While the use of artificial intelligence (AI) during colonoscopy may contribute to improved cancer prevention, it may also add to patient burden in terms of increased colonoscopy frequency and, in turn, health care costs, a new study suggests.

The study, published online in Clinical Gastroenterology and Hepatology, found that colonoscopy plus AI (vs. colonoscopy alone) increased the proportion of patients requiring intensive postpolypectomy colonoscopy surveillance by roughly 35% in the United States and Japan and by about 20% in Europe.

“It’s certainly possible that AI will lead to more frequent surveillance for some patients, but it may balance itself out given that recent surveillance guidelines have pushed off the surveillance interval depending on the size of the polyp,” senior author Seth A. Gross, MD, professor of medicine and clinical chief of the division of gastroenterology and hepatology at New York University Langone Health, said in an interview.
 

Impact on intensive colonoscopy surveillance

AI tools have been shown to increase the adenoma detection rate (ADR) during colonoscopy, but what impact this has on the frequency of surveillance colonoscopy is unknown.

To investigate, Dr. Gross and an international team conducted a pooled analysis of nine randomized, controlled trials comparing colonoscopy with or without AI detection aids. Five trials were done in China, two in Italy, one in Japan, and one in the United States.

The primary outcome was the proportion of patients recommended to undergo intensive surveillance (that is, 3-year interval).

Among a total of 5,796 patients (mean age, 53 years; 51% male), 2,894 underwent AI-assisted colonoscopy and 2,902 underwent standard colonoscopy without AI assistance.

Higher ADRs in the AI-assisted colonoscopy groups were observed in all of the trials.

When following the U.S. and Japanese guidelines, the proportion of patients recommended for intensive surveillance increased from 8.4% (95% confidence interval, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group, which is an absolute difference of 2.9% (95% CI, 1.4%-4.4%) and a risk ratio of 1.35 (95% CI, 1.16-1.57). When following the European guidelines, the increase was from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%), which is an absolute difference of 1.3% (95% CI, 0.01%-2.6%) and a RR of 1.22 (95% CI, 1.01-1.47).

The increases are primarily the result of reallocation of patients from low-risk to intermediate- or high-risk categories, the investigators said. That shift is likely caused by the AI-related increase in adenomas per colonoscopy, which may lead to more effective cancer prevention.

“AI does show us that there’s always an opportunity for improvement when we do screening and surveillance colonoscopy,” Dr. Gross said. “The goal is the same, which is to offer the highest quality colonoscopy exam and the best possible outcome for our patients, and I think that’s what we’re starting to see.”
 

Cost analysis needed

Dr. Gross noted that he sees a cost-effectiveness analysis of AI in colonoscopy in the future.

“As this becomes more and more part of regular clinical practice, if it’s not being done already, someone will look at the cost-effectiveness of incorporating AI, just like they would for other technologies that come into the area of endoscopy,” Dr. Gross said.

Commenting on the study, Atsushi Sakuraba, MD, PhD, a gastroenterologist with University of Chicago Medicine, said he believes that the “benefit of improved adenoma detection and resulting reduction in colon cancer would outweigh the downsides of increased colonoscopy frequency and cost.”

“However, an economic impact study would need to be performed to answer this question,” added Dr. Sakuraba, who wasn’t involved with this study.

The study had no specific funding. Dr. Gross has served as a consultant for Olympus, Cook, Pentax, Ambu, and Iterative Scopes, and served on the advisory board for Docbot. Dr. Sakuraba reported no relevant financial relationships.

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

While the use of artificial intelligence (AI) during colonoscopy may contribute to improved cancer prevention, it may also add to patient burden in terms of increased colonoscopy frequency and, in turn, health care costs, a new study suggests.

The study, published online in Clinical Gastroenterology and Hepatology, found that colonoscopy plus AI (vs. colonoscopy alone) increased the proportion of patients requiring intensive postpolypectomy colonoscopy surveillance by roughly 35% in the United States and Japan and by about 20% in Europe.

“It’s certainly possible that AI will lead to more frequent surveillance for some patients, but it may balance itself out given that recent surveillance guidelines have pushed off the surveillance interval depending on the size of the polyp,” senior author Seth A. Gross, MD, professor of medicine and clinical chief of the division of gastroenterology and hepatology at New York University Langone Health, said in an interview.
 

Impact on intensive colonoscopy surveillance

AI tools have been shown to increase the adenoma detection rate (ADR) during colonoscopy, but what impact this has on the frequency of surveillance colonoscopy is unknown.

To investigate, Dr. Gross and an international team conducted a pooled analysis of nine randomized, controlled trials comparing colonoscopy with or without AI detection aids. Five trials were done in China, two in Italy, one in Japan, and one in the United States.

The primary outcome was the proportion of patients recommended to undergo intensive surveillance (that is, 3-year interval).

Among a total of 5,796 patients (mean age, 53 years; 51% male), 2,894 underwent AI-assisted colonoscopy and 2,902 underwent standard colonoscopy without AI assistance.

Higher ADRs in the AI-assisted colonoscopy groups were observed in all of the trials.

When following the U.S. and Japanese guidelines, the proportion of patients recommended for intensive surveillance increased from 8.4% (95% confidence interval, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group, which is an absolute difference of 2.9% (95% CI, 1.4%-4.4%) and a risk ratio of 1.35 (95% CI, 1.16-1.57). When following the European guidelines, the increase was from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%), which is an absolute difference of 1.3% (95% CI, 0.01%-2.6%) and a RR of 1.22 (95% CI, 1.01-1.47).

The increases are primarily the result of reallocation of patients from low-risk to intermediate- or high-risk categories, the investigators said. That shift is likely caused by the AI-related increase in adenomas per colonoscopy, which may lead to more effective cancer prevention.

“AI does show us that there’s always an opportunity for improvement when we do screening and surveillance colonoscopy,” Dr. Gross said. “The goal is the same, which is to offer the highest quality colonoscopy exam and the best possible outcome for our patients, and I think that’s what we’re starting to see.”
 

Cost analysis needed

Dr. Gross noted that he sees a cost-effectiveness analysis of AI in colonoscopy in the future.

“As this becomes more and more part of regular clinical practice, if it’s not being done already, someone will look at the cost-effectiveness of incorporating AI, just like they would for other technologies that come into the area of endoscopy,” Dr. Gross said.

Commenting on the study, Atsushi Sakuraba, MD, PhD, a gastroenterologist with University of Chicago Medicine, said he believes that the “benefit of improved adenoma detection and resulting reduction in colon cancer would outweigh the downsides of increased colonoscopy frequency and cost.”

“However, an economic impact study would need to be performed to answer this question,” added Dr. Sakuraba, who wasn’t involved with this study.

The study had no specific funding. Dr. Gross has served as a consultant for Olympus, Cook, Pentax, Ambu, and Iterative Scopes, and served on the advisory board for Docbot. Dr. Sakuraba reported no relevant financial relationships.

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

While the use of artificial intelligence (AI) during colonoscopy may contribute to improved cancer prevention, it may also add to patient burden in terms of increased colonoscopy frequency and, in turn, health care costs, a new study suggests.

The study, published online in Clinical Gastroenterology and Hepatology, found that colonoscopy plus AI (vs. colonoscopy alone) increased the proportion of patients requiring intensive postpolypectomy colonoscopy surveillance by roughly 35% in the United States and Japan and by about 20% in Europe.

“It’s certainly possible that AI will lead to more frequent surveillance for some patients, but it may balance itself out given that recent surveillance guidelines have pushed off the surveillance interval depending on the size of the polyp,” senior author Seth A. Gross, MD, professor of medicine and clinical chief of the division of gastroenterology and hepatology at New York University Langone Health, said in an interview.
 

Impact on intensive colonoscopy surveillance

AI tools have been shown to increase the adenoma detection rate (ADR) during colonoscopy, but what impact this has on the frequency of surveillance colonoscopy is unknown.

To investigate, Dr. Gross and an international team conducted a pooled analysis of nine randomized, controlled trials comparing colonoscopy with or without AI detection aids. Five trials were done in China, two in Italy, one in Japan, and one in the United States.

The primary outcome was the proportion of patients recommended to undergo intensive surveillance (that is, 3-year interval).

Among a total of 5,796 patients (mean age, 53 years; 51% male), 2,894 underwent AI-assisted colonoscopy and 2,902 underwent standard colonoscopy without AI assistance.

Higher ADRs in the AI-assisted colonoscopy groups were observed in all of the trials.

When following the U.S. and Japanese guidelines, the proportion of patients recommended for intensive surveillance increased from 8.4% (95% confidence interval, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group, which is an absolute difference of 2.9% (95% CI, 1.4%-4.4%) and a risk ratio of 1.35 (95% CI, 1.16-1.57). When following the European guidelines, the increase was from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%), which is an absolute difference of 1.3% (95% CI, 0.01%-2.6%) and a RR of 1.22 (95% CI, 1.01-1.47).

The increases are primarily the result of reallocation of patients from low-risk to intermediate- or high-risk categories, the investigators said. That shift is likely caused by the AI-related increase in adenomas per colonoscopy, which may lead to more effective cancer prevention.

“AI does show us that there’s always an opportunity for improvement when we do screening and surveillance colonoscopy,” Dr. Gross said. “The goal is the same, which is to offer the highest quality colonoscopy exam and the best possible outcome for our patients, and I think that’s what we’re starting to see.”
 

Cost analysis needed

Dr. Gross noted that he sees a cost-effectiveness analysis of AI in colonoscopy in the future.

“As this becomes more and more part of regular clinical practice, if it’s not being done already, someone will look at the cost-effectiveness of incorporating AI, just like they would for other technologies that come into the area of endoscopy,” Dr. Gross said.

Commenting on the study, Atsushi Sakuraba, MD, PhD, a gastroenterologist with University of Chicago Medicine, said he believes that the “benefit of improved adenoma detection and resulting reduction in colon cancer would outweigh the downsides of increased colonoscopy frequency and cost.”

“However, an economic impact study would need to be performed to answer this question,” added Dr. Sakuraba, who wasn’t involved with this study.

The study had no specific funding. Dr. Gross has served as a consultant for Olympus, Cook, Pentax, Ambu, and Iterative Scopes, and served on the advisory board for Docbot. Dr. Sakuraba reported no relevant financial relationships.

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

Despite money’s central role in our psychic lives, many trainees – and some seasoned practitioners – skirt around financial issues. Some clinicians confess that inquiring about patients’ finances feels “too personal.” They fear that asking about money could suggest that the clinician is primarily concerned with getting paid. Some clinicians feel that looking into patients’ finances might be unprofessional, outside one’s scope of practice. But it is not.

Trainees often receive little guidance concerning money matters in patients’ lives and treatments, considerations we have labeled clinical psychoeconomics. Considerable evidence suggests that financial concerns often provoke emotional distress and dysfunctional behaviors, and directly influence patient’s health care decisions. Financial issues also influence how clinicians view and react to patients.

We have recently reviewed (and illustrated through case vignettes) how money matters might impact psychiatric assessment, case formulation, treatment planning, and ongoing psychiatric treatments including psychotherapies.¹ Consider how money affects people’s lives: Money helps people meet multiple practical, psychological, and social needs by enabling them to obtain food, clothing, shelter, other material goods, services, discretionary time, and opportunities. And money strongly influences relationships. Regardless of poverty or wealth, thoughts and behaviors connected to acquiring, possessing, and disposing of money, and feelings accompanying these processes such as greed, neediness, envy, pride, shame, guilt, and self-satisfaction often underly intrapsychic and interpersonal conflicts.

Individuals constantly engage in numerous simultaneous conscious, preconscious, and unconscious neuro-economic trade-offs that determine goals, efforts, and timing. Many are financially influenced. Money influences how virtually all patients seek, receive, and sustain their mental health care including psychotherapy.

Money problems can be associated with insecurity, impotence, feeling unloved, and lack of freedom or subjugation. Individuals may resent how they’re forced to acquire money, and feel shamed or morally injured by their jobs, financial dependence on other family members, public assistance, or their questionable ways of obtaining money.

Impoverished individuals may face choosing between food, housing, medications, and medical care. Domestically abused individuals may reluctantly remain with their abusers, risking physical harm or death rather than face destitution. Some families tolerate severely disabled individuals at home because they rely on their disability checks and caregiver payments. Suicides may turn on how individuals forecast financial repercussions affecting their families. Desires to avoid debt may lead to treatment avoidance.

Individuals with enough money to get by face daily financially related choices involving competing needs, desires, values, and loyalties. They may experience conflicts concerning spending on necessities vs. indulgences or spending on oneself vs. significant others.

Whereas some wealthy individuals may assume unwarranted airs of superiority and entitlement, others may feel guilty about wealth, or fearful that others like them only for their money. Individuals on the receiving end of wealth may feel emotionally and behaviorally manipulated by their benefactors.
 

Assessment

Assessments should consider how financial matters have shaped patients’ early psychological development as well their current lives. How do patients’ emotions, thoughts, and behaviors reflect money matters? What money-related pathologies are evident? What aspects of the patient’s “financial world” seem modifiable?

Financial questions should be posed colloquially. Screeners include: “Where do you live?”, “Who’s in the home?”, “How do you (all) manage financially?”, “What do you all do for a living?”, “How do you make ends meet?”, and “What financial problems are you facing?” Clinicians can quickly learn about patients’ financial self-sufficiencies, individuals for whom they bear financial responsibility, and others they rely on for support, for example, relatives. If patients avoid answering such questions forthrightly, particularly when financial arrangements are “complicated,” clinicians will want to revisit these issues later after establishing a firmer alliance but continue to wonder about the meaning of the patient’s reluctance.

Clinically, money matters manifest intrapsychically or interpersonally in three ways: as explicit conflicts, implicit issues, and unequivocal money-related pathologies. When explicit, patients, families, and couples are fully aware of the conflicts but have difficulty resolving financial disputes. When conflicts are implicit, money problems may be unacknowledged, avoided, denied, or minimized. Conflicts concerning money are often transmitted trans-generationally.

Psychopathological conditions unequivocally linked to money include compulsive shopping, gambling disorders, miserly hoarding, impulse buying, and spending sprees during hypomanic and manic states. Mounting debts may create progressively insurmountable sources of distress. Money can be weaponized to sadistically create enticement, envy, or deprivation. Some monetarily antisocial individuals compromise interpersonal relationships as well as treatments. Individuals with alcohol/substance use disorders may spend so much on substances that little is left for necessities. Financially needy individuals may engage in morally questionable behaviors they might otherwise shun.
 

Case formulation and treatment planning

Incorporating money matters into case formulations entails demonstrating how financial concerns influenced maladaptive development and distort current attitudes, perceptions, and behaviors.

Concurrently, clinicians should acknowledge patients’ reality-based fiscal decisions, appreciating cultural and family value differences concerning how money should be acquired and spent. Since money often determines frequency and duration of treatment visits, clinicians are ethically obligated to discuss with patients what they might expect from different medications and psychotherapies, and their comparative costs.
 

Money matters’ impact on psychotherapies

Money matters often affect transference and countertransference reactions. Some reactions stem from how patients and clinicians compare their own financial situations with those of the other.

To help identify and ameliorate money-related countertransference responses, clinicians can reflect on questions such as: “How comfortable are you with people who are much poorer or richer than you are?” “How comfortable are you with impoverished individuals or with multimillionaires or their children?” And “why?” For trainees, all these reactions should be discussed in supervision.
 

Conclusions

To summarize, four clinical psychoeconomic issues should be routinely assessed and factored into psychiatric case formulations and treatment plans: how financial issues 1) have impacted patients’ psychological development; 2) impact patients’ current lives; 3) are likely to impact access, type, intensity, and duration of treatment visits; and 4) might provoke money-related transference and countertransference concerns.

In advising patients about treatment options, clinicians should discuss each treatment’s relative effectiveness and estimated costs of care. Patients’ decisions will likely be heavily influenced by financial considerations.

Dr. Yager is based in the department of psychiatry, University of Colorado at Denver, Aurora. Dr. Kay is based in the department of psychiatry, Wright State University, Dayton, Ohio. No external funds were received for this project, and the authors have no conflicts to disclose.

Reference

1. Yager J and Kay J. Money matters in psychiatric assessment, case formulation, treatment planning, and ongoing psychotherapy: Clinical psychoeconomics. J Nerv Ment Dis. 2022 Jun 10. doi: 10.1097/NMD.0000000000001552.

Despite money’s central role in our psychic lives, many trainees – and some seasoned practitioners – skirt around financial issues. Some clinicians confess that inquiring about patients’ finances feels “too personal.” They fear that asking about money could suggest that the clinician is primarily concerned with getting paid. Some clinicians feel that looking into patients’ finances might be unprofessional, outside one’s scope of practice. But it is not.

Trainees often receive little guidance concerning money matters in patients’ lives and treatments, considerations we have labeled clinical psychoeconomics. Considerable evidence suggests that financial concerns often provoke emotional distress and dysfunctional behaviors, and directly influence patient’s health care decisions. Financial issues also influence how clinicians view and react to patients.

We have recently reviewed (and illustrated through case vignettes) how money matters might impact psychiatric assessment, case formulation, treatment planning, and ongoing psychiatric treatments including psychotherapies.¹ Consider how money affects people’s lives: Money helps people meet multiple practical, psychological, and social needs by enabling them to obtain food, clothing, shelter, other material goods, services, discretionary time, and opportunities. And money strongly influences relationships. Regardless of poverty or wealth, thoughts and behaviors connected to acquiring, possessing, and disposing of money, and feelings accompanying these processes such as greed, neediness, envy, pride, shame, guilt, and self-satisfaction often underly intrapsychic and interpersonal conflicts.

Individuals constantly engage in numerous simultaneous conscious, preconscious, and unconscious neuro-economic trade-offs that determine goals, efforts, and timing. Many are financially influenced. Money influences how virtually all patients seek, receive, and sustain their mental health care including psychotherapy.

Money problems can be associated with insecurity, impotence, feeling unloved, and lack of freedom or subjugation. Individuals may resent how they’re forced to acquire money, and feel shamed or morally injured by their jobs, financial dependence on other family members, public assistance, or their questionable ways of obtaining money.

Impoverished individuals may face choosing between food, housing, medications, and medical care. Domestically abused individuals may reluctantly remain with their abusers, risking physical harm or death rather than face destitution. Some families tolerate severely disabled individuals at home because they rely on their disability checks and caregiver payments. Suicides may turn on how individuals forecast financial repercussions affecting their families. Desires to avoid debt may lead to treatment avoidance.

Individuals with enough money to get by face daily financially related choices involving competing needs, desires, values, and loyalties. They may experience conflicts concerning spending on necessities vs. indulgences or spending on oneself vs. significant others.

Whereas some wealthy individuals may assume unwarranted airs of superiority and entitlement, others may feel guilty about wealth, or fearful that others like them only for their money. Individuals on the receiving end of wealth may feel emotionally and behaviorally manipulated by their benefactors.
 

Assessment

Assessments should consider how financial matters have shaped patients’ early psychological development as well their current lives. How do patients’ emotions, thoughts, and behaviors reflect money matters? What money-related pathologies are evident? What aspects of the patient’s “financial world” seem modifiable?

Financial questions should be posed colloquially. Screeners include: “Where do you live?”, “Who’s in the home?”, “How do you (all) manage financially?”, “What do you all do for a living?”, “How do you make ends meet?”, and “What financial problems are you facing?” Clinicians can quickly learn about patients’ financial self-sufficiencies, individuals for whom they bear financial responsibility, and others they rely on for support, for example, relatives. If patients avoid answering such questions forthrightly, particularly when financial arrangements are “complicated,” clinicians will want to revisit these issues later after establishing a firmer alliance but continue to wonder about the meaning of the patient’s reluctance.

Clinically, money matters manifest intrapsychically or interpersonally in three ways: as explicit conflicts, implicit issues, and unequivocal money-related pathologies. When explicit, patients, families, and couples are fully aware of the conflicts but have difficulty resolving financial disputes. When conflicts are implicit, money problems may be unacknowledged, avoided, denied, or minimized. Conflicts concerning money are often transmitted trans-generationally.

Psychopathological conditions unequivocally linked to money include compulsive shopping, gambling disorders, miserly hoarding, impulse buying, and spending sprees during hypomanic and manic states. Mounting debts may create progressively insurmountable sources of distress. Money can be weaponized to sadistically create enticement, envy, or deprivation. Some monetarily antisocial individuals compromise interpersonal relationships as well as treatments. Individuals with alcohol/substance use disorders may spend so much on substances that little is left for necessities. Financially needy individuals may engage in morally questionable behaviors they might otherwise shun.
 

Case formulation and treatment planning

Incorporating money matters into case formulations entails demonstrating how financial concerns influenced maladaptive development and distort current attitudes, perceptions, and behaviors.

Concurrently, clinicians should acknowledge patients’ reality-based fiscal decisions, appreciating cultural and family value differences concerning how money should be acquired and spent. Since money often determines frequency and duration of treatment visits, clinicians are ethically obligated to discuss with patients what they might expect from different medications and psychotherapies, and their comparative costs.
 

Money matters’ impact on psychotherapies

Money matters often affect transference and countertransference reactions. Some reactions stem from how patients and clinicians compare their own financial situations with those of the other.

To help identify and ameliorate money-related countertransference responses, clinicians can reflect on questions such as: “How comfortable are you with people who are much poorer or richer than you are?” “How comfortable are you with impoverished individuals or with multimillionaires or their children?” And “why?” For trainees, all these reactions should be discussed in supervision.
 

Conclusions

To summarize, four clinical psychoeconomic issues should be routinely assessed and factored into psychiatric case formulations and treatment plans: how financial issues 1) have impacted patients’ psychological development; 2) impact patients’ current lives; 3) are likely to impact access, type, intensity, and duration of treatment visits; and 4) might provoke money-related transference and countertransference concerns.

In advising patients about treatment options, clinicians should discuss each treatment’s relative effectiveness and estimated costs of care. Patients’ decisions will likely be heavily influenced by financial considerations.

Dr. Yager is based in the department of psychiatry, University of Colorado at Denver, Aurora. Dr. Kay is based in the department of psychiatry, Wright State University, Dayton, Ohio. No external funds were received for this project, and the authors have no conflicts to disclose.

Reference

1. Yager J and Kay J. Money matters in psychiatric assessment, case formulation, treatment planning, and ongoing psychotherapy: Clinical psychoeconomics. J Nerv Ment Dis. 2022 Jun 10. doi: 10.1097/NMD.0000000000001552.

Despite money’s central role in our psychic lives, many trainees – and some seasoned practitioners – skirt around financial issues. Some clinicians confess that inquiring about patients’ finances feels “too personal.” They fear that asking about money could suggest that the clinician is primarily concerned with getting paid. Some clinicians feel that looking into patients’ finances might be unprofessional, outside one’s scope of practice. But it is not.

Trainees often receive little guidance concerning money matters in patients’ lives and treatments, considerations we have labeled clinical psychoeconomics. Considerable evidence suggests that financial concerns often provoke emotional distress and dysfunctional behaviors, and directly influence patient’s health care decisions. Financial issues also influence how clinicians view and react to patients.

We have recently reviewed (and illustrated through case vignettes) how money matters might impact psychiatric assessment, case formulation, treatment planning, and ongoing psychiatric treatments including psychotherapies.¹ Consider how money affects people’s lives: Money helps people meet multiple practical, psychological, and social needs by enabling them to obtain food, clothing, shelter, other material goods, services, discretionary time, and opportunities. And money strongly influences relationships. Regardless of poverty or wealth, thoughts and behaviors connected to acquiring, possessing, and disposing of money, and feelings accompanying these processes such as greed, neediness, envy, pride, shame, guilt, and self-satisfaction often underly intrapsychic and interpersonal conflicts.

Individuals constantly engage in numerous simultaneous conscious, preconscious, and unconscious neuro-economic trade-offs that determine goals, efforts, and timing. Many are financially influenced. Money influences how virtually all patients seek, receive, and sustain their mental health care including psychotherapy.

Money problems can be associated with insecurity, impotence, feeling unloved, and lack of freedom or subjugation. Individuals may resent how they’re forced to acquire money, and feel shamed or morally injured by their jobs, financial dependence on other family members, public assistance, or their questionable ways of obtaining money.

Impoverished individuals may face choosing between food, housing, medications, and medical care. Domestically abused individuals may reluctantly remain with their abusers, risking physical harm or death rather than face destitution. Some families tolerate severely disabled individuals at home because they rely on their disability checks and caregiver payments. Suicides may turn on how individuals forecast financial repercussions affecting their families. Desires to avoid debt may lead to treatment avoidance.

Individuals with enough money to get by face daily financially related choices involving competing needs, desires, values, and loyalties. They may experience conflicts concerning spending on necessities vs. indulgences or spending on oneself vs. significant others.

Whereas some wealthy individuals may assume unwarranted airs of superiority and entitlement, others may feel guilty about wealth, or fearful that others like them only for their money. Individuals on the receiving end of wealth may feel emotionally and behaviorally manipulated by their benefactors.
 

Assessment

Assessments should consider how financial matters have shaped patients’ early psychological development as well their current lives. How do patients’ emotions, thoughts, and behaviors reflect money matters? What money-related pathologies are evident? What aspects of the patient’s “financial world” seem modifiable?

Financial questions should be posed colloquially. Screeners include: “Where do you live?”, “Who’s in the home?”, “How do you (all) manage financially?”, “What do you all do for a living?”, “How do you make ends meet?”, and “What financial problems are you facing?” Clinicians can quickly learn about patients’ financial self-sufficiencies, individuals for whom they bear financial responsibility, and others they rely on for support, for example, relatives. If patients avoid answering such questions forthrightly, particularly when financial arrangements are “complicated,” clinicians will want to revisit these issues later after establishing a firmer alliance but continue to wonder about the meaning of the patient’s reluctance.

Clinically, money matters manifest intrapsychically or interpersonally in three ways: as explicit conflicts, implicit issues, and unequivocal money-related pathologies. When explicit, patients, families, and couples are fully aware of the conflicts but have difficulty resolving financial disputes. When conflicts are implicit, money problems may be unacknowledged, avoided, denied, or minimized. Conflicts concerning money are often transmitted trans-generationally.

Psychopathological conditions unequivocally linked to money include compulsive shopping, gambling disorders, miserly hoarding, impulse buying, and spending sprees during hypomanic and manic states. Mounting debts may create progressively insurmountable sources of distress. Money can be weaponized to sadistically create enticement, envy, or deprivation. Some monetarily antisocial individuals compromise interpersonal relationships as well as treatments. Individuals with alcohol/substance use disorders may spend so much on substances that little is left for necessities. Financially needy individuals may engage in morally questionable behaviors they might otherwise shun.
 

Case formulation and treatment planning

Incorporating money matters into case formulations entails demonstrating how financial concerns influenced maladaptive development and distort current attitudes, perceptions, and behaviors.

Concurrently, clinicians should acknowledge patients’ reality-based fiscal decisions, appreciating cultural and family value differences concerning how money should be acquired and spent. Since money often determines frequency and duration of treatment visits, clinicians are ethically obligated to discuss with patients what they might expect from different medications and psychotherapies, and their comparative costs.
 

Money matters’ impact on psychotherapies

Money matters often affect transference and countertransference reactions. Some reactions stem from how patients and clinicians compare their own financial situations with those of the other.

To help identify and ameliorate money-related countertransference responses, clinicians can reflect on questions such as: “How comfortable are you with people who are much poorer or richer than you are?” “How comfortable are you with impoverished individuals or with multimillionaires or their children?” And “why?” For trainees, all these reactions should be discussed in supervision.
 

Conclusions

To summarize, four clinical psychoeconomic issues should be routinely assessed and factored into psychiatric case formulations and treatment plans: how financial issues 1) have impacted patients’ psychological development; 2) impact patients’ current lives; 3) are likely to impact access, type, intensity, and duration of treatment visits; and 4) might provoke money-related transference and countertransference concerns.

In advising patients about treatment options, clinicians should discuss each treatment’s relative effectiveness and estimated costs of care. Patients’ decisions will likely be heavily influenced by financial considerations.

Dr. Yager is based in the department of psychiatry, University of Colorado at Denver, Aurora. Dr. Kay is based in the department of psychiatry, Wright State University, Dayton, Ohio. No external funds were received for this project, and the authors have no conflicts to disclose.

Reference

1. Yager J and Kay J. Money matters in psychiatric assessment, case formulation, treatment planning, and ongoing psychotherapy: Clinical psychoeconomics. J Nerv Ment Dis. 2022 Jun 10. doi: 10.1097/NMD.0000000000001552.

Using artificial intelligence, researchers have developed an algorithm that can help improve the prediction of colorectal cancer (CRC) recurrence.

The QuantCRC algorithm can identify patients with CRC who might be able to skip chemotherapy, given a low probability of recurrence, and identify those patients at high risk for recurrence who may benefit from more intensive treatment or follow-up, the researchers say.

“For patients with colon cancer, the algorithm gives oncologists another tool to help guide therapy and follow-up,” Rish Pai, MD, PhD, a pathologist at Mayo Clinic, Phoenix, who developed the tool, said in a news release.

The study was published online in the journal Gastroenterology.

The tool is a deep-learning segmentation algorithm developed using 6,468 digitized CRC images. It quantifies 15 features from a CRC image and uses them to improve prediction of recurrence.

“QuantCRC can identify different regions within the tumor and extract quantitative data from these regions,” Dr. Pai explained.

“The algorithm converts an image into a set of numbers that is unique to that tumor. The large number of tumors that we analyzed allowed us to learn which features were most predictive of tumor behavior. We can now apply what we have learned to new colon cancers to predict how the tumor will behave,” Dr. Pai said.

The researchers developed a prognostic model incorporating stage, mismatch repair, and QuantCRC that resulted in a concordance (c)-index of 0.714 in the internal test and 0.744 in the external cohort. Removing QuantCRC from the model reduced the c-index to 0.679 in the external cohort.

Using QuantCRC, they identified prognostic risk groups for recurrence, which provided a hazard ratio of 2.24 for low- versus high-risk stage III CRC and 2.36 for low- versus high-risk stage II CRC, in the external cohort after adjusting for established risk factors.

The predicted median 36-month recurrence rate for high-risk stage III CRC was 32.7% versus 13.4% for low-risk stage III CRC and 15.8% for high-risk stage II CRC versus 5.4% for low-risk stage II CRC, the researchers report.

QuantCRC provides a “powerful adjunct” to routine pathologic reporting of CRC, and a prognostic model using QuantCRC can improve prediction of recurrence-free survival, they write.

Looking ahead, Dr. Pai plans to use QuantCRC to better understand mechanisms of tumor recurrence and see if it can predict the response to certain treatments, like immunotherapy, he said.

Funding for this study was provided in part by the Colon Cancer Family Registry, which is supported in part by funding from the National Cancer Institute and National Institutes of Health. Dr. Pai reports consulting income from Alimentiv, Eli Lilly, AbbVie, Allergan, Genentech, and PathAI outside of the submitted work.

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

Using artificial intelligence, researchers have developed an algorithm that can help improve the prediction of colorectal cancer (CRC) recurrence.

The QuantCRC algorithm can identify patients with CRC who might be able to skip chemotherapy, given a low probability of recurrence, and identify those patients at high risk for recurrence who may benefit from more intensive treatment or follow-up, the researchers say.

“For patients with colon cancer, the algorithm gives oncologists another tool to help guide therapy and follow-up,” Rish Pai, MD, PhD, a pathologist at Mayo Clinic, Phoenix, who developed the tool, said in a news release.

The study was published online in the journal Gastroenterology.

The tool is a deep-learning segmentation algorithm developed using 6,468 digitized CRC images. It quantifies 15 features from a CRC image and uses them to improve prediction of recurrence.

“QuantCRC can identify different regions within the tumor and extract quantitative data from these regions,” Dr. Pai explained.

“The algorithm converts an image into a set of numbers that is unique to that tumor. The large number of tumors that we analyzed allowed us to learn which features were most predictive of tumor behavior. We can now apply what we have learned to new colon cancers to predict how the tumor will behave,” Dr. Pai said.

The researchers developed a prognostic model incorporating stage, mismatch repair, and QuantCRC that resulted in a concordance (c)-index of 0.714 in the internal test and 0.744 in the external cohort. Removing QuantCRC from the model reduced the c-index to 0.679 in the external cohort.

Using QuantCRC, they identified prognostic risk groups for recurrence, which provided a hazard ratio of 2.24 for low- versus high-risk stage III CRC and 2.36 for low- versus high-risk stage II CRC, in the external cohort after adjusting for established risk factors.

The predicted median 36-month recurrence rate for high-risk stage III CRC was 32.7% versus 13.4% for low-risk stage III CRC and 15.8% for high-risk stage II CRC versus 5.4% for low-risk stage II CRC, the researchers report.

QuantCRC provides a “powerful adjunct” to routine pathologic reporting of CRC, and a prognostic model using QuantCRC can improve prediction of recurrence-free survival, they write.

Looking ahead, Dr. Pai plans to use QuantCRC to better understand mechanisms of tumor recurrence and see if it can predict the response to certain treatments, like immunotherapy, he said.

Funding for this study was provided in part by the Colon Cancer Family Registry, which is supported in part by funding from the National Cancer Institute and National Institutes of Health. Dr. Pai reports consulting income from Alimentiv, Eli Lilly, AbbVie, Allergan, Genentech, and PathAI outside of the submitted work.

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

Using artificial intelligence, researchers have developed an algorithm that can help improve the prediction of colorectal cancer (CRC) recurrence.

The QuantCRC algorithm can identify patients with CRC who might be able to skip chemotherapy, given a low probability of recurrence, and identify those patients at high risk for recurrence who may benefit from more intensive treatment or follow-up, the researchers say.

“For patients with colon cancer, the algorithm gives oncologists another tool to help guide therapy and follow-up,” Rish Pai, MD, PhD, a pathologist at Mayo Clinic, Phoenix, who developed the tool, said in a news release.

The study was published online in the journal Gastroenterology.

The tool is a deep-learning segmentation algorithm developed using 6,468 digitized CRC images. It quantifies 15 features from a CRC image and uses them to improve prediction of recurrence.

“QuantCRC can identify different regions within the tumor and extract quantitative data from these regions,” Dr. Pai explained.

“The algorithm converts an image into a set of numbers that is unique to that tumor. The large number of tumors that we analyzed allowed us to learn which features were most predictive of tumor behavior. We can now apply what we have learned to new colon cancers to predict how the tumor will behave,” Dr. Pai said.

The researchers developed a prognostic model incorporating stage, mismatch repair, and QuantCRC that resulted in a concordance (c)-index of 0.714 in the internal test and 0.744 in the external cohort. Removing QuantCRC from the model reduced the c-index to 0.679 in the external cohort.

Using QuantCRC, they identified prognostic risk groups for recurrence, which provided a hazard ratio of 2.24 for low- versus high-risk stage III CRC and 2.36 for low- versus high-risk stage II CRC, in the external cohort after adjusting for established risk factors.

The predicted median 36-month recurrence rate for high-risk stage III CRC was 32.7% versus 13.4% for low-risk stage III CRC and 15.8% for high-risk stage II CRC versus 5.4% for low-risk stage II CRC, the researchers report.

QuantCRC provides a “powerful adjunct” to routine pathologic reporting of CRC, and a prognostic model using QuantCRC can improve prediction of recurrence-free survival, they write.

Looking ahead, Dr. Pai plans to use QuantCRC to better understand mechanisms of tumor recurrence and see if it can predict the response to certain treatments, like immunotherapy, he said.

Funding for this study was provided in part by the Colon Cancer Family Registry, which is supported in part by funding from the National Cancer Institute and National Institutes of Health. Dr. Pai reports consulting income from Alimentiv, Eli Lilly, AbbVie, Allergan, Genentech, and PathAI outside of the submitted work.

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

Type 2 diabetes (T2D) has become a noncommunicable pandemic. Approximately 14.7% of the US adult population has diabetes.¹ Additionally, nearly 25% of the geriatric population has diabetes and nearly 50% has prediabetes.² Needless to say, most practices, regardless of specialty, see many patients with diabetes. We have made major advances in diabetes treatments, yet diabetes mellitus is still the leading cause of legal blindness, nontraumatic amputation, and end-stage renal disease requiring dialysis.³ 

While the prevalence of diabetes in adults is concerning, what is even more startling is the significant increase of T2D within the pediatric population. It was not too long ago that we considered T2D an “adult-only” disease. Now, 24% of children with diabetes have T2D, and 18% of adolescents have prediabetes.^4,5 This is not the end of the story. Recent studies have identified that the earlier you are diagnosed with T2D, the less responsive you are to diabetes treatments—and the disease will progress more rapidly to complications. 
 

We know that pediatric patients are not little adults. There are important physiologic and metabolic differences in our younger patients. The RISE study found that adolescents have lower insulin sensitivity than adults.^4,6 The pancreatic beta cells are more responsive at first and there is less clearance by the liver, which may indeed make insulin resistance worse. Finally, pancreatic beta cell function declines more rapidly in adolescents than in adults.^4,6 These physiologic changes can be even worse during puberty. The hormonal changes seen in puberty accelerate and amplify insulin secretion and worsen insulin resistance, which can result in hyperglycemia in those at risk.^7,8

The other complicating factor is the rapid rise in obesity in Americans. While childhood obesity is not quite at adult levels, it is a major risk factor for adult obesity. The prevalence of obesity in childhood was recently estimated to be 19.7% and is still on the rise.⁹ Obesity can be diabetogenic as we see an increase in visceral obesity. This triggers an inflammatory response that leads to worsening systemic insulin resistance and lipotoxicity from elevated circulating free fatty acids.⁸ 

Lifestyle and behavioral factors are also important in adolescents with T2D. While they are more independent than younger children, they are still largely dependent on the foods that are available in their home. Family food choices have a major impact on our youth. Further, the foods that our adolescents eat outside the home are more likely to be fast food or ultra-processed foods, which have been shown to contribute to obesity and T2D. 

Family history is a strong predictor of risk for T2D. In the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) cohort, 89.4% of pediatric participants had a first-degree relative or grandparent with T2D.¹⁰ This highlights the importance of both genetic risk and living environment as risks for T2D. 

The American Diabetes Association recommends that all children with specific risk factors be screened for diabetes starting at the age 10 years or at puberty, whichever comes first.¹¹ The screening tests recommended for diabetes are currently the same as for adults, yet there are few data supporting this regimen. To diagnose diabetes, you can use any of the following screening tests: fasting glucose, glucose tolerance, or glycated hemoglobin (HbA1c).¹ 

Risk Factors That Should Prompt Diabetes Screening¹¹

Screening is recommended in children who are overweight (≥85%) or obese (≥95%) and who also have ≥1 of the following risk factors:

• Family history of T2D in a first- or second-degree relative
• Maternal history of gestational diabetes
• Low birth weight for gestational age
• Physical signs of insulin resistance or related conditions (eg, hypertension, dyslipidemia, polycystic ovary syndrome)
• High-risk race/ethnicity (Native American, African American, Pacific Islander, Latino)

Diagnostic Criteria for Diabetes Mellitus¹¹

A childhood or adolescent T2D diagnosis should be taken seriously and communicated to the patient and family in a timely manner. Treatment should start immediately. There are several factors that make managing T2D in adolescents more challenging. Children do not control key aspects of their life, including nutrition and, often, free time activity. There are a lot of social pressures to be “normal,” and having a chronic disease will definitely make the child feel “different” and potentially feel socially isolated. There are high rates of mood disorders in children with diabetes, which can make self-management even harder.¹²

As mentioned above, treatment should begin immediately upon diagnosis. This is because T2D in younger people tends to be more progressive and less responsive to treatment options, and patients are much more likely to develop.^1,13,14 These same complications can be seen in adult patients, but in younger patients they develop earlier in the disease; specifically, renal and neurologic complications occur at even higher rates.¹⁴ 

The initial treatment should include both family-based therapeutic lifestyle changes (ie, nutrition, physical activity intervention) and medication.¹¹ There are fewer US Food and Drug Administration–approved medication options for children and adolescents, and those treatments that have been approved are less durable in this population. 

Metformin and insulin are the most-used medications, but their initiation is often delayed, as therapeutic lifestyle change is tried first. This has not been shown to be an effective strategy and may even undermine the value of therapeutic lifestyle change if the family is told later that medication may still need to be added. 

Recent studies have shown the benefit of select glucagon-like peptide-1 receptor agonists (GLP-1 RAs) as important therapeutic tools to treat T2D in adolescence. Dulaglutide, exenatide, and liraglutide have been shown to be safe and effective in trials for adolescents with T2D.^15-17 These agents reduce glucose and body weight and may be important tools to help reduce extra glycemic risks (eg, cardiovascular disease, kidney disease), but they have not been studied for this purpose yet. 

Further, there is good support for the use of bariatric surgery for adolescents. While this is a relatively new treatment option, early and mid-term results are favorable compared with medication-based strategies.¹⁸ Further studies are needed to determine the long-term benefits.

Take home points:

1. T2D is becoming increasingly common in our youth.
2. T2D, when diagnosed earlier in life, is more progressive, less responsive to treatment options, and associated with earlier complications.
3. New studies support the use of novel therapies such as GLP-1 RAs and metabolic surgery in this age group.

Dr. Shubrook and Dr. Antonia M. Molinari have written a comprehensive review on treatment options and current guidelines for the management of T2D in the pediatric population, which can supply further information.¹⁹ 

Type 2 diabetes (T2D) has become a noncommunicable pandemic. Approximately 14.7% of the US adult population has diabetes.¹ Additionally, nearly 25% of the geriatric population has diabetes and nearly 50% has prediabetes.² Needless to say, most practices, regardless of specialty, see many patients with diabetes. We have made major advances in diabetes treatments, yet diabetes mellitus is still the leading cause of legal blindness, nontraumatic amputation, and end-stage renal disease requiring dialysis.³ 

While the prevalence of diabetes in adults is concerning, what is even more startling is the significant increase of T2D within the pediatric population. It was not too long ago that we considered T2D an “adult-only” disease. Now, 24% of children with diabetes have T2D, and 18% of adolescents have prediabetes.^4,5 This is not the end of the story. Recent studies have identified that the earlier you are diagnosed with T2D, the less responsive you are to diabetes treatments—and the disease will progress more rapidly to complications. 
 

We know that pediatric patients are not little adults. There are important physiologic and metabolic differences in our younger patients. The RISE study found that adolescents have lower insulin sensitivity than adults.^4,6 The pancreatic beta cells are more responsive at first and there is less clearance by the liver, which may indeed make insulin resistance worse. Finally, pancreatic beta cell function declines more rapidly in adolescents than in adults.^4,6 These physiologic changes can be even worse during puberty. The hormonal changes seen in puberty accelerate and amplify insulin secretion and worsen insulin resistance, which can result in hyperglycemia in those at risk.^7,8

The other complicating factor is the rapid rise in obesity in Americans. While childhood obesity is not quite at adult levels, it is a major risk factor for adult obesity. The prevalence of obesity in childhood was recently estimated to be 19.7% and is still on the rise.⁹ Obesity can be diabetogenic as we see an increase in visceral obesity. This triggers an inflammatory response that leads to worsening systemic insulin resistance and lipotoxicity from elevated circulating free fatty acids.⁸ 

Lifestyle and behavioral factors are also important in adolescents with T2D. While they are more independent than younger children, they are still largely dependent on the foods that are available in their home. Family food choices have a major impact on our youth. Further, the foods that our adolescents eat outside the home are more likely to be fast food or ultra-processed foods, which have been shown to contribute to obesity and T2D. 

Family history is a strong predictor of risk for T2D. In the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) cohort, 89.4% of pediatric participants had a first-degree relative or grandparent with T2D.¹⁰ This highlights the importance of both genetic risk and living environment as risks for T2D. 

The American Diabetes Association recommends that all children with specific risk factors be screened for diabetes starting at the age 10 years or at puberty, whichever comes first.¹¹ The screening tests recommended for diabetes are currently the same as for adults, yet there are few data supporting this regimen. To diagnose diabetes, you can use any of the following screening tests: fasting glucose, glucose tolerance, or glycated hemoglobin (HbA1c).¹ 

Risk Factors That Should Prompt Diabetes Screening¹¹

Screening is recommended in children who are overweight (≥85%) or obese (≥95%) and who also have ≥1 of the following risk factors:

• Family history of T2D in a first- or second-degree relative
• Maternal history of gestational diabetes
• Low birth weight for gestational age
• Physical signs of insulin resistance or related conditions (eg, hypertension, dyslipidemia, polycystic ovary syndrome)
• High-risk race/ethnicity (Native American, African American, Pacific Islander, Latino)

Diagnostic Criteria for Diabetes Mellitus¹¹

A childhood or adolescent T2D diagnosis should be taken seriously and communicated to the patient and family in a timely manner. Treatment should start immediately. There are several factors that make managing T2D in adolescents more challenging. Children do not control key aspects of their life, including nutrition and, often, free time activity. There are a lot of social pressures to be “normal,” and having a chronic disease will definitely make the child feel “different” and potentially feel socially isolated. There are high rates of mood disorders in children with diabetes, which can make self-management even harder.¹²

As mentioned above, treatment should begin immediately upon diagnosis. This is because T2D in younger people tends to be more progressive and less responsive to treatment options, and patients are much more likely to develop.^1,13,14 These same complications can be seen in adult patients, but in younger patients they develop earlier in the disease; specifically, renal and neurologic complications occur at even higher rates.¹⁴ 

The initial treatment should include both family-based therapeutic lifestyle changes (ie, nutrition, physical activity intervention) and medication.¹¹ There are fewer US Food and Drug Administration–approved medication options for children and adolescents, and those treatments that have been approved are less durable in this population. 

Metformin and insulin are the most-used medications, but their initiation is often delayed, as therapeutic lifestyle change is tried first. This has not been shown to be an effective strategy and may even undermine the value of therapeutic lifestyle change if the family is told later that medication may still need to be added. 

Recent studies have shown the benefit of select glucagon-like peptide-1 receptor agonists (GLP-1 RAs) as important therapeutic tools to treat T2D in adolescence. Dulaglutide, exenatide, and liraglutide have been shown to be safe and effective in trials for adolescents with T2D.^15-17 These agents reduce glucose and body weight and may be important tools to help reduce extra glycemic risks (eg, cardiovascular disease, kidney disease), but they have not been studied for this purpose yet. 

Further, there is good support for the use of bariatric surgery for adolescents. While this is a relatively new treatment option, early and mid-term results are favorable compared with medication-based strategies.¹⁸ Further studies are needed to determine the long-term benefits.

Take home points:

1. T2D is becoming increasingly common in our youth.
2. T2D, when diagnosed earlier in life, is more progressive, less responsive to treatment options, and associated with earlier complications.
3. New studies support the use of novel therapies such as GLP-1 RAs and metabolic surgery in this age group.

Dr. Shubrook and Dr. Antonia M. Molinari have written a comprehensive review on treatment options and current guidelines for the management of T2D in the pediatric population, which can supply further information.¹⁹ 

Type 2 diabetes (T2D) has become a noncommunicable pandemic. Approximately 14.7% of the US adult population has diabetes.¹ Additionally, nearly 25% of the geriatric population has diabetes and nearly 50% has prediabetes.² Needless to say, most practices, regardless of specialty, see many patients with diabetes. We have made major advances in diabetes treatments, yet diabetes mellitus is still the leading cause of legal blindness, nontraumatic amputation, and end-stage renal disease requiring dialysis.³ 

While the prevalence of diabetes in adults is concerning, what is even more startling is the significant increase of T2D within the pediatric population. It was not too long ago that we considered T2D an “adult-only” disease. Now, 24% of children with diabetes have T2D, and 18% of adolescents have prediabetes.^4,5 This is not the end of the story. Recent studies have identified that the earlier you are diagnosed with T2D, the less responsive you are to diabetes treatments—and the disease will progress more rapidly to complications. 
 

We know that pediatric patients are not little adults. There are important physiologic and metabolic differences in our younger patients. The RISE study found that adolescents have lower insulin sensitivity than adults.^4,6 The pancreatic beta cells are more responsive at first and there is less clearance by the liver, which may indeed make insulin resistance worse. Finally, pancreatic beta cell function declines more rapidly in adolescents than in adults.^4,6 These physiologic changes can be even worse during puberty. The hormonal changes seen in puberty accelerate and amplify insulin secretion and worsen insulin resistance, which can result in hyperglycemia in those at risk.^7,8

The other complicating factor is the rapid rise in obesity in Americans. While childhood obesity is not quite at adult levels, it is a major risk factor for adult obesity. The prevalence of obesity in childhood was recently estimated to be 19.7% and is still on the rise.⁹ Obesity can be diabetogenic as we see an increase in visceral obesity. This triggers an inflammatory response that leads to worsening systemic insulin resistance and lipotoxicity from elevated circulating free fatty acids.⁸ 

Lifestyle and behavioral factors are also important in adolescents with T2D. While they are more independent than younger children, they are still largely dependent on the foods that are available in their home. Family food choices have a major impact on our youth. Further, the foods that our adolescents eat outside the home are more likely to be fast food or ultra-processed foods, which have been shown to contribute to obesity and T2D. 

Family history is a strong predictor of risk for T2D. In the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) cohort, 89.4% of pediatric participants had a first-degree relative or grandparent with T2D.¹⁰ This highlights the importance of both genetic risk and living environment as risks for T2D. 

The American Diabetes Association recommends that all children with specific risk factors be screened for diabetes starting at the age 10 years or at puberty, whichever comes first.¹¹ The screening tests recommended for diabetes are currently the same as for adults, yet there are few data supporting this regimen. To diagnose diabetes, you can use any of the following screening tests: fasting glucose, glucose tolerance, or glycated hemoglobin (HbA1c).¹ 

Risk Factors That Should Prompt Diabetes Screening¹¹

Screening is recommended in children who are overweight (≥85%) or obese (≥95%) and who also have ≥1 of the following risk factors:

• Family history of T2D in a first- or second-degree relative
• Maternal history of gestational diabetes
• Low birth weight for gestational age
• Physical signs of insulin resistance or related conditions (eg, hypertension, dyslipidemia, polycystic ovary syndrome)
• High-risk race/ethnicity (Native American, African American, Pacific Islander, Latino)

Diagnostic Criteria for Diabetes Mellitus¹¹

A childhood or adolescent T2D diagnosis should be taken seriously and communicated to the patient and family in a timely manner. Treatment should start immediately. There are several factors that make managing T2D in adolescents more challenging. Children do not control key aspects of their life, including nutrition and, often, free time activity. There are a lot of social pressures to be “normal,” and having a chronic disease will definitely make the child feel “different” and potentially feel socially isolated. There are high rates of mood disorders in children with diabetes, which can make self-management even harder.¹²

As mentioned above, treatment should begin immediately upon diagnosis. This is because T2D in younger people tends to be more progressive and less responsive to treatment options, and patients are much more likely to develop.^1,13,14 These same complications can be seen in adult patients, but in younger patients they develop earlier in the disease; specifically, renal and neurologic complications occur at even higher rates.¹⁴ 

The initial treatment should include both family-based therapeutic lifestyle changes (ie, nutrition, physical activity intervention) and medication.¹¹ There are fewer US Food and Drug Administration–approved medication options for children and adolescents, and those treatments that have been approved are less durable in this population. 

Metformin and insulin are the most-used medications, but their initiation is often delayed, as therapeutic lifestyle change is tried first. This has not been shown to be an effective strategy and may even undermine the value of therapeutic lifestyle change if the family is told later that medication may still need to be added. 

Recent studies have shown the benefit of select glucagon-like peptide-1 receptor agonists (GLP-1 RAs) as important therapeutic tools to treat T2D in adolescence. Dulaglutide, exenatide, and liraglutide have been shown to be safe and effective in trials for adolescents with T2D.^15-17 These agents reduce glucose and body weight and may be important tools to help reduce extra glycemic risks (eg, cardiovascular disease, kidney disease), but they have not been studied for this purpose yet. 

Further, there is good support for the use of bariatric surgery for adolescents. While this is a relatively new treatment option, early and mid-term results are favorable compared with medication-based strategies.¹⁸ Further studies are needed to determine the long-term benefits.

Take home points:

1. T2D is becoming increasingly common in our youth.
2. T2D, when diagnosed earlier in life, is more progressive, less responsive to treatment options, and associated with earlier complications.
3. New studies support the use of novel therapies such as GLP-1 RAs and metabolic surgery in this age group.

Dr. Shubrook and Dr. Antonia M. Molinari have written a comprehensive review on treatment options and current guidelines for the management of T2D in the pediatric population, which can supply further information.¹⁹ 

The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

A provider-only patient care protocol was safe and efficient for delivery of emergency department care in response to pandemic-related staff shortages, based on data from nearly 3,000 patients.

The COVID-19 pandemic sparked a shortage of health care personnel, according to Tanveer Gaibi, MD, of INOVA Fairfax Hospital, Falls Church, Va., and colleagues. To help manage these challenges, the INOVA emergency department developed a Provider-Only Patients (POP) protocol for patients who required minimal nursing care.

In a study presented at the American College of Emergency Physicians 2022 Scientific Assembly, the researchers reported the outcomes of a cohort of patients with suspected COVID-19 who were treated in the emergency department using the POP protocol between Dec. 1, 2021, and Jan. 15, 2022. The patients ranged in age from 21 to 64, and all presented with COVID-19-related complaints, with an Emergency Severity Index (ESI) of 4 or 5, with 1 being the most urgent and 5 being the least urgent.

Patients were triaged by a physician or nurse to determine POP status. Those deemed POP were seen and discharged directly by a physician or advanced-practice provider (APP). The researchers reviewed data from a total of 640 patients treated via the POP protocol and 2,386 patients who were not POP with ESI of 4 or 5.

Overall, the mean time from when a patient was initially seen by a provider to the discharge disposition was 48 minutes shorter for POP, and the mean time from discharge disposition placement to leaving the ED was 66 minutes shorter. None of the POP-protocol patients were readmitted within 72 hours of discharge. The researchers estimated that the 640 patients in the POP protocol saved approximately 1892.27 hours of nursing and 705.1 provider hours during the study period, and no additional physician hours or advanced-practice provider hours were needed.

The study findings suggest that POP holds up as a safe, efficient, and effective process that can reduce discharge length of stay and provider to disposition times. Although more research is needed, the POP model also may be considered to address staffing challenges unrelated to the pandemic, the researchers concluded.

“This study was conducted at [a] time when our emergency department was experiencing a sudden and disproportionate increase in volume related to the Omicron variant of COVID-19,” Dr. Gaibi told this news organization. “This novel process was developed by brainstorming untested ways of managing this increased demand. The research study was a natural outcome once the process was implemented,” he said.

“Once barriers to implementing this process were overcome, we were not surprised by the results,” Dr. Gaibi said. “Subtracting at the time for nursing process was anticipated to shorten cycle times.”

The clinical implications of POP relate to generalizability outside of the pandemic setting, Dr. Gaibi noted. “We anticipate that POP could be used for patients with minor complaints to greatly shorten their time in the emergency department,” he said.

“Potential barriers to the generalized use of POP relate, in part, to local administrative barriers related to nursing assessments,” Dr. Gaibi explained. “Further, POP patients should be simple and require little or no testing. Keeping to this strict definition of the provider-only patient may be a pitfall in terms of its hard wiring,” he added.

Looking ahead, more research is needed to study POP in ED patients with minor complaints not necessarily related to COVID-19, Dr. Gaibi said.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

A provider-only patient care protocol was safe and efficient for delivery of emergency department care in response to pandemic-related staff shortages, based on data from nearly 3,000 patients.

The COVID-19 pandemic sparked a shortage of health care personnel, according to Tanveer Gaibi, MD, of INOVA Fairfax Hospital, Falls Church, Va., and colleagues. To help manage these challenges, the INOVA emergency department developed a Provider-Only Patients (POP) protocol for patients who required minimal nursing care.

In a study presented at the American College of Emergency Physicians 2022 Scientific Assembly, the researchers reported the outcomes of a cohort of patients with suspected COVID-19 who were treated in the emergency department using the POP protocol between Dec. 1, 2021, and Jan. 15, 2022. The patients ranged in age from 21 to 64, and all presented with COVID-19-related complaints, with an Emergency Severity Index (ESI) of 4 or 5, with 1 being the most urgent and 5 being the least urgent.

Patients were triaged by a physician or nurse to determine POP status. Those deemed POP were seen and discharged directly by a physician or advanced-practice provider (APP). The researchers reviewed data from a total of 640 patients treated via the POP protocol and 2,386 patients who were not POP with ESI of 4 or 5.

Overall, the mean time from when a patient was initially seen by a provider to the discharge disposition was 48 minutes shorter for POP, and the mean time from discharge disposition placement to leaving the ED was 66 minutes shorter. None of the POP-protocol patients were readmitted within 72 hours of discharge. The researchers estimated that the 640 patients in the POP protocol saved approximately 1892.27 hours of nursing and 705.1 provider hours during the study period, and no additional physician hours or advanced-practice provider hours were needed.

The study findings suggest that POP holds up as a safe, efficient, and effective process that can reduce discharge length of stay and provider to disposition times. Although more research is needed, the POP model also may be considered to address staffing challenges unrelated to the pandemic, the researchers concluded.

“This study was conducted at [a] time when our emergency department was experiencing a sudden and disproportionate increase in volume related to the Omicron variant of COVID-19,” Dr. Gaibi told this news organization. “This novel process was developed by brainstorming untested ways of managing this increased demand. The research study was a natural outcome once the process was implemented,” he said.

“Once barriers to implementing this process were overcome, we were not surprised by the results,” Dr. Gaibi said. “Subtracting at the time for nursing process was anticipated to shorten cycle times.”

The clinical implications of POP relate to generalizability outside of the pandemic setting, Dr. Gaibi noted. “We anticipate that POP could be used for patients with minor complaints to greatly shorten their time in the emergency department,” he said.

“Potential barriers to the generalized use of POP relate, in part, to local administrative barriers related to nursing assessments,” Dr. Gaibi explained. “Further, POP patients should be simple and require little or no testing. Keeping to this strict definition of the provider-only patient may be a pitfall in terms of its hard wiring,” he added.

Looking ahead, more research is needed to study POP in ED patients with minor complaints not necessarily related to COVID-19, Dr. Gaibi said.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

A provider-only patient care protocol was safe and efficient for delivery of emergency department care in response to pandemic-related staff shortages, based on data from nearly 3,000 patients.

The COVID-19 pandemic sparked a shortage of health care personnel, according to Tanveer Gaibi, MD, of INOVA Fairfax Hospital, Falls Church, Va., and colleagues. To help manage these challenges, the INOVA emergency department developed a Provider-Only Patients (POP) protocol for patients who required minimal nursing care.

In a study presented at the American College of Emergency Physicians 2022 Scientific Assembly, the researchers reported the outcomes of a cohort of patients with suspected COVID-19 who were treated in the emergency department using the POP protocol between Dec. 1, 2021, and Jan. 15, 2022. The patients ranged in age from 21 to 64, and all presented with COVID-19-related complaints, with an Emergency Severity Index (ESI) of 4 or 5, with 1 being the most urgent and 5 being the least urgent.

Patients were triaged by a physician or nurse to determine POP status. Those deemed POP were seen and discharged directly by a physician or advanced-practice provider (APP). The researchers reviewed data from a total of 640 patients treated via the POP protocol and 2,386 patients who were not POP with ESI of 4 or 5.

Overall, the mean time from when a patient was initially seen by a provider to the discharge disposition was 48 minutes shorter for POP, and the mean time from discharge disposition placement to leaving the ED was 66 minutes shorter. None of the POP-protocol patients were readmitted within 72 hours of discharge. The researchers estimated that the 640 patients in the POP protocol saved approximately 1892.27 hours of nursing and 705.1 provider hours during the study period, and no additional physician hours or advanced-practice provider hours were needed.

The study findings suggest that POP holds up as a safe, efficient, and effective process that can reduce discharge length of stay and provider to disposition times. Although more research is needed, the POP model also may be considered to address staffing challenges unrelated to the pandemic, the researchers concluded.

“This study was conducted at [a] time when our emergency department was experiencing a sudden and disproportionate increase in volume related to the Omicron variant of COVID-19,” Dr. Gaibi told this news organization. “This novel process was developed by brainstorming untested ways of managing this increased demand. The research study was a natural outcome once the process was implemented,” he said.

“Once barriers to implementing this process were overcome, we were not surprised by the results,” Dr. Gaibi said. “Subtracting at the time for nursing process was anticipated to shorten cycle times.”

The clinical implications of POP relate to generalizability outside of the pandemic setting, Dr. Gaibi noted. “We anticipate that POP could be used for patients with minor complaints to greatly shorten their time in the emergency department,” he said.

“Potential barriers to the generalized use of POP relate, in part, to local administrative barriers related to nursing assessments,” Dr. Gaibi explained. “Further, POP patients should be simple and require little or no testing. Keeping to this strict definition of the provider-only patient may be a pitfall in terms of its hard wiring,” he added.

Looking ahead, more research is needed to study POP in ED patients with minor complaints not necessarily related to COVID-19, Dr. Gaibi said.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Monthly injections of dupilumab significantly improved symptoms of moderate to severe atopic dermatitis (AD) in children aged 6 months to under 6 years after 16 weeks, in a study of 162 children at 31 treatment centers in North America and Europe.

Children younger than 6 years with moderate to severe AD have few options if their symptoms are uncontrolled with topical therapies, and persistent itchiness has a negative impact on quality of life for patients and families, Amy S. Paller, MD, professor and chair of dermatology, and professor of pediatrics at Northwestern University, Chicago, and colleagues wrote in the study, published in the Lancet.

The study was the basis of the Food and Drug Administration expanded approval of dupilumab in June 2022, to include children aged 6 months to 5 years with moderate to severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory submission for this age group is under review by the European Medicines Agency, and by regulatory authorities in other countries, according to the manufacturers.

Dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, was first approved in 2017 for treating adults with moderate to severe AD.

“There has not been a biologic approved before at such a young age, and for such a common disease,” Dr. Paller said in an interview. “This is the drug that has revolutionized care of the most common inflammatory skin disease in children, and this is the pivotal study that brought it to market for the youngest children who suffer from the severe forms.”

The study also sets a precedent for a lower threshold for starting systemic medication in young children for treating moderate to severe disease given the absence of severe side effects and no need for lab monitoring, Dr. Paller noted. However, dupilumab will also be closely watched “for both impact on the developing immune system and the possibility that it will alter the long-term course of the eczema and the development of allergic comorbidities, such as lowering the risk of developing asthma, GI, allergy, and possibly other conditions.”

In the study, the researchers randomized 83 children aged 6 months up to 6 years to treatment with dupilumab, administered subcutaneously, and 79 to placebo every 4 weeks for 16 weeks; both groups also received topical corticosteroids. Dosage of dupilumab was based on body weight; those with a body weight of 5-15 kg received 200 mg, while those with a body weight of 15-30 kg received 300 mg. The primary endpoint was the proportion of patients with clear or almost clear skin at 16 weeks, defined as scores of 0 or 1 on the Investigator’s Global Assessment.

After 16 weeks, 28% of dupilumab patients met the primary endpoint versus 4% of those on placebo (P < .0001). In addition, 53% of dupilumab patients met the key secondary endpoint of a 75% improvement from baseline in Eczema Area and Severity Index, compared with 11% of patients on placebo (P < .0001). Treatment with dupilumab also resulted in significantly greater improvements in pruritus and skin pain, and sleep quality, as well as improved quality of life for patients and their caregivers, the authors reported.

Overall, adverse event rates were slightly lower in the dupilumab-treated patients, compared with patients on placebo (64% vs. 74%); there were no adverse events related to dupilumab that were serious or resulted in treatment discontinuation. Treatment-emergent adverse effects that were reported in 3% or more of patients and affected more of those on dupilumab than those on placebo included molluscum contagiosum (5% vs. 3%), viral gastroenteritis (4% vs. 0), rhinorrhea (5% vs. 1%), dental caries (5% vs. 0), and conjunctivitis (4% vs 0).

The rate of skin infections among the children on dupilumab was 12% vs. 24% among those on placebo.

Severe and treatment-related adverse events also were similar in both subgroups of body weight.

The findings were limited by the small number of patients younger than 2 years and the lack of study sites outside of North America and Europe, the researchers noted. However, the results were strengthened by the randomized, double-blind design and use of background topical therapy to provide a real-world safety and efficacy assessment in a very young population.
 

Overcoming injection issues

The safety profile for dupilumab, which is of the highest importance, “did not surprise me at all,” Dr. Paller said in an interview. “My only surprise is that the placebo injections actually led to more injection site reactions than [with] dupilumab, but numbers were quite low in both groups.” (Rates were 2% among those on dupilumab and 3% among those on placebo.)

The major barrier to the use of dupilumab in clinical practice is the requirement for injection, which, she explained, can be “unbearable for some young children, and thus becomes impossible for parents because of lack of cooperation and their intensified concern about giving the injection,” because of their child’s response.

“We like to administer the first dose in the office, allowing us to teach parents a few tricks related to proper technique,” including audio and visual distraction, tactile stimulation before and during the injection, use of topical anesthetic if helpful, “and making sure that the medication is at room temperature before administration,” she said. Cost is another potential barrier; however, even public insurance has been covering the medication, often after optimized use of topical medications has been unsuccessful.
 

Future research questions

As for additional research, the current study had a relatively small number of patients younger than 2 years, and more data are needed for this age group, said Dr. Paller. “We also need better understanding of the safety of dupilumab administration when live vaccines are administered. Finally, we certainly want to know what additional effects dupilumab may have beyond just the efficacy for treating eczema.”

In particular, these questions include whether dupilumab modifies the long-term course of the disease, possibly reducing the risk of persistence of disease with advancing age, or even cures the disease if started at a young age, she said. In addition, research has yet to show whether dupilumab might reduce the risk of other atopic disorders, such as asthma, food allergy, and allergic rhinitis.

“Ongoing studies and real-life experiences in the next several years will help us to answer these questions,” Dr. Paller said.
 

Data support safety, efficacy, quality of life

AD is associated with immense quality of life impairment, Raj Chovatiya, MD, of Northwestern University, Chicago, said in an interview. Most AD is initially diagnosed in early childhood, but previous treatment options for those with moderate to severe disease have been limited by safety concerns, which adds to the burden on infants and young children, and their parents and caregivers, said Dr. Chovatiya, who was not involved in the study.

“This phase 3 study showed that dupilumab, a fully human monoclonal antibody that selectively inhibits IL-4 and IL-13 mediated type 2 inflammatory signaling, provided both meaningful and statistically significant improvement in AD severity, extent of disease, and itch in patients,” he said. Dupilumab also improved children’s sleep quality and the overall quality of life in both patients and caregivers.

“These findings were quite similar to those described in older children and adults, where dupilumab is already approved for the treatment of moderate-severe AD and has demonstrated real-world safety and efficacy,” said Dr. Chovatiya. However, “the current study was limited to only a short-term analysis of 16 weeks, an ongoing open-label study should further address long-term treatment responses.”

The study was supported by Sanofi and Regeneron Pharmaceuticals. In addition to being an investigator for Regeneron, and several other pharmaceutical companies, Dr. Paller has been a consultant with honorarium for Regeneron, Sanofi, and multiple other companies. Dr. Chovatiya disclosed serving as a consultant and speaker for Regeneron and Sanofi, but was not involved in the current study.

Monthly injections of dupilumab significantly improved symptoms of moderate to severe atopic dermatitis (AD) in children aged 6 months to under 6 years after 16 weeks, in a study of 162 children at 31 treatment centers in North America and Europe.

Children younger than 6 years with moderate to severe AD have few options if their symptoms are uncontrolled with topical therapies, and persistent itchiness has a negative impact on quality of life for patients and families, Amy S. Paller, MD, professor and chair of dermatology, and professor of pediatrics at Northwestern University, Chicago, and colleagues wrote in the study, published in the Lancet.

The study was the basis of the Food and Drug Administration expanded approval of dupilumab in June 2022, to include children aged 6 months to 5 years with moderate to severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory submission for this age group is under review by the European Medicines Agency, and by regulatory authorities in other countries, according to the manufacturers.

Dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, was first approved in 2017 for treating adults with moderate to severe AD.

“There has not been a biologic approved before at such a young age, and for such a common disease,” Dr. Paller said in an interview. “This is the drug that has revolutionized care of the most common inflammatory skin disease in children, and this is the pivotal study that brought it to market for the youngest children who suffer from the severe forms.”

The study also sets a precedent for a lower threshold for starting systemic medication in young children for treating moderate to severe disease given the absence of severe side effects and no need for lab monitoring, Dr. Paller noted. However, dupilumab will also be closely watched “for both impact on the developing immune system and the possibility that it will alter the long-term course of the eczema and the development of allergic comorbidities, such as lowering the risk of developing asthma, GI, allergy, and possibly other conditions.”

In the study, the researchers randomized 83 children aged 6 months up to 6 years to treatment with dupilumab, administered subcutaneously, and 79 to placebo every 4 weeks for 16 weeks; both groups also received topical corticosteroids. Dosage of dupilumab was based on body weight; those with a body weight of 5-15 kg received 200 mg, while those with a body weight of 15-30 kg received 300 mg. The primary endpoint was the proportion of patients with clear or almost clear skin at 16 weeks, defined as scores of 0 or 1 on the Investigator’s Global Assessment.

After 16 weeks, 28% of dupilumab patients met the primary endpoint versus 4% of those on placebo (P < .0001). In addition, 53% of dupilumab patients met the key secondary endpoint of a 75% improvement from baseline in Eczema Area and Severity Index, compared with 11% of patients on placebo (P < .0001). Treatment with dupilumab also resulted in significantly greater improvements in pruritus and skin pain, and sleep quality, as well as improved quality of life for patients and their caregivers, the authors reported.

Overall, adverse event rates were slightly lower in the dupilumab-treated patients, compared with patients on placebo (64% vs. 74%); there were no adverse events related to dupilumab that were serious or resulted in treatment discontinuation. Treatment-emergent adverse effects that were reported in 3% or more of patients and affected more of those on dupilumab than those on placebo included molluscum contagiosum (5% vs. 3%), viral gastroenteritis (4% vs. 0), rhinorrhea (5% vs. 1%), dental caries (5% vs. 0), and conjunctivitis (4% vs 0).

The rate of skin infections among the children on dupilumab was 12% vs. 24% among those on placebo.

Severe and treatment-related adverse events also were similar in both subgroups of body weight.

The findings were limited by the small number of patients younger than 2 years and the lack of study sites outside of North America and Europe, the researchers noted. However, the results were strengthened by the randomized, double-blind design and use of background topical therapy to provide a real-world safety and efficacy assessment in a very young population.
 

Overcoming injection issues

The safety profile for dupilumab, which is of the highest importance, “did not surprise me at all,” Dr. Paller said in an interview. “My only surprise is that the placebo injections actually led to more injection site reactions than [with] dupilumab, but numbers were quite low in both groups.” (Rates were 2% among those on dupilumab and 3% among those on placebo.)

The major barrier to the use of dupilumab in clinical practice is the requirement for injection, which, she explained, can be “unbearable for some young children, and thus becomes impossible for parents because of lack of cooperation and their intensified concern about giving the injection,” because of their child’s response.

“We like to administer the first dose in the office, allowing us to teach parents a few tricks related to proper technique,” including audio and visual distraction, tactile stimulation before and during the injection, use of topical anesthetic if helpful, “and making sure that the medication is at room temperature before administration,” she said. Cost is another potential barrier; however, even public insurance has been covering the medication, often after optimized use of topical medications has been unsuccessful.
 

Future research questions

As for additional research, the current study had a relatively small number of patients younger than 2 years, and more data are needed for this age group, said Dr. Paller. “We also need better understanding of the safety of dupilumab administration when live vaccines are administered. Finally, we certainly want to know what additional effects dupilumab may have beyond just the efficacy for treating eczema.”

In particular, these questions include whether dupilumab modifies the long-term course of the disease, possibly reducing the risk of persistence of disease with advancing age, or even cures the disease if started at a young age, she said. In addition, research has yet to show whether dupilumab might reduce the risk of other atopic disorders, such as asthma, food allergy, and allergic rhinitis.

“Ongoing studies and real-life experiences in the next several years will help us to answer these questions,” Dr. Paller said.
 

Data support safety, efficacy, quality of life

AD is associated with immense quality of life impairment, Raj Chovatiya, MD, of Northwestern University, Chicago, said in an interview. Most AD is initially diagnosed in early childhood, but previous treatment options for those with moderate to severe disease have been limited by safety concerns, which adds to the burden on infants and young children, and their parents and caregivers, said Dr. Chovatiya, who was not involved in the study.

“This phase 3 study showed that dupilumab, a fully human monoclonal antibody that selectively inhibits IL-4 and IL-13 mediated type 2 inflammatory signaling, provided both meaningful and statistically significant improvement in AD severity, extent of disease, and itch in patients,” he said. Dupilumab also improved children’s sleep quality and the overall quality of life in both patients and caregivers.

“These findings were quite similar to those described in older children and adults, where dupilumab is already approved for the treatment of moderate-severe AD and has demonstrated real-world safety and efficacy,” said Dr. Chovatiya. However, “the current study was limited to only a short-term analysis of 16 weeks, an ongoing open-label study should further address long-term treatment responses.”

The study was supported by Sanofi and Regeneron Pharmaceuticals. In addition to being an investigator for Regeneron, and several other pharmaceutical companies, Dr. Paller has been a consultant with honorarium for Regeneron, Sanofi, and multiple other companies. Dr. Chovatiya disclosed serving as a consultant and speaker for Regeneron and Sanofi, but was not involved in the current study.

Monthly injections of dupilumab significantly improved symptoms of moderate to severe atopic dermatitis (AD) in children aged 6 months to under 6 years after 16 weeks, in a study of 162 children at 31 treatment centers in North America and Europe.

Children younger than 6 years with moderate to severe AD have few options if their symptoms are uncontrolled with topical therapies, and persistent itchiness has a negative impact on quality of life for patients and families, Amy S. Paller, MD, professor and chair of dermatology, and professor of pediatrics at Northwestern University, Chicago, and colleagues wrote in the study, published in the Lancet.

The study was the basis of the Food and Drug Administration expanded approval of dupilumab in June 2022, to include children aged 6 months to 5 years with moderate to severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory submission for this age group is under review by the European Medicines Agency, and by regulatory authorities in other countries, according to the manufacturers.

Dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, was first approved in 2017 for treating adults with moderate to severe AD.

“There has not been a biologic approved before at such a young age, and for such a common disease,” Dr. Paller said in an interview. “This is the drug that has revolutionized care of the most common inflammatory skin disease in children, and this is the pivotal study that brought it to market for the youngest children who suffer from the severe forms.”

The study also sets a precedent for a lower threshold for starting systemic medication in young children for treating moderate to severe disease given the absence of severe side effects and no need for lab monitoring, Dr. Paller noted. However, dupilumab will also be closely watched “for both impact on the developing immune system and the possibility that it will alter the long-term course of the eczema and the development of allergic comorbidities, such as lowering the risk of developing asthma, GI, allergy, and possibly other conditions.”

In the study, the researchers randomized 83 children aged 6 months up to 6 years to treatment with dupilumab, administered subcutaneously, and 79 to placebo every 4 weeks for 16 weeks; both groups also received topical corticosteroids. Dosage of dupilumab was based on body weight; those with a body weight of 5-15 kg received 200 mg, while those with a body weight of 15-30 kg received 300 mg. The primary endpoint was the proportion of patients with clear or almost clear skin at 16 weeks, defined as scores of 0 or 1 on the Investigator’s Global Assessment.

After 16 weeks, 28% of dupilumab patients met the primary endpoint versus 4% of those on placebo (P < .0001). In addition, 53% of dupilumab patients met the key secondary endpoint of a 75% improvement from baseline in Eczema Area and Severity Index, compared with 11% of patients on placebo (P < .0001). Treatment with dupilumab also resulted in significantly greater improvements in pruritus and skin pain, and sleep quality, as well as improved quality of life for patients and their caregivers, the authors reported.

Overall, adverse event rates were slightly lower in the dupilumab-treated patients, compared with patients on placebo (64% vs. 74%); there were no adverse events related to dupilumab that were serious or resulted in treatment discontinuation. Treatment-emergent adverse effects that were reported in 3% or more of patients and affected more of those on dupilumab than those on placebo included molluscum contagiosum (5% vs. 3%), viral gastroenteritis (4% vs. 0), rhinorrhea (5% vs. 1%), dental caries (5% vs. 0), and conjunctivitis (4% vs 0).

The rate of skin infections among the children on dupilumab was 12% vs. 24% among those on placebo.

Severe and treatment-related adverse events also were similar in both subgroups of body weight.

The findings were limited by the small number of patients younger than 2 years and the lack of study sites outside of North America and Europe, the researchers noted. However, the results were strengthened by the randomized, double-blind design and use of background topical therapy to provide a real-world safety and efficacy assessment in a very young population.
 

Overcoming injection issues

The safety profile for dupilumab, which is of the highest importance, “did not surprise me at all,” Dr. Paller said in an interview. “My only surprise is that the placebo injections actually led to more injection site reactions than [with] dupilumab, but numbers were quite low in both groups.” (Rates were 2% among those on dupilumab and 3% among those on placebo.)

The major barrier to the use of dupilumab in clinical practice is the requirement for injection, which, she explained, can be “unbearable for some young children, and thus becomes impossible for parents because of lack of cooperation and their intensified concern about giving the injection,” because of their child’s response.

“We like to administer the first dose in the office, allowing us to teach parents a few tricks related to proper technique,” including audio and visual distraction, tactile stimulation before and during the injection, use of topical anesthetic if helpful, “and making sure that the medication is at room temperature before administration,” she said. Cost is another potential barrier; however, even public insurance has been covering the medication, often after optimized use of topical medications has been unsuccessful.
 

Future research questions

As for additional research, the current study had a relatively small number of patients younger than 2 years, and more data are needed for this age group, said Dr. Paller. “We also need better understanding of the safety of dupilumab administration when live vaccines are administered. Finally, we certainly want to know what additional effects dupilumab may have beyond just the efficacy for treating eczema.”

In particular, these questions include whether dupilumab modifies the long-term course of the disease, possibly reducing the risk of persistence of disease with advancing age, or even cures the disease if started at a young age, she said. In addition, research has yet to show whether dupilumab might reduce the risk of other atopic disorders, such as asthma, food allergy, and allergic rhinitis.

“Ongoing studies and real-life experiences in the next several years will help us to answer these questions,” Dr. Paller said.
 

Data support safety, efficacy, quality of life

AD is associated with immense quality of life impairment, Raj Chovatiya, MD, of Northwestern University, Chicago, said in an interview. Most AD is initially diagnosed in early childhood, but previous treatment options for those with moderate to severe disease have been limited by safety concerns, which adds to the burden on infants and young children, and their parents and caregivers, said Dr. Chovatiya, who was not involved in the study.

“This phase 3 study showed that dupilumab, a fully human monoclonal antibody that selectively inhibits IL-4 and IL-13 mediated type 2 inflammatory signaling, provided both meaningful and statistically significant improvement in AD severity, extent of disease, and itch in patients,” he said. Dupilumab also improved children’s sleep quality and the overall quality of life in both patients and caregivers.

“These findings were quite similar to those described in older children and adults, where dupilumab is already approved for the treatment of moderate-severe AD and has demonstrated real-world safety and efficacy,” said Dr. Chovatiya. However, “the current study was limited to only a short-term analysis of 16 weeks, an ongoing open-label study should further address long-term treatment responses.”

The study was supported by Sanofi and Regeneron Pharmaceuticals. In addition to being an investigator for Regeneron, and several other pharmaceutical companies, Dr. Paller has been a consultant with honorarium for Regeneron, Sanofi, and multiple other companies. Dr. Chovatiya disclosed serving as a consultant and speaker for Regeneron and Sanofi, but was not involved in the current study.

Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.

In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.

“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.

“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”

The study was published online in the BMJ journal Gut.
 

Assessing prevalence

The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.

Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.

Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.

Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.

Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.

Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.

“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
 

Hypotheses accounting for the higher prevalence

Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.

They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.

“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”

For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.

In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
 

Future studies needed to address limitations

Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.

“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”

Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.

“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”

The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.

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

Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.

In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.

“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.

“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”

The study was published online in the BMJ journal Gut.
 

Assessing prevalence

The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.

Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.

Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.

Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.

Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.

Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.

“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
 

Hypotheses accounting for the higher prevalence

Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.

They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.

“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”

For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.

In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
 

Future studies needed to address limitations

Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.

“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”

Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.

“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”

The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.

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

Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.

In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.

“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.

“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”

The study was published online in the BMJ journal Gut.
 

Assessing prevalence

The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.

Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.

Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.

Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.

Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.

Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.

“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
 

Hypotheses accounting for the higher prevalence

Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.

They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.

“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”

For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.

In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
 

Future studies needed to address limitations

Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.

“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”

Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.

“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”

The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.

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

Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.

Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.” 

Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.

By the time diabetic foot ulcers are identified, “over 50% are already infected and over 70% of cases result in lower limb amputation,” they said.
 

Drug-loaded scaffold

In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.

Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized. 

Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.

Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
 

Low-cost treatment alternative

For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.

“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.

The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.

“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.

Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”

She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.

A version of this article first appeared on Medscape UK.

Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.

Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.” 

Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.

By the time diabetic foot ulcers are identified, “over 50% are already infected and over 70% of cases result in lower limb amputation,” they said.
 

Drug-loaded scaffold

In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.

Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized. 

Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.

Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
 

Low-cost treatment alternative

For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.

“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.

The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.

“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.

Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”

She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.

A version of this article first appeared on Medscape UK.

Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.

Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.” 

Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.

By the time diabetic foot ulcers are identified, “over 50% are already infected and over 70% of cases result in lower limb amputation,” they said.
 

Drug-loaded scaffold

In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.

Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized. 

Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.

Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
 

Low-cost treatment alternative

For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.

“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.

The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.

“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.

Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”

She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.

A version of this article first appeared on Medscape UK.