Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent. As one respondent said in a recent Medscape PA Burnout report, there are expectations for PAs to see the same complexity and quantity of patients as physician providers with less support, little oversight, less respect, and less pay.

Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.

“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”

Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.

He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.

“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
 

See How Other PAs Are Managing

Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.

“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”

Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms^® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.

“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
 

Speak Up

Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.

“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”

None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.

“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
 

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

Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent. As one respondent said in a recent Medscape PA Burnout report, there are expectations for PAs to see the same complexity and quantity of patients as physician providers with less support, little oversight, less respect, and less pay.

Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.

“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”

Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.

He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.

“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
 

See How Other PAs Are Managing

Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.

“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”

Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms^® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.

“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
 

Speak Up

Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.

“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”

None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.

“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
 

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

Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent. As one respondent said in a recent Medscape PA Burnout report, there are expectations for PAs to see the same complexity and quantity of patients as physician providers with less support, little oversight, less respect, and less pay.

Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.

“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”

Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.

He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.

“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
 

See How Other PAs Are Managing

Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.

“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”

Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms^® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.

“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
 

Speak Up

Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.

“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”

None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.

“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
 

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

Nearly one-third of US adults may have low iron levels that can add to problems ranging from fatigue to heart failure. 

Researchers in a new study estimated that 7% of US adults have anemia, a blood disorder that can be iron related and is particularly well-known in part because of screenings given during pregnancy. But more striking was the finding in this latest study that a significant portion of the population may have less severe iron deficiencies that have been linked to serious health problems.

The body gets iron from food, and it can store iron for times when there isn’t enough it can access right away. The research team looked at test results that show whether people have enough iron stored, as well as whether their bodies could effectively use available iron. If you don’t have enough iron stored, you have a condition called absolute iron deficiency. And if you have stored iron but problems using it, you have what’s called functional iron deficiency. The study found that an estimated 14% of adults have absolute iron deficiency, and another 15% have functional iron deficiency.

The findings, published in JAMA Network Open, are based on data from more than 8,000 people who had laboratory iron levels on file as part of the National Health and Nutrition Examination Survey that was done from 2017 to 2020.

Besides anemia, iron deficiency is linked to other serious health problems, including restless legs syndrome, mental and thinking difficulties, reduced physical abilities, and heart failure, the authors noted. The effects of iron deficiency can significantly impact a person’s quality of life.

Routine blood work as part of an annual physical doesn’t typically include a check of iron levels unless there is a cause for concern. The out-of-pocket cost without using insurance for a blood test to check iron levels is typically around $60. 

“This is a common yet underappreciated public health problem,” study author Leo Buckley, PharmD, MPH, a clinical pharmacology specialist at Brigham and Women’s Hospital in Boston, Massachusetts, told NBC News. “What’s unique about our study is we were looking at regular people who would not otherwise have been screened or tested.”

Treatment for low iron levels can include changes to your diet, as well as intravenous or oral supplements. Taking an iron supplement should be done under the guidance of a health care provider because of the risk of iron toxicity.

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

Nearly one-third of US adults may have low iron levels that can add to problems ranging from fatigue to heart failure. 

Researchers in a new study estimated that 7% of US adults have anemia, a blood disorder that can be iron related and is particularly well-known in part because of screenings given during pregnancy. But more striking was the finding in this latest study that a significant portion of the population may have less severe iron deficiencies that have been linked to serious health problems.

The body gets iron from food, and it can store iron for times when there isn’t enough it can access right away. The research team looked at test results that show whether people have enough iron stored, as well as whether their bodies could effectively use available iron. If you don’t have enough iron stored, you have a condition called absolute iron deficiency. And if you have stored iron but problems using it, you have what’s called functional iron deficiency. The study found that an estimated 14% of adults have absolute iron deficiency, and another 15% have functional iron deficiency.

The findings, published in JAMA Network Open, are based on data from more than 8,000 people who had laboratory iron levels on file as part of the National Health and Nutrition Examination Survey that was done from 2017 to 2020.

Besides anemia, iron deficiency is linked to other serious health problems, including restless legs syndrome, mental and thinking difficulties, reduced physical abilities, and heart failure, the authors noted. The effects of iron deficiency can significantly impact a person’s quality of life.

Routine blood work as part of an annual physical doesn’t typically include a check of iron levels unless there is a cause for concern. The out-of-pocket cost without using insurance for a blood test to check iron levels is typically around $60. 

“This is a common yet underappreciated public health problem,” study author Leo Buckley, PharmD, MPH, a clinical pharmacology specialist at Brigham and Women’s Hospital in Boston, Massachusetts, told NBC News. “What’s unique about our study is we were looking at regular people who would not otherwise have been screened or tested.”

Treatment for low iron levels can include changes to your diet, as well as intravenous or oral supplements. Taking an iron supplement should be done under the guidance of a health care provider because of the risk of iron toxicity.

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

Nearly one-third of US adults may have low iron levels that can add to problems ranging from fatigue to heart failure. 

Researchers in a new study estimated that 7% of US adults have anemia, a blood disorder that can be iron related and is particularly well-known in part because of screenings given during pregnancy. But more striking was the finding in this latest study that a significant portion of the population may have less severe iron deficiencies that have been linked to serious health problems.

The body gets iron from food, and it can store iron for times when there isn’t enough it can access right away. The research team looked at test results that show whether people have enough iron stored, as well as whether their bodies could effectively use available iron. If you don’t have enough iron stored, you have a condition called absolute iron deficiency. And if you have stored iron but problems using it, you have what’s called functional iron deficiency. The study found that an estimated 14% of adults have absolute iron deficiency, and another 15% have functional iron deficiency.

The findings, published in JAMA Network Open, are based on data from more than 8,000 people who had laboratory iron levels on file as part of the National Health and Nutrition Examination Survey that was done from 2017 to 2020.

Besides anemia, iron deficiency is linked to other serious health problems, including restless legs syndrome, mental and thinking difficulties, reduced physical abilities, and heart failure, the authors noted. The effects of iron deficiency can significantly impact a person’s quality of life.

Routine blood work as part of an annual physical doesn’t typically include a check of iron levels unless there is a cause for concern. The out-of-pocket cost without using insurance for a blood test to check iron levels is typically around $60. 

“This is a common yet underappreciated public health problem,” study author Leo Buckley, PharmD, MPH, a clinical pharmacology specialist at Brigham and Women’s Hospital in Boston, Massachusetts, told NBC News. “What’s unique about our study is we were looking at regular people who would not otherwise have been screened or tested.”

Treatment for low iron levels can include changes to your diet, as well as intravenous or oral supplements. Taking an iron supplement should be done under the guidance of a health care provider because of the risk of iron toxicity.

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

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

• Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
• Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
• SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
• The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
• Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

• Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
• The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
• Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
• Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

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

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

• Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
• Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
• SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
• The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
• Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

• Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
• The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
• Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
• Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

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

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

• Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
• Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
• SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
• The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
• Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

• Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
• The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
• Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
• Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

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

MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.

At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.

Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.

One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”

Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
 

The ‘Alarming’ Finding of CAD in Asymptomatic Patients

Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L. 

All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.

Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.

Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.

Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm², a lipid arch > 180 degrees, and macrophages. 

“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.

He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk. 

Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
 

Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D

Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.

Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages. 

Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.

Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.

Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).

“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
 

BMI: Often Overlooked in T1D, but a Major CVD Risk Factor

Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.

Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women. 

However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.

The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.

After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively. 

MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33. 

“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded. 
 

Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk

Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.

Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported. 

“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.

Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
 

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

MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.

At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.

Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.

One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”

Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
 

The ‘Alarming’ Finding of CAD in Asymptomatic Patients

Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L. 

All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.

Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.

Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.

Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm², a lipid arch > 180 degrees, and macrophages. 

“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.

He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk. 

Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
 

Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D

Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.

Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages. 

Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.

Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.

Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).

“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
 

BMI: Often Overlooked in T1D, but a Major CVD Risk Factor

Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.

Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women. 

However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.

The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.

After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively. 

MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33. 

“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded. 
 

Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk

Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.

Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported. 

“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.

Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
 

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

MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.

At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.

Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.

One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”

Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
 

The ‘Alarming’ Finding of CAD in Asymptomatic Patients

Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L. 

All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.

Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.

Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.

Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm², a lipid arch > 180 degrees, and macrophages. 

“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.

He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk. 

Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
 

Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D

Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.

Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages. 

Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.

Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.

Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).

“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
 

BMI: Often Overlooked in T1D, but a Major CVD Risk Factor

Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.

Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women. 

However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.

The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.

After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively. 

MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33. 

“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded. 
 

Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk

Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.

Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported. 

“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.

Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
 

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

AMSTERDAM — There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with data from more than 30,000 individuals showed that adults whose AD started in childhood carry a far greater psychological and social burden throughout their life relative to AD starting after childhood.

These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.

Dr. Silverberg

One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
 

More Than 30,000 From Five Continents Participated

In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.

The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.

In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.

Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.

For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
 

AD From Childhood Consistently Results in Worse Outcomes

Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).

Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.

He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.

Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.

For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.

“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.

What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
 

Data Provide Evidence of Systemic Therapy in Kids

For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.

“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”

In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.

Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.

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

AMSTERDAM — There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with data from more than 30,000 individuals showed that adults whose AD started in childhood carry a far greater psychological and social burden throughout their life relative to AD starting after childhood.

These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.

Dr. Silverberg

One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
 

More Than 30,000 From Five Continents Participated

In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.

The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.

In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.

Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.

For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
 

AD From Childhood Consistently Results in Worse Outcomes

Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).

Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.

He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.

Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.

For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.

“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.

What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
 

Data Provide Evidence of Systemic Therapy in Kids

For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.

“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”

In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.

Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.

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

AMSTERDAM — There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with data from more than 30,000 individuals showed that adults whose AD started in childhood carry a far greater psychological and social burden throughout their life relative to AD starting after childhood.

These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.

Dr. Silverberg

One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
 

More Than 30,000 From Five Continents Participated

In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.

The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.

In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.

Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.

For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
 

AD From Childhood Consistently Results in Worse Outcomes

Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).

Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.

He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.

Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.

For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.

“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.

What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
 

Data Provide Evidence of Systemic Therapy in Kids

For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.

“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”

In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.

Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.

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

BARCELONA, SPAIN — Not all patients with colorectal cancer are the same, and more research is needed to examine differences between patients according to their sex, gender, and even menopause status, according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.

“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
 

Sex and Gender: What’s New? 

Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”

Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.

Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.

From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.

However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.

Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.

“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
 

Toward a More Targeted and Inclusive Approach

Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.

“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.

In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.

Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.

To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.

“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.

“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”

Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.

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

BARCELONA, SPAIN — Not all patients with colorectal cancer are the same, and more research is needed to examine differences between patients according to their sex, gender, and even menopause status, according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.

“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
 

Sex and Gender: What’s New? 

Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”

Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.

Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.

From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.

However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.

Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.

“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
 

Toward a More Targeted and Inclusive Approach

Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.

“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.

In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.

Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.

To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.

“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.

“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”

Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.

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

BARCELONA, SPAIN — Not all patients with colorectal cancer are the same, and more research is needed to examine differences between patients according to their sex, gender, and even menopause status, according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.

“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
 

Sex and Gender: What’s New? 

Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”

Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.

Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.

From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.

However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.

Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.

“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
 

Toward a More Targeted and Inclusive Approach

Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.

“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.

In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.

Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.

To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.

“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.

“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”

Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.

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

Guinea pigs are important to Ohio State University leukemia specialist Kerry A. Rogers, MD, but not because they’re in her research laboratory, where the focus is on studying treatments for chronic lymphocytic leukemia (CLL), hairy cell leukemia, and autoimmune hemolytic anemia. Instead, two of these little creatures — Pancake and Maple — are pets who live with her at home. 

Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.

courtesy Ohio State University

“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”

For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.

The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”

In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty. 

How did you get drawn to medicine?

Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling. 

The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them. 

What changes have you seen in leukemia care during your career?

The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects. 

Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”

What are you most excited about working on? 

I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t. 

The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t. 

What are some challenges that remain in CLL?

There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.

I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing. 

We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half. 

It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs. 

You also specialize in hairy cell leukemia. Could you talk about what it is? 

CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.

It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan. 

But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan. 

What are some challenges in hairy cell leukemia?

It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.

Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it. 

I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State? 

I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern! 

And I understand that you live with a pair of guinea pigs. Do tell.

I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home. 

Courtesy Dr. Rogers

Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground. 

I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”

Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences. 

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

Guinea pigs are important to Ohio State University leukemia specialist Kerry A. Rogers, MD, but not because they’re in her research laboratory, where the focus is on studying treatments for chronic lymphocytic leukemia (CLL), hairy cell leukemia, and autoimmune hemolytic anemia. Instead, two of these little creatures — Pancake and Maple — are pets who live with her at home. 

Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.

courtesy Ohio State University

“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”

For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.

The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”

In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty. 

How did you get drawn to medicine?

Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling. 

The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them. 

What changes have you seen in leukemia care during your career?

The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects. 

Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”

What are you most excited about working on? 

I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t. 

The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t. 

What are some challenges that remain in CLL?

There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.

I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing. 

We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half. 

It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs. 

You also specialize in hairy cell leukemia. Could you talk about what it is? 

CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.

It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan. 

But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan. 

What are some challenges in hairy cell leukemia?

It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.

Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it. 

I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State? 

I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern! 

And I understand that you live with a pair of guinea pigs. Do tell.

I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home. 

Courtesy Dr. Rogers

Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground. 

I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”

Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences. 

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

Guinea pigs are important to Ohio State University leukemia specialist Kerry A. Rogers, MD, but not because they’re in her research laboratory, where the focus is on studying treatments for chronic lymphocytic leukemia (CLL), hairy cell leukemia, and autoimmune hemolytic anemia. Instead, two of these little creatures — Pancake and Maple — are pets who live with her at home. 

Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.

courtesy Ohio State University

“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”

For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.

The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”

In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty. 

How did you get drawn to medicine?

Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling. 

The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them. 

What changes have you seen in leukemia care during your career?

The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects. 

Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”

What are you most excited about working on? 

I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t. 

The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t. 

What are some challenges that remain in CLL?

There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.

I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing. 

We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half. 

It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs. 

You also specialize in hairy cell leukemia. Could you talk about what it is? 

CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.

It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan. 

But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan. 

What are some challenges in hairy cell leukemia?

It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.

Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it. 

I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State? 

I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern! 

And I understand that you live with a pair of guinea pigs. Do tell.

I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home. 

Courtesy Dr. Rogers

Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground. 

I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”

Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences. 

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

Nasal Staphylococcus aureus (SA) carriage is associated with SA surgical site and bloodstream infections following a surgical procedure, according to findings from a new prospective, multicenter clinical study published in the August issue of Open Forum Infectious Diseases.

“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.

The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.

There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.

Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).

A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.

The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.

However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.

He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”

The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.

The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.

She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.

Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.

The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.

Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.

Nasal Staphylococcus aureus (SA) carriage is associated with SA surgical site and bloodstream infections following a surgical procedure, according to findings from a new prospective, multicenter clinical study published in the August issue of Open Forum Infectious Diseases.

“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.

The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.

There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.

Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).

A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.

The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.

However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.

He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”

The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.

The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.

She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.

Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.

The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.

Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.

Nasal Staphylococcus aureus (SA) carriage is associated with SA surgical site and bloodstream infections following a surgical procedure, according to findings from a new prospective, multicenter clinical study published in the August issue of Open Forum Infectious Diseases.

“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.

The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.

There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.

Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).

A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.

The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.

However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.

He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”

The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.

The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.

She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.

Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.

The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.

Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.

Meet your new patients.

You can’t see them, but trillions — maybe quadrillions — of them travel in and out of your practice every day. They’re hungry, mysterious, community-oriented, and small. Very, very small.

They’re the microbes occupying your current patients’ guts.

Someday soon, you’ll prescribe medicine not just for humans but also for these microbes.

“I am convinced in the future our medicine cabinets are going to have not just medications like a statin for treating us, but [also] pills that treat and inhibit an enzyme in our microbes and elicit a health benefit in some chronic disease,” said Stanley Hazen, MD, PhD, co-section head of Preventive Cardiology & Rehabilitation and director of the Center for Microbiome & Human Health at Cleveland Clinic, Cleveland, Ohio.

Evidence is mounting that the gut microbiome influences just about every major human disease. These trillions of microbes use our food to generate substances called metabolites that can protect or harm our health, with consequences reaching far beyond our gastrointestinal tracts.

Research has linked microbial metabolites to diabetes, cardiovascular disease, liver disease, obesity, high blood pressure, neurological disorders, depression, cancer, and more. Gastroenterologist Christopher Damman, MD, a clinical associate professor at the University of Washington Medical Center, Seattle, calls it a “growing theme” in microbiome science.

Now scientists are developing treatments targeting gut microbial pathways, designed to eliminate the bad metabolites and boost the good metabolites.

One close to human therapeutic intervention is an oral treatment from Dr. Hazen’s lab targeting the metabolite trimethylamine N-oxide (TMAO), a predictor of and contributor to both cardiovascular disease and chronic kidney disease. The drug, which blocks TMAO formation, is nearing clinical trials, Dr. Hazen said.

The advantage is safety. By targeting the microbe instead of, say, an enzyme, the host (your patient) must absorb little if any drug.

Implications for the future of medicine are huge. “Gut microbial pathways contribute to diabetes, obesity, virtually everything,” Dr. Hazen said. “Therapies that target gut microbiome processes will probably even be used for psychiatric disorders within, I’ll say, 10 or 20 years.”
 

The Science

About 100 trillion strains of bacteria live in our guts. As humans have evolved, so have they.

Between 70% and 90% come from the phyla Firmicutes and Bacteroidetes, with person-to-person variation shaped by genetics, environment, and lifestyle.

“Everyone’s microbiome is subtly different,” said Dr. Hazen. “So the combination of what they’re making is different. All these different biologically active compounds are influencing us in subtly different ways.”

How it works: When you eat, your microbes eat, breaking down food into metabolites that interact with the thin layer of epithelial cells lining your gut. Some can be absorbed through the lining and into your bloodstream, a phenomenon known as “leaky gut.” Once in your blood, they can trigger irritation and inflammation, potentially leading to a wide variety of health issues, from gas and bloating to autoimmune conditions and mood disorders.

“On the other side of the epithelial lining, you have some of the largest concentrations of immune cells,” said Narendra Kumar, PhD, associate professor of pharmaceutical sciences at Texas A&M University, College Station, Texas.

Metabolites can influence how these immune cells work, possibly explaining why each person’s immune system behaves distinctively.

Of the 1000-plus metabolites linked to the gut microbiome, scientists have identified several that matter.

Short-chain fatty acids. When we eat fiber, colon bacteria ferment it into the beneficial short-chain fatty acids acetate, propionate, and butyrate. These bind to receptors in muscle, liver, and fat tissue, affecting the secretion of gut hormones and peptides related to appetite, inflammation, energy expenditure, and fat oxidation.

Butyrate has been linked to health benefits. It supports the integrity of the gut’s lining, stifling pathogenic gut bacteria, fighting cancer-promoting inflammation, and protecting against obesity and diabetes. It can function as a prebiotic, helping beneficial bacteria thrive. And recent studies linked an abundance of butyrate-producing bacteria with reduced bone fracture risk and hospitalization for infectious disease.

TMAO and phenylacetylglutamine. When we eat foods rich in animal proteins — think eggs, milk, fish, and especially red meat — some gut bacteria convert nutrients like choline and L-carnitine into TMAO and phenylalanine into phenylacetylglutamine. Research conducted by Dr. Hazen’s lab and replicated by others has linked both metabolites to heart problems.

In a landmark study from Dr. Hazen’s group, healthy adults who went on to develop coronary artery disease had significantly higher plasma TMAO levels than those who did not wind up with the condition. The association remained strong, even after controlling for risk factors like age, sex, smoking, high blood pressure, and high cholesterol.

In preclinical studies, elevated TMAO enhanced cardiovascular disease. TMAO-producing microbes also accentuated cardiovascular disease phenotypes in mouse models, while blocking these pathways inhibited the phenotypes.

Research suggests TMAO may harm cardiomyocytes (cells that contract and relax the heart) in dozens of ways, such as activating the expression of proteins to promote hypertrophy and fibrosis, decreasing mitochondrial function, and disrupting calcium signaling.

Another study linked phenylacetylglutamine levels to cardiac event risk in patients with heart failure. Recent mechanistic investigations suggest the metabolite alters signaling in a beta-adrenergic receptor involved in our fight-or-flight response, said Hazen.

“It’s like a rheostat on the light switch, a dimmer switch, and it’s what’s called a negative allosteric modulator,” he said. “It’s the first time that this type of behavior has ever been shown to be present for a gut microbial metabolite and a host receptor.”

Tryptophan metabolites. Microbes in your colon can convert the amino acid tryptophan, also found in animal-based foods, into neurotransmitters like serotonin and melatonin.

“The enteric nervous system, the nervous system around the gut, is immense,” said James Versalovic, MD, PhD, professor of pathology and immunology at Baylor College of Medicine, Houston. “The gut-brain axis has become a very fertile area of research.”

Lesser-known tryptophan metabolites — like indole, tryptamine, and indoleethanol — have been linked to benefits like fortifying the gut barrier, promoting the release of glucagon-like peptide 1 to reduce appetite, and protecting the liver from hepatitis. However, indole can also spur the production of indoxyl sulfate, a toxin linked to chronic kidney disease. 

Bile acid byproducts. Your gut bugs also feast on (and transform) bile acids before they reabsorb and travel back to the liver.

Research is gaining traction on these secondary bile acids, which can affect inflammation and immune function in helpful and harmful ways.

One area of interest is how microbes break down hormones in bile. A recent study from Harvard showed that gut microbes convert corticoid hormones in bile into progestins, which could affect postpartum depression risk. And researchers are exploring the estrobolome — a gut microbial community dedicated to breaking down estrogen into its active form so it can be reabsorbed.

“Depending on the bacteria that you have, more or less can be recirculated back into your blood,” said Beatriz Peñalver Bernabé, PhD, an assistant professor of biomedical engineering and urology at the University of Illinois Chicago. “So you may be producing the same amount of estrogen, but depending on the bacteria you have, the real free estrogen that can bind to your cells may be very different.”

The gut microbiome can also regulate testosterone, with studies showing microbial differences in men with high testosterone vs those with less.
 

What Patients Can Do Now

Advances in the field of microbiome research — and the related “gut health” wellness craze — have spawned all kinds of new microbiome-based products: Like over-the-counter probiotic supplements and at-home test kits, which let you send a stool sample for analysis to reveal microbiome health and personalized diet recommendations.

But the science behind these tests is still evolving, said Dr. Damman. “The clinical inferences and applications are still pretty limited.”

For most people, the first step to fostering healthier microbial metabolites is much simpler: Diversify your diet.

“A lot of folks are missing that diversity,” Dr. Damman said.

“Eat foods and experiment with foods that you might not eat all the time,” especially fruits, vegetables, nuts, seeds, and beans.

Another strategy: Eat foods with probiotic bacteria. “I view it as an insurance policy,” said Dr. Versalovic, “fortifying my gut with probiotics, with daily yogurt, for example, at breakfast.”

Fermented foods like kimchi and kombucha can also increase microbial diversity and can even contain health-promoting postbiotics, research shows.

As for probiotic supplements, the jury’s still out.

Certain strains of probiotic bacteria may be beneficial for some patients, like those with diarrhea, Crohn’s disease, and irritable bowel syndrome, according to World Gastroenterology Organisation guidelines.

As with other interventions, individual responses can vary. A Stanford study showed that some people with metabolic syndrome improved when taking a probiotic, while others didn’t. Both groups had key differences in gut bacteria and dietary habits.

For best results, such microbiome-based interventions will need to be personalized, experts say. And the technology to do that is coming sooner than you might think.
 

Microbiome’s Medical Future: ‘We Are on the Cusp of a New Era’

In just a few years, artificial intelligence (AI) models could predict gut microbial composition based on data such as dietary habits and household characteristics, Dr. Kumar said.

Advancements in metabolomics and bioinformatics could soon help physicians and patients personalize their treatment approaches, said Dr. Damman.

One focus will be on fortifying the gut with whatever it lacks.

“In those individuals where certain microbes are missing, (a) how could we add them back potentially in a rational, science-driven way, and (b) maybe some of those factors that the microbes are producing out the other ends, you could give directly,” said Dr. Damman.

For example, multiple companies make butyrate as a dietary supplement, although the research is too early to support widespread use. Another option could be eating something that spurs butyrate production. One small study found that a fiber supplement formulated to increase butyrate levels in the colon reduced participants’ systolic blood pressure by an average of six points.

Another option could be synbiotics, products that combine bacteria and the food source they feed on. “If you just give a diet-based therapy, it is not going to work as much. Because what if that diet needs certain bacteria to have these beneficial metabolites?” said Ashutosh Mangalam, PhD, associate professor of pathology at the University of Iowa Carver College of Medicine, Iowa City.

Dr. Mangalam studies links between bacterial metabolism of phytoestrogens in soy foods and multiple sclerosis (MS) development. He is using AI to understand differences in metabolites in patients with MS vs healthy controls to determine how to target them.

Gut microbial metabolites could also affect disease screening and intervention. What if gut microbe sequencing could predict a pregnant person’s risk of developing depression, something now assessed through simple questionnaires?

“Imagine that your doctor says, ‘Okay, give me a poop sample,’ ” Dr. Bernabé said. “Then they phenotype it, and then they put it in your electronic medical record, and they say, ‘Well, you have high likelihood of having a mood disorder down the line in your pregnancy. Why don’t we directly refer you to a provider now so you can follow up?’ ”

Research is already underway to understand how metabolites might be linked to pregnancy outcomes, complex regional pain syndrome, and anxiety. Researchers are also investigating whether supplementing our diets with things like prebiotic fibers, apple polyphenols, or tomato paste might influence metabolites. And fecal transplants that shift the gut microbiome and metabolites could have potential in diseases like unexplained atherosclerosis, post-COVID syndrome, and hidradenitis suppurativa.

Dr. Hazen’s discovery linking TMAO with cardiovascular risk has already changed clinical practice. A blood TMAO test can help identify patients at risk who may not have traditional risk factors. “Millions have been done,” Dr. Hazen said.

Meanwhile, his drug targeting the TMAO pathway inches closer to clinical trials.

“In an animal model, we elicit improvement in heart failure, renal disease, atherosclerosis, thrombosis, aortic aneurysm, and obesity,” Dr. Hazen said. The first clinical trials will focus on renal disease.

As with any drug, the road to approval takes time. And success is not guaranteed.

But Dr. Hazen for one is optimistic.

“We are on the cusp of a new era,” Dr. Hazen said. “Like when humans first discovered insulin and glucagon were hormones that impact sugar metabolism. We now recognize myriad new ‘hormones’ in the form of gut microbiome metabolites that impact our physiology and susceptibility to diseases.”
 

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

Meet your new patients.

You can’t see them, but trillions — maybe quadrillions — of them travel in and out of your practice every day. They’re hungry, mysterious, community-oriented, and small. Very, very small.

They’re the microbes occupying your current patients’ guts.

Someday soon, you’ll prescribe medicine not just for humans but also for these microbes.

“I am convinced in the future our medicine cabinets are going to have not just medications like a statin for treating us, but [also] pills that treat and inhibit an enzyme in our microbes and elicit a health benefit in some chronic disease,” said Stanley Hazen, MD, PhD, co-section head of Preventive Cardiology & Rehabilitation and director of the Center for Microbiome & Human Health at Cleveland Clinic, Cleveland, Ohio.

Evidence is mounting that the gut microbiome influences just about every major human disease. These trillions of microbes use our food to generate substances called metabolites that can protect or harm our health, with consequences reaching far beyond our gastrointestinal tracts.

Research has linked microbial metabolites to diabetes, cardiovascular disease, liver disease, obesity, high blood pressure, neurological disorders, depression, cancer, and more. Gastroenterologist Christopher Damman, MD, a clinical associate professor at the University of Washington Medical Center, Seattle, calls it a “growing theme” in microbiome science.

Now scientists are developing treatments targeting gut microbial pathways, designed to eliminate the bad metabolites and boost the good metabolites.

One close to human therapeutic intervention is an oral treatment from Dr. Hazen’s lab targeting the metabolite trimethylamine N-oxide (TMAO), a predictor of and contributor to both cardiovascular disease and chronic kidney disease. The drug, which blocks TMAO formation, is nearing clinical trials, Dr. Hazen said.

The advantage is safety. By targeting the microbe instead of, say, an enzyme, the host (your patient) must absorb little if any drug.

Implications for the future of medicine are huge. “Gut microbial pathways contribute to diabetes, obesity, virtually everything,” Dr. Hazen said. “Therapies that target gut microbiome processes will probably even be used for psychiatric disorders within, I’ll say, 10 or 20 years.”
 

The Science

About 100 trillion strains of bacteria live in our guts. As humans have evolved, so have they.

Between 70% and 90% come from the phyla Firmicutes and Bacteroidetes, with person-to-person variation shaped by genetics, environment, and lifestyle.

“Everyone’s microbiome is subtly different,” said Dr. Hazen. “So the combination of what they’re making is different. All these different biologically active compounds are influencing us in subtly different ways.”

How it works: When you eat, your microbes eat, breaking down food into metabolites that interact with the thin layer of epithelial cells lining your gut. Some can be absorbed through the lining and into your bloodstream, a phenomenon known as “leaky gut.” Once in your blood, they can trigger irritation and inflammation, potentially leading to a wide variety of health issues, from gas and bloating to autoimmune conditions and mood disorders.

“On the other side of the epithelial lining, you have some of the largest concentrations of immune cells,” said Narendra Kumar, PhD, associate professor of pharmaceutical sciences at Texas A&M University, College Station, Texas.

Metabolites can influence how these immune cells work, possibly explaining why each person’s immune system behaves distinctively.

Of the 1000-plus metabolites linked to the gut microbiome, scientists have identified several that matter.

Short-chain fatty acids. When we eat fiber, colon bacteria ferment it into the beneficial short-chain fatty acids acetate, propionate, and butyrate. These bind to receptors in muscle, liver, and fat tissue, affecting the secretion of gut hormones and peptides related to appetite, inflammation, energy expenditure, and fat oxidation.

Butyrate has been linked to health benefits. It supports the integrity of the gut’s lining, stifling pathogenic gut bacteria, fighting cancer-promoting inflammation, and protecting against obesity and diabetes. It can function as a prebiotic, helping beneficial bacteria thrive. And recent studies linked an abundance of butyrate-producing bacteria with reduced bone fracture risk and hospitalization for infectious disease.

TMAO and phenylacetylglutamine. When we eat foods rich in animal proteins — think eggs, milk, fish, and especially red meat — some gut bacteria convert nutrients like choline and L-carnitine into TMAO and phenylalanine into phenylacetylglutamine. Research conducted by Dr. Hazen’s lab and replicated by others has linked both metabolites to heart problems.

In a landmark study from Dr. Hazen’s group, healthy adults who went on to develop coronary artery disease had significantly higher plasma TMAO levels than those who did not wind up with the condition. The association remained strong, even after controlling for risk factors like age, sex, smoking, high blood pressure, and high cholesterol.

In preclinical studies, elevated TMAO enhanced cardiovascular disease. TMAO-producing microbes also accentuated cardiovascular disease phenotypes in mouse models, while blocking these pathways inhibited the phenotypes.

Research suggests TMAO may harm cardiomyocytes (cells that contract and relax the heart) in dozens of ways, such as activating the expression of proteins to promote hypertrophy and fibrosis, decreasing mitochondrial function, and disrupting calcium signaling.

Another study linked phenylacetylglutamine levels to cardiac event risk in patients with heart failure. Recent mechanistic investigations suggest the metabolite alters signaling in a beta-adrenergic receptor involved in our fight-or-flight response, said Hazen.

“It’s like a rheostat on the light switch, a dimmer switch, and it’s what’s called a negative allosteric modulator,” he said. “It’s the first time that this type of behavior has ever been shown to be present for a gut microbial metabolite and a host receptor.”

Tryptophan metabolites. Microbes in your colon can convert the amino acid tryptophan, also found in animal-based foods, into neurotransmitters like serotonin and melatonin.

“The enteric nervous system, the nervous system around the gut, is immense,” said James Versalovic, MD, PhD, professor of pathology and immunology at Baylor College of Medicine, Houston. “The gut-brain axis has become a very fertile area of research.”

Lesser-known tryptophan metabolites — like indole, tryptamine, and indoleethanol — have been linked to benefits like fortifying the gut barrier, promoting the release of glucagon-like peptide 1 to reduce appetite, and protecting the liver from hepatitis. However, indole can also spur the production of indoxyl sulfate, a toxin linked to chronic kidney disease. 

Bile acid byproducts. Your gut bugs also feast on (and transform) bile acids before they reabsorb and travel back to the liver.

Research is gaining traction on these secondary bile acids, which can affect inflammation and immune function in helpful and harmful ways.

One area of interest is how microbes break down hormones in bile. A recent study from Harvard showed that gut microbes convert corticoid hormones in bile into progestins, which could affect postpartum depression risk. And researchers are exploring the estrobolome — a gut microbial community dedicated to breaking down estrogen into its active form so it can be reabsorbed.

“Depending on the bacteria that you have, more or less can be recirculated back into your blood,” said Beatriz Peñalver Bernabé, PhD, an assistant professor of biomedical engineering and urology at the University of Illinois Chicago. “So you may be producing the same amount of estrogen, but depending on the bacteria you have, the real free estrogen that can bind to your cells may be very different.”

The gut microbiome can also regulate testosterone, with studies showing microbial differences in men with high testosterone vs those with less.
 

What Patients Can Do Now

Advances in the field of microbiome research — and the related “gut health” wellness craze — have spawned all kinds of new microbiome-based products: Like over-the-counter probiotic supplements and at-home test kits, which let you send a stool sample for analysis to reveal microbiome health and personalized diet recommendations.

But the science behind these tests is still evolving, said Dr. Damman. “The clinical inferences and applications are still pretty limited.”

For most people, the first step to fostering healthier microbial metabolites is much simpler: Diversify your diet.

“A lot of folks are missing that diversity,” Dr. Damman said.

“Eat foods and experiment with foods that you might not eat all the time,” especially fruits, vegetables, nuts, seeds, and beans.

Another strategy: Eat foods with probiotic bacteria. “I view it as an insurance policy,” said Dr. Versalovic, “fortifying my gut with probiotics, with daily yogurt, for example, at breakfast.”

Fermented foods like kimchi and kombucha can also increase microbial diversity and can even contain health-promoting postbiotics, research shows.

As for probiotic supplements, the jury’s still out.

Certain strains of probiotic bacteria may be beneficial for some patients, like those with diarrhea, Crohn’s disease, and irritable bowel syndrome, according to World Gastroenterology Organisation guidelines.

As with other interventions, individual responses can vary. A Stanford study showed that some people with metabolic syndrome improved when taking a probiotic, while others didn’t. Both groups had key differences in gut bacteria and dietary habits.

For best results, such microbiome-based interventions will need to be personalized, experts say. And the technology to do that is coming sooner than you might think.
 

Microbiome’s Medical Future: ‘We Are on the Cusp of a New Era’

In just a few years, artificial intelligence (AI) models could predict gut microbial composition based on data such as dietary habits and household characteristics, Dr. Kumar said.

Advancements in metabolomics and bioinformatics could soon help physicians and patients personalize their treatment approaches, said Dr. Damman.

One focus will be on fortifying the gut with whatever it lacks.

“In those individuals where certain microbes are missing, (a) how could we add them back potentially in a rational, science-driven way, and (b) maybe some of those factors that the microbes are producing out the other ends, you could give directly,” said Dr. Damman.

For example, multiple companies make butyrate as a dietary supplement, although the research is too early to support widespread use. Another option could be eating something that spurs butyrate production. One small study found that a fiber supplement formulated to increase butyrate levels in the colon reduced participants’ systolic blood pressure by an average of six points.

Another option could be synbiotics, products that combine bacteria and the food source they feed on. “If you just give a diet-based therapy, it is not going to work as much. Because what if that diet needs certain bacteria to have these beneficial metabolites?” said Ashutosh Mangalam, PhD, associate professor of pathology at the University of Iowa Carver College of Medicine, Iowa City.

Dr. Mangalam studies links between bacterial metabolism of phytoestrogens in soy foods and multiple sclerosis (MS) development. He is using AI to understand differences in metabolites in patients with MS vs healthy controls to determine how to target them.

Gut microbial metabolites could also affect disease screening and intervention. What if gut microbe sequencing could predict a pregnant person’s risk of developing depression, something now assessed through simple questionnaires?

“Imagine that your doctor says, ‘Okay, give me a poop sample,’ ” Dr. Bernabé said. “Then they phenotype it, and then they put it in your electronic medical record, and they say, ‘Well, you have high likelihood of having a mood disorder down the line in your pregnancy. Why don’t we directly refer you to a provider now so you can follow up?’ ”

Research is already underway to understand how metabolites might be linked to pregnancy outcomes, complex regional pain syndrome, and anxiety. Researchers are also investigating whether supplementing our diets with things like prebiotic fibers, apple polyphenols, or tomato paste might influence metabolites. And fecal transplants that shift the gut microbiome and metabolites could have potential in diseases like unexplained atherosclerosis, post-COVID syndrome, and hidradenitis suppurativa.

Dr. Hazen’s discovery linking TMAO with cardiovascular risk has already changed clinical practice. A blood TMAO test can help identify patients at risk who may not have traditional risk factors. “Millions have been done,” Dr. Hazen said.

Meanwhile, his drug targeting the TMAO pathway inches closer to clinical trials.

“In an animal model, we elicit improvement in heart failure, renal disease, atherosclerosis, thrombosis, aortic aneurysm, and obesity,” Dr. Hazen said. The first clinical trials will focus on renal disease.

As with any drug, the road to approval takes time. And success is not guaranteed.

But Dr. Hazen for one is optimistic.

“We are on the cusp of a new era,” Dr. Hazen said. “Like when humans first discovered insulin and glucagon were hormones that impact sugar metabolism. We now recognize myriad new ‘hormones’ in the form of gut microbiome metabolites that impact our physiology and susceptibility to diseases.”
 

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

Meet your new patients.

You can’t see them, but trillions — maybe quadrillions — of them travel in and out of your practice every day. They’re hungry, mysterious, community-oriented, and small. Very, very small.

They’re the microbes occupying your current patients’ guts.

Someday soon, you’ll prescribe medicine not just for humans but also for these microbes.

“I am convinced in the future our medicine cabinets are going to have not just medications like a statin for treating us, but [also] pills that treat and inhibit an enzyme in our microbes and elicit a health benefit in some chronic disease,” said Stanley Hazen, MD, PhD, co-section head of Preventive Cardiology & Rehabilitation and director of the Center for Microbiome & Human Health at Cleveland Clinic, Cleveland, Ohio.

Evidence is mounting that the gut microbiome influences just about every major human disease. These trillions of microbes use our food to generate substances called metabolites that can protect or harm our health, with consequences reaching far beyond our gastrointestinal tracts.

Research has linked microbial metabolites to diabetes, cardiovascular disease, liver disease, obesity, high blood pressure, neurological disorders, depression, cancer, and more. Gastroenterologist Christopher Damman, MD, a clinical associate professor at the University of Washington Medical Center, Seattle, calls it a “growing theme” in microbiome science.

Now scientists are developing treatments targeting gut microbial pathways, designed to eliminate the bad metabolites and boost the good metabolites.

One close to human therapeutic intervention is an oral treatment from Dr. Hazen’s lab targeting the metabolite trimethylamine N-oxide (TMAO), a predictor of and contributor to both cardiovascular disease and chronic kidney disease. The drug, which blocks TMAO formation, is nearing clinical trials, Dr. Hazen said.

The advantage is safety. By targeting the microbe instead of, say, an enzyme, the host (your patient) must absorb little if any drug.

Implications for the future of medicine are huge. “Gut microbial pathways contribute to diabetes, obesity, virtually everything,” Dr. Hazen said. “Therapies that target gut microbiome processes will probably even be used for psychiatric disorders within, I’ll say, 10 or 20 years.”
 

The Science

About 100 trillion strains of bacteria live in our guts. As humans have evolved, so have they.

Between 70% and 90% come from the phyla Firmicutes and Bacteroidetes, with person-to-person variation shaped by genetics, environment, and lifestyle.

“Everyone’s microbiome is subtly different,” said Dr. Hazen. “So the combination of what they’re making is different. All these different biologically active compounds are influencing us in subtly different ways.”

How it works: When you eat, your microbes eat, breaking down food into metabolites that interact with the thin layer of epithelial cells lining your gut. Some can be absorbed through the lining and into your bloodstream, a phenomenon known as “leaky gut.” Once in your blood, they can trigger irritation and inflammation, potentially leading to a wide variety of health issues, from gas and bloating to autoimmune conditions and mood disorders.

“On the other side of the epithelial lining, you have some of the largest concentrations of immune cells,” said Narendra Kumar, PhD, associate professor of pharmaceutical sciences at Texas A&M University, College Station, Texas.

Metabolites can influence how these immune cells work, possibly explaining why each person’s immune system behaves distinctively.

Of the 1000-plus metabolites linked to the gut microbiome, scientists have identified several that matter.

Short-chain fatty acids. When we eat fiber, colon bacteria ferment it into the beneficial short-chain fatty acids acetate, propionate, and butyrate. These bind to receptors in muscle, liver, and fat tissue, affecting the secretion of gut hormones and peptides related to appetite, inflammation, energy expenditure, and fat oxidation.

Butyrate has been linked to health benefits. It supports the integrity of the gut’s lining, stifling pathogenic gut bacteria, fighting cancer-promoting inflammation, and protecting against obesity and diabetes. It can function as a prebiotic, helping beneficial bacteria thrive. And recent studies linked an abundance of butyrate-producing bacteria with reduced bone fracture risk and hospitalization for infectious disease.

TMAO and phenylacetylglutamine. When we eat foods rich in animal proteins — think eggs, milk, fish, and especially red meat — some gut bacteria convert nutrients like choline and L-carnitine into TMAO and phenylalanine into phenylacetylglutamine. Research conducted by Dr. Hazen’s lab and replicated by others has linked both metabolites to heart problems.

In a landmark study from Dr. Hazen’s group, healthy adults who went on to develop coronary artery disease had significantly higher plasma TMAO levels than those who did not wind up with the condition. The association remained strong, even after controlling for risk factors like age, sex, smoking, high blood pressure, and high cholesterol.

In preclinical studies, elevated TMAO enhanced cardiovascular disease. TMAO-producing microbes also accentuated cardiovascular disease phenotypes in mouse models, while blocking these pathways inhibited the phenotypes.

Research suggests TMAO may harm cardiomyocytes (cells that contract and relax the heart) in dozens of ways, such as activating the expression of proteins to promote hypertrophy and fibrosis, decreasing mitochondrial function, and disrupting calcium signaling.

Another study linked phenylacetylglutamine levels to cardiac event risk in patients with heart failure. Recent mechanistic investigations suggest the metabolite alters signaling in a beta-adrenergic receptor involved in our fight-or-flight response, said Hazen.

“It’s like a rheostat on the light switch, a dimmer switch, and it’s what’s called a negative allosteric modulator,” he said. “It’s the first time that this type of behavior has ever been shown to be present for a gut microbial metabolite and a host receptor.”

Tryptophan metabolites. Microbes in your colon can convert the amino acid tryptophan, also found in animal-based foods, into neurotransmitters like serotonin and melatonin.

“The enteric nervous system, the nervous system around the gut, is immense,” said James Versalovic, MD, PhD, professor of pathology and immunology at Baylor College of Medicine, Houston. “The gut-brain axis has become a very fertile area of research.”

Lesser-known tryptophan metabolites — like indole, tryptamine, and indoleethanol — have been linked to benefits like fortifying the gut barrier, promoting the release of glucagon-like peptide 1 to reduce appetite, and protecting the liver from hepatitis. However, indole can also spur the production of indoxyl sulfate, a toxin linked to chronic kidney disease. 

Bile acid byproducts. Your gut bugs also feast on (and transform) bile acids before they reabsorb and travel back to the liver.

Research is gaining traction on these secondary bile acids, which can affect inflammation and immune function in helpful and harmful ways.

One area of interest is how microbes break down hormones in bile. A recent study from Harvard showed that gut microbes convert corticoid hormones in bile into progestins, which could affect postpartum depression risk. And researchers are exploring the estrobolome — a gut microbial community dedicated to breaking down estrogen into its active form so it can be reabsorbed.

“Depending on the bacteria that you have, more or less can be recirculated back into your blood,” said Beatriz Peñalver Bernabé, PhD, an assistant professor of biomedical engineering and urology at the University of Illinois Chicago. “So you may be producing the same amount of estrogen, but depending on the bacteria you have, the real free estrogen that can bind to your cells may be very different.”

The gut microbiome can also regulate testosterone, with studies showing microbial differences in men with high testosterone vs those with less.
 

What Patients Can Do Now

Advances in the field of microbiome research — and the related “gut health” wellness craze — have spawned all kinds of new microbiome-based products: Like over-the-counter probiotic supplements and at-home test kits, which let you send a stool sample for analysis to reveal microbiome health and personalized diet recommendations.

But the science behind these tests is still evolving, said Dr. Damman. “The clinical inferences and applications are still pretty limited.”

For most people, the first step to fostering healthier microbial metabolites is much simpler: Diversify your diet.

“A lot of folks are missing that diversity,” Dr. Damman said.

“Eat foods and experiment with foods that you might not eat all the time,” especially fruits, vegetables, nuts, seeds, and beans.

Another strategy: Eat foods with probiotic bacteria. “I view it as an insurance policy,” said Dr. Versalovic, “fortifying my gut with probiotics, with daily yogurt, for example, at breakfast.”

Fermented foods like kimchi and kombucha can also increase microbial diversity and can even contain health-promoting postbiotics, research shows.

As for probiotic supplements, the jury’s still out.

Certain strains of probiotic bacteria may be beneficial for some patients, like those with diarrhea, Crohn’s disease, and irritable bowel syndrome, according to World Gastroenterology Organisation guidelines.

As with other interventions, individual responses can vary. A Stanford study showed that some people with metabolic syndrome improved when taking a probiotic, while others didn’t. Both groups had key differences in gut bacteria and dietary habits.

For best results, such microbiome-based interventions will need to be personalized, experts say. And the technology to do that is coming sooner than you might think.
 

Microbiome’s Medical Future: ‘We Are on the Cusp of a New Era’

In just a few years, artificial intelligence (AI) models could predict gut microbial composition based on data such as dietary habits and household characteristics, Dr. Kumar said.

Advancements in metabolomics and bioinformatics could soon help physicians and patients personalize their treatment approaches, said Dr. Damman.

One focus will be on fortifying the gut with whatever it lacks.

“In those individuals where certain microbes are missing, (a) how could we add them back potentially in a rational, science-driven way, and (b) maybe some of those factors that the microbes are producing out the other ends, you could give directly,” said Dr. Damman.

For example, multiple companies make butyrate as a dietary supplement, although the research is too early to support widespread use. Another option could be eating something that spurs butyrate production. One small study found that a fiber supplement formulated to increase butyrate levels in the colon reduced participants’ systolic blood pressure by an average of six points.

Another option could be synbiotics, products that combine bacteria and the food source they feed on. “If you just give a diet-based therapy, it is not going to work as much. Because what if that diet needs certain bacteria to have these beneficial metabolites?” said Ashutosh Mangalam, PhD, associate professor of pathology at the University of Iowa Carver College of Medicine, Iowa City.

Dr. Mangalam studies links between bacterial metabolism of phytoestrogens in soy foods and multiple sclerosis (MS) development. He is using AI to understand differences in metabolites in patients with MS vs healthy controls to determine how to target them.

Gut microbial metabolites could also affect disease screening and intervention. What if gut microbe sequencing could predict a pregnant person’s risk of developing depression, something now assessed through simple questionnaires?

“Imagine that your doctor says, ‘Okay, give me a poop sample,’ ” Dr. Bernabé said. “Then they phenotype it, and then they put it in your electronic medical record, and they say, ‘Well, you have high likelihood of having a mood disorder down the line in your pregnancy. Why don’t we directly refer you to a provider now so you can follow up?’ ”

Research is already underway to understand how metabolites might be linked to pregnancy outcomes, complex regional pain syndrome, and anxiety. Researchers are also investigating whether supplementing our diets with things like prebiotic fibers, apple polyphenols, or tomato paste might influence metabolites. And fecal transplants that shift the gut microbiome and metabolites could have potential in diseases like unexplained atherosclerosis, post-COVID syndrome, and hidradenitis suppurativa.

Dr. Hazen’s discovery linking TMAO with cardiovascular risk has already changed clinical practice. A blood TMAO test can help identify patients at risk who may not have traditional risk factors. “Millions have been done,” Dr. Hazen said.

Meanwhile, his drug targeting the TMAO pathway inches closer to clinical trials.

“In an animal model, we elicit improvement in heart failure, renal disease, atherosclerosis, thrombosis, aortic aneurysm, and obesity,” Dr. Hazen said. The first clinical trials will focus on renal disease.

As with any drug, the road to approval takes time. And success is not guaranteed.

But Dr. Hazen for one is optimistic.

“We are on the cusp of a new era,” Dr. Hazen said. “Like when humans first discovered insulin and glucagon were hormones that impact sugar metabolism. We now recognize myriad new ‘hormones’ in the form of gut microbiome metabolites that impact our physiology and susceptibility to diseases.”
 

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

TOPLINE:

Survival rates for patients with hepatocellular carcinoma (HCC) have improved, but overall survival remains low. Early detection and treatment significantly enhanced survival outcomes between January 1, 2006, and December 31, 2019.

METHODOLOGY:

• Researchers conducted a retrospective cohort study including 3441 adult patients diagnosed with HCC. The study aimed to evaluate survival trends among patients with HCC, the most common cause of cancer-related morbidity and mortality globally. The incidence of HCC has more than doubled in the United States over the past 2 decades and is expected to continue increasing.
• The study was conducted within the Kaiser Permanente Northern California health system, with patients categorized into the eras of 2006-2012 and 2013-2019, and follow-up data collected on December 31, 2020.
• Data collection included patient demographics, disease factors, treatment types, and survival outcomes, with statistical analysis performed from January 2021 to June 2024.
• Treatment modalities were extracted from electronic health records using specific medical codes, and survival probabilities were estimated using the Kaplan-Meier method.

TAKEAWAY:

• Researchers found that survival rates for patients with HCC improved significantly between 2006-2012 and 2013-2019, particularly for those receiving curative treatments.
• Patients with early-stage disease (Barcelona Clinic Liver Cancer [BCLC] stage O or A) had higher survival probabilities than those with intermediate or advanced stages.
• Multivariable analysis showed that factors such as age ≥ 70 years, male sex, advanced BCLC stage, and higher alpha-fetoprotein levels were associated with higher all-cause mortality.
• Asian or Other Pacific Islander race and ethnicity were associated with lower all-cause mortality than non-Hispanic White patients.

IN PRACTICE:

“The trends observed ... clearly demonstrate the benefits of early detection, as patients with early-stage disease who received curative treatments had the best survival; this effect became more pronounced in recent years. This study also highlights important demographic factors associated with favorable survival, which may inform treatment allocation, particularly with respect to liver transplant,” wrote the authors of the study.

SOURCE:

The study was led by Mignote Yilma, MD, of Kaiser Permanente in Oakland, California. It was published online on September 24 in JAMA Network Open.

LIMITATIONS:

The study’s retrospective nature may introduce bias. Mortality data for 2020 were only captured if documented within the electronic health records, potentially missing some deaths. The study period did not fully capture the effects of newer treatments such as transarterial radioembolization or newer systemic immunotherapies.

DISCLOSURES:

The study was supported by grants from Kaiser Permanente Community Health. No conflicts of interest disclosures were reported.

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

TOPLINE:

Survival rates for patients with hepatocellular carcinoma (HCC) have improved, but overall survival remains low. Early detection and treatment significantly enhanced survival outcomes between January 1, 2006, and December 31, 2019.

METHODOLOGY:

• Researchers conducted a retrospective cohort study including 3441 adult patients diagnosed with HCC. The study aimed to evaluate survival trends among patients with HCC, the most common cause of cancer-related morbidity and mortality globally. The incidence of HCC has more than doubled in the United States over the past 2 decades and is expected to continue increasing.
• The study was conducted within the Kaiser Permanente Northern California health system, with patients categorized into the eras of 2006-2012 and 2013-2019, and follow-up data collected on December 31, 2020.
• Data collection included patient demographics, disease factors, treatment types, and survival outcomes, with statistical analysis performed from January 2021 to June 2024.
• Treatment modalities were extracted from electronic health records using specific medical codes, and survival probabilities were estimated using the Kaplan-Meier method.

TAKEAWAY:

• Researchers found that survival rates for patients with HCC improved significantly between 2006-2012 and 2013-2019, particularly for those receiving curative treatments.
• Patients with early-stage disease (Barcelona Clinic Liver Cancer [BCLC] stage O or A) had higher survival probabilities than those with intermediate or advanced stages.
• Multivariable analysis showed that factors such as age ≥ 70 years, male sex, advanced BCLC stage, and higher alpha-fetoprotein levels were associated with higher all-cause mortality.
• Asian or Other Pacific Islander race and ethnicity were associated with lower all-cause mortality than non-Hispanic White patients.

IN PRACTICE:

“The trends observed ... clearly demonstrate the benefits of early detection, as patients with early-stage disease who received curative treatments had the best survival; this effect became more pronounced in recent years. This study also highlights important demographic factors associated with favorable survival, which may inform treatment allocation, particularly with respect to liver transplant,” wrote the authors of the study.

SOURCE:

The study was led by Mignote Yilma, MD, of Kaiser Permanente in Oakland, California. It was published online on September 24 in JAMA Network Open.

LIMITATIONS:

The study’s retrospective nature may introduce bias. Mortality data for 2020 were only captured if documented within the electronic health records, potentially missing some deaths. The study period did not fully capture the effects of newer treatments such as transarterial radioembolization or newer systemic immunotherapies.

DISCLOSURES:

The study was supported by grants from Kaiser Permanente Community Health. No conflicts of interest disclosures were reported.

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

TOPLINE:

Survival rates for patients with hepatocellular carcinoma (HCC) have improved, but overall survival remains low. Early detection and treatment significantly enhanced survival outcomes between January 1, 2006, and December 31, 2019.

METHODOLOGY:

• Researchers conducted a retrospective cohort study including 3441 adult patients diagnosed with HCC. The study aimed to evaluate survival trends among patients with HCC, the most common cause of cancer-related morbidity and mortality globally. The incidence of HCC has more than doubled in the United States over the past 2 decades and is expected to continue increasing.
• The study was conducted within the Kaiser Permanente Northern California health system, with patients categorized into the eras of 2006-2012 and 2013-2019, and follow-up data collected on December 31, 2020.
• Data collection included patient demographics, disease factors, treatment types, and survival outcomes, with statistical analysis performed from January 2021 to June 2024.
• Treatment modalities were extracted from electronic health records using specific medical codes, and survival probabilities were estimated using the Kaplan-Meier method.

TAKEAWAY:

• Researchers found that survival rates for patients with HCC improved significantly between 2006-2012 and 2013-2019, particularly for those receiving curative treatments.
• Patients with early-stage disease (Barcelona Clinic Liver Cancer [BCLC] stage O or A) had higher survival probabilities than those with intermediate or advanced stages.
• Multivariable analysis showed that factors such as age ≥ 70 years, male sex, advanced BCLC stage, and higher alpha-fetoprotein levels were associated with higher all-cause mortality.
• Asian or Other Pacific Islander race and ethnicity were associated with lower all-cause mortality than non-Hispanic White patients.

IN PRACTICE:

“The trends observed ... clearly demonstrate the benefits of early detection, as patients with early-stage disease who received curative treatments had the best survival; this effect became more pronounced in recent years. This study also highlights important demographic factors associated with favorable survival, which may inform treatment allocation, particularly with respect to liver transplant,” wrote the authors of the study.

SOURCE:

The study was led by Mignote Yilma, MD, of Kaiser Permanente in Oakland, California. It was published online on September 24 in JAMA Network Open.

LIMITATIONS:

The study’s retrospective nature may introduce bias. Mortality data for 2020 were only captured if documented within the electronic health records, potentially missing some deaths. The study period did not fully capture the effects of newer treatments such as transarterial radioembolization or newer systemic immunotherapies.

DISCLOSURES:

The study was supported by grants from Kaiser Permanente Community Health. No conflicts of interest disclosures were reported.

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