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IBD appears more prevalent in men who have sex with men
Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.
In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.
“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.
“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”
The study was published online in the BMJ journal Gut.
Assessing prevalence
The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.
Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.
Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.
Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.
Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.
Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.
“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
Hypotheses accounting for the higher prevalence
Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.
They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.
“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”
For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.
In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
Future studies needed to address limitations
Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.
“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”
Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.
“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”
The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.
In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.
“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.
“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”
The study was published online in the BMJ journal Gut.
Assessing prevalence
The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.
Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.
Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.
Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.
Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.
Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.
“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
Hypotheses accounting for the higher prevalence
Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.
They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.
“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”
For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.
In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
Future studies needed to address limitations
Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.
“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”
Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.
“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”
The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.
In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.
“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.
“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”
The study was published online in the BMJ journal Gut.
Assessing prevalence
The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.
Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.
Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.
Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.
Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.
Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.
“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
Hypotheses accounting for the higher prevalence
Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.
They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.
“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”
For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.
In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
Future studies needed to address limitations
Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.
“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”
Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.
“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”
The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
3-D scaffold could revolutionize diabetes treatment
Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.
Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.”
Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.
they said.
Drug-loaded scaffold
In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.
Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized.
Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.
Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
Low-cost treatment alternative
For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.
“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.
The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.
“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.
Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”
She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.
A version of this article first appeared on Medscape UK.
Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.
Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.”
Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.
they said.
Drug-loaded scaffold
In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.
Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized.
Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.
Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
Low-cost treatment alternative
For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.
“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.
The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.
“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.
Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”
She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.
A version of this article first appeared on Medscape UK.
Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.
Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.”
Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.
they said.
Drug-loaded scaffold
In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.
Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized.
Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.
Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
Low-cost treatment alternative
For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.
“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.
The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.
“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.
Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”
She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.
A version of this article first appeared on Medscape UK.
FROM DRUG DELIVERY AND TRANSLATIONAL RESEARCH
The NP will see you now: Clinic staffed by nurses provides primary care
A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.
The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.
said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.
NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.
According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.
Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.
NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.
In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.
Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.
The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.
It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
Growth of NP field
Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.
“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.
Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.
“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
Doctors see need for NPs – with caution
“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”
With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.
The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”
It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
Continuing to collaborate
At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.
“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.
A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.
“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”
A version of this article first appeared on Medscape.com.
A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.
The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.
said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.
NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.
According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.
Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.
NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.
In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.
Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.
The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.
It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
Growth of NP field
Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.
“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.
Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.
“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
Doctors see need for NPs – with caution
“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”
With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.
The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”
It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
Continuing to collaborate
At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.
“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.
A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.
“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”
A version of this article first appeared on Medscape.com.
A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.
The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.
said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.
NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.
According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.
Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.
NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.
In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.
Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.
The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.
It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
Growth of NP field
Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.
“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.
Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.
“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
Doctors see need for NPs – with caution
“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”
With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.
The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”
It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
Continuing to collaborate
At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.
“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.
A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.
“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”
A version of this article first appeared on Medscape.com.
ED docs seek accountability for violence committed by patients
Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.
Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.
That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.
Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.
“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.
“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
A paralyzed ED
Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.
While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.
“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.
“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
Legislative solutions proposed
Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.
The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”
This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.
A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.
A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
Violence’s vicious cycle
“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.
“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”
The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”
Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”
What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.
But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.
In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.
ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.
Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.
That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.
Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.
“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.
“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
A paralyzed ED
Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.
While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.
“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.
“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
Legislative solutions proposed
Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.
The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”
This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.
A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.
A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
Violence’s vicious cycle
“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.
“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”
The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”
Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”
What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.
But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.
In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.
ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.
Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.
That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.
Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.
“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.
“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
A paralyzed ED
Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.
While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.
“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.
“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
Legislative solutions proposed
Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.
The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”
This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.
A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.
A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
Violence’s vicious cycle
“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.
“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”
The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”
Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”
What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.
But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.
In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.
ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Evusheld PrEP may protect immunocompromised patients from severe COVID-19
Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.
Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.
“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.
“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.
“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.
“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.
For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
EVUSHELD was well tolerated
After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.
All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:
- Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
- Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
- Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
- One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.
Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.
“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.
“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.
“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.
Evusheld not always easy to obtain
Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.
Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.
“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.
“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.
Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.
Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.
“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.
“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.
“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”
Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.
FDA: Evusheld may not neutralize certain SARS-CoV-2 variants
“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.
In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.
There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.
Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.
Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.
“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.
“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.
“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.
“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.
For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
EVUSHELD was well tolerated
After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.
All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:
- Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
- Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
- Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
- One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.
Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.
“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.
“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.
“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.
Evusheld not always easy to obtain
Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.
Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.
“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.
“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.
Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.
Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.
“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.
“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.
“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”
Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.
FDA: Evusheld may not neutralize certain SARS-CoV-2 variants
“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.
In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.
There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.
Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.
Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.
“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.
“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.
“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.
“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.
For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
EVUSHELD was well tolerated
After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.
All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:
- Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
- Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
- Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
- One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.
Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.
“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.
“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.
“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.
Evusheld not always easy to obtain
Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.
Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.
“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.
“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.
Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.
Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.
“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.
“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.
“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”
Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.
FDA: Evusheld may not neutralize certain SARS-CoV-2 variants
“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.
In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.
There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.
FROM RMD OPEN
Could vitamin C help reduce gout?
Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.
Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.
While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.
“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.
That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)
As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.
“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.
Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.
“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.
Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.
“Anything to reduce my flare-ups without having to take colchicine,” he said.
But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.
“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.
Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.
“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.
While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.
“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.
Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.
“I’m always looking for simple ways to keep my flare-ups at bay,” he said.
A version of this article first appeared on WebMD.com.
Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.
Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.
While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.
“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.
That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)
As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.
“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.
Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.
“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.
Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.
“Anything to reduce my flare-ups without having to take colchicine,” he said.
But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.
“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.
Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.
“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.
While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.
“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.
Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.
“I’m always looking for simple ways to keep my flare-ups at bay,” he said.
A version of this article first appeared on WebMD.com.
Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.
Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.
While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.
“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.
That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)
As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.
“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.
Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.
“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.
Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.
“Anything to reduce my flare-ups without having to take colchicine,” he said.
But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.
“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.
Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.
“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.
While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.
“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.
Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.
“I’m always looking for simple ways to keep my flare-ups at bay,” he said.
A version of this article first appeared on WebMD.com.
FROM THE AMERICAN JOURNAL OF CLINICAL NUTRITION
Increased HIV infection linked to pandemic-related access to PrEP
Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.
“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.
he said in an interview.
The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.
Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.
Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.
The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.
Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).
Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.
“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.
The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.
In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).
The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.
Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.
Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”
The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”
The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.
Dr. Morgan and Dr. Gandhi reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.
“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.
he said in an interview.
The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.
Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.
Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.
The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.
Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).
Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.
“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.
The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.
In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).
The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.
Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.
Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”
The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”
The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.
Dr. Morgan and Dr. Gandhi reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.
“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.
he said in an interview.
The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.
Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.
Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.
The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.
Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).
Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.
“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.
The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.
In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).
The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.
Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.
Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”
The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”
The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.
Dr. Morgan and Dr. Gandhi reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
HPV infection in pregnancy higher among women living with HIV
Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.
“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.
Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.
“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”
Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
A study of studies
Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.
They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).
Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:
- The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
- Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
- Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
- HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
- One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.
Experts urge HPV, cervical cancer screening for women living with HIV
“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.
“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”
Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.
“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”
Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.
“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.
“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
HPV vaccination recommended
The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”
The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.
“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.
“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.
Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.
“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.
Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.
“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”
Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
A study of studies
Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.
They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).
Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:
- The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
- Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
- Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
- HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
- One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.
Experts urge HPV, cervical cancer screening for women living with HIV
“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.
“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”
Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.
“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”
Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.
“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.
“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
HPV vaccination recommended
The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”
The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.
“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.
“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.
Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.
“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.
Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.
“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”
Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
A study of studies
Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.
They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).
Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:
- The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
- Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
- Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
- HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
- One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.
Experts urge HPV, cervical cancer screening for women living with HIV
“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.
“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”
Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.
“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”
Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.
“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.
“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
HPV vaccination recommended
The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”
The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.
“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.
“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.
Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROME.
AVAHO 2022: A Multidisciplinary Approach to Self-care in Cancer Care
Nick Burwick, MD, discusses important takeaways that he gathered from the AVAHO 2022 meeting in San Diego. In keeping with this year's theme of self-care in cancer care, the keynote speaker, 'Patient Lee' Tomlinson, made a big impact on Dr Burwick with a motivational message about practicing compassion for not only your patients, but also for yourself. This theme continued with Dr Fay Hlubocky's presentation on resources available for self-care.
Dr Burwick also appreciated the multidisciplinary aspects of this year's AVAHO meeting that showcased the range of VA Whole Health options, the implementation of the Schwartz Rounds, and a diverse group of cancer care providers.
Nick Burwick, MD, discusses important takeaways that he gathered from the AVAHO 2022 meeting in San Diego. In keeping with this year's theme of self-care in cancer care, the keynote speaker, 'Patient Lee' Tomlinson, made a big impact on Dr Burwick with a motivational message about practicing compassion for not only your patients, but also for yourself. This theme continued with Dr Fay Hlubocky's presentation on resources available for self-care.
Dr Burwick also appreciated the multidisciplinary aspects of this year's AVAHO meeting that showcased the range of VA Whole Health options, the implementation of the Schwartz Rounds, and a diverse group of cancer care providers.
Nick Burwick, MD, discusses important takeaways that he gathered from the AVAHO 2022 meeting in San Diego. In keeping with this year's theme of self-care in cancer care, the keynote speaker, 'Patient Lee' Tomlinson, made a big impact on Dr Burwick with a motivational message about practicing compassion for not only your patients, but also for yourself. This theme continued with Dr Fay Hlubocky's presentation on resources available for self-care.
Dr Burwick also appreciated the multidisciplinary aspects of this year's AVAHO meeting that showcased the range of VA Whole Health options, the implementation of the Schwartz Rounds, and a diverse group of cancer care providers.
AVAHO 2022: The Necessity of Self-care in Cancer Care
Bernadette Heron, PharmD, summarizes the offerings at the AVAHO 2022 meeting, from the standard sharing of updates across disciplines and specialties to the more specific focus on the role of self-care in cancer care.
Importantly, Dr Heron underscores the connection between the concept of self-care and the implements required for its realization in the clinical setting, resulting in an assortment of tools that practitioners can draw on as they continue the conversation that drives the evolution of cancer care.
Bernadette Heron, PharmD, summarizes the offerings at the AVAHO 2022 meeting, from the standard sharing of updates across disciplines and specialties to the more specific focus on the role of self-care in cancer care.
Importantly, Dr Heron underscores the connection between the concept of self-care and the implements required for its realization in the clinical setting, resulting in an assortment of tools that practitioners can draw on as they continue the conversation that drives the evolution of cancer care.
Bernadette Heron, PharmD, summarizes the offerings at the AVAHO 2022 meeting, from the standard sharing of updates across disciplines and specialties to the more specific focus on the role of self-care in cancer care.
Importantly, Dr Heron underscores the connection between the concept of self-care and the implements required for its realization in the clinical setting, resulting in an assortment of tools that practitioners can draw on as they continue the conversation that drives the evolution of cancer care.
