A meta-analysis by Australian researchers found no link between childhood vaccinations and an increase in allergies and asthma. In fact, children who received the BCG vaccine actually had a lesser incidence of eczema than other children, but there was no difference shown in any of the allergies or asthma.

The researchers, in a report published in the journal Allergy, write, “We found no evidence that childhood vaccination with commonly administered vaccines was associated with increased risk of later allergic disease.”

“Allergies have increased worldwide in the last 50 years, and in developed countries, earlier,” said study author Caroline J. Lodge, PhD, principal research fellow at the University of Melbourne, in an interview. “In developing countries, it is still a crisis.” No one knows why, she said. That was the reason for the recent study.

Allergic diseases such as allergic rhinitis (hay fever) and food allergies have a serious influence on quality of life, and the incidence is growing. According to the Global Asthma Network, there are 334 million people living with asthma. Between 2%-10% of adults have atopic eczema, and more than a 250,000 people have food allergies. This coincides temporally with an increase in mass vaccination of children.

Unlike the controversy surrounding vaccinations and autism, which has long been debunked as baseless, a hygiene hypothesis postulates that when children acquire immunity from many diseases, they become vulnerable to allergic reactions. Thanks to vaccinations, children in the developed world now are routinely immune to dozens of diseases.

That immunity leads to suppression of a major antibody response, increasing sensitivity to allergens and allergic disease. Suspicion of a link with childhood vaccinations has been used by opponents of vaccines in lobbying campaigns jeopardizing the sustainability of vaccine programs. In recent days, for example, the state of Tennessee has halted a program to encourage vaccination for COVID-19 as well as all other vaccinations, the result of pressure on the state by anti-vaccination lobbying.

But the Melbourne researchers reported that the meta-analysis of 42 published research studies doesn’t support the vaccine–allergy hypothesis. Using PubMed and EMBASE records between January 1946 and January 2018, researchers selected studies to be included in the analysis, looking for allergic outcomes in children given BCG or vaccines for measles or pertussis. Thirty-five publications reported cohort studies, and seven were based on randomized controlled trials.

The Australian study is not the only one showing the same lack of linkage between vaccination and allergy. The International Study of Asthma and Allergies in Childhood (ISAAC) found no association between mass vaccination and atopic disease. A 1998 Swedish study of 669 children found no differences in the incidence of allergic diseases between those who received pertussis vaccine and those who did not.

“The bottom line is that vaccines prevent infectious diseases,” said Matthew B. Laurens, associate professor of pediatrics at the University of Maryland, Baltimore, in an interview. Dr. Laurens was not part of the Australian study.

“Large-scale epidemiological studies do not support the theory that vaccines are associated with an increased risk of allergy or asthma,” he stressed. “Parents should not be deterred from vaccinating their children because of fears that this would increase risks of allergy and/or asthma.”

Dr. Lodge and Dr. Laurens have disclosed no relevant financial relationships.

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

A meta-analysis by Australian researchers found no link between childhood vaccinations and an increase in allergies and asthma. In fact, children who received the BCG vaccine actually had a lesser incidence of eczema than other children, but there was no difference shown in any of the allergies or asthma.

The researchers, in a report published in the journal Allergy, write, “We found no evidence that childhood vaccination with commonly administered vaccines was associated with increased risk of later allergic disease.”

“Allergies have increased worldwide in the last 50 years, and in developed countries, earlier,” said study author Caroline J. Lodge, PhD, principal research fellow at the University of Melbourne, in an interview. “In developing countries, it is still a crisis.” No one knows why, she said. That was the reason for the recent study.

Allergic diseases such as allergic rhinitis (hay fever) and food allergies have a serious influence on quality of life, and the incidence is growing. According to the Global Asthma Network, there are 334 million people living with asthma. Between 2%-10% of adults have atopic eczema, and more than a 250,000 people have food allergies. This coincides temporally with an increase in mass vaccination of children.

Unlike the controversy surrounding vaccinations and autism, which has long been debunked as baseless, a hygiene hypothesis postulates that when children acquire immunity from many diseases, they become vulnerable to allergic reactions. Thanks to vaccinations, children in the developed world now are routinely immune to dozens of diseases.

That immunity leads to suppression of a major antibody response, increasing sensitivity to allergens and allergic disease. Suspicion of a link with childhood vaccinations has been used by opponents of vaccines in lobbying campaigns jeopardizing the sustainability of vaccine programs. In recent days, for example, the state of Tennessee has halted a program to encourage vaccination for COVID-19 as well as all other vaccinations, the result of pressure on the state by anti-vaccination lobbying.

But the Melbourne researchers reported that the meta-analysis of 42 published research studies doesn’t support the vaccine–allergy hypothesis. Using PubMed and EMBASE records between January 1946 and January 2018, researchers selected studies to be included in the analysis, looking for allergic outcomes in children given BCG or vaccines for measles or pertussis. Thirty-five publications reported cohort studies, and seven were based on randomized controlled trials.

The Australian study is not the only one showing the same lack of linkage between vaccination and allergy. The International Study of Asthma and Allergies in Childhood (ISAAC) found no association between mass vaccination and atopic disease. A 1998 Swedish study of 669 children found no differences in the incidence of allergic diseases between those who received pertussis vaccine and those who did not.

“The bottom line is that vaccines prevent infectious diseases,” said Matthew B. Laurens, associate professor of pediatrics at the University of Maryland, Baltimore, in an interview. Dr. Laurens was not part of the Australian study.

“Large-scale epidemiological studies do not support the theory that vaccines are associated with an increased risk of allergy or asthma,” he stressed. “Parents should not be deterred from vaccinating their children because of fears that this would increase risks of allergy and/or asthma.”

Dr. Lodge and Dr. Laurens have disclosed no relevant financial relationships.

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

A meta-analysis by Australian researchers found no link between childhood vaccinations and an increase in allergies and asthma. In fact, children who received the BCG vaccine actually had a lesser incidence of eczema than other children, but there was no difference shown in any of the allergies or asthma.

The researchers, in a report published in the journal Allergy, write, “We found no evidence that childhood vaccination with commonly administered vaccines was associated with increased risk of later allergic disease.”

“Allergies have increased worldwide in the last 50 years, and in developed countries, earlier,” said study author Caroline J. Lodge, PhD, principal research fellow at the University of Melbourne, in an interview. “In developing countries, it is still a crisis.” No one knows why, she said. That was the reason for the recent study.

Allergic diseases such as allergic rhinitis (hay fever) and food allergies have a serious influence on quality of life, and the incidence is growing. According to the Global Asthma Network, there are 334 million people living with asthma. Between 2%-10% of adults have atopic eczema, and more than a 250,000 people have food allergies. This coincides temporally with an increase in mass vaccination of children.

Unlike the controversy surrounding vaccinations and autism, which has long been debunked as baseless, a hygiene hypothesis postulates that when children acquire immunity from many diseases, they become vulnerable to allergic reactions. Thanks to vaccinations, children in the developed world now are routinely immune to dozens of diseases.

That immunity leads to suppression of a major antibody response, increasing sensitivity to allergens and allergic disease. Suspicion of a link with childhood vaccinations has been used by opponents of vaccines in lobbying campaigns jeopardizing the sustainability of vaccine programs. In recent days, for example, the state of Tennessee has halted a program to encourage vaccination for COVID-19 as well as all other vaccinations, the result of pressure on the state by anti-vaccination lobbying.

But the Melbourne researchers reported that the meta-analysis of 42 published research studies doesn’t support the vaccine–allergy hypothesis. Using PubMed and EMBASE records between January 1946 and January 2018, researchers selected studies to be included in the analysis, looking for allergic outcomes in children given BCG or vaccines for measles or pertussis. Thirty-five publications reported cohort studies, and seven were based on randomized controlled trials.

The Australian study is not the only one showing the same lack of linkage between vaccination and allergy. The International Study of Asthma and Allergies in Childhood (ISAAC) found no association between mass vaccination and atopic disease. A 1998 Swedish study of 669 children found no differences in the incidence of allergic diseases between those who received pertussis vaccine and those who did not.

“The bottom line is that vaccines prevent infectious diseases,” said Matthew B. Laurens, associate professor of pediatrics at the University of Maryland, Baltimore, in an interview. Dr. Laurens was not part of the Australian study.

“Large-scale epidemiological studies do not support the theory that vaccines are associated with an increased risk of allergy or asthma,” he stressed. “Parents should not be deterred from vaccinating their children because of fears that this would increase risks of allergy and/or asthma.”

Dr. Lodge and Dr. Laurens have disclosed no relevant financial relationships.

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

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Inspired by the ABIM Foundation’s Choosing Wisely^® campaign, the “Things We Do for No Reason^™” (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

A 78-year-old female nursing home resident presents to the emergency department for evaluation of a several-hour history of confusion and restlessness. The patient is accompanied by one of her caregivers from the nursing home. Initial evaluation reveals an awake but inattentive, disoriented, and agitated woman who can answer basic questions appropriately. The caregiver denies the patient having had any antecedent concerns, such as pain with urination, abdominal pain, subjective fevers, chills, or night sweats. Vital signs include a temperature of 37.5 °C (99.5 °F), heart rate of 90 beats per minute, blood pressure of 110/60 mm Hg, respiratory rate of 14 breaths per minute, and oxygen saturation of 98% on room air. The patient has a normal lung and abdominal exam without any suprapubic or flank tenderness. There is no Foley catheter in place.

Delirium, defined by the World Health Organization’s 10th revision of the International Classification of Diseases as “an etiologically nonspecific organic cerebral syndrome characterized by concurrent disturbances of consciousness and attention, perception, thinking, memory, psychomotor behavior, emotion, and the sleep-wake schedule,” is associated with poor clinical outcomes in older patients.^1,2 Mental status changes, which can arise rapidly over the course of hours to days, often fluctuate, with most cases resolving within days of onset.³ In the United States, more than 2.6 million adults aged 65 years and older develop delirium each year, accounting for an estimated $38 to $152 billion in annual healthcare expenditures.⁴

Some clinicians believe that the evaluation for delirium should include an empiric urinary infectious workup with urinalysis and/or urine cultures, even in the absence of local genitourinary symptoms or other signs of infection. In fact, altered mental status is the most common indication for ordering a urine culture in older adult patients.⁵

Urinary tract infections (UTIs) account for almost 25% of all reported infections in older patients, with delirium occurring in up to 30% of this patient population.⁶ As one study demonstrated, given this population’s very high prevalence of asymptomatic bacteriuria (ASB), urine studies sent during a delirium work-up often yield positive findings (defined as ≥10⁵ colony-forming units [CFU]/mL [≥10⁸ CFU/L]) in older patients with no signs or symptoms attributable to UTI.⁷ The incidence of ASB increases significantly with age, with prevalence estimated to be between 6% and 10% in women older than 60 years and approximately 5% in men older than 65 years.⁵ Among older patients residing in long-term care facilities, up to 50% of female residents and up to 40% of male residents have ASB.⁸ These findings, in part, created the common perception of causation between UTI and delirium.

A recent systematic review demonstrated that there is insufficient evidence to associate UTI with acute confusion in older patients.⁹ The Centers for Disease Control and Prevention’s National Health Safety Network notes that at least one of the following criteria must be present for the diagnosis of UTI in noncatheterized patients: fever (>38 °C), suprapubic tenderness, costovertebral angle tenderness, urinary frequency, urinary urgency, or dysuria.¹⁰ Recent studies have identified that ASB—by definition, without dysuria, frequency, bladder discomfort, or fever—is an unlikely cause of delirium.^6,11

The 2019 Infectious Diseases Society of America (IDSA) practice guidelines suggest that clinicians not screen for ASB in older functionally or cognitively impaired patients with no local genitourinary symptoms or other signs of infection. The IDSA acknowledges that the potential adverse outcomes of antimicrobial therapy, including Clostridioides difficile infection, increased antimicrobial resistance, or adverse drug effects, outweigh the potential benefit of treatment given the absence of evidence that such treatment improves outcomes for this vulnerable patient population (strong recommendation, very low-quality evidence).¹² Per the IDSA guidelines, recommendations are strong when there is “moderate- or high-quality evidence that the desirable consequences outweigh the undesirable consequences for a course of action” and “may also be strong when there is high-quality evidence of harm and benefits are uncertain (ie, low or very low quality),” as in this case scenario. Studies of older institutionalized and hospitalized patients have found that ASB often results in inappropriate antimicrobial use with limited benefit.^7,13,14 In addition to noting the lack of benefit from treatment, these studies have found that these patients treated with antimicrobials have worse outcomes when compared to untreated patients with ASB. One study of hospitalized patients treated for ASB concluded that participants given antimicrobial agents experienced longer durations of hospitalization, with no benefits from treatment.¹³ Moreover, another study identified poor long-term functional recovery in patients treated for ASB.¹⁴

Overtreatment also has public health implications given that it may increase the prevalence of multidrug-resistant bacteria in long-term care facilities.¹⁵ One recent study of nursing home residents demonstrated an association between bacteriuria, increased antibiotic use, and subsequent isolation of multidrug-resistant gram-negative organisms.¹⁶ The increased prevalence of these organisms limits options for oral antibiotic therapies in the outpatient setting, potentially leading to increased healthcare utilization and further harms relating to institutionalization in this vulnerable patient population. In light of the ethical concept of nonmaleficence, recognizing the potential harms of treating ASB without clear benefit is important for clinicians to take into account when considering urinalysis in this patient population.

In addition, obtaining a urine culture in an older patient with no signs or symptoms of UTI may lead to premature closure from a diagnostic perspective, resulting in missed diagnoses during clinical evaluation. A missed alternative diagnosis could then cause additional, ongoing harm to the patient if left untreated. Subsequent harms from delayed treatment can thus compound the direct harms and added costs incurred by inappropriate testing and treatment of patients with delirium.

Since 2013, the American Geriatrics Society (AGS) has recommended against the use of antimicrobials in older patients with no urinary tract symptoms, stating that “Antimicrobial treatment studies for asymptomatic bacteriuria in older adults demonstrate no benefits and show increased adverse antimicrobial effects.”¹⁷ The IDSA practice guidelines state the following: “In older patients with functional and/or cognitive impairment with bacteriuria and delirium (acute mental status change, confusion) and without local genitourinary symptoms or other systemic signs of infection (eg, fever or hemodynamic instability), we recommend assessment for other causes and careful observation rather than antimicrobial treatment (strong recommendation, very low-quality evidence).”¹²

Older patients presenting with confusion in the setting of recognized symptoms of UTI (eg, acute dysuria, urinary urgency or frequency) warrant urinalysis and urine culture. Additionally, urinalysis and urine cultures may be warranted to assess for UTI—even in the absence of a localizing source—in older patients with signs and symptoms of delirium who also exhibit systemic signs of infection (eg, fever, leukocytosis, hemodynamic instability).¹²

Initial evaluation of an older patient with delirium should include a thorough review of their recent history and baseline mental status with a knowledgeable informant, a careful physical and neurologic examination, and laboratory studies to determine the presence of electrolyte or metabolic derangements as well as infection and organ failure.⁴ Clinicians should take into account nonmodifiable risk factors for delirium and conduct a careful review of the time course of changes in mental status and modifiable risk factors, including environment, sleep deprivation, medications, immobilization, and sensory impairments.¹⁸

To manage delirium in older patients, clinicians should identify reversible causes of the delirium and minimize modifiable exacerbating factors (eg, sensory impairment, sleep deprivation) in the immediate environment of the patient. They should also carefully review medications that may contribute to delirium, using tools such as the AGS Beers Criteria to identify high-risk medications and concerning medication combinations.¹⁹ Patients who develop local or systemic signs of infection (ie, fevers, chills, dysuria) should undergo appropriate testing, including urinalysis if there is clinical suspicion for urinary etiology.

• For older patients presenting with delirium without localized urinary symptoms or systemic signs of a serious infection, forgo routine ordering of urinalysis and urine culture.
• For older patients presenting with delirium and localized or systemic signs of infection, routine urine studies and antimicrobial therapy may be appropriate.
• For older patients presenting with delirium without localized symptoms or systemic signs of serious infection, attempt to first identify the cause of the change in mental status by obtaining history from a reliable informant, performing a thorough physical and neurologic examination, and evaluating for metabolic and electrolyte derangements.

Returning to the clinical scenario, older patients presenting with signs and symptoms of delirium should undergo further work-up to determine underlying causes for their altered mental status. The patient’s history, ideally obtained from a knowledgeable informant, should offer insight into her baseline mental status and risk factors for delirium. This should be followed by a careful physical and neurologic examination, and evaluation for electrolyte, metabolic, and other derangements. In patients without localized or systemic signs of infection, routine urine testing and treatment of bacteriuria should be avoided.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to pro­pose ideas for other “Things We Do for No Reason^™" topics by emailing [email protected]

Inspired by the ABIM Foundation’s Choosing Wisely^® campaign, the “Things We Do for No Reason^™” (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

A 78-year-old female nursing home resident presents to the emergency department for evaluation of a several-hour history of confusion and restlessness. The patient is accompanied by one of her caregivers from the nursing home. Initial evaluation reveals an awake but inattentive, disoriented, and agitated woman who can answer basic questions appropriately. The caregiver denies the patient having had any antecedent concerns, such as pain with urination, abdominal pain, subjective fevers, chills, or night sweats. Vital signs include a temperature of 37.5 °C (99.5 °F), heart rate of 90 beats per minute, blood pressure of 110/60 mm Hg, respiratory rate of 14 breaths per minute, and oxygen saturation of 98% on room air. The patient has a normal lung and abdominal exam without any suprapubic or flank tenderness. There is no Foley catheter in place.

Delirium, defined by the World Health Organization’s 10th revision of the International Classification of Diseases as “an etiologically nonspecific organic cerebral syndrome characterized by concurrent disturbances of consciousness and attention, perception, thinking, memory, psychomotor behavior, emotion, and the sleep-wake schedule,” is associated with poor clinical outcomes in older patients.^1,2 Mental status changes, which can arise rapidly over the course of hours to days, often fluctuate, with most cases resolving within days of onset.³ In the United States, more than 2.6 million adults aged 65 years and older develop delirium each year, accounting for an estimated $38 to $152 billion in annual healthcare expenditures.⁴

Some clinicians believe that the evaluation for delirium should include an empiric urinary infectious workup with urinalysis and/or urine cultures, even in the absence of local genitourinary symptoms or other signs of infection. In fact, altered mental status is the most common indication for ordering a urine culture in older adult patients.⁵

Urinary tract infections (UTIs) account for almost 25% of all reported infections in older patients, with delirium occurring in up to 30% of this patient population.⁶ As one study demonstrated, given this population’s very high prevalence of asymptomatic bacteriuria (ASB), urine studies sent during a delirium work-up often yield positive findings (defined as ≥10⁵ colony-forming units [CFU]/mL [≥10⁸ CFU/L]) in older patients with no signs or symptoms attributable to UTI.⁷ The incidence of ASB increases significantly with age, with prevalence estimated to be between 6% and 10% in women older than 60 years and approximately 5% in men older than 65 years.⁵ Among older patients residing in long-term care facilities, up to 50% of female residents and up to 40% of male residents have ASB.⁸ These findings, in part, created the common perception of causation between UTI and delirium.

A recent systematic review demonstrated that there is insufficient evidence to associate UTI with acute confusion in older patients.⁹ The Centers for Disease Control and Prevention’s National Health Safety Network notes that at least one of the following criteria must be present for the diagnosis of UTI in noncatheterized patients: fever (>38 °C), suprapubic tenderness, costovertebral angle tenderness, urinary frequency, urinary urgency, or dysuria.¹⁰ Recent studies have identified that ASB—by definition, without dysuria, frequency, bladder discomfort, or fever—is an unlikely cause of delirium.^6,11

The 2019 Infectious Diseases Society of America (IDSA) practice guidelines suggest that clinicians not screen for ASB in older functionally or cognitively impaired patients with no local genitourinary symptoms or other signs of infection. The IDSA acknowledges that the potential adverse outcomes of antimicrobial therapy, including Clostridioides difficile infection, increased antimicrobial resistance, or adverse drug effects, outweigh the potential benefit of treatment given the absence of evidence that such treatment improves outcomes for this vulnerable patient population (strong recommendation, very low-quality evidence).¹² Per the IDSA guidelines, recommendations are strong when there is “moderate- or high-quality evidence that the desirable consequences outweigh the undesirable consequences for a course of action” and “may also be strong when there is high-quality evidence of harm and benefits are uncertain (ie, low or very low quality),” as in this case scenario. Studies of older institutionalized and hospitalized patients have found that ASB often results in inappropriate antimicrobial use with limited benefit.^7,13,14 In addition to noting the lack of benefit from treatment, these studies have found that these patients treated with antimicrobials have worse outcomes when compared to untreated patients with ASB. One study of hospitalized patients treated for ASB concluded that participants given antimicrobial agents experienced longer durations of hospitalization, with no benefits from treatment.¹³ Moreover, another study identified poor long-term functional recovery in patients treated for ASB.¹⁴

Overtreatment also has public health implications given that it may increase the prevalence of multidrug-resistant bacteria in long-term care facilities.¹⁵ One recent study of nursing home residents demonstrated an association between bacteriuria, increased antibiotic use, and subsequent isolation of multidrug-resistant gram-negative organisms.¹⁶ The increased prevalence of these organisms limits options for oral antibiotic therapies in the outpatient setting, potentially leading to increased healthcare utilization and further harms relating to institutionalization in this vulnerable patient population. In light of the ethical concept of nonmaleficence, recognizing the potential harms of treating ASB without clear benefit is important for clinicians to take into account when considering urinalysis in this patient population.

In addition, obtaining a urine culture in an older patient with no signs or symptoms of UTI may lead to premature closure from a diagnostic perspective, resulting in missed diagnoses during clinical evaluation. A missed alternative diagnosis could then cause additional, ongoing harm to the patient if left untreated. Subsequent harms from delayed treatment can thus compound the direct harms and added costs incurred by inappropriate testing and treatment of patients with delirium.

Since 2013, the American Geriatrics Society (AGS) has recommended against the use of antimicrobials in older patients with no urinary tract symptoms, stating that “Antimicrobial treatment studies for asymptomatic bacteriuria in older adults demonstrate no benefits and show increased adverse antimicrobial effects.”¹⁷ The IDSA practice guidelines state the following: “In older patients with functional and/or cognitive impairment with bacteriuria and delirium (acute mental status change, confusion) and without local genitourinary symptoms or other systemic signs of infection (eg, fever or hemodynamic instability), we recommend assessment for other causes and careful observation rather than antimicrobial treatment (strong recommendation, very low-quality evidence).”¹²

Older patients presenting with confusion in the setting of recognized symptoms of UTI (eg, acute dysuria, urinary urgency or frequency) warrant urinalysis and urine culture. Additionally, urinalysis and urine cultures may be warranted to assess for UTI—even in the absence of a localizing source—in older patients with signs and symptoms of delirium who also exhibit systemic signs of infection (eg, fever, leukocytosis, hemodynamic instability).¹²

Initial evaluation of an older patient with delirium should include a thorough review of their recent history and baseline mental status with a knowledgeable informant, a careful physical and neurologic examination, and laboratory studies to determine the presence of electrolyte or metabolic derangements as well as infection and organ failure.⁴ Clinicians should take into account nonmodifiable risk factors for delirium and conduct a careful review of the time course of changes in mental status and modifiable risk factors, including environment, sleep deprivation, medications, immobilization, and sensory impairments.¹⁸

To manage delirium in older patients, clinicians should identify reversible causes of the delirium and minimize modifiable exacerbating factors (eg, sensory impairment, sleep deprivation) in the immediate environment of the patient. They should also carefully review medications that may contribute to delirium, using tools such as the AGS Beers Criteria to identify high-risk medications and concerning medication combinations.¹⁹ Patients who develop local or systemic signs of infection (ie, fevers, chills, dysuria) should undergo appropriate testing, including urinalysis if there is clinical suspicion for urinary etiology.

• For older patients presenting with delirium without localized urinary symptoms or systemic signs of a serious infection, forgo routine ordering of urinalysis and urine culture.
• For older patients presenting with delirium and localized or systemic signs of infection, routine urine studies and antimicrobial therapy may be appropriate.
• For older patients presenting with delirium without localized symptoms or systemic signs of serious infection, attempt to first identify the cause of the change in mental status by obtaining history from a reliable informant, performing a thorough physical and neurologic examination, and evaluating for metabolic and electrolyte derangements.

Returning to the clinical scenario, older patients presenting with signs and symptoms of delirium should undergo further work-up to determine underlying causes for their altered mental status. The patient’s history, ideally obtained from a knowledgeable informant, should offer insight into her baseline mental status and risk factors for delirium. This should be followed by a careful physical and neurologic examination, and evaluation for electrolyte, metabolic, and other derangements. In patients without localized or systemic signs of infection, routine urine testing and treatment of bacteriuria should be avoided.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to pro­pose ideas for other “Things We Do for No Reason^™" topics by emailing [email protected]

Inspired by the ABIM Foundation’s Choosing Wisely^® campaign, the “Things We Do for No Reason^™” (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

A 78-year-old female nursing home resident presents to the emergency department for evaluation of a several-hour history of confusion and restlessness. The patient is accompanied by one of her caregivers from the nursing home. Initial evaluation reveals an awake but inattentive, disoriented, and agitated woman who can answer basic questions appropriately. The caregiver denies the patient having had any antecedent concerns, such as pain with urination, abdominal pain, subjective fevers, chills, or night sweats. Vital signs include a temperature of 37.5 °C (99.5 °F), heart rate of 90 beats per minute, blood pressure of 110/60 mm Hg, respiratory rate of 14 breaths per minute, and oxygen saturation of 98% on room air. The patient has a normal lung and abdominal exam without any suprapubic or flank tenderness. There is no Foley catheter in place.

Delirium, defined by the World Health Organization’s 10th revision of the International Classification of Diseases as “an etiologically nonspecific organic cerebral syndrome characterized by concurrent disturbances of consciousness and attention, perception, thinking, memory, psychomotor behavior, emotion, and the sleep-wake schedule,” is associated with poor clinical outcomes in older patients.^1,2 Mental status changes, which can arise rapidly over the course of hours to days, often fluctuate, with most cases resolving within days of onset.³ In the United States, more than 2.6 million adults aged 65 years and older develop delirium each year, accounting for an estimated $38 to $152 billion in annual healthcare expenditures.⁴

Some clinicians believe that the evaluation for delirium should include an empiric urinary infectious workup with urinalysis and/or urine cultures, even in the absence of local genitourinary symptoms or other signs of infection. In fact, altered mental status is the most common indication for ordering a urine culture in older adult patients.⁵

Urinary tract infections (UTIs) account for almost 25% of all reported infections in older patients, with delirium occurring in up to 30% of this patient population.⁶ As one study demonstrated, given this population’s very high prevalence of asymptomatic bacteriuria (ASB), urine studies sent during a delirium work-up often yield positive findings (defined as ≥10⁵ colony-forming units [CFU]/mL [≥10⁸ CFU/L]) in older patients with no signs or symptoms attributable to UTI.⁷ The incidence of ASB increases significantly with age, with prevalence estimated to be between 6% and 10% in women older than 60 years and approximately 5% in men older than 65 years.⁵ Among older patients residing in long-term care facilities, up to 50% of female residents and up to 40% of male residents have ASB.⁸ These findings, in part, created the common perception of causation between UTI and delirium.

A recent systematic review demonstrated that there is insufficient evidence to associate UTI with acute confusion in older patients.⁹ The Centers for Disease Control and Prevention’s National Health Safety Network notes that at least one of the following criteria must be present for the diagnosis of UTI in noncatheterized patients: fever (>38 °C), suprapubic tenderness, costovertebral angle tenderness, urinary frequency, urinary urgency, or dysuria.¹⁰ Recent studies have identified that ASB—by definition, without dysuria, frequency, bladder discomfort, or fever—is an unlikely cause of delirium.^6,11

The 2019 Infectious Diseases Society of America (IDSA) practice guidelines suggest that clinicians not screen for ASB in older functionally or cognitively impaired patients with no local genitourinary symptoms or other signs of infection. The IDSA acknowledges that the potential adverse outcomes of antimicrobial therapy, including Clostridioides difficile infection, increased antimicrobial resistance, or adverse drug effects, outweigh the potential benefit of treatment given the absence of evidence that such treatment improves outcomes for this vulnerable patient population (strong recommendation, very low-quality evidence).¹² Per the IDSA guidelines, recommendations are strong when there is “moderate- or high-quality evidence that the desirable consequences outweigh the undesirable consequences for a course of action” and “may also be strong when there is high-quality evidence of harm and benefits are uncertain (ie, low or very low quality),” as in this case scenario. Studies of older institutionalized and hospitalized patients have found that ASB often results in inappropriate antimicrobial use with limited benefit.^7,13,14 In addition to noting the lack of benefit from treatment, these studies have found that these patients treated with antimicrobials have worse outcomes when compared to untreated patients with ASB. One study of hospitalized patients treated for ASB concluded that participants given antimicrobial agents experienced longer durations of hospitalization, with no benefits from treatment.¹³ Moreover, another study identified poor long-term functional recovery in patients treated for ASB.¹⁴

Overtreatment also has public health implications given that it may increase the prevalence of multidrug-resistant bacteria in long-term care facilities.¹⁵ One recent study of nursing home residents demonstrated an association between bacteriuria, increased antibiotic use, and subsequent isolation of multidrug-resistant gram-negative organisms.¹⁶ The increased prevalence of these organisms limits options for oral antibiotic therapies in the outpatient setting, potentially leading to increased healthcare utilization and further harms relating to institutionalization in this vulnerable patient population. In light of the ethical concept of nonmaleficence, recognizing the potential harms of treating ASB without clear benefit is important for clinicians to take into account when considering urinalysis in this patient population.

In addition, obtaining a urine culture in an older patient with no signs or symptoms of UTI may lead to premature closure from a diagnostic perspective, resulting in missed diagnoses during clinical evaluation. A missed alternative diagnosis could then cause additional, ongoing harm to the patient if left untreated. Subsequent harms from delayed treatment can thus compound the direct harms and added costs incurred by inappropriate testing and treatment of patients with delirium.

Since 2013, the American Geriatrics Society (AGS) has recommended against the use of antimicrobials in older patients with no urinary tract symptoms, stating that “Antimicrobial treatment studies for asymptomatic bacteriuria in older adults demonstrate no benefits and show increased adverse antimicrobial effects.”¹⁷ The IDSA practice guidelines state the following: “In older patients with functional and/or cognitive impairment with bacteriuria and delirium (acute mental status change, confusion) and without local genitourinary symptoms or other systemic signs of infection (eg, fever or hemodynamic instability), we recommend assessment for other causes and careful observation rather than antimicrobial treatment (strong recommendation, very low-quality evidence).”¹²

Older patients presenting with confusion in the setting of recognized symptoms of UTI (eg, acute dysuria, urinary urgency or frequency) warrant urinalysis and urine culture. Additionally, urinalysis and urine cultures may be warranted to assess for UTI—even in the absence of a localizing source—in older patients with signs and symptoms of delirium who also exhibit systemic signs of infection (eg, fever, leukocytosis, hemodynamic instability).¹²

Initial evaluation of an older patient with delirium should include a thorough review of their recent history and baseline mental status with a knowledgeable informant, a careful physical and neurologic examination, and laboratory studies to determine the presence of electrolyte or metabolic derangements as well as infection and organ failure.⁴ Clinicians should take into account nonmodifiable risk factors for delirium and conduct a careful review of the time course of changes in mental status and modifiable risk factors, including environment, sleep deprivation, medications, immobilization, and sensory impairments.¹⁸

To manage delirium in older patients, clinicians should identify reversible causes of the delirium and minimize modifiable exacerbating factors (eg, sensory impairment, sleep deprivation) in the immediate environment of the patient. They should also carefully review medications that may contribute to delirium, using tools such as the AGS Beers Criteria to identify high-risk medications and concerning medication combinations.¹⁹ Patients who develop local or systemic signs of infection (ie, fevers, chills, dysuria) should undergo appropriate testing, including urinalysis if there is clinical suspicion for urinary etiology.

• For older patients presenting with delirium without localized urinary symptoms or systemic signs of a serious infection, forgo routine ordering of urinalysis and urine culture.
• For older patients presenting with delirium and localized or systemic signs of infection, routine urine studies and antimicrobial therapy may be appropriate.
• For older patients presenting with delirium without localized symptoms or systemic signs of serious infection, attempt to first identify the cause of the change in mental status by obtaining history from a reliable informant, performing a thorough physical and neurologic examination, and evaluating for metabolic and electrolyte derangements.

Returning to the clinical scenario, older patients presenting with signs and symptoms of delirium should undergo further work-up to determine underlying causes for their altered mental status. The patient’s history, ideally obtained from a knowledgeable informant, should offer insight into her baseline mental status and risk factors for delirium. This should be followed by a careful physical and neurologic examination, and evaluation for electrolyte, metabolic, and other derangements. In patients without localized or systemic signs of infection, routine urine testing and treatment of bacteriuria should be avoided.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to pro­pose ideas for other “Things We Do for No Reason^™" topics by emailing [email protected]

Key clinical point: Risk for serious infection requiring hospitalization was 9-fold higher in children with inflammatory bowel disease (IBD) compared with the general population.

Major finding: Risk for serious infection was significantly higher among children with IBD vs the reference group (hazard ratio [HR], 9.50; 95% confidence interval [CI], 8.56-10.5). In addition to a higher risk for gastrointestinal infections (HR, 31.8; 95% CI, 25.6-39.3), children with IBD were at a substantially higher risk for opportunistic infections (HR, 11.8; 95% CI, 6.17-22.5) and sepsis (HR, 26.1; 95% CI, 15.6-43.7).

Study details: Findings are from an analysis of 5,767 children with incident IBD diagnosed before 18 years of age who were compared with 58,418 matched reference individuals.

Disclosures: No funding interests were declared. O Olén, P Malmborg, and J Järås declared receiving research grants and/or serving as a speaker for various sources.

Source: Ludvigsson JF et al. J Pediatr. 2021 Jun 30. doi: 10.1016/j.jpeds.2021.06.076.

Key clinical point: Risk for serious infection requiring hospitalization was 9-fold higher in children with inflammatory bowel disease (IBD) compared with the general population.

Major finding: Risk for serious infection was significantly higher among children with IBD vs the reference group (hazard ratio [HR], 9.50; 95% confidence interval [CI], 8.56-10.5). In addition to a higher risk for gastrointestinal infections (HR, 31.8; 95% CI, 25.6-39.3), children with IBD were at a substantially higher risk for opportunistic infections (HR, 11.8; 95% CI, 6.17-22.5) and sepsis (HR, 26.1; 95% CI, 15.6-43.7).

Study details: Findings are from an analysis of 5,767 children with incident IBD diagnosed before 18 years of age who were compared with 58,418 matched reference individuals.

Disclosures: No funding interests were declared. O Olén, P Malmborg, and J Järås declared receiving research grants and/or serving as a speaker for various sources.

Source: Ludvigsson JF et al. J Pediatr. 2021 Jun 30. doi: 10.1016/j.jpeds.2021.06.076.

Key clinical point: Risk for serious infection requiring hospitalization was 9-fold higher in children with inflammatory bowel disease (IBD) compared with the general population.

Major finding: Risk for serious infection was significantly higher among children with IBD vs the reference group (hazard ratio [HR], 9.50; 95% confidence interval [CI], 8.56-10.5). In addition to a higher risk for gastrointestinal infections (HR, 31.8; 95% CI, 25.6-39.3), children with IBD were at a substantially higher risk for opportunistic infections (HR, 11.8; 95% CI, 6.17-22.5) and sepsis (HR, 26.1; 95% CI, 15.6-43.7).

Study details: Findings are from an analysis of 5,767 children with incident IBD diagnosed before 18 years of age who were compared with 58,418 matched reference individuals.

Disclosures: No funding interests were declared. O Olén, P Malmborg, and J Järås declared receiving research grants and/or serving as a speaker for various sources.

Source: Ludvigsson JF et al. J Pediatr. 2021 Jun 30. doi: 10.1016/j.jpeds.2021.06.076.

Key clinical point: In a nationwide cohort of patients with inflammatory bowel disease (IBD), vedolizumab showed similar therapeutic efficacy among elderly and younger patients, with a similar proportion of patients in steroid-free remission after vedolizumab initiation.

Major finding: The proportion of patients in steroid-free remission while still on vedolizumab during the 6- to 12-month period after vedolizumab initiation was not significantly different among patients younger than 60 years of age (younger group; 46.8%) and those aged 60 years or older (elderly group; 40.1%; P = .2374). IBD-related hospitalization (P = .9737) and surgeries (P = .9851) within 1 year were similar between younger and elderly groups.

Study details: Findings are from a retrospective cohort study of 568 patients with IBD from the US national Veterans Affairs Healthcare System. Patients were categorized into elderly (n=279) and younger (n=289) groups based on their age at vedolizumab initiation.

Disclosures: The study was supported by Takeda Pharmaceutical Company Limited. N Khan declared receiving an unrestricted research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Other authors had no disclosures.

Source: Khan N et al. Inflamm Bowel Dis. 2021 Jul 10. doi: 10.1093/ibd/izab163.

Key clinical point: In a nationwide cohort of patients with inflammatory bowel disease (IBD), vedolizumab showed similar therapeutic efficacy among elderly and younger patients, with a similar proportion of patients in steroid-free remission after vedolizumab initiation.

Major finding: The proportion of patients in steroid-free remission while still on vedolizumab during the 6- to 12-month period after vedolizumab initiation was not significantly different among patients younger than 60 years of age (younger group; 46.8%) and those aged 60 years or older (elderly group; 40.1%; P = .2374). IBD-related hospitalization (P = .9737) and surgeries (P = .9851) within 1 year were similar between younger and elderly groups.

Study details: Findings are from a retrospective cohort study of 568 patients with IBD from the US national Veterans Affairs Healthcare System. Patients were categorized into elderly (n=279) and younger (n=289) groups based on their age at vedolizumab initiation.

Disclosures: The study was supported by Takeda Pharmaceutical Company Limited. N Khan declared receiving an unrestricted research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Other authors had no disclosures.

Source: Khan N et al. Inflamm Bowel Dis. 2021 Jul 10. doi: 10.1093/ibd/izab163.

Key clinical point: In a nationwide cohort of patients with inflammatory bowel disease (IBD), vedolizumab showed similar therapeutic efficacy among elderly and younger patients, with a similar proportion of patients in steroid-free remission after vedolizumab initiation.

Major finding: The proportion of patients in steroid-free remission while still on vedolizumab during the 6- to 12-month period after vedolizumab initiation was not significantly different among patients younger than 60 years of age (younger group; 46.8%) and those aged 60 years or older (elderly group; 40.1%; P = .2374). IBD-related hospitalization (P = .9737) and surgeries (P = .9851) within 1 year were similar between younger and elderly groups.

Study details: Findings are from a retrospective cohort study of 568 patients with IBD from the US national Veterans Affairs Healthcare System. Patients were categorized into elderly (n=279) and younger (n=289) groups based on their age at vedolizumab initiation.

Disclosures: The study was supported by Takeda Pharmaceutical Company Limited. N Khan declared receiving an unrestricted research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Other authors had no disclosures.

Source: Khan N et al. Inflamm Bowel Dis. 2021 Jul 10. doi: 10.1093/ibd/izab163.

Key clinical point: Vedolizumab showed superior histological outcomes than adalimumab in patients with moderate-to-severe ulcerative colitis (UC).

Major finding: At 52 weeks, vedolizumab induced greater histologic remission (Robarts Histology Index [RHI], 2 or lower; Δ, 17.6%; P less than .0001) and minimal histologic disease activity (RHI, 4 or lower; Δ, 16.6%; P less than .0001) than adalimumab. Findings were similar in both antitumor necrosis factor-naive and -failure subgroups.

Study details: VARSITY, a phase 3b trial included 769 adult patients with moderately to severely active UC randomly assigned to intravenous vedolizumab or subcutaneous adalimumab.

Disclosures: This study was funded by Takeda. Some of the authors declared receiving grant support, personal fees, consultancy, and/or lecture fees from various sources. R Rogers, RA Lirio, JD Bornstein, and J Chen declared being employees and holding stocks of Takeda.

Source: Peyrin-Biroulet L et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.015.

Key clinical point: Vedolizumab showed superior histological outcomes than adalimumab in patients with moderate-to-severe ulcerative colitis (UC).

Major finding: At 52 weeks, vedolizumab induced greater histologic remission (Robarts Histology Index [RHI], 2 or lower; Δ, 17.6%; P less than .0001) and minimal histologic disease activity (RHI, 4 or lower; Δ, 16.6%; P less than .0001) than adalimumab. Findings were similar in both antitumor necrosis factor-naive and -failure subgroups.

Study details: VARSITY, a phase 3b trial included 769 adult patients with moderately to severely active UC randomly assigned to intravenous vedolizumab or subcutaneous adalimumab.

Disclosures: This study was funded by Takeda. Some of the authors declared receiving grant support, personal fees, consultancy, and/or lecture fees from various sources. R Rogers, RA Lirio, JD Bornstein, and J Chen declared being employees and holding stocks of Takeda.

Source: Peyrin-Biroulet L et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.015.

Key clinical point: Vedolizumab showed superior histological outcomes than adalimumab in patients with moderate-to-severe ulcerative colitis (UC).

Major finding: At 52 weeks, vedolizumab induced greater histologic remission (Robarts Histology Index [RHI], 2 or lower; Δ, 17.6%; P less than .0001) and minimal histologic disease activity (RHI, 4 or lower; Δ, 16.6%; P less than .0001) than adalimumab. Findings were similar in both antitumor necrosis factor-naive and -failure subgroups.

Study details: VARSITY, a phase 3b trial included 769 adult patients with moderately to severely active UC randomly assigned to intravenous vedolizumab or subcutaneous adalimumab.

Disclosures: This study was funded by Takeda. Some of the authors declared receiving grant support, personal fees, consultancy, and/or lecture fees from various sources. R Rogers, RA Lirio, JD Bornstein, and J Chen declared being employees and holding stocks of Takeda.

Source: Peyrin-Biroulet L et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.015.

Key clinical point: Infliximab de-escalation is safe and well tolerated in patients with Crohn’s disease (CD) in clinical remission and with supratherapeutic trough levels.

Major finding: More than half of the patients had a trough level of 10 ug/mL or higher at baseline. Trough levels were not significant among patients de-escalating to 5 mg/kg and 3 mg/kg at the final infusion (11.9 vs 9.2, respectively; P = .55). At the final visit, all patients were in clinical remission and remained on their de-escalated dose.

Study details: This was a prospective pilot trial of 52 patients with CD in clinical remission on infliximab at a consistent dose for at least 1 year. Thirteen and 6 patients de-escalated from 10/7.5 mg/kg to 5 mg/kg and from 5 mg/kg to 3 mg/kg, respectively.

Disclosures: No source of funding was declared. JR Allegretti and MJ Hamilton declared serving as a consultant and receiving grant support from various sources.

Source: Allegretti JR et al. Inflamm Bowel Dis. 2021 Jun 18. doi: 10.1093/ibd/izab131.

Key clinical point: Infliximab de-escalation is safe and well tolerated in patients with Crohn’s disease (CD) in clinical remission and with supratherapeutic trough levels.

Major finding: More than half of the patients had a trough level of 10 ug/mL or higher at baseline. Trough levels were not significant among patients de-escalating to 5 mg/kg and 3 mg/kg at the final infusion (11.9 vs 9.2, respectively; P = .55). At the final visit, all patients were in clinical remission and remained on their de-escalated dose.

Study details: This was a prospective pilot trial of 52 patients with CD in clinical remission on infliximab at a consistent dose for at least 1 year. Thirteen and 6 patients de-escalated from 10/7.5 mg/kg to 5 mg/kg and from 5 mg/kg to 3 mg/kg, respectively.

Disclosures: No source of funding was declared. JR Allegretti and MJ Hamilton declared serving as a consultant and receiving grant support from various sources.

Source: Allegretti JR et al. Inflamm Bowel Dis. 2021 Jun 18. doi: 10.1093/ibd/izab131.

Key clinical point: Infliximab de-escalation is safe and well tolerated in patients with Crohn’s disease (CD) in clinical remission and with supratherapeutic trough levels.

Major finding: More than half of the patients had a trough level of 10 ug/mL or higher at baseline. Trough levels were not significant among patients de-escalating to 5 mg/kg and 3 mg/kg at the final infusion (11.9 vs 9.2, respectively; P = .55). At the final visit, all patients were in clinical remission and remained on their de-escalated dose.

Study details: This was a prospective pilot trial of 52 patients with CD in clinical remission on infliximab at a consistent dose for at least 1 year. Thirteen and 6 patients de-escalated from 10/7.5 mg/kg to 5 mg/kg and from 5 mg/kg to 3 mg/kg, respectively.

Disclosures: No source of funding was declared. JR Allegretti and MJ Hamilton declared serving as a consultant and receiving grant support from various sources.

Source: Allegretti JR et al. Inflamm Bowel Dis. 2021 Jun 18. doi: 10.1093/ibd/izab131.

Key clinical point: Patients with inflammatory bowel disease (IBD) who contract SARS-CoV-2 infection are at a significantly higher risk for venous thromboembolism (VTE) and thus may benefit from thromboprophylaxis.

Major finding: SARS-CoV-2 infection was associated with 8.15-fold increased odds of VTE (P less than .001). The risk was however mitigated in patients on chronic anticoagulation (odds ratio [OR], 0.63; P = .66) and was even stronger among patients not previously on anticoagulation (OR, 14.31; P less than .001).

Study details: This was a case-crossover study of 482 patients with IBD who developed VTE between April 1, 2020, and March 30, 2021, in an established Veterans Affairs cohort.

Disclosures: The study was supported by grants from Pfizer Pharmaceuticals. J Lewis and N Khan declared receiving research funding and serving as a consultant or on data safety monitoring boards for various sources including Pfizer. Other authors had no disclosures.

Source: Mahmud N et al. Gastroenterology. 2021 Jun 14. doi: 10.1053/j.gastro.2021.06.012.

Key clinical point: Patients with inflammatory bowel disease (IBD) who contract SARS-CoV-2 infection are at a significantly higher risk for venous thromboembolism (VTE) and thus may benefit from thromboprophylaxis.

Major finding: SARS-CoV-2 infection was associated with 8.15-fold increased odds of VTE (P less than .001). The risk was however mitigated in patients on chronic anticoagulation (odds ratio [OR], 0.63; P = .66) and was even stronger among patients not previously on anticoagulation (OR, 14.31; P less than .001).

Study details: This was a case-crossover study of 482 patients with IBD who developed VTE between April 1, 2020, and March 30, 2021, in an established Veterans Affairs cohort.

Disclosures: The study was supported by grants from Pfizer Pharmaceuticals. J Lewis and N Khan declared receiving research funding and serving as a consultant or on data safety monitoring boards for various sources including Pfizer. Other authors had no disclosures.

Source: Mahmud N et al. Gastroenterology. 2021 Jun 14. doi: 10.1053/j.gastro.2021.06.012.

Key clinical point: Patients with inflammatory bowel disease (IBD) who contract SARS-CoV-2 infection are at a significantly higher risk for venous thromboembolism (VTE) and thus may benefit from thromboprophylaxis.

Major finding: SARS-CoV-2 infection was associated with 8.15-fold increased odds of VTE (P less than .001). The risk was however mitigated in patients on chronic anticoagulation (odds ratio [OR], 0.63; P = .66) and was even stronger among patients not previously on anticoagulation (OR, 14.31; P less than .001).

Study details: This was a case-crossover study of 482 patients with IBD who developed VTE between April 1, 2020, and March 30, 2021, in an established Veterans Affairs cohort.

Disclosures: The study was supported by grants from Pfizer Pharmaceuticals. J Lewis and N Khan declared receiving research funding and serving as a consultant or on data safety monitoring boards for various sources including Pfizer. Other authors had no disclosures.

Source: Mahmud N et al. Gastroenterology. 2021 Jun 14. doi: 10.1053/j.gastro.2021.06.012.

Key clinical point: SARS-CoV-2 mRNA vaccine is safe and effective in patients with inflammatory bowel disease (IBD).

Major finding: The immediate adverse reaction after vaccination was rare. Adverse events of special interest (relative risk [RR], 1.15; 95% confidence interval [CI], 0.88-1.51) and new diagnosis of COVID-19 (RR, 0.95; 95% CI, 0.51-1.78) were small and similar between matched IBD and non-IBD cohorts.

Study details: Findings are from a retrospective study of 864,575 patients from multiple institutes across the USA who received the SARS-CoV-2 mRNA vaccine, of which 5,562 patients had a previous diagnosis for IBD. One and 2 vaccine doses were administered in 1,822 and 3,740 patients with IBD, respectively.

Disclosures: The authors declared receiving no financial support or grants for this study. The authors declared no relevant disclosures.

Source: Hadi YB et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.014.

Key clinical point: SARS-CoV-2 mRNA vaccine is safe and effective in patients with inflammatory bowel disease (IBD).

Major finding: The immediate adverse reaction after vaccination was rare. Adverse events of special interest (relative risk [RR], 1.15; 95% confidence interval [CI], 0.88-1.51) and new diagnosis of COVID-19 (RR, 0.95; 95% CI, 0.51-1.78) were small and similar between matched IBD and non-IBD cohorts.

Study details: Findings are from a retrospective study of 864,575 patients from multiple institutes across the USA who received the SARS-CoV-2 mRNA vaccine, of which 5,562 patients had a previous diagnosis for IBD. One and 2 vaccine doses were administered in 1,822 and 3,740 patients with IBD, respectively.

Disclosures: The authors declared receiving no financial support or grants for this study. The authors declared no relevant disclosures.

Source: Hadi YB et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.014.

Key clinical point: SARS-CoV-2 mRNA vaccine is safe and effective in patients with inflammatory bowel disease (IBD).

Major finding: The immediate adverse reaction after vaccination was rare. Adverse events of special interest (relative risk [RR], 1.15; 95% confidence interval [CI], 0.88-1.51) and new diagnosis of COVID-19 (RR, 0.95; 95% CI, 0.51-1.78) were small and similar between matched IBD and non-IBD cohorts.

Study details: Findings are from a retrospective study of 864,575 patients from multiple institutes across the USA who received the SARS-CoV-2 mRNA vaccine, of which 5,562 patients had a previous diagnosis for IBD. One and 2 vaccine doses were administered in 1,822 and 3,740 patients with IBD, respectively.

Disclosures: The authors declared receiving no financial support or grants for this study. The authors declared no relevant disclosures.

Source: Hadi YB et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.014.

Key clinical point: Patients with inflammatory bowel disease (IBD) who switched from one infliximab biosimilar to another had no adverse impact on infliximab trough levels and clinical disease activity, regardless of whether switching for the first or second time.

Major finding: Median infliximab trough levels were higher after vs before switch (5.5 vs 4.9 μg/mL; P = .007). C-reactive protein (P = .43) and disease activity scores (P = .82) did not change significantly before vs early after switch, regardless of whether switching for the first or second time; the proportion of patients in remission also did not change significantly (91% vs 92%; P = .75).

Study details: Findings are from a prospective observational cohort study of 222 patients with IBD treated with infliximab biosimilar CT-P13 who underwent a nonmedical switch to SB2, of which 99 patients underwent a second switch.

Disclosures: No funding interests were declared. RP Luber, S Honap, MA Samaan, and PM Irving declared receiving grants and serving as speaker, consultant, and/or on advisory board for various sources.

Source: Luber RP et al. Aliment Pharmacol Ther. 2021 Jul 5. doi: 10.1111/apt.16497.

Key clinical point: Patients with inflammatory bowel disease (IBD) who switched from one infliximab biosimilar to another had no adverse impact on infliximab trough levels and clinical disease activity, regardless of whether switching for the first or second time.

Major finding: Median infliximab trough levels were higher after vs before switch (5.5 vs 4.9 μg/mL; P = .007). C-reactive protein (P = .43) and disease activity scores (P = .82) did not change significantly before vs early after switch, regardless of whether switching for the first or second time; the proportion of patients in remission also did not change significantly (91% vs 92%; P = .75).

Study details: Findings are from a prospective observational cohort study of 222 patients with IBD treated with infliximab biosimilar CT-P13 who underwent a nonmedical switch to SB2, of which 99 patients underwent a second switch.

Disclosures: No funding interests were declared. RP Luber, S Honap, MA Samaan, and PM Irving declared receiving grants and serving as speaker, consultant, and/or on advisory board for various sources.

Source: Luber RP et al. Aliment Pharmacol Ther. 2021 Jul 5. doi: 10.1111/apt.16497.

Key clinical point: Patients with inflammatory bowel disease (IBD) who switched from one infliximab biosimilar to another had no adverse impact on infliximab trough levels and clinical disease activity, regardless of whether switching for the first or second time.

Major finding: Median infliximab trough levels were higher after vs before switch (5.5 vs 4.9 μg/mL; P = .007). C-reactive protein (P = .43) and disease activity scores (P = .82) did not change significantly before vs early after switch, regardless of whether switching for the first or second time; the proportion of patients in remission also did not change significantly (91% vs 92%; P = .75).

Study details: Findings are from a prospective observational cohort study of 222 patients with IBD treated with infliximab biosimilar CT-P13 who underwent a nonmedical switch to SB2, of which 99 patients underwent a second switch.

Disclosures: No funding interests were declared. RP Luber, S Honap, MA Samaan, and PM Irving declared receiving grants and serving as speaker, consultant, and/or on advisory board for various sources.

Source: Luber RP et al. Aliment Pharmacol Ther. 2021 Jul 5. doi: 10.1111/apt.16497.