Clinician Reviews

Omitting race and ethnicity from colorectal cancer (CRC) recurrence risk prediction models could decrease their accuracy and fairness, particularly for minority groups, potentially leading to inappropriate care advice and contributing to existing health disparities, new research suggests.

“Our study has important implications for developing clinical algorithms that are both accurate and fair,” write first author Sara Khor, MASc, with University of Washington, Seattle, and colleagues.

“Many groups have called for the removal of race in clinical algorithms,” Dr. Khor said in an interview. “We wanted to better understand, using CRC recurrence as a case study, what some of the implications might be if we simply remove race as a predictor in a risk prediction algorithm.”

Their findings suggest that doing so could lead to higher racial bias in model accuracy and less accurate estimation of risk for racial and ethnic minority groups. This could lead to inadequate or inappropriate surveillance and follow-up care more often in patients of minoritized racial and ethnic groups.

The study was published online in JAMA Network Open.
 

Lack of data and consensus

There is currently a lack of consensus on whether and how race and ethnicity should be included in clinical risk prediction models used to guide health care decisions, the authors note.

The inclusion of race and ethnicity in clinical risk prediction algorithms has come under increased scrutiny, because of concerns over the potential for racial profiling and biased treatment. On the other hand, some argue that excluding race and ethnicity could harm all groups by reducing predictive accuracy and would especially disadvantage minority groups.

It remains unclear whether simply omitting race and ethnicity from algorithms will ultimately improve care decisions for patients of minoritized racial and ethnic groups.

Dr. Khor and colleagues investigated the performance of four risk prediction models for CRC recurrence using data from 4,230 patients with CRC (53% non-Hispanic white; 22% Hispanic; 13% Black or African American; and 12% Asian, Hawaiian, or Pacific Islander).

The four models were:

• A race-neutral model that explicitly excluded race and ethnicity as a predictor.
• A race-sensitive model that included race and ethnicity.
• A model with two-way interactions between clinical predictors and race and ethnicity.
• Separate models stratified by race and ethnicity.

They found that the race-neutral model had poorer performance (worse calibration, negative predictive value, and false-negative rates) among racial and ethnic minority subgroups, compared with the non-Hispanic subgroup. The false-negative rate for Hispanic patients was 12% vs. 3% for non-Hispanic white patients.

Conversely, including race and ethnicity as a predictor of postoperative cancer recurrence improved the model’s accuracy and increased “algorithmic fairness” in terms of calibration slope, discriminative ability, positive predictive value, and false-negative rates. The false-negative rate for Hispanic patients was 9% and 8% for non-Hispanic white patients.

The inclusion of race interaction terms or using race-stratified models did not improve model fairness, likely due to small sample sizes in subgroups, the authors add.
 

‘No one-size-fits-all answer’

“There is no one-size-fits-all answer to whether race/ethnicity should be included, because the health disparity consequences that can result from each clinical decision are different,” Dr. Khor told this news organization.

“The downstream harms and benefits of including or excluding race will need to be carefully considered in each case,” Dr. Khor said.

“When developing a clinical risk prediction algorithm, one should consider the potential racial/ethnic biases present in clinical practice, which translate to bias in the data,” Dr. Khor added. “Care must be taken to think through the implications of such biases during the algorithm development and evaluation process in order to avoid further propagating those biases.”

The coauthors of a linked commentary say this study “highlights current challenges in measuring and addressing algorithmic bias, with implications for both patient care and health policy decision-making.”

Ankur Pandya, PhD, with Harvard School of Public Health, Boston, and Jinyi Zhu, PhD, with Vanderbilt University, Nashville, Tenn., agree that there is no “one-size-fits-all solution” – such as always excluding race and ethnicity from risk models – to confronting algorithmic bias.

“When possible, approaches for identifying and responding to algorithmic bias should focus on the decisions made by patients and policymakers as they relate to the ultimate outcomes of interest (such as length of life, quality of life, and costs) and the distribution of these outcomes across the subgroups that define important health disparities,” Dr. Pandya and Dr. Zhu suggest.

“What is most promising,” they write, is the high level of engagement from researchers, philosophers, policymakers, physicians and other healthcare professionals, caregivers, and patients to this cause in recent years, “suggesting that algorithmic bias will not be left unchecked as access to unprecedented amounts of data and methods continues to increase moving forward.”

This research was supported by a grant from the National Cancer Institute of the National Institutes of Health. The authors and editorial writers have disclosed no relevant financial relationships.

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

Omitting race and ethnicity from colorectal cancer (CRC) recurrence risk prediction models could decrease their accuracy and fairness, particularly for minority groups, potentially leading to inappropriate care advice and contributing to existing health disparities, new research suggests.

“Our study has important implications for developing clinical algorithms that are both accurate and fair,” write first author Sara Khor, MASc, with University of Washington, Seattle, and colleagues.

“Many groups have called for the removal of race in clinical algorithms,” Dr. Khor said in an interview. “We wanted to better understand, using CRC recurrence as a case study, what some of the implications might be if we simply remove race as a predictor in a risk prediction algorithm.”

Their findings suggest that doing so could lead to higher racial bias in model accuracy and less accurate estimation of risk for racial and ethnic minority groups. This could lead to inadequate or inappropriate surveillance and follow-up care more often in patients of minoritized racial and ethnic groups.

The study was published online in JAMA Network Open.
 

Lack of data and consensus

There is currently a lack of consensus on whether and how race and ethnicity should be included in clinical risk prediction models used to guide health care decisions, the authors note.

The inclusion of race and ethnicity in clinical risk prediction algorithms has come under increased scrutiny, because of concerns over the potential for racial profiling and biased treatment. On the other hand, some argue that excluding race and ethnicity could harm all groups by reducing predictive accuracy and would especially disadvantage minority groups.

It remains unclear whether simply omitting race and ethnicity from algorithms will ultimately improve care decisions for patients of minoritized racial and ethnic groups.

Dr. Khor and colleagues investigated the performance of four risk prediction models for CRC recurrence using data from 4,230 patients with CRC (53% non-Hispanic white; 22% Hispanic; 13% Black or African American; and 12% Asian, Hawaiian, or Pacific Islander).

The four models were:

• A race-neutral model that explicitly excluded race and ethnicity as a predictor.
• A race-sensitive model that included race and ethnicity.
• A model with two-way interactions between clinical predictors and race and ethnicity.
• Separate models stratified by race and ethnicity.

They found that the race-neutral model had poorer performance (worse calibration, negative predictive value, and false-negative rates) among racial and ethnic minority subgroups, compared with the non-Hispanic subgroup. The false-negative rate for Hispanic patients was 12% vs. 3% for non-Hispanic white patients.

Conversely, including race and ethnicity as a predictor of postoperative cancer recurrence improved the model’s accuracy and increased “algorithmic fairness” in terms of calibration slope, discriminative ability, positive predictive value, and false-negative rates. The false-negative rate for Hispanic patients was 9% and 8% for non-Hispanic white patients.

The inclusion of race interaction terms or using race-stratified models did not improve model fairness, likely due to small sample sizes in subgroups, the authors add.
 

‘No one-size-fits-all answer’

“There is no one-size-fits-all answer to whether race/ethnicity should be included, because the health disparity consequences that can result from each clinical decision are different,” Dr. Khor told this news organization.

“The downstream harms and benefits of including or excluding race will need to be carefully considered in each case,” Dr. Khor said.

“When developing a clinical risk prediction algorithm, one should consider the potential racial/ethnic biases present in clinical practice, which translate to bias in the data,” Dr. Khor added. “Care must be taken to think through the implications of such biases during the algorithm development and evaluation process in order to avoid further propagating those biases.”

The coauthors of a linked commentary say this study “highlights current challenges in measuring and addressing algorithmic bias, with implications for both patient care and health policy decision-making.”

Ankur Pandya, PhD, with Harvard School of Public Health, Boston, and Jinyi Zhu, PhD, with Vanderbilt University, Nashville, Tenn., agree that there is no “one-size-fits-all solution” – such as always excluding race and ethnicity from risk models – to confronting algorithmic bias.

“When possible, approaches for identifying and responding to algorithmic bias should focus on the decisions made by patients and policymakers as they relate to the ultimate outcomes of interest (such as length of life, quality of life, and costs) and the distribution of these outcomes across the subgroups that define important health disparities,” Dr. Pandya and Dr. Zhu suggest.

“What is most promising,” they write, is the high level of engagement from researchers, philosophers, policymakers, physicians and other healthcare professionals, caregivers, and patients to this cause in recent years, “suggesting that algorithmic bias will not be left unchecked as access to unprecedented amounts of data and methods continues to increase moving forward.”

This research was supported by a grant from the National Cancer Institute of the National Institutes of Health. The authors and editorial writers have disclosed no relevant financial relationships.

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

Omitting race and ethnicity from colorectal cancer (CRC) recurrence risk prediction models could decrease their accuracy and fairness, particularly for minority groups, potentially leading to inappropriate care advice and contributing to existing health disparities, new research suggests.

“Our study has important implications for developing clinical algorithms that are both accurate and fair,” write first author Sara Khor, MASc, with University of Washington, Seattle, and colleagues.

“Many groups have called for the removal of race in clinical algorithms,” Dr. Khor said in an interview. “We wanted to better understand, using CRC recurrence as a case study, what some of the implications might be if we simply remove race as a predictor in a risk prediction algorithm.”

Their findings suggest that doing so could lead to higher racial bias in model accuracy and less accurate estimation of risk for racial and ethnic minority groups. This could lead to inadequate or inappropriate surveillance and follow-up care more often in patients of minoritized racial and ethnic groups.

The study was published online in JAMA Network Open.
 

Lack of data and consensus

There is currently a lack of consensus on whether and how race and ethnicity should be included in clinical risk prediction models used to guide health care decisions, the authors note.

The inclusion of race and ethnicity in clinical risk prediction algorithms has come under increased scrutiny, because of concerns over the potential for racial profiling and biased treatment. On the other hand, some argue that excluding race and ethnicity could harm all groups by reducing predictive accuracy and would especially disadvantage minority groups.

It remains unclear whether simply omitting race and ethnicity from algorithms will ultimately improve care decisions for patients of minoritized racial and ethnic groups.

Dr. Khor and colleagues investigated the performance of four risk prediction models for CRC recurrence using data from 4,230 patients with CRC (53% non-Hispanic white; 22% Hispanic; 13% Black or African American; and 12% Asian, Hawaiian, or Pacific Islander).

The four models were:

• A race-neutral model that explicitly excluded race and ethnicity as a predictor.
• A race-sensitive model that included race and ethnicity.
• A model with two-way interactions between clinical predictors and race and ethnicity.
• Separate models stratified by race and ethnicity.

They found that the race-neutral model had poorer performance (worse calibration, negative predictive value, and false-negative rates) among racial and ethnic minority subgroups, compared with the non-Hispanic subgroup. The false-negative rate for Hispanic patients was 12% vs. 3% for non-Hispanic white patients.

Conversely, including race and ethnicity as a predictor of postoperative cancer recurrence improved the model’s accuracy and increased “algorithmic fairness” in terms of calibration slope, discriminative ability, positive predictive value, and false-negative rates. The false-negative rate for Hispanic patients was 9% and 8% for non-Hispanic white patients.

The inclusion of race interaction terms or using race-stratified models did not improve model fairness, likely due to small sample sizes in subgroups, the authors add.
 

‘No one-size-fits-all answer’

“There is no one-size-fits-all answer to whether race/ethnicity should be included, because the health disparity consequences that can result from each clinical decision are different,” Dr. Khor told this news organization.

“The downstream harms and benefits of including or excluding race will need to be carefully considered in each case,” Dr. Khor said.

“When developing a clinical risk prediction algorithm, one should consider the potential racial/ethnic biases present in clinical practice, which translate to bias in the data,” Dr. Khor added. “Care must be taken to think through the implications of such biases during the algorithm development and evaluation process in order to avoid further propagating those biases.”

The coauthors of a linked commentary say this study “highlights current challenges in measuring and addressing algorithmic bias, with implications for both patient care and health policy decision-making.”

Ankur Pandya, PhD, with Harvard School of Public Health, Boston, and Jinyi Zhu, PhD, with Vanderbilt University, Nashville, Tenn., agree that there is no “one-size-fits-all solution” – such as always excluding race and ethnicity from risk models – to confronting algorithmic bias.

“When possible, approaches for identifying and responding to algorithmic bias should focus on the decisions made by patients and policymakers as they relate to the ultimate outcomes of interest (such as length of life, quality of life, and costs) and the distribution of these outcomes across the subgroups that define important health disparities,” Dr. Pandya and Dr. Zhu suggest.

“What is most promising,” they write, is the high level of engagement from researchers, philosophers, policymakers, physicians and other healthcare professionals, caregivers, and patients to this cause in recent years, “suggesting that algorithmic bias will not be left unchecked as access to unprecedented amounts of data and methods continues to increase moving forward.”

This research was supported by a grant from the National Cancer Institute of the National Institutes of Health. The authors and editorial writers have disclosed no relevant financial relationships.

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

Daily napping may help preserve brain health, new research suggests.

Investigators at University College London, and the University of the Republic of Uruguay, Montevideo, found individuals genetically predisposed to regular napping had larger total brain volume, a surrogate of better cognitive health.

“Our results suggest that napping may improve brain health,” first author Valentina Paz, MSc, a PhD candidate at the University of the Republic of Uruguay said in an interview. “Specifically, our work revealed a 15.8 cubic cm increase in total brain volume with more frequent daytime napping,” she said.

The findings were published online in Sleep Health.
 

Higher brain volume

Previous studies examining the potential link between napping and cognition in older adults have yielded conflicting results.

To clarify this association, Ms. Paz and colleagues used Mendelian randomization to study DNA samples, cognitive outcomes, and functional magnetic resonance imaging data in participants from the ongoing UK Biobank Study.  

Starting with data from 378,932 study participants (mean age 57), investigators compared measures of brain health and cognition of those who are more genetically programmed to nap with people who did not have these genetic variations.

More specifically, the investigators examined 97 sections of genetic code previously linked to the likelihood of regular napping and correlated these results with fMRI and cognitive outcomes between those genetically predisposed to take regular naps and those who weren’t.

Study outcomes included total brain volume, hippocampal volume, reaction time, and visual memory.

The final study sample included 35,080 with neuroimaging, cognitive assessment, and genotype data.

The researchers estimated that the average difference in brain volume between individuals genetically programmed to be habitual nappers and those who were not was equivalent to 15.8 cubic cm, or 2.6-6.5 years of aging.

However, there was no difference in the other three outcomes – hippocampal volume, reaction time, and visual processing – between the two study groups.

Since investigators did not have information on the length of time participants napped, Ms. Paz suggested that “taking a short nap in the early afternoon may help cognition in those needing it.”

However, she added, the study’s findings need to be replicated before any firm conclusions can be made.

“More work is needed to examine the associations between napping and cognition, and the replication of these findings using other datasets and methods,” she said.

The investigators note that the study’s findings augment the knowledge of the “impact of habitual daytime napping on brain health, which is essential to understanding cognitive impairment in the aging population. The lack of evidence for an association between napping and hippocampal volume and cognitive outcomes (for example, alertness) may be affected by habitual daytime napping and should be studied in the future.”
 

Strengths, limitations

Tara Spires-Jones, PhD, president of the British Neuroscience Association and group leader at the UK Dementia Research Institute, said, “the study shows a small but significant increase in brain volume in people who have a genetic signature associated with taking daytime naps.”

Dr. Spires-Jones, who was not involved in the research, noted that while the study is well-conducted, it has limitations. Because Mendelian randomization uses a genetic signature, she noted, outcomes depend on the accuracy of the signature. 

“The napping habits of UK Biobank participants were self-reported, which might not be entirely accurate, and the ‘napping’ signature overlapped substantially with the signature for cognitive outcomes in the study, which makes the causal link weaker,” she said.

“Even with those limitations, this study is interesting because it adds to the data indicating that sleep is important for brain health,” said Dr. Spires-Jones.

The study was supported by Diabetes UK, the British Heart Foundation, and the Diabetes Research and Wellness Foundation. In Uruguay, it was supported by Programa de Desarrollo de las Ciencias Básicas, Agencia Nacional de Investigación e Innovación, Comisión Sectorial de Investigación Científica, and Comisión Académica de Posgrado. In the United States it was supported by the National Heart, Lung, and Blood Institute. There were no disclosures reported.

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

Daily napping may help preserve brain health, new research suggests.

Investigators at University College London, and the University of the Republic of Uruguay, Montevideo, found individuals genetically predisposed to regular napping had larger total brain volume, a surrogate of better cognitive health.

“Our results suggest that napping may improve brain health,” first author Valentina Paz, MSc, a PhD candidate at the University of the Republic of Uruguay said in an interview. “Specifically, our work revealed a 15.8 cubic cm increase in total brain volume with more frequent daytime napping,” she said.

The findings were published online in Sleep Health.
 

Higher brain volume

Previous studies examining the potential link between napping and cognition in older adults have yielded conflicting results.

To clarify this association, Ms. Paz and colleagues used Mendelian randomization to study DNA samples, cognitive outcomes, and functional magnetic resonance imaging data in participants from the ongoing UK Biobank Study.  

Starting with data from 378,932 study participants (mean age 57), investigators compared measures of brain health and cognition of those who are more genetically programmed to nap with people who did not have these genetic variations.

More specifically, the investigators examined 97 sections of genetic code previously linked to the likelihood of regular napping and correlated these results with fMRI and cognitive outcomes between those genetically predisposed to take regular naps and those who weren’t.

Study outcomes included total brain volume, hippocampal volume, reaction time, and visual memory.

The final study sample included 35,080 with neuroimaging, cognitive assessment, and genotype data.

The researchers estimated that the average difference in brain volume between individuals genetically programmed to be habitual nappers and those who were not was equivalent to 15.8 cubic cm, or 2.6-6.5 years of aging.

However, there was no difference in the other three outcomes – hippocampal volume, reaction time, and visual processing – between the two study groups.

Since investigators did not have information on the length of time participants napped, Ms. Paz suggested that “taking a short nap in the early afternoon may help cognition in those needing it.”

However, she added, the study’s findings need to be replicated before any firm conclusions can be made.

“More work is needed to examine the associations between napping and cognition, and the replication of these findings using other datasets and methods,” she said.

The investigators note that the study’s findings augment the knowledge of the “impact of habitual daytime napping on brain health, which is essential to understanding cognitive impairment in the aging population. The lack of evidence for an association between napping and hippocampal volume and cognitive outcomes (for example, alertness) may be affected by habitual daytime napping and should be studied in the future.”
 

Strengths, limitations

Tara Spires-Jones, PhD, president of the British Neuroscience Association and group leader at the UK Dementia Research Institute, said, “the study shows a small but significant increase in brain volume in people who have a genetic signature associated with taking daytime naps.”

Dr. Spires-Jones, who was not involved in the research, noted that while the study is well-conducted, it has limitations. Because Mendelian randomization uses a genetic signature, she noted, outcomes depend on the accuracy of the signature. 

“The napping habits of UK Biobank participants were self-reported, which might not be entirely accurate, and the ‘napping’ signature overlapped substantially with the signature for cognitive outcomes in the study, which makes the causal link weaker,” she said.

“Even with those limitations, this study is interesting because it adds to the data indicating that sleep is important for brain health,” said Dr. Spires-Jones.

The study was supported by Diabetes UK, the British Heart Foundation, and the Diabetes Research and Wellness Foundation. In Uruguay, it was supported by Programa de Desarrollo de las Ciencias Básicas, Agencia Nacional de Investigación e Innovación, Comisión Sectorial de Investigación Científica, and Comisión Académica de Posgrado. In the United States it was supported by the National Heart, Lung, and Blood Institute. There were no disclosures reported.

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

Daily napping may help preserve brain health, new research suggests.

Investigators at University College London, and the University of the Republic of Uruguay, Montevideo, found individuals genetically predisposed to regular napping had larger total brain volume, a surrogate of better cognitive health.

“Our results suggest that napping may improve brain health,” first author Valentina Paz, MSc, a PhD candidate at the University of the Republic of Uruguay said in an interview. “Specifically, our work revealed a 15.8 cubic cm increase in total brain volume with more frequent daytime napping,” she said.

The findings were published online in Sleep Health.
 

Higher brain volume

Previous studies examining the potential link between napping and cognition in older adults have yielded conflicting results.

To clarify this association, Ms. Paz and colleagues used Mendelian randomization to study DNA samples, cognitive outcomes, and functional magnetic resonance imaging data in participants from the ongoing UK Biobank Study.  

Starting with data from 378,932 study participants (mean age 57), investigators compared measures of brain health and cognition of those who are more genetically programmed to nap with people who did not have these genetic variations.

More specifically, the investigators examined 97 sections of genetic code previously linked to the likelihood of regular napping and correlated these results with fMRI and cognitive outcomes between those genetically predisposed to take regular naps and those who weren’t.

Study outcomes included total brain volume, hippocampal volume, reaction time, and visual memory.

The final study sample included 35,080 with neuroimaging, cognitive assessment, and genotype data.

The researchers estimated that the average difference in brain volume between individuals genetically programmed to be habitual nappers and those who were not was equivalent to 15.8 cubic cm, or 2.6-6.5 years of aging.

However, there was no difference in the other three outcomes – hippocampal volume, reaction time, and visual processing – between the two study groups.

Since investigators did not have information on the length of time participants napped, Ms. Paz suggested that “taking a short nap in the early afternoon may help cognition in those needing it.”

However, she added, the study’s findings need to be replicated before any firm conclusions can be made.

“More work is needed to examine the associations between napping and cognition, and the replication of these findings using other datasets and methods,” she said.

The investigators note that the study’s findings augment the knowledge of the “impact of habitual daytime napping on brain health, which is essential to understanding cognitive impairment in the aging population. The lack of evidence for an association between napping and hippocampal volume and cognitive outcomes (for example, alertness) may be affected by habitual daytime napping and should be studied in the future.”
 

Strengths, limitations

Tara Spires-Jones, PhD, president of the British Neuroscience Association and group leader at the UK Dementia Research Institute, said, “the study shows a small but significant increase in brain volume in people who have a genetic signature associated with taking daytime naps.”

Dr. Spires-Jones, who was not involved in the research, noted that while the study is well-conducted, it has limitations. Because Mendelian randomization uses a genetic signature, she noted, outcomes depend on the accuracy of the signature. 

“The napping habits of UK Biobank participants were self-reported, which might not be entirely accurate, and the ‘napping’ signature overlapped substantially with the signature for cognitive outcomes in the study, which makes the causal link weaker,” she said.

“Even with those limitations, this study is interesting because it adds to the data indicating that sleep is important for brain health,” said Dr. Spires-Jones.

The study was supported by Diabetes UK, the British Heart Foundation, and the Diabetes Research and Wellness Foundation. In Uruguay, it was supported by Programa de Desarrollo de las Ciencias Básicas, Agencia Nacional de Investigación e Innovación, Comisión Sectorial de Investigación Científica, and Comisión Académica de Posgrado. In the United States it was supported by the National Heart, Lung, and Blood Institute. There were no disclosures reported.

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

TOPLINE:

The less U.S. patients pay out of pocket for drugs that often have high copays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) agonists, the more adherent they are.

METHODOLOGY:

• Review of 90,041 U.S. adults who started a GLP-1 agonist (n = 39,149) or SGLT2 inhibitor (n = 50,892) in 2014-2020.
• Participants had type 2 diabetes, heart failure, or both.
• Data are from Clinformatics Data Mart, including both commercial and Medicare health insurance plans.
• Primary outcome: 12-month adherence to prescribed GLP-1 agonist or SGLT2 inhibitor.

TAKEAWAYS:

• U.S. adults with a lower drug copay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher copay.
• These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.
• After full adjustment, patients with a high copay (≥ $50/month) were, after 12 months, 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a low copay (< $10/month) for these agents.

IN PRACTICE:

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” say the authors.

STUDY DETAILS:

The study was led by Utibe R. Essien, MD, from the University of California, Los Angeles, and Balvindar Singh, MD, PhD, from the University of Pittsburgh, and included several authors from other U.S. centers.

LIMITATIONS:

Study could not exclude residual confounding.

Generalizability uncertain for those without health insurance or with public insurance.

Study did not have information on patient preferences associated with medication use, including specific reasons for poor adherence.

Possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities.

Study could not assess how copayments influenced initial prescription receipt or abandonment at the pharmacy, nor other factors including possible price inflation.
 

DISCLOSURES:

The study received no commercial funding. One author (not a lead author) is an advisor to several drug companies, including ones that market SGLT2 inhibitors or GLP-1 agonists.

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

TOPLINE:

The less U.S. patients pay out of pocket for drugs that often have high copays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) agonists, the more adherent they are.

METHODOLOGY:

• Review of 90,041 U.S. adults who started a GLP-1 agonist (n = 39,149) or SGLT2 inhibitor (n = 50,892) in 2014-2020.
• Participants had type 2 diabetes, heart failure, or both.
• Data are from Clinformatics Data Mart, including both commercial and Medicare health insurance plans.
• Primary outcome: 12-month adherence to prescribed GLP-1 agonist or SGLT2 inhibitor.

TAKEAWAYS:

• U.S. adults with a lower drug copay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher copay.
• These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.
• After full adjustment, patients with a high copay (≥ $50/month) were, after 12 months, 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a low copay (< $10/month) for these agents.

IN PRACTICE:

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” say the authors.

STUDY DETAILS:

The study was led by Utibe R. Essien, MD, from the University of California, Los Angeles, and Balvindar Singh, MD, PhD, from the University of Pittsburgh, and included several authors from other U.S. centers.

LIMITATIONS:

Study could not exclude residual confounding.

Generalizability uncertain for those without health insurance or with public insurance.

Study did not have information on patient preferences associated with medication use, including specific reasons for poor adherence.

Possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities.

Study could not assess how copayments influenced initial prescription receipt or abandonment at the pharmacy, nor other factors including possible price inflation.
 

DISCLOSURES:

The study received no commercial funding. One author (not a lead author) is an advisor to several drug companies, including ones that market SGLT2 inhibitors or GLP-1 agonists.

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

TOPLINE:

The less U.S. patients pay out of pocket for drugs that often have high copays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) agonists, the more adherent they are.

METHODOLOGY:

• Review of 90,041 U.S. adults who started a GLP-1 agonist (n = 39,149) or SGLT2 inhibitor (n = 50,892) in 2014-2020.
• Participants had type 2 diabetes, heart failure, or both.
• Data are from Clinformatics Data Mart, including both commercial and Medicare health insurance plans.
• Primary outcome: 12-month adherence to prescribed GLP-1 agonist or SGLT2 inhibitor.

TAKEAWAYS:

• U.S. adults with a lower drug copay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher copay.
• These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.
• After full adjustment, patients with a high copay (≥ $50/month) were, after 12 months, 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a low copay (< $10/month) for these agents.

IN PRACTICE:

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” say the authors.

STUDY DETAILS:

The study was led by Utibe R. Essien, MD, from the University of California, Los Angeles, and Balvindar Singh, MD, PhD, from the University of Pittsburgh, and included several authors from other U.S. centers.

LIMITATIONS:

Study could not exclude residual confounding.

Generalizability uncertain for those without health insurance or with public insurance.

Study did not have information on patient preferences associated with medication use, including specific reasons for poor adherence.

Possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities.

Study could not assess how copayments influenced initial prescription receipt or abandonment at the pharmacy, nor other factors including possible price inflation.
 

DISCLOSURES:

The study received no commercial funding. One author (not a lead author) is an advisor to several drug companies, including ones that market SGLT2 inhibitors or GLP-1 agonists.

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

The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.

Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.

The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.

The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.

David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.

“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
 

Early results ‘exciting’

Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”

Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.

Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.

It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.

Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
 

Complete response letter issued

F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”

Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.

Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”

In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.

“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
 

Plant drug undermining olorofim efficacy in humans

“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.

Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”

F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.

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

The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.

Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.

The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.

The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.

David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.

“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
 

Early results ‘exciting’

Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”

Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.

Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.

It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.

Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
 

Complete response letter issued

F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”

Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.

Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”

In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.

“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
 

Plant drug undermining olorofim efficacy in humans

“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.

Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”

F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.

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

The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.

Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.

The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.

The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.

David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.

“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
 

Early results ‘exciting’

Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”

Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.

Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.

It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.

Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
 

Complete response letter issued

F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”

Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.

Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”

In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.

“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
 

Plant drug undermining olorofim efficacy in humans

“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.

Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”

F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.

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

This transcript has been edited for clarity.

I’m Art Caplan, PhD. I’m at the division of medical ethics at NYU’s Grossman School of Medicine.

An interesting situation has arisen that many doctors who do physical examinations and primary care are facing, which is whether a chaperone has to be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area.

In some institutions, there has been a movement toward saying a chaperone must be present, that it’s mandatory. I know that is true at Yale’s health care centers and clinics. Others do so when the patient requests it. An interesting situation sometimes occurs when the hospital or the clinic requires a chaperone but the patient says, “I don’t want a chaperone. I want my privacy. I want the gynecologist or the urologist only. I don’t want anyone else to be seeing me. I’m not comfortable with anyone other than the doctor in the room.”

Complicating this issue of when is a chaperone appropriate and when can it be refused, if ever, is the fact that the role of chaperone is ill defined. For example, there isn’t really agreement on who can be a chaperone. Could it be a medical student? Could it be a nurse? Could it be another doctor? Should it be someone who at least has finished nursing school or medical school? Can it be a patient representative? There are no standards about who can play the role.

Should the chaperone be available to be seen when they’re in the room? Should they stay behind a curtain or somewhere where they’re not, so to speak, intrusive into what’s going on in the exam room? Do they sit in a chair? Do they stand? How do they behave, if you will? There’s no agreement.

There’s still no agreement on the training that a chaperone should have. Do we charge them with trying to represent what’s going on with the patient or trying to protect the doctor against any accusations that are ill founded about inappropriate conduct? Are they supposed to do both? How do they obtain consent, if they do, from the patient undergoing an examination in a sensitive part of their body or one that they’re sensitive about?

This area really requires some hard thinking if you’re considering having chaperones present. I think there are some online courses that offer some training. I haven’t looked at them, but they might be worth a look to see if they make you more comfortable about getting a chaperone oriented. I think it’s probably important to set a policy saying a chaperone must always be present for these kinds of examinations and list them, or one can be requested no matter what is going on in terms of the kind of exam being conducted.

There needs to be some statement saying that you have permission to either accept them or refuse them – or you don’t. Should they always be present, for example, with patients who are minors, adolescents or children? Does that extend that far out where a guardian, parent, or someone has to give permission?

In this area, I think we can all understand why chaperones have come to the fore, including allegations of misconduct and inappropriate touching, and considering comfort levels of patients to just put them more at ease. It’s obvious that we haven’t, as a nation or a medical profession, thought it through to the degree to which we have to.

I’m certainly not anti-chaperone, and I believe that if patients are more comfortable having one present, or a doctor is more comfortable having one present, or if we all agree that there are certain patients – kids – where certain types of examinations require or ought to expect the chaperone to be present, that’s wonderful.

We’ve got to lay out the rights of the doctors. We’ve got to lay out the rights of the institutions. We’ve got to lay out the rights of the patients. We should agree on who these people are. We should agree on how they’re trained.

We’ve got some work ahead of us if we’re going to have chaperones become a standard part of the medical examination.

Dr. Kaplan reported conflicts of interest with the Franklin Institute, Tengion, Biogen Idec, Johnson & Johnson, and PriCara.

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

This transcript has been edited for clarity.

I’m Art Caplan, PhD. I’m at the division of medical ethics at NYU’s Grossman School of Medicine.

An interesting situation has arisen that many doctors who do physical examinations and primary care are facing, which is whether a chaperone has to be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area.

In some institutions, there has been a movement toward saying a chaperone must be present, that it’s mandatory. I know that is true at Yale’s health care centers and clinics. Others do so when the patient requests it. An interesting situation sometimes occurs when the hospital or the clinic requires a chaperone but the patient says, “I don’t want a chaperone. I want my privacy. I want the gynecologist or the urologist only. I don’t want anyone else to be seeing me. I’m not comfortable with anyone other than the doctor in the room.”

Complicating this issue of when is a chaperone appropriate and when can it be refused, if ever, is the fact that the role of chaperone is ill defined. For example, there isn’t really agreement on who can be a chaperone. Could it be a medical student? Could it be a nurse? Could it be another doctor? Should it be someone who at least has finished nursing school or medical school? Can it be a patient representative? There are no standards about who can play the role.

Should the chaperone be available to be seen when they’re in the room? Should they stay behind a curtain or somewhere where they’re not, so to speak, intrusive into what’s going on in the exam room? Do they sit in a chair? Do they stand? How do they behave, if you will? There’s no agreement.

There’s still no agreement on the training that a chaperone should have. Do we charge them with trying to represent what’s going on with the patient or trying to protect the doctor against any accusations that are ill founded about inappropriate conduct? Are they supposed to do both? How do they obtain consent, if they do, from the patient undergoing an examination in a sensitive part of their body or one that they’re sensitive about?

This area really requires some hard thinking if you’re considering having chaperones present. I think there are some online courses that offer some training. I haven’t looked at them, but they might be worth a look to see if they make you more comfortable about getting a chaperone oriented. I think it’s probably important to set a policy saying a chaperone must always be present for these kinds of examinations and list them, or one can be requested no matter what is going on in terms of the kind of exam being conducted.

There needs to be some statement saying that you have permission to either accept them or refuse them – or you don’t. Should they always be present, for example, with patients who are minors, adolescents or children? Does that extend that far out where a guardian, parent, or someone has to give permission?

In this area, I think we can all understand why chaperones have come to the fore, including allegations of misconduct and inappropriate touching, and considering comfort levels of patients to just put them more at ease. It’s obvious that we haven’t, as a nation or a medical profession, thought it through to the degree to which we have to.

I’m certainly not anti-chaperone, and I believe that if patients are more comfortable having one present, or a doctor is more comfortable having one present, or if we all agree that there are certain patients – kids – where certain types of examinations require or ought to expect the chaperone to be present, that’s wonderful.

We’ve got to lay out the rights of the doctors. We’ve got to lay out the rights of the institutions. We’ve got to lay out the rights of the patients. We should agree on who these people are. We should agree on how they’re trained.

We’ve got some work ahead of us if we’re going to have chaperones become a standard part of the medical examination.

Dr. Kaplan reported conflicts of interest with the Franklin Institute, Tengion, Biogen Idec, Johnson & Johnson, and PriCara.

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

This transcript has been edited for clarity.

I’m Art Caplan, PhD. I’m at the division of medical ethics at NYU’s Grossman School of Medicine.

An interesting situation has arisen that many doctors who do physical examinations and primary care are facing, which is whether a chaperone has to be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area.

In some institutions, there has been a movement toward saying a chaperone must be present, that it’s mandatory. I know that is true at Yale’s health care centers and clinics. Others do so when the patient requests it. An interesting situation sometimes occurs when the hospital or the clinic requires a chaperone but the patient says, “I don’t want a chaperone. I want my privacy. I want the gynecologist or the urologist only. I don’t want anyone else to be seeing me. I’m not comfortable with anyone other than the doctor in the room.”

Complicating this issue of when is a chaperone appropriate and when can it be refused, if ever, is the fact that the role of chaperone is ill defined. For example, there isn’t really agreement on who can be a chaperone. Could it be a medical student? Could it be a nurse? Could it be another doctor? Should it be someone who at least has finished nursing school or medical school? Can it be a patient representative? There are no standards about who can play the role.

Should the chaperone be available to be seen when they’re in the room? Should they stay behind a curtain or somewhere where they’re not, so to speak, intrusive into what’s going on in the exam room? Do they sit in a chair? Do they stand? How do they behave, if you will? There’s no agreement.

There’s still no agreement on the training that a chaperone should have. Do we charge them with trying to represent what’s going on with the patient or trying to protect the doctor against any accusations that are ill founded about inappropriate conduct? Are they supposed to do both? How do they obtain consent, if they do, from the patient undergoing an examination in a sensitive part of their body or one that they’re sensitive about?

This area really requires some hard thinking if you’re considering having chaperones present. I think there are some online courses that offer some training. I haven’t looked at them, but they might be worth a look to see if they make you more comfortable about getting a chaperone oriented. I think it’s probably important to set a policy saying a chaperone must always be present for these kinds of examinations and list them, or one can be requested no matter what is going on in terms of the kind of exam being conducted.

There needs to be some statement saying that you have permission to either accept them or refuse them – or you don’t. Should they always be present, for example, with patients who are minors, adolescents or children? Does that extend that far out where a guardian, parent, or someone has to give permission?

In this area, I think we can all understand why chaperones have come to the fore, including allegations of misconduct and inappropriate touching, and considering comfort levels of patients to just put them more at ease. It’s obvious that we haven’t, as a nation or a medical profession, thought it through to the degree to which we have to.

I’m certainly not anti-chaperone, and I believe that if patients are more comfortable having one present, or a doctor is more comfortable having one present, or if we all agree that there are certain patients – kids – where certain types of examinations require or ought to expect the chaperone to be present, that’s wonderful.

We’ve got to lay out the rights of the doctors. We’ve got to lay out the rights of the institutions. We’ve got to lay out the rights of the patients. We should agree on who these people are. We should agree on how they’re trained.

We’ve got some work ahead of us if we’re going to have chaperones become a standard part of the medical examination.

Dr. Kaplan reported conflicts of interest with the Franklin Institute, Tengion, Biogen Idec, Johnson & Johnson, and PriCara.

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

After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. As a prerequisite for the use of the anti-CD3 antibody teplizumab, patients must undergo a general screening for type 1 diabetes. Whether this prerequisite makes sense was the subject of hot debate among experts at the Diabetes Congress in Berlin.

Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
 

Two autoantibodies

One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”

The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:

• Early stage 1: Two or more islet autoantibodies and normoglycemia.
• Early stage 2: Two or more islet autoantibodies and dysglycemia.
• Early stage 3: Symptoms, hyperglycemia, insulin therapy.

The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
 

Education and care

The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.

The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.

“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”

The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
 

Dubious benefits?

The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.

In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.

Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
 

Severe side effects

Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.

“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
 

Education reduces ketoacidosis

“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.

Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.

Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.

“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
 

New therapeutic options

Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.

For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”

This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.

After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. As a prerequisite for the use of the anti-CD3 antibody teplizumab, patients must undergo a general screening for type 1 diabetes. Whether this prerequisite makes sense was the subject of hot debate among experts at the Diabetes Congress in Berlin.

Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
 

Two autoantibodies

One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”

The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:

• Early stage 1: Two or more islet autoantibodies and normoglycemia.
• Early stage 2: Two or more islet autoantibodies and dysglycemia.
• Early stage 3: Symptoms, hyperglycemia, insulin therapy.

The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
 

Education and care

The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.

The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.

“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”

The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
 

Dubious benefits?

The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.

In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.

Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
 

Severe side effects

Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.

“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
 

Education reduces ketoacidosis

“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.

Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.

Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.

“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
 

New therapeutic options

Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.

For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”

This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.

After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. As a prerequisite for the use of the anti-CD3 antibody teplizumab, patients must undergo a general screening for type 1 diabetes. Whether this prerequisite makes sense was the subject of hot debate among experts at the Diabetes Congress in Berlin.

Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
 

Two autoantibodies

One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”

The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:

• Early stage 1: Two or more islet autoantibodies and normoglycemia.
• Early stage 2: Two or more islet autoantibodies and dysglycemia.
• Early stage 3: Symptoms, hyperglycemia, insulin therapy.

The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
 

Education and care

The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.

The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.

“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”

The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
 

Dubious benefits?

The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.

In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.

Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
 

Severe side effects

Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.

“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
 

Education reduces ketoacidosis

“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.

Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.

Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.

“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
 

New therapeutic options

Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.

For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”

This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.

Is it time to start recommending regular sauna bathing to improve heart health?

Mounting evidence shows that hitting the heated chambers can produce some of the same cardiovascular benefits as aerobic exercise. While a post-workout sauna can compound the benefits of exercise, the hormetic effects of heat therapy alone can produce significant gains for microvascular and endothelial function, no workout required.

“There’s enough evidence to say that regular sauna use improves cardiovascular health,” Matthew S. Ganio, PhD, a professor of exercise science at the University of Arkansas in Fayetteville, who studies thermoregulatory responses and cardiovascular health, said.

“The more they used it, the greater the reduction in cardiovascular events like heart attack. But you don’t need to be in there more than 20-30 minutes. That’s where it seemed to have the best effect,” Dr. Ganio said, adding that studies have shown a dose-response.

A prospective cohort study published in 2015 in JAMA Internal Medicine included 20 years of data on more than 2,300 Finnish men who regularly sauna bathed. The researchers found that among participants who sat in saunas more frequently, rates of death from heart disease and stroke were lower than among those who did so less often.
 

Cutaneous vasodilation

The body experiences several physiologic changes when exposed to heat therapy of any kind, including sauna, hot water submerging, shortwave diathermy, and heat wrapping. Many of these changes involve elements of the cardiovascular system, said Earric Lee, PhD, an exercise physiologist and postdoctoral researcher at the University of Jyväskylä in Finland, who has studied the effects of sauna on cardiovascular health.

The mechanisms by which heat therapy improves cardiovascular fitness have not been determined, as few studies of sauna bathing have been conducted to this degree. One driver appears to be cutaneous vasodilation. To cool the body when exposed to extreme external heat, cutaneous vessels dilate and push blood to the skin, which lowers body temperature, increases heart rate, and delivers oxygen to muscles in the limbs in a way similar to aerobic exercise.

Sauna bathing has similar effects on heart rate and cardiac output. Studies have shown it can improve the circulation of blood through the body, as well as vascular endothelial function, which is closely tied to vascular tone.

“Increased cardiac output is one of the physiologic reasons sauna is good for heart health,” Dr. Ganio said.

During a sauna session, cardiac output can increase by as much as 70% in relation to elevated heart rate. And while heart rate and cardiac output rise, stroke volume remains stable. As stroke volume increases, the effort that muscle must exert increases. When heart rate rises, stroke volume often falls, which subjects the heart to less of a workout and reduces the amount of oxygen and blood circulating throughout the body.

Heat therapy also temporarily increases blood pressure, but in a way similar to exercise, which supports better long-term heart health, said Christopher Minson, PhD, the Kenneth M. and Kenda H. Singer Endowed Professor of Human Physiology at the University of Oregon in Eugene.

A small study of 19 healthy adults that was published in Complementary Therapies in Medicine in 2019 found that blood pressure and heart rate rose during a 25-minute sauna session as they might during moderate exercise, equivalent to an exercise load of about 60-100 watts. These parameters then steadily decreased for 30 minutes after the sauna. An earlier study found that in the long term, blood pressure was lower after a sauna than before a sauna.
 

Upregulated heat shock proteins

Both aerobic exercise and heat stress from sauna bathing increase the activity of heat shock proteins. A 2021 review published in Experimental Gerontology found that heat shock proteins become elevated in cells within 30 minutes of exposure to heat and remain elevated over time – an effect similar to exercise.

“Saunas increase heat shock proteins that break down old, dysfunctional proteins and then protect new proteins from becoming dysfunctional,” Hunter S. Waldman, PhD, an assistant professor of exercise science at the University of North Alabama in Florence, said. This effect is one way sauna bathing may quell systemic inflammation, Dr. Waldman said.

According to a 2018 review published in BioMed Research International, an abundance of heat shock proteins may increase exercise tolerance. The researchers concluded that the positive stress associated with elevated body temperature could help people be physically active for longer periods.

Added stress, especially heat-related strain, is not good for everyone, however. Dr. Waldman cautioned that heat exposure, be it through a sauna, hot tub, or other source, can be harmful for pregnant women and children and can be dangerous for people who have low blood pressure, since blood pressure often drops to rates that are lower than before taking a sauna. It also can impair semen quality for months after exposure, so people who are trying to conceive should avoid sauna bathing.

Anyone who has been diagnosed with a heart condition, including cardiac arrhythmia, coronary artery disease, and congestive heart failure, should always consult their physician prior to using sauna for the first time or before using it habitually, Dr. Lee said.
 

Effects compounded by exercise

Dr. Minson stressed that any type of heat therapy should be part of a lifestyle that includes mostly healthy habits overall, especially a regular exercise regime when possible.

“You have to have everything else working as well: finding time to relax, not being overly stressed, staying hydrated – all those things are critical with any exercise training and heat therapy program,” he said.

Dr. Lee said it’s easy to overhype the benefits of sauna bathing and agreed the practice should be used in tandem with other therapies, not as a replacement. So far, stacking research has shown it to be an effective extension of aerobic exercise.

A June 2023 review published in Mayo Clinic Proceedings found that while sauna bathing can produce benefits on its own, a post-workout sauna can extend the benefits of exercise. As a result, the researchers concluded, saunas likely provide the most benefit when combined with aerobic and strength training.

While some of the benefits of exercise overlap those associated with sauna bathing, “you’re going to get some benefits with exercise that you’re never going to get with sauna,” Dr. Ganio said.

For instance, strength training or aerobic exercise usually results in muscle contractions, which sauna bathing does not produce.

If a person is impaired in a way that makes exercise difficult, taking a sauna after aerobic activity can extend the cardiovascular benefits of the workout, even if muscle-building does not occur, Dr. Lee said.

“All other things considered, especially with aerobic exercise, it is very comparable, so we can look at adding sauna bathing post exercise as a way to lengthen the aerobic exercise workout,” he said. “It’s not to the same degree, but you can get many of the ranging benefits of exercising simply by going into the sauna.”

The authors have disclosed no relevant financial relationships.

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

Is it time to start recommending regular sauna bathing to improve heart health?

Mounting evidence shows that hitting the heated chambers can produce some of the same cardiovascular benefits as aerobic exercise. While a post-workout sauna can compound the benefits of exercise, the hormetic effects of heat therapy alone can produce significant gains for microvascular and endothelial function, no workout required.

“There’s enough evidence to say that regular sauna use improves cardiovascular health,” Matthew S. Ganio, PhD, a professor of exercise science at the University of Arkansas in Fayetteville, who studies thermoregulatory responses and cardiovascular health, said.

“The more they used it, the greater the reduction in cardiovascular events like heart attack. But you don’t need to be in there more than 20-30 minutes. That’s where it seemed to have the best effect,” Dr. Ganio said, adding that studies have shown a dose-response.

A prospective cohort study published in 2015 in JAMA Internal Medicine included 20 years of data on more than 2,300 Finnish men who regularly sauna bathed. The researchers found that among participants who sat in saunas more frequently, rates of death from heart disease and stroke were lower than among those who did so less often.
 

Cutaneous vasodilation

The body experiences several physiologic changes when exposed to heat therapy of any kind, including sauna, hot water submerging, shortwave diathermy, and heat wrapping. Many of these changes involve elements of the cardiovascular system, said Earric Lee, PhD, an exercise physiologist and postdoctoral researcher at the University of Jyväskylä in Finland, who has studied the effects of sauna on cardiovascular health.

The mechanisms by which heat therapy improves cardiovascular fitness have not been determined, as few studies of sauna bathing have been conducted to this degree. One driver appears to be cutaneous vasodilation. To cool the body when exposed to extreme external heat, cutaneous vessels dilate and push blood to the skin, which lowers body temperature, increases heart rate, and delivers oxygen to muscles in the limbs in a way similar to aerobic exercise.

Sauna bathing has similar effects on heart rate and cardiac output. Studies have shown it can improve the circulation of blood through the body, as well as vascular endothelial function, which is closely tied to vascular tone.

“Increased cardiac output is one of the physiologic reasons sauna is good for heart health,” Dr. Ganio said.

During a sauna session, cardiac output can increase by as much as 70% in relation to elevated heart rate. And while heart rate and cardiac output rise, stroke volume remains stable. As stroke volume increases, the effort that muscle must exert increases. When heart rate rises, stroke volume often falls, which subjects the heart to less of a workout and reduces the amount of oxygen and blood circulating throughout the body.

Heat therapy also temporarily increases blood pressure, but in a way similar to exercise, which supports better long-term heart health, said Christopher Minson, PhD, the Kenneth M. and Kenda H. Singer Endowed Professor of Human Physiology at the University of Oregon in Eugene.

A small study of 19 healthy adults that was published in Complementary Therapies in Medicine in 2019 found that blood pressure and heart rate rose during a 25-minute sauna session as they might during moderate exercise, equivalent to an exercise load of about 60-100 watts. These parameters then steadily decreased for 30 minutes after the sauna. An earlier study found that in the long term, blood pressure was lower after a sauna than before a sauna.
 

Upregulated heat shock proteins

Both aerobic exercise and heat stress from sauna bathing increase the activity of heat shock proteins. A 2021 review published in Experimental Gerontology found that heat shock proteins become elevated in cells within 30 minutes of exposure to heat and remain elevated over time – an effect similar to exercise.

“Saunas increase heat shock proteins that break down old, dysfunctional proteins and then protect new proteins from becoming dysfunctional,” Hunter S. Waldman, PhD, an assistant professor of exercise science at the University of North Alabama in Florence, said. This effect is one way sauna bathing may quell systemic inflammation, Dr. Waldman said.

According to a 2018 review published in BioMed Research International, an abundance of heat shock proteins may increase exercise tolerance. The researchers concluded that the positive stress associated with elevated body temperature could help people be physically active for longer periods.

Added stress, especially heat-related strain, is not good for everyone, however. Dr. Waldman cautioned that heat exposure, be it through a sauna, hot tub, or other source, can be harmful for pregnant women and children and can be dangerous for people who have low blood pressure, since blood pressure often drops to rates that are lower than before taking a sauna. It also can impair semen quality for months after exposure, so people who are trying to conceive should avoid sauna bathing.

Anyone who has been diagnosed with a heart condition, including cardiac arrhythmia, coronary artery disease, and congestive heart failure, should always consult their physician prior to using sauna for the first time or before using it habitually, Dr. Lee said.
 

Effects compounded by exercise

Dr. Minson stressed that any type of heat therapy should be part of a lifestyle that includes mostly healthy habits overall, especially a regular exercise regime when possible.

“You have to have everything else working as well: finding time to relax, not being overly stressed, staying hydrated – all those things are critical with any exercise training and heat therapy program,” he said.

Dr. Lee said it’s easy to overhype the benefits of sauna bathing and agreed the practice should be used in tandem with other therapies, not as a replacement. So far, stacking research has shown it to be an effective extension of aerobic exercise.

A June 2023 review published in Mayo Clinic Proceedings found that while sauna bathing can produce benefits on its own, a post-workout sauna can extend the benefits of exercise. As a result, the researchers concluded, saunas likely provide the most benefit when combined with aerobic and strength training.

While some of the benefits of exercise overlap those associated with sauna bathing, “you’re going to get some benefits with exercise that you’re never going to get with sauna,” Dr. Ganio said.

For instance, strength training or aerobic exercise usually results in muscle contractions, which sauna bathing does not produce.

If a person is impaired in a way that makes exercise difficult, taking a sauna after aerobic activity can extend the cardiovascular benefits of the workout, even if muscle-building does not occur, Dr. Lee said.

“All other things considered, especially with aerobic exercise, it is very comparable, so we can look at adding sauna bathing post exercise as a way to lengthen the aerobic exercise workout,” he said. “It’s not to the same degree, but you can get many of the ranging benefits of exercising simply by going into the sauna.”

The authors have disclosed no relevant financial relationships.

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

Is it time to start recommending regular sauna bathing to improve heart health?

Mounting evidence shows that hitting the heated chambers can produce some of the same cardiovascular benefits as aerobic exercise. While a post-workout sauna can compound the benefits of exercise, the hormetic effects of heat therapy alone can produce significant gains for microvascular and endothelial function, no workout required.

“There’s enough evidence to say that regular sauna use improves cardiovascular health,” Matthew S. Ganio, PhD, a professor of exercise science at the University of Arkansas in Fayetteville, who studies thermoregulatory responses and cardiovascular health, said.

“The more they used it, the greater the reduction in cardiovascular events like heart attack. But you don’t need to be in there more than 20-30 minutes. That’s where it seemed to have the best effect,” Dr. Ganio said, adding that studies have shown a dose-response.

A prospective cohort study published in 2015 in JAMA Internal Medicine included 20 years of data on more than 2,300 Finnish men who regularly sauna bathed. The researchers found that among participants who sat in saunas more frequently, rates of death from heart disease and stroke were lower than among those who did so less often.
 

Cutaneous vasodilation

The body experiences several physiologic changes when exposed to heat therapy of any kind, including sauna, hot water submerging, shortwave diathermy, and heat wrapping. Many of these changes involve elements of the cardiovascular system, said Earric Lee, PhD, an exercise physiologist and postdoctoral researcher at the University of Jyväskylä in Finland, who has studied the effects of sauna on cardiovascular health.

The mechanisms by which heat therapy improves cardiovascular fitness have not been determined, as few studies of sauna bathing have been conducted to this degree. One driver appears to be cutaneous vasodilation. To cool the body when exposed to extreme external heat, cutaneous vessels dilate and push blood to the skin, which lowers body temperature, increases heart rate, and delivers oxygen to muscles in the limbs in a way similar to aerobic exercise.

Sauna bathing has similar effects on heart rate and cardiac output. Studies have shown it can improve the circulation of blood through the body, as well as vascular endothelial function, which is closely tied to vascular tone.

“Increased cardiac output is one of the physiologic reasons sauna is good for heart health,” Dr. Ganio said.

During a sauna session, cardiac output can increase by as much as 70% in relation to elevated heart rate. And while heart rate and cardiac output rise, stroke volume remains stable. As stroke volume increases, the effort that muscle must exert increases. When heart rate rises, stroke volume often falls, which subjects the heart to less of a workout and reduces the amount of oxygen and blood circulating throughout the body.

Heat therapy also temporarily increases blood pressure, but in a way similar to exercise, which supports better long-term heart health, said Christopher Minson, PhD, the Kenneth M. and Kenda H. Singer Endowed Professor of Human Physiology at the University of Oregon in Eugene.

A small study of 19 healthy adults that was published in Complementary Therapies in Medicine in 2019 found that blood pressure and heart rate rose during a 25-minute sauna session as they might during moderate exercise, equivalent to an exercise load of about 60-100 watts. These parameters then steadily decreased for 30 minutes after the sauna. An earlier study found that in the long term, blood pressure was lower after a sauna than before a sauna.
 

Upregulated heat shock proteins

Both aerobic exercise and heat stress from sauna bathing increase the activity of heat shock proteins. A 2021 review published in Experimental Gerontology found that heat shock proteins become elevated in cells within 30 minutes of exposure to heat and remain elevated over time – an effect similar to exercise.

“Saunas increase heat shock proteins that break down old, dysfunctional proteins and then protect new proteins from becoming dysfunctional,” Hunter S. Waldman, PhD, an assistant professor of exercise science at the University of North Alabama in Florence, said. This effect is one way sauna bathing may quell systemic inflammation, Dr. Waldman said.

According to a 2018 review published in BioMed Research International, an abundance of heat shock proteins may increase exercise tolerance. The researchers concluded that the positive stress associated with elevated body temperature could help people be physically active for longer periods.

Added stress, especially heat-related strain, is not good for everyone, however. Dr. Waldman cautioned that heat exposure, be it through a sauna, hot tub, or other source, can be harmful for pregnant women and children and can be dangerous for people who have low blood pressure, since blood pressure often drops to rates that are lower than before taking a sauna. It also can impair semen quality for months after exposure, so people who are trying to conceive should avoid sauna bathing.

Anyone who has been diagnosed with a heart condition, including cardiac arrhythmia, coronary artery disease, and congestive heart failure, should always consult their physician prior to using sauna for the first time or before using it habitually, Dr. Lee said.
 

Effects compounded by exercise

Dr. Minson stressed that any type of heat therapy should be part of a lifestyle that includes mostly healthy habits overall, especially a regular exercise regime when possible.

“You have to have everything else working as well: finding time to relax, not being overly stressed, staying hydrated – all those things are critical with any exercise training and heat therapy program,” he said.

Dr. Lee said it’s easy to overhype the benefits of sauna bathing and agreed the practice should be used in tandem with other therapies, not as a replacement. So far, stacking research has shown it to be an effective extension of aerobic exercise.

A June 2023 review published in Mayo Clinic Proceedings found that while sauna bathing can produce benefits on its own, a post-workout sauna can extend the benefits of exercise. As a result, the researchers concluded, saunas likely provide the most benefit when combined with aerobic and strength training.

While some of the benefits of exercise overlap those associated with sauna bathing, “you’re going to get some benefits with exercise that you’re never going to get with sauna,” Dr. Ganio said.

For instance, strength training or aerobic exercise usually results in muscle contractions, which sauna bathing does not produce.

If a person is impaired in a way that makes exercise difficult, taking a sauna after aerobic activity can extend the cardiovascular benefits of the workout, even if muscle-building does not occur, Dr. Lee said.

“All other things considered, especially with aerobic exercise, it is very comparable, so we can look at adding sauna bathing post exercise as a way to lengthen the aerobic exercise workout,” he said. “It’s not to the same degree, but you can get many of the ranging benefits of exercising simply by going into the sauna.”

The authors have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved empagliflozin (Jardiance, Boehringer Ingelheim) and empagliflozin combined with metformin (Synjardy, BI) for the treatment of type 2 diabetes in children aged 10 years and older.

This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.

Olivier Le Moal/Getty Images

Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).

Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.

“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
 

Type 2 diabetes rising exponentially in children, mainly non-Whites

Type 2 diabetes is rising exponentially in children and adolescents in the United States.

Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and  it continues to rise.

A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.

Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.

At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.

Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.

Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).

“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.

“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.

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

The Food and Drug Administration has approved empagliflozin (Jardiance, Boehringer Ingelheim) and empagliflozin combined with metformin (Synjardy, BI) for the treatment of type 2 diabetes in children aged 10 years and older.

This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.

Olivier Le Moal/Getty Images

Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).

Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.

“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
 

Type 2 diabetes rising exponentially in children, mainly non-Whites

Type 2 diabetes is rising exponentially in children and adolescents in the United States.

Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and  it continues to rise.

A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.

Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.

At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.

Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.

Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).

“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.

“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.

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

The Food and Drug Administration has approved empagliflozin (Jardiance, Boehringer Ingelheim) and empagliflozin combined with metformin (Synjardy, BI) for the treatment of type 2 diabetes in children aged 10 years and older.

This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.

Olivier Le Moal/Getty Images

Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).

Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.

“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
 

Type 2 diabetes rising exponentially in children, mainly non-Whites

Type 2 diabetes is rising exponentially in children and adolescents in the United States.

Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and  it continues to rise.

A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.

Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.

At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.

Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.

Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).

“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.

“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.

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

While increases in colorectal cancer screening have been linked to drops in disease incidence, marginalized racial and ethnic populations in the United States continue to see lower screening rates along with higher disease incidence and mortality. Disparities in colorectal screening represent a serious public health challenge, say the authors of a new literature review that describes specific areas of concern and recommendations for improvement.

For their research, published in Techniques and Innovations in Gastrointestinal Endoscopy, gastroenterologists Abraham Segura, MD, and Shazia Mehmood Siddique, MD, of the University of Pennsylvania, Philadelphia, sought to identify studies that shed light on ethnicity or race-based differences in screening uptake, as well as known barriers and facilitators to screening.

Significant racial and ethnic disparities can be seen in rates of colonoscopy selection as a screening method, and of screening completion, Dr. Segura and Dr. Siddique noted, with White individuals who chose the method three times more likely to complete screening as Asian, Hispanic, or Black individuals. Disparities were also seen reflected in people’s choice of screening method, with non–English-speaking Hispanic individuals less likely to choose colonoscopy compared with other groups.

Use of stool-based screening methods, such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), has risen over time across ethnic and racial groups. However, Hispanic and Asian individuals were more likely to complete and adhere to the FOBT, compared with non-Hispanic White individuals. Follow-up colonoscopy rates after FOBT or FIT also differ along ethnic and racial lines, Dr. Segura and Dr. Siddique noted, with Asian and American Indian groups less likely to complete follow-up after an abnormal result.

The study authors pointed to structural racism at the root of some observed disparities, citing barriers to healthcare access and quality that include higher rates of noninsurance among Black and Hispanic populations and a lower likelihood of the same populations to receive physician counseling regarding screening.

Barriers to economic stability, including living in impoverished neighborhoods, were also cited as contributors to lower colorectal screening. Patients covered by Medicaid were more than twice as likely as non-Medicaid patients to have suboptimal bowel preparation at screening, the authors noted. Access to transportation remained another frequently observed barrier to completing recommended testing and follow-up.

Mistrust of doctors has been linked to lower screening uptake among Black men. “Longstanding conscious and implicit racism, differences in communication, and socioeconomic context ... engender medical mistrust among racial and ethnic groups,” the authors wrote. Reversing it “ultimately requires vast societal change, and we as physicians can facilitate this by encouraging patient-centered discussions that humanize and empower traditionally marginalized populations.”

Dr. Segura and Dr. Siddique described strategies that have been shown to result in better uptake in specific populations, including removing out-of-pocket costs for screening and follow-up, and designing faith-based or culturally specific outreach delivered through churches and local businesses.

They recommended that researchers change how they study the disparities that bear on colorectal screening and outcomes. “Collection and use of data on race and ethnicity must be optimized and standardized to ensure that all groups are adequately captured,” they wrote. Standardizing self-reporting of race and ethnicity would help address issues of misclassification.

The authors also advised designing studies with longer follow-up, noting that “we must better understand the mechanisms of long-term adherence.” Additional research is needed, they said, to evaluate the efficacy of older outreach strategies after societal changes resulting from the COVID-19 pandemic. Efforts to increase the number of Black, Hispanic, Asian, and Alaskan Native/American Indian groups in CRC screening interventions and studies “must be prioritized.”

Dr. Segura’s and Dr. Siddique’s study was funded with grants from the National Institutes of Health. They disclosed no conflicts of interest.
 

While increases in colorectal cancer screening have been linked to drops in disease incidence, marginalized racial and ethnic populations in the United States continue to see lower screening rates along with higher disease incidence and mortality. Disparities in colorectal screening represent a serious public health challenge, say the authors of a new literature review that describes specific areas of concern and recommendations for improvement.

For their research, published in Techniques and Innovations in Gastrointestinal Endoscopy, gastroenterologists Abraham Segura, MD, and Shazia Mehmood Siddique, MD, of the University of Pennsylvania, Philadelphia, sought to identify studies that shed light on ethnicity or race-based differences in screening uptake, as well as known barriers and facilitators to screening.

Significant racial and ethnic disparities can be seen in rates of colonoscopy selection as a screening method, and of screening completion, Dr. Segura and Dr. Siddique noted, with White individuals who chose the method three times more likely to complete screening as Asian, Hispanic, or Black individuals. Disparities were also seen reflected in people’s choice of screening method, with non–English-speaking Hispanic individuals less likely to choose colonoscopy compared with other groups.

Use of stool-based screening methods, such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), has risen over time across ethnic and racial groups. However, Hispanic and Asian individuals were more likely to complete and adhere to the FOBT, compared with non-Hispanic White individuals. Follow-up colonoscopy rates after FOBT or FIT also differ along ethnic and racial lines, Dr. Segura and Dr. Siddique noted, with Asian and American Indian groups less likely to complete follow-up after an abnormal result.

The study authors pointed to structural racism at the root of some observed disparities, citing barriers to healthcare access and quality that include higher rates of noninsurance among Black and Hispanic populations and a lower likelihood of the same populations to receive physician counseling regarding screening.

Barriers to economic stability, including living in impoverished neighborhoods, were also cited as contributors to lower colorectal screening. Patients covered by Medicaid were more than twice as likely as non-Medicaid patients to have suboptimal bowel preparation at screening, the authors noted. Access to transportation remained another frequently observed barrier to completing recommended testing and follow-up.

Mistrust of doctors has been linked to lower screening uptake among Black men. “Longstanding conscious and implicit racism, differences in communication, and socioeconomic context ... engender medical mistrust among racial and ethnic groups,” the authors wrote. Reversing it “ultimately requires vast societal change, and we as physicians can facilitate this by encouraging patient-centered discussions that humanize and empower traditionally marginalized populations.”

Dr. Segura and Dr. Siddique described strategies that have been shown to result in better uptake in specific populations, including removing out-of-pocket costs for screening and follow-up, and designing faith-based or culturally specific outreach delivered through churches and local businesses.

They recommended that researchers change how they study the disparities that bear on colorectal screening and outcomes. “Collection and use of data on race and ethnicity must be optimized and standardized to ensure that all groups are adequately captured,” they wrote. Standardizing self-reporting of race and ethnicity would help address issues of misclassification.

The authors also advised designing studies with longer follow-up, noting that “we must better understand the mechanisms of long-term adherence.” Additional research is needed, they said, to evaluate the efficacy of older outreach strategies after societal changes resulting from the COVID-19 pandemic. Efforts to increase the number of Black, Hispanic, Asian, and Alaskan Native/American Indian groups in CRC screening interventions and studies “must be prioritized.”

Dr. Segura’s and Dr. Siddique’s study was funded with grants from the National Institutes of Health. They disclosed no conflicts of interest.
 

While increases in colorectal cancer screening have been linked to drops in disease incidence, marginalized racial and ethnic populations in the United States continue to see lower screening rates along with higher disease incidence and mortality. Disparities in colorectal screening represent a serious public health challenge, say the authors of a new literature review that describes specific areas of concern and recommendations for improvement.

For their research, published in Techniques and Innovations in Gastrointestinal Endoscopy, gastroenterologists Abraham Segura, MD, and Shazia Mehmood Siddique, MD, of the University of Pennsylvania, Philadelphia, sought to identify studies that shed light on ethnicity or race-based differences in screening uptake, as well as known barriers and facilitators to screening.

Significant racial and ethnic disparities can be seen in rates of colonoscopy selection as a screening method, and of screening completion, Dr. Segura and Dr. Siddique noted, with White individuals who chose the method three times more likely to complete screening as Asian, Hispanic, or Black individuals. Disparities were also seen reflected in people’s choice of screening method, with non–English-speaking Hispanic individuals less likely to choose colonoscopy compared with other groups.

Use of stool-based screening methods, such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), has risen over time across ethnic and racial groups. However, Hispanic and Asian individuals were more likely to complete and adhere to the FOBT, compared with non-Hispanic White individuals. Follow-up colonoscopy rates after FOBT or FIT also differ along ethnic and racial lines, Dr. Segura and Dr. Siddique noted, with Asian and American Indian groups less likely to complete follow-up after an abnormal result.

The study authors pointed to structural racism at the root of some observed disparities, citing barriers to healthcare access and quality that include higher rates of noninsurance among Black and Hispanic populations and a lower likelihood of the same populations to receive physician counseling regarding screening.

Barriers to economic stability, including living in impoverished neighborhoods, were also cited as contributors to lower colorectal screening. Patients covered by Medicaid were more than twice as likely as non-Medicaid patients to have suboptimal bowel preparation at screening, the authors noted. Access to transportation remained another frequently observed barrier to completing recommended testing and follow-up.

Mistrust of doctors has been linked to lower screening uptake among Black men. “Longstanding conscious and implicit racism, differences in communication, and socioeconomic context ... engender medical mistrust among racial and ethnic groups,” the authors wrote. Reversing it “ultimately requires vast societal change, and we as physicians can facilitate this by encouraging patient-centered discussions that humanize and empower traditionally marginalized populations.”

Dr. Segura and Dr. Siddique described strategies that have been shown to result in better uptake in specific populations, including removing out-of-pocket costs for screening and follow-up, and designing faith-based or culturally specific outreach delivered through churches and local businesses.

They recommended that researchers change how they study the disparities that bear on colorectal screening and outcomes. “Collection and use of data on race and ethnicity must be optimized and standardized to ensure that all groups are adequately captured,” they wrote. Standardizing self-reporting of race and ethnicity would help address issues of misclassification.

The authors also advised designing studies with longer follow-up, noting that “we must better understand the mechanisms of long-term adherence.” Additional research is needed, they said, to evaluate the efficacy of older outreach strategies after societal changes resulting from the COVID-19 pandemic. Efforts to increase the number of Black, Hispanic, Asian, and Alaskan Native/American Indian groups in CRC screening interventions and studies “must be prioritized.”

Dr. Segura’s and Dr. Siddique’s study was funded with grants from the National Institutes of Health. They disclosed no conflicts of interest.
 

Warts in children with cancer who are undergoing active treatment are particularly difficult to eradicate, new findings show.

Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.

In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.

David Carillet/Dreamstime

“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.

In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.

Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.

The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.

Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.

The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.

The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.

Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.

The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”

Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.

The authors declared no conflict of interest. No outside funding source was listed.

Warts in children with cancer who are undergoing active treatment are particularly difficult to eradicate, new findings show.

Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.

In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.

David Carillet/Dreamstime

“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.

In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.

Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.

The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.

Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.

The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.

The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.

Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.

The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”

Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.

The authors declared no conflict of interest. No outside funding source was listed.

Warts in children with cancer who are undergoing active treatment are particularly difficult to eradicate, new findings show.

Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.

In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.

David Carillet/Dreamstime

“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.

In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.

Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.

The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.

Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.

The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.

The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.

Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.

The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”

Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.

The authors declared no conflict of interest. No outside funding source was listed.