Open. 2021;4[6]:e216827).

“This was an unanticipated, significant, and disproportionate change, but fortunately a very good change,” lead author Stephen Sanko, MD, said in an interview.

While the T-CPR rate among English-proficient callers increased from 55% with the MPDS to 67% with the LA-TDS (odds ratio, 1.66; P = .007), it rose from 28% to 69% (OR, 5.66; P = .003) among callers with limited English proficiency. In the adjusted analysis, the new LA-TDS was associated with a 69% higher prevalence of T-CPR among English-proficient callers, compared with a 350% greater prevalence among callers with limited English proficiency.

“The emergency communication process between a caller and 911 telecommunicator is more complex than we thought, and likely constitutes a unique subsubspecialty that interacts with fields as diverse as medicine, health equity, linguistics, sociology, consumer behavior and others,” said Dr. Sanko, who is from the division of emergency medical services at the University of Southern California in Los Angeles.

“Yet in spite of this complexity, we’re starting to be able to reproducibly classify elements of the emergency conversation that we believe are tied to outcomes we all care about. ... Modulators of health disparities are present as early as the dispatch conversation, and, importantly, they can be intervened upon to promote improved outcomes,” he continued.

The retrospective cohort study was a predefined secondary analysis of a previously published study comparing telecommunicator management of out-of-hospital cardiac arrest over 3 months with the MPDS versus 3 months with the LA-TDS. The primary outcome was the number of patients who received telecommunicator-assisted chest compressions from callers with limited English proficiency.

Of the 597 emergency calls that met the inclusion criteria, 289 (48%) were in the MPDS cohort and 308 (52%) were in the LA-TDS cohort. In the MPDS cohort, 263 callers had English proficiency and 26 had limited proficiency; in the latter cohort, those figures were 273 and 35, respectively.

There were no significant differences between cohorts in the use of real-time translation services, which were employed 27%-31% of the time.

The reason for the overall T-CPR improvement is likely that the LA-TDS was tailored to the community needs, said Dr. Sanko. “Most people, including doctors, think of 911 dispatch as something simple and straightforward, like ordering a pizza or calling a ride share. [But] LA-TDS is a ‘home grown’ dispatch system whose structure, questions, and emergency instructions were all developed by EMS medical directors and telecommunicators with extensive experience in our community.”

That being said, the researchers acknowledge that the reason behind the bigger T-CPR boost in LEP callers remains unclear. Although the link between language and system was statistically significant, they noted “it was not an a priori hypothesis and appeared to be largely attributable to the low T-CPR rates for callers with limited English proficiency using MPDS.” Additionally, such callers were “remarkably under-represented” in the sample, “which included approximately 600 calls over two quarters in a large city,” said Dr Sanko.

“We hypothesize that a more direct structure, earlier commitment to treating patients with abnormal life status indicators as being suspected cardiac arrest cases, and earlier reassurance may have improved caller confidence that telecommunicators knew what they were doing. This in turn may have translated into an increased likelihood of bystander caller willingness to perform immediate life-saving maneuvers.”

Despite a number of limitations, “the study is important and highlights instructive topics for discussion that suggest potential next-step opportunities,” noted Richard Chocron, MD, PhD, Miranda Lewis, MD, and Thomas Rea, MD, MPH, in an invited commentary that accompanied the publication. Dr. Chocron is from the Paris University, Paris Research Cardiovascular Center, INSERM; Dr. Lewis is from the Georges Pompidou European Hospital in Paris; and Dr. Rea is from the Division of Emergency Medical Services, Public Health–Seattle & King County. Both Dr. Lewis and Dr. Rea are also at the University of Washington, Seattle.

“Sanko et al. found that approximately 10% of all emergency calls were classified as limited English proficiency calls in a community in which 19% of the population was considered to have limited English proficiency,” they added. “This finding suggests the possibility that populations with limited English proficiency are less likely to activate 911 for incidence of cardiac arrest. If true, this finding would compound the health disparity observed among those with limited English proficiency. This topic is important in that it transcends the role of EMS personnel and engages a broad spectrum of societal stakeholders. We must listen, learn, and ultimately deliver public safety resources to groups who have not been well served by conventional approaches.”

None of the authors or editorialists reported any conflicts of interest.

The improved Los Angeles medical dispatch system prompted more callers with limited English proficiency to initiate telecommunicator-assisted cardiopulmonary resuscitation (T-CPR), compared with the previous system, a new study shows.

Chalabala/iStock/Getty Images Plus

The Los Angeles Tiered Dispatch System (LA-TDS), adopted in late 2014, used simplified questions aimed at identifying cardiac arrest, compared with the city’s earlier Medical Priority Dispatch System (MPDS).

The result was substantially decreased call processing times, decreased “undertriage” of out-of-hospital cardiac arrest (OHCA), and improved overall T-CPR rates (Resuscitation. 2020 Oct;155:74-81).

But now, a secondary analysis of the data shows there was a much higher jump in T-CPR rates among a small subset of callers with limited English proficiency, compared with those proficient in English (JAMA Network Open. 2021;4[6]:e216827).

“This was an unanticipated, significant, and disproportionate change, but fortunately a very good change,” lead author Stephen Sanko, MD, said in an interview.

While the T-CPR rate among English-proficient callers increased from 55% with the MPDS to 67% with the LA-TDS (odds ratio, 1.66; P = .007), it rose from 28% to 69% (OR, 5.66; P = .003) among callers with limited English proficiency. In the adjusted analysis, the new LA-TDS was associated with a 69% higher prevalence of T-CPR among English-proficient callers, compared with a 350% greater prevalence among callers with limited English proficiency.

“The emergency communication process between a caller and 911 telecommunicator is more complex than we thought, and likely constitutes a unique subsubspecialty that interacts with fields as diverse as medicine, health equity, linguistics, sociology, consumer behavior and others,” said Dr. Sanko, who is from the division of emergency medical services at the University of Southern California in Los Angeles.

“Yet in spite of this complexity, we’re starting to be able to reproducibly classify elements of the emergency conversation that we believe are tied to outcomes we all care about. ... Modulators of health disparities are present as early as the dispatch conversation, and, importantly, they can be intervened upon to promote improved outcomes,” he continued.

The retrospective cohort study was a predefined secondary analysis of a previously published study comparing telecommunicator management of out-of-hospital cardiac arrest over 3 months with the MPDS versus 3 months with the LA-TDS. The primary outcome was the number of patients who received telecommunicator-assisted chest compressions from callers with limited English proficiency.

Of the 597 emergency calls that met the inclusion criteria, 289 (48%) were in the MPDS cohort and 308 (52%) were in the LA-TDS cohort. In the MPDS cohort, 263 callers had English proficiency and 26 had limited proficiency; in the latter cohort, those figures were 273 and 35, respectively.

There were no significant differences between cohorts in the use of real-time translation services, which were employed 27%-31% of the time.

The reason for the overall T-CPR improvement is likely that the LA-TDS was tailored to the community needs, said Dr. Sanko. “Most people, including doctors, think of 911 dispatch as something simple and straightforward, like ordering a pizza or calling a ride share. [But] LA-TDS is a ‘home grown’ dispatch system whose structure, questions, and emergency instructions were all developed by EMS medical directors and telecommunicators with extensive experience in our community.”

That being said, the researchers acknowledge that the reason behind the bigger T-CPR boost in LEP callers remains unclear. Although the link between language and system was statistically significant, they noted “it was not an a priori hypothesis and appeared to be largely attributable to the low T-CPR rates for callers with limited English proficiency using MPDS.” Additionally, such callers were “remarkably under-represented” in the sample, “which included approximately 600 calls over two quarters in a large city,” said Dr Sanko.

“We hypothesize that a more direct structure, earlier commitment to treating patients with abnormal life status indicators as being suspected cardiac arrest cases, and earlier reassurance may have improved caller confidence that telecommunicators knew what they were doing. This in turn may have translated into an increased likelihood of bystander caller willingness to perform immediate life-saving maneuvers.”

Despite a number of limitations, “the study is important and highlights instructive topics for discussion that suggest potential next-step opportunities,” noted Richard Chocron, MD, PhD, Miranda Lewis, MD, and Thomas Rea, MD, MPH, in an invited commentary that accompanied the publication. Dr. Chocron is from the Paris University, Paris Research Cardiovascular Center, INSERM; Dr. Lewis is from the Georges Pompidou European Hospital in Paris; and Dr. Rea is from the Division of Emergency Medical Services, Public Health–Seattle & King County. Both Dr. Lewis and Dr. Rea are also at the University of Washington, Seattle.

“Sanko et al. found that approximately 10% of all emergency calls were classified as limited English proficiency calls in a community in which 19% of the population was considered to have limited English proficiency,” they added. “This finding suggests the possibility that populations with limited English proficiency are less likely to activate 911 for incidence of cardiac arrest. If true, this finding would compound the health disparity observed among those with limited English proficiency. This topic is important in that it transcends the role of EMS personnel and engages a broad spectrum of societal stakeholders. We must listen, learn, and ultimately deliver public safety resources to groups who have not been well served by conventional approaches.”

None of the authors or editorialists reported any conflicts of interest.

The improved Los Angeles medical dispatch system prompted more callers with limited English proficiency to initiate telecommunicator-assisted cardiopulmonary resuscitation (T-CPR), compared with the previous system, a new study shows.

Chalabala/iStock/Getty Images Plus

The Los Angeles Tiered Dispatch System (LA-TDS), adopted in late 2014, used simplified questions aimed at identifying cardiac arrest, compared with the city’s earlier Medical Priority Dispatch System (MPDS).

The result was substantially decreased call processing times, decreased “undertriage” of out-of-hospital cardiac arrest (OHCA), and improved overall T-CPR rates (Resuscitation. 2020 Oct;155:74-81).

But now, a secondary analysis of the data shows there was a much higher jump in T-CPR rates among a small subset of callers with limited English proficiency, compared with those proficient in English (JAMA Network Open. 2021;4[6]:e216827).

“This was an unanticipated, significant, and disproportionate change, but fortunately a very good change,” lead author Stephen Sanko, MD, said in an interview.

While the T-CPR rate among English-proficient callers increased from 55% with the MPDS to 67% with the LA-TDS (odds ratio, 1.66; P = .007), it rose from 28% to 69% (OR, 5.66; P = .003) among callers with limited English proficiency. In the adjusted analysis, the new LA-TDS was associated with a 69% higher prevalence of T-CPR among English-proficient callers, compared with a 350% greater prevalence among callers with limited English proficiency.

“The emergency communication process between a caller and 911 telecommunicator is more complex than we thought, and likely constitutes a unique subsubspecialty that interacts with fields as diverse as medicine, health equity, linguistics, sociology, consumer behavior and others,” said Dr. Sanko, who is from the division of emergency medical services at the University of Southern California in Los Angeles.

“Yet in spite of this complexity, we’re starting to be able to reproducibly classify elements of the emergency conversation that we believe are tied to outcomes we all care about. ... Modulators of health disparities are present as early as the dispatch conversation, and, importantly, they can be intervened upon to promote improved outcomes,” he continued.

The retrospective cohort study was a predefined secondary analysis of a previously published study comparing telecommunicator management of out-of-hospital cardiac arrest over 3 months with the MPDS versus 3 months with the LA-TDS. The primary outcome was the number of patients who received telecommunicator-assisted chest compressions from callers with limited English proficiency.

Of the 597 emergency calls that met the inclusion criteria, 289 (48%) were in the MPDS cohort and 308 (52%) were in the LA-TDS cohort. In the MPDS cohort, 263 callers had English proficiency and 26 had limited proficiency; in the latter cohort, those figures were 273 and 35, respectively.

There were no significant differences between cohorts in the use of real-time translation services, which were employed 27%-31% of the time.

The reason for the overall T-CPR improvement is likely that the LA-TDS was tailored to the community needs, said Dr. Sanko. “Most people, including doctors, think of 911 dispatch as something simple and straightforward, like ordering a pizza or calling a ride share. [But] LA-TDS is a ‘home grown’ dispatch system whose structure, questions, and emergency instructions were all developed by EMS medical directors and telecommunicators with extensive experience in our community.”

That being said, the researchers acknowledge that the reason behind the bigger T-CPR boost in LEP callers remains unclear. Although the link between language and system was statistically significant, they noted “it was not an a priori hypothesis and appeared to be largely attributable to the low T-CPR rates for callers with limited English proficiency using MPDS.” Additionally, such callers were “remarkably under-represented” in the sample, “which included approximately 600 calls over two quarters in a large city,” said Dr Sanko.

“We hypothesize that a more direct structure, earlier commitment to treating patients with abnormal life status indicators as being suspected cardiac arrest cases, and earlier reassurance may have improved caller confidence that telecommunicators knew what they were doing. This in turn may have translated into an increased likelihood of bystander caller willingness to perform immediate life-saving maneuvers.”

Despite a number of limitations, “the study is important and highlights instructive topics for discussion that suggest potential next-step opportunities,” noted Richard Chocron, MD, PhD, Miranda Lewis, MD, and Thomas Rea, MD, MPH, in an invited commentary that accompanied the publication. Dr. Chocron is from the Paris University, Paris Research Cardiovascular Center, INSERM; Dr. Lewis is from the Georges Pompidou European Hospital in Paris; and Dr. Rea is from the Division of Emergency Medical Services, Public Health–Seattle & King County. Both Dr. Lewis and Dr. Rea are also at the University of Washington, Seattle.

“Sanko et al. found that approximately 10% of all emergency calls were classified as limited English proficiency calls in a community in which 19% of the population was considered to have limited English proficiency,” they added. “This finding suggests the possibility that populations with limited English proficiency are less likely to activate 911 for incidence of cardiac arrest. If true, this finding would compound the health disparity observed among those with limited English proficiency. This topic is important in that it transcends the role of EMS personnel and engages a broad spectrum of societal stakeholders. We must listen, learn, and ultimately deliver public safety resources to groups who have not been well served by conventional approaches.”

None of the authors or editorialists reported any conflicts of interest.

Psychotherapy and pharmacotherapy appear to be similarly effective for the treatment of depression, and a combination of both treatments might pack the biggest punch, according to a network meta-analysis (NMA) comparing either and both approaches with control conditions in the primary care setting.

The findings are important, since the majority of depressed patients are treated by primary care physicians, yet relatively few randomized trials of treatment have focused on this setting, noted senior study author Pim Cuijpers, PhD, from Vrije Universiteit Amsterdam, and colleagues, in the paper, which was published in Annals of Family Medicine.

“The main message is that clinicians should certainly consider psychotherapy instead of pharmacotherapy, because this is preferred by most patients, and when possible, combined treatments should be the preferred choice because the outcomes are considerably better,” he said in an interview. Either way, he emphasized that “preference of patients is very important and all three treatments are better than usual care.”

The NMA included studies comparing psychotherapy, antidepressant medication, or a combination of both, with control conditions (defined as usual care, wait list, or pill placebo) in adult primary care patients with depression.

Patients could have major depression, persistent mood disorders (dysthymia), both, or high scores on self-rating depression scales. The primary outcome of the NMA was response, defined as a 50% improvement in the Hamilton Depression Rating scores (HAM-D).

A total of 58 studies met inclusion criteria, involving 9,301 patients.
 

Treatment options compared

Compared with usual care, both psychotherapy alone and pharmacotherapy alone had significantly better response rates, with no significant difference between them (relative risk, 1.60 and RR, 1.65, respectively). The combination of psychotherapy and pharmacotherapy was even better (RR, 2.15), whereas the wait list was less effective (RR, 0.68).

When comparing combined therapy with psychotherapy or pharmacotherapy, the superiority of combination therapy over psychotherapy was only slightly statistically significant (RR, 1.35; 95% confidence interval, 1.00-1.81), while pharmacotherapy was only slightly inferior (RR, 1.30; 95% CI, 0.98-1.73).

“The significance level is not very high, which is related to statistical power,” said Dr. Cuijpers. “But the mean benefit is quite substantial in my opinion, with a 35% higher chance of response in the combined treatment, compared to psychotherapy alone.”

Looking at the outcome of remission, (normally defined as a score of 7 or less on the HAM-D), the outcomes were “comparable to those for response, with the exception that combined treatment was not significantly different from psychotherapy,” they wrote.

One important caveat is that several studies included in the NMA included patients with moderate to severe depression, a population that is different from the usual primary care population of depressed patients who have mild to moderate symptoms. Antidepressant medications are also assumed to work better against more severe symptoms, added the authors. “The inclusion of these studies might therefore have resulted in an overestimation of the effects of pharmacotherapy in the present NMA.”

Among other limitations, the authors noted that studies included mixed populations of patients with dysthymia and major depression; they also made no distinction between different types of antidepressants.
 

Psychotherapies unknown, but meta-analysis is still useful

Commenting on these findings, Neil Skolnik, MD, professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, said this is “an important study, confirming and extending the conclusions” of a systematic review published in 2016 as a Clinical Practice Guideline from the American College of Physicians.

“Unfortunately, the authors did not specify what type of psychotherapy was studied in the meta-analysis, so we have to look elsewhere if we want to advise our patients on what type of psychotherapy to seek, since there are important differences between different types of therapy,” he said.

Still, he described the study as providing “helpful information for the practicing clinician, as it gives us solid information with which to engage and advise patients in a shared decision-making process for effective treatment of depression.”

“Some patients will choose psychotherapy, some will choose medications. They can make either choice with the confidence that both approaches are effective,” Dr. Skolnik elaborated. “In addition, if psychotherapy does not seem to be sufficiently helping we are on solid ground adding an antidepressant medication to psychotherapy, with this data showing that the combined treatment works better than psychotherapy alone.”

Dr. Cuijpers receives allowances for his memberships on the board of directors of Mind, Fonds Psychische Gezondheid, and Korrelatie, and for being chair of the PACO committee of the Raad voor Civiel-militaire Zorg en Onderzoek of the Dutch Ministry of Defense. He also serves as deputy editor of Depression and Anxiety and associate editor of Psychological Bulletin, and he receives royalties for books he has authored or coauthored. He received grants from the European Union, ZonMw, and PFGV. Another study author reported receiving personal fees from Mitsubishi-Tanabe, MSD, and Shionogi and a grant from Mitsubishi-Tanabe outside the submitted work. One author has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO Foundation, and Angelini Pharmam, while another reported receiving personal fees from Boehringer Ingelheim, Kyowa Kirin, ASKA Pharmaceutical, and Toyota Motor Corporation outside the submitted work. The other authors and Dr. Skolnik reported no conflicts.

Psychotherapy and pharmacotherapy appear to be similarly effective for the treatment of depression, and a combination of both treatments might pack the biggest punch, according to a network meta-analysis (NMA) comparing either and both approaches with control conditions in the primary care setting.

The findings are important, since the majority of depressed patients are treated by primary care physicians, yet relatively few randomized trials of treatment have focused on this setting, noted senior study author Pim Cuijpers, PhD, from Vrije Universiteit Amsterdam, and colleagues, in the paper, which was published in Annals of Family Medicine.

“The main message is that clinicians should certainly consider psychotherapy instead of pharmacotherapy, because this is preferred by most patients, and when possible, combined treatments should be the preferred choice because the outcomes are considerably better,” he said in an interview. Either way, he emphasized that “preference of patients is very important and all three treatments are better than usual care.”

The NMA included studies comparing psychotherapy, antidepressant medication, or a combination of both, with control conditions (defined as usual care, wait list, or pill placebo) in adult primary care patients with depression.

Patients could have major depression, persistent mood disorders (dysthymia), both, or high scores on self-rating depression scales. The primary outcome of the NMA was response, defined as a 50% improvement in the Hamilton Depression Rating scores (HAM-D).

A total of 58 studies met inclusion criteria, involving 9,301 patients.
 

Treatment options compared

Compared with usual care, both psychotherapy alone and pharmacotherapy alone had significantly better response rates, with no significant difference between them (relative risk, 1.60 and RR, 1.65, respectively). The combination of psychotherapy and pharmacotherapy was even better (RR, 2.15), whereas the wait list was less effective (RR, 0.68).

When comparing combined therapy with psychotherapy or pharmacotherapy, the superiority of combination therapy over psychotherapy was only slightly statistically significant (RR, 1.35; 95% confidence interval, 1.00-1.81), while pharmacotherapy was only slightly inferior (RR, 1.30; 95% CI, 0.98-1.73).

“The significance level is not very high, which is related to statistical power,” said Dr. Cuijpers. “But the mean benefit is quite substantial in my opinion, with a 35% higher chance of response in the combined treatment, compared to psychotherapy alone.”

Looking at the outcome of remission, (normally defined as a score of 7 or less on the HAM-D), the outcomes were “comparable to those for response, with the exception that combined treatment was not significantly different from psychotherapy,” they wrote.

One important caveat is that several studies included in the NMA included patients with moderate to severe depression, a population that is different from the usual primary care population of depressed patients who have mild to moderate symptoms. Antidepressant medications are also assumed to work better against more severe symptoms, added the authors. “The inclusion of these studies might therefore have resulted in an overestimation of the effects of pharmacotherapy in the present NMA.”

Among other limitations, the authors noted that studies included mixed populations of patients with dysthymia and major depression; they also made no distinction between different types of antidepressants.
 

Psychotherapies unknown, but meta-analysis is still useful

Commenting on these findings, Neil Skolnik, MD, professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, said this is “an important study, confirming and extending the conclusions” of a systematic review published in 2016 as a Clinical Practice Guideline from the American College of Physicians.

“Unfortunately, the authors did not specify what type of psychotherapy was studied in the meta-analysis, so we have to look elsewhere if we want to advise our patients on what type of psychotherapy to seek, since there are important differences between different types of therapy,” he said.

Still, he described the study as providing “helpful information for the practicing clinician, as it gives us solid information with which to engage and advise patients in a shared decision-making process for effective treatment of depression.”

“Some patients will choose psychotherapy, some will choose medications. They can make either choice with the confidence that both approaches are effective,” Dr. Skolnik elaborated. “In addition, if psychotherapy does not seem to be sufficiently helping we are on solid ground adding an antidepressant medication to psychotherapy, with this data showing that the combined treatment works better than psychotherapy alone.”

Dr. Cuijpers receives allowances for his memberships on the board of directors of Mind, Fonds Psychische Gezondheid, and Korrelatie, and for being chair of the PACO committee of the Raad voor Civiel-militaire Zorg en Onderzoek of the Dutch Ministry of Defense. He also serves as deputy editor of Depression and Anxiety and associate editor of Psychological Bulletin, and he receives royalties for books he has authored or coauthored. He received grants from the European Union, ZonMw, and PFGV. Another study author reported receiving personal fees from Mitsubishi-Tanabe, MSD, and Shionogi and a grant from Mitsubishi-Tanabe outside the submitted work. One author has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO Foundation, and Angelini Pharmam, while another reported receiving personal fees from Boehringer Ingelheim, Kyowa Kirin, ASKA Pharmaceutical, and Toyota Motor Corporation outside the submitted work. The other authors and Dr. Skolnik reported no conflicts.

Psychotherapy and pharmacotherapy appear to be similarly effective for the treatment of depression, and a combination of both treatments might pack the biggest punch, according to a network meta-analysis (NMA) comparing either and both approaches with control conditions in the primary care setting.

The findings are important, since the majority of depressed patients are treated by primary care physicians, yet relatively few randomized trials of treatment have focused on this setting, noted senior study author Pim Cuijpers, PhD, from Vrije Universiteit Amsterdam, and colleagues, in the paper, which was published in Annals of Family Medicine.

“The main message is that clinicians should certainly consider psychotherapy instead of pharmacotherapy, because this is preferred by most patients, and when possible, combined treatments should be the preferred choice because the outcomes are considerably better,” he said in an interview. Either way, he emphasized that “preference of patients is very important and all three treatments are better than usual care.”

The NMA included studies comparing psychotherapy, antidepressant medication, or a combination of both, with control conditions (defined as usual care, wait list, or pill placebo) in adult primary care patients with depression.

Patients could have major depression, persistent mood disorders (dysthymia), both, or high scores on self-rating depression scales. The primary outcome of the NMA was response, defined as a 50% improvement in the Hamilton Depression Rating scores (HAM-D).

A total of 58 studies met inclusion criteria, involving 9,301 patients.
 

Treatment options compared

Compared with usual care, both psychotherapy alone and pharmacotherapy alone had significantly better response rates, with no significant difference between them (relative risk, 1.60 and RR, 1.65, respectively). The combination of psychotherapy and pharmacotherapy was even better (RR, 2.15), whereas the wait list was less effective (RR, 0.68).

When comparing combined therapy with psychotherapy or pharmacotherapy, the superiority of combination therapy over psychotherapy was only slightly statistically significant (RR, 1.35; 95% confidence interval, 1.00-1.81), while pharmacotherapy was only slightly inferior (RR, 1.30; 95% CI, 0.98-1.73).

“The significance level is not very high, which is related to statistical power,” said Dr. Cuijpers. “But the mean benefit is quite substantial in my opinion, with a 35% higher chance of response in the combined treatment, compared to psychotherapy alone.”

Looking at the outcome of remission, (normally defined as a score of 7 or less on the HAM-D), the outcomes were “comparable to those for response, with the exception that combined treatment was not significantly different from psychotherapy,” they wrote.

One important caveat is that several studies included in the NMA included patients with moderate to severe depression, a population that is different from the usual primary care population of depressed patients who have mild to moderate symptoms. Antidepressant medications are also assumed to work better against more severe symptoms, added the authors. “The inclusion of these studies might therefore have resulted in an overestimation of the effects of pharmacotherapy in the present NMA.”

Among other limitations, the authors noted that studies included mixed populations of patients with dysthymia and major depression; they also made no distinction between different types of antidepressants.
 

Psychotherapies unknown, but meta-analysis is still useful

Commenting on these findings, Neil Skolnik, MD, professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, said this is “an important study, confirming and extending the conclusions” of a systematic review published in 2016 as a Clinical Practice Guideline from the American College of Physicians.

“Unfortunately, the authors did not specify what type of psychotherapy was studied in the meta-analysis, so we have to look elsewhere if we want to advise our patients on what type of psychotherapy to seek, since there are important differences between different types of therapy,” he said.

Still, he described the study as providing “helpful information for the practicing clinician, as it gives us solid information with which to engage and advise patients in a shared decision-making process for effective treatment of depression.”

“Some patients will choose psychotherapy, some will choose medications. They can make either choice with the confidence that both approaches are effective,” Dr. Skolnik elaborated. “In addition, if psychotherapy does not seem to be sufficiently helping we are on solid ground adding an antidepressant medication to psychotherapy, with this data showing that the combined treatment works better than psychotherapy alone.”

Dr. Cuijpers receives allowances for his memberships on the board of directors of Mind, Fonds Psychische Gezondheid, and Korrelatie, and for being chair of the PACO committee of the Raad voor Civiel-militaire Zorg en Onderzoek of the Dutch Ministry of Defense. He also serves as deputy editor of Depression and Anxiety and associate editor of Psychological Bulletin, and he receives royalties for books he has authored or coauthored. He received grants from the European Union, ZonMw, and PFGV. Another study author reported receiving personal fees from Mitsubishi-Tanabe, MSD, and Shionogi and a grant from Mitsubishi-Tanabe outside the submitted work. One author has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO Foundation, and Angelini Pharmam, while another reported receiving personal fees from Boehringer Ingelheim, Kyowa Kirin, ASKA Pharmaceutical, and Toyota Motor Corporation outside the submitted work. The other authors and Dr. Skolnik reported no conflicts.