MDedge Pediatrics

The percentage of kindergarteners in the United States who have received routine vaccines to protect against illnesses such as measles, whooping cough, and polio has declined for 2 straight years, a new study has found.

Drops in vaccine coverage leave communities more susceptible to outbreaks of vaccine-preventable diseases, such as those that occurred in 2022, public health officials said.

Coverage for four vaccines – against measles, mumps, and rubella (MMR); diphtheria, tetanus, and acellular pertussis (DTaP); poliovirus; and varicella – among kindergarten students was about 95% in 2019-2020.

The rate fell to 94% the following year.

For the 2021-2022 school year, coverage dropped another point, to 93%, according to the report, published online in Morbidity and Mortality Weekly Report.

The rate of vaccination overall remains high, but about 250,000 kindergarten students may not be protected against measles, the researchers estimate. Measles, which is highly infectious, can lead to serious illness and even death in children who have not been vaccinated against the virus.

“In 2022, two communities in the United States responded to outbreaks of measles where children have been hospitalized,” Georgina Peacock, MD, MPH, director of the immunization services division of the Centers for Disease Control and Prevention, said in a media briefing about the report. “One community reported a case of paralytic polio in an unvaccinated person. These outbreaks were preventable. The best way to prevent these diseases and their devastating impact on children is through vaccination.”
 

Exemptions steady

For the new study, Ranee Seither, MPH, with the CDC’s National Center for Immunization and Respiratory Diseases and her colleagues analyzed data reported by states to estimate nationwide coverage for the four routine vaccines.

The number of students with exemptions remained low, at 2.6%, but another 3.9% who were without exemptions were not up to date with the MMR vaccine, the investigators report.

In a separate study, researchers found that vaccination coverage for 2-year-olds has increased. Approximately 70% of children were up to date with a seven-vaccine series by age 24 months. The coverage rate was higher for children born during 2018-2019 than for those born during 2016-2017.

Although the COVID-19 pandemic was not associated with decreased vaccination rates in this younger age group overall, coverage fell by 4-5 percentage points for children living below the poverty level or in rural areas, according to the study.

In addition, uninsured children were eight times more likely than those with private insurance to not be vaccinated by their second birthday, the researchers found.

Strategies to increase vaccination coverage include enforcing school vaccination requirements and holding vaccination clinics at schools, the CDC said.

“Providers should review children’s histories and recommend needed vaccinations during every clinical encounter and address parental hesitancy to help reduce disparities and ensure that all children are protected from vaccine-preventable diseases,” the agency said.

To that end, the agency launched an initiative this week called Let’s RISE (Routine Immunizations on Schedule for Everyone) to provide clinicians with resources to help patients get on track with their immunizations.
 

Hundreds of thousands unprotected

MMR vaccination coverage for kindergartners is the lowest it has been in over a decade, Dr. Peacock noted. Decreased coverage for kindergarten students might be tied to pandemic-related disruptions in health care systems and schools, she said. School administrators and parents may have been less focused on routine vaccination paperwork amid the return to in-person learning, for instance.

Hesitancy about COVID vaccines could be affecting routine vaccinations. “That’s something that we are watching very closely,” Dr. Peacock said.

The 2-point decrease in vaccination coverage “translates to hundreds of thousands of children starting school without being fully protected” against preventable diseases that can spread easily in classrooms, Sean O’Leary, MD, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said.

Despite the drop in coverage, Dr. O’Leary said he saw some encouraging signs in the data: Nonmedical exemptions for kindergarten students have not increased. And the vast majority of parents are still having their children vaccinated. At the same time, the reports highlight a need to address child poverty and improve vaccine access in rural areas, he said.

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

The percentage of kindergarteners in the United States who have received routine vaccines to protect against illnesses such as measles, whooping cough, and polio has declined for 2 straight years, a new study has found.

Drops in vaccine coverage leave communities more susceptible to outbreaks of vaccine-preventable diseases, such as those that occurred in 2022, public health officials said.

Coverage for four vaccines – against measles, mumps, and rubella (MMR); diphtheria, tetanus, and acellular pertussis (DTaP); poliovirus; and varicella – among kindergarten students was about 95% in 2019-2020.

The rate fell to 94% the following year.

For the 2021-2022 school year, coverage dropped another point, to 93%, according to the report, published online in Morbidity and Mortality Weekly Report.

The rate of vaccination overall remains high, but about 250,000 kindergarten students may not be protected against measles, the researchers estimate. Measles, which is highly infectious, can lead to serious illness and even death in children who have not been vaccinated against the virus.

“In 2022, two communities in the United States responded to outbreaks of measles where children have been hospitalized,” Georgina Peacock, MD, MPH, director of the immunization services division of the Centers for Disease Control and Prevention, said in a media briefing about the report. “One community reported a case of paralytic polio in an unvaccinated person. These outbreaks were preventable. The best way to prevent these diseases and their devastating impact on children is through vaccination.”
 

Exemptions steady

For the new study, Ranee Seither, MPH, with the CDC’s National Center for Immunization and Respiratory Diseases and her colleagues analyzed data reported by states to estimate nationwide coverage for the four routine vaccines.

The number of students with exemptions remained low, at 2.6%, but another 3.9% who were without exemptions were not up to date with the MMR vaccine, the investigators report.

In a separate study, researchers found that vaccination coverage for 2-year-olds has increased. Approximately 70% of children were up to date with a seven-vaccine series by age 24 months. The coverage rate was higher for children born during 2018-2019 than for those born during 2016-2017.

Although the COVID-19 pandemic was not associated with decreased vaccination rates in this younger age group overall, coverage fell by 4-5 percentage points for children living below the poverty level or in rural areas, according to the study.

In addition, uninsured children were eight times more likely than those with private insurance to not be vaccinated by their second birthday, the researchers found.

Strategies to increase vaccination coverage include enforcing school vaccination requirements and holding vaccination clinics at schools, the CDC said.

“Providers should review children’s histories and recommend needed vaccinations during every clinical encounter and address parental hesitancy to help reduce disparities and ensure that all children are protected from vaccine-preventable diseases,” the agency said.

To that end, the agency launched an initiative this week called Let’s RISE (Routine Immunizations on Schedule for Everyone) to provide clinicians with resources to help patients get on track with their immunizations.
 

Hundreds of thousands unprotected

MMR vaccination coverage for kindergartners is the lowest it has been in over a decade, Dr. Peacock noted. Decreased coverage for kindergarten students might be tied to pandemic-related disruptions in health care systems and schools, she said. School administrators and parents may have been less focused on routine vaccination paperwork amid the return to in-person learning, for instance.

Hesitancy about COVID vaccines could be affecting routine vaccinations. “That’s something that we are watching very closely,” Dr. Peacock said.

The 2-point decrease in vaccination coverage “translates to hundreds of thousands of children starting school without being fully protected” against preventable diseases that can spread easily in classrooms, Sean O’Leary, MD, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said.

Despite the drop in coverage, Dr. O’Leary said he saw some encouraging signs in the data: Nonmedical exemptions for kindergarten students have not increased. And the vast majority of parents are still having their children vaccinated. At the same time, the reports highlight a need to address child poverty and improve vaccine access in rural areas, he said.

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

The percentage of kindergarteners in the United States who have received routine vaccines to protect against illnesses such as measles, whooping cough, and polio has declined for 2 straight years, a new study has found.

Drops in vaccine coverage leave communities more susceptible to outbreaks of vaccine-preventable diseases, such as those that occurred in 2022, public health officials said.

Coverage for four vaccines – against measles, mumps, and rubella (MMR); diphtheria, tetanus, and acellular pertussis (DTaP); poliovirus; and varicella – among kindergarten students was about 95% in 2019-2020.

The rate fell to 94% the following year.

For the 2021-2022 school year, coverage dropped another point, to 93%, according to the report, published online in Morbidity and Mortality Weekly Report.

The rate of vaccination overall remains high, but about 250,000 kindergarten students may not be protected against measles, the researchers estimate. Measles, which is highly infectious, can lead to serious illness and even death in children who have not been vaccinated against the virus.

“In 2022, two communities in the United States responded to outbreaks of measles where children have been hospitalized,” Georgina Peacock, MD, MPH, director of the immunization services division of the Centers for Disease Control and Prevention, said in a media briefing about the report. “One community reported a case of paralytic polio in an unvaccinated person. These outbreaks were preventable. The best way to prevent these diseases and their devastating impact on children is through vaccination.”
 

Exemptions steady

For the new study, Ranee Seither, MPH, with the CDC’s National Center for Immunization and Respiratory Diseases and her colleagues analyzed data reported by states to estimate nationwide coverage for the four routine vaccines.

The number of students with exemptions remained low, at 2.6%, but another 3.9% who were without exemptions were not up to date with the MMR vaccine, the investigators report.

In a separate study, researchers found that vaccination coverage for 2-year-olds has increased. Approximately 70% of children were up to date with a seven-vaccine series by age 24 months. The coverage rate was higher for children born during 2018-2019 than for those born during 2016-2017.

Although the COVID-19 pandemic was not associated with decreased vaccination rates in this younger age group overall, coverage fell by 4-5 percentage points for children living below the poverty level or in rural areas, according to the study.

In addition, uninsured children were eight times more likely than those with private insurance to not be vaccinated by their second birthday, the researchers found.

Strategies to increase vaccination coverage include enforcing school vaccination requirements and holding vaccination clinics at schools, the CDC said.

“Providers should review children’s histories and recommend needed vaccinations during every clinical encounter and address parental hesitancy to help reduce disparities and ensure that all children are protected from vaccine-preventable diseases,” the agency said.

To that end, the agency launched an initiative this week called Let’s RISE (Routine Immunizations on Schedule for Everyone) to provide clinicians with resources to help patients get on track with their immunizations.
 

Hundreds of thousands unprotected

MMR vaccination coverage for kindergartners is the lowest it has been in over a decade, Dr. Peacock noted. Decreased coverage for kindergarten students might be tied to pandemic-related disruptions in health care systems and schools, she said. School administrators and parents may have been less focused on routine vaccination paperwork amid the return to in-person learning, for instance.

Hesitancy about COVID vaccines could be affecting routine vaccinations. “That’s something that we are watching very closely,” Dr. Peacock said.

The 2-point decrease in vaccination coverage “translates to hundreds of thousands of children starting school without being fully protected” against preventable diseases that can spread easily in classrooms, Sean O’Leary, MD, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said.

Despite the drop in coverage, Dr. O’Leary said he saw some encouraging signs in the data: Nonmedical exemptions for kindergarten students have not increased. And the vast majority of parents are still having their children vaccinated. At the same time, the reports highlight a need to address child poverty and improve vaccine access in rural areas, he said.

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

Adult and adolescent patients with moderate to severe atopic dermatitis (AD) showed significant improvements with the addition of lebrikizumab to topical corticosteroid (TCS) therapy, compared with TCS plus placebo, according to results of the 16-week phase 3 ADhere trial.

“Lebrikizumab, a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate to severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies,” noted lead author Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, and coauthors in their article on the study, which was published in JAMA Dermatology.

The double-blind trial, conducted at 54 sites across Germany, Poland, Canada, and the United States, included 211 patients, mean age 37.2 years, of whom 48.8% were female and roughly 22% were adolescents. Almost 15% were Asian, and about 13% were Black.

At baseline, participants had a score of 16 or higher on the Eczema Area and Severity Index (EASI), a score of 3 or higher on the Investigator’s Global Assessment (IGA) scale, AD covering a body surface area of 10% or greater, and a history of inadequate response to treatment with topical medications.

After a minimum 1-week washout period from topical and systemic therapy, participants were randomized in a 2:1 ratio to receive lebrikizumab plus TCS (n = 145) or placebo plus TCS (n = 66) for 16 weeks.

Lebrikizumab or placebo was administered by subcutaneous injection every 2 weeks; the loading and week-2 doses of lebrikizumab were 500 mg, followed by 250 mg thereafter. All patients were instructed to use low- to mid-potency TCS at their own discretion. Study sites provided a mid-potency TCS (triamcinolone acetonide 0.1% cream) and a low-potency TCS (hydrocortisone 1% cream), with topical calcineurin inhibitors permitted for sensitive skin areas.

Primary outcomes at 16 weeks included a 2-point or more reduction in IGA score from baseline and EASI-75 response. Patients in the lebrikizumab arm had superior responses on both of these outcomes, with statistical significance achieved as early as week 8 and week 4, respectively, and maintained through week 16. Specifically, 41.2% of those treated with lebrikizumab had an IGA reduction of 2 points or more, compared with 22.1% of those receiving placebo plus TCS (P = .01), and the proportion of patients achieving EASI-75 responses was 69.5% vs. 42.2%, respectively (P < .001).

Patients treated with lebrikizumab also showed statistically significant improvements, compared with TCS alone in all key secondary endpoints, “including skin clearance, improvement in itch, itch interference on sleep, and enhanced QoL [quality of life],” noted the authors. “This study captured the clinical benefit of lebrikizumab through the combined end point of physician-assessed clinical sign of skin clearance (EASI-75) and patient-reported outcome of improvement in itch (Pruritus NRS).”

The percentage of patients who achieved the combined endpoint was more than double for the lebrikizumab plus TCS group vs. the group on TCS alone, indicating that patients treated with lebrikizumab plus TCS “were more likely to experience improvement in skin symptoms and itch,” the investigators added.

The authors noted that most treatment-emergent adverse events “were nonserious, mild, or moderate in severity, and did not lead to study discontinuation.” These included conjunctivitis (4.8%), headache (4.8%), hypertension (2.8%), injection-site reactions (2.8%), and herpes infection (3.4%) – all of which occurred in 1.5% or less of patients in the placebo group.

“The higher incidence of conjunctivitis has also been reported in other biologics inhibiting IL [interleukin]–13 and/or IL-4 signaling, as well as lebrikizumab monotherapy studies,” they noted. The 4.8% rate of conjunctivitis reported in the combination study, they added, is “compared with 7.5% frequency in 16-week data from the lebrikizumab monotherapy studies. Although the mechanism remains unclear, it has been reported that conjunctival goblet cell scarcity due to IL-13 and IL-4 inhibition, and subsequent effects on the homeostasis of the conjunctival mucosal surface, results in ocular AEs [adverse events].”

“This truly is a time of great hope and promise for our patients with AD,” commented Zelma Chiesa Fuxench, MD, who was not involved in the study. “The advent of newer, targeted therapeutic agents for AD continues to revolutionize the treatment experience for our patients, offering the possibility of greater AD disease control with a favorable risk profile and less need for blood work monitoring compared to traditional systemic agents.”

On the basis of the study results, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said in an interview that “lebrikizumab represents an additional option in the treatment armamentarium for providers who care for patients with AD.” She added that, “while head-to-head trials comparing lebrikizumab to dupilumab, the first FDA-approved biologic for AD, would be beneficial, to the best of my knowledge this data is currently lacking. However, based on the results of this study, we would expect lebrikizumab to work at least similarly to dupilumab, based on the reported improvements in IGA and EASI score.”

Additionally, lebrikizumab showed a favorable safety profile, “with most treatment-emergent adverse effects reported as nonserious and not leading to drug discontinuation,” she said. “Of interest to clinicians may be the reported rates of conjunctivitis in this study. Rates of conjunctivitis for lebrikizumab appear to be lower than those reported in the LIBERTY AD CHRONOS study for dupilumab – a finding that merits further scrutiny in my opinion, as this one of the most frequent treatment-emergent adverse events that I encounter in my clinical practice.”

The study was funded by Dermira, a subsidiary of Eli Lilly. Dr. Simpson reported personal fees and grants from multiple sources, including Dermira and Eli Lilly, the companies developing lebrikizumab. Several authors were employees of Eli Lilly. Dr. Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

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

Adult and adolescent patients with moderate to severe atopic dermatitis (AD) showed significant improvements with the addition of lebrikizumab to topical corticosteroid (TCS) therapy, compared with TCS plus placebo, according to results of the 16-week phase 3 ADhere trial.

“Lebrikizumab, a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate to severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies,” noted lead author Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, and coauthors in their article on the study, which was published in JAMA Dermatology.

The double-blind trial, conducted at 54 sites across Germany, Poland, Canada, and the United States, included 211 patients, mean age 37.2 years, of whom 48.8% were female and roughly 22% were adolescents. Almost 15% were Asian, and about 13% were Black.

At baseline, participants had a score of 16 or higher on the Eczema Area and Severity Index (EASI), a score of 3 or higher on the Investigator’s Global Assessment (IGA) scale, AD covering a body surface area of 10% or greater, and a history of inadequate response to treatment with topical medications.

After a minimum 1-week washout period from topical and systemic therapy, participants were randomized in a 2:1 ratio to receive lebrikizumab plus TCS (n = 145) or placebo plus TCS (n = 66) for 16 weeks.

Lebrikizumab or placebo was administered by subcutaneous injection every 2 weeks; the loading and week-2 doses of lebrikizumab were 500 mg, followed by 250 mg thereafter. All patients were instructed to use low- to mid-potency TCS at their own discretion. Study sites provided a mid-potency TCS (triamcinolone acetonide 0.1% cream) and a low-potency TCS (hydrocortisone 1% cream), with topical calcineurin inhibitors permitted for sensitive skin areas.

Primary outcomes at 16 weeks included a 2-point or more reduction in IGA score from baseline and EASI-75 response. Patients in the lebrikizumab arm had superior responses on both of these outcomes, with statistical significance achieved as early as week 8 and week 4, respectively, and maintained through week 16. Specifically, 41.2% of those treated with lebrikizumab had an IGA reduction of 2 points or more, compared with 22.1% of those receiving placebo plus TCS (P = .01), and the proportion of patients achieving EASI-75 responses was 69.5% vs. 42.2%, respectively (P < .001).

Patients treated with lebrikizumab also showed statistically significant improvements, compared with TCS alone in all key secondary endpoints, “including skin clearance, improvement in itch, itch interference on sleep, and enhanced QoL [quality of life],” noted the authors. “This study captured the clinical benefit of lebrikizumab through the combined end point of physician-assessed clinical sign of skin clearance (EASI-75) and patient-reported outcome of improvement in itch (Pruritus NRS).”

The percentage of patients who achieved the combined endpoint was more than double for the lebrikizumab plus TCS group vs. the group on TCS alone, indicating that patients treated with lebrikizumab plus TCS “were more likely to experience improvement in skin symptoms and itch,” the investigators added.

The authors noted that most treatment-emergent adverse events “were nonserious, mild, or moderate in severity, and did not lead to study discontinuation.” These included conjunctivitis (4.8%), headache (4.8%), hypertension (2.8%), injection-site reactions (2.8%), and herpes infection (3.4%) – all of which occurred in 1.5% or less of patients in the placebo group.

“The higher incidence of conjunctivitis has also been reported in other biologics inhibiting IL [interleukin]–13 and/or IL-4 signaling, as well as lebrikizumab monotherapy studies,” they noted. The 4.8% rate of conjunctivitis reported in the combination study, they added, is “compared with 7.5% frequency in 16-week data from the lebrikizumab monotherapy studies. Although the mechanism remains unclear, it has been reported that conjunctival goblet cell scarcity due to IL-13 and IL-4 inhibition, and subsequent effects on the homeostasis of the conjunctival mucosal surface, results in ocular AEs [adverse events].”

“This truly is a time of great hope and promise for our patients with AD,” commented Zelma Chiesa Fuxench, MD, who was not involved in the study. “The advent of newer, targeted therapeutic agents for AD continues to revolutionize the treatment experience for our patients, offering the possibility of greater AD disease control with a favorable risk profile and less need for blood work monitoring compared to traditional systemic agents.”

On the basis of the study results, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said in an interview that “lebrikizumab represents an additional option in the treatment armamentarium for providers who care for patients with AD.” She added that, “while head-to-head trials comparing lebrikizumab to dupilumab, the first FDA-approved biologic for AD, would be beneficial, to the best of my knowledge this data is currently lacking. However, based on the results of this study, we would expect lebrikizumab to work at least similarly to dupilumab, based on the reported improvements in IGA and EASI score.”

Additionally, lebrikizumab showed a favorable safety profile, “with most treatment-emergent adverse effects reported as nonserious and not leading to drug discontinuation,” she said. “Of interest to clinicians may be the reported rates of conjunctivitis in this study. Rates of conjunctivitis for lebrikizumab appear to be lower than those reported in the LIBERTY AD CHRONOS study for dupilumab – a finding that merits further scrutiny in my opinion, as this one of the most frequent treatment-emergent adverse events that I encounter in my clinical practice.”

The study was funded by Dermira, a subsidiary of Eli Lilly. Dr. Simpson reported personal fees and grants from multiple sources, including Dermira and Eli Lilly, the companies developing lebrikizumab. Several authors were employees of Eli Lilly. Dr. Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

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

Adult and adolescent patients with moderate to severe atopic dermatitis (AD) showed significant improvements with the addition of lebrikizumab to topical corticosteroid (TCS) therapy, compared with TCS plus placebo, according to results of the 16-week phase 3 ADhere trial.

“Lebrikizumab, a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate to severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies,” noted lead author Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, and coauthors in their article on the study, which was published in JAMA Dermatology.

The double-blind trial, conducted at 54 sites across Germany, Poland, Canada, and the United States, included 211 patients, mean age 37.2 years, of whom 48.8% were female and roughly 22% were adolescents. Almost 15% were Asian, and about 13% were Black.

At baseline, participants had a score of 16 or higher on the Eczema Area and Severity Index (EASI), a score of 3 or higher on the Investigator’s Global Assessment (IGA) scale, AD covering a body surface area of 10% or greater, and a history of inadequate response to treatment with topical medications.

After a minimum 1-week washout period from topical and systemic therapy, participants were randomized in a 2:1 ratio to receive lebrikizumab plus TCS (n = 145) or placebo plus TCS (n = 66) for 16 weeks.

Lebrikizumab or placebo was administered by subcutaneous injection every 2 weeks; the loading and week-2 doses of lebrikizumab were 500 mg, followed by 250 mg thereafter. All patients were instructed to use low- to mid-potency TCS at their own discretion. Study sites provided a mid-potency TCS (triamcinolone acetonide 0.1% cream) and a low-potency TCS (hydrocortisone 1% cream), with topical calcineurin inhibitors permitted for sensitive skin areas.

Primary outcomes at 16 weeks included a 2-point or more reduction in IGA score from baseline and EASI-75 response. Patients in the lebrikizumab arm had superior responses on both of these outcomes, with statistical significance achieved as early as week 8 and week 4, respectively, and maintained through week 16. Specifically, 41.2% of those treated with lebrikizumab had an IGA reduction of 2 points or more, compared with 22.1% of those receiving placebo plus TCS (P = .01), and the proportion of patients achieving EASI-75 responses was 69.5% vs. 42.2%, respectively (P < .001).

Patients treated with lebrikizumab also showed statistically significant improvements, compared with TCS alone in all key secondary endpoints, “including skin clearance, improvement in itch, itch interference on sleep, and enhanced QoL [quality of life],” noted the authors. “This study captured the clinical benefit of lebrikizumab through the combined end point of physician-assessed clinical sign of skin clearance (EASI-75) and patient-reported outcome of improvement in itch (Pruritus NRS).”

The percentage of patients who achieved the combined endpoint was more than double for the lebrikizumab plus TCS group vs. the group on TCS alone, indicating that patients treated with lebrikizumab plus TCS “were more likely to experience improvement in skin symptoms and itch,” the investigators added.

The authors noted that most treatment-emergent adverse events “were nonserious, mild, or moderate in severity, and did not lead to study discontinuation.” These included conjunctivitis (4.8%), headache (4.8%), hypertension (2.8%), injection-site reactions (2.8%), and herpes infection (3.4%) – all of which occurred in 1.5% or less of patients in the placebo group.

“The higher incidence of conjunctivitis has also been reported in other biologics inhibiting IL [interleukin]–13 and/or IL-4 signaling, as well as lebrikizumab monotherapy studies,” they noted. The 4.8% rate of conjunctivitis reported in the combination study, they added, is “compared with 7.5% frequency in 16-week data from the lebrikizumab monotherapy studies. Although the mechanism remains unclear, it has been reported that conjunctival goblet cell scarcity due to IL-13 and IL-4 inhibition, and subsequent effects on the homeostasis of the conjunctival mucosal surface, results in ocular AEs [adverse events].”

“This truly is a time of great hope and promise for our patients with AD,” commented Zelma Chiesa Fuxench, MD, who was not involved in the study. “The advent of newer, targeted therapeutic agents for AD continues to revolutionize the treatment experience for our patients, offering the possibility of greater AD disease control with a favorable risk profile and less need for blood work monitoring compared to traditional systemic agents.”

On the basis of the study results, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said in an interview that “lebrikizumab represents an additional option in the treatment armamentarium for providers who care for patients with AD.” She added that, “while head-to-head trials comparing lebrikizumab to dupilumab, the first FDA-approved biologic for AD, would be beneficial, to the best of my knowledge this data is currently lacking. However, based on the results of this study, we would expect lebrikizumab to work at least similarly to dupilumab, based on the reported improvements in IGA and EASI score.”

Additionally, lebrikizumab showed a favorable safety profile, “with most treatment-emergent adverse effects reported as nonserious and not leading to drug discontinuation,” she said. “Of interest to clinicians may be the reported rates of conjunctivitis in this study. Rates of conjunctivitis for lebrikizumab appear to be lower than those reported in the LIBERTY AD CHRONOS study for dupilumab – a finding that merits further scrutiny in my opinion, as this one of the most frequent treatment-emergent adverse events that I encounter in my clinical practice.”

The study was funded by Dermira, a subsidiary of Eli Lilly. Dr. Simpson reported personal fees and grants from multiple sources, including Dermira and Eli Lilly, the companies developing lebrikizumab. Several authors were employees of Eli Lilly. Dr. Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

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

Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.

Rates of ED visits involving diagnosed COVID-19 in children had been rising since mid-November, 2022, but are now declining in early January, 2023. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.

The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.

The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.

The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.

The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.

Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.

Rates of ED visits involving diagnosed COVID-19 in children had been rising since mid-November, 2022, but are now declining in early January, 2023. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.

The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.

The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.

The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.

The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.

Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.

Rates of ED visits involving diagnosed COVID-19 in children had been rising since mid-November, 2022, but are now declining in early January, 2023. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.

The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.

The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.

The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.

The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.

Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

People with long COVID may have dizziness, headaches, sleep problems, sluggish thinking, and many other problems. But they can also face another problem – stigma.

Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.

The U.K. team found that more than three-quarters of people studied had experienced stigma often or always. 

In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.

Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.

“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”

Even some doctors argue that the growing attention paid to long COVID is excessive.

“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.

Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.

“Putting that spin on things, it’s just hurting people,” she says.

One example is people who cannot return to work.

“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”

Some experts say the U.K. study represents a landmark.

“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.

She recalls her first patient with long COVID.

“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.

Another one of her patients is working at her job from home but facing doubt about her condition from her employers.

“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.

Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.

Half of them said they had a clinical diagnosis of long COVID.

More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.

That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.

“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.

Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.

He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”

The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:

• Enacted stigma: People were directly treated unfairly because of their condition.
• Internalized stigma: People felt embarrassed by that condition.
• Anticipated stigma: People expected they would be treated poorly because of their diagnosis.

Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.

“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.

Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.

Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.

Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.

The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.

“Stigma within medicine or health care is nothing new,” she says.

In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”

Dr. Pantelic says she and her colleagues are continuing their research.

“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.

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

People with long COVID may have dizziness, headaches, sleep problems, sluggish thinking, and many other problems. But they can also face another problem – stigma.

Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.

The U.K. team found that more than three-quarters of people studied had experienced stigma often or always. 

In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.

Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.

“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”

Even some doctors argue that the growing attention paid to long COVID is excessive.

“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.

Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.

“Putting that spin on things, it’s just hurting people,” she says.

One example is people who cannot return to work.

“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”

Some experts say the U.K. study represents a landmark.

“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.

She recalls her first patient with long COVID.

“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.

Another one of her patients is working at her job from home but facing doubt about her condition from her employers.

“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.

Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.

Half of them said they had a clinical diagnosis of long COVID.

More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.

That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.

“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.

Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.

He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”

The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:

• Enacted stigma: People were directly treated unfairly because of their condition.
• Internalized stigma: People felt embarrassed by that condition.
• Anticipated stigma: People expected they would be treated poorly because of their diagnosis.

Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.

“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.

Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.

Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.

Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.

The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.

“Stigma within medicine or health care is nothing new,” she says.

In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”

Dr. Pantelic says she and her colleagues are continuing their research.

“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.

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

People with long COVID may have dizziness, headaches, sleep problems, sluggish thinking, and many other problems. But they can also face another problem – stigma.

Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.

The U.K. team found that more than three-quarters of people studied had experienced stigma often or always. 

In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.

Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.

“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”

Even some doctors argue that the growing attention paid to long COVID is excessive.

“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.

Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.

“Putting that spin on things, it’s just hurting people,” she says.

One example is people who cannot return to work.

“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”

Some experts say the U.K. study represents a landmark.

“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.

She recalls her first patient with long COVID.

“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.

Another one of her patients is working at her job from home but facing doubt about her condition from her employers.

“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.

Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.

Half of them said they had a clinical diagnosis of long COVID.

More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.

That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.

“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.

Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.

He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”

The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:

• Enacted stigma: People were directly treated unfairly because of their condition.
• Internalized stigma: People felt embarrassed by that condition.
• Anticipated stigma: People expected they would be treated poorly because of their diagnosis.

Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.

“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.

Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.

Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.

Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.

The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.

“Stigma within medicine or health care is nothing new,” she says.

In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”

Dr. Pantelic says she and her colleagues are continuing their research.

“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.

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

PARIS – How can the problem of poor treatment compliance in patients with hypertension be resolved? A new therapeutic approach could be a game-changer.

Many approaches have been explored in recent years to make life easier for patients living with chronic conditions that require them to take daily medication: subcutaneous implantable devices, nanogels, and, more specifically in the case of hypertension, renal denervation or small interfering RNA (siRNA) with a long half-life.

It’s siRNA that Michel Azizi, MD, PhD, head of the blood pressure clinic at Georges Pompidou European Hospital (HEGP) in Paris, discussed at the International Meeting of the French Society of Hypertension.

These small molecules have already shown their worth in treating rare diseases such as transthyretin amyloidosis. More recently, treating hypercholesterolemia with the PCSK9 inhibitor inclisiran has proven effective. “One subcutaneous injection of inclisiran reduces LDL cholesterol by 50% for a period of 210 days,” said Dr. Azizi.

The benefit of a new therapeutic siRNA – zilebesiran, administered subcutaneously – in treating hypertension is currently the subject of a phase II clinical trial.

This is a double-stranded RNA. One of the strands is linked to a sugar, N-acetylgalactosamine (GalNAc), which protects these highly fragile siRNA and binds with a very strong affinity in the liver. The second strand binds to a specific area of the RNA to prevent synthesis of the precursor peptide of angiotensin, angiotensinogen. The resulting effect is suppression of the production of angiotensin I and II, which leads to a long-lasting lowering of blood pressure.
 

Lasting efficacy

Phase I studies with zilebesiran have demonstrated a long-term effect, with a reduction of greater than 90% in circulating angiotensinogen over 6 months after a single subcutaneous dose (800 mg). The peak in reduction of circulating angiotensinogen occurs after approximately 3 weeks.

“It’s extremely powerful,” said Dr. Azizi.

Lasting reductions in blood pressure have also been observed, with 24-hour ambulatory blood pressure monitoring showing a reduction in systolic BP of greater than 15 mm Hg 8 weeks after administration of a single dose of zilebesiran (800 mg).

Zilebesiran was also well tolerated, with only mild to moderate reactions at the site of the injection (n = 5/56) and no serious treatment-related adverse events, hypotension, or significant changes in kidney or liver function.

“In terms of benefits, the effect is ongoing. Zilebesiran leads to reduced medication use and causes less variability in blood pressure response. Nevertheless, interfering RNA acts slowly, meaning that zilebesiran would not be suitable for people presenting with a hypertensive crisis. The fact that it blocks the renin-angiotensin system [RAS] for a very long period of time also poses the question of how to reverse its hypotensive effects,” said Dr. Azizi.
 

Unanswered questions

The lasting RAS antagonist and blood pressure–lowering effects pose a potential safety problem in circumstances involving patients in a state of hypovolemia and hypotension who require rapid blood pressure–raising interventions to prevent morbidity and mortality.

In recent studies, Estrellita Uijl et al. have thus examined strategies to counteract the blood pressure–lowering effect of siRNA in spontaneously hypertensive rats.

Fludrocortisone and a high-salt diet were both successful in gradually increasing blood pressure, which returned to its baseline levels on days 5 and 7, respectively. Yet this rate of response would be wholly inadequate in an urgent clinical situation.

However, midodrine could not reduce blood pressure to normal levels, whether administered subcutaneously or orally.

A rapid and short-lasting increase in blood pressure was observed with bolus doses of vasopressors, but clinically, these would need to be administered intravenously to achieve a lasting effect. Such administration would require hospitalization, close monitoring, and the use of human resources and additional health care provisions.

Encouragingly, the laboratory that created this molecule, Alnylam Pharmaceuticals, has come up with an antidote: Reversir. It is a GalNAc-conjugated, single-stranded, high-affinity oligonucleotide complementary to the zilebesiran strand that achieves effective reversal of siRNA activity in 24 hours.

In the future, after the phase 2 trials have been completed, whether or not zilebesiran reduces the incidence of cardiovascular events and mortality remains to be seen. But as for Dr. Azizi, the director of HEGP’s blood pressure clinic in Paris, he has no doubt that “this approach is about to shake up how we treat patients in the cardiovascular field.”
 

On the horizon

Zilebesiran is being studied in phase 2 trials in patients with mild to moderate hypertension not taking antihypertensive drugs (KARDIA-1: 375 patients; double-blind, placebo-controlled, five-arm trial; zilebesiran at 150, 300, and 600 mg twice per year and 300 mg once every 3 months) and in patients whose blood pressure is not controlled (KARDIA-2: 800 patients; initial open-label start-up period of 4 weeks with indapamide/amlodipine/olmesartan, followed by a double-blind, placebo-controlled study over 6 months, then an open-label extension study for up to 12 additional months; zilebesiran at 600 mg on the first day of the initial double-blind period, then every 6 months during the open-label extension period).

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

PARIS – How can the problem of poor treatment compliance in patients with hypertension be resolved? A new therapeutic approach could be a game-changer.

Many approaches have been explored in recent years to make life easier for patients living with chronic conditions that require them to take daily medication: subcutaneous implantable devices, nanogels, and, more specifically in the case of hypertension, renal denervation or small interfering RNA (siRNA) with a long half-life.

It’s siRNA that Michel Azizi, MD, PhD, head of the blood pressure clinic at Georges Pompidou European Hospital (HEGP) in Paris, discussed at the International Meeting of the French Society of Hypertension.

These small molecules have already shown their worth in treating rare diseases such as transthyretin amyloidosis. More recently, treating hypercholesterolemia with the PCSK9 inhibitor inclisiran has proven effective. “One subcutaneous injection of inclisiran reduces LDL cholesterol by 50% for a period of 210 days,” said Dr. Azizi.

The benefit of a new therapeutic siRNA – zilebesiran, administered subcutaneously – in treating hypertension is currently the subject of a phase II clinical trial.

This is a double-stranded RNA. One of the strands is linked to a sugar, N-acetylgalactosamine (GalNAc), which protects these highly fragile siRNA and binds with a very strong affinity in the liver. The second strand binds to a specific area of the RNA to prevent synthesis of the precursor peptide of angiotensin, angiotensinogen. The resulting effect is suppression of the production of angiotensin I and II, which leads to a long-lasting lowering of blood pressure.
 

Lasting efficacy

Phase I studies with zilebesiran have demonstrated a long-term effect, with a reduction of greater than 90% in circulating angiotensinogen over 6 months after a single subcutaneous dose (800 mg). The peak in reduction of circulating angiotensinogen occurs after approximately 3 weeks.

“It’s extremely powerful,” said Dr. Azizi.

Lasting reductions in blood pressure have also been observed, with 24-hour ambulatory blood pressure monitoring showing a reduction in systolic BP of greater than 15 mm Hg 8 weeks after administration of a single dose of zilebesiran (800 mg).

Zilebesiran was also well tolerated, with only mild to moderate reactions at the site of the injection (n = 5/56) and no serious treatment-related adverse events, hypotension, or significant changes in kidney or liver function.

“In terms of benefits, the effect is ongoing. Zilebesiran leads to reduced medication use and causes less variability in blood pressure response. Nevertheless, interfering RNA acts slowly, meaning that zilebesiran would not be suitable for people presenting with a hypertensive crisis. The fact that it blocks the renin-angiotensin system [RAS] for a very long period of time also poses the question of how to reverse its hypotensive effects,” said Dr. Azizi.
 

Unanswered questions

The lasting RAS antagonist and blood pressure–lowering effects pose a potential safety problem in circumstances involving patients in a state of hypovolemia and hypotension who require rapid blood pressure–raising interventions to prevent morbidity and mortality.

In recent studies, Estrellita Uijl et al. have thus examined strategies to counteract the blood pressure–lowering effect of siRNA in spontaneously hypertensive rats.

Fludrocortisone and a high-salt diet were both successful in gradually increasing blood pressure, which returned to its baseline levels on days 5 and 7, respectively. Yet this rate of response would be wholly inadequate in an urgent clinical situation.

However, midodrine could not reduce blood pressure to normal levels, whether administered subcutaneously or orally.

A rapid and short-lasting increase in blood pressure was observed with bolus doses of vasopressors, but clinically, these would need to be administered intravenously to achieve a lasting effect. Such administration would require hospitalization, close monitoring, and the use of human resources and additional health care provisions.

Encouragingly, the laboratory that created this molecule, Alnylam Pharmaceuticals, has come up with an antidote: Reversir. It is a GalNAc-conjugated, single-stranded, high-affinity oligonucleotide complementary to the zilebesiran strand that achieves effective reversal of siRNA activity in 24 hours.

In the future, after the phase 2 trials have been completed, whether or not zilebesiran reduces the incidence of cardiovascular events and mortality remains to be seen. But as for Dr. Azizi, the director of HEGP’s blood pressure clinic in Paris, he has no doubt that “this approach is about to shake up how we treat patients in the cardiovascular field.”
 

On the horizon

Zilebesiran is being studied in phase 2 trials in patients with mild to moderate hypertension not taking antihypertensive drugs (KARDIA-1: 375 patients; double-blind, placebo-controlled, five-arm trial; zilebesiran at 150, 300, and 600 mg twice per year and 300 mg once every 3 months) and in patients whose blood pressure is not controlled (KARDIA-2: 800 patients; initial open-label start-up period of 4 weeks with indapamide/amlodipine/olmesartan, followed by a double-blind, placebo-controlled study over 6 months, then an open-label extension study for up to 12 additional months; zilebesiran at 600 mg on the first day of the initial double-blind period, then every 6 months during the open-label extension period).

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

PARIS – How can the problem of poor treatment compliance in patients with hypertension be resolved? A new therapeutic approach could be a game-changer.

Many approaches have been explored in recent years to make life easier for patients living with chronic conditions that require them to take daily medication: subcutaneous implantable devices, nanogels, and, more specifically in the case of hypertension, renal denervation or small interfering RNA (siRNA) with a long half-life.

It’s siRNA that Michel Azizi, MD, PhD, head of the blood pressure clinic at Georges Pompidou European Hospital (HEGP) in Paris, discussed at the International Meeting of the French Society of Hypertension.

These small molecules have already shown their worth in treating rare diseases such as transthyretin amyloidosis. More recently, treating hypercholesterolemia with the PCSK9 inhibitor inclisiran has proven effective. “One subcutaneous injection of inclisiran reduces LDL cholesterol by 50% for a period of 210 days,” said Dr. Azizi.

The benefit of a new therapeutic siRNA – zilebesiran, administered subcutaneously – in treating hypertension is currently the subject of a phase II clinical trial.

This is a double-stranded RNA. One of the strands is linked to a sugar, N-acetylgalactosamine (GalNAc), which protects these highly fragile siRNA and binds with a very strong affinity in the liver. The second strand binds to a specific area of the RNA to prevent synthesis of the precursor peptide of angiotensin, angiotensinogen. The resulting effect is suppression of the production of angiotensin I and II, which leads to a long-lasting lowering of blood pressure.
 

Lasting efficacy

Phase I studies with zilebesiran have demonstrated a long-term effect, with a reduction of greater than 90% in circulating angiotensinogen over 6 months after a single subcutaneous dose (800 mg). The peak in reduction of circulating angiotensinogen occurs after approximately 3 weeks.

“It’s extremely powerful,” said Dr. Azizi.

Lasting reductions in blood pressure have also been observed, with 24-hour ambulatory blood pressure monitoring showing a reduction in systolic BP of greater than 15 mm Hg 8 weeks after administration of a single dose of zilebesiran (800 mg).

Zilebesiran was also well tolerated, with only mild to moderate reactions at the site of the injection (n = 5/56) and no serious treatment-related adverse events, hypotension, or significant changes in kidney or liver function.

“In terms of benefits, the effect is ongoing. Zilebesiran leads to reduced medication use and causes less variability in blood pressure response. Nevertheless, interfering RNA acts slowly, meaning that zilebesiran would not be suitable for people presenting with a hypertensive crisis. The fact that it blocks the renin-angiotensin system [RAS] for a very long period of time also poses the question of how to reverse its hypotensive effects,” said Dr. Azizi.
 

Unanswered questions

The lasting RAS antagonist and blood pressure–lowering effects pose a potential safety problem in circumstances involving patients in a state of hypovolemia and hypotension who require rapid blood pressure–raising interventions to prevent morbidity and mortality.

In recent studies, Estrellita Uijl et al. have thus examined strategies to counteract the blood pressure–lowering effect of siRNA in spontaneously hypertensive rats.

Fludrocortisone and a high-salt diet were both successful in gradually increasing blood pressure, which returned to its baseline levels on days 5 and 7, respectively. Yet this rate of response would be wholly inadequate in an urgent clinical situation.

However, midodrine could not reduce blood pressure to normal levels, whether administered subcutaneously or orally.

A rapid and short-lasting increase in blood pressure was observed with bolus doses of vasopressors, but clinically, these would need to be administered intravenously to achieve a lasting effect. Such administration would require hospitalization, close monitoring, and the use of human resources and additional health care provisions.

Encouragingly, the laboratory that created this molecule, Alnylam Pharmaceuticals, has come up with an antidote: Reversir. It is a GalNAc-conjugated, single-stranded, high-affinity oligonucleotide complementary to the zilebesiran strand that achieves effective reversal of siRNA activity in 24 hours.

In the future, after the phase 2 trials have been completed, whether or not zilebesiran reduces the incidence of cardiovascular events and mortality remains to be seen. But as for Dr. Azizi, the director of HEGP’s blood pressure clinic in Paris, he has no doubt that “this approach is about to shake up how we treat patients in the cardiovascular field.”
 

On the horizon

Zilebesiran is being studied in phase 2 trials in patients with mild to moderate hypertension not taking antihypertensive drugs (KARDIA-1: 375 patients; double-blind, placebo-controlled, five-arm trial; zilebesiran at 150, 300, and 600 mg twice per year and 300 mg once every 3 months) and in patients whose blood pressure is not controlled (KARDIA-2: 800 patients; initial open-label start-up period of 4 weeks with indapamide/amlodipine/olmesartan, followed by a double-blind, placebo-controlled study over 6 months, then an open-label extension study for up to 12 additional months; zilebesiran at 600 mg on the first day of the initial double-blind period, then every 6 months during the open-label extension period).

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Screening for amblyopia during primary care visits is more cost-effective than screening in school settings and optometric examinations in kindergarten-aged children in Toronto, data suggest.

Because of the low prevalence of amblyopia among young children, a population-based screening program may not warrant the resources required, despite the added health benefits of a universal program, according to the researchers.

“Amblyopia is a public health problem. For this reason, population-wide approaches to detect and treat amblyopia are critical, and approaches such as school screening and mandated optometry exams have been recommended and introduced in some jurisdictions,” study author Afua Oteng Asare, OD, PhD, a research assistant professor at the University of Utah in Salt Lake City, told this news organization. Dr. Asare conducted the study as a PhD student at the University of Toronto.

“With increasing budgeting constraints and limited resources, policymakers are relying more on economic analyses that measure value-for-money to inform their decisions on programming,” she said. “Evidence comparing the cost-effectiveness of vision-testing approaches to the status quo is, however, limited.”

The study was published in JAMA Network Open.
 

Analyzing costs

Despite recommendations for routine testing, a notable percentage of children in Canada and the United States don’t receive an annual vision exam. The percentage is even higher among children from low-income households, said Dr. Asare. Universal screening in schools and mandatory optometric examinations may improve vision care. But the cost-effectiveness of these measures is unknown for certain conditions, such as amblyopia, the prevalence of which ranges between 3% and 5% in young children.

In Ontario, Canada’s largest province with about 3 million children, universal funding for children’s annual comprehensive eye exams and vision screening during well-child visits is provided through provincial health insurance.

In 2018, the Ontario Ministry of Health introduced guidelines for administering vision screening in kindergartens by public health departments. However, school-based screening has been difficult to introduce because of increasing costs and budgeting constraints, the authors wrote. As an alternative to underfunded programs, optometric associations in Canada have advocated for physicians to recommend early childhood optometric exams.

The investigators analyzed the incremental costs and health benefits, from the perspective of the Ontario government, of public health school screening and optometrist-based vision exams, compared with standard vision screening conducted during well-child visits with primary care physicians. They focused on the aim of detecting amblyopia and amblyopia-related risk factors in children between ages 3 and 5 years in Toronto.

For the analysis, the research team simulated a hypothetical cohort of 25,000 children over 15 years in a probabilistic health state transition model. They incorporated various assumptions, including that children had irreversible vision impairment if not diagnosed by an optometrist. In addition, incremental costs were adjusted to favor the standard screening strategy during well-child visits.

In the school-based and primary care scenarios, children with a positive or inconclusive test result were referred to an optometrist for diagnosis and treatment, which would incur the cost of an optometric evaluation. If positive, children were treated with prescription glasses and additional patching for amblyopia.

The research team measured outcomes as incremental quality-adjusted life-years (QALYs), and health utilities were derived from data on adults, because of the lack of data on children under age 6 years with amblyopia or amblyopia risk factors. The researchers also estimated direct costs to the Ontario government, including visits with primary care doctors, optometrists, public health nurses, and contract screeners, as well as prescription glasses for children with vision impairment who receive social assistance. Costs were expressed in Canadian dollars (CAD).

Overall, compared with the primary care screening strategy, the school screening and optometric examination strategies were generally less costly and had more health benefits. The incremental difference in cost was a savings per child of $84.09 CAD for school screening and $74.47 CAD for optometric examinations. Optometric examinations yielded the largest gain in QALYs, compared with the primary care screening strategy, producing average QALYs of 0.0508 per child.

However, only 20% of school screening iterations and 29% of optometric exam iterations were cost-effective, relative to the primary care screening strategy, at a willingness-to-pay threshold of $50,000 CAD per QALY gained. For instance, when comparing optometric exams with primary care screenings, if the cost of vision screening was $11.50 CAD, the incremental cost-effectiveness ratio would be $77.95 CAD per QALY gained.
 

Results ‘make sense’  

“We were initially surprised that the alternative screening programs were not cost-effective, compared to status quo vision screening in well-child visits,” said Dr. Asare. “However, the results make sense, considering the study’s universal approach (screening all children regardless of their vision status) and the study’s consideration only of amblyopia, and not of refractive errors, which are even more common in kindergarten children.”

Dr. Asare noted the lack of current data on the rate of vision screenings conducted in childhood by primary care practitioners and on referrals to eye care providers for children with abnormal screenings. Data on vision health disparities and barriers to accessing vision care in young children also are scarce.

“My ultimate research goal is to create and evaluate evidence-based, cost-effective interventions to be used at the point of care by pediatric primary care providers to improve the quality of vision care for children, especially those from socioeconomically deprived backgrounds,” she said. “The take-home message is that school vision screening and mandated eye exams are excellent programs, but they may not be suitable for all contexts.”

Additional studies are needed to look at the cost-effectiveness of the different screening strategies for other aspects included in childhood vision tests, including binocular vision problems, refractive disorders, myopia, allergies, and rare eye diseases.
 

Significant underestimation?

Susan Leat, PhD, a researcher and professor emerita at the University of Waterloo (Ont.) School of Optometry and Vision Science, said, “This study only considers amblyopia, and not all eye diseases and disorders, which significantly underestimates the cost-effectiveness of optometric eye exams.”

Dr. Leat, who wasn’t involved with this study, has researched pediatric optometry and visual development. She and colleagues are developing new tools to test visual acuity in young children.

“If all disorders were taken into account, then optometric testing would be by far the most cost-effective,” she said. “Optometrists can detect all disorders, including more subtle disorders, which if uncorrected or untreated, can impact a child’s early learning.”

The study authors reported no funding for the study. Dr. Asare and Dr. Leat reported no relevant disclosures.

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

Screening for amblyopia during primary care visits is more cost-effective than screening in school settings and optometric examinations in kindergarten-aged children in Toronto, data suggest.

Because of the low prevalence of amblyopia among young children, a population-based screening program may not warrant the resources required, despite the added health benefits of a universal program, according to the researchers.

“Amblyopia is a public health problem. For this reason, population-wide approaches to detect and treat amblyopia are critical, and approaches such as school screening and mandated optometry exams have been recommended and introduced in some jurisdictions,” study author Afua Oteng Asare, OD, PhD, a research assistant professor at the University of Utah in Salt Lake City, told this news organization. Dr. Asare conducted the study as a PhD student at the University of Toronto.

“With increasing budgeting constraints and limited resources, policymakers are relying more on economic analyses that measure value-for-money to inform their decisions on programming,” she said. “Evidence comparing the cost-effectiveness of vision-testing approaches to the status quo is, however, limited.”

The study was published in JAMA Network Open.
 

Analyzing costs

Despite recommendations for routine testing, a notable percentage of children in Canada and the United States don’t receive an annual vision exam. The percentage is even higher among children from low-income households, said Dr. Asare. Universal screening in schools and mandatory optometric examinations may improve vision care. But the cost-effectiveness of these measures is unknown for certain conditions, such as amblyopia, the prevalence of which ranges between 3% and 5% in young children.

In Ontario, Canada’s largest province with about 3 million children, universal funding for children’s annual comprehensive eye exams and vision screening during well-child visits is provided through provincial health insurance.

In 2018, the Ontario Ministry of Health introduced guidelines for administering vision screening in kindergartens by public health departments. However, school-based screening has been difficult to introduce because of increasing costs and budgeting constraints, the authors wrote. As an alternative to underfunded programs, optometric associations in Canada have advocated for physicians to recommend early childhood optometric exams.

The investigators analyzed the incremental costs and health benefits, from the perspective of the Ontario government, of public health school screening and optometrist-based vision exams, compared with standard vision screening conducted during well-child visits with primary care physicians. They focused on the aim of detecting amblyopia and amblyopia-related risk factors in children between ages 3 and 5 years in Toronto.

For the analysis, the research team simulated a hypothetical cohort of 25,000 children over 15 years in a probabilistic health state transition model. They incorporated various assumptions, including that children had irreversible vision impairment if not diagnosed by an optometrist. In addition, incremental costs were adjusted to favor the standard screening strategy during well-child visits.

In the school-based and primary care scenarios, children with a positive or inconclusive test result were referred to an optometrist for diagnosis and treatment, which would incur the cost of an optometric evaluation. If positive, children were treated with prescription glasses and additional patching for amblyopia.

The research team measured outcomes as incremental quality-adjusted life-years (QALYs), and health utilities were derived from data on adults, because of the lack of data on children under age 6 years with amblyopia or amblyopia risk factors. The researchers also estimated direct costs to the Ontario government, including visits with primary care doctors, optometrists, public health nurses, and contract screeners, as well as prescription glasses for children with vision impairment who receive social assistance. Costs were expressed in Canadian dollars (CAD).

Overall, compared with the primary care screening strategy, the school screening and optometric examination strategies were generally less costly and had more health benefits. The incremental difference in cost was a savings per child of $84.09 CAD for school screening and $74.47 CAD for optometric examinations. Optometric examinations yielded the largest gain in QALYs, compared with the primary care screening strategy, producing average QALYs of 0.0508 per child.

However, only 20% of school screening iterations and 29% of optometric exam iterations were cost-effective, relative to the primary care screening strategy, at a willingness-to-pay threshold of $50,000 CAD per QALY gained. For instance, when comparing optometric exams with primary care screenings, if the cost of vision screening was $11.50 CAD, the incremental cost-effectiveness ratio would be $77.95 CAD per QALY gained.
 

Results ‘make sense’  

“We were initially surprised that the alternative screening programs were not cost-effective, compared to status quo vision screening in well-child visits,” said Dr. Asare. “However, the results make sense, considering the study’s universal approach (screening all children regardless of their vision status) and the study’s consideration only of amblyopia, and not of refractive errors, which are even more common in kindergarten children.”

Dr. Asare noted the lack of current data on the rate of vision screenings conducted in childhood by primary care practitioners and on referrals to eye care providers for children with abnormal screenings. Data on vision health disparities and barriers to accessing vision care in young children also are scarce.

“My ultimate research goal is to create and evaluate evidence-based, cost-effective interventions to be used at the point of care by pediatric primary care providers to improve the quality of vision care for children, especially those from socioeconomically deprived backgrounds,” she said. “The take-home message is that school vision screening and mandated eye exams are excellent programs, but they may not be suitable for all contexts.”

Additional studies are needed to look at the cost-effectiveness of the different screening strategies for other aspects included in childhood vision tests, including binocular vision problems, refractive disorders, myopia, allergies, and rare eye diseases.
 

Significant underestimation?

Susan Leat, PhD, a researcher and professor emerita at the University of Waterloo (Ont.) School of Optometry and Vision Science, said, “This study only considers amblyopia, and not all eye diseases and disorders, which significantly underestimates the cost-effectiveness of optometric eye exams.”

Dr. Leat, who wasn’t involved with this study, has researched pediatric optometry and visual development. She and colleagues are developing new tools to test visual acuity in young children.

“If all disorders were taken into account, then optometric testing would be by far the most cost-effective,” she said. “Optometrists can detect all disorders, including more subtle disorders, which if uncorrected or untreated, can impact a child’s early learning.”

The study authors reported no funding for the study. Dr. Asare and Dr. Leat reported no relevant disclosures.

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

Screening for amblyopia during primary care visits is more cost-effective than screening in school settings and optometric examinations in kindergarten-aged children in Toronto, data suggest.

Because of the low prevalence of amblyopia among young children, a population-based screening program may not warrant the resources required, despite the added health benefits of a universal program, according to the researchers.

“Amblyopia is a public health problem. For this reason, population-wide approaches to detect and treat amblyopia are critical, and approaches such as school screening and mandated optometry exams have been recommended and introduced in some jurisdictions,” study author Afua Oteng Asare, OD, PhD, a research assistant professor at the University of Utah in Salt Lake City, told this news organization. Dr. Asare conducted the study as a PhD student at the University of Toronto.

“With increasing budgeting constraints and limited resources, policymakers are relying more on economic analyses that measure value-for-money to inform their decisions on programming,” she said. “Evidence comparing the cost-effectiveness of vision-testing approaches to the status quo is, however, limited.”

The study was published in JAMA Network Open.
 

Analyzing costs

Despite recommendations for routine testing, a notable percentage of children in Canada and the United States don’t receive an annual vision exam. The percentage is even higher among children from low-income households, said Dr. Asare. Universal screening in schools and mandatory optometric examinations may improve vision care. But the cost-effectiveness of these measures is unknown for certain conditions, such as amblyopia, the prevalence of which ranges between 3% and 5% in young children.

In Ontario, Canada’s largest province with about 3 million children, universal funding for children’s annual comprehensive eye exams and vision screening during well-child visits is provided through provincial health insurance.

In 2018, the Ontario Ministry of Health introduced guidelines for administering vision screening in kindergartens by public health departments. However, school-based screening has been difficult to introduce because of increasing costs and budgeting constraints, the authors wrote. As an alternative to underfunded programs, optometric associations in Canada have advocated for physicians to recommend early childhood optometric exams.

The investigators analyzed the incremental costs and health benefits, from the perspective of the Ontario government, of public health school screening and optometrist-based vision exams, compared with standard vision screening conducted during well-child visits with primary care physicians. They focused on the aim of detecting amblyopia and amblyopia-related risk factors in children between ages 3 and 5 years in Toronto.

For the analysis, the research team simulated a hypothetical cohort of 25,000 children over 15 years in a probabilistic health state transition model. They incorporated various assumptions, including that children had irreversible vision impairment if not diagnosed by an optometrist. In addition, incremental costs were adjusted to favor the standard screening strategy during well-child visits.

In the school-based and primary care scenarios, children with a positive or inconclusive test result were referred to an optometrist for diagnosis and treatment, which would incur the cost of an optometric evaluation. If positive, children were treated with prescription glasses and additional patching for amblyopia.

The research team measured outcomes as incremental quality-adjusted life-years (QALYs), and health utilities were derived from data on adults, because of the lack of data on children under age 6 years with amblyopia or amblyopia risk factors. The researchers also estimated direct costs to the Ontario government, including visits with primary care doctors, optometrists, public health nurses, and contract screeners, as well as prescription glasses for children with vision impairment who receive social assistance. Costs were expressed in Canadian dollars (CAD).

Overall, compared with the primary care screening strategy, the school screening and optometric examination strategies were generally less costly and had more health benefits. The incremental difference in cost was a savings per child of $84.09 CAD for school screening and $74.47 CAD for optometric examinations. Optometric examinations yielded the largest gain in QALYs, compared with the primary care screening strategy, producing average QALYs of 0.0508 per child.

However, only 20% of school screening iterations and 29% of optometric exam iterations were cost-effective, relative to the primary care screening strategy, at a willingness-to-pay threshold of $50,000 CAD per QALY gained. For instance, when comparing optometric exams with primary care screenings, if the cost of vision screening was $11.50 CAD, the incremental cost-effectiveness ratio would be $77.95 CAD per QALY gained.
 

Results ‘make sense’  

“We were initially surprised that the alternative screening programs were not cost-effective, compared to status quo vision screening in well-child visits,” said Dr. Asare. “However, the results make sense, considering the study’s universal approach (screening all children regardless of their vision status) and the study’s consideration only of amblyopia, and not of refractive errors, which are even more common in kindergarten children.”

Dr. Asare noted the lack of current data on the rate of vision screenings conducted in childhood by primary care practitioners and on referrals to eye care providers for children with abnormal screenings. Data on vision health disparities and barriers to accessing vision care in young children also are scarce.

“My ultimate research goal is to create and evaluate evidence-based, cost-effective interventions to be used at the point of care by pediatric primary care providers to improve the quality of vision care for children, especially those from socioeconomically deprived backgrounds,” she said. “The take-home message is that school vision screening and mandated eye exams are excellent programs, but they may not be suitable for all contexts.”

Additional studies are needed to look at the cost-effectiveness of the different screening strategies for other aspects included in childhood vision tests, including binocular vision problems, refractive disorders, myopia, allergies, and rare eye diseases.
 

Significant underestimation?

Susan Leat, PhD, a researcher and professor emerita at the University of Waterloo (Ont.) School of Optometry and Vision Science, said, “This study only considers amblyopia, and not all eye diseases and disorders, which significantly underestimates the cost-effectiveness of optometric eye exams.”

Dr. Leat, who wasn’t involved with this study, has researched pediatric optometry and visual development. She and colleagues are developing new tools to test visual acuity in young children.

“If all disorders were taken into account, then optometric testing would be by far the most cost-effective,” she said. “Optometrists can detect all disorders, including more subtle disorders, which if uncorrected or untreated, can impact a child’s early learning.”

The study authors reported no funding for the study. Dr. Asare and Dr. Leat reported no relevant disclosures.

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

Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.

The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.

Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.

“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.

The paper was published online in the Journal of Clinical Oncology.

Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”

“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.

The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.

Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.

Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.

No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.

Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.

“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.

The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
 

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

Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.

The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.

Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.

“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.

The paper was published online in the Journal of Clinical Oncology.

Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”

“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.

The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.

Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.

Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.

No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.

Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.

“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.

The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
 

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

Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.

The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.

Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.

“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.

The paper was published online in the Journal of Clinical Oncology.

Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”

“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.

The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.

Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.

Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.

No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.

Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.

“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.

The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
 

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