Lucy Hicks

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Female patients are more likely to experience adverse outcomes following common surgical procedures when treated by a male rather than a female surgeon, according to a new analysis of over 1.3 million surgery patients. The study found no difference in adverse outcomes in male patients treated by surgeons of either sex.

While the effect of patient and provider sex discordance (female patient/male physician or male patient/female physician) on care has been explored before, “to the best of our knowledge, this is the first study to assess this in patients undergoing surgery,” Christopher Wallis, MD, PhD, an assistant professor in the division of urology at the University of Toronto, said in an email. The study was published online December 8 in JAMA Surgery.

Past studies in primary care settings have found that sex discordance between a physician and patient can result in “worse rapport, lower certainty of diagnosis, lower likelihood of assessing patient’s conditions as being of high severity, concerns of a hidden agenda, and disagreements regarding advice provided,” the authors write in the paper. Gender discordance has also been shown to negatively affect cancer screening rates and survival after heart attack. Given these past findings, Dr. Wallis and colleagues postulated that gender match between patients and surgeons could affect postoperative outcomes.

To find out, researchers analyzed data from over 1,320,100 patients undergoing one of 21 common elective and emergent surgical procedures in Ontario, Canada, from January 1, 2007, through December 31, 2019. Procedures were performed across the following specialties: cardiothoracic surgery, general surgery, neurosurgery, orthopedic surgery, otolaryngology, plastic surgery, thoracic surgery, urology, and vascular surgery. The investigators compared adverse postoperative outcomes — death, readmission, or complications within 30 days after surgery — in patients of both sexes when treated by male or female surgeons.

The study included 2,937 surgeons, and nearly 46% of patients included in the study were the same sex as their surgeon. Of the remaining 717,548 sex-discordant pairings, 93% were female patients with male surgeons, and 7% were male patients with female surgeons.

Among all patients, 14.9% experienced at least one adverse outcome. The researchers found that sex discordance between patient and surgeon was associated with higher odds of complications (adjusted odds ratio [aOR], 1.09; 95% CI, 1.07 – 1.11) and death (aOR, 1.07; 95% CI, 1.02 – 1.13). There was no statistically significant relationship between sex discordance and readmission in the study.

Using multivariable modeling, the researchers then teased out how patient sex affected this association. They found that female patients treated by male surgeons, compared to those treated by female surgeons, were more likely to have worse outcomes (aOR, 1.15; 95% CI, 1.10 – 1.20); however, there was no difference in outcomes in male patients treated by female surgeons compared with those with male surgeons (aOR, 0.99; 95% CI, 0.95 – 1.03).

While the study did not look at the underlying reasons for this disparity, communication differences between surgeons and patients could be one factor, Dr. Wallis noted. “Prior research has suggested differences in communication style between male and female physicians. Further, there is evidence that female physicians, including surgeons, spend more time with patients,” he wrote in an email. “This, coupled with evidence that female patients may have disparities in the management of their pain, suggest that communication differences may underpin the observed disparity.”

The finding “sounds the alarm for urgent action,” write Andrea Riner, MD, MPH, and Amalia Cochran, MD, both from the department of surgery at the University of Florida College of Medicine in Gainesville, in an accompanying commentary. While recruiting more women into surgical specialties is one way to address this disparity, both Dr. Riner and Dr. Cochran note the importance of identifying unconscious biases in patient care. “Surgeons likely believe they provide the same quality of care to patients irrespective of identity,” they write. “However, these data underscore an underappreciated phenomenon and highlight a measurable repercussion of implicit bias.”

Training programs that work with surgeons to improve communication and care with diverse patients may help counter these biases, they suggest, and incorporating patient identity in surgical outcome metrics could help identify biases. “Female patients with surgical disease should not be disadvantaged because there simply are not enough female surgeons or surgeons who are competent in the care of female patients,” they note. “We owe it to patients to provide them with the best outcomes, regardless of how their identities may align with ours.”

Dr. Riner reports grants from the National Human Genome Research Institute and the National Cancer Institute.Dr. Cochran is a section editor for UpToDate. Dr. Wallis reports no relevant financial relationships.

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

Female patients are more likely to experience adverse outcomes following common surgical procedures when treated by a male rather than a female surgeon, according to a new analysis of over 1.3 million surgery patients. The study found no difference in adverse outcomes in male patients treated by surgeons of either sex.

While the effect of patient and provider sex discordance (female patient/male physician or male patient/female physician) on care has been explored before, “to the best of our knowledge, this is the first study to assess this in patients undergoing surgery,” Christopher Wallis, MD, PhD, an assistant professor in the division of urology at the University of Toronto, said in an email. The study was published online December 8 in JAMA Surgery.

Past studies in primary care settings have found that sex discordance between a physician and patient can result in “worse rapport, lower certainty of diagnosis, lower likelihood of assessing patient’s conditions as being of high severity, concerns of a hidden agenda, and disagreements regarding advice provided,” the authors write in the paper. Gender discordance has also been shown to negatively affect cancer screening rates and survival after heart attack. Given these past findings, Dr. Wallis and colleagues postulated that gender match between patients and surgeons could affect postoperative outcomes.

To find out, researchers analyzed data from over 1,320,100 patients undergoing one of 21 common elective and emergent surgical procedures in Ontario, Canada, from January 1, 2007, through December 31, 2019. Procedures were performed across the following specialties: cardiothoracic surgery, general surgery, neurosurgery, orthopedic surgery, otolaryngology, plastic surgery, thoracic surgery, urology, and vascular surgery. The investigators compared adverse postoperative outcomes — death, readmission, or complications within 30 days after surgery — in patients of both sexes when treated by male or female surgeons.

The study included 2,937 surgeons, and nearly 46% of patients included in the study were the same sex as their surgeon. Of the remaining 717,548 sex-discordant pairings, 93% were female patients with male surgeons, and 7% were male patients with female surgeons.

Among all patients, 14.9% experienced at least one adverse outcome. The researchers found that sex discordance between patient and surgeon was associated with higher odds of complications (adjusted odds ratio [aOR], 1.09; 95% CI, 1.07 – 1.11) and death (aOR, 1.07; 95% CI, 1.02 – 1.13). There was no statistically significant relationship between sex discordance and readmission in the study.

Using multivariable modeling, the researchers then teased out how patient sex affected this association. They found that female patients treated by male surgeons, compared to those treated by female surgeons, were more likely to have worse outcomes (aOR, 1.15; 95% CI, 1.10 – 1.20); however, there was no difference in outcomes in male patients treated by female surgeons compared with those with male surgeons (aOR, 0.99; 95% CI, 0.95 – 1.03).

While the study did not look at the underlying reasons for this disparity, communication differences between surgeons and patients could be one factor, Dr. Wallis noted. “Prior research has suggested differences in communication style between male and female physicians. Further, there is evidence that female physicians, including surgeons, spend more time with patients,” he wrote in an email. “This, coupled with evidence that female patients may have disparities in the management of their pain, suggest that communication differences may underpin the observed disparity.”

The finding “sounds the alarm for urgent action,” write Andrea Riner, MD, MPH, and Amalia Cochran, MD, both from the department of surgery at the University of Florida College of Medicine in Gainesville, in an accompanying commentary. While recruiting more women into surgical specialties is one way to address this disparity, both Dr. Riner and Dr. Cochran note the importance of identifying unconscious biases in patient care. “Surgeons likely believe they provide the same quality of care to patients irrespective of identity,” they write. “However, these data underscore an underappreciated phenomenon and highlight a measurable repercussion of implicit bias.”

Training programs that work with surgeons to improve communication and care with diverse patients may help counter these biases, they suggest, and incorporating patient identity in surgical outcome metrics could help identify biases. “Female patients with surgical disease should not be disadvantaged because there simply are not enough female surgeons or surgeons who are competent in the care of female patients,” they note. “We owe it to patients to provide them with the best outcomes, regardless of how their identities may align with ours.”

Dr. Riner reports grants from the National Human Genome Research Institute and the National Cancer Institute.Dr. Cochran is a section editor for UpToDate. Dr. Wallis reports no relevant financial relationships.

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

Female patients are more likely to experience adverse outcomes following common surgical procedures when treated by a male rather than a female surgeon, according to a new analysis of over 1.3 million surgery patients. The study found no difference in adverse outcomes in male patients treated by surgeons of either sex.

While the effect of patient and provider sex discordance (female patient/male physician or male patient/female physician) on care has been explored before, “to the best of our knowledge, this is the first study to assess this in patients undergoing surgery,” Christopher Wallis, MD, PhD, an assistant professor in the division of urology at the University of Toronto, said in an email. The study was published online December 8 in JAMA Surgery.

Past studies in primary care settings have found that sex discordance between a physician and patient can result in “worse rapport, lower certainty of diagnosis, lower likelihood of assessing patient’s conditions as being of high severity, concerns of a hidden agenda, and disagreements regarding advice provided,” the authors write in the paper. Gender discordance has also been shown to negatively affect cancer screening rates and survival after heart attack. Given these past findings, Dr. Wallis and colleagues postulated that gender match between patients and surgeons could affect postoperative outcomes.

To find out, researchers analyzed data from over 1,320,100 patients undergoing one of 21 common elective and emergent surgical procedures in Ontario, Canada, from January 1, 2007, through December 31, 2019. Procedures were performed across the following specialties: cardiothoracic surgery, general surgery, neurosurgery, orthopedic surgery, otolaryngology, plastic surgery, thoracic surgery, urology, and vascular surgery. The investigators compared adverse postoperative outcomes — death, readmission, or complications within 30 days after surgery — in patients of both sexes when treated by male or female surgeons.

The study included 2,937 surgeons, and nearly 46% of patients included in the study were the same sex as their surgeon. Of the remaining 717,548 sex-discordant pairings, 93% were female patients with male surgeons, and 7% were male patients with female surgeons.

Among all patients, 14.9% experienced at least one adverse outcome. The researchers found that sex discordance between patient and surgeon was associated with higher odds of complications (adjusted odds ratio [aOR], 1.09; 95% CI, 1.07 – 1.11) and death (aOR, 1.07; 95% CI, 1.02 – 1.13). There was no statistically significant relationship between sex discordance and readmission in the study.

Using multivariable modeling, the researchers then teased out how patient sex affected this association. They found that female patients treated by male surgeons, compared to those treated by female surgeons, were more likely to have worse outcomes (aOR, 1.15; 95% CI, 1.10 – 1.20); however, there was no difference in outcomes in male patients treated by female surgeons compared with those with male surgeons (aOR, 0.99; 95% CI, 0.95 – 1.03).

While the study did not look at the underlying reasons for this disparity, communication differences between surgeons and patients could be one factor, Dr. Wallis noted. “Prior research has suggested differences in communication style between male and female physicians. Further, there is evidence that female physicians, including surgeons, spend more time with patients,” he wrote in an email. “This, coupled with evidence that female patients may have disparities in the management of their pain, suggest that communication differences may underpin the observed disparity.”

The finding “sounds the alarm for urgent action,” write Andrea Riner, MD, MPH, and Amalia Cochran, MD, both from the department of surgery at the University of Florida College of Medicine in Gainesville, in an accompanying commentary. While recruiting more women into surgical specialties is one way to address this disparity, both Dr. Riner and Dr. Cochran note the importance of identifying unconscious biases in patient care. “Surgeons likely believe they provide the same quality of care to patients irrespective of identity,” they write. “However, these data underscore an underappreciated phenomenon and highlight a measurable repercussion of implicit bias.”

Training programs that work with surgeons to improve communication and care with diverse patients may help counter these biases, they suggest, and incorporating patient identity in surgical outcome metrics could help identify biases. “Female patients with surgical disease should not be disadvantaged because there simply are not enough female surgeons or surgeons who are competent in the care of female patients,” they note. “We owe it to patients to provide them with the best outcomes, regardless of how their identities may align with ours.”

Dr. Riner reports grants from the National Human Genome Research Institute and the National Cancer Institute.Dr. Cochran is a section editor for UpToDate. Dr. Wallis reports no relevant financial relationships.

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

Intrauterine contraceptive devices (IUDs) have been linked to increased background enhancement on breast MRI, according to research presented at the Radiological Society of North America 2021 annual meeting.

About 10.4% of women 15-49 years of age who use contraception have an IUD or contraceptive implant, according to the Centers for Disease Control and Prevention. Unlike oral or transdermal hormonal contraceptives and hormone replacement therapy, levonorgestrel-releasing IUDs release a small amount of the hormone directly into the uterus and are thought to have a much more localized effect, Luisa Huck, MD, the lead author of the study, said in an interview.

But women with IUDs have long reported adverse effects associated with other hormonal medication. “In the past, some women reported depression, headaches, sleep disorders, and panic attacks,” noted Dr. Huck, a radiology resident at RWTH Aachen University in Germany.

Christiane Kuhl, MD, chief of the department of radiology at RWTH Aachen University and senior author of the research, had also observed that women with hormonal IUDs often have increased background parenchymal enhancement (BPE) on contrast-enhanced MRI. BPE “has been established as a sensitive marker of hormonal stimulation of breast,” the study authors wrote, and previous studies have shown that women using hormonal medications have higher BPE on breast MRIs.

To better understand whether IUDs can increase BPE, Dr. Huck and colleagues used the hospital database to search for premenopausal women who had undergone breast MRIs for screening between January 2014 and July 2020. To be included, women had to have had at least two scans: one with and one without an IUD in place, with the scan conducted at least 4 weeks after IUD placement or removal. All women in the study had no history of breast cancer or hormone or antihormone intake.

The study involved 48 women with an average age of 45 years and a median of 27 months between the two scans. Forty-six of the women had the Mirena levonorgestrel-releasing IUD and two had the Jaydess IUD. To account for hormone variations between patients, the researchers used each patient as their own reference point. To control for age-related effects, 25 women had their first MRI without an IUD and their second scan with an IUD in place. The second group of 23 women underwent their first MRI with an IUD and had it removed before the second scan.

Hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging.

For 23 women in the study, background enhancement was higher on scans with the IUD than without (P < .001). For 24 women, there was no change in BPE with or without an IUD, and one woman had lower BPE with an IUD than without.

“It is very interesting and relevant to practice to consider that the presence of an intrauterine device would have potential impact on the enhancement we see in the breast on MRI imaging,” Samantha Heller, MD, PhD, associate professor of radiology at New York University, said in an interview.

However, the study used BPE as a measure for hormonal shifts, and “hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging,” she noted. BPE on MRI can fluctuate, so testing actual hormone levels in patients with elevated BPE could be helpful to identify hormonal shifts, she added. It is also important to understand why half of the women in the study showed no variation in BPE, she said.

The study findings are not very surprising, considering that it is known that low levels of progesterone from IUDs circulate in the blood stream, Frances Casey, MD, MPH, associate professor in the department of obstetrics and gynecology at Virginia Commonwealth University in Richmond, said in an interview. They do not suggest that there should be any changes to IUD guidelines, she added.

However, “the study findings raise the question as to whether IUD status should be documented as a matter of course prior to performing breast MRI,” said Dr. Heller. “It is standard to document the timing of a woman’s menstrual cycle, as well as to note any hormone suppression or replacement therapy. This is in part so that the radiologist may understand the etiology of any observed variation in background enhancement,” she explained.

Although increased enhancement on MRI has sometimes been linked to higher chances of recommendations for additional imaging or biopsies, she noted, “more work would be needed to understand the impact – if any – of an IUD on breast MRI recommendations due to enhancement changes.”

Dr. Huck, Dr. Heller, and Dr. Casey disclosed no relevant financial relationships.

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

Intrauterine contraceptive devices (IUDs) have been linked to increased background enhancement on breast MRI, according to research presented at the Radiological Society of North America 2021 annual meeting.

About 10.4% of women 15-49 years of age who use contraception have an IUD or contraceptive implant, according to the Centers for Disease Control and Prevention. Unlike oral or transdermal hormonal contraceptives and hormone replacement therapy, levonorgestrel-releasing IUDs release a small amount of the hormone directly into the uterus and are thought to have a much more localized effect, Luisa Huck, MD, the lead author of the study, said in an interview.

But women with IUDs have long reported adverse effects associated with other hormonal medication. “In the past, some women reported depression, headaches, sleep disorders, and panic attacks,” noted Dr. Huck, a radiology resident at RWTH Aachen University in Germany.

Christiane Kuhl, MD, chief of the department of radiology at RWTH Aachen University and senior author of the research, had also observed that women with hormonal IUDs often have increased background parenchymal enhancement (BPE) on contrast-enhanced MRI. BPE “has been established as a sensitive marker of hormonal stimulation of breast,” the study authors wrote, and previous studies have shown that women using hormonal medications have higher BPE on breast MRIs.

To better understand whether IUDs can increase BPE, Dr. Huck and colleagues used the hospital database to search for premenopausal women who had undergone breast MRIs for screening between January 2014 and July 2020. To be included, women had to have had at least two scans: one with and one without an IUD in place, with the scan conducted at least 4 weeks after IUD placement or removal. All women in the study had no history of breast cancer or hormone or antihormone intake.

The study involved 48 women with an average age of 45 years and a median of 27 months between the two scans. Forty-six of the women had the Mirena levonorgestrel-releasing IUD and two had the Jaydess IUD. To account for hormone variations between patients, the researchers used each patient as their own reference point. To control for age-related effects, 25 women had their first MRI without an IUD and their second scan with an IUD in place. The second group of 23 women underwent their first MRI with an IUD and had it removed before the second scan.

Hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging.

For 23 women in the study, background enhancement was higher on scans with the IUD than without (P < .001). For 24 women, there was no change in BPE with or without an IUD, and one woman had lower BPE with an IUD than without.

“It is very interesting and relevant to practice to consider that the presence of an intrauterine device would have potential impact on the enhancement we see in the breast on MRI imaging,” Samantha Heller, MD, PhD, associate professor of radiology at New York University, said in an interview.

However, the study used BPE as a measure for hormonal shifts, and “hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging,” she noted. BPE on MRI can fluctuate, so testing actual hormone levels in patients with elevated BPE could be helpful to identify hormonal shifts, she added. It is also important to understand why half of the women in the study showed no variation in BPE, she said.

The study findings are not very surprising, considering that it is known that low levels of progesterone from IUDs circulate in the blood stream, Frances Casey, MD, MPH, associate professor in the department of obstetrics and gynecology at Virginia Commonwealth University in Richmond, said in an interview. They do not suggest that there should be any changes to IUD guidelines, she added.

However, “the study findings raise the question as to whether IUD status should be documented as a matter of course prior to performing breast MRI,” said Dr. Heller. “It is standard to document the timing of a woman’s menstrual cycle, as well as to note any hormone suppression or replacement therapy. This is in part so that the radiologist may understand the etiology of any observed variation in background enhancement,” she explained.

Although increased enhancement on MRI has sometimes been linked to higher chances of recommendations for additional imaging or biopsies, she noted, “more work would be needed to understand the impact – if any – of an IUD on breast MRI recommendations due to enhancement changes.”

Dr. Huck, Dr. Heller, and Dr. Casey disclosed no relevant financial relationships.

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

Intrauterine contraceptive devices (IUDs) have been linked to increased background enhancement on breast MRI, according to research presented at the Radiological Society of North America 2021 annual meeting.

About 10.4% of women 15-49 years of age who use contraception have an IUD or contraceptive implant, according to the Centers for Disease Control and Prevention. Unlike oral or transdermal hormonal contraceptives and hormone replacement therapy, levonorgestrel-releasing IUDs release a small amount of the hormone directly into the uterus and are thought to have a much more localized effect, Luisa Huck, MD, the lead author of the study, said in an interview.

But women with IUDs have long reported adverse effects associated with other hormonal medication. “In the past, some women reported depression, headaches, sleep disorders, and panic attacks,” noted Dr. Huck, a radiology resident at RWTH Aachen University in Germany.

Christiane Kuhl, MD, chief of the department of radiology at RWTH Aachen University and senior author of the research, had also observed that women with hormonal IUDs often have increased background parenchymal enhancement (BPE) on contrast-enhanced MRI. BPE “has been established as a sensitive marker of hormonal stimulation of breast,” the study authors wrote, and previous studies have shown that women using hormonal medications have higher BPE on breast MRIs.

To better understand whether IUDs can increase BPE, Dr. Huck and colleagues used the hospital database to search for premenopausal women who had undergone breast MRIs for screening between January 2014 and July 2020. To be included, women had to have had at least two scans: one with and one without an IUD in place, with the scan conducted at least 4 weeks after IUD placement or removal. All women in the study had no history of breast cancer or hormone or antihormone intake.

The study involved 48 women with an average age of 45 years and a median of 27 months between the two scans. Forty-six of the women had the Mirena levonorgestrel-releasing IUD and two had the Jaydess IUD. To account for hormone variations between patients, the researchers used each patient as their own reference point. To control for age-related effects, 25 women had their first MRI without an IUD and their second scan with an IUD in place. The second group of 23 women underwent their first MRI with an IUD and had it removed before the second scan.

Hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging.

For 23 women in the study, background enhancement was higher on scans with the IUD than without (P < .001). For 24 women, there was no change in BPE with or without an IUD, and one woman had lower BPE with an IUD than without.

“It is very interesting and relevant to practice to consider that the presence of an intrauterine device would have potential impact on the enhancement we see in the breast on MRI imaging,” Samantha Heller, MD, PhD, associate professor of radiology at New York University, said in an interview.

However, the study used BPE as a measure for hormonal shifts, and “hormonal effects on breast enhancement are very complex, and hormonal stimulation is not always predictably correlated with changes on MRI imaging,” she noted. BPE on MRI can fluctuate, so testing actual hormone levels in patients with elevated BPE could be helpful to identify hormonal shifts, she added. It is also important to understand why half of the women in the study showed no variation in BPE, she said.

The study findings are not very surprising, considering that it is known that low levels of progesterone from IUDs circulate in the blood stream, Frances Casey, MD, MPH, associate professor in the department of obstetrics and gynecology at Virginia Commonwealth University in Richmond, said in an interview. They do not suggest that there should be any changes to IUD guidelines, she added.

However, “the study findings raise the question as to whether IUD status should be documented as a matter of course prior to performing breast MRI,” said Dr. Heller. “It is standard to document the timing of a woman’s menstrual cycle, as well as to note any hormone suppression or replacement therapy. This is in part so that the radiologist may understand the etiology of any observed variation in background enhancement,” she explained.

Although increased enhancement on MRI has sometimes been linked to higher chances of recommendations for additional imaging or biopsies, she noted, “more work would be needed to understand the impact – if any – of an IUD on breast MRI recommendations due to enhancement changes.”

Dr. Huck, Dr. Heller, and Dr. Casey disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved the first treatment for posttransplant cytomegalovirus (CMV) that is resistant to other drugs. The treatment, maribavir (Livtencity), is approved for adults and children 12 years and older who weigh at least 35 kg (77 pounds).

There are an estimated 200,000 adult transplants every year globally. CMV, a type of herpes virus, is one of the most common infections in transplant patients, occurring in 16%-56% of solid organ transplant recipients and 30%-70% of hematopoietic stem cell transplant recipients, according to Takeda Pharmaceutical Company Limited, the company that manufactures Livtencity. For immunosuppressed transplant patients, CMV infection can lead to complications that include loss of the transplanted or organ or even death.

“Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” John Farley, MD, MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

Livtencity, which is taken orally, works by preventing the activity of the enzyme responsible for virus replication. The approval, announced Nov. 23, was based on a phase 3 clinical trial that compared Livtencity with conventional antiviral treatments in the achievement of CMV DNA concentration levels below what is measurable in transplant patients with CMV infection that is refractory or treatment-resistant. After 8 weeks, of the 235 patients who received Livtencity, 56% achieved this primary endpoint, compared with 24% of the 117 patients who received conventional antiviral treatments, the press release says.

The most reported adverse reactions of Livtencity were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

“We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers,” Ramona Sequeira, president of the Takeda’s U.S. Business Unit and Global Portfolio Commercialization, said in a statement. “People undergoing transplants have a lengthy and complex health care journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease.”

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

The Food and Drug Administration has approved the first treatment for posttransplant cytomegalovirus (CMV) that is resistant to other drugs. The treatment, maribavir (Livtencity), is approved for adults and children 12 years and older who weigh at least 35 kg (77 pounds).

There are an estimated 200,000 adult transplants every year globally. CMV, a type of herpes virus, is one of the most common infections in transplant patients, occurring in 16%-56% of solid organ transplant recipients and 30%-70% of hematopoietic stem cell transplant recipients, according to Takeda Pharmaceutical Company Limited, the company that manufactures Livtencity. For immunosuppressed transplant patients, CMV infection can lead to complications that include loss of the transplanted or organ or even death.

“Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” John Farley, MD, MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

Livtencity, which is taken orally, works by preventing the activity of the enzyme responsible for virus replication. The approval, announced Nov. 23, was based on a phase 3 clinical trial that compared Livtencity with conventional antiviral treatments in the achievement of CMV DNA concentration levels below what is measurable in transplant patients with CMV infection that is refractory or treatment-resistant. After 8 weeks, of the 235 patients who received Livtencity, 56% achieved this primary endpoint, compared with 24% of the 117 patients who received conventional antiviral treatments, the press release says.

The most reported adverse reactions of Livtencity were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

“We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers,” Ramona Sequeira, president of the Takeda’s U.S. Business Unit and Global Portfolio Commercialization, said in a statement. “People undergoing transplants have a lengthy and complex health care journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease.”

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

The Food and Drug Administration has approved the first treatment for posttransplant cytomegalovirus (CMV) that is resistant to other drugs. The treatment, maribavir (Livtencity), is approved for adults and children 12 years and older who weigh at least 35 kg (77 pounds).

There are an estimated 200,000 adult transplants every year globally. CMV, a type of herpes virus, is one of the most common infections in transplant patients, occurring in 16%-56% of solid organ transplant recipients and 30%-70% of hematopoietic stem cell transplant recipients, according to Takeda Pharmaceutical Company Limited, the company that manufactures Livtencity. For immunosuppressed transplant patients, CMV infection can lead to complications that include loss of the transplanted or organ or even death.

“Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” John Farley, MD, MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

Livtencity, which is taken orally, works by preventing the activity of the enzyme responsible for virus replication. The approval, announced Nov. 23, was based on a phase 3 clinical trial that compared Livtencity with conventional antiviral treatments in the achievement of CMV DNA concentration levels below what is measurable in transplant patients with CMV infection that is refractory or treatment-resistant. After 8 weeks, of the 235 patients who received Livtencity, 56% achieved this primary endpoint, compared with 24% of the 117 patients who received conventional antiviral treatments, the press release says.

The most reported adverse reactions of Livtencity were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

“We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers,” Ramona Sequeira, president of the Takeda’s U.S. Business Unit and Global Portfolio Commercialization, said in a statement. “People undergoing transplants have a lengthy and complex health care journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease.”

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

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

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

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

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

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

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

Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.

“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.

In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”

To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.

Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”

More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.

The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.

Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.

“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.

Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”

Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.

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

Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.

“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.

In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”

To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.

Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”

More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.

The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.

Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.

“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.

Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”

Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.

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

Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.

“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.

In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”

To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.

Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”

More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.

The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.

Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.

“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.

Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”

Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.

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

Among active-duty men who have sex with men (MSM), Black and Latino military members are at least three times as likely to be prescribed HIV pre-exposure prophylaxis (PrEP) than their White counterparts, according to new survey results.

“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.

The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.

Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.

Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).

While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.

While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.

Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.  

“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.

Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.

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

Among active-duty men who have sex with men (MSM), Black and Latino military members are at least three times as likely to be prescribed HIV pre-exposure prophylaxis (PrEP) than their White counterparts, according to new survey results.

“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.

The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.

Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.

Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).

While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.

While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.

Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.  

“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.

Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.

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

Among active-duty men who have sex with men (MSM), Black and Latino military members are at least three times as likely to be prescribed HIV pre-exposure prophylaxis (PrEP) than their White counterparts, according to new survey results.

“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.

The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.

Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.

Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).

While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.

While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.

Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.  

“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.

Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.

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

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

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

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

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

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

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

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has unanimously voted to recommend universal hepatitis B (HBV) immunization in all unvaccinated adults aged 59 years or younger. The group also voted to expand recommendations for vaccinating people at risk for occupational exposure to Ebola and to recommend Jynneos, a smallpox and monkeypox vaccine, for at-risk populations.

The recommendations were approved Nov. 3.

Previously, ACIP recommended HBV vaccination for unvaccinated adults at increased risk for infection because of sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, HIV infection, and travel to areas with high to intermediate levels of HBV infection. But experts agreed a new strategy was needed, as previously falling rates of HBV have plateaued. “The past decade has illustrated that risk-based screening has got us as far as it can take us,” Mark Weng, MD, a lieutenant commander in the U.S. Public Health Service and lead of the ACIP Hepatitis Vaccine Working Group, said during the meeting.

There are 1.9 million people living with chronic HBV in the United States, with over 20,000 new acute infections every year. Rates are highest among those in their 40s and 50s, Dr. Weng noted.

The group debated whether to apply the universal recommendation to all ages, but in a close vote (eight yes, seven no), ACIP included an age cutoff of 59. The majority argued that adults 60 and older are at lower risk for infection and vaccination efforts targeting younger adults would be more effective. Those 60 and older would continue to follow the risk-based guidelines, but anyone, regardless of age, can receive the vaccine if they wish to be protected, the group added.

The CDC director as well as several professional societies need to approve the recommendation before it becomes public policy.

ACIP also voted to recommend the following:

• Adding updated recommendations to the 2022 immunization schedules for children, adolescents, and adults, including dengue vaccination for children aged 9-16 years in endemic areas and in adults over 65 and those aged 19-64 with certain chronic conditions.
• The use of Jynneos, a smallpox and monkeypox vaccine, as an alternative to ACAM2000 for those at risk for occupational exposure.
• Pre-exposure vaccination of health care personnel involved in the transport and treatment of suspected Ebola patients at special treatment centers, or lab and support staff working with or handling specimens that may contain the Ebola virus.

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

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has unanimously voted to recommend universal hepatitis B (HBV) immunization in all unvaccinated adults aged 59 years or younger. The group also voted to expand recommendations for vaccinating people at risk for occupational exposure to Ebola and to recommend Jynneos, a smallpox and monkeypox vaccine, for at-risk populations.

The recommendations were approved Nov. 3.

Previously, ACIP recommended HBV vaccination for unvaccinated adults at increased risk for infection because of sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, HIV infection, and travel to areas with high to intermediate levels of HBV infection. But experts agreed a new strategy was needed, as previously falling rates of HBV have plateaued. “The past decade has illustrated that risk-based screening has got us as far as it can take us,” Mark Weng, MD, a lieutenant commander in the U.S. Public Health Service and lead of the ACIP Hepatitis Vaccine Working Group, said during the meeting.

There are 1.9 million people living with chronic HBV in the United States, with over 20,000 new acute infections every year. Rates are highest among those in their 40s and 50s, Dr. Weng noted.

The group debated whether to apply the universal recommendation to all ages, but in a close vote (eight yes, seven no), ACIP included an age cutoff of 59. The majority argued that adults 60 and older are at lower risk for infection and vaccination efforts targeting younger adults would be more effective. Those 60 and older would continue to follow the risk-based guidelines, but anyone, regardless of age, can receive the vaccine if they wish to be protected, the group added.

The CDC director as well as several professional societies need to approve the recommendation before it becomes public policy.

ACIP also voted to recommend the following:

• Adding updated recommendations to the 2022 immunization schedules for children, adolescents, and adults, including dengue vaccination for children aged 9-16 years in endemic areas and in adults over 65 and those aged 19-64 with certain chronic conditions.
• The use of Jynneos, a smallpox and monkeypox vaccine, as an alternative to ACAM2000 for those at risk for occupational exposure.
• Pre-exposure vaccination of health care personnel involved in the transport and treatment of suspected Ebola patients at special treatment centers, or lab and support staff working with or handling specimens that may contain the Ebola virus.

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

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has unanimously voted to recommend universal hepatitis B (HBV) immunization in all unvaccinated adults aged 59 years or younger. The group also voted to expand recommendations for vaccinating people at risk for occupational exposure to Ebola and to recommend Jynneos, a smallpox and monkeypox vaccine, for at-risk populations.

The recommendations were approved Nov. 3.

Previously, ACIP recommended HBV vaccination for unvaccinated adults at increased risk for infection because of sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, HIV infection, and travel to areas with high to intermediate levels of HBV infection. But experts agreed a new strategy was needed, as previously falling rates of HBV have plateaued. “The past decade has illustrated that risk-based screening has got us as far as it can take us,” Mark Weng, MD, a lieutenant commander in the U.S. Public Health Service and lead of the ACIP Hepatitis Vaccine Working Group, said during the meeting.

There are 1.9 million people living with chronic HBV in the United States, with over 20,000 new acute infections every year. Rates are highest among those in their 40s and 50s, Dr. Weng noted.

The group debated whether to apply the universal recommendation to all ages, but in a close vote (eight yes, seven no), ACIP included an age cutoff of 59. The majority argued that adults 60 and older are at lower risk for infection and vaccination efforts targeting younger adults would be more effective. Those 60 and older would continue to follow the risk-based guidelines, but anyone, regardless of age, can receive the vaccine if they wish to be protected, the group added.

The CDC director as well as several professional societies need to approve the recommendation before it becomes public policy.

ACIP also voted to recommend the following:

• Adding updated recommendations to the 2022 immunization schedules for children, adolescents, and adults, including dengue vaccination for children aged 9-16 years in endemic areas and in adults over 65 and those aged 19-64 with certain chronic conditions.
• The use of Jynneos, a smallpox and monkeypox vaccine, as an alternative to ACAM2000 for those at risk for occupational exposure.
• Pre-exposure vaccination of health care personnel involved in the transport and treatment of suspected Ebola patients at special treatment centers, or lab and support staff working with or handling specimens that may contain the Ebola virus.

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

The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).

Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.

In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:

• A patient-decision checklist
• Updated silicone gel–filled breast implant rupture screening recommendations
• A device description including materials used in the device
• Patient device ID cards

The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.

The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”

Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.

To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.

But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”

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

The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).

Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.

In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:

• A patient-decision checklist
• Updated silicone gel–filled breast implant rupture screening recommendations
• A device description including materials used in the device
• Patient device ID cards

The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.

The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”

Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.

To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.

But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”

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

The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).

Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.

In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:

• A patient-decision checklist
• Updated silicone gel–filled breast implant rupture screening recommendations
• A device description including materials used in the device
• Patient device ID cards

The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.

The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”

Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.

To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.

But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”

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