Marilynn Larkin

New criteria for pediatric sepsis, based on a novel score that predicts mortality in children with suspected or confirmed infection, perform better than existing organ dysfunction scores and criteria and have the potential to improve clinical care globally, researchers say.

Current pediatric-specific criteria for sepsis were published in 2005, based on expert opinion. In 2016, sepsis was redefined for adults as life-threatening organ dysfunction caused by a dysregulated host response to infection, as opposed to an earlier focus on systemic inflammation. But the paradigm-shifting changes were not extended to children (< 18 years, but not newborns), setting the stage for the new initiative.

The new criteria, and their development and validation, were published in JAMA and presented the same day at the Society of Critical Care Medicine’s 2024 Critical Care Congress in Phoenix, Arizona.
 

International Consensus

“The new criteria we derived are based on data from electronic health records and analysis of more than 3 million pediatric healthcare encounters from 10 hospitals around the world, including in low-resource settings,” L. Nelson Sanchez-Pinto, MD, MBI, a critical care physician at the Ann and Robert H. Lurie Children’s Hospital of Chicago, told this news organization.

Dr. Sanchez-Pinto co-led the data group of the international expert task force convened by the Society of Critical Care Medicine (SCCM) to develop and validate the criteria, which are based on evidence from an international survey, systematic review and meta-analysis, a newly created organ dysfunction score (Phoenix Sepsis Score), and sites on four continents.

Based on the findings, the task force now suggests that pediatric sepsis be defined by a Phoenix Sepsis Score of at least 2 points in children with suspected infection, which indicates potentially life-threatening dysfunction of the respiratory, cardiovascular, coagulation, and/or neurological systems. Septic shock is defined as sepsis with at least 1 cardiovascular point in the score.
 

Disparities Across Settings

To derive and validate the new criteria across differently resourced settings, the researchers conducted a multicenter, international, retrospective cohort study involving 10 health systems in the United States, Colombia, Bangladesh, China, and Kenya, 3 of which were used as external validation sites.

Data were collected from pediatric emergency and inpatient encounters from 2010 to 2019. The development set comprised 3,049,699 children, and the external validation set included 581,317.

Stacked regression models to predict mortality in children with suspected infection were derived and validated using the best-performing organ dysfunction subscores from eight existing scores.

The final model was then translated into the integer-based Phoenix Sepsis Score and used to establish binary criteria for sepsis and septic shock.

Among 172,984 children with suspected infection in the first 24 hours (development set; 1.2% mortality), a four-organ-system model performed best. The Phoenix Sepsis Score — the integer version of the model — had areas under the precision recall curve of 0.23 to 0.38, and areas under the receiver operating characteristic curve of 0.71 to 0.92 to predict mortality in the validation sets.

A Phoenix Sepsis Score of 2 points or higher in children with suspected infection as criteria for sepsis, plus 1 or more cardiovascular points as criteria for septic shock, resulted in a higher positive predictive value and higher or similar sensitivity compared with the 2005 International Pediatric Sepsis Consensus Conference criteria across differently resourced settings.

Specifically, children with a Phoenix Sepsis Score of at least 2 points had in-hospital mortality of 7.1% in higher-resource settings and 28.5% in lower-resource settings — more than 8 times that of children with suspected infection not meeting these criteria.

Mortality also was higher in children who had organ dysfunction in at least one of four organ systems — respiratory, cardiovascular, coagulation, and/or neurological — that was not the primary site of infection.

Children with septic shock, indicated by at least 1 cardiovascular point in the Phoenix Sepsis Score, had severe hypotension for age, blood lactate exceeding 5 mmol/L, or need for vasoactive medication. These children had an in-hospital mortality rate of 10.8% in higher-resource settings and 33.5% in lower-resource settings.
 

A Better Score

Given the findings, the task force recommends that “the former criteria based on systemic inflammatory response syndrome should not be used to diagnose sepsis in children [and] the former term severe sepsis should no longer be used because sepsis is life-threatening organ dysfunction associated with infection and is thus indicative of a severe disease state.”

The task force cautions that although the four organs in the Phoenix Sepsis Score are most commonly involved in sepsis, “this does not diminish the crucial importance of the assessment and management of other organ dysfunction.”

Furthermore, they emphasize that the Phoenix score was designed to identify sepsis in children, not to screen children at risk for developing sepsis or early identification of children with suspected sepsis.
 

Additional Considerations

In related editorials, commentators noted some caveats and concerns with regard to the study design and the new criteria.

Roberto Jabornisky, MD, PhD, of National University of the Northeast, Corrientes, Argentina, and colleagues pointed out that “all the low-resource validation sites were institutions with electronic health records and most had PICUs [pediatric intensive care units], which does not adequately reflect conditions in most low-resource settings. These factors introduce a distinct bias favoring a ‘PICU-based consensus,’ potentially limiting the generalizability and adoption of the new criteria by health care practitioners in non-PICU and nonhospital settings responsible for recognizing and managing children with sepsis.” The editorialists called for additional prospective validation in differently resourced settings, especially those with the highest disease burdens.

“Until then,” they wrote, “it is essential to refrain from considering these criteria as an inflexible directive governing medical interventions for pediatric sepsis. No definition can fully substitute for the clinical judgment of an experienced, vigilant clinician caring for an unwell child.”

Erin F. Carlton, MD, MSc of the University of Michigan, Ann Arbor, and colleagues added in a separate editorial, “The Phoenix criteria identify a sicker subset of patients than prior SIRS [systemic inflammatory response syndrome]-based criteria. Some may worry this higher threshold could delay management of patients not meeting sepsis criteria. Just as patients with chest pain and a troponin leak warrant monitoring and treatment (but are not prioritized for immediate heart catheterization), patients with infection need monitoring and treatment. Improvements in care should thus be judged not only by improved outcomes among patients with sepsis but also by decreased progression to sepsis among patients with infection.”

The International Consensus Criteria paper was supported by the Society of Critical Care Medicine and a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to Tellen C. Bennett, MD, MS, and Nelson Sanchez-Pinto, MD. Data for the Kenya site were collected with support of the Wellcome Trust to the Kenya Major Overseas Programme. Dr. Jabornisky reported no conflicts of interest. Dr. Carlton reported serving on the Pediatric Surviving Sepsis Campaign Guideline committee and receiving grant support from the NIH.

New criteria for pediatric sepsis, based on a novel score that predicts mortality in children with suspected or confirmed infection, perform better than existing organ dysfunction scores and criteria and have the potential to improve clinical care globally, researchers say.

Current pediatric-specific criteria for sepsis were published in 2005, based on expert opinion. In 2016, sepsis was redefined for adults as life-threatening organ dysfunction caused by a dysregulated host response to infection, as opposed to an earlier focus on systemic inflammation. But the paradigm-shifting changes were not extended to children (< 18 years, but not newborns), setting the stage for the new initiative.

The new criteria, and their development and validation, were published in JAMA and presented the same day at the Society of Critical Care Medicine’s 2024 Critical Care Congress in Phoenix, Arizona.
 

International Consensus

“The new criteria we derived are based on data from electronic health records and analysis of more than 3 million pediatric healthcare encounters from 10 hospitals around the world, including in low-resource settings,” L. Nelson Sanchez-Pinto, MD, MBI, a critical care physician at the Ann and Robert H. Lurie Children’s Hospital of Chicago, told this news organization.

Dr. Sanchez-Pinto co-led the data group of the international expert task force convened by the Society of Critical Care Medicine (SCCM) to develop and validate the criteria, which are based on evidence from an international survey, systematic review and meta-analysis, a newly created organ dysfunction score (Phoenix Sepsis Score), and sites on four continents.

Based on the findings, the task force now suggests that pediatric sepsis be defined by a Phoenix Sepsis Score of at least 2 points in children with suspected infection, which indicates potentially life-threatening dysfunction of the respiratory, cardiovascular, coagulation, and/or neurological systems. Septic shock is defined as sepsis with at least 1 cardiovascular point in the score.
 

Disparities Across Settings

To derive and validate the new criteria across differently resourced settings, the researchers conducted a multicenter, international, retrospective cohort study involving 10 health systems in the United States, Colombia, Bangladesh, China, and Kenya, 3 of which were used as external validation sites.

Data were collected from pediatric emergency and inpatient encounters from 2010 to 2019. The development set comprised 3,049,699 children, and the external validation set included 581,317.

Stacked regression models to predict mortality in children with suspected infection were derived and validated using the best-performing organ dysfunction subscores from eight existing scores.

The final model was then translated into the integer-based Phoenix Sepsis Score and used to establish binary criteria for sepsis and septic shock.

Among 172,984 children with suspected infection in the first 24 hours (development set; 1.2% mortality), a four-organ-system model performed best. The Phoenix Sepsis Score — the integer version of the model — had areas under the precision recall curve of 0.23 to 0.38, and areas under the receiver operating characteristic curve of 0.71 to 0.92 to predict mortality in the validation sets.

A Phoenix Sepsis Score of 2 points or higher in children with suspected infection as criteria for sepsis, plus 1 or more cardiovascular points as criteria for septic shock, resulted in a higher positive predictive value and higher or similar sensitivity compared with the 2005 International Pediatric Sepsis Consensus Conference criteria across differently resourced settings.

Specifically, children with a Phoenix Sepsis Score of at least 2 points had in-hospital mortality of 7.1% in higher-resource settings and 28.5% in lower-resource settings — more than 8 times that of children with suspected infection not meeting these criteria.

Mortality also was higher in children who had organ dysfunction in at least one of four organ systems — respiratory, cardiovascular, coagulation, and/or neurological — that was not the primary site of infection.

Children with septic shock, indicated by at least 1 cardiovascular point in the Phoenix Sepsis Score, had severe hypotension for age, blood lactate exceeding 5 mmol/L, or need for vasoactive medication. These children had an in-hospital mortality rate of 10.8% in higher-resource settings and 33.5% in lower-resource settings.
 

A Better Score

Given the findings, the task force recommends that “the former criteria based on systemic inflammatory response syndrome should not be used to diagnose sepsis in children [and] the former term severe sepsis should no longer be used because sepsis is life-threatening organ dysfunction associated with infection and is thus indicative of a severe disease state.”

The task force cautions that although the four organs in the Phoenix Sepsis Score are most commonly involved in sepsis, “this does not diminish the crucial importance of the assessment and management of other organ dysfunction.”

Furthermore, they emphasize that the Phoenix score was designed to identify sepsis in children, not to screen children at risk for developing sepsis or early identification of children with suspected sepsis.
 

Additional Considerations

In related editorials, commentators noted some caveats and concerns with regard to the study design and the new criteria.

Roberto Jabornisky, MD, PhD, of National University of the Northeast, Corrientes, Argentina, and colleagues pointed out that “all the low-resource validation sites were institutions with electronic health records and most had PICUs [pediatric intensive care units], which does not adequately reflect conditions in most low-resource settings. These factors introduce a distinct bias favoring a ‘PICU-based consensus,’ potentially limiting the generalizability and adoption of the new criteria by health care practitioners in non-PICU and nonhospital settings responsible for recognizing and managing children with sepsis.” The editorialists called for additional prospective validation in differently resourced settings, especially those with the highest disease burdens.

“Until then,” they wrote, “it is essential to refrain from considering these criteria as an inflexible directive governing medical interventions for pediatric sepsis. No definition can fully substitute for the clinical judgment of an experienced, vigilant clinician caring for an unwell child.”

Erin F. Carlton, MD, MSc of the University of Michigan, Ann Arbor, and colleagues added in a separate editorial, “The Phoenix criteria identify a sicker subset of patients than prior SIRS [systemic inflammatory response syndrome]-based criteria. Some may worry this higher threshold could delay management of patients not meeting sepsis criteria. Just as patients with chest pain and a troponin leak warrant monitoring and treatment (but are not prioritized for immediate heart catheterization), patients with infection need monitoring and treatment. Improvements in care should thus be judged not only by improved outcomes among patients with sepsis but also by decreased progression to sepsis among patients with infection.”

The International Consensus Criteria paper was supported by the Society of Critical Care Medicine and a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to Tellen C. Bennett, MD, MS, and Nelson Sanchez-Pinto, MD. Data for the Kenya site were collected with support of the Wellcome Trust to the Kenya Major Overseas Programme. Dr. Jabornisky reported no conflicts of interest. Dr. Carlton reported serving on the Pediatric Surviving Sepsis Campaign Guideline committee and receiving grant support from the NIH.

New criteria for pediatric sepsis, based on a novel score that predicts mortality in children with suspected or confirmed infection, perform better than existing organ dysfunction scores and criteria and have the potential to improve clinical care globally, researchers say.

Current pediatric-specific criteria for sepsis were published in 2005, based on expert opinion. In 2016, sepsis was redefined for adults as life-threatening organ dysfunction caused by a dysregulated host response to infection, as opposed to an earlier focus on systemic inflammation. But the paradigm-shifting changes were not extended to children (< 18 years, but not newborns), setting the stage for the new initiative.

The new criteria, and their development and validation, were published in JAMA and presented the same day at the Society of Critical Care Medicine’s 2024 Critical Care Congress in Phoenix, Arizona.
 

International Consensus

“The new criteria we derived are based on data from electronic health records and analysis of more than 3 million pediatric healthcare encounters from 10 hospitals around the world, including in low-resource settings,” L. Nelson Sanchez-Pinto, MD, MBI, a critical care physician at the Ann and Robert H. Lurie Children’s Hospital of Chicago, told this news organization.

Dr. Sanchez-Pinto co-led the data group of the international expert task force convened by the Society of Critical Care Medicine (SCCM) to develop and validate the criteria, which are based on evidence from an international survey, systematic review and meta-analysis, a newly created organ dysfunction score (Phoenix Sepsis Score), and sites on four continents.

Based on the findings, the task force now suggests that pediatric sepsis be defined by a Phoenix Sepsis Score of at least 2 points in children with suspected infection, which indicates potentially life-threatening dysfunction of the respiratory, cardiovascular, coagulation, and/or neurological systems. Septic shock is defined as sepsis with at least 1 cardiovascular point in the score.
 

Disparities Across Settings

To derive and validate the new criteria across differently resourced settings, the researchers conducted a multicenter, international, retrospective cohort study involving 10 health systems in the United States, Colombia, Bangladesh, China, and Kenya, 3 of which were used as external validation sites.

Data were collected from pediatric emergency and inpatient encounters from 2010 to 2019. The development set comprised 3,049,699 children, and the external validation set included 581,317.

Stacked regression models to predict mortality in children with suspected infection were derived and validated using the best-performing organ dysfunction subscores from eight existing scores.

The final model was then translated into the integer-based Phoenix Sepsis Score and used to establish binary criteria for sepsis and septic shock.

Among 172,984 children with suspected infection in the first 24 hours (development set; 1.2% mortality), a four-organ-system model performed best. The Phoenix Sepsis Score — the integer version of the model — had areas under the precision recall curve of 0.23 to 0.38, and areas under the receiver operating characteristic curve of 0.71 to 0.92 to predict mortality in the validation sets.

A Phoenix Sepsis Score of 2 points or higher in children with suspected infection as criteria for sepsis, plus 1 or more cardiovascular points as criteria for septic shock, resulted in a higher positive predictive value and higher or similar sensitivity compared with the 2005 International Pediatric Sepsis Consensus Conference criteria across differently resourced settings.

Specifically, children with a Phoenix Sepsis Score of at least 2 points had in-hospital mortality of 7.1% in higher-resource settings and 28.5% in lower-resource settings — more than 8 times that of children with suspected infection not meeting these criteria.

Mortality also was higher in children who had organ dysfunction in at least one of four organ systems — respiratory, cardiovascular, coagulation, and/or neurological — that was not the primary site of infection.

Children with septic shock, indicated by at least 1 cardiovascular point in the Phoenix Sepsis Score, had severe hypotension for age, blood lactate exceeding 5 mmol/L, or need for vasoactive medication. These children had an in-hospital mortality rate of 10.8% in higher-resource settings and 33.5% in lower-resource settings.
 

A Better Score

Given the findings, the task force recommends that “the former criteria based on systemic inflammatory response syndrome should not be used to diagnose sepsis in children [and] the former term severe sepsis should no longer be used because sepsis is life-threatening organ dysfunction associated with infection and is thus indicative of a severe disease state.”

The task force cautions that although the four organs in the Phoenix Sepsis Score are most commonly involved in sepsis, “this does not diminish the crucial importance of the assessment and management of other organ dysfunction.”

Furthermore, they emphasize that the Phoenix score was designed to identify sepsis in children, not to screen children at risk for developing sepsis or early identification of children with suspected sepsis.
 

Additional Considerations

In related editorials, commentators noted some caveats and concerns with regard to the study design and the new criteria.

Roberto Jabornisky, MD, PhD, of National University of the Northeast, Corrientes, Argentina, and colleagues pointed out that “all the low-resource validation sites were institutions with electronic health records and most had PICUs [pediatric intensive care units], which does not adequately reflect conditions in most low-resource settings. These factors introduce a distinct bias favoring a ‘PICU-based consensus,’ potentially limiting the generalizability and adoption of the new criteria by health care practitioners in non-PICU and nonhospital settings responsible for recognizing and managing children with sepsis.” The editorialists called for additional prospective validation in differently resourced settings, especially those with the highest disease burdens.

“Until then,” they wrote, “it is essential to refrain from considering these criteria as an inflexible directive governing medical interventions for pediatric sepsis. No definition can fully substitute for the clinical judgment of an experienced, vigilant clinician caring for an unwell child.”

Erin F. Carlton, MD, MSc of the University of Michigan, Ann Arbor, and colleagues added in a separate editorial, “The Phoenix criteria identify a sicker subset of patients than prior SIRS [systemic inflammatory response syndrome]-based criteria. Some may worry this higher threshold could delay management of patients not meeting sepsis criteria. Just as patients with chest pain and a troponin leak warrant monitoring and treatment (but are not prioritized for immediate heart catheterization), patients with infection need monitoring and treatment. Improvements in care should thus be judged not only by improved outcomes among patients with sepsis but also by decreased progression to sepsis among patients with infection.”

The International Consensus Criteria paper was supported by the Society of Critical Care Medicine and a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to Tellen C. Bennett, MD, MS, and Nelson Sanchez-Pinto, MD. Data for the Kenya site were collected with support of the Wellcome Trust to the Kenya Major Overseas Programme. Dr. Jabornisky reported no conflicts of interest. Dr. Carlton reported serving on the Pediatric Surviving Sepsis Campaign Guideline committee and receiving grant support from the NIH.

Very few patients with type 2 diabetes (T2D) achieve and sustain diabetes remission via weight loss alone, new research suggests.

Among more than 37,000 people with T2D in Hong Kong, only 6% had achieved and sustained diabetes remission solely through weight loss up to 8 years after diagnosis. Among those who initially achieved remission, 67% had hyperglycemia at 3 years.

People who lost the most weight (10% of their body weight or more) in the first year after diagnosis were most likely to have sustained remission.

The study “helped to confirm the low rate of diabetes remission and high rate of returning to hyperglycemia in real-world practice,” Andrea Luk, MD, of the Chinese University of Hong Kong, told this news organization. “Over 80% of diabetes remission occurred within the first 5 years of a diabetes diagnosis. This is in line with our understanding that beta cell function will gradually decline over time, making diabetes remission increasingly difficult even with weight reduction.”

The study was published in PLOS Medicine.
 

Early Weight Management Works

Recent clinical trials have demonstrated that T2D remission can be achieved following sustained weight loss through bariatric surgery or lifestyle interventions, the authors noted. In this study, they investigated the association of weight change at 1 year after a diabetes diagnosis with the long-term incidence and sustainability of T2D remission in real-world settings, using data from the territory-wide Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM).

A total of 37,326 people with newly diagnosed T2D who were enrolled in the RAMP-DM between 2000 and 2017 were included and followed until 2019.

At baseline, participants’ mean age was 56.6 years, mean body mass index (BMI) was 26.4 kg/m², and mean A1c was 7.7%, and 65% were using glucose-lowering drugs (GLDs).

T2D remission was defined as two consecutive A1c < 6.5% measurements at least 6 months apart without GLDs currently or in the previous 3 months.

During a median follow-up of 7.9 years, 6.1% of people achieved remission, with an incidence rate of 7.8 per 1000 person-years. The proportion was higher among those with greater weight loss: 14.4% of people who lost 10% of their body weight or more achieved remission compared with 9.9% of those with 5%-9.9% weight loss, 6.5% of those with 0%-4.9% weight loss, and 4.5% of those who gained weight.

After adjustment for age at diagnosis, sex, assessment year, BMI, other metabolic indices, smoking, alcohol drinking, and medication use, the hazard ratio (HR) for diabetes remission was 3.28 for those with 10% or greater weight loss within 1 year of diagnosis, 2.29 for 5%-9.9% weight loss, and 1.34 for 0%-4.9% weight loss compared to weight gain.

The incidence of diabetes remission in the study was significantly lower than that in clinical trials, possibly because trial participants were in structured programs that included intensive lifestyle interventions, regular monitoring and feedback, and reinforcement of a holistic approach to managing diabetes, the authors noted. Real-world settings may or may not include such interventions.

Further analyses showed that within a median follow-up of 3.1 years, 67.2% of people who had achieved diabetes remission returned to hyperglycemia — an incidence rate of 184.8 per 1000 person-years.

The adjusted HR for returning to hyperglycemia was 0.52 for people with 10% or greater weight loss, 0.78 for those with 5%-9.9% weight loss, and 0.90 for those with 0%-4.9% weight loss compared to people with weight gain.

In addition, diabetes remission was associated with a 31% (HR, 0.69) decreased risk for all-cause mortality.

The study “provides evidence for policymakers to design and implement early weight management interventions” for people diagnosed with T2D, the authors concluded.

Clinicians also have a role to play, Dr. Luk said. “At the first encounter with an individual with newly diagnosed T2D, clinicians should emphasize the importance of weight reduction and guide the individual on how this can be achieved through making healthy lifestyle choices. Pharmacotherapy and metabolic surgery for weight management can be considered in appropriate individuals.”

Overall, she added, “clinicians should be informed that the likelihood of achieving and maintaining diabetes remission is low, and patients should be counseled accordingly.”
 

Similar to US Experience

Mona Mshayekhi, MD, PhD, an assistant professor of medicine in the division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center, Nashville, Tennessee, commented on the study for this news organization.

“These findings mirror clinical experience in the US very well,” she said. “We know that sustained weight loss without the use of medications or surgery is extremely difficult in the real-world setting due to the hormonal drivers of obesity, in combination with socioeconomic challenges.”

The study was done before newer weight-management strategies such as glucagon-like peptide 1 receptor agonists were widely available, she noted. “This actually strengthens the finding that weight loss without the routine use of medications has a multitude of benefits, including diabetes remission and reduction of all-cause mortality.”

That said, she added, “I suspect that future studies with more modern cohorts will reveal much higher rates of diabetes remission with the use of newer medications.”

“Our ability to help our patients lose meaningful weight has been limited until recently,” she said. “With new tools in our armamentarium, clinicians need to take the lead in helping patients address and treat obesity and fight the stigma that prevents many from even discussing it with their providers.”

The study did not receive funding. Dr. Luk has received research grants or contracts from Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Eli Lilly, Junshi, Lee Pharmaceutical, MSD, Novo Nordisk, Roche, Sanofi, Shanghai Junshi Biosciences, Sugardown, and Takeda and received travel grants and honoraria for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and MSD. Dr. Mshayekhi reported no conflicts of interest.

A version of this article appeared on Medscape.com.

Very few patients with type 2 diabetes (T2D) achieve and sustain diabetes remission via weight loss alone, new research suggests.

Among more than 37,000 people with T2D in Hong Kong, only 6% had achieved and sustained diabetes remission solely through weight loss up to 8 years after diagnosis. Among those who initially achieved remission, 67% had hyperglycemia at 3 years.

People who lost the most weight (10% of their body weight or more) in the first year after diagnosis were most likely to have sustained remission.

The study “helped to confirm the low rate of diabetes remission and high rate of returning to hyperglycemia in real-world practice,” Andrea Luk, MD, of the Chinese University of Hong Kong, told this news organization. “Over 80% of diabetes remission occurred within the first 5 years of a diabetes diagnosis. This is in line with our understanding that beta cell function will gradually decline over time, making diabetes remission increasingly difficult even with weight reduction.”

The study was published in PLOS Medicine.
 

Early Weight Management Works

Recent clinical trials have demonstrated that T2D remission can be achieved following sustained weight loss through bariatric surgery or lifestyle interventions, the authors noted. In this study, they investigated the association of weight change at 1 year after a diabetes diagnosis with the long-term incidence and sustainability of T2D remission in real-world settings, using data from the territory-wide Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM).

A total of 37,326 people with newly diagnosed T2D who were enrolled in the RAMP-DM between 2000 and 2017 were included and followed until 2019.

At baseline, participants’ mean age was 56.6 years, mean body mass index (BMI) was 26.4 kg/m², and mean A1c was 7.7%, and 65% were using glucose-lowering drugs (GLDs).

T2D remission was defined as two consecutive A1c < 6.5% measurements at least 6 months apart without GLDs currently or in the previous 3 months.

During a median follow-up of 7.9 years, 6.1% of people achieved remission, with an incidence rate of 7.8 per 1000 person-years. The proportion was higher among those with greater weight loss: 14.4% of people who lost 10% of their body weight or more achieved remission compared with 9.9% of those with 5%-9.9% weight loss, 6.5% of those with 0%-4.9% weight loss, and 4.5% of those who gained weight.

After adjustment for age at diagnosis, sex, assessment year, BMI, other metabolic indices, smoking, alcohol drinking, and medication use, the hazard ratio (HR) for diabetes remission was 3.28 for those with 10% or greater weight loss within 1 year of diagnosis, 2.29 for 5%-9.9% weight loss, and 1.34 for 0%-4.9% weight loss compared to weight gain.

The incidence of diabetes remission in the study was significantly lower than that in clinical trials, possibly because trial participants were in structured programs that included intensive lifestyle interventions, regular monitoring and feedback, and reinforcement of a holistic approach to managing diabetes, the authors noted. Real-world settings may or may not include such interventions.

Further analyses showed that within a median follow-up of 3.1 years, 67.2% of people who had achieved diabetes remission returned to hyperglycemia — an incidence rate of 184.8 per 1000 person-years.

The adjusted HR for returning to hyperglycemia was 0.52 for people with 10% or greater weight loss, 0.78 for those with 5%-9.9% weight loss, and 0.90 for those with 0%-4.9% weight loss compared to people with weight gain.

In addition, diabetes remission was associated with a 31% (HR, 0.69) decreased risk for all-cause mortality.

The study “provides evidence for policymakers to design and implement early weight management interventions” for people diagnosed with T2D, the authors concluded.

Clinicians also have a role to play, Dr. Luk said. “At the first encounter with an individual with newly diagnosed T2D, clinicians should emphasize the importance of weight reduction and guide the individual on how this can be achieved through making healthy lifestyle choices. Pharmacotherapy and metabolic surgery for weight management can be considered in appropriate individuals.”

Overall, she added, “clinicians should be informed that the likelihood of achieving and maintaining diabetes remission is low, and patients should be counseled accordingly.”
 

Similar to US Experience

Mona Mshayekhi, MD, PhD, an assistant professor of medicine in the division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center, Nashville, Tennessee, commented on the study for this news organization.

“These findings mirror clinical experience in the US very well,” she said. “We know that sustained weight loss without the use of medications or surgery is extremely difficult in the real-world setting due to the hormonal drivers of obesity, in combination with socioeconomic challenges.”

The study was done before newer weight-management strategies such as glucagon-like peptide 1 receptor agonists were widely available, she noted. “This actually strengthens the finding that weight loss without the routine use of medications has a multitude of benefits, including diabetes remission and reduction of all-cause mortality.”

That said, she added, “I suspect that future studies with more modern cohorts will reveal much higher rates of diabetes remission with the use of newer medications.”

“Our ability to help our patients lose meaningful weight has been limited until recently,” she said. “With new tools in our armamentarium, clinicians need to take the lead in helping patients address and treat obesity and fight the stigma that prevents many from even discussing it with their providers.”

The study did not receive funding. Dr. Luk has received research grants or contracts from Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Eli Lilly, Junshi, Lee Pharmaceutical, MSD, Novo Nordisk, Roche, Sanofi, Shanghai Junshi Biosciences, Sugardown, and Takeda and received travel grants and honoraria for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and MSD. Dr. Mshayekhi reported no conflicts of interest.

A version of this article appeared on Medscape.com.

Very few patients with type 2 diabetes (T2D) achieve and sustain diabetes remission via weight loss alone, new research suggests.

Among more than 37,000 people with T2D in Hong Kong, only 6% had achieved and sustained diabetes remission solely through weight loss up to 8 years after diagnosis. Among those who initially achieved remission, 67% had hyperglycemia at 3 years.

People who lost the most weight (10% of their body weight or more) in the first year after diagnosis were most likely to have sustained remission.

The study “helped to confirm the low rate of diabetes remission and high rate of returning to hyperglycemia in real-world practice,” Andrea Luk, MD, of the Chinese University of Hong Kong, told this news organization. “Over 80% of diabetes remission occurred within the first 5 years of a diabetes diagnosis. This is in line with our understanding that beta cell function will gradually decline over time, making diabetes remission increasingly difficult even with weight reduction.”

The study was published in PLOS Medicine.
 

Early Weight Management Works

Recent clinical trials have demonstrated that T2D remission can be achieved following sustained weight loss through bariatric surgery or lifestyle interventions, the authors noted. In this study, they investigated the association of weight change at 1 year after a diabetes diagnosis with the long-term incidence and sustainability of T2D remission in real-world settings, using data from the territory-wide Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM).

A total of 37,326 people with newly diagnosed T2D who were enrolled in the RAMP-DM between 2000 and 2017 were included and followed until 2019.

At baseline, participants’ mean age was 56.6 years, mean body mass index (BMI) was 26.4 kg/m², and mean A1c was 7.7%, and 65% were using glucose-lowering drugs (GLDs).

T2D remission was defined as two consecutive A1c < 6.5% measurements at least 6 months apart without GLDs currently or in the previous 3 months.

During a median follow-up of 7.9 years, 6.1% of people achieved remission, with an incidence rate of 7.8 per 1000 person-years. The proportion was higher among those with greater weight loss: 14.4% of people who lost 10% of their body weight or more achieved remission compared with 9.9% of those with 5%-9.9% weight loss, 6.5% of those with 0%-4.9% weight loss, and 4.5% of those who gained weight.

After adjustment for age at diagnosis, sex, assessment year, BMI, other metabolic indices, smoking, alcohol drinking, and medication use, the hazard ratio (HR) for diabetes remission was 3.28 for those with 10% or greater weight loss within 1 year of diagnosis, 2.29 for 5%-9.9% weight loss, and 1.34 for 0%-4.9% weight loss compared to weight gain.

The incidence of diabetes remission in the study was significantly lower than that in clinical trials, possibly because trial participants were in structured programs that included intensive lifestyle interventions, regular monitoring and feedback, and reinforcement of a holistic approach to managing diabetes, the authors noted. Real-world settings may or may not include such interventions.

Further analyses showed that within a median follow-up of 3.1 years, 67.2% of people who had achieved diabetes remission returned to hyperglycemia — an incidence rate of 184.8 per 1000 person-years.

The adjusted HR for returning to hyperglycemia was 0.52 for people with 10% or greater weight loss, 0.78 for those with 5%-9.9% weight loss, and 0.90 for those with 0%-4.9% weight loss compared to people with weight gain.

In addition, diabetes remission was associated with a 31% (HR, 0.69) decreased risk for all-cause mortality.

The study “provides evidence for policymakers to design and implement early weight management interventions” for people diagnosed with T2D, the authors concluded.

Clinicians also have a role to play, Dr. Luk said. “At the first encounter with an individual with newly diagnosed T2D, clinicians should emphasize the importance of weight reduction and guide the individual on how this can be achieved through making healthy lifestyle choices. Pharmacotherapy and metabolic surgery for weight management can be considered in appropriate individuals.”

Overall, she added, “clinicians should be informed that the likelihood of achieving and maintaining diabetes remission is low, and patients should be counseled accordingly.”
 

Similar to US Experience

Mona Mshayekhi, MD, PhD, an assistant professor of medicine in the division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center, Nashville, Tennessee, commented on the study for this news organization.

“These findings mirror clinical experience in the US very well,” she said. “We know that sustained weight loss without the use of medications or surgery is extremely difficult in the real-world setting due to the hormonal drivers of obesity, in combination with socioeconomic challenges.”

The study was done before newer weight-management strategies such as glucagon-like peptide 1 receptor agonists were widely available, she noted. “This actually strengthens the finding that weight loss without the routine use of medications has a multitude of benefits, including diabetes remission and reduction of all-cause mortality.”

That said, she added, “I suspect that future studies with more modern cohorts will reveal much higher rates of diabetes remission with the use of newer medications.”

“Our ability to help our patients lose meaningful weight has been limited until recently,” she said. “With new tools in our armamentarium, clinicians need to take the lead in helping patients address and treat obesity and fight the stigma that prevents many from even discussing it with their providers.”

The study did not receive funding. Dr. Luk has received research grants or contracts from Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Eli Lilly, Junshi, Lee Pharmaceutical, MSD, Novo Nordisk, Roche, Sanofi, Shanghai Junshi Biosciences, Sugardown, and Takeda and received travel grants and honoraria for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and MSD. Dr. Mshayekhi reported no conflicts of interest.

A version of this article appeared on Medscape.com.

Recent evidence suggests that more cardiologists are failing to pass their boards. Pass rates declined from a high of 96% in 2018 to a low of 86% in 2021 and 2022. COVID disruptions to training may be largely to blame, experts said.

Among the 1061 candidates who took their first American Board of Internal Medicine (ABIM) cardiovascular (CV) disease exam in 2022, about 80 fellows failed who might have passed had they trained in 2016-2019, according to Anis John Kadado, MD, University of Massachusetts Medical School–Baystate Campus, Springfield, Massachusetts, and colleagues, writing in a viewpoint article published in the Journal of the American College of Cardiology.

“The purpose of board examinations is to test the knowledge, core concepts, and fundamental principles of trainees as they deliver patient care,” said Dr. Kadado. “The decline in CV board pass rates reflects a potential gap in training, which may translate to suboptimal patient care.”

Why the Downturn?

Reasons for the increased failures are likely multifactorial, Dr. Kadado said. While some blame the ABIM, the exam has remained about the same over the past 6 years, so the test itself seems unlikely to explain the decline.

The main culprit, according to the viewpoint authors, is “the educational fallout from the disruptions caused by changes made in response to the COVID pandemic.” Changes that Dr. Kadado and colleagues said put the current class of graduating fellows at “high risk” of failing their boards in the fall.

The typical cardiology fellowship is 3 years or more for subspecialty training. Candidates who took the ABIM exam in 2021 had 18 months of training that overlapped with the pandemic response, and those who took the exam in 2022 had about 30 months of training disrupted by COVID. However, fellows who first took the exam in 2023 had essentially 36 months of training affected by COVID, potentially reducing their odds of passing.

“It is hard, if not impossible, to understand the driving forces for this recent decrease in performance on the initial ABIM certification examination, nor is it possible to forecast if there will be an end to this slide,” Jeffrey T. Kuvin, MD, chair of cardiology at the Zucker School of Medicine at Northwell Health, Manhasset, New York, and colleagues wrote in response to the viewpoint article.

The authors acknowledged that COVID disrupted graduate medical training and that the long-term effects of the disruption are now emerging. However, they also pinpoint other potential issues affecting fellows, including information/technology overload, a focus on patient volume over education, lack of attention to core concepts, and, as Dr. Kadado and colleagues noted, high burnout rates among fellows and knowledge gaps due to easy access to electronic resources rather than reading and studying to retain information.

COVID disruptions included limits on in-person learning, clinic exposure, research opportunities, and conference travel, according to the authors. From a 2020 viewpoint, Dr. Kuvin also noted the loss of bedside teaching and on-site grand rounds.

Furthermore, with deferrals of elective cardiac, endovascular, and structural catheterization procedures during the pandemic, elective cases normally done by fellows were postponed or canceled.

Restoring Education, Board Passing Rates

“Having recently passed the ABIM cardiovascular board exam myself, my take-home message at this point is for current fellows-in-training to remain organized, track training milestones, and foresee any training shortcomings,” Dr. Kadado said. Adding that fellows, graduates and leadership should “identify deficiencies and work on overcoming them.”

The viewpoint authors suggested strategies that fellowship leadership can use. These include:

• Regularly assessing faculty emotional well-being and burnout to ensure that they are engaged in meaningful teaching activities
• Emphasizing in-person learning, meaningful participation in conferences, and faculty oversight
• Encouraging fellows to pursue “self-directed learning” during off-hours
• Developing and implementing checklists, competency-based models, curricula, and rotations to ensure that training milestones are being met
• Returning to in-person imaging interpretation for imaging modalities such as echocardiography, cardiac CT, and cardiac MRI
• Ensuring that fellows take the American College of Cardiology in-training examination
• Providing practice question banks so that fellows can assess their knowledge gaps

“This might also be an opportune time to assess the assessment,” Dr. Kuvin and colleagues noted. “There are likely alternative or additional approaches that could provide a more comprehensive, modern tool to gauge clinical competence in a supportive manner.”

They suggested that these tools could include assessment by simulation for interventional cardiology and electrophysiology, oral case reviews, objective structured clinical exams, and evaluations of nonclinical competencies such as professionalism and health equity.

Implications for the New Cardiology Board

While the ABIM cardiology board exam days may be numbered, board certification via some type of exam process is not going away.

The American College of Cardiology and four other US CV societies — the American Heart Association, the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions — formally announced in September that they have joined forces to propose a new professional certification board called the American Board of Cardiovascular Medicine (ABCVM). The application to the ABMS for a separate cardiology board is still ongoing and will take time.

An initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured.

Preparing for the new board will likely be “largely the same” as for the ABIM board, Dr. Kadado said. “This includes access to practice question banks, faculty oversight, strong clinical exposure and practice, regular didactic sessions, and self-directed learning.”

“Passing the board exam is just one step in our ongoing journey as a cardiologist,” he added. “Our field is rapidly evolving, and continuous learning and adaptation are part of the very essence of being a healthcare professional.”

Dr. Kadado had no relevant relationships to disclose. Dr. Kuvin is an ACC trustee and has been heading up the working group to develop the ABCVM.

A version of this article appeared on Medscape.com.

Recent evidence suggests that more cardiologists are failing to pass their boards. Pass rates declined from a high of 96% in 2018 to a low of 86% in 2021 and 2022. COVID disruptions to training may be largely to blame, experts said.

Among the 1061 candidates who took their first American Board of Internal Medicine (ABIM) cardiovascular (CV) disease exam in 2022, about 80 fellows failed who might have passed had they trained in 2016-2019, according to Anis John Kadado, MD, University of Massachusetts Medical School–Baystate Campus, Springfield, Massachusetts, and colleagues, writing in a viewpoint article published in the Journal of the American College of Cardiology.

“The purpose of board examinations is to test the knowledge, core concepts, and fundamental principles of trainees as they deliver patient care,” said Dr. Kadado. “The decline in CV board pass rates reflects a potential gap in training, which may translate to suboptimal patient care.”

Why the Downturn?

Reasons for the increased failures are likely multifactorial, Dr. Kadado said. While some blame the ABIM, the exam has remained about the same over the past 6 years, so the test itself seems unlikely to explain the decline.

The main culprit, according to the viewpoint authors, is “the educational fallout from the disruptions caused by changes made in response to the COVID pandemic.” Changes that Dr. Kadado and colleagues said put the current class of graduating fellows at “high risk” of failing their boards in the fall.

The typical cardiology fellowship is 3 years or more for subspecialty training. Candidates who took the ABIM exam in 2021 had 18 months of training that overlapped with the pandemic response, and those who took the exam in 2022 had about 30 months of training disrupted by COVID. However, fellows who first took the exam in 2023 had essentially 36 months of training affected by COVID, potentially reducing their odds of passing.

“It is hard, if not impossible, to understand the driving forces for this recent decrease in performance on the initial ABIM certification examination, nor is it possible to forecast if there will be an end to this slide,” Jeffrey T. Kuvin, MD, chair of cardiology at the Zucker School of Medicine at Northwell Health, Manhasset, New York, and colleagues wrote in response to the viewpoint article.

The authors acknowledged that COVID disrupted graduate medical training and that the long-term effects of the disruption are now emerging. However, they also pinpoint other potential issues affecting fellows, including information/technology overload, a focus on patient volume over education, lack of attention to core concepts, and, as Dr. Kadado and colleagues noted, high burnout rates among fellows and knowledge gaps due to easy access to electronic resources rather than reading and studying to retain information.

COVID disruptions included limits on in-person learning, clinic exposure, research opportunities, and conference travel, according to the authors. From a 2020 viewpoint, Dr. Kuvin also noted the loss of bedside teaching and on-site grand rounds.

Furthermore, with deferrals of elective cardiac, endovascular, and structural catheterization procedures during the pandemic, elective cases normally done by fellows were postponed or canceled.

Restoring Education, Board Passing Rates

“Having recently passed the ABIM cardiovascular board exam myself, my take-home message at this point is for current fellows-in-training to remain organized, track training milestones, and foresee any training shortcomings,” Dr. Kadado said. Adding that fellows, graduates and leadership should “identify deficiencies and work on overcoming them.”

The viewpoint authors suggested strategies that fellowship leadership can use. These include:

• Regularly assessing faculty emotional well-being and burnout to ensure that they are engaged in meaningful teaching activities
• Emphasizing in-person learning, meaningful participation in conferences, and faculty oversight
• Encouraging fellows to pursue “self-directed learning” during off-hours
• Developing and implementing checklists, competency-based models, curricula, and rotations to ensure that training milestones are being met
• Returning to in-person imaging interpretation for imaging modalities such as echocardiography, cardiac CT, and cardiac MRI
• Ensuring that fellows take the American College of Cardiology in-training examination
• Providing practice question banks so that fellows can assess their knowledge gaps

“This might also be an opportune time to assess the assessment,” Dr. Kuvin and colleagues noted. “There are likely alternative or additional approaches that could provide a more comprehensive, modern tool to gauge clinical competence in a supportive manner.”

They suggested that these tools could include assessment by simulation for interventional cardiology and electrophysiology, oral case reviews, objective structured clinical exams, and evaluations of nonclinical competencies such as professionalism and health equity.

Implications for the New Cardiology Board

While the ABIM cardiology board exam days may be numbered, board certification via some type of exam process is not going away.

The American College of Cardiology and four other US CV societies — the American Heart Association, the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions — formally announced in September that they have joined forces to propose a new professional certification board called the American Board of Cardiovascular Medicine (ABCVM). The application to the ABMS for a separate cardiology board is still ongoing and will take time.

An initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured.

Preparing for the new board will likely be “largely the same” as for the ABIM board, Dr. Kadado said. “This includes access to practice question banks, faculty oversight, strong clinical exposure and practice, regular didactic sessions, and self-directed learning.”

“Passing the board exam is just one step in our ongoing journey as a cardiologist,” he added. “Our field is rapidly evolving, and continuous learning and adaptation are part of the very essence of being a healthcare professional.”

Dr. Kadado had no relevant relationships to disclose. Dr. Kuvin is an ACC trustee and has been heading up the working group to develop the ABCVM.

A version of this article appeared on Medscape.com.

Recent evidence suggests that more cardiologists are failing to pass their boards. Pass rates declined from a high of 96% in 2018 to a low of 86% in 2021 and 2022. COVID disruptions to training may be largely to blame, experts said.

Among the 1061 candidates who took their first American Board of Internal Medicine (ABIM) cardiovascular (CV) disease exam in 2022, about 80 fellows failed who might have passed had they trained in 2016-2019, according to Anis John Kadado, MD, University of Massachusetts Medical School–Baystate Campus, Springfield, Massachusetts, and colleagues, writing in a viewpoint article published in the Journal of the American College of Cardiology.

“The purpose of board examinations is to test the knowledge, core concepts, and fundamental principles of trainees as they deliver patient care,” said Dr. Kadado. “The decline in CV board pass rates reflects a potential gap in training, which may translate to suboptimal patient care.”

Why the Downturn?

Reasons for the increased failures are likely multifactorial, Dr. Kadado said. While some blame the ABIM, the exam has remained about the same over the past 6 years, so the test itself seems unlikely to explain the decline.

The main culprit, according to the viewpoint authors, is “the educational fallout from the disruptions caused by changes made in response to the COVID pandemic.” Changes that Dr. Kadado and colleagues said put the current class of graduating fellows at “high risk” of failing their boards in the fall.

The typical cardiology fellowship is 3 years or more for subspecialty training. Candidates who took the ABIM exam in 2021 had 18 months of training that overlapped with the pandemic response, and those who took the exam in 2022 had about 30 months of training disrupted by COVID. However, fellows who first took the exam in 2023 had essentially 36 months of training affected by COVID, potentially reducing their odds of passing.

“It is hard, if not impossible, to understand the driving forces for this recent decrease in performance on the initial ABIM certification examination, nor is it possible to forecast if there will be an end to this slide,” Jeffrey T. Kuvin, MD, chair of cardiology at the Zucker School of Medicine at Northwell Health, Manhasset, New York, and colleagues wrote in response to the viewpoint article.

The authors acknowledged that COVID disrupted graduate medical training and that the long-term effects of the disruption are now emerging. However, they also pinpoint other potential issues affecting fellows, including information/technology overload, a focus on patient volume over education, lack of attention to core concepts, and, as Dr. Kadado and colleagues noted, high burnout rates among fellows and knowledge gaps due to easy access to electronic resources rather than reading and studying to retain information.

COVID disruptions included limits on in-person learning, clinic exposure, research opportunities, and conference travel, according to the authors. From a 2020 viewpoint, Dr. Kuvin also noted the loss of bedside teaching and on-site grand rounds.

Furthermore, with deferrals of elective cardiac, endovascular, and structural catheterization procedures during the pandemic, elective cases normally done by fellows were postponed or canceled.

Restoring Education, Board Passing Rates

“Having recently passed the ABIM cardiovascular board exam myself, my take-home message at this point is for current fellows-in-training to remain organized, track training milestones, and foresee any training shortcomings,” Dr. Kadado said. Adding that fellows, graduates and leadership should “identify deficiencies and work on overcoming them.”

The viewpoint authors suggested strategies that fellowship leadership can use. These include:

• Regularly assessing faculty emotional well-being and burnout to ensure that they are engaged in meaningful teaching activities
• Emphasizing in-person learning, meaningful participation in conferences, and faculty oversight
• Encouraging fellows to pursue “self-directed learning” during off-hours
• Developing and implementing checklists, competency-based models, curricula, and rotations to ensure that training milestones are being met
• Returning to in-person imaging interpretation for imaging modalities such as echocardiography, cardiac CT, and cardiac MRI
• Ensuring that fellows take the American College of Cardiology in-training examination
• Providing practice question banks so that fellows can assess their knowledge gaps

“This might also be an opportune time to assess the assessment,” Dr. Kuvin and colleagues noted. “There are likely alternative or additional approaches that could provide a more comprehensive, modern tool to gauge clinical competence in a supportive manner.”

They suggested that these tools could include assessment by simulation for interventional cardiology and electrophysiology, oral case reviews, objective structured clinical exams, and evaluations of nonclinical competencies such as professionalism and health equity.

Implications for the New Cardiology Board

While the ABIM cardiology board exam days may be numbered, board certification via some type of exam process is not going away.

The American College of Cardiology and four other US CV societies — the American Heart Association, the Heart Failure Society of America, the Heart Rhythm Society, and the Society for Cardiovascular Angiography & Interventions — formally announced in September that they have joined forces to propose a new professional certification board called the American Board of Cardiovascular Medicine (ABCVM). The application to the ABMS for a separate cardiology board is still ongoing and will take time.

An initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured.

Preparing for the new board will likely be “largely the same” as for the ABIM board, Dr. Kadado said. “This includes access to practice question banks, faculty oversight, strong clinical exposure and practice, regular didactic sessions, and self-directed learning.”

“Passing the board exam is just one step in our ongoing journey as a cardiologist,” he added. “Our field is rapidly evolving, and continuous learning and adaptation are part of the very essence of being a healthcare professional.”

Dr. Kadado had no relevant relationships to disclose. Dr. Kuvin is an ACC trustee and has been heading up the working group to develop the ABCVM.

A version of this article appeared on Medscape.com.

TOPLINE:

Cognitive function in children aged 18 months to 10 years is associated with the enrichment or depletion of specific species of gut microbes, new research reveals.

METHODOLOGY: 

• Researchers analyzed the relationship between the microbiome, neuroanatomy, and cognition (ie, the microbiome-gut-brain axis) in stool samples from 381 neurotypically developing children aged 40 days to 10 years (mean age, 2 years and 2 months).
• Stool samples were taken within a week of age-appropriate cognitive and behavioral assessments.
• Shotgun metagenomic sequencing was used to analyze the DNA of the organisms present in each sample.
• MRI data were obtained, with machine models then used to predict whether participants’ brain region volume was influenced by microbial profiles.

TAKEAWAY: 

• Researchers found increasing variation in microbial species and microbial gene functions in children older than 18 months, and the overall variation was significantly associated with variation in cognitive function scores.
• Several microbial species were significantly enriched in children with higher cognitive function scores (eg, Alistipes obesi, Asaccharobacter celatus, Eubacterium eligens, and Faecalibacterium prausnitzii), with Sutterella wadsworthensis being the only species significantly negatively associated with these scores.
• Machine models indicated that taxa key in predicting cognitive function were similarly important for predicting individual brain regions and subscales of cognitive function.

IN PRACTICE:

“Understanding the gut-brain-microbiome axis in early life is particularly important since differences or interventions in early life can have outsized and longer-term consequences than those at later ages,” the authors wrote.

SOURCE:

The study, led by Kevin S. Bonham, PhD, Wellesley College, Wellesley, Massachusetts, was published online on December 22, 2023, in Science Advances.

LIMITATIONS:

Use of multiple age-appropriate cognitive assessments enabled analysis across multiple developmental periods, but test-retest reliability and differences between test administrators may have introduced noise into these observations, particularly in the youngest children. The study period overlapped with the beginning of the pandemic, and score reductions due to the lockdowns were more pronounced in some age groups than during the recruitment period. 

DISCLOSURES:

The study was funded by the US National Institutes of Health and Wellcome: LEAP 1kD. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Cognitive function in children aged 18 months to 10 years is associated with the enrichment or depletion of specific species of gut microbes, new research reveals.

METHODOLOGY: 

• Researchers analyzed the relationship between the microbiome, neuroanatomy, and cognition (ie, the microbiome-gut-brain axis) in stool samples from 381 neurotypically developing children aged 40 days to 10 years (mean age, 2 years and 2 months).
• Stool samples were taken within a week of age-appropriate cognitive and behavioral assessments.
• Shotgun metagenomic sequencing was used to analyze the DNA of the organisms present in each sample.
• MRI data were obtained, with machine models then used to predict whether participants’ brain region volume was influenced by microbial profiles.

TAKEAWAY: 

• Researchers found increasing variation in microbial species and microbial gene functions in children older than 18 months, and the overall variation was significantly associated with variation in cognitive function scores.
• Several microbial species were significantly enriched in children with higher cognitive function scores (eg, Alistipes obesi, Asaccharobacter celatus, Eubacterium eligens, and Faecalibacterium prausnitzii), with Sutterella wadsworthensis being the only species significantly negatively associated with these scores.
• Machine models indicated that taxa key in predicting cognitive function were similarly important for predicting individual brain regions and subscales of cognitive function.

IN PRACTICE:

“Understanding the gut-brain-microbiome axis in early life is particularly important since differences or interventions in early life can have outsized and longer-term consequences than those at later ages,” the authors wrote.

SOURCE:

The study, led by Kevin S. Bonham, PhD, Wellesley College, Wellesley, Massachusetts, was published online on December 22, 2023, in Science Advances.

LIMITATIONS:

Use of multiple age-appropriate cognitive assessments enabled analysis across multiple developmental periods, but test-retest reliability and differences between test administrators may have introduced noise into these observations, particularly in the youngest children. The study period overlapped with the beginning of the pandemic, and score reductions due to the lockdowns were more pronounced in some age groups than during the recruitment period. 

DISCLOSURES:

The study was funded by the US National Institutes of Health and Wellcome: LEAP 1kD. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Cognitive function in children aged 18 months to 10 years is associated with the enrichment or depletion of specific species of gut microbes, new research reveals.

METHODOLOGY: 

• Researchers analyzed the relationship between the microbiome, neuroanatomy, and cognition (ie, the microbiome-gut-brain axis) in stool samples from 381 neurotypically developing children aged 40 days to 10 years (mean age, 2 years and 2 months).
• Stool samples were taken within a week of age-appropriate cognitive and behavioral assessments.
• Shotgun metagenomic sequencing was used to analyze the DNA of the organisms present in each sample.
• MRI data were obtained, with machine models then used to predict whether participants’ brain region volume was influenced by microbial profiles.

TAKEAWAY: 

• Researchers found increasing variation in microbial species and microbial gene functions in children older than 18 months, and the overall variation was significantly associated with variation in cognitive function scores.
• Several microbial species were significantly enriched in children with higher cognitive function scores (eg, Alistipes obesi, Asaccharobacter celatus, Eubacterium eligens, and Faecalibacterium prausnitzii), with Sutterella wadsworthensis being the only species significantly negatively associated with these scores.
• Machine models indicated that taxa key in predicting cognitive function were similarly important for predicting individual brain regions and subscales of cognitive function.

IN PRACTICE:

“Understanding the gut-brain-microbiome axis in early life is particularly important since differences or interventions in early life can have outsized and longer-term consequences than those at later ages,” the authors wrote.

SOURCE:

The study, led by Kevin S. Bonham, PhD, Wellesley College, Wellesley, Massachusetts, was published online on December 22, 2023, in Science Advances.

LIMITATIONS:

Use of multiple age-appropriate cognitive assessments enabled analysis across multiple developmental periods, but test-retest reliability and differences between test administrators may have introduced noise into these observations, particularly in the youngest children. The study period overlapped with the beginning of the pandemic, and score reductions due to the lockdowns were more pronounced in some age groups than during the recruitment period. 

DISCLOSURES:

The study was funded by the US National Institutes of Health and Wellcome: LEAP 1kD. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

There’s no question that glucagon-like peptide 1 (GLP-1) agonists represent a major advance in the treatment of obesity for patients with or without diabetes. In clinical trials, participants lost 15%-20% of their body weight, depending on the drug.

But studies also have shown that once people stop taking these drugs — either by choice, because of shortage, or lack of access — they regain most, if not all, the weight they lost.

Arguably more frustrating is the fact that those who continue on the drug eventually reach a plateau, at which point, the body seemingly stubbornly refuses to lose more weight. Essentially, it stabilizes at its set point, said Fatima Cody Stanford, MD, MPH, MPA, MBA, an obesity medicine physician at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston.
 

‘Tug of War’

Every study of weight loss drugs done over the past 40 years or so shows a plateau, Dr. Stanford told this news organization. “If you look at the phentermine/topiramate studies, there’s a plateau. If you look at the bupropion/naltrexone studies, there’s a plateau. Or if we look at bariatric surgery, there’s a plateau. And it’s the same for the newer GLP-1 drugs.”

The reason? “It really depends on where the body gets to,” Dr. Stanford said. “The body knows what it needs to do to maintain itself, and the brain knows where it’s supposed to be. And when you lose weight and reach what you feel is a lower set point, the body resists.”

When the body goes below its set point, the hunger hormone ghrelin, which is housed in the brain, gets reactivated and gradually starts to reemerge, she explained. GLP-1, which is housed in the distal portion of the small intestine and in the colon, also starts to reemerge over time.

“It becomes kind of a tug of war” between the body and whatever weight loss strategy is being implemented, from drugs to surgery to lifestyle changes, Dr. Stanford said. “The patient will start to notice changes in how their body is responding. Usually, they’ll say they don’t feel like the treatment is working the same. But the treatment is working the same as it’s always been working — except their body is now acclimated to it.”

Anne L. Peters, MD, CDE, professor and clinical scholar, Keck School of Medicine of the University of Southern California, and director, agreed that in the simplest terms, a plateau occurs because “the body becomes more and more used to” the weight loss intervention.

However, when you lose weight, you lose both fat mass and lean body mass, and lean body mass is the metabolically active part of your body, explained Dr. Peters. “That’s what burns and basically makes up your basal metabolic rate.”

With weight loss, the metabolism slows down, she said. If patients need 2000 calories a day to survive at a certain weight and then lose 50 pounds, they may then need only a 1000 calories a day. “With any obesity treatment, you reach a point at which your metabolic rate and your daily caloric requirements become equal, and you stop losing weight, even though your daily caloric requirement is less than it was when your weight was higher.”
 

Managing the Plateau

Several strategies can be used to help patients break through a plateau. One is to try multiple weight loss agents with different targets — something often done in the real world, Dr. Stanford said. “You don’t see this in the studies, which are focused on just one drug, but many of our patients are on combination therapy. They’re on a GLP-1 drug plus phentermine/topiramate plus metformin, and more. They’re usually on three, four, five drugs, similar to what we would see with resistant hypertension.”

If a patient plateaus on a GLP-1 drug, Dr. Stanford might add phentermine. When the patient reaches a plateau on phentermine, she would switch again to another agent. “The goal is to use agents that treat different receptors in the brain,” she said. “You would never use two GLP-1 agonists; you would use the GLP-1, and then something that treats norepinephrine, for example.”

At the same time, Dr. Peters noted, “try to get them off the drugs that cause weight gain, like insulin and sulfonylurea agents.”

Tapering the GLP-1 dose can also help, Dr. Peters said. However, she added, “If I’m using a GLP-1 drug for type 2 diabetes, it’s different than if I’m using it just for weight loss. With type 2 diabetes, if you taper too much, the blood sugar and weight will go back up, so you need to reach a balance.”

Dr. Peters has successfully tapered patients from a 2-mg dose down to 1 mg. She has also changed the strategy for some — ie, the patient takes the drug every other week instead of every week. “I even have a patient or two who just take it once a month and that seems to be enough,” she said. “You want to help them be at the dose that maintains their weight and keeps them healthy with the least possible medication.”

Emphasizing lifestyle changes is also important, she said. Although resistance training won’t necessarily help with weight loss, “it’s critical to maintaining lean body mass. If people keep losing and regaining weight, they’re going to lose more and more lean body mass and gain the weight back primarily as fat mass. So, their exercise should include about half aerobic activity and half resistance training.”
 

Long-term Journey

Setting appropriate expectations is a key part of helping patients accept and deal with a plateau. “This is long-term, lifelong journey,” Dr. Stanford said. “We need to think about obesity as a complex, multifactorial chronic disease, like we think about hypertension or type 2 diabetes or hyperlipidemia.”

Furthermore, and in keeping with that perspective, emerging evidence is demonstrating that GLP-1 drugs also have important nonglycemic benefits that can be achieved and maintained, Dr. Peters said. “Obviously weight loss matters, and weight loss is good for you if you’re overweight or obese. But now we know that GLP-1 drugs have wonderful benefits for the heart as well as renal function.” These are reasons to continue the drugs even in the face of a plateau.

One of Dr. Peters’ patients, a physician with type 2 diabetes, had “fought with her weight her whole life. She’s been on one or another GLP-1 drug for more than 15 years, and while none seem to impact her weight, she’s gone from having relatively poorly controlled to now beautifully controlled diabetes,” Dr. Peters said. “Even if she hasn’t lost, she’s maintained her weight, a benefit since people tend to gain weight as they get older, and she hasn’t gained.”

Another patient was disabled, on oxygen, and had recurrent pulmonary embolisms. “She weighed 420 pounds, and I put her on semaglutide because she was too sick to be considered for bariatric surgery.” When that didn’t work, Dr. Peters switched her to tirzepatide, gradually increasing the dose; the patient lost 80 pounds, her emboli are gone, she can walk down the street, and went back to work.

“Part of why she could do that is that she started exercising,” Dr. Peters noted. “She felt so much better from the drug-related weight loss that she began to do things that help enhance weight loss. She became happier because she was no longer homebound.”

This points to another element that can help patients break through a plateau over time, Dr. Peters said — namely, behavioral health. “The more people lose weight, the more they feel better about themselves, and that may mean that they take better care of themselves. The psychological part of this journey is as important as anything else. Not everyone has the same response to these agents, and there are all sorts of issues behind why people are overweight that physicians can’t ignore.

“So, in addition to managing the drugs and lifestyle, it’s important to make sure that people access the behavioral health help they need, and that once they break through a plateau, they don’t develop an eating disorder or go to the opposite extreme and become too thin, which has happened with some of my patients,” she said. “We need to remember that we’re not just giving patients a miraculous weight loss. We’re helping them to be healthier, mentally as well as physically.”

Dr. Stanford disclosed that she had been a consultant for Calibrate, GoodRx, Pfizer, Eli Lilly, Boehringer Ingelheim, Gelesis, Vida Health, Life Force, Ilant Health, Melli Cell, and Novo Nordisk. Dr. Peters disclosed that she had been a consultant for Vertex, Medscape Medical News, and Lilly; received funding from Abbott and Insulet; and had stock options in Omada Health.

A version of this article appeared on Medscape.com.

There’s no question that glucagon-like peptide 1 (GLP-1) agonists represent a major advance in the treatment of obesity for patients with or without diabetes. In clinical trials, participants lost 15%-20% of their body weight, depending on the drug.

But studies also have shown that once people stop taking these drugs — either by choice, because of shortage, or lack of access — they regain most, if not all, the weight they lost.

Arguably more frustrating is the fact that those who continue on the drug eventually reach a plateau, at which point, the body seemingly stubbornly refuses to lose more weight. Essentially, it stabilizes at its set point, said Fatima Cody Stanford, MD, MPH, MPA, MBA, an obesity medicine physician at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston.
 

‘Tug of War’

Every study of weight loss drugs done over the past 40 years or so shows a plateau, Dr. Stanford told this news organization. “If you look at the phentermine/topiramate studies, there’s a plateau. If you look at the bupropion/naltrexone studies, there’s a plateau. Or if we look at bariatric surgery, there’s a plateau. And it’s the same for the newer GLP-1 drugs.”

The reason? “It really depends on where the body gets to,” Dr. Stanford said. “The body knows what it needs to do to maintain itself, and the brain knows where it’s supposed to be. And when you lose weight and reach what you feel is a lower set point, the body resists.”

When the body goes below its set point, the hunger hormone ghrelin, which is housed in the brain, gets reactivated and gradually starts to reemerge, she explained. GLP-1, which is housed in the distal portion of the small intestine and in the colon, also starts to reemerge over time.

“It becomes kind of a tug of war” between the body and whatever weight loss strategy is being implemented, from drugs to surgery to lifestyle changes, Dr. Stanford said. “The patient will start to notice changes in how their body is responding. Usually, they’ll say they don’t feel like the treatment is working the same. But the treatment is working the same as it’s always been working — except their body is now acclimated to it.”

Anne L. Peters, MD, CDE, professor and clinical scholar, Keck School of Medicine of the University of Southern California, and director, agreed that in the simplest terms, a plateau occurs because “the body becomes more and more used to” the weight loss intervention.

However, when you lose weight, you lose both fat mass and lean body mass, and lean body mass is the metabolically active part of your body, explained Dr. Peters. “That’s what burns and basically makes up your basal metabolic rate.”

With weight loss, the metabolism slows down, she said. If patients need 2000 calories a day to survive at a certain weight and then lose 50 pounds, they may then need only a 1000 calories a day. “With any obesity treatment, you reach a point at which your metabolic rate and your daily caloric requirements become equal, and you stop losing weight, even though your daily caloric requirement is less than it was when your weight was higher.”
 

Managing the Plateau

Several strategies can be used to help patients break through a plateau. One is to try multiple weight loss agents with different targets — something often done in the real world, Dr. Stanford said. “You don’t see this in the studies, which are focused on just one drug, but many of our patients are on combination therapy. They’re on a GLP-1 drug plus phentermine/topiramate plus metformin, and more. They’re usually on three, four, five drugs, similar to what we would see with resistant hypertension.”

If a patient plateaus on a GLP-1 drug, Dr. Stanford might add phentermine. When the patient reaches a plateau on phentermine, she would switch again to another agent. “The goal is to use agents that treat different receptors in the brain,” she said. “You would never use two GLP-1 agonists; you would use the GLP-1, and then something that treats norepinephrine, for example.”

At the same time, Dr. Peters noted, “try to get them off the drugs that cause weight gain, like insulin and sulfonylurea agents.”

Tapering the GLP-1 dose can also help, Dr. Peters said. However, she added, “If I’m using a GLP-1 drug for type 2 diabetes, it’s different than if I’m using it just for weight loss. With type 2 diabetes, if you taper too much, the blood sugar and weight will go back up, so you need to reach a balance.”

Dr. Peters has successfully tapered patients from a 2-mg dose down to 1 mg. She has also changed the strategy for some — ie, the patient takes the drug every other week instead of every week. “I even have a patient or two who just take it once a month and that seems to be enough,” she said. “You want to help them be at the dose that maintains their weight and keeps them healthy with the least possible medication.”

Emphasizing lifestyle changes is also important, she said. Although resistance training won’t necessarily help with weight loss, “it’s critical to maintaining lean body mass. If people keep losing and regaining weight, they’re going to lose more and more lean body mass and gain the weight back primarily as fat mass. So, their exercise should include about half aerobic activity and half resistance training.”
 

Long-term Journey

Setting appropriate expectations is a key part of helping patients accept and deal with a plateau. “This is long-term, lifelong journey,” Dr. Stanford said. “We need to think about obesity as a complex, multifactorial chronic disease, like we think about hypertension or type 2 diabetes or hyperlipidemia.”

Furthermore, and in keeping with that perspective, emerging evidence is demonstrating that GLP-1 drugs also have important nonglycemic benefits that can be achieved and maintained, Dr. Peters said. “Obviously weight loss matters, and weight loss is good for you if you’re overweight or obese. But now we know that GLP-1 drugs have wonderful benefits for the heart as well as renal function.” These are reasons to continue the drugs even in the face of a plateau.

One of Dr. Peters’ patients, a physician with type 2 diabetes, had “fought with her weight her whole life. She’s been on one or another GLP-1 drug for more than 15 years, and while none seem to impact her weight, she’s gone from having relatively poorly controlled to now beautifully controlled diabetes,” Dr. Peters said. “Even if she hasn’t lost, she’s maintained her weight, a benefit since people tend to gain weight as they get older, and she hasn’t gained.”

Another patient was disabled, on oxygen, and had recurrent pulmonary embolisms. “She weighed 420 pounds, and I put her on semaglutide because she was too sick to be considered for bariatric surgery.” When that didn’t work, Dr. Peters switched her to tirzepatide, gradually increasing the dose; the patient lost 80 pounds, her emboli are gone, she can walk down the street, and went back to work.

“Part of why she could do that is that she started exercising,” Dr. Peters noted. “She felt so much better from the drug-related weight loss that she began to do things that help enhance weight loss. She became happier because she was no longer homebound.”

This points to another element that can help patients break through a plateau over time, Dr. Peters said — namely, behavioral health. “The more people lose weight, the more they feel better about themselves, and that may mean that they take better care of themselves. The psychological part of this journey is as important as anything else. Not everyone has the same response to these agents, and there are all sorts of issues behind why people are overweight that physicians can’t ignore.

“So, in addition to managing the drugs and lifestyle, it’s important to make sure that people access the behavioral health help they need, and that once they break through a plateau, they don’t develop an eating disorder or go to the opposite extreme and become too thin, which has happened with some of my patients,” she said. “We need to remember that we’re not just giving patients a miraculous weight loss. We’re helping them to be healthier, mentally as well as physically.”

Dr. Stanford disclosed that she had been a consultant for Calibrate, GoodRx, Pfizer, Eli Lilly, Boehringer Ingelheim, Gelesis, Vida Health, Life Force, Ilant Health, Melli Cell, and Novo Nordisk. Dr. Peters disclosed that she had been a consultant for Vertex, Medscape Medical News, and Lilly; received funding from Abbott and Insulet; and had stock options in Omada Health.

A version of this article appeared on Medscape.com.

There’s no question that glucagon-like peptide 1 (GLP-1) agonists represent a major advance in the treatment of obesity for patients with or without diabetes. In clinical trials, participants lost 15%-20% of their body weight, depending on the drug.

But studies also have shown that once people stop taking these drugs — either by choice, because of shortage, or lack of access — they regain most, if not all, the weight they lost.

Arguably more frustrating is the fact that those who continue on the drug eventually reach a plateau, at which point, the body seemingly stubbornly refuses to lose more weight. Essentially, it stabilizes at its set point, said Fatima Cody Stanford, MD, MPH, MPA, MBA, an obesity medicine physician at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston.
 

‘Tug of War’

Every study of weight loss drugs done over the past 40 years or so shows a plateau, Dr. Stanford told this news organization. “If you look at the phentermine/topiramate studies, there’s a plateau. If you look at the bupropion/naltrexone studies, there’s a plateau. Or if we look at bariatric surgery, there’s a plateau. And it’s the same for the newer GLP-1 drugs.”

The reason? “It really depends on where the body gets to,” Dr. Stanford said. “The body knows what it needs to do to maintain itself, and the brain knows where it’s supposed to be. And when you lose weight and reach what you feel is a lower set point, the body resists.”

When the body goes below its set point, the hunger hormone ghrelin, which is housed in the brain, gets reactivated and gradually starts to reemerge, she explained. GLP-1, which is housed in the distal portion of the small intestine and in the colon, also starts to reemerge over time.

“It becomes kind of a tug of war” between the body and whatever weight loss strategy is being implemented, from drugs to surgery to lifestyle changes, Dr. Stanford said. “The patient will start to notice changes in how their body is responding. Usually, they’ll say they don’t feel like the treatment is working the same. But the treatment is working the same as it’s always been working — except their body is now acclimated to it.”

Anne L. Peters, MD, CDE, professor and clinical scholar, Keck School of Medicine of the University of Southern California, and director, agreed that in the simplest terms, a plateau occurs because “the body becomes more and more used to” the weight loss intervention.

However, when you lose weight, you lose both fat mass and lean body mass, and lean body mass is the metabolically active part of your body, explained Dr. Peters. “That’s what burns and basically makes up your basal metabolic rate.”

With weight loss, the metabolism slows down, she said. If patients need 2000 calories a day to survive at a certain weight and then lose 50 pounds, they may then need only a 1000 calories a day. “With any obesity treatment, you reach a point at which your metabolic rate and your daily caloric requirements become equal, and you stop losing weight, even though your daily caloric requirement is less than it was when your weight was higher.”
 

Managing the Plateau

Several strategies can be used to help patients break through a plateau. One is to try multiple weight loss agents with different targets — something often done in the real world, Dr. Stanford said. “You don’t see this in the studies, which are focused on just one drug, but many of our patients are on combination therapy. They’re on a GLP-1 drug plus phentermine/topiramate plus metformin, and more. They’re usually on three, four, five drugs, similar to what we would see with resistant hypertension.”

If a patient plateaus on a GLP-1 drug, Dr. Stanford might add phentermine. When the patient reaches a plateau on phentermine, she would switch again to another agent. “The goal is to use agents that treat different receptors in the brain,” she said. “You would never use two GLP-1 agonists; you would use the GLP-1, and then something that treats norepinephrine, for example.”

At the same time, Dr. Peters noted, “try to get them off the drugs that cause weight gain, like insulin and sulfonylurea agents.”

Tapering the GLP-1 dose can also help, Dr. Peters said. However, she added, “If I’m using a GLP-1 drug for type 2 diabetes, it’s different than if I’m using it just for weight loss. With type 2 diabetes, if you taper too much, the blood sugar and weight will go back up, so you need to reach a balance.”

Dr. Peters has successfully tapered patients from a 2-mg dose down to 1 mg. She has also changed the strategy for some — ie, the patient takes the drug every other week instead of every week. “I even have a patient or two who just take it once a month and that seems to be enough,” she said. “You want to help them be at the dose that maintains their weight and keeps them healthy with the least possible medication.”

Emphasizing lifestyle changes is also important, she said. Although resistance training won’t necessarily help with weight loss, “it’s critical to maintaining lean body mass. If people keep losing and regaining weight, they’re going to lose more and more lean body mass and gain the weight back primarily as fat mass. So, their exercise should include about half aerobic activity and half resistance training.”
 

Long-term Journey

Setting appropriate expectations is a key part of helping patients accept and deal with a plateau. “This is long-term, lifelong journey,” Dr. Stanford said. “We need to think about obesity as a complex, multifactorial chronic disease, like we think about hypertension or type 2 diabetes or hyperlipidemia.”

Furthermore, and in keeping with that perspective, emerging evidence is demonstrating that GLP-1 drugs also have important nonglycemic benefits that can be achieved and maintained, Dr. Peters said. “Obviously weight loss matters, and weight loss is good for you if you’re overweight or obese. But now we know that GLP-1 drugs have wonderful benefits for the heart as well as renal function.” These are reasons to continue the drugs even in the face of a plateau.

One of Dr. Peters’ patients, a physician with type 2 diabetes, had “fought with her weight her whole life. She’s been on one or another GLP-1 drug for more than 15 years, and while none seem to impact her weight, she’s gone from having relatively poorly controlled to now beautifully controlled diabetes,” Dr. Peters said. “Even if she hasn’t lost, she’s maintained her weight, a benefit since people tend to gain weight as they get older, and she hasn’t gained.”

Another patient was disabled, on oxygen, and had recurrent pulmonary embolisms. “She weighed 420 pounds, and I put her on semaglutide because she was too sick to be considered for bariatric surgery.” When that didn’t work, Dr. Peters switched her to tirzepatide, gradually increasing the dose; the patient lost 80 pounds, her emboli are gone, she can walk down the street, and went back to work.

“Part of why she could do that is that she started exercising,” Dr. Peters noted. “She felt so much better from the drug-related weight loss that she began to do things that help enhance weight loss. She became happier because she was no longer homebound.”

This points to another element that can help patients break through a plateau over time, Dr. Peters said — namely, behavioral health. “The more people lose weight, the more they feel better about themselves, and that may mean that they take better care of themselves. The psychological part of this journey is as important as anything else. Not everyone has the same response to these agents, and there are all sorts of issues behind why people are overweight that physicians can’t ignore.

“So, in addition to managing the drugs and lifestyle, it’s important to make sure that people access the behavioral health help they need, and that once they break through a plateau, they don’t develop an eating disorder or go to the opposite extreme and become too thin, which has happened with some of my patients,” she said. “We need to remember that we’re not just giving patients a miraculous weight loss. We’re helping them to be healthier, mentally as well as physically.”

Dr. Stanford disclosed that she had been a consultant for Calibrate, GoodRx, Pfizer, Eli Lilly, Boehringer Ingelheim, Gelesis, Vida Health, Life Force, Ilant Health, Melli Cell, and Novo Nordisk. Dr. Peters disclosed that she had been a consultant for Vertex, Medscape Medical News, and Lilly; received funding from Abbott and Insulet; and had stock options in Omada Health.

A version of this article appeared on Medscape.com.

TOPLINE:

In people with obesity, weight loss by intermittent energy restriction (IER) has multiple, dynamic effects on the brain-gut-microbiome (BGM) axis, including reduced activity in brain regions affecting eating behavior and increased microbial diversity in the gut, over the short term, new research suggested.

METHODOLOGY:

• Researchers studied 25 individuals with obesity in China who successfully lost weight during a three-phase IER intervention. In the first phase, participants were on a normal diet without restriction for 4 days. In the second, they were on a tightly controlled diet of clinically formulated IER meals every other day that decreased stepwise in caloric value to one quarter of their basic energy intake over 32 days. The last phase was a 30-day low-controlled fasting period.
• Blood and stool samples were collected at baseline, at the midpoint and endpoint of the tightly controlled fasting phase, and at the endpoint of the low-controlled fasting phase.
• A functional MRI was used to determine the activity of specific brain regions, and metagenomic sequencing was performed to identify differentially abundant gut microbes and pathways from stool samples.

TAKEAWAY:

• Patients lost weight (7.6 kg on average) and showed sustained, significant reductions on several measures, including body mass index, body fat, systolic blood pressure, and serum levels of glycosylated hemoglobin during the IER. Diastolic blood pressure, serum levels of fasting plasma glucose, total cholesterol, various lipids, and levels of several key liver enzymes were significantly decreased at at least one timepoint during the IER.
• IER reduced the activity of obesity-related brain regions (ie, the inferior frontal orbital gyrus in the cognitive control circuit, the putamen in the emotion and learning circuit, and the anterior cingulate cortex in the sensory circuit) at different timepoints during the intervention. No significant changes were observed in brain activity in the reward circuit.
• Gut microbial diversity increased during the tightly controlled fasting phase. The abundance of the probiotic Faecalibacterium prausnitzii, Parabacteroides distasonis, and Bacterokles uniformis was elevated during this phase. The abundance of pathogenic Escherichia coli was reduced across multiple timepoints. A correlation analysis revealed longitudinal correlations between gut bacteria abundance alterations and brain activity changes.
• Overall, there was a dynamical alteration of the BGM axis during weight loss using IER, although whether changes in the gut microbiome drive changes in the brain, or vice versa, is still unknown.

IN PRACTICE:

“IER induced constant, significant reductions in the activity of eating behavior-related brain regions…[and] significant, dynamic changes in the abundance of some gut bacteria. Importantly, gut microbiota alterations correlated with brain activity changes across different timepoints in IER intervention. These data suggest that the dynamic interplay between the brain and gut microbiota plays an important role in weight loss,” the authors wrote.

SOURCE:

Jing Zhou, Henan Provincial People’s Hospital, Zhengzhou University People’s Hospital, Henan University People’s Hospital, Zhengzhou, China, led the study, which was published online on December 30, 2023, in Frontiers in Cellular and Infection Microbiology.

LIMITATIONS:

The study examines BGM axis changes during weight loss only in the short term and does not establish causation. Longer follow-up is needed to establish the BGM axis changes that may influence long-term weight loss.

DISCLOSURES:

This work was supported by the National Natural Science Foundation of China, the National Key R&D Program of China, Young and Middle-Aged Health Science and Technology Innovative Talent Cultivation Project of Henan Provincial Leading Talents, and the Medical Science and Technology Research Program of Henan Province. One coauthor was employed by a supplement company and another by a biotech company. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

In people with obesity, weight loss by intermittent energy restriction (IER) has multiple, dynamic effects on the brain-gut-microbiome (BGM) axis, including reduced activity in brain regions affecting eating behavior and increased microbial diversity in the gut, over the short term, new research suggested.

METHODOLOGY:

• Researchers studied 25 individuals with obesity in China who successfully lost weight during a three-phase IER intervention. In the first phase, participants were on a normal diet without restriction for 4 days. In the second, they were on a tightly controlled diet of clinically formulated IER meals every other day that decreased stepwise in caloric value to one quarter of their basic energy intake over 32 days. The last phase was a 30-day low-controlled fasting period.
• Blood and stool samples were collected at baseline, at the midpoint and endpoint of the tightly controlled fasting phase, and at the endpoint of the low-controlled fasting phase.
• A functional MRI was used to determine the activity of specific brain regions, and metagenomic sequencing was performed to identify differentially abundant gut microbes and pathways from stool samples.

TAKEAWAY:

• Patients lost weight (7.6 kg on average) and showed sustained, significant reductions on several measures, including body mass index, body fat, systolic blood pressure, and serum levels of glycosylated hemoglobin during the IER. Diastolic blood pressure, serum levels of fasting plasma glucose, total cholesterol, various lipids, and levels of several key liver enzymes were significantly decreased at at least one timepoint during the IER.
• IER reduced the activity of obesity-related brain regions (ie, the inferior frontal orbital gyrus in the cognitive control circuit, the putamen in the emotion and learning circuit, and the anterior cingulate cortex in the sensory circuit) at different timepoints during the intervention. No significant changes were observed in brain activity in the reward circuit.
• Gut microbial diversity increased during the tightly controlled fasting phase. The abundance of the probiotic Faecalibacterium prausnitzii, Parabacteroides distasonis, and Bacterokles uniformis was elevated during this phase. The abundance of pathogenic Escherichia coli was reduced across multiple timepoints. A correlation analysis revealed longitudinal correlations between gut bacteria abundance alterations and brain activity changes.
• Overall, there was a dynamical alteration of the BGM axis during weight loss using IER, although whether changes in the gut microbiome drive changes in the brain, or vice versa, is still unknown.

IN PRACTICE:

“IER induced constant, significant reductions in the activity of eating behavior-related brain regions…[and] significant, dynamic changes in the abundance of some gut bacteria. Importantly, gut microbiota alterations correlated with brain activity changes across different timepoints in IER intervention. These data suggest that the dynamic interplay between the brain and gut microbiota plays an important role in weight loss,” the authors wrote.

SOURCE:

Jing Zhou, Henan Provincial People’s Hospital, Zhengzhou University People’s Hospital, Henan University People’s Hospital, Zhengzhou, China, led the study, which was published online on December 30, 2023, in Frontiers in Cellular and Infection Microbiology.

LIMITATIONS:

The study examines BGM axis changes during weight loss only in the short term and does not establish causation. Longer follow-up is needed to establish the BGM axis changes that may influence long-term weight loss.

DISCLOSURES:

This work was supported by the National Natural Science Foundation of China, the National Key R&D Program of China, Young and Middle-Aged Health Science and Technology Innovative Talent Cultivation Project of Henan Provincial Leading Talents, and the Medical Science and Technology Research Program of Henan Province. One coauthor was employed by a supplement company and another by a biotech company. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

In people with obesity, weight loss by intermittent energy restriction (IER) has multiple, dynamic effects on the brain-gut-microbiome (BGM) axis, including reduced activity in brain regions affecting eating behavior and increased microbial diversity in the gut, over the short term, new research suggested.

METHODOLOGY:

• Researchers studied 25 individuals with obesity in China who successfully lost weight during a three-phase IER intervention. In the first phase, participants were on a normal diet without restriction for 4 days. In the second, they were on a tightly controlled diet of clinically formulated IER meals every other day that decreased stepwise in caloric value to one quarter of their basic energy intake over 32 days. The last phase was a 30-day low-controlled fasting period.
• Blood and stool samples were collected at baseline, at the midpoint and endpoint of the tightly controlled fasting phase, and at the endpoint of the low-controlled fasting phase.
• A functional MRI was used to determine the activity of specific brain regions, and metagenomic sequencing was performed to identify differentially abundant gut microbes and pathways from stool samples.

TAKEAWAY:

• Patients lost weight (7.6 kg on average) and showed sustained, significant reductions on several measures, including body mass index, body fat, systolic blood pressure, and serum levels of glycosylated hemoglobin during the IER. Diastolic blood pressure, serum levels of fasting plasma glucose, total cholesterol, various lipids, and levels of several key liver enzymes were significantly decreased at at least one timepoint during the IER.
• IER reduced the activity of obesity-related brain regions (ie, the inferior frontal orbital gyrus in the cognitive control circuit, the putamen in the emotion and learning circuit, and the anterior cingulate cortex in the sensory circuit) at different timepoints during the intervention. No significant changes were observed in brain activity in the reward circuit.
• Gut microbial diversity increased during the tightly controlled fasting phase. The abundance of the probiotic Faecalibacterium prausnitzii, Parabacteroides distasonis, and Bacterokles uniformis was elevated during this phase. The abundance of pathogenic Escherichia coli was reduced across multiple timepoints. A correlation analysis revealed longitudinal correlations between gut bacteria abundance alterations and brain activity changes.
• Overall, there was a dynamical alteration of the BGM axis during weight loss using IER, although whether changes in the gut microbiome drive changes in the brain, or vice versa, is still unknown.

IN PRACTICE:

“IER induced constant, significant reductions in the activity of eating behavior-related brain regions…[and] significant, dynamic changes in the abundance of some gut bacteria. Importantly, gut microbiota alterations correlated with brain activity changes across different timepoints in IER intervention. These data suggest that the dynamic interplay between the brain and gut microbiota plays an important role in weight loss,” the authors wrote.

SOURCE:

Jing Zhou, Henan Provincial People’s Hospital, Zhengzhou University People’s Hospital, Henan University People’s Hospital, Zhengzhou, China, led the study, which was published online on December 30, 2023, in Frontiers in Cellular and Infection Microbiology.

LIMITATIONS:

The study examines BGM axis changes during weight loss only in the short term and does not establish causation. Longer follow-up is needed to establish the BGM axis changes that may influence long-term weight loss.

DISCLOSURES:

This work was supported by the National Natural Science Foundation of China, the National Key R&D Program of China, Young and Middle-Aged Health Science and Technology Innovative Talent Cultivation Project of Henan Provincial Leading Talents, and the Medical Science and Technology Research Program of Henan Province. One coauthor was employed by a supplement company and another by a biotech company. No other disclosures were reported.

A version of this article appeared on Medscape.com.

A virtual visit with one’s own primary care physician (PCP) is less likely to result in a subsequent emergency department (ED) visit compared with a visit with an outside physician, research suggested.

A cohort study of more than 5 million Ontario residents with a PCP found that those who had a virtual visit with a physician other than their own were 66% more likely to visit the ED within 7 days.

“Because our study relied on health administrative data only, we cannot know for sure how necessary each ED visit was,” lead author Lauren Lapointe-Shaw, MD, PhD, assistant professor of medicine at the University of Toronto, told this news organization. “We did note, however, that the association between the type of virtual visit and ED use was stronger for low-acuity ED visits — those that are most likely to have been avoided with timely access to a PCP familiar with the patient.”

The study was published online on December 27, 2023, in JAMA Network Open.
 

Existing Relationship Beneficial

To investigate potential differences in subsequent ED use between patients who had a virtual visit with their own PCP and patients who had a virtual visit with an outside physician, the researchers conducted a propensity score–matched cohort study among all Ontario residents with a PCP who had a virtual PCP visit from April 2021 through March 2022. In a secondary analysis, visits with one’s own physician were compared with visits with a physician working in direct-to-consumer telemedicine. The primary outcome was an ED visit within 7 days after the virtual visit.

Among 5,229,240 patients, 79.8% (mean age, 49.3 years; 58% women) had a virtual visit with their own physician, and 20.2% (mean age, 41.8 years; 57.4% women) had a virtual visit with an outside physician.

In the matched cohort of 1,885,966 patients, those who saw an outside physician were 66% more likely to visit an ED within 7 days than those who had a virtual visit with their own physician (3.3% vs 2.0%). This corresponds to one additional ED visit for every 77 virtual visits with an outside physician. The increased risk was greater for low-acuity patients (0.8% vs 0.4%; relative risk [RR], 1.90) than for high-acuity patients (0.7% vs 0.5%; RR, 1.46).

Increased use of the ED associated with low-continuity virtual visits was front-loaded in the first few days. Therefore, the authors suggested that virtual visits may serve a triaging function, enabling the identification of patients who would benefit from an in-person assessment.

Patients who had an outside-physician virtual visit also were more likely than those with an own-physician visit to have an in-person PCP visit within 7 days of the virtual visit (6.1% vs 4.9%; RR, 1.25), but that visit was less likely to be with their own physician (1.1% vs 4.2%; RR, 0.25).

Similarly, they were nearly twice as likely to have a repeat virtual visit within 7 days (8.9% vs 4.7%; RR, 1.88), but again, the visit was less likely to be with their own physician (2.1% vs 4.2%; RR, 0.50).

A subgroup analysis showed that the increased risk for a 7-day ED visit associated with an outside-physician virtual visit was greater for younger age groups. Children and adolescents were at the highest risk (RR, 1.96), followed by adults aged 18-64 years (RR, 1.69) and those aged 65 years or older (RR, 1.40).

Furthermore, the increased risk for ED visits was greater when comparing patients with direct-to-consumer telemedicine visits with patients with own-physician visits (RR, 2.99). As in the main cohort, the increased risk was front-loaded in the first 2 days.

“Our findings add to a growing body of evidence suggesting that virtual care is most efficient when used within an existing therapeutic relationship,” said Dr. Lapointe-Shaw. The team currently is studying patient outcomes of physicians who provide walk-in clinic care.
 

Insurance Coverage Questions

Asif Ansari, MD, regional medical director at Montefiore Medical Group in New York, told this news organization that his experience as a PCP “has led to the conclusion that care delivered by a patient’s own provider is superior, whether in person or via telemedicine. Nothing can replace that relationship, level of familiarity, and access to personal health information.” Dr. Ansari was not involved in the study.

The study did not include virtual visits with another physician in the same clinical group, he noted. A physician in the same group “likely operates on the same electronic health record, which contains valuable information including medical problem lists, lab results, medication lists, and allergies. Theoretically, access to such information would lower ED utilization. This is a significant missing piece when we look at the overall impact of virtual care.”

More patients are now looking for the convenience and access that virtual medicine provides, noted Dr. Ansari. “If we do not appropriately leverage this tool in primary care, we will see more and more external entities enter the field, leading to further care fragmentation.”

“The rate-limiting step may be what the insurers cover as they review future trends in utilization and quality metrics,” he added. “It is important [for us] as clinicians to thoughtfully engage and help determine where the future leads us in the interest of our patients.”

Steven Shook, MD, lead for virtual health at Cleveland Clinic in Ohio, also commented on the study for this news organization. He noted that without additional information, “it’s hard to say that the two groups they’re comparing are identical. For example, patients who are self-selecting to do virtual visits with an outside physician or direct-to-consumer telemedicine may have good reasons — maybe they can’t see their own doctor in the hours available, or maybe their own doctor doesn’t do virtual visits. We don’t know the urgency of the need to see a doctor. So, lots of factors aren’t included or measured in this study.”

Future studies need to assess how virtual visits affect the total cost of care, Dr. Shook added. “It’s not just whether the patients end up in the ED, but whether we may be more likely to order an MRI because we can’t lay hands on the patient. And we need to know how the need for any additional tests affects the patient’s diagnosis and outcome.”

Overall, Dr. Shook said, “virtual visits need to be integrated into patient care. They need to be part of a comprehensive program that primary care practices provide to a patient, to balance the access, convenience, and continuity that comes with that.”

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care. The study also received funding from the MOH through a grant awarded to Dr. Lapointe-Shaw and a project grant from the Canadian Institutes of Health Research awarded to Dr. Lapointe-Shaw and another coauthor. Dr. Lapointe-Shaw, Dr. Ansari, and Dr. Shook reported no conflicts of interest.

A version of this article appeared on Medscape.com.

A virtual visit with one’s own primary care physician (PCP) is less likely to result in a subsequent emergency department (ED) visit compared with a visit with an outside physician, research suggested.

A cohort study of more than 5 million Ontario residents with a PCP found that those who had a virtual visit with a physician other than their own were 66% more likely to visit the ED within 7 days.

“Because our study relied on health administrative data only, we cannot know for sure how necessary each ED visit was,” lead author Lauren Lapointe-Shaw, MD, PhD, assistant professor of medicine at the University of Toronto, told this news organization. “We did note, however, that the association between the type of virtual visit and ED use was stronger for low-acuity ED visits — those that are most likely to have been avoided with timely access to a PCP familiar with the patient.”

The study was published online on December 27, 2023, in JAMA Network Open.
 

Existing Relationship Beneficial

To investigate potential differences in subsequent ED use between patients who had a virtual visit with their own PCP and patients who had a virtual visit with an outside physician, the researchers conducted a propensity score–matched cohort study among all Ontario residents with a PCP who had a virtual PCP visit from April 2021 through March 2022. In a secondary analysis, visits with one’s own physician were compared with visits with a physician working in direct-to-consumer telemedicine. The primary outcome was an ED visit within 7 days after the virtual visit.

Among 5,229,240 patients, 79.8% (mean age, 49.3 years; 58% women) had a virtual visit with their own physician, and 20.2% (mean age, 41.8 years; 57.4% women) had a virtual visit with an outside physician.

In the matched cohort of 1,885,966 patients, those who saw an outside physician were 66% more likely to visit an ED within 7 days than those who had a virtual visit with their own physician (3.3% vs 2.0%). This corresponds to one additional ED visit for every 77 virtual visits with an outside physician. The increased risk was greater for low-acuity patients (0.8% vs 0.4%; relative risk [RR], 1.90) than for high-acuity patients (0.7% vs 0.5%; RR, 1.46).

Increased use of the ED associated with low-continuity virtual visits was front-loaded in the first few days. Therefore, the authors suggested that virtual visits may serve a triaging function, enabling the identification of patients who would benefit from an in-person assessment.

Patients who had an outside-physician virtual visit also were more likely than those with an own-physician visit to have an in-person PCP visit within 7 days of the virtual visit (6.1% vs 4.9%; RR, 1.25), but that visit was less likely to be with their own physician (1.1% vs 4.2%; RR, 0.25).

Similarly, they were nearly twice as likely to have a repeat virtual visit within 7 days (8.9% vs 4.7%; RR, 1.88), but again, the visit was less likely to be with their own physician (2.1% vs 4.2%; RR, 0.50).

A subgroup analysis showed that the increased risk for a 7-day ED visit associated with an outside-physician virtual visit was greater for younger age groups. Children and adolescents were at the highest risk (RR, 1.96), followed by adults aged 18-64 years (RR, 1.69) and those aged 65 years or older (RR, 1.40).

Furthermore, the increased risk for ED visits was greater when comparing patients with direct-to-consumer telemedicine visits with patients with own-physician visits (RR, 2.99). As in the main cohort, the increased risk was front-loaded in the first 2 days.

“Our findings add to a growing body of evidence suggesting that virtual care is most efficient when used within an existing therapeutic relationship,” said Dr. Lapointe-Shaw. The team currently is studying patient outcomes of physicians who provide walk-in clinic care.
 

Insurance Coverage Questions

Asif Ansari, MD, regional medical director at Montefiore Medical Group in New York, told this news organization that his experience as a PCP “has led to the conclusion that care delivered by a patient’s own provider is superior, whether in person or via telemedicine. Nothing can replace that relationship, level of familiarity, and access to personal health information.” Dr. Ansari was not involved in the study.

The study did not include virtual visits with another physician in the same clinical group, he noted. A physician in the same group “likely operates on the same electronic health record, which contains valuable information including medical problem lists, lab results, medication lists, and allergies. Theoretically, access to such information would lower ED utilization. This is a significant missing piece when we look at the overall impact of virtual care.”

More patients are now looking for the convenience and access that virtual medicine provides, noted Dr. Ansari. “If we do not appropriately leverage this tool in primary care, we will see more and more external entities enter the field, leading to further care fragmentation.”

“The rate-limiting step may be what the insurers cover as they review future trends in utilization and quality metrics,” he added. “It is important [for us] as clinicians to thoughtfully engage and help determine where the future leads us in the interest of our patients.”

Steven Shook, MD, lead for virtual health at Cleveland Clinic in Ohio, also commented on the study for this news organization. He noted that without additional information, “it’s hard to say that the two groups they’re comparing are identical. For example, patients who are self-selecting to do virtual visits with an outside physician or direct-to-consumer telemedicine may have good reasons — maybe they can’t see their own doctor in the hours available, or maybe their own doctor doesn’t do virtual visits. We don’t know the urgency of the need to see a doctor. So, lots of factors aren’t included or measured in this study.”

Future studies need to assess how virtual visits affect the total cost of care, Dr. Shook added. “It’s not just whether the patients end up in the ED, but whether we may be more likely to order an MRI because we can’t lay hands on the patient. And we need to know how the need for any additional tests affects the patient’s diagnosis and outcome.”

Overall, Dr. Shook said, “virtual visits need to be integrated into patient care. They need to be part of a comprehensive program that primary care practices provide to a patient, to balance the access, convenience, and continuity that comes with that.”

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care. The study also received funding from the MOH through a grant awarded to Dr. Lapointe-Shaw and a project grant from the Canadian Institutes of Health Research awarded to Dr. Lapointe-Shaw and another coauthor. Dr. Lapointe-Shaw, Dr. Ansari, and Dr. Shook reported no conflicts of interest.

A version of this article appeared on Medscape.com.

A virtual visit with one’s own primary care physician (PCP) is less likely to result in a subsequent emergency department (ED) visit compared with a visit with an outside physician, research suggested.

A cohort study of more than 5 million Ontario residents with a PCP found that those who had a virtual visit with a physician other than their own were 66% more likely to visit the ED within 7 days.

“Because our study relied on health administrative data only, we cannot know for sure how necessary each ED visit was,” lead author Lauren Lapointe-Shaw, MD, PhD, assistant professor of medicine at the University of Toronto, told this news organization. “We did note, however, that the association between the type of virtual visit and ED use was stronger for low-acuity ED visits — those that are most likely to have been avoided with timely access to a PCP familiar with the patient.”

The study was published online on December 27, 2023, in JAMA Network Open.
 

Existing Relationship Beneficial

To investigate potential differences in subsequent ED use between patients who had a virtual visit with their own PCP and patients who had a virtual visit with an outside physician, the researchers conducted a propensity score–matched cohort study among all Ontario residents with a PCP who had a virtual PCP visit from April 2021 through March 2022. In a secondary analysis, visits with one’s own physician were compared with visits with a physician working in direct-to-consumer telemedicine. The primary outcome was an ED visit within 7 days after the virtual visit.

Among 5,229,240 patients, 79.8% (mean age, 49.3 years; 58% women) had a virtual visit with their own physician, and 20.2% (mean age, 41.8 years; 57.4% women) had a virtual visit with an outside physician.

In the matched cohort of 1,885,966 patients, those who saw an outside physician were 66% more likely to visit an ED within 7 days than those who had a virtual visit with their own physician (3.3% vs 2.0%). This corresponds to one additional ED visit for every 77 virtual visits with an outside physician. The increased risk was greater for low-acuity patients (0.8% vs 0.4%; relative risk [RR], 1.90) than for high-acuity patients (0.7% vs 0.5%; RR, 1.46).

Increased use of the ED associated with low-continuity virtual visits was front-loaded in the first few days. Therefore, the authors suggested that virtual visits may serve a triaging function, enabling the identification of patients who would benefit from an in-person assessment.

Patients who had an outside-physician virtual visit also were more likely than those with an own-physician visit to have an in-person PCP visit within 7 days of the virtual visit (6.1% vs 4.9%; RR, 1.25), but that visit was less likely to be with their own physician (1.1% vs 4.2%; RR, 0.25).

Similarly, they were nearly twice as likely to have a repeat virtual visit within 7 days (8.9% vs 4.7%; RR, 1.88), but again, the visit was less likely to be with their own physician (2.1% vs 4.2%; RR, 0.50).

A subgroup analysis showed that the increased risk for a 7-day ED visit associated with an outside-physician virtual visit was greater for younger age groups. Children and adolescents were at the highest risk (RR, 1.96), followed by adults aged 18-64 years (RR, 1.69) and those aged 65 years or older (RR, 1.40).

Furthermore, the increased risk for ED visits was greater when comparing patients with direct-to-consumer telemedicine visits with patients with own-physician visits (RR, 2.99). As in the main cohort, the increased risk was front-loaded in the first 2 days.

“Our findings add to a growing body of evidence suggesting that virtual care is most efficient when used within an existing therapeutic relationship,” said Dr. Lapointe-Shaw. The team currently is studying patient outcomes of physicians who provide walk-in clinic care.
 

Insurance Coverage Questions

Asif Ansari, MD, regional medical director at Montefiore Medical Group in New York, told this news organization that his experience as a PCP “has led to the conclusion that care delivered by a patient’s own provider is superior, whether in person or via telemedicine. Nothing can replace that relationship, level of familiarity, and access to personal health information.” Dr. Ansari was not involved in the study.

The study did not include virtual visits with another physician in the same clinical group, he noted. A physician in the same group “likely operates on the same electronic health record, which contains valuable information including medical problem lists, lab results, medication lists, and allergies. Theoretically, access to such information would lower ED utilization. This is a significant missing piece when we look at the overall impact of virtual care.”

More patients are now looking for the convenience and access that virtual medicine provides, noted Dr. Ansari. “If we do not appropriately leverage this tool in primary care, we will see more and more external entities enter the field, leading to further care fragmentation.”

“The rate-limiting step may be what the insurers cover as they review future trends in utilization and quality metrics,” he added. “It is important [for us] as clinicians to thoughtfully engage and help determine where the future leads us in the interest of our patients.”

Steven Shook, MD, lead for virtual health at Cleveland Clinic in Ohio, also commented on the study for this news organization. He noted that without additional information, “it’s hard to say that the two groups they’re comparing are identical. For example, patients who are self-selecting to do virtual visits with an outside physician or direct-to-consumer telemedicine may have good reasons — maybe they can’t see their own doctor in the hours available, or maybe their own doctor doesn’t do virtual visits. We don’t know the urgency of the need to see a doctor. So, lots of factors aren’t included or measured in this study.”

Future studies need to assess how virtual visits affect the total cost of care, Dr. Shook added. “It’s not just whether the patients end up in the ED, but whether we may be more likely to order an MRI because we can’t lay hands on the patient. And we need to know how the need for any additional tests affects the patient’s diagnosis and outcome.”

Overall, Dr. Shook said, “virtual visits need to be integrated into patient care. They need to be part of a comprehensive program that primary care practices provide to a patient, to balance the access, convenience, and continuity that comes with that.”

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care. The study also received funding from the MOH through a grant awarded to Dr. Lapointe-Shaw and a project grant from the Canadian Institutes of Health Research awarded to Dr. Lapointe-Shaw and another coauthor. Dr. Lapointe-Shaw, Dr. Ansari, and Dr. Shook reported no conflicts of interest.

A version of this article appeared on Medscape.com.

A first-of-its-kind partial heart transplant in a neonate delivered valves that continue to grow and function beyond 1 year of age, researchers said.

The surgery was performed on the 18th day of life of a 5-pound newborn boy diagnosed prenatally with persistent truncus arteriosus and severe truncal valve dysfunction. The procedure involved transplantation of the part of the heart containing the aorta and pulmonary valves from an infant donor upon cardiac death.

The standard of care for neonatal heart valve implants are cadaver grafts. But these grafts are not viable and can’t grow or self-repair. Therefore, recipient neonates need to undergo repeated implant-exchange surgeries until an adult-sized heart valve can fit. Clinical outcomes generally are poor.

“We have learned that these partial heart transplant valves, when procured fresh and the [recipient] baby is placed on low-dose antirejection medicine, can grow with the child and function completely normally,” Joseph W. Turek, MD, PhD, MBA of Duke University Medical Center in Durham, North Carolina, told this news organization.

“This represents a new field in heart surgery that could dramatically change the way we care for children with poorly functioning heart valves by allowing valve implants that grow with them.”

A case report describing the novel intervention was published online on January 2, 2024, in JAMA.

‘Expected to Last a Lifetime’

The donor was a 2-day-old female weighing 8 pounds. Delivery had been complicated by hypoxic ischemic brain injury, but echocardiography showed structurally normal, functioning outflow heart valves. The heart was donated after cardiac death and procured using standard surgical techniques.

The recipient infant’s operation involved sternotomy, cardiopulmonary bypass, and cardioplegic arrest of the heart. The pulmonary artery ostia and coronary artery buttons were dissected, and the infant’s irreparable truncal valve was excised.

The donor aortic root was transplanted first, using donor tissue to close the ventricular septal defect. Then, the coronary artery buttons were reimplanted; the right ventricular outflow tract was enlarged; and the pulmonary root was transplanted. Postoperative immunosuppression followed.

On the follow-up at age 14 months, the transplanted valves showed no obstruction or insufficiency on echocardiography. Now, almost 21 months later, the recipient is doing well, Dr. Turek said. “His family has shared his many milestones with me, including eating his first birthday cake, videos of his first steps, and his newfound oral appetite (he was largely g-tube fed for a while).”

“The rationale for partial heart transplant is that pediatric heart transplants grow,” Dr. Turek and coauthors wrote. “Moreover, failure of heart transplant outflow valves is exceedingly rare. While heart transplant long-term outcomes are limited by inevitable ventricular dysfunction, partial heart transplants spare the native ventricles and are therefore expected to last a lifetime.”

‘Domino Hearts’

“While this particular baby had truncus arteriosus, this operation should prove to be beneficial for a host of congenital heart conditions with valves that are either too small or poorly functioning,” Dr. Turek said. “We have performed subsequent partial heart operations for babies with aortic stenosis, tetralogy of Fallot with pulmonary atresia, and biventricular outflow tract obstruction.”

The challenge is organ availability, he noted. “While this procedure does make use of hearts that would be otherwise unusable for full heart transplant, such as hearts with poor ventricular function or hearts removed from recipients of full heart transplants (aka domino hearts), the availability is still low compared to the need.”

With domino hearts, “you could potentially double the number of hearts that are used for the benefit of children with heart disease,” Dr. Turek said in a Duke communication released with the paper. In a domino heart procedure, a patient who has healthy valves but needs stronger heart muscle receives a full heart transplant, and the healthy valves are then donated to another patient in need, creating a domino effect.

Since this breakthrough procedure in 2022, partial heart transplants have been performed 13 times at four centers, including nine at Duke, three of which used the domino technique.

For now, Dr. Turek told this news organization, “we are hoping to receive funds for a clinical trial that will evaluate these partial heart transplant valves on a larger basis and determine an optimal antirejection dose necessary to maintain viability.”

Preclinical research leading to this case report was supported by the Brett Boyer Foundation. Dr. Turek reported no conflicts of interest.

A version of this article appeared on Medscape.com.

A first-of-its-kind partial heart transplant in a neonate delivered valves that continue to grow and function beyond 1 year of age, researchers said.

The surgery was performed on the 18th day of life of a 5-pound newborn boy diagnosed prenatally with persistent truncus arteriosus and severe truncal valve dysfunction. The procedure involved transplantation of the part of the heart containing the aorta and pulmonary valves from an infant donor upon cardiac death.

The standard of care for neonatal heart valve implants are cadaver grafts. But these grafts are not viable and can’t grow or self-repair. Therefore, recipient neonates need to undergo repeated implant-exchange surgeries until an adult-sized heart valve can fit. Clinical outcomes generally are poor.

“We have learned that these partial heart transplant valves, when procured fresh and the [recipient] baby is placed on low-dose antirejection medicine, can grow with the child and function completely normally,” Joseph W. Turek, MD, PhD, MBA of Duke University Medical Center in Durham, North Carolina, told this news organization.

“This represents a new field in heart surgery that could dramatically change the way we care for children with poorly functioning heart valves by allowing valve implants that grow with them.”

A case report describing the novel intervention was published online on January 2, 2024, in JAMA.

‘Expected to Last a Lifetime’

The donor was a 2-day-old female weighing 8 pounds. Delivery had been complicated by hypoxic ischemic brain injury, but echocardiography showed structurally normal, functioning outflow heart valves. The heart was donated after cardiac death and procured using standard surgical techniques.

The recipient infant’s operation involved sternotomy, cardiopulmonary bypass, and cardioplegic arrest of the heart. The pulmonary artery ostia and coronary artery buttons were dissected, and the infant’s irreparable truncal valve was excised.

The donor aortic root was transplanted first, using donor tissue to close the ventricular septal defect. Then, the coronary artery buttons were reimplanted; the right ventricular outflow tract was enlarged; and the pulmonary root was transplanted. Postoperative immunosuppression followed.

On the follow-up at age 14 months, the transplanted valves showed no obstruction or insufficiency on echocardiography. Now, almost 21 months later, the recipient is doing well, Dr. Turek said. “His family has shared his many milestones with me, including eating his first birthday cake, videos of his first steps, and his newfound oral appetite (he was largely g-tube fed for a while).”

“The rationale for partial heart transplant is that pediatric heart transplants grow,” Dr. Turek and coauthors wrote. “Moreover, failure of heart transplant outflow valves is exceedingly rare. While heart transplant long-term outcomes are limited by inevitable ventricular dysfunction, partial heart transplants spare the native ventricles and are therefore expected to last a lifetime.”

‘Domino Hearts’

“While this particular baby had truncus arteriosus, this operation should prove to be beneficial for a host of congenital heart conditions with valves that are either too small or poorly functioning,” Dr. Turek said. “We have performed subsequent partial heart operations for babies with aortic stenosis, tetralogy of Fallot with pulmonary atresia, and biventricular outflow tract obstruction.”

The challenge is organ availability, he noted. “While this procedure does make use of hearts that would be otherwise unusable for full heart transplant, such as hearts with poor ventricular function or hearts removed from recipients of full heart transplants (aka domino hearts), the availability is still low compared to the need.”

With domino hearts, “you could potentially double the number of hearts that are used for the benefit of children with heart disease,” Dr. Turek said in a Duke communication released with the paper. In a domino heart procedure, a patient who has healthy valves but needs stronger heart muscle receives a full heart transplant, and the healthy valves are then donated to another patient in need, creating a domino effect.

Since this breakthrough procedure in 2022, partial heart transplants have been performed 13 times at four centers, including nine at Duke, three of which used the domino technique.

For now, Dr. Turek told this news organization, “we are hoping to receive funds for a clinical trial that will evaluate these partial heart transplant valves on a larger basis and determine an optimal antirejection dose necessary to maintain viability.”

Preclinical research leading to this case report was supported by the Brett Boyer Foundation. Dr. Turek reported no conflicts of interest.

A version of this article appeared on Medscape.com.

A first-of-its-kind partial heart transplant in a neonate delivered valves that continue to grow and function beyond 1 year of age, researchers said.

The surgery was performed on the 18th day of life of a 5-pound newborn boy diagnosed prenatally with persistent truncus arteriosus and severe truncal valve dysfunction. The procedure involved transplantation of the part of the heart containing the aorta and pulmonary valves from an infant donor upon cardiac death.

The standard of care for neonatal heart valve implants are cadaver grafts. But these grafts are not viable and can’t grow or self-repair. Therefore, recipient neonates need to undergo repeated implant-exchange surgeries until an adult-sized heart valve can fit. Clinical outcomes generally are poor.

“We have learned that these partial heart transplant valves, when procured fresh and the [recipient] baby is placed on low-dose antirejection medicine, can grow with the child and function completely normally,” Joseph W. Turek, MD, PhD, MBA of Duke University Medical Center in Durham, North Carolina, told this news organization.

“This represents a new field in heart surgery that could dramatically change the way we care for children with poorly functioning heart valves by allowing valve implants that grow with them.”

A case report describing the novel intervention was published online on January 2, 2024, in JAMA.

‘Expected to Last a Lifetime’

The donor was a 2-day-old female weighing 8 pounds. Delivery had been complicated by hypoxic ischemic brain injury, but echocardiography showed structurally normal, functioning outflow heart valves. The heart was donated after cardiac death and procured using standard surgical techniques.

The recipient infant’s operation involved sternotomy, cardiopulmonary bypass, and cardioplegic arrest of the heart. The pulmonary artery ostia and coronary artery buttons were dissected, and the infant’s irreparable truncal valve was excised.

The donor aortic root was transplanted first, using donor tissue to close the ventricular septal defect. Then, the coronary artery buttons were reimplanted; the right ventricular outflow tract was enlarged; and the pulmonary root was transplanted. Postoperative immunosuppression followed.

On the follow-up at age 14 months, the transplanted valves showed no obstruction or insufficiency on echocardiography. Now, almost 21 months later, the recipient is doing well, Dr. Turek said. “His family has shared his many milestones with me, including eating his first birthday cake, videos of his first steps, and his newfound oral appetite (he was largely g-tube fed for a while).”

“The rationale for partial heart transplant is that pediatric heart transplants grow,” Dr. Turek and coauthors wrote. “Moreover, failure of heart transplant outflow valves is exceedingly rare. While heart transplant long-term outcomes are limited by inevitable ventricular dysfunction, partial heart transplants spare the native ventricles and are therefore expected to last a lifetime.”

‘Domino Hearts’

“While this particular baby had truncus arteriosus, this operation should prove to be beneficial for a host of congenital heart conditions with valves that are either too small or poorly functioning,” Dr. Turek said. “We have performed subsequent partial heart operations for babies with aortic stenosis, tetralogy of Fallot with pulmonary atresia, and biventricular outflow tract obstruction.”

The challenge is organ availability, he noted. “While this procedure does make use of hearts that would be otherwise unusable for full heart transplant, such as hearts with poor ventricular function or hearts removed from recipients of full heart transplants (aka domino hearts), the availability is still low compared to the need.”

With domino hearts, “you could potentially double the number of hearts that are used for the benefit of children with heart disease,” Dr. Turek said in a Duke communication released with the paper. In a domino heart procedure, a patient who has healthy valves but needs stronger heart muscle receives a full heart transplant, and the healthy valves are then donated to another patient in need, creating a domino effect.

Since this breakthrough procedure in 2022, partial heart transplants have been performed 13 times at four centers, including nine at Duke, three of which used the domino technique.

For now, Dr. Turek told this news organization, “we are hoping to receive funds for a clinical trial that will evaluate these partial heart transplant valves on a larger basis and determine an optimal antirejection dose necessary to maintain viability.”

Preclinical research leading to this case report was supported by the Brett Boyer Foundation. Dr. Turek reported no conflicts of interest.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) holds the promise of identifying premalignant and advanced malignant lesions during colonoscopy that might otherwise be missed. 

Is it living up to that promise? 

It seems that depends on where, how, and by whom it’s being implemented.
 

Clinical Trials vs the Real World

The majority of randomized clinical trials of AI use conducted worldwide “clearly show an increase in the adenoma detection rate (ADR) during colonoscopy,” Prateek Sharma, MD, a gastroenterologist at The University of Kansas Cancer Center, Kansas City, told this news. “But the real-world results have been quite varied; some show improvement, and others don’t.”

Dr. Sharma is coauthor of a recent pooled analysis of nine randomized controlled trials on the impact of AI on colonoscopy surveillance after polyp removal. It found that AI use increased the proportion of patients requiring intensive surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). 

“While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs,” the authors concluded.

A recent retrospective analysis of staggered implementation of a computer-aided detection (CADe) system at a single academic center in Chicago found that for screening and surveillance colonoscopy combined, endoscopists using CADe identified more adenomas and serrated polyps — but only endoscopists who used CADe regularly (“majority” users). 

A systematic review and meta-analysis of 21 randomized controlled trials comparing CADe with standard colonoscopy found increased detection of adenomas, but not of advanced adenomas, as well as higher rates of unnecessary removal of non-neoplastic polyps. 

Adding to the mix, a multicenter randomized controlled trial of patients with a positive fecal immunochemical test found that AI use was not associated with better detection of advanced neoplasias. Lead author Carolina Mangas Sanjuán, MD, PhD, Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization the results were “surprising,” given previous studies showing benefit.

Similarly, a pragmatic implementation trial conducted by Stanford, California, researchers showed no significant effect of CADe on ADR, adenomas per colonoscopy, or any other detection metric. Furthermore, CADe had no effect on procedure times or non-neoplastic detection rates. 

The authors cautioned against viewing their study as an “outlier,” however, and pointed to an Israeli study comparing adenoma and polyp detection rates 6 months before and after the introduction of AI-aided colonoscopy. Those authors reported no performance improvement with the AI device and concluded that it was not useful in routine practice. 
 

A ‘Mishmash’ of Methods

“It’s not clear why some studies are positive, and some are negative,” Dr. Sharma acknowledged. 

Study design is a factor, particularly in real-world studies, he said. Some researchers use the before/after approach, as in the Israeli study; others compare use in different rooms — that is, one with a CADe device and one without. Like the Chicago analysis, findings from such studies probably depend on whether the colonoscopists with the CADe device in the room actually use it.

Other real-world studies look at detection by time, Dr. Sharma said. 

For example, a study of 1780 colonoscopies in China found that AI systems showed higher assistance ability among colonoscopies performed later in the day, when adenoma detection rates typically declined, perhaps owing to fatigue. 

These authors suggest that AI may have the potential to maintain high quality and homogeneity of colonoscopies and improve endoscopist performance in large screening programs and centers with high workloads.

“There’s a mishmash of different kinds of real-world studies coming in, and it’s very difficult to figure it all out,” Dr. Sharma said. “We just have to look at these devices as innovations and embrace them and work with them to see how it fits it in our practice.”
 

Perceptions and Expectations

Emerging evidence suggests that endoscopists’ perceptions and expectations may affect assessments of AI’s potential benefits in practice, Dr. Sharma noted.

“Someone might say, ‘I’m a trained physician. Why do I need a machine to help me?’ That can create a situation in which the endoscopist is constantly challenging the device, trying to overrule it or not give it credit.”

Others might perceive that the AI device will definitely help and therefore not look as carefully themselves for adenomas.

A study at The University of Texas MD Anderson Cancer Center in Houston in which activation of the AI system was at the discretion of the endoscopist found that real-time CADe did not improve adenoma detection among endoscopists with high baseline detection rates. 

However, despite its availability, AI-assisted colonoscopy was activated in only half of the cases, and multiple concerns were raised by staff and endoscopists in a postprocedural survey. In particular, endoscopists were concerned that the system would result in too many false-positive signals (82.4%), was too distracting (58.8%), and prolonged procedure time (47.1%). 

The authors of the Stanford study that found no benefit with CADe in routine practice noted, “Most concerning would be if, inadvertently, CADe use was accompanied by a simultaneous unconscious degradation in the quality of mucosal exposure, possibly due to a false sense of comfort that CADe would ensure a high-quality examination.”

“We’re trying to evaluate some of these interactions between endoscopists and AI devices both pragmatically in practice as well as in clinical trials,” Dr. Sharma said. “Much depends on the context of how you approach and present the devices. We tell physicians that this is an assist device, not something you’re competing against and not something that’s here to replace you. This is something which may make your lives easier, so try it out.”
 

Are Less Experienced Endoscopists Helped More?

It seems intuitive that less experienced endoscopists would be helped by AI, and indeed, some recent studies confirm this. 

A small randomized controlled trial in Japan, presented during the Presidential Plenary at the American Society for Gastrointestinal Endoscopy (ASGE) annual meeting in May 2023, showed that a CADe system was “particularly useful” for beginning endoscopists, who had lower adenoma miss rates with the device vs a white light control device.

Another randomized controlled trial in Japan found that CADe use was associated with an increased overall ADR among endoscopists in training.

But experienced endoscopists probably can benefit as well, noted Jennifer Christie, MD, Division Director, Gastroenterology and Hepatology at the University of Colorado School of Medicine Anschutz Medical Campus in Aurora.

“We know that these AI devices can be useful in training our fellows to detect certain lesions in the colon,” she said. “However, they’re also helpful for many very seasoned practitioners, as an adjunctive tool to help in terms of diagnosis.” 

Some studies reflect that dual benefit. 

The AID-2 study, designed specifically to look at whether experience had an effect on AI findings during colonoscopy, was conducted among nonexpert endoscopists (lifetime volume of less than 2000 colonoscopies). The researchers, including Dr. Sharma, found that CADe increased the ADR by 22% compared with the control group.

An earlier study, AID-1 , used a similar design but was conducted among experienced endoscopists. In AID-1, the ADR was also significantly higher in the CADe group (54.8%) compared with the control group (40.4%), and adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07) than in the control group (mean, 0.71).

A multivariate post hoc analysis that pooled results from both AID-1 and AID-2 showed that use of CADe and colonoscopy indication, but not the level of examiner experience, were associated with ADR differences. This led the researchers to conclude, “Experience appears to play a minor role as a determining factor for ADR.”

Similarly, a 2023 study from China looked at the mean number of adenomas detected per colonoscopy according to the endoscopist’s experience. All rates were significantly higher in AI-assisted colonoscopies compared with conventional non-AI colonoscopy: overall ADR, 39.9% vs 32.4%; advanced ADR, 6.6% vs 4.9%; ADR of expert endoscopists, 42.3% vs 32.8%; ADR of nonexpert endoscopists, 37.5% vs 32.1%; and adenomas per colonoscopy, 0.59 vs 0.45, respectively. 

The authors concluded that “AI-assisted colonoscopy improved overall ADR, advanced ADR, and ADR of both expert and nonexpert attending endoscopists.”
 

Improving the Algorithms 

Experts agree that current and future research will improve the accuracy and quality of AI colonoscopy for all users, leading to new standards and more consistent outcomes in both clinical trials and real-world applications. 

Work underway now to improve the algorithms will be an important step in that direction, according to Dr. Christie.

“We need to have enough information to create AI algorithms that allow us to detect early lesions, at least from an imaging standpoint, and we need to improve and increase the sensitivity and the specificity, as well as the predictive value,” she said.

AI can also play a role in health equity, she noted. 

“But it’s a double-edged sword, because it depends again on algorithms and machine learning. Perhaps AI can eliminate some of the bias in our clinical decision-making. However, if we don’t train the machine properly with a good, diverse sample of patients and figure out how to integrate some of the social determinants of health that a computer may not otherwise consider, it can create larger disparities and larger biases. AI devices can only be as good and as inclusive as we make them,” Dr. Christie said. 
 

Looking Ahead

Dr. Sharma predicts that “the next slew of studies are going to be on characterization — not just saying there’s an abnormality but distinguishing it further and saying whether the lesion is noncancerous, precancerous, or cancer.” 

Other studies will focus on quality improvement of factors, such as withdrawal time and bowel preparation. 

In its clinical practice update on AI, the American Gastroenterological Association states, “Eventually, we predict an AI suite of tools for colonoscopy will seem indispensable, as a powerful adjunct to support safe and efficient clinical practice. AI tools that improve colonoscopy quality may become more accepted, and perhaps demanded, by payors, administrators, and possibly even by well-informed patients who want to ensure the highest-quality examination of their colon.” 

Dr. Sharma and Dr. Christie disclose no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) holds the promise of identifying premalignant and advanced malignant lesions during colonoscopy that might otherwise be missed. 

Is it living up to that promise? 

It seems that depends on where, how, and by whom it’s being implemented.
 

Clinical Trials vs the Real World

The majority of randomized clinical trials of AI use conducted worldwide “clearly show an increase in the adenoma detection rate (ADR) during colonoscopy,” Prateek Sharma, MD, a gastroenterologist at The University of Kansas Cancer Center, Kansas City, told this news. “But the real-world results have been quite varied; some show improvement, and others don’t.”

Dr. Sharma is coauthor of a recent pooled analysis of nine randomized controlled trials on the impact of AI on colonoscopy surveillance after polyp removal. It found that AI use increased the proportion of patients requiring intensive surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). 

“While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs,” the authors concluded.

A recent retrospective analysis of staggered implementation of a computer-aided detection (CADe) system at a single academic center in Chicago found that for screening and surveillance colonoscopy combined, endoscopists using CADe identified more adenomas and serrated polyps — but only endoscopists who used CADe regularly (“majority” users). 

A systematic review and meta-analysis of 21 randomized controlled trials comparing CADe with standard colonoscopy found increased detection of adenomas, but not of advanced adenomas, as well as higher rates of unnecessary removal of non-neoplastic polyps. 

Adding to the mix, a multicenter randomized controlled trial of patients with a positive fecal immunochemical test found that AI use was not associated with better detection of advanced neoplasias. Lead author Carolina Mangas Sanjuán, MD, PhD, Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization the results were “surprising,” given previous studies showing benefit.

Similarly, a pragmatic implementation trial conducted by Stanford, California, researchers showed no significant effect of CADe on ADR, adenomas per colonoscopy, or any other detection metric. Furthermore, CADe had no effect on procedure times or non-neoplastic detection rates. 

The authors cautioned against viewing their study as an “outlier,” however, and pointed to an Israeli study comparing adenoma and polyp detection rates 6 months before and after the introduction of AI-aided colonoscopy. Those authors reported no performance improvement with the AI device and concluded that it was not useful in routine practice. 
 

A ‘Mishmash’ of Methods

“It’s not clear why some studies are positive, and some are negative,” Dr. Sharma acknowledged. 

Study design is a factor, particularly in real-world studies, he said. Some researchers use the before/after approach, as in the Israeli study; others compare use in different rooms — that is, one with a CADe device and one without. Like the Chicago analysis, findings from such studies probably depend on whether the colonoscopists with the CADe device in the room actually use it.

Other real-world studies look at detection by time, Dr. Sharma said. 

For example, a study of 1780 colonoscopies in China found that AI systems showed higher assistance ability among colonoscopies performed later in the day, when adenoma detection rates typically declined, perhaps owing to fatigue. 

These authors suggest that AI may have the potential to maintain high quality and homogeneity of colonoscopies and improve endoscopist performance in large screening programs and centers with high workloads.

“There’s a mishmash of different kinds of real-world studies coming in, and it’s very difficult to figure it all out,” Dr. Sharma said. “We just have to look at these devices as innovations and embrace them and work with them to see how it fits it in our practice.”
 

Perceptions and Expectations

Emerging evidence suggests that endoscopists’ perceptions and expectations may affect assessments of AI’s potential benefits in practice, Dr. Sharma noted.

“Someone might say, ‘I’m a trained physician. Why do I need a machine to help me?’ That can create a situation in which the endoscopist is constantly challenging the device, trying to overrule it or not give it credit.”

Others might perceive that the AI device will definitely help and therefore not look as carefully themselves for adenomas.

A study at The University of Texas MD Anderson Cancer Center in Houston in which activation of the AI system was at the discretion of the endoscopist found that real-time CADe did not improve adenoma detection among endoscopists with high baseline detection rates. 

However, despite its availability, AI-assisted colonoscopy was activated in only half of the cases, and multiple concerns were raised by staff and endoscopists in a postprocedural survey. In particular, endoscopists were concerned that the system would result in too many false-positive signals (82.4%), was too distracting (58.8%), and prolonged procedure time (47.1%). 

The authors of the Stanford study that found no benefit with CADe in routine practice noted, “Most concerning would be if, inadvertently, CADe use was accompanied by a simultaneous unconscious degradation in the quality of mucosal exposure, possibly due to a false sense of comfort that CADe would ensure a high-quality examination.”

“We’re trying to evaluate some of these interactions between endoscopists and AI devices both pragmatically in practice as well as in clinical trials,” Dr. Sharma said. “Much depends on the context of how you approach and present the devices. We tell physicians that this is an assist device, not something you’re competing against and not something that’s here to replace you. This is something which may make your lives easier, so try it out.”
 

Are Less Experienced Endoscopists Helped More?

It seems intuitive that less experienced endoscopists would be helped by AI, and indeed, some recent studies confirm this. 

A small randomized controlled trial in Japan, presented during the Presidential Plenary at the American Society for Gastrointestinal Endoscopy (ASGE) annual meeting in May 2023, showed that a CADe system was “particularly useful” for beginning endoscopists, who had lower adenoma miss rates with the device vs a white light control device.

Another randomized controlled trial in Japan found that CADe use was associated with an increased overall ADR among endoscopists in training.

But experienced endoscopists probably can benefit as well, noted Jennifer Christie, MD, Division Director, Gastroenterology and Hepatology at the University of Colorado School of Medicine Anschutz Medical Campus in Aurora.

“We know that these AI devices can be useful in training our fellows to detect certain lesions in the colon,” she said. “However, they’re also helpful for many very seasoned practitioners, as an adjunctive tool to help in terms of diagnosis.” 

Some studies reflect that dual benefit. 

The AID-2 study, designed specifically to look at whether experience had an effect on AI findings during colonoscopy, was conducted among nonexpert endoscopists (lifetime volume of less than 2000 colonoscopies). The researchers, including Dr. Sharma, found that CADe increased the ADR by 22% compared with the control group.

An earlier study, AID-1 , used a similar design but was conducted among experienced endoscopists. In AID-1, the ADR was also significantly higher in the CADe group (54.8%) compared with the control group (40.4%), and adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07) than in the control group (mean, 0.71).

A multivariate post hoc analysis that pooled results from both AID-1 and AID-2 showed that use of CADe and colonoscopy indication, but not the level of examiner experience, were associated with ADR differences. This led the researchers to conclude, “Experience appears to play a minor role as a determining factor for ADR.”

Similarly, a 2023 study from China looked at the mean number of adenomas detected per colonoscopy according to the endoscopist’s experience. All rates were significantly higher in AI-assisted colonoscopies compared with conventional non-AI colonoscopy: overall ADR, 39.9% vs 32.4%; advanced ADR, 6.6% vs 4.9%; ADR of expert endoscopists, 42.3% vs 32.8%; ADR of nonexpert endoscopists, 37.5% vs 32.1%; and adenomas per colonoscopy, 0.59 vs 0.45, respectively. 

The authors concluded that “AI-assisted colonoscopy improved overall ADR, advanced ADR, and ADR of both expert and nonexpert attending endoscopists.”
 

Improving the Algorithms 

Experts agree that current and future research will improve the accuracy and quality of AI colonoscopy for all users, leading to new standards and more consistent outcomes in both clinical trials and real-world applications. 

Work underway now to improve the algorithms will be an important step in that direction, according to Dr. Christie.

“We need to have enough information to create AI algorithms that allow us to detect early lesions, at least from an imaging standpoint, and we need to improve and increase the sensitivity and the specificity, as well as the predictive value,” she said.

AI can also play a role in health equity, she noted. 

“But it’s a double-edged sword, because it depends again on algorithms and machine learning. Perhaps AI can eliminate some of the bias in our clinical decision-making. However, if we don’t train the machine properly with a good, diverse sample of patients and figure out how to integrate some of the social determinants of health that a computer may not otherwise consider, it can create larger disparities and larger biases. AI devices can only be as good and as inclusive as we make them,” Dr. Christie said. 
 

Looking Ahead

Dr. Sharma predicts that “the next slew of studies are going to be on characterization — not just saying there’s an abnormality but distinguishing it further and saying whether the lesion is noncancerous, precancerous, or cancer.” 

Other studies will focus on quality improvement of factors, such as withdrawal time and bowel preparation. 

In its clinical practice update on AI, the American Gastroenterological Association states, “Eventually, we predict an AI suite of tools for colonoscopy will seem indispensable, as a powerful adjunct to support safe and efficient clinical practice. AI tools that improve colonoscopy quality may become more accepted, and perhaps demanded, by payors, administrators, and possibly even by well-informed patients who want to ensure the highest-quality examination of their colon.” 

Dr. Sharma and Dr. Christie disclose no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) holds the promise of identifying premalignant and advanced malignant lesions during colonoscopy that might otherwise be missed. 

Is it living up to that promise? 

It seems that depends on where, how, and by whom it’s being implemented.
 

Clinical Trials vs the Real World

The majority of randomized clinical trials of AI use conducted worldwide “clearly show an increase in the adenoma detection rate (ADR) during colonoscopy,” Prateek Sharma, MD, a gastroenterologist at The University of Kansas Cancer Center, Kansas City, told this news. “But the real-world results have been quite varied; some show improvement, and others don’t.”

Dr. Sharma is coauthor of a recent pooled analysis of nine randomized controlled trials on the impact of AI on colonoscopy surveillance after polyp removal. It found that AI use increased the proportion of patients requiring intensive surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). 

“While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs,” the authors concluded.

A recent retrospective analysis of staggered implementation of a computer-aided detection (CADe) system at a single academic center in Chicago found that for screening and surveillance colonoscopy combined, endoscopists using CADe identified more adenomas and serrated polyps — but only endoscopists who used CADe regularly (“majority” users). 

A systematic review and meta-analysis of 21 randomized controlled trials comparing CADe with standard colonoscopy found increased detection of adenomas, but not of advanced adenomas, as well as higher rates of unnecessary removal of non-neoplastic polyps. 

Adding to the mix, a multicenter randomized controlled trial of patients with a positive fecal immunochemical test found that AI use was not associated with better detection of advanced neoplasias. Lead author Carolina Mangas Sanjuán, MD, PhD, Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization the results were “surprising,” given previous studies showing benefit.

Similarly, a pragmatic implementation trial conducted by Stanford, California, researchers showed no significant effect of CADe on ADR, adenomas per colonoscopy, or any other detection metric. Furthermore, CADe had no effect on procedure times or non-neoplastic detection rates. 

The authors cautioned against viewing their study as an “outlier,” however, and pointed to an Israeli study comparing adenoma and polyp detection rates 6 months before and after the introduction of AI-aided colonoscopy. Those authors reported no performance improvement with the AI device and concluded that it was not useful in routine practice. 
 

A ‘Mishmash’ of Methods

“It’s not clear why some studies are positive, and some are negative,” Dr. Sharma acknowledged. 

Study design is a factor, particularly in real-world studies, he said. Some researchers use the before/after approach, as in the Israeli study; others compare use in different rooms — that is, one with a CADe device and one without. Like the Chicago analysis, findings from such studies probably depend on whether the colonoscopists with the CADe device in the room actually use it.

Other real-world studies look at detection by time, Dr. Sharma said. 

For example, a study of 1780 colonoscopies in China found that AI systems showed higher assistance ability among colonoscopies performed later in the day, when adenoma detection rates typically declined, perhaps owing to fatigue. 

These authors suggest that AI may have the potential to maintain high quality and homogeneity of colonoscopies and improve endoscopist performance in large screening programs and centers with high workloads.

“There’s a mishmash of different kinds of real-world studies coming in, and it’s very difficult to figure it all out,” Dr. Sharma said. “We just have to look at these devices as innovations and embrace them and work with them to see how it fits it in our practice.”
 

Perceptions and Expectations

Emerging evidence suggests that endoscopists’ perceptions and expectations may affect assessments of AI’s potential benefits in practice, Dr. Sharma noted.

“Someone might say, ‘I’m a trained physician. Why do I need a machine to help me?’ That can create a situation in which the endoscopist is constantly challenging the device, trying to overrule it or not give it credit.”

Others might perceive that the AI device will definitely help and therefore not look as carefully themselves for adenomas.

A study at The University of Texas MD Anderson Cancer Center in Houston in which activation of the AI system was at the discretion of the endoscopist found that real-time CADe did not improve adenoma detection among endoscopists with high baseline detection rates. 

However, despite its availability, AI-assisted colonoscopy was activated in only half of the cases, and multiple concerns were raised by staff and endoscopists in a postprocedural survey. In particular, endoscopists were concerned that the system would result in too many false-positive signals (82.4%), was too distracting (58.8%), and prolonged procedure time (47.1%). 

The authors of the Stanford study that found no benefit with CADe in routine practice noted, “Most concerning would be if, inadvertently, CADe use was accompanied by a simultaneous unconscious degradation in the quality of mucosal exposure, possibly due to a false sense of comfort that CADe would ensure a high-quality examination.”

“We’re trying to evaluate some of these interactions between endoscopists and AI devices both pragmatically in practice as well as in clinical trials,” Dr. Sharma said. “Much depends on the context of how you approach and present the devices. We tell physicians that this is an assist device, not something you’re competing against and not something that’s here to replace you. This is something which may make your lives easier, so try it out.”
 

Are Less Experienced Endoscopists Helped More?

It seems intuitive that less experienced endoscopists would be helped by AI, and indeed, some recent studies confirm this. 

A small randomized controlled trial in Japan, presented during the Presidential Plenary at the American Society for Gastrointestinal Endoscopy (ASGE) annual meeting in May 2023, showed that a CADe system was “particularly useful” for beginning endoscopists, who had lower adenoma miss rates with the device vs a white light control device.

Another randomized controlled trial in Japan found that CADe use was associated with an increased overall ADR among endoscopists in training.

But experienced endoscopists probably can benefit as well, noted Jennifer Christie, MD, Division Director, Gastroenterology and Hepatology at the University of Colorado School of Medicine Anschutz Medical Campus in Aurora.

“We know that these AI devices can be useful in training our fellows to detect certain lesions in the colon,” she said. “However, they’re also helpful for many very seasoned practitioners, as an adjunctive tool to help in terms of diagnosis.” 

Some studies reflect that dual benefit. 

The AID-2 study, designed specifically to look at whether experience had an effect on AI findings during colonoscopy, was conducted among nonexpert endoscopists (lifetime volume of less than 2000 colonoscopies). The researchers, including Dr. Sharma, found that CADe increased the ADR by 22% compared with the control group.

An earlier study, AID-1 , used a similar design but was conducted among experienced endoscopists. In AID-1, the ADR was also significantly higher in the CADe group (54.8%) compared with the control group (40.4%), and adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07) than in the control group (mean, 0.71).

A multivariate post hoc analysis that pooled results from both AID-1 and AID-2 showed that use of CADe and colonoscopy indication, but not the level of examiner experience, were associated with ADR differences. This led the researchers to conclude, “Experience appears to play a minor role as a determining factor for ADR.”

Similarly, a 2023 study from China looked at the mean number of adenomas detected per colonoscopy according to the endoscopist’s experience. All rates were significantly higher in AI-assisted colonoscopies compared with conventional non-AI colonoscopy: overall ADR, 39.9% vs 32.4%; advanced ADR, 6.6% vs 4.9%; ADR of expert endoscopists, 42.3% vs 32.8%; ADR of nonexpert endoscopists, 37.5% vs 32.1%; and adenomas per colonoscopy, 0.59 vs 0.45, respectively. 

The authors concluded that “AI-assisted colonoscopy improved overall ADR, advanced ADR, and ADR of both expert and nonexpert attending endoscopists.”
 

Improving the Algorithms 

Experts agree that current and future research will improve the accuracy and quality of AI colonoscopy for all users, leading to new standards and more consistent outcomes in both clinical trials and real-world applications. 

Work underway now to improve the algorithms will be an important step in that direction, according to Dr. Christie.

“We need to have enough information to create AI algorithms that allow us to detect early lesions, at least from an imaging standpoint, and we need to improve and increase the sensitivity and the specificity, as well as the predictive value,” she said.

AI can also play a role in health equity, she noted. 

“But it’s a double-edged sword, because it depends again on algorithms and machine learning. Perhaps AI can eliminate some of the bias in our clinical decision-making. However, if we don’t train the machine properly with a good, diverse sample of patients and figure out how to integrate some of the social determinants of health that a computer may not otherwise consider, it can create larger disparities and larger biases. AI devices can only be as good and as inclusive as we make them,” Dr. Christie said. 
 

Looking Ahead

Dr. Sharma predicts that “the next slew of studies are going to be on characterization — not just saying there’s an abnormality but distinguishing it further and saying whether the lesion is noncancerous, precancerous, or cancer.” 

Other studies will focus on quality improvement of factors, such as withdrawal time and bowel preparation. 

In its clinical practice update on AI, the American Gastroenterological Association states, “Eventually, we predict an AI suite of tools for colonoscopy will seem indispensable, as a powerful adjunct to support safe and efficient clinical practice. AI tools that improve colonoscopy quality may become more accepted, and perhaps demanded, by payors, administrators, and possibly even by well-informed patients who want to ensure the highest-quality examination of their colon.” 

Dr. Sharma and Dr. Christie disclose no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Consuming nonsugar sweeteners (NSS) leads to significant changes in both stool and duodenal microbial diversity and composition and levels of circulating inflammatory markers.

METHODOLOGY:

• Researchers analyzed samples from the REIMAGINE (Revealing the Entire Intestinal Microbiota and its Associations with the Genetic, Immunologic, and Neuroendocrine Ecosystem) study to assess the potential effects of NSS consumption on the duodenal luminal microbiome.
• They analyzed subjects consuming non-aspartame nonsugar sweeteners (NANS; n = 35) and aspartame only (ASP; n = 9), who were compared with 55 control participants matched for age, sex, and body mass index.
• A subset of 40 participants provided stool samples for additional analysis.

TAKEAWAY:

• Duodenal alpha diversity was lower in NANS consumers vs controls.
• Duodenal relative abundance (RA) of Escherichia, Klebsiella, and Salmonella was lower in both NANS and ASP vs controls, whereas stool RA of these phylum Proteobacteria was increased in both NANS and ASP.
• Compared with controls, NANS and ASP differed in how they altered predicted duodenal microbial metabolic pathways, with NANS impacting polysaccharides biosynthesis and D-galactose degradation and ASP significantly enriching biosynthesis of cylindrospermopsin, a potential cancer-causing agent known to adversely impact the liver and nervous system.
• Circulating levels of interleukin (IL)-1b, a pro-inflammatory cytokine that plays a key role in the immune response, were significantly decreased in NANS vs controls, whereas IL-6 and IL-10, two cytokines with protective properties, were decreased in the ASP group vs controls.

IN PRACTICE:

“Given the crucial role played by small intestinal microbes in digestion, nutrient absorption, immune regulation, and endocrine functions, coupled with the substantial prevalence of NSS consumption among US adults (estimated at 41.4%), our findings have potential implications for metabolic and gastrointestinal health in a considerable proportion of the American adult population.”

SOURCE:

The study, conducted by Ava Hosseini, MPH, and colleagues at Cedars-Sinai, Los Angeles, was published online on November 22, 2023, in iScience.

LIMITATIONS:

The study population may not be representative of healthy individuals as they underwent upper endoscopy for various reasons (eg, evaluation of intestinal complaints). After exclusions, the duodenal sample size for the aspartame group was small. Samples were collected at a single timepoint, limiting the ability to establish causal relationships.

DISCLOSURES:

This research was supported by Frank Lee, the Monica Lester Charitable Trust, and the Elias, Genevieve, and Georgianna Atol Charitable Trust through their support of the Medically Associated Science and Technology Program, Cedars-Sinai, Los Angeles. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Consuming nonsugar sweeteners (NSS) leads to significant changes in both stool and duodenal microbial diversity and composition and levels of circulating inflammatory markers.

METHODOLOGY:

• Researchers analyzed samples from the REIMAGINE (Revealing the Entire Intestinal Microbiota and its Associations with the Genetic, Immunologic, and Neuroendocrine Ecosystem) study to assess the potential effects of NSS consumption on the duodenal luminal microbiome.
• They analyzed subjects consuming non-aspartame nonsugar sweeteners (NANS; n = 35) and aspartame only (ASP; n = 9), who were compared with 55 control participants matched for age, sex, and body mass index.
• A subset of 40 participants provided stool samples for additional analysis.

TAKEAWAY:

• Duodenal alpha diversity was lower in NANS consumers vs controls.
• Duodenal relative abundance (RA) of Escherichia, Klebsiella, and Salmonella was lower in both NANS and ASP vs controls, whereas stool RA of these phylum Proteobacteria was increased in both NANS and ASP.
• Compared with controls, NANS and ASP differed in how they altered predicted duodenal microbial metabolic pathways, with NANS impacting polysaccharides biosynthesis and D-galactose degradation and ASP significantly enriching biosynthesis of cylindrospermopsin, a potential cancer-causing agent known to adversely impact the liver and nervous system.
• Circulating levels of interleukin (IL)-1b, a pro-inflammatory cytokine that plays a key role in the immune response, were significantly decreased in NANS vs controls, whereas IL-6 and IL-10, two cytokines with protective properties, were decreased in the ASP group vs controls.

IN PRACTICE:

“Given the crucial role played by small intestinal microbes in digestion, nutrient absorption, immune regulation, and endocrine functions, coupled with the substantial prevalence of NSS consumption among US adults (estimated at 41.4%), our findings have potential implications for metabolic and gastrointestinal health in a considerable proportion of the American adult population.”

SOURCE:

The study, conducted by Ava Hosseini, MPH, and colleagues at Cedars-Sinai, Los Angeles, was published online on November 22, 2023, in iScience.

LIMITATIONS:

The study population may not be representative of healthy individuals as they underwent upper endoscopy for various reasons (eg, evaluation of intestinal complaints). After exclusions, the duodenal sample size for the aspartame group was small. Samples were collected at a single timepoint, limiting the ability to establish causal relationships.

DISCLOSURES:

This research was supported by Frank Lee, the Monica Lester Charitable Trust, and the Elias, Genevieve, and Georgianna Atol Charitable Trust through their support of the Medically Associated Science and Technology Program, Cedars-Sinai, Los Angeles. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Consuming nonsugar sweeteners (NSS) leads to significant changes in both stool and duodenal microbial diversity and composition and levels of circulating inflammatory markers.

METHODOLOGY:

• Researchers analyzed samples from the REIMAGINE (Revealing the Entire Intestinal Microbiota and its Associations with the Genetic, Immunologic, and Neuroendocrine Ecosystem) study to assess the potential effects of NSS consumption on the duodenal luminal microbiome.
• They analyzed subjects consuming non-aspartame nonsugar sweeteners (NANS; n = 35) and aspartame only (ASP; n = 9), who were compared with 55 control participants matched for age, sex, and body mass index.
• A subset of 40 participants provided stool samples for additional analysis.

TAKEAWAY:

• Duodenal alpha diversity was lower in NANS consumers vs controls.
• Duodenal relative abundance (RA) of Escherichia, Klebsiella, and Salmonella was lower in both NANS and ASP vs controls, whereas stool RA of these phylum Proteobacteria was increased in both NANS and ASP.
• Compared with controls, NANS and ASP differed in how they altered predicted duodenal microbial metabolic pathways, with NANS impacting polysaccharides biosynthesis and D-galactose degradation and ASP significantly enriching biosynthesis of cylindrospermopsin, a potential cancer-causing agent known to adversely impact the liver and nervous system.
• Circulating levels of interleukin (IL)-1b, a pro-inflammatory cytokine that plays a key role in the immune response, were significantly decreased in NANS vs controls, whereas IL-6 and IL-10, two cytokines with protective properties, were decreased in the ASP group vs controls.

IN PRACTICE:

“Given the crucial role played by small intestinal microbes in digestion, nutrient absorption, immune regulation, and endocrine functions, coupled with the substantial prevalence of NSS consumption among US adults (estimated at 41.4%), our findings have potential implications for metabolic and gastrointestinal health in a considerable proportion of the American adult population.”

SOURCE:

The study, conducted by Ava Hosseini, MPH, and colleagues at Cedars-Sinai, Los Angeles, was published online on November 22, 2023, in iScience.

LIMITATIONS:

The study population may not be representative of healthy individuals as they underwent upper endoscopy for various reasons (eg, evaluation of intestinal complaints). After exclusions, the duodenal sample size for the aspartame group was small. Samples were collected at a single timepoint, limiting the ability to establish causal relationships.

DISCLOSURES:

This research was supported by Frank Lee, the Monica Lester Charitable Trust, and the Elias, Genevieve, and Georgianna Atol Charitable Trust through their support of the Medically Associated Science and Technology Program, Cedars-Sinai, Los Angeles. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.