Periodontitis Management: GPs Should Play a Role

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Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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SCD: Can Atrial Arrhythmias Predict Strokes?

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TOPLINE:

Atrial arrhythmias were found in 26% of patients with sickle cell disease (SCD), with a significant association with stroke history. Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.

METHODOLOGY:

  • A total of 130 adult patients with SCD were included in the DREPACOEUR prospective registry from November 2018 to November 2022.
  • The patients underwent a comprehensive cardiac evaluation, including 24-hour electrocardiogram monitoring, echocardiography, and laboratory tests.
  • The primary endpoint was the occurrence of atrial arrhythmias, defined by excessive supraventricular ectopic activity or any recent history of atrial fibrillation.
  • Patients with a history of stroke or transient ischemic attack were also included in the PCDREP prospective registry for further assessment.
  • Written informed consent was collected from all participating patients, and the study was approved by the ethics committee.
  •  

TAKEAWAY:

  • Atrial arrhythmias were found in 26% of patients with SCD, with a significant association with stroke history (P = .001).
  • Age and left atrial volume were independently associated with atrial arrhythmias, with optimal cutoffs of 47 years and 55 mL/m2, respectively.
  • Patients with atrial arrhythmias had higher diastolic blood pressure, worse kidney function, and higher NT pro-BNP levels than those without arrhythmias.
  • Atrial arrhythmias were associated with an increased risk for stroke unrelated to cerebral vasculopathy or other defined causes (odds ratio, 6.6; P = .009).
  •  

“Atrial arrhythmias were found in 26% of patients with sickle cell anemia, with a significant association with stroke history,” wrote the authors of the study. In a commentary published concurrently, Jonathan Uniat, MD, of Children’s Hospital Los Angeles in California, wrote, “Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.”

 

SOURCE:

The study was led by Thomas d’Humières, Henri Mondor Hospital in Créteil, France. It was published online on November 12 in Blood Advances.

 

LIMITATIONS:

This study was a pilot prospective study and was underpowered with atrial arrhythmias occurring in only 34 patients. The population was relatively old for sickle cell anemia (45 years), and the study was biased because patients were selected based on clinical criteria indicative of underlying cardiovascular abnormalities. The population was heterogeneous in terms of antiarrhythmic therapy, and overall, at an advanced stage of the disease with frequent organ complications.

 

DISCLOSURES:

The study was supported by grants from FHU-SENEC. Pablo Bartolucci received grants from Addmedica, the Fabre Foundation, Novartis, and Bluebird in the past 36 months; received consulting fees from Addmedica, Novartis, Roche, GBT, Bluebird, Emmaus, Hemanext, and Agios; received honoraria for lectures from Novartis, Addmedica, and Jazz Pharmaceuticals; and reported being a member of the Novartis steering committee and cofounder of Innovhem. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Atrial arrhythmias were found in 26% of patients with sickle cell disease (SCD), with a significant association with stroke history. Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.

METHODOLOGY:

  • A total of 130 adult patients with SCD were included in the DREPACOEUR prospective registry from November 2018 to November 2022.
  • The patients underwent a comprehensive cardiac evaluation, including 24-hour electrocardiogram monitoring, echocardiography, and laboratory tests.
  • The primary endpoint was the occurrence of atrial arrhythmias, defined by excessive supraventricular ectopic activity or any recent history of atrial fibrillation.
  • Patients with a history of stroke or transient ischemic attack were also included in the PCDREP prospective registry for further assessment.
  • Written informed consent was collected from all participating patients, and the study was approved by the ethics committee.
  •  

TAKEAWAY:

  • Atrial arrhythmias were found in 26% of patients with SCD, with a significant association with stroke history (P = .001).
  • Age and left atrial volume were independently associated with atrial arrhythmias, with optimal cutoffs of 47 years and 55 mL/m2, respectively.
  • Patients with atrial arrhythmias had higher diastolic blood pressure, worse kidney function, and higher NT pro-BNP levels than those without arrhythmias.
  • Atrial arrhythmias were associated with an increased risk for stroke unrelated to cerebral vasculopathy or other defined causes (odds ratio, 6.6; P = .009).
  •  

“Atrial arrhythmias were found in 26% of patients with sickle cell anemia, with a significant association with stroke history,” wrote the authors of the study. In a commentary published concurrently, Jonathan Uniat, MD, of Children’s Hospital Los Angeles in California, wrote, “Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.”

 

SOURCE:

The study was led by Thomas d’Humières, Henri Mondor Hospital in Créteil, France. It was published online on November 12 in Blood Advances.

 

LIMITATIONS:

This study was a pilot prospective study and was underpowered with atrial arrhythmias occurring in only 34 patients. The population was relatively old for sickle cell anemia (45 years), and the study was biased because patients were selected based on clinical criteria indicative of underlying cardiovascular abnormalities. The population was heterogeneous in terms of antiarrhythmic therapy, and overall, at an advanced stage of the disease with frequent organ complications.

 

DISCLOSURES:

The study was supported by grants from FHU-SENEC. Pablo Bartolucci received grants from Addmedica, the Fabre Foundation, Novartis, and Bluebird in the past 36 months; received consulting fees from Addmedica, Novartis, Roche, GBT, Bluebird, Emmaus, Hemanext, and Agios; received honoraria for lectures from Novartis, Addmedica, and Jazz Pharmaceuticals; and reported being a member of the Novartis steering committee and cofounder of Innovhem. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Atrial arrhythmias were found in 26% of patients with sickle cell disease (SCD), with a significant association with stroke history. Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.

METHODOLOGY:

  • A total of 130 adult patients with SCD were included in the DREPACOEUR prospective registry from November 2018 to November 2022.
  • The patients underwent a comprehensive cardiac evaluation, including 24-hour electrocardiogram monitoring, echocardiography, and laboratory tests.
  • The primary endpoint was the occurrence of atrial arrhythmias, defined by excessive supraventricular ectopic activity or any recent history of atrial fibrillation.
  • Patients with a history of stroke or transient ischemic attack were also included in the PCDREP prospective registry for further assessment.
  • Written informed consent was collected from all participating patients, and the study was approved by the ethics committee.
  •  

TAKEAWAY:

  • Atrial arrhythmias were found in 26% of patients with SCD, with a significant association with stroke history (P = .001).
  • Age and left atrial volume were independently associated with atrial arrhythmias, with optimal cutoffs of 47 years and 55 mL/m2, respectively.
  • Patients with atrial arrhythmias had higher diastolic blood pressure, worse kidney function, and higher NT pro-BNP levels than those without arrhythmias.
  • Atrial arrhythmias were associated with an increased risk for stroke unrelated to cerebral vasculopathy or other defined causes (odds ratio, 6.6; P = .009).
  •  

“Atrial arrhythmias were found in 26% of patients with sickle cell anemia, with a significant association with stroke history,” wrote the authors of the study. In a commentary published concurrently, Jonathan Uniat, MD, of Children’s Hospital Los Angeles in California, wrote, “Early detection and treatment of atrial arrhythmias may help prevent strokes in this population.”

 

SOURCE:

The study was led by Thomas d’Humières, Henri Mondor Hospital in Créteil, France. It was published online on November 12 in Blood Advances.

 

LIMITATIONS:

This study was a pilot prospective study and was underpowered with atrial arrhythmias occurring in only 34 patients. The population was relatively old for sickle cell anemia (45 years), and the study was biased because patients were selected based on clinical criteria indicative of underlying cardiovascular abnormalities. The population was heterogeneous in terms of antiarrhythmic therapy, and overall, at an advanced stage of the disease with frequent organ complications.

 

DISCLOSURES:

The study was supported by grants from FHU-SENEC. Pablo Bartolucci received grants from Addmedica, the Fabre Foundation, Novartis, and Bluebird in the past 36 months; received consulting fees from Addmedica, Novartis, Roche, GBT, Bluebird, Emmaus, Hemanext, and Agios; received honoraria for lectures from Novartis, Addmedica, and Jazz Pharmaceuticals; and reported being a member of the Novartis steering committee and cofounder of Innovhem. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Smoldering MS May Warrant Unique Diagnosis, Treatment, and Research Strategies

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Smoldering-associated worsening (SAW) of multiple sclerosis (MS) deserves a broader, more comprehensive approach to diagnosis, treatment, and research that goes beyond neurologists’ understanding of progression independent of relapse activity (PIRA), according to a recently published international consensus. However, an outside expert said that promulgating the “smoldering” concept may stoke patient and provider confusion.

Although current disease-modifying therapies (DMTs) for MS exclusively target focal white matter (WM) inflammation, wrote authors lead by Antonio Scalfari, MD, PhD, of Charing Cross Hospital, Imperial College London in England, many people with MS experience worsening disability in a more indolent fashion — despite stable inflammatory markers.

“The gradual accumulation of physical and cognitive disability is driven by smoldering pathological processes via biological substrates, which are different from those of acute focal damage, remain an important unmet therapeutic target,” they wrote.

The same research team first described smoldering MS in a 2022 publication. In the present paper, Scalfari and colleagues reviewed emerging clinical, radiological, and pathological evidence and presented 29 consensus statements in areas ranging from the definition, pathology, and clinical manifestations of smoldering MS to appropriate biomarkers and best clinical practices.

 

Definition

By definition, the authors wrote, SAW encompasses PIRA but also includes a range of gradually worsening, relapse-independent symptoms that remain undetectable on standard assessments, including the Expanded Disability Status Scale (EDSS) or EDSS-Plus, especially in early disease. To capture symptoms such as subtle motor impairment, cognitive slowing, and fatigue, Scalfari and colleagues recommend tools such as neurological stress tests, fatigue/mood scales, wearable devices, and patient reported outcomes.

Disease Mechanisms

Pathologically, the authors wrote, smoldering MS may stem from intrinsic central nervous system processes that likely incorporate various glial, immune, and neural cells. Smoldering MS also could contribute to aging, and vice versa, the latter possibly through dynamics such as age-related exhaustion of compensatory mechanisms, reduction in remyelination efficiency, and telomere shortening, they added.

Clinical Implementation

Current MS management rests on crude estimates of physical disability and overemphasizes identifying relapses and new MRI lesions as the principal markers of disease activity, wrote Scalfari and colleagues. Instead, they suggested combining motor-associated assessments such as EDSS-Plus with cognitive gauges such as the Brief International Cognitive Assessment for Multiple Sclerosis.

Providers are uncomfortable identifying and discussing smoldering MS, authors allowed, because no licensed treatments target SAW. However, the authors wrote, a principal reason for discussing smoldering MS with patients is to help manage their expectations of current DMTs, which may have little effect on SAW.

 

‘More Than Lesions’

Bruce Cree, MD, PhD, MAS, professor of neurology at the University of California, San Francisco, said that it is extremely important to raise awareness of physicians’ emerging understanding that “there is more going on in MS than lesions and relapses,” a concept that has been a work in progress for several years. He was not involved with the study but was asked to comment.

Dr. Bruce Cree

A 2019 report on the EPIC cohort coauthored by Cree labeled the disconnect between disability accumulation and relapse occurrence “silent progression.” The observation that disability accumulates in early relapsing MS independent of relapsing activity has been replicated in virtually every dataset worldwide, he added.

“What I don’t like about this article is the reliance on the term ‘smoldering’ and the acceptance that this is an actual phenomenon supported by data.” And authors’ leveraging “smoldering” into additional acronyms such as SAW likely will confuse rather than clarify physicians’ and patients’ understanding of the situation, Cree added. “Clinicians don’t need yet another snappy acronym.” Many are still trying to grasp the PIRA concept in relapsing MS, he said.

“One of the reasons this topic has become so important is that we recognize that even when we have very good control of relapsing disease activity — clinical relapses as well as radiographic large lesion formation on MRI — some patients still develop insidious worsening of disability. And the reasons for that are not well understood,” said Cree.

Accumulating disability absent relapse activity could stem from any number of microscopic inflammatory processes, possibly involving abnormal microglial activation, fibrinogen deposition, microscopic inflammatory infiltrates of CD8-positive T cells, or mitochondrial damage from iron deposition, he said. Or the processes driving PIRA may not even involve inflammation, he added. “We still don’t have a unifying way of understanding how these processes work.”

Cree suspects that, despite investigators’ good intentions, the study’s sponsor, Sanofi, may have influenced the resultant messaging. The company’s tolebrutinib recently completed phase 3 trials in secondary progressive MS and relapsing MS, and a phase 3 trial in primary progressive MS is scheduled for completion in 2025. “A hallmark of Sanofi’s messaging has been this idea that there is smoldering inflammation occurring in MS that tolebrutinib is going to address,” he said.

If clinicians really knew what drove progressive MS, said Cree, “we would be keen on developing therapies targeting that fundamental process. But because we don’t know what’s driving it, we don’t know what to go after.”

The study was supported by Sanofi. Cree is a coauthor of the GEMINI 1 and GEMINI 2 tolebrutinib studies.

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

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Smoldering-associated worsening (SAW) of multiple sclerosis (MS) deserves a broader, more comprehensive approach to diagnosis, treatment, and research that goes beyond neurologists’ understanding of progression independent of relapse activity (PIRA), according to a recently published international consensus. However, an outside expert said that promulgating the “smoldering” concept may stoke patient and provider confusion.

Although current disease-modifying therapies (DMTs) for MS exclusively target focal white matter (WM) inflammation, wrote authors lead by Antonio Scalfari, MD, PhD, of Charing Cross Hospital, Imperial College London in England, many people with MS experience worsening disability in a more indolent fashion — despite stable inflammatory markers.

“The gradual accumulation of physical and cognitive disability is driven by smoldering pathological processes via biological substrates, which are different from those of acute focal damage, remain an important unmet therapeutic target,” they wrote.

The same research team first described smoldering MS in a 2022 publication. In the present paper, Scalfari and colleagues reviewed emerging clinical, radiological, and pathological evidence and presented 29 consensus statements in areas ranging from the definition, pathology, and clinical manifestations of smoldering MS to appropriate biomarkers and best clinical practices.

 

Definition

By definition, the authors wrote, SAW encompasses PIRA but also includes a range of gradually worsening, relapse-independent symptoms that remain undetectable on standard assessments, including the Expanded Disability Status Scale (EDSS) or EDSS-Plus, especially in early disease. To capture symptoms such as subtle motor impairment, cognitive slowing, and fatigue, Scalfari and colleagues recommend tools such as neurological stress tests, fatigue/mood scales, wearable devices, and patient reported outcomes.

Disease Mechanisms

Pathologically, the authors wrote, smoldering MS may stem from intrinsic central nervous system processes that likely incorporate various glial, immune, and neural cells. Smoldering MS also could contribute to aging, and vice versa, the latter possibly through dynamics such as age-related exhaustion of compensatory mechanisms, reduction in remyelination efficiency, and telomere shortening, they added.

Clinical Implementation

Current MS management rests on crude estimates of physical disability and overemphasizes identifying relapses and new MRI lesions as the principal markers of disease activity, wrote Scalfari and colleagues. Instead, they suggested combining motor-associated assessments such as EDSS-Plus with cognitive gauges such as the Brief International Cognitive Assessment for Multiple Sclerosis.

Providers are uncomfortable identifying and discussing smoldering MS, authors allowed, because no licensed treatments target SAW. However, the authors wrote, a principal reason for discussing smoldering MS with patients is to help manage their expectations of current DMTs, which may have little effect on SAW.

 

‘More Than Lesions’

Bruce Cree, MD, PhD, MAS, professor of neurology at the University of California, San Francisco, said that it is extremely important to raise awareness of physicians’ emerging understanding that “there is more going on in MS than lesions and relapses,” a concept that has been a work in progress for several years. He was not involved with the study but was asked to comment.

Dr. Bruce Cree

A 2019 report on the EPIC cohort coauthored by Cree labeled the disconnect between disability accumulation and relapse occurrence “silent progression.” The observation that disability accumulates in early relapsing MS independent of relapsing activity has been replicated in virtually every dataset worldwide, he added.

“What I don’t like about this article is the reliance on the term ‘smoldering’ and the acceptance that this is an actual phenomenon supported by data.” And authors’ leveraging “smoldering” into additional acronyms such as SAW likely will confuse rather than clarify physicians’ and patients’ understanding of the situation, Cree added. “Clinicians don’t need yet another snappy acronym.” Many are still trying to grasp the PIRA concept in relapsing MS, he said.

“One of the reasons this topic has become so important is that we recognize that even when we have very good control of relapsing disease activity — clinical relapses as well as radiographic large lesion formation on MRI — some patients still develop insidious worsening of disability. And the reasons for that are not well understood,” said Cree.

Accumulating disability absent relapse activity could stem from any number of microscopic inflammatory processes, possibly involving abnormal microglial activation, fibrinogen deposition, microscopic inflammatory infiltrates of CD8-positive T cells, or mitochondrial damage from iron deposition, he said. Or the processes driving PIRA may not even involve inflammation, he added. “We still don’t have a unifying way of understanding how these processes work.”

Cree suspects that, despite investigators’ good intentions, the study’s sponsor, Sanofi, may have influenced the resultant messaging. The company’s tolebrutinib recently completed phase 3 trials in secondary progressive MS and relapsing MS, and a phase 3 trial in primary progressive MS is scheduled for completion in 2025. “A hallmark of Sanofi’s messaging has been this idea that there is smoldering inflammation occurring in MS that tolebrutinib is going to address,” he said.

If clinicians really knew what drove progressive MS, said Cree, “we would be keen on developing therapies targeting that fundamental process. But because we don’t know what’s driving it, we don’t know what to go after.”

The study was supported by Sanofi. Cree is a coauthor of the GEMINI 1 and GEMINI 2 tolebrutinib studies.

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

Smoldering-associated worsening (SAW) of multiple sclerosis (MS) deserves a broader, more comprehensive approach to diagnosis, treatment, and research that goes beyond neurologists’ understanding of progression independent of relapse activity (PIRA), according to a recently published international consensus. However, an outside expert said that promulgating the “smoldering” concept may stoke patient and provider confusion.

Although current disease-modifying therapies (DMTs) for MS exclusively target focal white matter (WM) inflammation, wrote authors lead by Antonio Scalfari, MD, PhD, of Charing Cross Hospital, Imperial College London in England, many people with MS experience worsening disability in a more indolent fashion — despite stable inflammatory markers.

“The gradual accumulation of physical and cognitive disability is driven by smoldering pathological processes via biological substrates, which are different from those of acute focal damage, remain an important unmet therapeutic target,” they wrote.

The same research team first described smoldering MS in a 2022 publication. In the present paper, Scalfari and colleagues reviewed emerging clinical, radiological, and pathological evidence and presented 29 consensus statements in areas ranging from the definition, pathology, and clinical manifestations of smoldering MS to appropriate biomarkers and best clinical practices.

 

Definition

By definition, the authors wrote, SAW encompasses PIRA but also includes a range of gradually worsening, relapse-independent symptoms that remain undetectable on standard assessments, including the Expanded Disability Status Scale (EDSS) or EDSS-Plus, especially in early disease. To capture symptoms such as subtle motor impairment, cognitive slowing, and fatigue, Scalfari and colleagues recommend tools such as neurological stress tests, fatigue/mood scales, wearable devices, and patient reported outcomes.

Disease Mechanisms

Pathologically, the authors wrote, smoldering MS may stem from intrinsic central nervous system processes that likely incorporate various glial, immune, and neural cells. Smoldering MS also could contribute to aging, and vice versa, the latter possibly through dynamics such as age-related exhaustion of compensatory mechanisms, reduction in remyelination efficiency, and telomere shortening, they added.

Clinical Implementation

Current MS management rests on crude estimates of physical disability and overemphasizes identifying relapses and new MRI lesions as the principal markers of disease activity, wrote Scalfari and colleagues. Instead, they suggested combining motor-associated assessments such as EDSS-Plus with cognitive gauges such as the Brief International Cognitive Assessment for Multiple Sclerosis.

Providers are uncomfortable identifying and discussing smoldering MS, authors allowed, because no licensed treatments target SAW. However, the authors wrote, a principal reason for discussing smoldering MS with patients is to help manage their expectations of current DMTs, which may have little effect on SAW.

 

‘More Than Lesions’

Bruce Cree, MD, PhD, MAS, professor of neurology at the University of California, San Francisco, said that it is extremely important to raise awareness of physicians’ emerging understanding that “there is more going on in MS than lesions and relapses,” a concept that has been a work in progress for several years. He was not involved with the study but was asked to comment.

Dr. Bruce Cree

A 2019 report on the EPIC cohort coauthored by Cree labeled the disconnect between disability accumulation and relapse occurrence “silent progression.” The observation that disability accumulates in early relapsing MS independent of relapsing activity has been replicated in virtually every dataset worldwide, he added.

“What I don’t like about this article is the reliance on the term ‘smoldering’ and the acceptance that this is an actual phenomenon supported by data.” And authors’ leveraging “smoldering” into additional acronyms such as SAW likely will confuse rather than clarify physicians’ and patients’ understanding of the situation, Cree added. “Clinicians don’t need yet another snappy acronym.” Many are still trying to grasp the PIRA concept in relapsing MS, he said.

“One of the reasons this topic has become so important is that we recognize that even when we have very good control of relapsing disease activity — clinical relapses as well as radiographic large lesion formation on MRI — some patients still develop insidious worsening of disability. And the reasons for that are not well understood,” said Cree.

Accumulating disability absent relapse activity could stem from any number of microscopic inflammatory processes, possibly involving abnormal microglial activation, fibrinogen deposition, microscopic inflammatory infiltrates of CD8-positive T cells, or mitochondrial damage from iron deposition, he said. Or the processes driving PIRA may not even involve inflammation, he added. “We still don’t have a unifying way of understanding how these processes work.”

Cree suspects that, despite investigators’ good intentions, the study’s sponsor, Sanofi, may have influenced the resultant messaging. The company’s tolebrutinib recently completed phase 3 trials in secondary progressive MS and relapsing MS, and a phase 3 trial in primary progressive MS is scheduled for completion in 2025. “A hallmark of Sanofi’s messaging has been this idea that there is smoldering inflammation occurring in MS that tolebrutinib is going to address,” he said.

If clinicians really knew what drove progressive MS, said Cree, “we would be keen on developing therapies targeting that fundamental process. But because we don’t know what’s driving it, we don’t know what to go after.”

The study was supported by Sanofi. Cree is a coauthor of the GEMINI 1 and GEMINI 2 tolebrutinib studies.

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

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FROM ANNALS OF NEUROLOGY

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Hemorrhoidal Disease Management: When and How to Intervene

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For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

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For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

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New Cause of Sexually Transmitted Fungal Infection Reported in MSM

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A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

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

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A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

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

A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

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

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Social Determinants of Health: The Impact on Pediatric Health and Well-Being

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Case vignette: A 16-year-old Nepali-born English-speaking adolescent presents for a well-child visit and notes concerns for anxiety, depression, and a history of trauma. She resides with her parents who work in hospitality with limited time off, and thus she presented for the initial office visit with a neighbor. Parents were not readily available to discuss treatment recommendations, including medication options. The teen shares a number of challenges that makes coming to appointments difficult. You also notice that the patient currently is not enrolled in insurance, though she appears eligible.

The above vignette highlights various social issues and concerns that impact access to healthcare and overall health/well-being. Social determinants of health (SDOH) and factors centered on mental health are now widely known to impact pediatric health and wellbeing. The Office of Disease Prevention and Health Promotion defines SDOH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” SDOH can be grouped into five domains: Economic Stability, Education Access and Quality, Health Care Access and Quality, Neighborhood and Built Environment, and Social and Community Context.1

 

Dr. Yasmeen Abdul-Karim, University of Vermont, Burlington
Dr. Abdul-Karim
Dr. Yasmeen Abdul-Karim

Additionally, when considering determinants that impact the mental health of children, it is prudent to consider parental psychosocial factors and adverse childhood experiences (ACEs), such as witnessing interpersonal violence, child abuse, parental substance use, and parental depression.2 All these factors have been shown to impact an individual’s mental and physical health not only contemporaneously but also later in life.3

Screening Tool for Pediatric Social Histories

One screening tool to assist with gathering an expanded pediatric social history is called IHELP, developed by Kenyon et al,4 with further derivations from Colvin et al.5 Utilizing this tool can assist providers with identifying social needs.

The tool begins with a framing statement — “Let me ask you some questions I ask every family” — then proceeds to discuss relevant topics as shared below:

I: Income; Insurance

  • Do you have any concerns about making ends meet?
  • Do you have any concerns about your child’s health insurance?

H: Hunger, Housing Conditions; Homeless

  • Do you have any concerns about having enough food?
  • Have you ever been worried whether your food would run out before you got money to buy more?
  • Within the past year has the food you bought ever not lasted, and you didn’t have money to get more?
  • Do you have any concerns about poor housing conditions like mice, mold, or cockroaches?
  • Do you have any concerns about being evicted or not being able to pay the rent?
  • Do you have any concerns about not being able to pay your mortgage?

E: Education; Ensuring Safety (Violence)

  • Do you have any concerns about your child’s educational needs?
  • [DO NOT ASK IN FRONT OF CHILD 3 OR OLDER OR IN FRONT OF OTHER PARTNER] “From speaking to families, I have learned that violence in the home is common and now I ask all families about violence in the home. Do you have any concerns about violence in your home?”
 

 

L: Legal status (Immigration)

  • What hospital was your child born in?
  • If not in the United States: “Are you aware that your child may be eligible for benefits even though they were not born in the US? If you would like, I can have a social worker come talk to you about some possible benefits your child may be eligible for. Would you like me to do that?”

P: Power of Attorney; Guardianship

  • Are you the biological mother or father of this child?
  • [If not] “Can you show me the power of attorney or guardianship document you have?”
  • **PATIENTS >17+ with Mental Incapacity: Ask for Guardianship.

This tool can help with identifying families with significant social needs so that one can attain further historical information and subsequently share resources to assist with any challenges.
 

Consider the Role of Adverse Childhood Experiences

Additionally, as noted, ACEs often play an important role in overall health and well-being; they include experiencing childhood abuse, neglect, and/or household dysfunction. The impact of these early exposures can lead to toxic stress that can negatively alter the brain and the body’s response to stress over time.3 There are various tools readily available online that can assist with identifying ACEs and interpreting their prevalence. The American Academy of Pediatrics has an updated page of commonly used screening tools. Early identification and intervention can help mitigate the impact of these experiences on long-term outcomes.

Important Considerations Regarding Screening for SDOH and/or ACEs:

  • Please consider if screening is helpful in your space, recognizing that there are benefits and potential ethical considerations to screen or not. Ensure an interdisciplinary approach if screening is implemented to ensure that the patient’s experience and well-being is prioritized.
  • Try to be intentional in your communication with parents. The patient and family are our teachers and know best what they need.
  • Consider what is available in your community and what can be offered to ensure that parents and families are appropriate and eligible for a particular resource.
  • Encourage continuous collaboration and partnership with community providers who offer resources that a family may benefit from to ensure that the resource continues to be available.

Returning to the Vignette

Administering the IHELP tool has led to identifying that the adolescent’s insurance has lapsed, but she remains eligible, and the family seeks support to re-enroll. The family shares concerns regarding educational needs, as the child has not attended school for the past year and is not on track to graduate. The IHELP tool also helps you identify inconsistent transportation availability. Ultimately, a social work consultation is placed which assists with re-enrolling in insurance for the child and obtaining a bus pass for in-person visits. The patient is also supported in enrolling in the use of a videoconferencing platform for virtual visits. You and your team reach out to the school, which provides valuable information regarding the child’s status and how best to support re-engagement. On follow-up, she is now readily engaged in appointments and shares she is no longer worrying about transportation, which has been helpful. She has started initial conversations with the school and has a condensed schedule for reintegration.

Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. Office of Disease Prevention and Health Promotion, US Department of Health & Human Services. Social Determinants of Health. https://odphp.health.gov/healthypeople/priority-areas/social-determinants-health

2. Cotton N and Shim R. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1385-1389. doi: 10.1016/j.jaac.2022.04.020.

3. US Centers for Disease Control and Prevention. Adverse Childhood Experiences (ACEs): Preventing Early Trauma to Improve Adult Health. https://www.cdc.gov/vitalsigns/aces/index.html.

4. Kenyon C et al. Pediatrics. 2007 Sep;120(3):e734-e738. doi: 10.1542/peds.2006-2495.

5. Colvin JD et al. Acad Pediatr. 2016 Mar;16(2):168-174. doi: 10.1016/j.acap.2015.06.001.

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Case vignette: A 16-year-old Nepali-born English-speaking adolescent presents for a well-child visit and notes concerns for anxiety, depression, and a history of trauma. She resides with her parents who work in hospitality with limited time off, and thus she presented for the initial office visit with a neighbor. Parents were not readily available to discuss treatment recommendations, including medication options. The teen shares a number of challenges that makes coming to appointments difficult. You also notice that the patient currently is not enrolled in insurance, though she appears eligible.

The above vignette highlights various social issues and concerns that impact access to healthcare and overall health/well-being. Social determinants of health (SDOH) and factors centered on mental health are now widely known to impact pediatric health and wellbeing. The Office of Disease Prevention and Health Promotion defines SDOH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” SDOH can be grouped into five domains: Economic Stability, Education Access and Quality, Health Care Access and Quality, Neighborhood and Built Environment, and Social and Community Context.1

 

Dr. Yasmeen Abdul-Karim, University of Vermont, Burlington
Dr. Abdul-Karim
Dr. Yasmeen Abdul-Karim

Additionally, when considering determinants that impact the mental health of children, it is prudent to consider parental psychosocial factors and adverse childhood experiences (ACEs), such as witnessing interpersonal violence, child abuse, parental substance use, and parental depression.2 All these factors have been shown to impact an individual’s mental and physical health not only contemporaneously but also later in life.3

Screening Tool for Pediatric Social Histories

One screening tool to assist with gathering an expanded pediatric social history is called IHELP, developed by Kenyon et al,4 with further derivations from Colvin et al.5 Utilizing this tool can assist providers with identifying social needs.

The tool begins with a framing statement — “Let me ask you some questions I ask every family” — then proceeds to discuss relevant topics as shared below:

I: Income; Insurance

  • Do you have any concerns about making ends meet?
  • Do you have any concerns about your child’s health insurance?

H: Hunger, Housing Conditions; Homeless

  • Do you have any concerns about having enough food?
  • Have you ever been worried whether your food would run out before you got money to buy more?
  • Within the past year has the food you bought ever not lasted, and you didn’t have money to get more?
  • Do you have any concerns about poor housing conditions like mice, mold, or cockroaches?
  • Do you have any concerns about being evicted or not being able to pay the rent?
  • Do you have any concerns about not being able to pay your mortgage?

E: Education; Ensuring Safety (Violence)

  • Do you have any concerns about your child’s educational needs?
  • [DO NOT ASK IN FRONT OF CHILD 3 OR OLDER OR IN FRONT OF OTHER PARTNER] “From speaking to families, I have learned that violence in the home is common and now I ask all families about violence in the home. Do you have any concerns about violence in your home?”
 

 

L: Legal status (Immigration)

  • What hospital was your child born in?
  • If not in the United States: “Are you aware that your child may be eligible for benefits even though they were not born in the US? If you would like, I can have a social worker come talk to you about some possible benefits your child may be eligible for. Would you like me to do that?”

P: Power of Attorney; Guardianship

  • Are you the biological mother or father of this child?
  • [If not] “Can you show me the power of attorney or guardianship document you have?”
  • **PATIENTS >17+ with Mental Incapacity: Ask for Guardianship.

This tool can help with identifying families with significant social needs so that one can attain further historical information and subsequently share resources to assist with any challenges.
 

Consider the Role of Adverse Childhood Experiences

Additionally, as noted, ACEs often play an important role in overall health and well-being; they include experiencing childhood abuse, neglect, and/or household dysfunction. The impact of these early exposures can lead to toxic stress that can negatively alter the brain and the body’s response to stress over time.3 There are various tools readily available online that can assist with identifying ACEs and interpreting their prevalence. The American Academy of Pediatrics has an updated page of commonly used screening tools. Early identification and intervention can help mitigate the impact of these experiences on long-term outcomes.

Important Considerations Regarding Screening for SDOH and/or ACEs:

  • Please consider if screening is helpful in your space, recognizing that there are benefits and potential ethical considerations to screen or not. Ensure an interdisciplinary approach if screening is implemented to ensure that the patient’s experience and well-being is prioritized.
  • Try to be intentional in your communication with parents. The patient and family are our teachers and know best what they need.
  • Consider what is available in your community and what can be offered to ensure that parents and families are appropriate and eligible for a particular resource.
  • Encourage continuous collaboration and partnership with community providers who offer resources that a family may benefit from to ensure that the resource continues to be available.

Returning to the Vignette

Administering the IHELP tool has led to identifying that the adolescent’s insurance has lapsed, but she remains eligible, and the family seeks support to re-enroll. The family shares concerns regarding educational needs, as the child has not attended school for the past year and is not on track to graduate. The IHELP tool also helps you identify inconsistent transportation availability. Ultimately, a social work consultation is placed which assists with re-enrolling in insurance for the child and obtaining a bus pass for in-person visits. The patient is also supported in enrolling in the use of a videoconferencing platform for virtual visits. You and your team reach out to the school, which provides valuable information regarding the child’s status and how best to support re-engagement. On follow-up, she is now readily engaged in appointments and shares she is no longer worrying about transportation, which has been helpful. She has started initial conversations with the school and has a condensed schedule for reintegration.

Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. Office of Disease Prevention and Health Promotion, US Department of Health & Human Services. Social Determinants of Health. https://odphp.health.gov/healthypeople/priority-areas/social-determinants-health

2. Cotton N and Shim R. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1385-1389. doi: 10.1016/j.jaac.2022.04.020.

3. US Centers for Disease Control and Prevention. Adverse Childhood Experiences (ACEs): Preventing Early Trauma to Improve Adult Health. https://www.cdc.gov/vitalsigns/aces/index.html.

4. Kenyon C et al. Pediatrics. 2007 Sep;120(3):e734-e738. doi: 10.1542/peds.2006-2495.

5. Colvin JD et al. Acad Pediatr. 2016 Mar;16(2):168-174. doi: 10.1016/j.acap.2015.06.001.

Case vignette: A 16-year-old Nepali-born English-speaking adolescent presents for a well-child visit and notes concerns for anxiety, depression, and a history of trauma. She resides with her parents who work in hospitality with limited time off, and thus she presented for the initial office visit with a neighbor. Parents were not readily available to discuss treatment recommendations, including medication options. The teen shares a number of challenges that makes coming to appointments difficult. You also notice that the patient currently is not enrolled in insurance, though she appears eligible.

The above vignette highlights various social issues and concerns that impact access to healthcare and overall health/well-being. Social determinants of health (SDOH) and factors centered on mental health are now widely known to impact pediatric health and wellbeing. The Office of Disease Prevention and Health Promotion defines SDOH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” SDOH can be grouped into five domains: Economic Stability, Education Access and Quality, Health Care Access and Quality, Neighborhood and Built Environment, and Social and Community Context.1

 

Dr. Yasmeen Abdul-Karim, University of Vermont, Burlington
Dr. Abdul-Karim
Dr. Yasmeen Abdul-Karim

Additionally, when considering determinants that impact the mental health of children, it is prudent to consider parental psychosocial factors and adverse childhood experiences (ACEs), such as witnessing interpersonal violence, child abuse, parental substance use, and parental depression.2 All these factors have been shown to impact an individual’s mental and physical health not only contemporaneously but also later in life.3

Screening Tool for Pediatric Social Histories

One screening tool to assist with gathering an expanded pediatric social history is called IHELP, developed by Kenyon et al,4 with further derivations from Colvin et al.5 Utilizing this tool can assist providers with identifying social needs.

The tool begins with a framing statement — “Let me ask you some questions I ask every family” — then proceeds to discuss relevant topics as shared below:

I: Income; Insurance

  • Do you have any concerns about making ends meet?
  • Do you have any concerns about your child’s health insurance?

H: Hunger, Housing Conditions; Homeless

  • Do you have any concerns about having enough food?
  • Have you ever been worried whether your food would run out before you got money to buy more?
  • Within the past year has the food you bought ever not lasted, and you didn’t have money to get more?
  • Do you have any concerns about poor housing conditions like mice, mold, or cockroaches?
  • Do you have any concerns about being evicted or not being able to pay the rent?
  • Do you have any concerns about not being able to pay your mortgage?

E: Education; Ensuring Safety (Violence)

  • Do you have any concerns about your child’s educational needs?
  • [DO NOT ASK IN FRONT OF CHILD 3 OR OLDER OR IN FRONT OF OTHER PARTNER] “From speaking to families, I have learned that violence in the home is common and now I ask all families about violence in the home. Do you have any concerns about violence in your home?”
 

 

L: Legal status (Immigration)

  • What hospital was your child born in?
  • If not in the United States: “Are you aware that your child may be eligible for benefits even though they were not born in the US? If you would like, I can have a social worker come talk to you about some possible benefits your child may be eligible for. Would you like me to do that?”

P: Power of Attorney; Guardianship

  • Are you the biological mother or father of this child?
  • [If not] “Can you show me the power of attorney or guardianship document you have?”
  • **PATIENTS >17+ with Mental Incapacity: Ask for Guardianship.

This tool can help with identifying families with significant social needs so that one can attain further historical information and subsequently share resources to assist with any challenges.
 

Consider the Role of Adverse Childhood Experiences

Additionally, as noted, ACEs often play an important role in overall health and well-being; they include experiencing childhood abuse, neglect, and/or household dysfunction. The impact of these early exposures can lead to toxic stress that can negatively alter the brain and the body’s response to stress over time.3 There are various tools readily available online that can assist with identifying ACEs and interpreting their prevalence. The American Academy of Pediatrics has an updated page of commonly used screening tools. Early identification and intervention can help mitigate the impact of these experiences on long-term outcomes.

Important Considerations Regarding Screening for SDOH and/or ACEs:

  • Please consider if screening is helpful in your space, recognizing that there are benefits and potential ethical considerations to screen or not. Ensure an interdisciplinary approach if screening is implemented to ensure that the patient’s experience and well-being is prioritized.
  • Try to be intentional in your communication with parents. The patient and family are our teachers and know best what they need.
  • Consider what is available in your community and what can be offered to ensure that parents and families are appropriate and eligible for a particular resource.
  • Encourage continuous collaboration and partnership with community providers who offer resources that a family may benefit from to ensure that the resource continues to be available.

Returning to the Vignette

Administering the IHELP tool has led to identifying that the adolescent’s insurance has lapsed, but she remains eligible, and the family seeks support to re-enroll. The family shares concerns regarding educational needs, as the child has not attended school for the past year and is not on track to graduate. The IHELP tool also helps you identify inconsistent transportation availability. Ultimately, a social work consultation is placed which assists with re-enrolling in insurance for the child and obtaining a bus pass for in-person visits. The patient is also supported in enrolling in the use of a videoconferencing platform for virtual visits. You and your team reach out to the school, which provides valuable information regarding the child’s status and how best to support re-engagement. On follow-up, she is now readily engaged in appointments and shares she is no longer worrying about transportation, which has been helpful. She has started initial conversations with the school and has a condensed schedule for reintegration.

Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. Office of Disease Prevention and Health Promotion, US Department of Health & Human Services. Social Determinants of Health. https://odphp.health.gov/healthypeople/priority-areas/social-determinants-health

2. Cotton N and Shim R. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1385-1389. doi: 10.1016/j.jaac.2022.04.020.

3. US Centers for Disease Control and Prevention. Adverse Childhood Experiences (ACEs): Preventing Early Trauma to Improve Adult Health. https://www.cdc.gov/vitalsigns/aces/index.html.

4. Kenyon C et al. Pediatrics. 2007 Sep;120(3):e734-e738. doi: 10.1542/peds.2006-2495.

5. Colvin JD et al. Acad Pediatr. 2016 Mar;16(2):168-174. doi: 10.1016/j.acap.2015.06.001.

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Faster Brain Atrophy Linked to MCI

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A long-term brain imaging study in aging adults showed faster rates of atrophy in certain brain structures to be associated with the risk of developing mild cognitive impairment (MCI).

While some brain atrophy is expected in aging, high levels of atrophy in the white matter and high enlargement in the ventricles are associated with earlier progression from normal cognition to MCI, the study found. The researchers also identified diabetes and atypical levels of amyloid beta protein in the cerebrospinal fluid as risk factors for brain atrophy and MCI.

For their research, published online on JAMA Network Open, Yuto Uchida, MD, PhD, and his colleagues at the Johns Hopkins University School of Medicine in Baltimore, Maryland, looked at data for 185 individuals (mean age, 55.4 years; 63% women) who were cognitively normal at baseline and followed for a median of 20 years.

All had been enrolled in a longitudinal cohort study on biomarkers of cognitive decline conducted at Johns Hopkins. Each participant underwent a median of five structural MRI studies during the follow-up period as well as annual cognitive testing. Altogether 60 individuals developed MCI, with eight of them progressing to dementia.

“We hypothesized that annual rates of change of segmental brain volumes would be associated with vascular risk factors among middle-aged and older adults and that these trends would be associated with the progression from normal cognition to MCI,” Uchida and colleagues wrote.
 

Uniquely Long Follow-Up

Most longitudinal studies using structural MRI count a decade or less of follow-up, the study authors noted. This makes it difficult to discern whether the annual rates of change of brain volumes are affected by vascular risk factors or are useful in predicting MCI, they said. Individual differences in brain aging make population-based studies less informative.

This study’s long timeframe allowed for tracking of brain changes “on an individual basis, which facilitates the differentiation between interindividual and intraindividual variations and leads to more accurate estimations of rates of brain atrophy,” Uchida and colleagues wrote.

People with high levels of atrophy in the white matter and enlargement in the ventricles saw earlier progression to MCI (hazard ratio [HR], 1.86; 95% CI, 1.24-2.49; P = .001). Diabetes mellitus was associated with progression to MCI (HR, 1.41; 95% CI, 1.06-1.76; P = .04), as was a low CSF Abeta42:Abeta40 ratio (HR, 1.48; 95% CI, 1.09-1.88; P = .04).

People with both diabetes and an abnormal amyloid profile were even more vulnerable to developing MCI (HR, 1.55; 95% CI, 1.13-1.98; P = .03). This indicated “a synergic association of diabetes and amyloid pathology with MCI progression,” Uchida and colleagues wrote, noting that insulin resistance has been shown to promote the formation of amyloid plaques, a hallmark of Alzheimer’s disease.

The findings also underscore that “white matter volume changes are closely associated with cognitive function in aging, suggesting that white matter degeneration may play a crucial role in cognitive decline,” the authors noted.

Uchida and colleagues acknowledged the modest size and imbalanced sex ratio of their study cohort as potential weaknesses, as well as the fact that the imaging technologies had changed over the course of the study. Most of the participants were White with family histories of dementia.
 

Findings May Lead to Targeted Interventions

In an editorial comment accompanying Uchida and colleagues’ study, Shohei Fujita, MD, PhD, of Massachusetts General Hospital, Boston, said that, while a more diverse population sample would be desirable and should be sought for future studies, the results nonetheless highlight “the potential of long-term longitudinal brain MRI datasets in elucidating the interplay of risk factors underlying cognitive decline and the potential benefits of controlling diabetes to reduce the risk of progression” along the Alzheimer’s disease continuum.

The findings may prove informative, Fujita said, in developing “targeted interventions for those most susceptible to progressive brain changes, potentially combining lifestyle modifications and pharmacological treatments.”

Uchida and colleagues’ study was funded by the Alzheimer’s Association, the National Alzheimer’s Coordinating Center, and the National Institutes of Health. The study’s corresponding author, Kenichi Oishi, disclosed funding from the Richman Family Foundation, Richman, the Sharp Family Foundation, and others. Uchida and Fujita reported no relevant financial conflicts of interest.

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

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A long-term brain imaging study in aging adults showed faster rates of atrophy in certain brain structures to be associated with the risk of developing mild cognitive impairment (MCI).

While some brain atrophy is expected in aging, high levels of atrophy in the white matter and high enlargement in the ventricles are associated with earlier progression from normal cognition to MCI, the study found. The researchers also identified diabetes and atypical levels of amyloid beta protein in the cerebrospinal fluid as risk factors for brain atrophy and MCI.

For their research, published online on JAMA Network Open, Yuto Uchida, MD, PhD, and his colleagues at the Johns Hopkins University School of Medicine in Baltimore, Maryland, looked at data for 185 individuals (mean age, 55.4 years; 63% women) who were cognitively normal at baseline and followed for a median of 20 years.

All had been enrolled in a longitudinal cohort study on biomarkers of cognitive decline conducted at Johns Hopkins. Each participant underwent a median of five structural MRI studies during the follow-up period as well as annual cognitive testing. Altogether 60 individuals developed MCI, with eight of them progressing to dementia.

“We hypothesized that annual rates of change of segmental brain volumes would be associated with vascular risk factors among middle-aged and older adults and that these trends would be associated with the progression from normal cognition to MCI,” Uchida and colleagues wrote.
 

Uniquely Long Follow-Up

Most longitudinal studies using structural MRI count a decade or less of follow-up, the study authors noted. This makes it difficult to discern whether the annual rates of change of brain volumes are affected by vascular risk factors or are useful in predicting MCI, they said. Individual differences in brain aging make population-based studies less informative.

This study’s long timeframe allowed for tracking of brain changes “on an individual basis, which facilitates the differentiation between interindividual and intraindividual variations and leads to more accurate estimations of rates of brain atrophy,” Uchida and colleagues wrote.

People with high levels of atrophy in the white matter and enlargement in the ventricles saw earlier progression to MCI (hazard ratio [HR], 1.86; 95% CI, 1.24-2.49; P = .001). Diabetes mellitus was associated with progression to MCI (HR, 1.41; 95% CI, 1.06-1.76; P = .04), as was a low CSF Abeta42:Abeta40 ratio (HR, 1.48; 95% CI, 1.09-1.88; P = .04).

People with both diabetes and an abnormal amyloid profile were even more vulnerable to developing MCI (HR, 1.55; 95% CI, 1.13-1.98; P = .03). This indicated “a synergic association of diabetes and amyloid pathology with MCI progression,” Uchida and colleagues wrote, noting that insulin resistance has been shown to promote the formation of amyloid plaques, a hallmark of Alzheimer’s disease.

The findings also underscore that “white matter volume changes are closely associated with cognitive function in aging, suggesting that white matter degeneration may play a crucial role in cognitive decline,” the authors noted.

Uchida and colleagues acknowledged the modest size and imbalanced sex ratio of their study cohort as potential weaknesses, as well as the fact that the imaging technologies had changed over the course of the study. Most of the participants were White with family histories of dementia.
 

Findings May Lead to Targeted Interventions

In an editorial comment accompanying Uchida and colleagues’ study, Shohei Fujita, MD, PhD, of Massachusetts General Hospital, Boston, said that, while a more diverse population sample would be desirable and should be sought for future studies, the results nonetheless highlight “the potential of long-term longitudinal brain MRI datasets in elucidating the interplay of risk factors underlying cognitive decline and the potential benefits of controlling diabetes to reduce the risk of progression” along the Alzheimer’s disease continuum.

The findings may prove informative, Fujita said, in developing “targeted interventions for those most susceptible to progressive brain changes, potentially combining lifestyle modifications and pharmacological treatments.”

Uchida and colleagues’ study was funded by the Alzheimer’s Association, the National Alzheimer’s Coordinating Center, and the National Institutes of Health. The study’s corresponding author, Kenichi Oishi, disclosed funding from the Richman Family Foundation, Richman, the Sharp Family Foundation, and others. Uchida and Fujita reported no relevant financial conflicts of interest.

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

 

A long-term brain imaging study in aging adults showed faster rates of atrophy in certain brain structures to be associated with the risk of developing mild cognitive impairment (MCI).

While some brain atrophy is expected in aging, high levels of atrophy in the white matter and high enlargement in the ventricles are associated with earlier progression from normal cognition to MCI, the study found. The researchers also identified diabetes and atypical levels of amyloid beta protein in the cerebrospinal fluid as risk factors for brain atrophy and MCI.

For their research, published online on JAMA Network Open, Yuto Uchida, MD, PhD, and his colleagues at the Johns Hopkins University School of Medicine in Baltimore, Maryland, looked at data for 185 individuals (mean age, 55.4 years; 63% women) who were cognitively normal at baseline and followed for a median of 20 years.

All had been enrolled in a longitudinal cohort study on biomarkers of cognitive decline conducted at Johns Hopkins. Each participant underwent a median of five structural MRI studies during the follow-up period as well as annual cognitive testing. Altogether 60 individuals developed MCI, with eight of them progressing to dementia.

“We hypothesized that annual rates of change of segmental brain volumes would be associated with vascular risk factors among middle-aged and older adults and that these trends would be associated with the progression from normal cognition to MCI,” Uchida and colleagues wrote.
 

Uniquely Long Follow-Up

Most longitudinal studies using structural MRI count a decade or less of follow-up, the study authors noted. This makes it difficult to discern whether the annual rates of change of brain volumes are affected by vascular risk factors or are useful in predicting MCI, they said. Individual differences in brain aging make population-based studies less informative.

This study’s long timeframe allowed for tracking of brain changes “on an individual basis, which facilitates the differentiation between interindividual and intraindividual variations and leads to more accurate estimations of rates of brain atrophy,” Uchida and colleagues wrote.

People with high levels of atrophy in the white matter and enlargement in the ventricles saw earlier progression to MCI (hazard ratio [HR], 1.86; 95% CI, 1.24-2.49; P = .001). Diabetes mellitus was associated with progression to MCI (HR, 1.41; 95% CI, 1.06-1.76; P = .04), as was a low CSF Abeta42:Abeta40 ratio (HR, 1.48; 95% CI, 1.09-1.88; P = .04).

People with both diabetes and an abnormal amyloid profile were even more vulnerable to developing MCI (HR, 1.55; 95% CI, 1.13-1.98; P = .03). This indicated “a synergic association of diabetes and amyloid pathology with MCI progression,” Uchida and colleagues wrote, noting that insulin resistance has been shown to promote the formation of amyloid plaques, a hallmark of Alzheimer’s disease.

The findings also underscore that “white matter volume changes are closely associated with cognitive function in aging, suggesting that white matter degeneration may play a crucial role in cognitive decline,” the authors noted.

Uchida and colleagues acknowledged the modest size and imbalanced sex ratio of their study cohort as potential weaknesses, as well as the fact that the imaging technologies had changed over the course of the study. Most of the participants were White with family histories of dementia.
 

Findings May Lead to Targeted Interventions

In an editorial comment accompanying Uchida and colleagues’ study, Shohei Fujita, MD, PhD, of Massachusetts General Hospital, Boston, said that, while a more diverse population sample would be desirable and should be sought for future studies, the results nonetheless highlight “the potential of long-term longitudinal brain MRI datasets in elucidating the interplay of risk factors underlying cognitive decline and the potential benefits of controlling diabetes to reduce the risk of progression” along the Alzheimer’s disease continuum.

The findings may prove informative, Fujita said, in developing “targeted interventions for those most susceptible to progressive brain changes, potentially combining lifestyle modifications and pharmacological treatments.”

Uchida and colleagues’ study was funded by the Alzheimer’s Association, the National Alzheimer’s Coordinating Center, and the National Institutes of Health. The study’s corresponding author, Kenichi Oishi, disclosed funding from the Richman Family Foundation, Richman, the Sharp Family Foundation, and others. Uchida and Fujita reported no relevant financial conflicts of interest.

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

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Survey Study Shows How to Reduce Family Physician Burnout

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Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.

In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.

Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.

“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
 

More Than 10,000 Physicians; 100% Response Rate

The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.

The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.

Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).

Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
 

Numbers Needed to Treat

“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.

The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.

“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”

Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.

Fee-for-service models are often painted as the culprit, she noted.

“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
 

 

 

Medical Assistants (MAs) Replacing Nurses on Core Teams

In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.

“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.

Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.

Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”

Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.

Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.

He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.

“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.

Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.

She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
 

Nearly 30 Hours a Week of EHR Work at Home

Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.

She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”

She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.

The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”

This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.

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

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Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.

In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.

Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.

“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
 

More Than 10,000 Physicians; 100% Response Rate

The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.

The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.

Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).

Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
 

Numbers Needed to Treat

“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.

The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.

“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”

Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.

Fee-for-service models are often painted as the culprit, she noted.

“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
 

 

 

Medical Assistants (MAs) Replacing Nurses on Core Teams

In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.

“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.

Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.

Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”

Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.

Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.

He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.

“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.

Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.

She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
 

Nearly 30 Hours a Week of EHR Work at Home

Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.

She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”

She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.

The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”

This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.

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

Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.

In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.

Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.

“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
 

More Than 10,000 Physicians; 100% Response Rate

The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.

The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.

Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).

Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
 

Numbers Needed to Treat

“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.

The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.

“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”

Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.

Fee-for-service models are often painted as the culprit, she noted.

“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
 

 

 

Medical Assistants (MAs) Replacing Nurses on Core Teams

In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.

“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.

Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.

Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”

Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.

Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.

He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.

“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.

Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.

She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
 

Nearly 30 Hours a Week of EHR Work at Home

Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.

She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”

She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.

The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”

This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.

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

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How to Manage Patients on GLP-1s Before Surgery

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Wed, 11/27/2024 - 04:37

 

Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

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

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Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

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

 

Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

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

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Wed, 11/27/2024 - 04:37

Continuous Glucose Monitors for All? Opinions Remain Mixed

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Wed, 11/27/2024 - 04:39

 

The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.

There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes? 

The short answer to these questions is, we don’t know.

“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.

“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.

“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.” 

Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.

“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.” 

Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.

“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
 

Potential Benefits Right Now

Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.

“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.

He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.

Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.

“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”

Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”

“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”

Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”

Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.” 
 

 

 

Potential Downsides

Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”

Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.

Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.

Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”

Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.

“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
 

Educate Patients, Primary Care Physicians

To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use. 

“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”

This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.

“A discrepancy of 20% is totally acceptable for that reason,” Bao said.

She has also seen several examples where patients were misled by their CGM when its censor became dislodged.

“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.” 

At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.

Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.

“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”

Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.” 

“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”

Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.

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

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The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.

There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes? 

The short answer to these questions is, we don’t know.

“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.

“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.

“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.” 

Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.

“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.” 

Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.

“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
 

Potential Benefits Right Now

Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.

“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.

He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.

Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.

“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”

Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”

“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”

Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”

Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.” 
 

 

 

Potential Downsides

Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”

Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.

Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.

Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”

Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.

“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
 

Educate Patients, Primary Care Physicians

To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use. 

“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”

This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.

“A discrepancy of 20% is totally acceptable for that reason,” Bao said.

She has also seen several examples where patients were misled by their CGM when its censor became dislodged.

“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.” 

At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.

Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.

“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”

Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.” 

“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”

Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.

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

 

The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.

There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes? 

The short answer to these questions is, we don’t know.

“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.

“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.

“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.” 

Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.

“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.” 

Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.

“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
 

Potential Benefits Right Now

Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.

“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.

He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.

Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.

“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”

Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”

“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”

Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”

Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.” 
 

 

 

Potential Downsides

Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”

Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.

Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.

Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”

Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.

“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
 

Educate Patients, Primary Care Physicians

To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use. 

“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”

This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.

“A discrepancy of 20% is totally acceptable for that reason,” Bao said.

She has also seen several examples where patients were misled by their CGM when its censor became dislodged.

“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.” 

At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.

Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.

“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”

Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.” 

“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”

Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.

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

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