Pediatric News

NEW ORLEANS – In the nearly 1 year since the Janus kinase (JAK) inhibitor baricitinib was approved for adults with severe alopecia areata (AA), mounting long-term efficacy and safety data suggest that the earlier candidates take the drug in the course of their disease, the better.

“The journey to JAK inhibition in alopecia areata has been incredible,” Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, said at the annual meeting of the American Academy of Dermatology. “JAK inhibitors are here to stay, and I think baricitinib offers an amazing opportunity for the right patients.”

The efficacy and safety of baricitinib (Olumiant) for AA was studied in two randomized, double-blind, placebo-controlled trials (BRAVE-AA1 and BRAVE-AA2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months. Patients in these trials received either a placebo, 2 mg of baricitinib, or 4 mg of baricitinib every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved a SALT score of 20 or less, or at least 80% scalp hair coverage at week 36. The researchers found that 36%-39% of individuals in the 4-mg arm achieved a SALT score of less than 20, compared with 19%-23% of individuals in the 2 mg arm. Similar outcomes were observed for eyebrow and eyelash hair loss.

Most adverse events observed in BRAVE-AA1 and BRAVE-AA2 were in the mild to moderate range, and the actual number of adverse events leading to permanent discontinuation was extremely low. The most common adverse events were upper respiratory tract infections, headache, nasopharyngitis, acne, urinary tract infections, and an increase in blood creatine kinase.

Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other potent immunosuppressants, Dr. Chovatiya said. Required lab evaluations include baseline testing for tuberculosis and viral hepatitis; CBC, hepatic function, and renal function at baseline and then as clinically indicated; and lipids after 12 weeks of therapy, then as clinically indicated. The recommended starting dose of baricitinib is 2 mg per day, which can be increased to 4 mg per day if the response is not adequate. “However, for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, 4 mg once daily is recommended,” he said. “Once an adequate response is achieved, it’s recommended to reduce from 4 to 2 mg daily.”

52-week, 76-week data

According to pooled data from BRAVE-AA1 and BRAVE-AA2 published online March 1, 2023, efficacy continues to increase out to 52 weeks. Specifically, by week 52, 39% of individuals in the 4 mg arm achieved a SALT score of 20 or less, compared with 22.6% of individuals in the 2 mg arm. “You see similar linear growth in the eyebrow and eyelash response loss as well,” Dr. Chovatiya said.

In other findings, patients in the 4 mg treatment arm who achieved a SALT score of 20 or less at week 52 were eligible for randomized down titration, provided that they had stayed on the same dose of baricitinib from initial randomization. According to data from baricitinib manufacturer Eli Lilly, 77.5% of patients who stepped down to the 2 mg dose from the 4 mg dose at week 52 achieved a SALT score of 20 or less at week 76, Dr. Chovatiya said. “If I can keep someone on 4 mg that’s great, but it looks like you can go to a lower dose and do a pretty good job,” he said.

Patients in the baricitinib arms who achieved a SALT score of 20 or less at week 52 were eligible for randomized withdrawal, provided that they had stayed on the same dose of the drug from initial randomization. According to Dr. Chovatiya, 89.4% of individuals who remained on the 4 mg dose to week 76 maintained a SALT score of 20 or less, compared with 33.3% of those who switched from the 4 mg to placebo. “The takeaway here is that clinically, longitudinal treatment looks to be required in this time period” for continued efficacy, he said. “However, what this looks like in the real world remains to be seen.”

A recently published integrated analysis of safety data from BRAVE-AA1 and BRAVE-AA2 reported that no deaths occurred and of the few reported serious infections, nearly half were COVID-19. There was a single case of multidermatomal herpes zoster and no cases of tuberculosis. One patient with risk factors for MI had an MI during a placebo-controlled period, and one study participant with a history of COVID-19 infection developed a pulmonary embolism at day 638. There was one case each of chronic lymphocytic leukemia, B-cell lymphoma, breast cancer, and appendicitis.
 

Baseline severity and treatment response

“Does treatment response vary with baseline disease status?” Dr. Chovatiya asked. “Yes. People with very severe hair loss [defined as a SALT score of 95 or higher] tended to do worse, while the rest of the study population did even better – an almost twofold difference. This means that you want to treat as early as you possibly can. It’s interesting to note that you don’t see this difference as much in the case of eyebrows and eyelashes. This makes sense, though. Eyebrows and eyelashes probably behave differently in terms of growth than the scalp does.”

Certain baseline characteristics of patients in BRAVE-AA1 and BRAVE-AA2 portended better outcomes. Women tended to fare better than men, but individuals who had longer histories of AA did not respond well. “People who had a shorter duration of their current episode of AA also did better than people who had a longer current episode, so we want to think about treating as soon as we possibly can,” Dr. Chovatiya said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including Eli Lilly.

NEW ORLEANS – In the nearly 1 year since the Janus kinase (JAK) inhibitor baricitinib was approved for adults with severe alopecia areata (AA), mounting long-term efficacy and safety data suggest that the earlier candidates take the drug in the course of their disease, the better.

“The journey to JAK inhibition in alopecia areata has been incredible,” Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, said at the annual meeting of the American Academy of Dermatology. “JAK inhibitors are here to stay, and I think baricitinib offers an amazing opportunity for the right patients.”

The efficacy and safety of baricitinib (Olumiant) for AA was studied in two randomized, double-blind, placebo-controlled trials (BRAVE-AA1 and BRAVE-AA2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months. Patients in these trials received either a placebo, 2 mg of baricitinib, or 4 mg of baricitinib every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved a SALT score of 20 or less, or at least 80% scalp hair coverage at week 36. The researchers found that 36%-39% of individuals in the 4-mg arm achieved a SALT score of less than 20, compared with 19%-23% of individuals in the 2 mg arm. Similar outcomes were observed for eyebrow and eyelash hair loss.

Most adverse events observed in BRAVE-AA1 and BRAVE-AA2 were in the mild to moderate range, and the actual number of adverse events leading to permanent discontinuation was extremely low. The most common adverse events were upper respiratory tract infections, headache, nasopharyngitis, acne, urinary tract infections, and an increase in blood creatine kinase.

Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other potent immunosuppressants, Dr. Chovatiya said. Required lab evaluations include baseline testing for tuberculosis and viral hepatitis; CBC, hepatic function, and renal function at baseline and then as clinically indicated; and lipids after 12 weeks of therapy, then as clinically indicated. The recommended starting dose of baricitinib is 2 mg per day, which can be increased to 4 mg per day if the response is not adequate. “However, for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, 4 mg once daily is recommended,” he said. “Once an adequate response is achieved, it’s recommended to reduce from 4 to 2 mg daily.”

52-week, 76-week data

According to pooled data from BRAVE-AA1 and BRAVE-AA2 published online March 1, 2023, efficacy continues to increase out to 52 weeks. Specifically, by week 52, 39% of individuals in the 4 mg arm achieved a SALT score of 20 or less, compared with 22.6% of individuals in the 2 mg arm. “You see similar linear growth in the eyebrow and eyelash response loss as well,” Dr. Chovatiya said.

In other findings, patients in the 4 mg treatment arm who achieved a SALT score of 20 or less at week 52 were eligible for randomized down titration, provided that they had stayed on the same dose of baricitinib from initial randomization. According to data from baricitinib manufacturer Eli Lilly, 77.5% of patients who stepped down to the 2 mg dose from the 4 mg dose at week 52 achieved a SALT score of 20 or less at week 76, Dr. Chovatiya said. “If I can keep someone on 4 mg that’s great, but it looks like you can go to a lower dose and do a pretty good job,” he said.

Patients in the baricitinib arms who achieved a SALT score of 20 or less at week 52 were eligible for randomized withdrawal, provided that they had stayed on the same dose of the drug from initial randomization. According to Dr. Chovatiya, 89.4% of individuals who remained on the 4 mg dose to week 76 maintained a SALT score of 20 or less, compared with 33.3% of those who switched from the 4 mg to placebo. “The takeaway here is that clinically, longitudinal treatment looks to be required in this time period” for continued efficacy, he said. “However, what this looks like in the real world remains to be seen.”

A recently published integrated analysis of safety data from BRAVE-AA1 and BRAVE-AA2 reported that no deaths occurred and of the few reported serious infections, nearly half were COVID-19. There was a single case of multidermatomal herpes zoster and no cases of tuberculosis. One patient with risk factors for MI had an MI during a placebo-controlled period, and one study participant with a history of COVID-19 infection developed a pulmonary embolism at day 638. There was one case each of chronic lymphocytic leukemia, B-cell lymphoma, breast cancer, and appendicitis.
 

Baseline severity and treatment response

“Does treatment response vary with baseline disease status?” Dr. Chovatiya asked. “Yes. People with very severe hair loss [defined as a SALT score of 95 or higher] tended to do worse, while the rest of the study population did even better – an almost twofold difference. This means that you want to treat as early as you possibly can. It’s interesting to note that you don’t see this difference as much in the case of eyebrows and eyelashes. This makes sense, though. Eyebrows and eyelashes probably behave differently in terms of growth than the scalp does.”

Certain baseline characteristics of patients in BRAVE-AA1 and BRAVE-AA2 portended better outcomes. Women tended to fare better than men, but individuals who had longer histories of AA did not respond well. “People who had a shorter duration of their current episode of AA also did better than people who had a longer current episode, so we want to think about treating as soon as we possibly can,” Dr. Chovatiya said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including Eli Lilly.

NEW ORLEANS – In the nearly 1 year since the Janus kinase (JAK) inhibitor baricitinib was approved for adults with severe alopecia areata (AA), mounting long-term efficacy and safety data suggest that the earlier candidates take the drug in the course of their disease, the better.

“The journey to JAK inhibition in alopecia areata has been incredible,” Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, said at the annual meeting of the American Academy of Dermatology. “JAK inhibitors are here to stay, and I think baricitinib offers an amazing opportunity for the right patients.”

The efficacy and safety of baricitinib (Olumiant) for AA was studied in two randomized, double-blind, placebo-controlled trials (BRAVE-AA1 and BRAVE-AA2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months. Patients in these trials received either a placebo, 2 mg of baricitinib, or 4 mg of baricitinib every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved a SALT score of 20 or less, or at least 80% scalp hair coverage at week 36. The researchers found that 36%-39% of individuals in the 4-mg arm achieved a SALT score of less than 20, compared with 19%-23% of individuals in the 2 mg arm. Similar outcomes were observed for eyebrow and eyelash hair loss.

Most adverse events observed in BRAVE-AA1 and BRAVE-AA2 were in the mild to moderate range, and the actual number of adverse events leading to permanent discontinuation was extremely low. The most common adverse events were upper respiratory tract infections, headache, nasopharyngitis, acne, urinary tract infections, and an increase in blood creatine kinase.

Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other potent immunosuppressants, Dr. Chovatiya said. Required lab evaluations include baseline testing for tuberculosis and viral hepatitis; CBC, hepatic function, and renal function at baseline and then as clinically indicated; and lipids after 12 weeks of therapy, then as clinically indicated. The recommended starting dose of baricitinib is 2 mg per day, which can be increased to 4 mg per day if the response is not adequate. “However, for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, 4 mg once daily is recommended,” he said. “Once an adequate response is achieved, it’s recommended to reduce from 4 to 2 mg daily.”

52-week, 76-week data

According to pooled data from BRAVE-AA1 and BRAVE-AA2 published online March 1, 2023, efficacy continues to increase out to 52 weeks. Specifically, by week 52, 39% of individuals in the 4 mg arm achieved a SALT score of 20 or less, compared with 22.6% of individuals in the 2 mg arm. “You see similar linear growth in the eyebrow and eyelash response loss as well,” Dr. Chovatiya said.

In other findings, patients in the 4 mg treatment arm who achieved a SALT score of 20 or less at week 52 were eligible for randomized down titration, provided that they had stayed on the same dose of baricitinib from initial randomization. According to data from baricitinib manufacturer Eli Lilly, 77.5% of patients who stepped down to the 2 mg dose from the 4 mg dose at week 52 achieved a SALT score of 20 or less at week 76, Dr. Chovatiya said. “If I can keep someone on 4 mg that’s great, but it looks like you can go to a lower dose and do a pretty good job,” he said.

Patients in the baricitinib arms who achieved a SALT score of 20 or less at week 52 were eligible for randomized withdrawal, provided that they had stayed on the same dose of the drug from initial randomization. According to Dr. Chovatiya, 89.4% of individuals who remained on the 4 mg dose to week 76 maintained a SALT score of 20 or less, compared with 33.3% of those who switched from the 4 mg to placebo. “The takeaway here is that clinically, longitudinal treatment looks to be required in this time period” for continued efficacy, he said. “However, what this looks like in the real world remains to be seen.”

A recently published integrated analysis of safety data from BRAVE-AA1 and BRAVE-AA2 reported that no deaths occurred and of the few reported serious infections, nearly half were COVID-19. There was a single case of multidermatomal herpes zoster and no cases of tuberculosis. One patient with risk factors for MI had an MI during a placebo-controlled period, and one study participant with a history of COVID-19 infection developed a pulmonary embolism at day 638. There was one case each of chronic lymphocytic leukemia, B-cell lymphoma, breast cancer, and appendicitis.
 

Baseline severity and treatment response

“Does treatment response vary with baseline disease status?” Dr. Chovatiya asked. “Yes. People with very severe hair loss [defined as a SALT score of 95 or higher] tended to do worse, while the rest of the study population did even better – an almost twofold difference. This means that you want to treat as early as you possibly can. It’s interesting to note that you don’t see this difference as much in the case of eyebrows and eyelashes. This makes sense, though. Eyebrows and eyelashes probably behave differently in terms of growth than the scalp does.”

Certain baseline characteristics of patients in BRAVE-AA1 and BRAVE-AA2 portended better outcomes. Women tended to fare better than men, but individuals who had longer histories of AA did not respond well. “People who had a shorter duration of their current episode of AA also did better than people who had a longer current episode, so we want to think about treating as soon as we possibly can,” Dr. Chovatiya said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including Eli Lilly.

A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

For Sonja O’Leary, MD, higher rates of vaccination against human papillomavirus came with the flip of a switch.

Dr. O’Leary, the interim director of service for outpatient pediatric services at Denver Health and Hospital Authority, and her colleagues saw rates of HPV and other childhood immunizations drop during the COVID-19 pandemic and decided to act. Their health system, which includes 28 federally qualified health centers, offers vaccines at any inpatient or outpatient visit based on alerts from their electronic health record.

“It was actually really simple; it was really just changing our best-practice alert,” Dr. O’Leary said. Beginning in May 2021, and after notifying clinic staff of the impending change, DHHA dropped the alert for first dose of HPV from age 11 to 9.

The approach worked. Compared with the first 5 months of 2021, the percentage of children aged 9-13 years with an in-person visit who received at least one dose of HPV vaccine between June 2021 and August 2022 rose from 30.3% to 42.8% – a 41% increase. The share who received two doses by age 13 years more than doubled, from 19.3% to 42.7%, Dr. O’Leary said.
 

Frustrated efforts

Although those figures might seem to make an iron-clad case for earlier vaccinations against HPV – which is responsible for nearly 35,000 cases of cancer annually – factors beyond statistics have frustrated efforts to increase acceptance of the shots.

Data published in 2022 from the U.S. Centers for Disease Control and Prevention found that 89.6% of teens aged 13-17 years received at least one dose of tetanus, diphtheria, and acellular pertussis vaccine, and 89% got one or more doses of meningococcal conjugate vaccine. However, only 76.9% had received one or more doses of HPV vaccine. The rate of receiving both doses needed for full protection was much lower (61.7%).

Both the American Academy of Pediatrics and the American Cancer Society now endorse the strategy of offering HPV vaccine as early as age 9, which avoids the need for multiple shots at a single visit and results in more kids getting both doses. In a recent study that surveyed primary care professionals who see pediatric patients, 21% were already offering HPV vaccine at age 9, and another 48% were willing to try the approach.

What was the most common objection to the earlier age? Nearly three-quarters of clinicians said they felt that parents weren’t ready to talk about HPV vaccination yet.

Noel Brewer, PhD, one of the authors of the survey study, wondered why clinicians feel the need to bring up sex at all. “Providers should never be talking about sex when they are talking about vaccine, because that’s not the point,” said Dr. Brewer, the distinguished professor in public health at the University of North Carolina at Chapel Hill. He pointed out that providers don’t talk about the route of transmission for any other vaccine.

Dr. Brewer led a randomized controlled trial that trained pediatric clinicians in the “announcement” strategy, in which the clinician announces the vaccines that are due at that visit. If the parent hesitates, the clinician then probes further to identify and address their concerns and provides more information. If the parent is still not convinced, the clinician notes the discussion in the chart and tries again at the next visit.

The strategy was effective: Intervention clinics had a 5.4% higher rate of HPV vaccination coverage than control clinics after six months. Dr. Brewer and his colleagues have trained over 1,700 providers in the technique since 2020.
 

A cancer – not STI – vaccine

Although DHHA hasn’t participated in Dr. Brewer’s training, Dr. O’Leary and her colleagues take a similar approach of simply stating which vaccines the child should receive that day. And they talk about HPV as a cancer vaccine instead of one to prevent a sexually transmitted infection. 

In her experience, this emphasis changes the conversation. Dr. O’Leary described a typical comment from parents as, “Oh, of course I would give my child a vaccine that could prevent cancer.”

Ana Rodriguez, MD, MPH, an obstetrician, became interested in raising rates of vaccination against HPV after watching too many women battle a preventable cancer. She worked for several years in the Rio Grande Valley along the U.S. border with Mexico, an impoverished rural area with poor access to health care and high rates of HPV infection.

“I would treat women very young – not even 30 years of age – already fighting advanced precancerous lesions secondary to HPV,” said Dr. Rodriguez, an associate professor of Obstetrics & Gynecology at the University of Texas Medical Branch at Galveston.

In 2016, when Texas ranked 47th in the nation for rates of up-to-date HPV vaccination, Dr. Rodriguez helped launch a community-based educational campaign in four rural counties in the Rio Grande Valley using social media, radio, and in-person meetings with school PTA members and members of school boards to educate staff and parents about the need for vaccination against the infection.

In 2019, the team began offering the vaccine to children ages 9-12 years at back-to-school events, progress report nights, and other school events, pivoting to outdoor events using a mobile vaccine van after COVID-19 struck. They recently published a study showing that 73.6% of students who received their first dose of vaccine at age 11 or younger completed the series, compared with only 45.1% of children who got their first dose at age 12 or older.

Dr. Rodriguez encountered parents who felt 9 or 10 years old was too young because their children were not going to be sexually active anytime soon. Her response was to describe HPV as a tool to prevent cancer, telling parents, “If you vaccinate your kids young enough, they will be protected for life.”

Lifetime protection is another point in favor of giving HPV vaccine prior to Tdap and MenACWY. The response to the two-dose series of HPV in preadolescents is robust and long-lasting, with no downside to giving it a few years earlier. In contrast, immunity to MenACWY wanes after a few years, so the immunization must be given before children enter high school, when their risk for meningitis increases.

The annual toll of deaths in the United States from meningococcus, tetanus, diphtheria, and pertussis typically totals less than 100, whereas cancer deaths attributable to HPV infection number in the thousands each year. And that may be the best reason for attempting new strategies to help HPV vaccination rates catch up to the rest of the preteen vaccines.

Dr. Brewer’s work was supported by the Gillings School of Global Public Health, the Lineberger Comprehensive Cancer Center at the University of North Carolina, and from training grants from the National Cancer Institute. Dr. Brewer has received research funding from Merck, Pfizer, and GSK and served as a paid advisor for Merck. Dr. O’Leary reports no relevant financial relationships. Dr. Rodriguez received a grant from the Cancer Prevention Research Institute of Texas, and the study was supported by the Institute for Translational Sciences at the University of Texas Medical Branch.

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

For Sonja O’Leary, MD, higher rates of vaccination against human papillomavirus came with the flip of a switch.

Dr. O’Leary, the interim director of service for outpatient pediatric services at Denver Health and Hospital Authority, and her colleagues saw rates of HPV and other childhood immunizations drop during the COVID-19 pandemic and decided to act. Their health system, which includes 28 federally qualified health centers, offers vaccines at any inpatient or outpatient visit based on alerts from their electronic health record.

“It was actually really simple; it was really just changing our best-practice alert,” Dr. O’Leary said. Beginning in May 2021, and after notifying clinic staff of the impending change, DHHA dropped the alert for first dose of HPV from age 11 to 9.

The approach worked. Compared with the first 5 months of 2021, the percentage of children aged 9-13 years with an in-person visit who received at least one dose of HPV vaccine between June 2021 and August 2022 rose from 30.3% to 42.8% – a 41% increase. The share who received two doses by age 13 years more than doubled, from 19.3% to 42.7%, Dr. O’Leary said.
 

Frustrated efforts

Although those figures might seem to make an iron-clad case for earlier vaccinations against HPV – which is responsible for nearly 35,000 cases of cancer annually – factors beyond statistics have frustrated efforts to increase acceptance of the shots.

Data published in 2022 from the U.S. Centers for Disease Control and Prevention found that 89.6% of teens aged 13-17 years received at least one dose of tetanus, diphtheria, and acellular pertussis vaccine, and 89% got one or more doses of meningococcal conjugate vaccine. However, only 76.9% had received one or more doses of HPV vaccine. The rate of receiving both doses needed for full protection was much lower (61.7%).

Both the American Academy of Pediatrics and the American Cancer Society now endorse the strategy of offering HPV vaccine as early as age 9, which avoids the need for multiple shots at a single visit and results in more kids getting both doses. In a recent study that surveyed primary care professionals who see pediatric patients, 21% were already offering HPV vaccine at age 9, and another 48% were willing to try the approach.

What was the most common objection to the earlier age? Nearly three-quarters of clinicians said they felt that parents weren’t ready to talk about HPV vaccination yet.

Noel Brewer, PhD, one of the authors of the survey study, wondered why clinicians feel the need to bring up sex at all. “Providers should never be talking about sex when they are talking about vaccine, because that’s not the point,” said Dr. Brewer, the distinguished professor in public health at the University of North Carolina at Chapel Hill. He pointed out that providers don’t talk about the route of transmission for any other vaccine.

Dr. Brewer led a randomized controlled trial that trained pediatric clinicians in the “announcement” strategy, in which the clinician announces the vaccines that are due at that visit. If the parent hesitates, the clinician then probes further to identify and address their concerns and provides more information. If the parent is still not convinced, the clinician notes the discussion in the chart and tries again at the next visit.

The strategy was effective: Intervention clinics had a 5.4% higher rate of HPV vaccination coverage than control clinics after six months. Dr. Brewer and his colleagues have trained over 1,700 providers in the technique since 2020.
 

A cancer – not STI – vaccine

Although DHHA hasn’t participated in Dr. Brewer’s training, Dr. O’Leary and her colleagues take a similar approach of simply stating which vaccines the child should receive that day. And they talk about HPV as a cancer vaccine instead of one to prevent a sexually transmitted infection. 

In her experience, this emphasis changes the conversation. Dr. O’Leary described a typical comment from parents as, “Oh, of course I would give my child a vaccine that could prevent cancer.”

Ana Rodriguez, MD, MPH, an obstetrician, became interested in raising rates of vaccination against HPV after watching too many women battle a preventable cancer. She worked for several years in the Rio Grande Valley along the U.S. border with Mexico, an impoverished rural area with poor access to health care and high rates of HPV infection.

“I would treat women very young – not even 30 years of age – already fighting advanced precancerous lesions secondary to HPV,” said Dr. Rodriguez, an associate professor of Obstetrics & Gynecology at the University of Texas Medical Branch at Galveston.

In 2016, when Texas ranked 47th in the nation for rates of up-to-date HPV vaccination, Dr. Rodriguez helped launch a community-based educational campaign in four rural counties in the Rio Grande Valley using social media, radio, and in-person meetings with school PTA members and members of school boards to educate staff and parents about the need for vaccination against the infection.

In 2019, the team began offering the vaccine to children ages 9-12 years at back-to-school events, progress report nights, and other school events, pivoting to outdoor events using a mobile vaccine van after COVID-19 struck. They recently published a study showing that 73.6% of students who received their first dose of vaccine at age 11 or younger completed the series, compared with only 45.1% of children who got their first dose at age 12 or older.

Dr. Rodriguez encountered parents who felt 9 or 10 years old was too young because their children were not going to be sexually active anytime soon. Her response was to describe HPV as a tool to prevent cancer, telling parents, “If you vaccinate your kids young enough, they will be protected for life.”

Lifetime protection is another point in favor of giving HPV vaccine prior to Tdap and MenACWY. The response to the two-dose series of HPV in preadolescents is robust and long-lasting, with no downside to giving it a few years earlier. In contrast, immunity to MenACWY wanes after a few years, so the immunization must be given before children enter high school, when their risk for meningitis increases.

The annual toll of deaths in the United States from meningococcus, tetanus, diphtheria, and pertussis typically totals less than 100, whereas cancer deaths attributable to HPV infection number in the thousands each year. And that may be the best reason for attempting new strategies to help HPV vaccination rates catch up to the rest of the preteen vaccines.

Dr. Brewer’s work was supported by the Gillings School of Global Public Health, the Lineberger Comprehensive Cancer Center at the University of North Carolina, and from training grants from the National Cancer Institute. Dr. Brewer has received research funding from Merck, Pfizer, and GSK and served as a paid advisor for Merck. Dr. O’Leary reports no relevant financial relationships. Dr. Rodriguez received a grant from the Cancer Prevention Research Institute of Texas, and the study was supported by the Institute for Translational Sciences at the University of Texas Medical Branch.

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

For Sonja O’Leary, MD, higher rates of vaccination against human papillomavirus came with the flip of a switch.

Dr. O’Leary, the interim director of service for outpatient pediatric services at Denver Health and Hospital Authority, and her colleagues saw rates of HPV and other childhood immunizations drop during the COVID-19 pandemic and decided to act. Their health system, which includes 28 federally qualified health centers, offers vaccines at any inpatient or outpatient visit based on alerts from their electronic health record.

“It was actually really simple; it was really just changing our best-practice alert,” Dr. O’Leary said. Beginning in May 2021, and after notifying clinic staff of the impending change, DHHA dropped the alert for first dose of HPV from age 11 to 9.

The approach worked. Compared with the first 5 months of 2021, the percentage of children aged 9-13 years with an in-person visit who received at least one dose of HPV vaccine between June 2021 and August 2022 rose from 30.3% to 42.8% – a 41% increase. The share who received two doses by age 13 years more than doubled, from 19.3% to 42.7%, Dr. O’Leary said.
 

Frustrated efforts

Although those figures might seem to make an iron-clad case for earlier vaccinations against HPV – which is responsible for nearly 35,000 cases of cancer annually – factors beyond statistics have frustrated efforts to increase acceptance of the shots.

Data published in 2022 from the U.S. Centers for Disease Control and Prevention found that 89.6% of teens aged 13-17 years received at least one dose of tetanus, diphtheria, and acellular pertussis vaccine, and 89% got one or more doses of meningococcal conjugate vaccine. However, only 76.9% had received one or more doses of HPV vaccine. The rate of receiving both doses needed for full protection was much lower (61.7%).

Both the American Academy of Pediatrics and the American Cancer Society now endorse the strategy of offering HPV vaccine as early as age 9, which avoids the need for multiple shots at a single visit and results in more kids getting both doses. In a recent study that surveyed primary care professionals who see pediatric patients, 21% were already offering HPV vaccine at age 9, and another 48% were willing to try the approach.

What was the most common objection to the earlier age? Nearly three-quarters of clinicians said they felt that parents weren’t ready to talk about HPV vaccination yet.

Noel Brewer, PhD, one of the authors of the survey study, wondered why clinicians feel the need to bring up sex at all. “Providers should never be talking about sex when they are talking about vaccine, because that’s not the point,” said Dr. Brewer, the distinguished professor in public health at the University of North Carolina at Chapel Hill. He pointed out that providers don’t talk about the route of transmission for any other vaccine.

Dr. Brewer led a randomized controlled trial that trained pediatric clinicians in the “announcement” strategy, in which the clinician announces the vaccines that are due at that visit. If the parent hesitates, the clinician then probes further to identify and address their concerns and provides more information. If the parent is still not convinced, the clinician notes the discussion in the chart and tries again at the next visit.

The strategy was effective: Intervention clinics had a 5.4% higher rate of HPV vaccination coverage than control clinics after six months. Dr. Brewer and his colleagues have trained over 1,700 providers in the technique since 2020.
 

A cancer – not STI – vaccine

Although DHHA hasn’t participated in Dr. Brewer’s training, Dr. O’Leary and her colleagues take a similar approach of simply stating which vaccines the child should receive that day. And they talk about HPV as a cancer vaccine instead of one to prevent a sexually transmitted infection. 

In her experience, this emphasis changes the conversation. Dr. O’Leary described a typical comment from parents as, “Oh, of course I would give my child a vaccine that could prevent cancer.”

Ana Rodriguez, MD, MPH, an obstetrician, became interested in raising rates of vaccination against HPV after watching too many women battle a preventable cancer. She worked for several years in the Rio Grande Valley along the U.S. border with Mexico, an impoverished rural area with poor access to health care and high rates of HPV infection.

“I would treat women very young – not even 30 years of age – already fighting advanced precancerous lesions secondary to HPV,” said Dr. Rodriguez, an associate professor of Obstetrics & Gynecology at the University of Texas Medical Branch at Galveston.

In 2016, when Texas ranked 47th in the nation for rates of up-to-date HPV vaccination, Dr. Rodriguez helped launch a community-based educational campaign in four rural counties in the Rio Grande Valley using social media, radio, and in-person meetings with school PTA members and members of school boards to educate staff and parents about the need for vaccination against the infection.

In 2019, the team began offering the vaccine to children ages 9-12 years at back-to-school events, progress report nights, and other school events, pivoting to outdoor events using a mobile vaccine van after COVID-19 struck. They recently published a study showing that 73.6% of students who received their first dose of vaccine at age 11 or younger completed the series, compared with only 45.1% of children who got their first dose at age 12 or older.

Dr. Rodriguez encountered parents who felt 9 or 10 years old was too young because their children were not going to be sexually active anytime soon. Her response was to describe HPV as a tool to prevent cancer, telling parents, “If you vaccinate your kids young enough, they will be protected for life.”

Lifetime protection is another point in favor of giving HPV vaccine prior to Tdap and MenACWY. The response to the two-dose series of HPV in preadolescents is robust and long-lasting, with no downside to giving it a few years earlier. In contrast, immunity to MenACWY wanes after a few years, so the immunization must be given before children enter high school, when their risk for meningitis increases.

The annual toll of deaths in the United States from meningococcus, tetanus, diphtheria, and pertussis typically totals less than 100, whereas cancer deaths attributable to HPV infection number in the thousands each year. And that may be the best reason for attempting new strategies to help HPV vaccination rates catch up to the rest of the preteen vaccines.

Dr. Brewer’s work was supported by the Gillings School of Global Public Health, the Lineberger Comprehensive Cancer Center at the University of North Carolina, and from training grants from the National Cancer Institute. Dr. Brewer has received research funding from Merck, Pfizer, and GSK and served as a paid advisor for Merck. Dr. O’Leary reports no relevant financial relationships. Dr. Rodriguez received a grant from the Cancer Prevention Research Institute of Texas, and the study was supported by the Institute for Translational Sciences at the University of Texas Medical Branch.

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

Although I have worked with depressed patients for many years, I have come to realize that it is now unfortunately an essential primary care skill to have nuanced conversations about reducing access to and use of deadly weapons (lethal means) for all families.

Firearms are now the leading cause of death for U.S. children and youth aged 1-24 years, an increase of 29.5% from 2019 to 2020. Among all youth firearm deaths, homicides (58%), suicides (37%), unintentional shootings (2%), and legal intervention (1%) were causes. These horrific numbers do not even include almost 400,000 child ED visits from 2010 to 2019 for nonfatal firearm injuries that were unintentional (39.4%), assault-related (37.7%), or self-harm (1.7%).

Accidental injury from firearms is greater when the weapon is a handgun or pistol as these are small enough to be fired by a 2-year-old, more likely to be stored loaded with ammunition as “self-protection,” and less likely to be in a gun storage case.

While an overall decline in gun ownership has occurred in homes with children ages 1-5, the proportion of weapons that are handguns has actually increased, posing higher danger to the family itself. We can’t assume hiding a weapon is ever enough as children often know the location of guns and their keys or lock codes.

Many Americans fear for their safety, have doubts about policing as protective, and strongly assert the need to protect themselves. While asking about guns in the home is universally recommended, these beliefs need to be taken into account in the discussion. It is also important to speak with the firearm owner, most often the father. We might ask, “Do you feel that you need a firearm in your home to feel safe?” as a way to nonjudgmentally acknowledge their beliefs. Because women are more likely to be killed by their spouses than by all other types of assailants combined, we can ask, “What dangers worry you the most?” and “Do you feel safe in your current and any past relationships?” If their answer is worrisome, the discussion must first turn to dealing with the family situation. If the perceived threat is outside the family, we can inform families that having a gun in evidence in the home greatly increases the risk of being hurt by an assailant as well as risk for child injury and death. We might ask, “Can you think of any other ways to protect your home (for example, alarm system, outdoor lighting, dog, or pepper spray)?”

If parents insist on keeping a gun, we can strongly and directly recommend that all firearms be stored locked, unloaded, and with ammunition locked and stored separately. We can provide information on such locking and storage options. Programs in which information on devices to disable the gun were provided – such as cables to pass through the chamber or trigger locks – have shown big increases in safe gun storage. It may be worth saying/posting information on the Child Access Prevention (CAP) laws, enacted by many states, making adults owning firearms that are not stored safely unloaded legally responsible for any resulting injuries or deaths. Such laws have reduced injuries of both children and adults by 30%-40%, unintentional gun deaths by 23%, and gun suicides by 11% (for 14- to 17-year-olds).

If the reason for owning a gun is for hunting, the owner is more likely to have had firearm safety training and use a long gun. Long guns are more difficult for a child. Discussing safe hunting gun storage is still worth recommending, as is removing any handguns they may own as these are most dangerous.

Removing or securing firearms is important for everyone’s safety but it is an essential and perhaps more difficult topic of discussion when a child is at risk for suicide or harming others. We need to consider some crucial facts about completed suicide, now the leading cause of death in children and adolescents and largely from guns. Most suicide attempts occur within 10 minutes of having a wave of suicidal thoughts. These waves of thoughts may be acted upon immediately when lethal means are available, with guns by far the most likely to result in death. It is therefore critical to assess access and counsel about lethal means in every family with a child reporting thoughts of killing themselves or others, or a history of violence or substance use. Even without imminent risk of self-harm, we can start a discussion about securing lethal means by saying, “It’s like wearing a seatbelt; you don’t expect a car crash, but if one happens, wearing a safety belt can greatly reduce injury. Guns are the most frequent cause of dying, so let’s make a plan to reduce access to those.”

Creating a written plan to deal with waves of suicidal thoughts is the basis of a Safety Plan. We can accurately remind families and youth that “When someone is struggling like this, sometimes suicidal feelings can show up and get worse fast. There are steps I routinely recommend to make things safer at home.”

It is important to assess the presence of guns in the primary home and other places the child spends time even if we have asked in the past, as things change. If firearms are present, even if locked up appropriately, when a child is having suicidal thoughts we can say, “What some gun owners in your situation do is store weapons elsewhere temporarily with someone they trust, at a self-storage unit, gun or pawn shop, or police department. I’d like to talk over storage options like that with you.” If the child themself owns the firearm, they need to agree with a removal or lock up plan for giving up their access.

If the gun owner is unwilling to remove firearms, even temporarily, we can ask them to lock them up separately from ammunition, a move that alone reduces danger a lot, and ensure the child has no access to the keys or combination. Better yet, we can ask, “Would you be willing to ask someone who doesn’t live in your home to hold the keys or to change the combination temporarily or at least store the ammunition?” They could also remove from the home a critical component of the gun so that it can’t fire, such as the slide or firing pin. If even those steps are not accepted, we can ask, “What other options would you be willing to consider to increase your child’s safety, at least until s/he is doing better?”

Whatever plan we negotiate with the family, as for any health behavior change strategy, it is more likely to be implemented if we summarize the specifics, write them down, and set a time-frame for carrying it out. We might say, “Let’s review who’s doing what and when: Dad will take the guns to his uncle’s house tomorrow and meanwhile, he will put them in the gun safe.” A follow-up call or contact soon, a key part of management of suicidal ideation, also signals how strongly we care about these safety measures and has been shown to increase implementation. We might call to say, “I wanted to check in and see how [you/your child] is doing and also ask how the plan is going that we talked about for gun storage.”

Discussions about firearms can spark strong emotions, especially if the family suspects political motivations. The Florida law prohibiting health care providers from discussing guns with patients was overturned but the thinking remains and may give us pause before having these important conversations. First of all, we need to stay calm and be prepared with key facts. The “sandwich” method is a useful approach to reduce resistance: start with something you can agree on (such as “What we hear on the news can make us all scared about safety”); then add the facts we want to convey (such as “You are actually less likely to get hurt in a break-in if you do not have a gun”); then conclude with a positive (such as “I can see that you are giving a lot of thought to how to keep your family safe”). Families generally trust our intentions and knowledge and appreciate rather than resent safety counseling when it is given in a nonjudgmental manner. Because we are protectors of child health, firearm safety must be an essential part of our anticipatory guidance.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

*Wording suggestions adapted from https://www.hsph.harvard.edu/means-matter/recommendations/clinicians.

Although I have worked with depressed patients for many years, I have come to realize that it is now unfortunately an essential primary care skill to have nuanced conversations about reducing access to and use of deadly weapons (lethal means) for all families.

Firearms are now the leading cause of death for U.S. children and youth aged 1-24 years, an increase of 29.5% from 2019 to 2020. Among all youth firearm deaths, homicides (58%), suicides (37%), unintentional shootings (2%), and legal intervention (1%) were causes. These horrific numbers do not even include almost 400,000 child ED visits from 2010 to 2019 for nonfatal firearm injuries that were unintentional (39.4%), assault-related (37.7%), or self-harm (1.7%).

Accidental injury from firearms is greater when the weapon is a handgun or pistol as these are small enough to be fired by a 2-year-old, more likely to be stored loaded with ammunition as “self-protection,” and less likely to be in a gun storage case.

While an overall decline in gun ownership has occurred in homes with children ages 1-5, the proportion of weapons that are handguns has actually increased, posing higher danger to the family itself. We can’t assume hiding a weapon is ever enough as children often know the location of guns and their keys or lock codes.

Many Americans fear for their safety, have doubts about policing as protective, and strongly assert the need to protect themselves. While asking about guns in the home is universally recommended, these beliefs need to be taken into account in the discussion. It is also important to speak with the firearm owner, most often the father. We might ask, “Do you feel that you need a firearm in your home to feel safe?” as a way to nonjudgmentally acknowledge their beliefs. Because women are more likely to be killed by their spouses than by all other types of assailants combined, we can ask, “What dangers worry you the most?” and “Do you feel safe in your current and any past relationships?” If their answer is worrisome, the discussion must first turn to dealing with the family situation. If the perceived threat is outside the family, we can inform families that having a gun in evidence in the home greatly increases the risk of being hurt by an assailant as well as risk for child injury and death. We might ask, “Can you think of any other ways to protect your home (for example, alarm system, outdoor lighting, dog, or pepper spray)?”

If parents insist on keeping a gun, we can strongly and directly recommend that all firearms be stored locked, unloaded, and with ammunition locked and stored separately. We can provide information on such locking and storage options. Programs in which information on devices to disable the gun were provided – such as cables to pass through the chamber or trigger locks – have shown big increases in safe gun storage. It may be worth saying/posting information on the Child Access Prevention (CAP) laws, enacted by many states, making adults owning firearms that are not stored safely unloaded legally responsible for any resulting injuries or deaths. Such laws have reduced injuries of both children and adults by 30%-40%, unintentional gun deaths by 23%, and gun suicides by 11% (for 14- to 17-year-olds).

If the reason for owning a gun is for hunting, the owner is more likely to have had firearm safety training and use a long gun. Long guns are more difficult for a child. Discussing safe hunting gun storage is still worth recommending, as is removing any handguns they may own as these are most dangerous.

Removing or securing firearms is important for everyone’s safety but it is an essential and perhaps more difficult topic of discussion when a child is at risk for suicide or harming others. We need to consider some crucial facts about completed suicide, now the leading cause of death in children and adolescents and largely from guns. Most suicide attempts occur within 10 minutes of having a wave of suicidal thoughts. These waves of thoughts may be acted upon immediately when lethal means are available, with guns by far the most likely to result in death. It is therefore critical to assess access and counsel about lethal means in every family with a child reporting thoughts of killing themselves or others, or a history of violence or substance use. Even without imminent risk of self-harm, we can start a discussion about securing lethal means by saying, “It’s like wearing a seatbelt; you don’t expect a car crash, but if one happens, wearing a safety belt can greatly reduce injury. Guns are the most frequent cause of dying, so let’s make a plan to reduce access to those.”

Creating a written plan to deal with waves of suicidal thoughts is the basis of a Safety Plan. We can accurately remind families and youth that “When someone is struggling like this, sometimes suicidal feelings can show up and get worse fast. There are steps I routinely recommend to make things safer at home.”

It is important to assess the presence of guns in the primary home and other places the child spends time even if we have asked in the past, as things change. If firearms are present, even if locked up appropriately, when a child is having suicidal thoughts we can say, “What some gun owners in your situation do is store weapons elsewhere temporarily with someone they trust, at a self-storage unit, gun or pawn shop, or police department. I’d like to talk over storage options like that with you.” If the child themself owns the firearm, they need to agree with a removal or lock up plan for giving up their access.

If the gun owner is unwilling to remove firearms, even temporarily, we can ask them to lock them up separately from ammunition, a move that alone reduces danger a lot, and ensure the child has no access to the keys or combination. Better yet, we can ask, “Would you be willing to ask someone who doesn’t live in your home to hold the keys or to change the combination temporarily or at least store the ammunition?” They could also remove from the home a critical component of the gun so that it can’t fire, such as the slide or firing pin. If even those steps are not accepted, we can ask, “What other options would you be willing to consider to increase your child’s safety, at least until s/he is doing better?”

Whatever plan we negotiate with the family, as for any health behavior change strategy, it is more likely to be implemented if we summarize the specifics, write them down, and set a time-frame for carrying it out. We might say, “Let’s review who’s doing what and when: Dad will take the guns to his uncle’s house tomorrow and meanwhile, he will put them in the gun safe.” A follow-up call or contact soon, a key part of management of suicidal ideation, also signals how strongly we care about these safety measures and has been shown to increase implementation. We might call to say, “I wanted to check in and see how [you/your child] is doing and also ask how the plan is going that we talked about for gun storage.”

Discussions about firearms can spark strong emotions, especially if the family suspects political motivations. The Florida law prohibiting health care providers from discussing guns with patients was overturned but the thinking remains and may give us pause before having these important conversations. First of all, we need to stay calm and be prepared with key facts. The “sandwich” method is a useful approach to reduce resistance: start with something you can agree on (such as “What we hear on the news can make us all scared about safety”); then add the facts we want to convey (such as “You are actually less likely to get hurt in a break-in if you do not have a gun”); then conclude with a positive (such as “I can see that you are giving a lot of thought to how to keep your family safe”). Families generally trust our intentions and knowledge and appreciate rather than resent safety counseling when it is given in a nonjudgmental manner. Because we are protectors of child health, firearm safety must be an essential part of our anticipatory guidance.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

*Wording suggestions adapted from https://www.hsph.harvard.edu/means-matter/recommendations/clinicians.

Although I have worked with depressed patients for many years, I have come to realize that it is now unfortunately an essential primary care skill to have nuanced conversations about reducing access to and use of deadly weapons (lethal means) for all families.

Firearms are now the leading cause of death for U.S. children and youth aged 1-24 years, an increase of 29.5% from 2019 to 2020. Among all youth firearm deaths, homicides (58%), suicides (37%), unintentional shootings (2%), and legal intervention (1%) were causes. These horrific numbers do not even include almost 400,000 child ED visits from 2010 to 2019 for nonfatal firearm injuries that were unintentional (39.4%), assault-related (37.7%), or self-harm (1.7%).

Accidental injury from firearms is greater when the weapon is a handgun or pistol as these are small enough to be fired by a 2-year-old, more likely to be stored loaded with ammunition as “self-protection,” and less likely to be in a gun storage case.

While an overall decline in gun ownership has occurred in homes with children ages 1-5, the proportion of weapons that are handguns has actually increased, posing higher danger to the family itself. We can’t assume hiding a weapon is ever enough as children often know the location of guns and their keys or lock codes.

Many Americans fear for their safety, have doubts about policing as protective, and strongly assert the need to protect themselves. While asking about guns in the home is universally recommended, these beliefs need to be taken into account in the discussion. It is also important to speak with the firearm owner, most often the father. We might ask, “Do you feel that you need a firearm in your home to feel safe?” as a way to nonjudgmentally acknowledge their beliefs. Because women are more likely to be killed by their spouses than by all other types of assailants combined, we can ask, “What dangers worry you the most?” and “Do you feel safe in your current and any past relationships?” If their answer is worrisome, the discussion must first turn to dealing with the family situation. If the perceived threat is outside the family, we can inform families that having a gun in evidence in the home greatly increases the risk of being hurt by an assailant as well as risk for child injury and death. We might ask, “Can you think of any other ways to protect your home (for example, alarm system, outdoor lighting, dog, or pepper spray)?”

If parents insist on keeping a gun, we can strongly and directly recommend that all firearms be stored locked, unloaded, and with ammunition locked and stored separately. We can provide information on such locking and storage options. Programs in which information on devices to disable the gun were provided – such as cables to pass through the chamber or trigger locks – have shown big increases in safe gun storage. It may be worth saying/posting information on the Child Access Prevention (CAP) laws, enacted by many states, making adults owning firearms that are not stored safely unloaded legally responsible for any resulting injuries or deaths. Such laws have reduced injuries of both children and adults by 30%-40%, unintentional gun deaths by 23%, and gun suicides by 11% (for 14- to 17-year-olds).

If the reason for owning a gun is for hunting, the owner is more likely to have had firearm safety training and use a long gun. Long guns are more difficult for a child. Discussing safe hunting gun storage is still worth recommending, as is removing any handguns they may own as these are most dangerous.

Removing or securing firearms is important for everyone’s safety but it is an essential and perhaps more difficult topic of discussion when a child is at risk for suicide or harming others. We need to consider some crucial facts about completed suicide, now the leading cause of death in children and adolescents and largely from guns. Most suicide attempts occur within 10 minutes of having a wave of suicidal thoughts. These waves of thoughts may be acted upon immediately when lethal means are available, with guns by far the most likely to result in death. It is therefore critical to assess access and counsel about lethal means in every family with a child reporting thoughts of killing themselves or others, or a history of violence or substance use. Even without imminent risk of self-harm, we can start a discussion about securing lethal means by saying, “It’s like wearing a seatbelt; you don’t expect a car crash, but if one happens, wearing a safety belt can greatly reduce injury. Guns are the most frequent cause of dying, so let’s make a plan to reduce access to those.”

Creating a written plan to deal with waves of suicidal thoughts is the basis of a Safety Plan. We can accurately remind families and youth that “When someone is struggling like this, sometimes suicidal feelings can show up and get worse fast. There are steps I routinely recommend to make things safer at home.”

It is important to assess the presence of guns in the primary home and other places the child spends time even if we have asked in the past, as things change. If firearms are present, even if locked up appropriately, when a child is having suicidal thoughts we can say, “What some gun owners in your situation do is store weapons elsewhere temporarily with someone they trust, at a self-storage unit, gun or pawn shop, or police department. I’d like to talk over storage options like that with you.” If the child themself owns the firearm, they need to agree with a removal or lock up plan for giving up their access.

If the gun owner is unwilling to remove firearms, even temporarily, we can ask them to lock them up separately from ammunition, a move that alone reduces danger a lot, and ensure the child has no access to the keys or combination. Better yet, we can ask, “Would you be willing to ask someone who doesn’t live in your home to hold the keys or to change the combination temporarily or at least store the ammunition?” They could also remove from the home a critical component of the gun so that it can’t fire, such as the slide or firing pin. If even those steps are not accepted, we can ask, “What other options would you be willing to consider to increase your child’s safety, at least until s/he is doing better?”

Whatever plan we negotiate with the family, as for any health behavior change strategy, it is more likely to be implemented if we summarize the specifics, write them down, and set a time-frame for carrying it out. We might say, “Let’s review who’s doing what and when: Dad will take the guns to his uncle’s house tomorrow and meanwhile, he will put them in the gun safe.” A follow-up call or contact soon, a key part of management of suicidal ideation, also signals how strongly we care about these safety measures and has been shown to increase implementation. We might call to say, “I wanted to check in and see how [you/your child] is doing and also ask how the plan is going that we talked about for gun storage.”

Discussions about firearms can spark strong emotions, especially if the family suspects political motivations. The Florida law prohibiting health care providers from discussing guns with patients was overturned but the thinking remains and may give us pause before having these important conversations. First of all, we need to stay calm and be prepared with key facts. The “sandwich” method is a useful approach to reduce resistance: start with something you can agree on (such as “What we hear on the news can make us all scared about safety”); then add the facts we want to convey (such as “You are actually less likely to get hurt in a break-in if you do not have a gun”); then conclude with a positive (such as “I can see that you are giving a lot of thought to how to keep your family safe”). Families generally trust our intentions and knowledge and appreciate rather than resent safety counseling when it is given in a nonjudgmental manner. Because we are protectors of child health, firearm safety must be an essential part of our anticipatory guidance.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

*Wording suggestions adapted from https://www.hsph.harvard.edu/means-matter/recommendations/clinicians.

A few months ago, after several months of considerable foot dragging, I wrote that I have accepted the American Academy of Pediatrics’ proclamation that we should begin to treat obesity as a disease.

While it may feel like we are just throwing in the towel, it sounds better if we admit that we may have reached the threshold beyond which total focus on prevention is not going to work.

I continue to be troubled by the lingering fear that, in declaring that obesity is a disease, we will suspend our current efforts at preventing the condition. Granted, most of these efforts at prevention have been woefully ineffective. However, I still believe that, much like ADHD, the rise in obesity in this country is a reflection of some serious flaws in our society. On the other hand, as an inveterate optimist I have not given up on the belief that we will find some yet-to-be-discovered changes in our societal fabric that will eventually turn the ship around.

With this somewhat contradictory combination of resignation and optimism in mind, I continue to seek out studies that hold some promise for prevention while we begin tinkering with the let’s-treat-it-like-a-disease approach.

I recently discovered a story about one such study from the Center for Economic and Social Research at the University of Southern California. Using data collected about adolescent dependents of military personnel, the researchers found that “exposure to a more advantageous built environment for more than 2 years was associated with lower probabilities of obesity.” Because more than half of these teenagers were living in housing that had been assigned by the military, the researchers could more easily control for a variety of factors some related to self-selection.

Interestingly, the data did not support associations between the adolescents’ diet, physical activity, or socioeconomic environments. The investigators noted that “more advantageous built environments were associated with lower consumption of unhealthy foods.” However, the study lacked the granularity to determine what segments of the built environment were most associated with the effect they were observing.

Like me, you may not be familiar with the term “built environment.” Turns out it is just exactly what we might expect – anything about the environment that is the result of human action – buildings, roadways, dams, neighborhoods – and what they do and don’t contain. For example, is the adolescent living in an environment that encourages walking or one that is overly motor vehicle–centric? Does his or her neighborhood have easily reachable grocery stores that offer a range of healthy foods or does the teenager live in a nutritional desert populated only by convenience stores? Is there ample space for outdoor physical activity?

The authors’ observation that the adolescents who benefited from living in advantageous environments had a lower consumption of unhealthy foods might suggest that access to a healthy diet might be a significant factor. For me, the take-home message is that in our search for preventive strategies we have barely scratched the surface. The observation that the associations these researchers were making was over a relatively short time span of 2 years should give us hope that if we think more broadly and creatively we may be to find solutions on a grand scale.

Over the last century we have built an environment that is clearly obesogenic. This paper offers a starting point from which we can learn which components of that environment are the most potent contributors to the obesity epidemic. Once we have that information the question remains: Can we find the political will to tear down and rebuilt?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A few months ago, after several months of considerable foot dragging, I wrote that I have accepted the American Academy of Pediatrics’ proclamation that we should begin to treat obesity as a disease.

While it may feel like we are just throwing in the towel, it sounds better if we admit that we may have reached the threshold beyond which total focus on prevention is not going to work.

I continue to be troubled by the lingering fear that, in declaring that obesity is a disease, we will suspend our current efforts at preventing the condition. Granted, most of these efforts at prevention have been woefully ineffective. However, I still believe that, much like ADHD, the rise in obesity in this country is a reflection of some serious flaws in our society. On the other hand, as an inveterate optimist I have not given up on the belief that we will find some yet-to-be-discovered changes in our societal fabric that will eventually turn the ship around.

With this somewhat contradictory combination of resignation and optimism in mind, I continue to seek out studies that hold some promise for prevention while we begin tinkering with the let’s-treat-it-like-a-disease approach.

I recently discovered a story about one such study from the Center for Economic and Social Research at the University of Southern California. Using data collected about adolescent dependents of military personnel, the researchers found that “exposure to a more advantageous built environment for more than 2 years was associated with lower probabilities of obesity.” Because more than half of these teenagers were living in housing that had been assigned by the military, the researchers could more easily control for a variety of factors some related to self-selection.

Interestingly, the data did not support associations between the adolescents’ diet, physical activity, or socioeconomic environments. The investigators noted that “more advantageous built environments were associated with lower consumption of unhealthy foods.” However, the study lacked the granularity to determine what segments of the built environment were most associated with the effect they were observing.

Like me, you may not be familiar with the term “built environment.” Turns out it is just exactly what we might expect – anything about the environment that is the result of human action – buildings, roadways, dams, neighborhoods – and what they do and don’t contain. For example, is the adolescent living in an environment that encourages walking or one that is overly motor vehicle–centric? Does his or her neighborhood have easily reachable grocery stores that offer a range of healthy foods or does the teenager live in a nutritional desert populated only by convenience stores? Is there ample space for outdoor physical activity?

The authors’ observation that the adolescents who benefited from living in advantageous environments had a lower consumption of unhealthy foods might suggest that access to a healthy diet might be a significant factor. For me, the take-home message is that in our search for preventive strategies we have barely scratched the surface. The observation that the associations these researchers were making was over a relatively short time span of 2 years should give us hope that if we think more broadly and creatively we may be to find solutions on a grand scale.

Over the last century we have built an environment that is clearly obesogenic. This paper offers a starting point from which we can learn which components of that environment are the most potent contributors to the obesity epidemic. Once we have that information the question remains: Can we find the political will to tear down and rebuilt?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A few months ago, after several months of considerable foot dragging, I wrote that I have accepted the American Academy of Pediatrics’ proclamation that we should begin to treat obesity as a disease.

While it may feel like we are just throwing in the towel, it sounds better if we admit that we may have reached the threshold beyond which total focus on prevention is not going to work.

I continue to be troubled by the lingering fear that, in declaring that obesity is a disease, we will suspend our current efforts at preventing the condition. Granted, most of these efforts at prevention have been woefully ineffective. However, I still believe that, much like ADHD, the rise in obesity in this country is a reflection of some serious flaws in our society. On the other hand, as an inveterate optimist I have not given up on the belief that we will find some yet-to-be-discovered changes in our societal fabric that will eventually turn the ship around.

With this somewhat contradictory combination of resignation and optimism in mind, I continue to seek out studies that hold some promise for prevention while we begin tinkering with the let’s-treat-it-like-a-disease approach.

I recently discovered a story about one such study from the Center for Economic and Social Research at the University of Southern California. Using data collected about adolescent dependents of military personnel, the researchers found that “exposure to a more advantageous built environment for more than 2 years was associated with lower probabilities of obesity.” Because more than half of these teenagers were living in housing that had been assigned by the military, the researchers could more easily control for a variety of factors some related to self-selection.

Interestingly, the data did not support associations between the adolescents’ diet, physical activity, or socioeconomic environments. The investigators noted that “more advantageous built environments were associated with lower consumption of unhealthy foods.” However, the study lacked the granularity to determine what segments of the built environment were most associated with the effect they were observing.

Like me, you may not be familiar with the term “built environment.” Turns out it is just exactly what we might expect – anything about the environment that is the result of human action – buildings, roadways, dams, neighborhoods – and what they do and don’t contain. For example, is the adolescent living in an environment that encourages walking or one that is overly motor vehicle–centric? Does his or her neighborhood have easily reachable grocery stores that offer a range of healthy foods or does the teenager live in a nutritional desert populated only by convenience stores? Is there ample space for outdoor physical activity?

The authors’ observation that the adolescents who benefited from living in advantageous environments had a lower consumption of unhealthy foods might suggest that access to a healthy diet might be a significant factor. For me, the take-home message is that in our search for preventive strategies we have barely scratched the surface. The observation that the associations these researchers were making was over a relatively short time span of 2 years should give us hope that if we think more broadly and creatively we may be to find solutions on a grand scale.

Over the last century we have built an environment that is clearly obesogenic. This paper offers a starting point from which we can learn which components of that environment are the most potent contributors to the obesity epidemic. Once we have that information the question remains: Can we find the political will to tear down and rebuilt?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Although people who survive a childhood cancer are at an increased risk of developing and dying from subsequent cancers, as well as heart disease and stroke, they can reduce this risk by following a healthy lifestyle, say U.S. investigators.

This message comes from a retrospective analysis of more than 34,000 childhood cancer survivors, which found that 40 years after the initial cancer diagnosis, the cumulative all-cause mortality rate was 23.3%, compared with less than 5% in the general population.

However, following a healthy lifestyle was associated with a 20% reduction in health-related mortality, independent of other factors, the analysis showed. This rose even further, up to a 30% reduction, among individuals who did not have hypertension or diabetes.

The study was published online  in The Lancet.

“We identified that long-term survivors of childhood cancer are experiencing a large number of deaths in excess of what would be expected for the general, aging population,” first author Stephanie Dixon, MD, MPH, oncology department, St. Jude Children’s Research Hospital, Memphis, Tenn., said in a press release.

“These excess deaths are predominantly due to the same leading causes of death as in the general population,” including subsequent cancers, heart disease, cerebrovascular disease/stroke, chronic liver and kidney disease, and infectious diseases, she noted. However, in these childhood cancer survivors they are occurring “at a younger age and higher rate.”

“What was most exciting to see,” Dr. Dixon added, “was that, independent of prior treatment exposures and sociodemographic factors, a healthy lifestyle and absence of hypertension or diabetes were each associated with a reduced risk of health-related mortality.”

“This is important because our goal is to extend the life span of survivors and to improve their ‘health span’ as well,” said senior author Greg Armstrong, MD, MSCE, chair of the department of epidemiology and cancer control at St. Jude.

As such, “the study highlights the importance of encouraging survivors to practice healthy behaviors and maintain good control of cardiovascular disease risk factors,” emphasized coauthor Melissa M. Hudson, MD, director of the cancer survivorship division at St. Jude.

Future research should focus on interventions for modifiable lifestyle and cardiovascular risk factors that “may need to be specifically tailored to survivors, with the goal of reducing chronic disease development” and extending their lifespan, the researchers said.
 

Late effects of treatment

Childhood cancer has a tremendous success rate: In the United States, the 5-year survival rate is now more than 85%.

However, long-term survivors experience excess morbidity and late mortality compared with the general population, both of which are “attributable to late effects of treatment,” the team pointed out.

Their study focused on individuals who had been diagnosed with cancer before they were 21 years old and who had survived at least 5 years after the cancer diagnosis.

The median age at diagnosis was 6 years, and the most common diagnoses were acute lymphoblastic leukemia (36%), Hodgkin lymphoma (11%), astrocytoma (10%), and kidney tumors (8%).

The team identified 34,230 survivors who had been treated between Jan. 1, 1970, and Dec. 31, 1999, at 31 institutions in the United States and Canada.

They  represented approximately 20% of all childhood cancer survivors in the United States over the study period. The team noted that 56% of the survivors were male, and the majority (64%) were non-Hispanic White.

The date and causes of death through December 2017 were obtained via linkage to the National Death Index, and cancer treatment information was collated for 21,418 survivors who provided consent. Lifestyle factors – including smoking, alcohol use, physical activity, and unhealthy weight – were graded on a score of 0-4.

Over a median follow-up of 29.1 years, there were 5,916 deaths, with 34% attributable to the recurrence or progression of the primary cancer, and 51.2% attributable to other causes, such as subsequent neoplasms, and cardiac, pulmonary, and other health-related causes.

Overall, survivors were at an elevated risk of death compared with the general population, at a standardized mortality ratio of 5.6. This ratio peaked at 5-9 years after diagnosis at an 18.1-fold increased risk of death compared with the general population.

Forty years or more from the initial diagnosis, two-thirds of the 131 per 10,000 person-years excess deaths from health-related causes were due to the top three causes of health-related death in the general population, the team reported.

This included an absolute excess risk of death from cancer of 54 per 10,000 person-years, an excess risk of heart disease mortality of 27 per 10,000 person-years, and an excess risk of cerebrovascular disease mortality of 10 per 10,000 person-years.

The individual cases of death contributing the greatest excess risk were gastrointestinal cancers (11 per 10,000 person-years), cerebrovascular disease (10 per 10,000 person-years), ischemic heart disease (10 per 10,000 person-years), and valvular heart disease (9 per 10,000 person-years).

The good news is that following a healthy lifestyle was associated with a 20% reduction in health-related mortality versus an unhealthy lifestyle (P = .0020).

Moreover, following even a moderately healthy lifestyle was associated with a 10% reduction in health-related mortality, the researchers noted.

The study was supported by grants from the National Cancer Institute, St. Jude Children’s Research Hospital Cancer Center Support, and the American Lebanese-Syrian Associated Charities. The authors reported no relevant financial relationships.

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

Although people who survive a childhood cancer are at an increased risk of developing and dying from subsequent cancers, as well as heart disease and stroke, they can reduce this risk by following a healthy lifestyle, say U.S. investigators.

This message comes from a retrospective analysis of more than 34,000 childhood cancer survivors, which found that 40 years after the initial cancer diagnosis, the cumulative all-cause mortality rate was 23.3%, compared with less than 5% in the general population.

However, following a healthy lifestyle was associated with a 20% reduction in health-related mortality, independent of other factors, the analysis showed. This rose even further, up to a 30% reduction, among individuals who did not have hypertension or diabetes.

The study was published online  in The Lancet.

“We identified that long-term survivors of childhood cancer are experiencing a large number of deaths in excess of what would be expected for the general, aging population,” first author Stephanie Dixon, MD, MPH, oncology department, St. Jude Children’s Research Hospital, Memphis, Tenn., said in a press release.

“These excess deaths are predominantly due to the same leading causes of death as in the general population,” including subsequent cancers, heart disease, cerebrovascular disease/stroke, chronic liver and kidney disease, and infectious diseases, she noted. However, in these childhood cancer survivors they are occurring “at a younger age and higher rate.”

“What was most exciting to see,” Dr. Dixon added, “was that, independent of prior treatment exposures and sociodemographic factors, a healthy lifestyle and absence of hypertension or diabetes were each associated with a reduced risk of health-related mortality.”

“This is important because our goal is to extend the life span of survivors and to improve their ‘health span’ as well,” said senior author Greg Armstrong, MD, MSCE, chair of the department of epidemiology and cancer control at St. Jude.

As such, “the study highlights the importance of encouraging survivors to practice healthy behaviors and maintain good control of cardiovascular disease risk factors,” emphasized coauthor Melissa M. Hudson, MD, director of the cancer survivorship division at St. Jude.

Future research should focus on interventions for modifiable lifestyle and cardiovascular risk factors that “may need to be specifically tailored to survivors, with the goal of reducing chronic disease development” and extending their lifespan, the researchers said.
 

Late effects of treatment

Childhood cancer has a tremendous success rate: In the United States, the 5-year survival rate is now more than 85%.

However, long-term survivors experience excess morbidity and late mortality compared with the general population, both of which are “attributable to late effects of treatment,” the team pointed out.

Their study focused on individuals who had been diagnosed with cancer before they were 21 years old and who had survived at least 5 years after the cancer diagnosis.

The median age at diagnosis was 6 years, and the most common diagnoses were acute lymphoblastic leukemia (36%), Hodgkin lymphoma (11%), astrocytoma (10%), and kidney tumors (8%).

The team identified 34,230 survivors who had been treated between Jan. 1, 1970, and Dec. 31, 1999, at 31 institutions in the United States and Canada.

They  represented approximately 20% of all childhood cancer survivors in the United States over the study period. The team noted that 56% of the survivors were male, and the majority (64%) were non-Hispanic White.

The date and causes of death through December 2017 were obtained via linkage to the National Death Index, and cancer treatment information was collated for 21,418 survivors who provided consent. Lifestyle factors – including smoking, alcohol use, physical activity, and unhealthy weight – were graded on a score of 0-4.

Over a median follow-up of 29.1 years, there were 5,916 deaths, with 34% attributable to the recurrence or progression of the primary cancer, and 51.2% attributable to other causes, such as subsequent neoplasms, and cardiac, pulmonary, and other health-related causes.

Overall, survivors were at an elevated risk of death compared with the general population, at a standardized mortality ratio of 5.6. This ratio peaked at 5-9 years after diagnosis at an 18.1-fold increased risk of death compared with the general population.

Forty years or more from the initial diagnosis, two-thirds of the 131 per 10,000 person-years excess deaths from health-related causes were due to the top three causes of health-related death in the general population, the team reported.

This included an absolute excess risk of death from cancer of 54 per 10,000 person-years, an excess risk of heart disease mortality of 27 per 10,000 person-years, and an excess risk of cerebrovascular disease mortality of 10 per 10,000 person-years.

The individual cases of death contributing the greatest excess risk were gastrointestinal cancers (11 per 10,000 person-years), cerebrovascular disease (10 per 10,000 person-years), ischemic heart disease (10 per 10,000 person-years), and valvular heart disease (9 per 10,000 person-years).

The good news is that following a healthy lifestyle was associated with a 20% reduction in health-related mortality versus an unhealthy lifestyle (P = .0020).

Moreover, following even a moderately healthy lifestyle was associated with a 10% reduction in health-related mortality, the researchers noted.

The study was supported by grants from the National Cancer Institute, St. Jude Children’s Research Hospital Cancer Center Support, and the American Lebanese-Syrian Associated Charities. The authors reported no relevant financial relationships.

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

Although people who survive a childhood cancer are at an increased risk of developing and dying from subsequent cancers, as well as heart disease and stroke, they can reduce this risk by following a healthy lifestyle, say U.S. investigators.

This message comes from a retrospective analysis of more than 34,000 childhood cancer survivors, which found that 40 years after the initial cancer diagnosis, the cumulative all-cause mortality rate was 23.3%, compared with less than 5% in the general population.

However, following a healthy lifestyle was associated with a 20% reduction in health-related mortality, independent of other factors, the analysis showed. This rose even further, up to a 30% reduction, among individuals who did not have hypertension or diabetes.

The study was published online  in The Lancet.

“We identified that long-term survivors of childhood cancer are experiencing a large number of deaths in excess of what would be expected for the general, aging population,” first author Stephanie Dixon, MD, MPH, oncology department, St. Jude Children’s Research Hospital, Memphis, Tenn., said in a press release.

“These excess deaths are predominantly due to the same leading causes of death as in the general population,” including subsequent cancers, heart disease, cerebrovascular disease/stroke, chronic liver and kidney disease, and infectious diseases, she noted. However, in these childhood cancer survivors they are occurring “at a younger age and higher rate.”

“What was most exciting to see,” Dr. Dixon added, “was that, independent of prior treatment exposures and sociodemographic factors, a healthy lifestyle and absence of hypertension or diabetes were each associated with a reduced risk of health-related mortality.”

“This is important because our goal is to extend the life span of survivors and to improve their ‘health span’ as well,” said senior author Greg Armstrong, MD, MSCE, chair of the department of epidemiology and cancer control at St. Jude.

As such, “the study highlights the importance of encouraging survivors to practice healthy behaviors and maintain good control of cardiovascular disease risk factors,” emphasized coauthor Melissa M. Hudson, MD, director of the cancer survivorship division at St. Jude.

Future research should focus on interventions for modifiable lifestyle and cardiovascular risk factors that “may need to be specifically tailored to survivors, with the goal of reducing chronic disease development” and extending their lifespan, the researchers said.
 

Late effects of treatment

Childhood cancer has a tremendous success rate: In the United States, the 5-year survival rate is now more than 85%.

However, long-term survivors experience excess morbidity and late mortality compared with the general population, both of which are “attributable to late effects of treatment,” the team pointed out.

Their study focused on individuals who had been diagnosed with cancer before they were 21 years old and who had survived at least 5 years after the cancer diagnosis.

The median age at diagnosis was 6 years, and the most common diagnoses were acute lymphoblastic leukemia (36%), Hodgkin lymphoma (11%), astrocytoma (10%), and kidney tumors (8%).

The team identified 34,230 survivors who had been treated between Jan. 1, 1970, and Dec. 31, 1999, at 31 institutions in the United States and Canada.

They  represented approximately 20% of all childhood cancer survivors in the United States over the study period. The team noted that 56% of the survivors were male, and the majority (64%) were non-Hispanic White.

The date and causes of death through December 2017 were obtained via linkage to the National Death Index, and cancer treatment information was collated for 21,418 survivors who provided consent. Lifestyle factors – including smoking, alcohol use, physical activity, and unhealthy weight – were graded on a score of 0-4.

Over a median follow-up of 29.1 years, there were 5,916 deaths, with 34% attributable to the recurrence or progression of the primary cancer, and 51.2% attributable to other causes, such as subsequent neoplasms, and cardiac, pulmonary, and other health-related causes.

Overall, survivors were at an elevated risk of death compared with the general population, at a standardized mortality ratio of 5.6. This ratio peaked at 5-9 years after diagnosis at an 18.1-fold increased risk of death compared with the general population.

Forty years or more from the initial diagnosis, two-thirds of the 131 per 10,000 person-years excess deaths from health-related causes were due to the top three causes of health-related death in the general population, the team reported.

This included an absolute excess risk of death from cancer of 54 per 10,000 person-years, an excess risk of heart disease mortality of 27 per 10,000 person-years, and an excess risk of cerebrovascular disease mortality of 10 per 10,000 person-years.

The individual cases of death contributing the greatest excess risk were gastrointestinal cancers (11 per 10,000 person-years), cerebrovascular disease (10 per 10,000 person-years), ischemic heart disease (10 per 10,000 person-years), and valvular heart disease (9 per 10,000 person-years).

The good news is that following a healthy lifestyle was associated with a 20% reduction in health-related mortality versus an unhealthy lifestyle (P = .0020).

Moreover, following even a moderately healthy lifestyle was associated with a 10% reduction in health-related mortality, the researchers noted.

The study was supported by grants from the National Cancer Institute, St. Jude Children’s Research Hospital Cancer Center Support, and the American Lebanese-Syrian Associated Charities. The authors reported no relevant financial relationships.

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

BUENOS AIRES – Antimicrobial resistance (AMR) has become a global concern. And while one issue to be addressed is the deficit in research and development for new antibiotics, efforts to tackle this public health threat also should be directed toward promoting more rational prescription practices and strengthening the ability to identify the microorganisms responsible for infections, according to the World Health Organization. This was the conclusion reached at the fourth meeting of the WHO AMR Surveillance and Quality Assessment Collaborating Centres Network, which was held in Buenos Aires.

“We have to provide assistance to countries to ensure that the drugs are being used responsibly. We can come up with new antibiotics, but the issue at hand is not simply one of innovation: If nothing is done to correct inappropriate prescription practices and to overcome the lack of diagnostic laboratories at the country level, we’re going to miss out on those drugs as soon as they become available,” Kitty van Weezenbeek, MD, PhD, MPH, director of the AMR Surveillance, Prevention, and Control (AMR/SPC) Department at the WHO’s headquarters in Geneva, told this news organization.

Dr. van Weezenbeek pointed out that although there are currently no shortages of antimicrobials, the development and launch of new drugs that fight multidrug-resistant infections – infections for which there are few therapeutic options – has proceeded slowly. “It takes 10 to 15 years to develop a new antibiotic,” she said, adding that “the majority of pharmaceutical companies that had been engaged in the development of antimicrobials have filed for bankruptcy.”

In 2019, more people died – 1.2 million – from AMR than from malaria, tuberculosis, and HIV combined. Why are there so few market incentives when there is such a great need for those drugs? “One reason is that the pharmaceutical industry makes more money with long-term treatments, such as those for cancer and respiratory diseases. The other problem is that people everywhere are told not to use antibiotics,” said Dr. van Weezenbeek.

“A course of antibiotics lasts a few days, especially because we’re promoting rational use. Therefore, the trend is for the total amount of antimicrobials being used to be lower. So, it’s not as profitable,” added Carmem Lucia Pessoa-Silva, MD, PhD, head of the Surveillance, Evidence, and Laboratory Strengthening Unit of the WHO’s AMR/SPC Department.

On that note, Dr. van Weezenbeek mentioned that member countries are working with pharmaceutical companies and universities to address this problem. The WHO, for its part, has responded by implementing a global mechanism with a public health approach to create a “healthy” and equitable market for these medicines.

AMR is one of the top 10 global threats to human health. But it also has an impact on animal production, agricultural production, and the environment. Strategies to tackle AMR based on the One Health approach should involve all actors, social sectors, and citizens, according to Eva Jané Llopis, PhD, the representative of the Pan American Health Organization/WHO in Argentina.

At the root of the AMR problem is the widespread use of these drugs as growth promoters in animal production – for which several countries have enacted regulations – as well as “misunderstandings” between patients and physicians when there is not sufficient, timely access to laboratory diagnostics, especially in low- and middle-income countries.

“People think that if they’re given broad-spectrum antibiotics, they’re being prescribed the best antibiotics; and doctors, because there are no laboratory services, prescribe broad-spectrum antibiotics because they want to help patients. But that ends up causing more resistance to drugs, and thus, those antibiotics aren’t good for the patients,” said Dr. van Weezenbeek.

The WHO Global AMR and Use Surveillance System (GLASS) was launched in 2015. Its 2022 report, which marked the end of the system’s early implementation period, noted that the reported AMR rates are often lower in countries, territories, and areas with better testing coverage for most pathogen-drug-infection site combinations. However, as Dr. Pessoa-Silva acknowledged, monitoring “has not yet generated representative data,” because in many cases, countries either do not have surveillance systems or have only recently started implementing them.

Even so, the indicators that are available paint an increasingly worrisome picture. “For example, in many countries, resistance rates to first-line antibiotics were around 10%-20% with respect to Escherichia coli urinary tract infections and bloodstream bacteriologically confirmed infections. So, the risk of treatment failure is very high,” explained Dr. Pessoa-Silva.

The latest estimates indicate that every 2 or 3 minutes, somewhere in the world, a child dies from AMR. And the situation is particularly “dramatic” in neonatal intensive care units, where outbreaks of multidrug-resistant infections have a mortality rate of 50%, said Pilar Ramón-Pardo, MD, PhD, lead of the Special Program on AMR at the Pan American Health Organization, the WHO Regional Office for the Americas.

AMR rates also got worse during the pandemic because of the inappropriate prescription of massive amounts of antibiotics to hospitalized patients – something that was not in compliance with guidelines or protocols. Silvia Bertagnolio, MD, is an infectious disease specialist and the head of the Control and Response Strategies Unit in the WHO’s AMR Division. She spoke about the global clinical platform data pertaining to more than 1,500,000 patients who were hospitalized for COVID-19. Since 2020, 85% received antimicrobial treatment, despite the fact that only 5% had a concomitant infection at admission. “It’s easier to give antibiotics than to make a proper diagnosis,” said Dr. Bertagnolio.

This article was translated from Medscape’s Spanish edition and a version appeared on Medscape.com.

BUENOS AIRES – Antimicrobial resistance (AMR) has become a global concern. And while one issue to be addressed is the deficit in research and development for new antibiotics, efforts to tackle this public health threat also should be directed toward promoting more rational prescription practices and strengthening the ability to identify the microorganisms responsible for infections, according to the World Health Organization. This was the conclusion reached at the fourth meeting of the WHO AMR Surveillance and Quality Assessment Collaborating Centres Network, which was held in Buenos Aires.

“We have to provide assistance to countries to ensure that the drugs are being used responsibly. We can come up with new antibiotics, but the issue at hand is not simply one of innovation: If nothing is done to correct inappropriate prescription practices and to overcome the lack of diagnostic laboratories at the country level, we’re going to miss out on those drugs as soon as they become available,” Kitty van Weezenbeek, MD, PhD, MPH, director of the AMR Surveillance, Prevention, and Control (AMR/SPC) Department at the WHO’s headquarters in Geneva, told this news organization.

Dr. van Weezenbeek pointed out that although there are currently no shortages of antimicrobials, the development and launch of new drugs that fight multidrug-resistant infections – infections for which there are few therapeutic options – has proceeded slowly. “It takes 10 to 15 years to develop a new antibiotic,” she said, adding that “the majority of pharmaceutical companies that had been engaged in the development of antimicrobials have filed for bankruptcy.”

In 2019, more people died – 1.2 million – from AMR than from malaria, tuberculosis, and HIV combined. Why are there so few market incentives when there is such a great need for those drugs? “One reason is that the pharmaceutical industry makes more money with long-term treatments, such as those for cancer and respiratory diseases. The other problem is that people everywhere are told not to use antibiotics,” said Dr. van Weezenbeek.

“A course of antibiotics lasts a few days, especially because we’re promoting rational use. Therefore, the trend is for the total amount of antimicrobials being used to be lower. So, it’s not as profitable,” added Carmem Lucia Pessoa-Silva, MD, PhD, head of the Surveillance, Evidence, and Laboratory Strengthening Unit of the WHO’s AMR/SPC Department.

On that note, Dr. van Weezenbeek mentioned that member countries are working with pharmaceutical companies and universities to address this problem. The WHO, for its part, has responded by implementing a global mechanism with a public health approach to create a “healthy” and equitable market for these medicines.

AMR is one of the top 10 global threats to human health. But it also has an impact on animal production, agricultural production, and the environment. Strategies to tackle AMR based on the One Health approach should involve all actors, social sectors, and citizens, according to Eva Jané Llopis, PhD, the representative of the Pan American Health Organization/WHO in Argentina.

At the root of the AMR problem is the widespread use of these drugs as growth promoters in animal production – for which several countries have enacted regulations – as well as “misunderstandings” between patients and physicians when there is not sufficient, timely access to laboratory diagnostics, especially in low- and middle-income countries.

“People think that if they’re given broad-spectrum antibiotics, they’re being prescribed the best antibiotics; and doctors, because there are no laboratory services, prescribe broad-spectrum antibiotics because they want to help patients. But that ends up causing more resistance to drugs, and thus, those antibiotics aren’t good for the patients,” said Dr. van Weezenbeek.

The WHO Global AMR and Use Surveillance System (GLASS) was launched in 2015. Its 2022 report, which marked the end of the system’s early implementation period, noted that the reported AMR rates are often lower in countries, territories, and areas with better testing coverage for most pathogen-drug-infection site combinations. However, as Dr. Pessoa-Silva acknowledged, monitoring “has not yet generated representative data,” because in many cases, countries either do not have surveillance systems or have only recently started implementing them.

Even so, the indicators that are available paint an increasingly worrisome picture. “For example, in many countries, resistance rates to first-line antibiotics were around 10%-20% with respect to Escherichia coli urinary tract infections and bloodstream bacteriologically confirmed infections. So, the risk of treatment failure is very high,” explained Dr. Pessoa-Silva.

The latest estimates indicate that every 2 or 3 minutes, somewhere in the world, a child dies from AMR. And the situation is particularly “dramatic” in neonatal intensive care units, where outbreaks of multidrug-resistant infections have a mortality rate of 50%, said Pilar Ramón-Pardo, MD, PhD, lead of the Special Program on AMR at the Pan American Health Organization, the WHO Regional Office for the Americas.

AMR rates also got worse during the pandemic because of the inappropriate prescription of massive amounts of antibiotics to hospitalized patients – something that was not in compliance with guidelines or protocols. Silvia Bertagnolio, MD, is an infectious disease specialist and the head of the Control and Response Strategies Unit in the WHO’s AMR Division. She spoke about the global clinical platform data pertaining to more than 1,500,000 patients who were hospitalized for COVID-19. Since 2020, 85% received antimicrobial treatment, despite the fact that only 5% had a concomitant infection at admission. “It’s easier to give antibiotics than to make a proper diagnosis,” said Dr. Bertagnolio.

This article was translated from Medscape’s Spanish edition and a version appeared on Medscape.com.

BUENOS AIRES – Antimicrobial resistance (AMR) has become a global concern. And while one issue to be addressed is the deficit in research and development for new antibiotics, efforts to tackle this public health threat also should be directed toward promoting more rational prescription practices and strengthening the ability to identify the microorganisms responsible for infections, according to the World Health Organization. This was the conclusion reached at the fourth meeting of the WHO AMR Surveillance and Quality Assessment Collaborating Centres Network, which was held in Buenos Aires.

“We have to provide assistance to countries to ensure that the drugs are being used responsibly. We can come up with new antibiotics, but the issue at hand is not simply one of innovation: If nothing is done to correct inappropriate prescription practices and to overcome the lack of diagnostic laboratories at the country level, we’re going to miss out on those drugs as soon as they become available,” Kitty van Weezenbeek, MD, PhD, MPH, director of the AMR Surveillance, Prevention, and Control (AMR/SPC) Department at the WHO’s headquarters in Geneva, told this news organization.

Dr. van Weezenbeek pointed out that although there are currently no shortages of antimicrobials, the development and launch of new drugs that fight multidrug-resistant infections – infections for which there are few therapeutic options – has proceeded slowly. “It takes 10 to 15 years to develop a new antibiotic,” she said, adding that “the majority of pharmaceutical companies that had been engaged in the development of antimicrobials have filed for bankruptcy.”

In 2019, more people died – 1.2 million – from AMR than from malaria, tuberculosis, and HIV combined. Why are there so few market incentives when there is such a great need for those drugs? “One reason is that the pharmaceutical industry makes more money with long-term treatments, such as those for cancer and respiratory diseases. The other problem is that people everywhere are told not to use antibiotics,” said Dr. van Weezenbeek.

“A course of antibiotics lasts a few days, especially because we’re promoting rational use. Therefore, the trend is for the total amount of antimicrobials being used to be lower. So, it’s not as profitable,” added Carmem Lucia Pessoa-Silva, MD, PhD, head of the Surveillance, Evidence, and Laboratory Strengthening Unit of the WHO’s AMR/SPC Department.

On that note, Dr. van Weezenbeek mentioned that member countries are working with pharmaceutical companies and universities to address this problem. The WHO, for its part, has responded by implementing a global mechanism with a public health approach to create a “healthy” and equitable market for these medicines.

AMR is one of the top 10 global threats to human health. But it also has an impact on animal production, agricultural production, and the environment. Strategies to tackle AMR based on the One Health approach should involve all actors, social sectors, and citizens, according to Eva Jané Llopis, PhD, the representative of the Pan American Health Organization/WHO in Argentina.

At the root of the AMR problem is the widespread use of these drugs as growth promoters in animal production – for which several countries have enacted regulations – as well as “misunderstandings” between patients and physicians when there is not sufficient, timely access to laboratory diagnostics, especially in low- and middle-income countries.

“People think that if they’re given broad-spectrum antibiotics, they’re being prescribed the best antibiotics; and doctors, because there are no laboratory services, prescribe broad-spectrum antibiotics because they want to help patients. But that ends up causing more resistance to drugs, and thus, those antibiotics aren’t good for the patients,” said Dr. van Weezenbeek.

The WHO Global AMR and Use Surveillance System (GLASS) was launched in 2015. Its 2022 report, which marked the end of the system’s early implementation period, noted that the reported AMR rates are often lower in countries, territories, and areas with better testing coverage for most pathogen-drug-infection site combinations. However, as Dr. Pessoa-Silva acknowledged, monitoring “has not yet generated representative data,” because in many cases, countries either do not have surveillance systems or have only recently started implementing them.

Even so, the indicators that are available paint an increasingly worrisome picture. “For example, in many countries, resistance rates to first-line antibiotics were around 10%-20% with respect to Escherichia coli urinary tract infections and bloodstream bacteriologically confirmed infections. So, the risk of treatment failure is very high,” explained Dr. Pessoa-Silva.

The latest estimates indicate that every 2 or 3 minutes, somewhere in the world, a child dies from AMR. And the situation is particularly “dramatic” in neonatal intensive care units, where outbreaks of multidrug-resistant infections have a mortality rate of 50%, said Pilar Ramón-Pardo, MD, PhD, lead of the Special Program on AMR at the Pan American Health Organization, the WHO Regional Office for the Americas.

AMR rates also got worse during the pandemic because of the inappropriate prescription of massive amounts of antibiotics to hospitalized patients – something that was not in compliance with guidelines or protocols. Silvia Bertagnolio, MD, is an infectious disease specialist and the head of the Control and Response Strategies Unit in the WHO’s AMR Division. She spoke about the global clinical platform data pertaining to more than 1,500,000 patients who were hospitalized for COVID-19. Since 2020, 85% received antimicrobial treatment, despite the fact that only 5% had a concomitant infection at admission. “It’s easier to give antibiotics than to make a proper diagnosis,” said Dr. Bertagnolio.

This article was translated from Medscape’s Spanish edition and a version appeared on Medscape.com.

NEW ORLEANS – As the study of cutaneous dysbiosis and its role in the pathogenesis of dermatoses continues to evolve, how the mounting evidence on this topic translates into clinical practice remains largely unknown.

“There’s still a lot for us to learn,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said at the annual meeting of the American Academy of Dermatology. “Multiple factors contribute to the variability in the skin microbiota, including age, sex, environment, immune system, host genotype, lifestyle, and pathobiology. The question becomes, when do these factors or impacts on the microbiota become clinically significant?”

According to Dr. Friedman, there are 10 times more bacteria cells than human cells in the human body, “but it’s not a fight to the finish; it’s not us versus them,” he said. “Together, we are a super organism.” There are also more than 500 species of bacteria on human skin excluding viruses and fungi, and each person carries up to 5 pounds of bacteria, which is akin to finding a new organ in the body.

Credit: Daryl Leja, NHGRI (National Human Genome Research Institute)

“What’s so unique is that we each have our own bacterial fingerprint,” he said. “Whoever is sitting next to you? Their microbiota makeup is different than yours.”

Beyond genetics and environment, activities that can contribute to alterations in skin flora or skin dysbiosis include topical application of steroids, antibiotics, retinoids, harsh soaps, chemical and physical exfoliants, and resurfacing techniques. “With anything we apply or do to the skin, we are literally changing the home of many microorganisms, for good or bad,” he said.

In the realm of atopic dermatitis (AD), Staphylococcus aureus has been implicated as an offender in the pathophysiology of the disease. “It’s not about one single species of Staphylococcus, though,” said Dr. Friedman, who also is director of translational research at George Washington University. “We’re finding out that, depending on the severity of disease, Staph. epidermis may be part of the problem as opposed to it just being about Staph. aureus. Furthermore, and more importantly, these changes in the microbiota, specifically a decrease in microbial diversity, has been shown to precede a disease flare, highlighting the central role of maintaining microbial diversity and by definition, supporting the living barrier in our management of AD.”

With this in mind, researchers in one study used high-throughput sequencing to evaluate the microbial communities associated with affected and unaffected skin of 49 patients with AD before and after emollient treatment. Following 84 days of emollient application, clinical symptoms of AD improved in 72% of the study population and Stenotrophomonas species were significantly more abundant among responders.
 

Prebiotics, probiotics

“Our treatments certainly can positively impact the microbiota, as we have seen even recently with some of our new targeted therapies, but we can also directly provide support,” he continued. Prebiotics, which he defined as supplements or foods that contain a nondigestible ingredient that selectively stimulates the growth and/or activity of indigenous bacteria, can be found in many over-the-counter moisturizers.

For example, colloidal oatmeal has been found to support the growth of S. epidermidis and enhance the production of lactic acid. “We really don’t know much about what these induced changes mean from a clinical perspective; that has yet to be elucidated,” Dr. Friedman said.

In light of the recent attention to the early application of moisturizers in infants at high risk of developing AD in an effort to prevent or limit AD, “maybe part of this has to do with applying something that’s nurturing an evolving microbiota,” Dr. Friedman noted. “It’s something to think about.”

Yet another area of study involves the use of probiotics, which Dr. Friedman defined as supplements or foods that contain viable microorganisms that alter the microflora of the host. In a first-of-its-kind trial, researchers evaluated the safety and efficacy of self-administered topical Roseomonas mucosa in 10 adults and 5 children with AD. No adverse events or treatment complications were observed, and the topical R. mucosa was associated with significant decreases in measures of disease severity, topical steroid requirement, and S. aureus burden

In a more recent randomized trial of 11 patients with AD, Richard L. Gallo, MD, PhD, chair of dermatology, University of California, San Diego, and colleagues found that application of a personalized topical cream formulated from coagulase-negative Staphylococcus with antimicrobial activity against S. aureus reduced colonization of S. aureus and improved disease severity.

And in another randomized, controlled trial, Italian researchers enrolled 80 adults with mild to severe AD to receive a placebo or a supplement that was a mixture of lactobacilli for 56 days. They found that adults in the treatment arm showed an improvement in skin smoothness, skin moisturization, self-perception, and a decrease in the SCORing Atopic Dermatitis (SCORAD) index as well as in levels of inflammatory markers associated with AD.

Dr. Friedman also discussed postbiotics, nonviable bacterial products or metabolic byproducts from probiotic microorganisms that have biologic activity in the host. In one trial, French researchers enrolled 75 people with AD who ranged in age from 6 to 70 years to receive a cream containing a 5% lysate of the nonpathogenic bacteria Vitreoscilla filiformis, or a vehicle cream for 30 days. They found that compared with the vehicle, V. filiformis lysate significantly decreased SCORAD levels and pruritus; active cream was shown to significantly decrease loss of sleep from day 0 to day 29.

Dr. Friedman characterized these novel approaches to AD as “an exciting area, one we need to pay attention to. But what I really want to know is, aside from these purposefully made and marketed products that have pre- and postprobiotics, is there a difference with some of the products we use already? My assumption is that there is, but we need to see that data.”

Dr. Friedman disclosed that he is a consultant and/or advisory board member for Medscape/SanovaWorks, Oakstone Institute, L’Oréal, La Roche Posay, Galderma, Aveeno, Ortho Dermatologic, Microcures, Pfizer, Novartis, Lilly, Hoth Therapeutics, Zylo Therapeutics, BMS, Vial, Janssen, Novocure, Dermavant, Regeneron/Sanofi, and Incyte. He has also received grants from Pfizer, the Dermatology Foundation, Lilly, Janssen, Incyte, and Galderma.

NEW ORLEANS – As the study of cutaneous dysbiosis and its role in the pathogenesis of dermatoses continues to evolve, how the mounting evidence on this topic translates into clinical practice remains largely unknown.

“There’s still a lot for us to learn,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said at the annual meeting of the American Academy of Dermatology. “Multiple factors contribute to the variability in the skin microbiota, including age, sex, environment, immune system, host genotype, lifestyle, and pathobiology. The question becomes, when do these factors or impacts on the microbiota become clinically significant?”

According to Dr. Friedman, there are 10 times more bacteria cells than human cells in the human body, “but it’s not a fight to the finish; it’s not us versus them,” he said. “Together, we are a super organism.” There are also more than 500 species of bacteria on human skin excluding viruses and fungi, and each person carries up to 5 pounds of bacteria, which is akin to finding a new organ in the body.

Credit: Daryl Leja, NHGRI (National Human Genome Research Institute)

“What’s so unique is that we each have our own bacterial fingerprint,” he said. “Whoever is sitting next to you? Their microbiota makeup is different than yours.”

Beyond genetics and environment, activities that can contribute to alterations in skin flora or skin dysbiosis include topical application of steroids, antibiotics, retinoids, harsh soaps, chemical and physical exfoliants, and resurfacing techniques. “With anything we apply or do to the skin, we are literally changing the home of many microorganisms, for good or bad,” he said.

In the realm of atopic dermatitis (AD), Staphylococcus aureus has been implicated as an offender in the pathophysiology of the disease. “It’s not about one single species of Staphylococcus, though,” said Dr. Friedman, who also is director of translational research at George Washington University. “We’re finding out that, depending on the severity of disease, Staph. epidermis may be part of the problem as opposed to it just being about Staph. aureus. Furthermore, and more importantly, these changes in the microbiota, specifically a decrease in microbial diversity, has been shown to precede a disease flare, highlighting the central role of maintaining microbial diversity and by definition, supporting the living barrier in our management of AD.”

With this in mind, researchers in one study used high-throughput sequencing to evaluate the microbial communities associated with affected and unaffected skin of 49 patients with AD before and after emollient treatment. Following 84 days of emollient application, clinical symptoms of AD improved in 72% of the study population and Stenotrophomonas species were significantly more abundant among responders.
 

Prebiotics, probiotics

“Our treatments certainly can positively impact the microbiota, as we have seen even recently with some of our new targeted therapies, but we can also directly provide support,” he continued. Prebiotics, which he defined as supplements or foods that contain a nondigestible ingredient that selectively stimulates the growth and/or activity of indigenous bacteria, can be found in many over-the-counter moisturizers.

For example, colloidal oatmeal has been found to support the growth of S. epidermidis and enhance the production of lactic acid. “We really don’t know much about what these induced changes mean from a clinical perspective; that has yet to be elucidated,” Dr. Friedman said.

In light of the recent attention to the early application of moisturizers in infants at high risk of developing AD in an effort to prevent or limit AD, “maybe part of this has to do with applying something that’s nurturing an evolving microbiota,” Dr. Friedman noted. “It’s something to think about.”

Yet another area of study involves the use of probiotics, which Dr. Friedman defined as supplements or foods that contain viable microorganisms that alter the microflora of the host. In a first-of-its-kind trial, researchers evaluated the safety and efficacy of self-administered topical Roseomonas mucosa in 10 adults and 5 children with AD. No adverse events or treatment complications were observed, and the topical R. mucosa was associated with significant decreases in measures of disease severity, topical steroid requirement, and S. aureus burden

In a more recent randomized trial of 11 patients with AD, Richard L. Gallo, MD, PhD, chair of dermatology, University of California, San Diego, and colleagues found that application of a personalized topical cream formulated from coagulase-negative Staphylococcus with antimicrobial activity against S. aureus reduced colonization of S. aureus and improved disease severity.

And in another randomized, controlled trial, Italian researchers enrolled 80 adults with mild to severe AD to receive a placebo or a supplement that was a mixture of lactobacilli for 56 days. They found that adults in the treatment arm showed an improvement in skin smoothness, skin moisturization, self-perception, and a decrease in the SCORing Atopic Dermatitis (SCORAD) index as well as in levels of inflammatory markers associated with AD.

Dr. Friedman also discussed postbiotics, nonviable bacterial products or metabolic byproducts from probiotic microorganisms that have biologic activity in the host. In one trial, French researchers enrolled 75 people with AD who ranged in age from 6 to 70 years to receive a cream containing a 5% lysate of the nonpathogenic bacteria Vitreoscilla filiformis, or a vehicle cream for 30 days. They found that compared with the vehicle, V. filiformis lysate significantly decreased SCORAD levels and pruritus; active cream was shown to significantly decrease loss of sleep from day 0 to day 29.

Dr. Friedman characterized these novel approaches to AD as “an exciting area, one we need to pay attention to. But what I really want to know is, aside from these purposefully made and marketed products that have pre- and postprobiotics, is there a difference with some of the products we use already? My assumption is that there is, but we need to see that data.”

Dr. Friedman disclosed that he is a consultant and/or advisory board member for Medscape/SanovaWorks, Oakstone Institute, L’Oréal, La Roche Posay, Galderma, Aveeno, Ortho Dermatologic, Microcures, Pfizer, Novartis, Lilly, Hoth Therapeutics, Zylo Therapeutics, BMS, Vial, Janssen, Novocure, Dermavant, Regeneron/Sanofi, and Incyte. He has also received grants from Pfizer, the Dermatology Foundation, Lilly, Janssen, Incyte, and Galderma.

NEW ORLEANS – As the study of cutaneous dysbiosis and its role in the pathogenesis of dermatoses continues to evolve, how the mounting evidence on this topic translates into clinical practice remains largely unknown.

“There’s still a lot for us to learn,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said at the annual meeting of the American Academy of Dermatology. “Multiple factors contribute to the variability in the skin microbiota, including age, sex, environment, immune system, host genotype, lifestyle, and pathobiology. The question becomes, when do these factors or impacts on the microbiota become clinically significant?”

According to Dr. Friedman, there are 10 times more bacteria cells than human cells in the human body, “but it’s not a fight to the finish; it’s not us versus them,” he said. “Together, we are a super organism.” There are also more than 500 species of bacteria on human skin excluding viruses and fungi, and each person carries up to 5 pounds of bacteria, which is akin to finding a new organ in the body.

Credit: Daryl Leja, NHGRI (National Human Genome Research Institute)

“What’s so unique is that we each have our own bacterial fingerprint,” he said. “Whoever is sitting next to you? Their microbiota makeup is different than yours.”

Beyond genetics and environment, activities that can contribute to alterations in skin flora or skin dysbiosis include topical application of steroids, antibiotics, retinoids, harsh soaps, chemical and physical exfoliants, and resurfacing techniques. “With anything we apply or do to the skin, we are literally changing the home of many microorganisms, for good or bad,” he said.

In the realm of atopic dermatitis (AD), Staphylococcus aureus has been implicated as an offender in the pathophysiology of the disease. “It’s not about one single species of Staphylococcus, though,” said Dr. Friedman, who also is director of translational research at George Washington University. “We’re finding out that, depending on the severity of disease, Staph. epidermis may be part of the problem as opposed to it just being about Staph. aureus. Furthermore, and more importantly, these changes in the microbiota, specifically a decrease in microbial diversity, has been shown to precede a disease flare, highlighting the central role of maintaining microbial diversity and by definition, supporting the living barrier in our management of AD.”

With this in mind, researchers in one study used high-throughput sequencing to evaluate the microbial communities associated with affected and unaffected skin of 49 patients with AD before and after emollient treatment. Following 84 days of emollient application, clinical symptoms of AD improved in 72% of the study population and Stenotrophomonas species were significantly more abundant among responders.
 

Prebiotics, probiotics

“Our treatments certainly can positively impact the microbiota, as we have seen even recently with some of our new targeted therapies, but we can also directly provide support,” he continued. Prebiotics, which he defined as supplements or foods that contain a nondigestible ingredient that selectively stimulates the growth and/or activity of indigenous bacteria, can be found in many over-the-counter moisturizers.

For example, colloidal oatmeal has been found to support the growth of S. epidermidis and enhance the production of lactic acid. “We really don’t know much about what these induced changes mean from a clinical perspective; that has yet to be elucidated,” Dr. Friedman said.

In light of the recent attention to the early application of moisturizers in infants at high risk of developing AD in an effort to prevent or limit AD, “maybe part of this has to do with applying something that’s nurturing an evolving microbiota,” Dr. Friedman noted. “It’s something to think about.”

Yet another area of study involves the use of probiotics, which Dr. Friedman defined as supplements or foods that contain viable microorganisms that alter the microflora of the host. In a first-of-its-kind trial, researchers evaluated the safety and efficacy of self-administered topical Roseomonas mucosa in 10 adults and 5 children with AD. No adverse events or treatment complications were observed, and the topical R. mucosa was associated with significant decreases in measures of disease severity, topical steroid requirement, and S. aureus burden

In a more recent randomized trial of 11 patients with AD, Richard L. Gallo, MD, PhD, chair of dermatology, University of California, San Diego, and colleagues found that application of a personalized topical cream formulated from coagulase-negative Staphylococcus with antimicrobial activity against S. aureus reduced colonization of S. aureus and improved disease severity.

And in another randomized, controlled trial, Italian researchers enrolled 80 adults with mild to severe AD to receive a placebo or a supplement that was a mixture of lactobacilli for 56 days. They found that adults in the treatment arm showed an improvement in skin smoothness, skin moisturization, self-perception, and a decrease in the SCORing Atopic Dermatitis (SCORAD) index as well as in levels of inflammatory markers associated with AD.

Dr. Friedman also discussed postbiotics, nonviable bacterial products or metabolic byproducts from probiotic microorganisms that have biologic activity in the host. In one trial, French researchers enrolled 75 people with AD who ranged in age from 6 to 70 years to receive a cream containing a 5% lysate of the nonpathogenic bacteria Vitreoscilla filiformis, or a vehicle cream for 30 days. They found that compared with the vehicle, V. filiformis lysate significantly decreased SCORAD levels and pruritus; active cream was shown to significantly decrease loss of sleep from day 0 to day 29.

Dr. Friedman characterized these novel approaches to AD as “an exciting area, one we need to pay attention to. But what I really want to know is, aside from these purposefully made and marketed products that have pre- and postprobiotics, is there a difference with some of the products we use already? My assumption is that there is, but we need to see that data.”

Dr. Friedman disclosed that he is a consultant and/or advisory board member for Medscape/SanovaWorks, Oakstone Institute, L’Oréal, La Roche Posay, Galderma, Aveeno, Ortho Dermatologic, Microcures, Pfizer, Novartis, Lilly, Hoth Therapeutics, Zylo Therapeutics, BMS, Vial, Janssen, Novocure, Dermavant, Regeneron/Sanofi, and Incyte. He has also received grants from Pfizer, the Dermatology Foundation, Lilly, Janssen, Incyte, and Galderma.

Compared with infants who were not exposed to COVID-19 in the womb, those who were exposed had a lower weight and body mass index at birth, but greater weight gain, during the first year of life, in a new analysis.

This “exaggerated growth pattern observed among infants with COVID-19 exposure may in some cases be a catch-up response to a prenatal growth deficit,” Mollie W. Ockene and colleagues wrote in a report published recently in the Journal of Clinical Endocrinology & Metabolism.

But given that lower birth weight and accelerated postnatal weight gain are risk factors for cardiometabolic disease, the findings “raise concern” about whether children born to mothers with prenatal COVID-19 go on to develop obesity, diabetes, or cardiovascular disease, senior coauthors Andrea G. Edlow, MD, and Lindsay T. Fourman, MD, of Massachusetts General Hospital, Boston, told this news organization.

Further studies in larger numbers of patients with longer follow-up and detailed assessments are needed, the researchers said, but this points to “a potentially increased cardiometabolic disease risk for the large global population of children with in utero COVID-19 exposure.”

It will be “important for clinicians caring for children with in utero exposure to maternal COVID-19 to be aware of this history,” Dr. Edlow and Dr. Fourman added, “and to view the child’s growth trajectory and metabolic risk factors in a holistic context that includes this prenatal infection exposure.”
 

COVID-19 vaccination important during and prior to pregnancy

The study also underscores the importance of primary prevention of COVID-19 among women who are contemplating pregnancy or who are already pregnant, the researchers noted, “including the need for widespread implementation of protective measures such as indoor masking and COVID-19 vaccination and boosting during or prior to pregnancy.”

Dr. Edlow and Dr. Fourman added, “Given the disproportionate impact that COVID-19 has had on historically marginalized populations, adverse health outcomes following in utero exposure to maternal COVID-19 may threaten to widen existing disparities in child health.”

On the other hand, although “COVID-19 vaccination rates lagged behind in minority populations following the initial vaccine rollout,” they noted, “these differences have fortunately narrowed over time, particularly for Hispanic individuals, though they do still persist in the Black population,” according to a recent report.
 

BMI trajectories during first year of life

In utero exposure to COVID-19 has been linked to fetal/neonatal morbidity and mortality, including stillbirth, preterm birth, preeclampsia, and gestational hypertension, but less is known about infant outcomes during the first year of life.

The researchers aimed to compare weight, length, and BMI trajectories over the first year of life in infants with, versus without, in utero exposure to COVID-19.

They identified 149 infants with in utero exposure to COVID-19 and 127 unexposed infants; all were born between March 30, 2020, and May 30, 2021, to mothers who participated in the Mass General Brigham COVID-19 Perinatal Biorepository.

The study excluded infants whose mothers received the vaccine (n = 5) or who had unclear vaccination status during pregnancy (n = 4) to reduce sample heterogeneity.

At the time of the study, few women had received the COVID-19 vaccine because vaccines were approved by the Food and Drug Administration for emergency use in December 2020 and the CDC recommended them for all pregnant women much later, in August 2021.

The researchers examined the weight, length, and BMI of the infants at birth, and at 2, 6, and 12 months, standardized using World Health Organization (WHO) growth charts.

Compared with mothers who did not have COVID-19 during pregnancy, those who had COVID-19 were younger (mean age, 32 vs. 34 years) and had a higher earliest BMI during pregnancy (29 vs. 26 kg/m²) and greater parity (previous births, excluding the index pregnancy, 1.2 vs. 0.9), and they were more likely to be Hispanic or Black and less likely to have private insurance.

Compared with infants exposed to COVID-19 in utero, infants who were not exposed were more likely to be male (47% vs. 55%).

Both infant groups were equally likely to be breastfed (90%).

Compared with the unexposed infants, infants born to mothers with prenatal COVID-19 had lower BMI z-scores at birth (effect size, −0.35; P = .03) and greater gain in BMI z-scores from birth to 12 months (effect size, 0.53; P = .03), but they had similar length at birth and over 12 months, after adjustment for maternal age at delivery, ethnicity, parity, insurance status, and earliest BMI during pregnancy, as well as infant sex, date of birth, and if applicable, history of breastfeeding.

The study received funding from the National Institutes of Health, Harvard Nutrition Obesity Research Center, Boston Area Diabetes Endocrinology Research Centers, American Heart Association, and Simons Foundation. Ms. Ockene has reported no relevant financial relationships. Dr. Edlow has reported being a consultant for Mirvie and receiving research funding from Merck outside the study. Dr. Fourman has reported serving as a consultant and receiving grant funding to her institution from Amryt outside the study. Disclosures for the other authors are listed with the article.

Compared with infants who were not exposed to COVID-19 in the womb, those who were exposed had a lower weight and body mass index at birth, but greater weight gain, during the first year of life, in a new analysis.

This “exaggerated growth pattern observed among infants with COVID-19 exposure may in some cases be a catch-up response to a prenatal growth deficit,” Mollie W. Ockene and colleagues wrote in a report published recently in the Journal of Clinical Endocrinology & Metabolism.

But given that lower birth weight and accelerated postnatal weight gain are risk factors for cardiometabolic disease, the findings “raise concern” about whether children born to mothers with prenatal COVID-19 go on to develop obesity, diabetes, or cardiovascular disease, senior coauthors Andrea G. Edlow, MD, and Lindsay T. Fourman, MD, of Massachusetts General Hospital, Boston, told this news organization.

Further studies in larger numbers of patients with longer follow-up and detailed assessments are needed, the researchers said, but this points to “a potentially increased cardiometabolic disease risk for the large global population of children with in utero COVID-19 exposure.”

It will be “important for clinicians caring for children with in utero exposure to maternal COVID-19 to be aware of this history,” Dr. Edlow and Dr. Fourman added, “and to view the child’s growth trajectory and metabolic risk factors in a holistic context that includes this prenatal infection exposure.”
 

COVID-19 vaccination important during and prior to pregnancy

The study also underscores the importance of primary prevention of COVID-19 among women who are contemplating pregnancy or who are already pregnant, the researchers noted, “including the need for widespread implementation of protective measures such as indoor masking and COVID-19 vaccination and boosting during or prior to pregnancy.”

Dr. Edlow and Dr. Fourman added, “Given the disproportionate impact that COVID-19 has had on historically marginalized populations, adverse health outcomes following in utero exposure to maternal COVID-19 may threaten to widen existing disparities in child health.”

On the other hand, although “COVID-19 vaccination rates lagged behind in minority populations following the initial vaccine rollout,” they noted, “these differences have fortunately narrowed over time, particularly for Hispanic individuals, though they do still persist in the Black population,” according to a recent report.
 

BMI trajectories during first year of life

In utero exposure to COVID-19 has been linked to fetal/neonatal morbidity and mortality, including stillbirth, preterm birth, preeclampsia, and gestational hypertension, but less is known about infant outcomes during the first year of life.

The researchers aimed to compare weight, length, and BMI trajectories over the first year of life in infants with, versus without, in utero exposure to COVID-19.

They identified 149 infants with in utero exposure to COVID-19 and 127 unexposed infants; all were born between March 30, 2020, and May 30, 2021, to mothers who participated in the Mass General Brigham COVID-19 Perinatal Biorepository.

The study excluded infants whose mothers received the vaccine (n = 5) or who had unclear vaccination status during pregnancy (n = 4) to reduce sample heterogeneity.

At the time of the study, few women had received the COVID-19 vaccine because vaccines were approved by the Food and Drug Administration for emergency use in December 2020 and the CDC recommended them for all pregnant women much later, in August 2021.

The researchers examined the weight, length, and BMI of the infants at birth, and at 2, 6, and 12 months, standardized using World Health Organization (WHO) growth charts.

Compared with mothers who did not have COVID-19 during pregnancy, those who had COVID-19 were younger (mean age, 32 vs. 34 years) and had a higher earliest BMI during pregnancy (29 vs. 26 kg/m²) and greater parity (previous births, excluding the index pregnancy, 1.2 vs. 0.9), and they were more likely to be Hispanic or Black and less likely to have private insurance.

Compared with infants exposed to COVID-19 in utero, infants who were not exposed were more likely to be male (47% vs. 55%).

Both infant groups were equally likely to be breastfed (90%).

Compared with the unexposed infants, infants born to mothers with prenatal COVID-19 had lower BMI z-scores at birth (effect size, −0.35; P = .03) and greater gain in BMI z-scores from birth to 12 months (effect size, 0.53; P = .03), but they had similar length at birth and over 12 months, after adjustment for maternal age at delivery, ethnicity, parity, insurance status, and earliest BMI during pregnancy, as well as infant sex, date of birth, and if applicable, history of breastfeeding.

The study received funding from the National Institutes of Health, Harvard Nutrition Obesity Research Center, Boston Area Diabetes Endocrinology Research Centers, American Heart Association, and Simons Foundation. Ms. Ockene has reported no relevant financial relationships. Dr. Edlow has reported being a consultant for Mirvie and receiving research funding from Merck outside the study. Dr. Fourman has reported serving as a consultant and receiving grant funding to her institution from Amryt outside the study. Disclosures for the other authors are listed with the article.

Compared with infants who were not exposed to COVID-19 in the womb, those who were exposed had a lower weight and body mass index at birth, but greater weight gain, during the first year of life, in a new analysis.

This “exaggerated growth pattern observed among infants with COVID-19 exposure may in some cases be a catch-up response to a prenatal growth deficit,” Mollie W. Ockene and colleagues wrote in a report published recently in the Journal of Clinical Endocrinology & Metabolism.

But given that lower birth weight and accelerated postnatal weight gain are risk factors for cardiometabolic disease, the findings “raise concern” about whether children born to mothers with prenatal COVID-19 go on to develop obesity, diabetes, or cardiovascular disease, senior coauthors Andrea G. Edlow, MD, and Lindsay T. Fourman, MD, of Massachusetts General Hospital, Boston, told this news organization.

Further studies in larger numbers of patients with longer follow-up and detailed assessments are needed, the researchers said, but this points to “a potentially increased cardiometabolic disease risk for the large global population of children with in utero COVID-19 exposure.”

It will be “important for clinicians caring for children with in utero exposure to maternal COVID-19 to be aware of this history,” Dr. Edlow and Dr. Fourman added, “and to view the child’s growth trajectory and metabolic risk factors in a holistic context that includes this prenatal infection exposure.”
 

COVID-19 vaccination important during and prior to pregnancy

The study also underscores the importance of primary prevention of COVID-19 among women who are contemplating pregnancy or who are already pregnant, the researchers noted, “including the need for widespread implementation of protective measures such as indoor masking and COVID-19 vaccination and boosting during or prior to pregnancy.”

Dr. Edlow and Dr. Fourman added, “Given the disproportionate impact that COVID-19 has had on historically marginalized populations, adverse health outcomes following in utero exposure to maternal COVID-19 may threaten to widen existing disparities in child health.”

On the other hand, although “COVID-19 vaccination rates lagged behind in minority populations following the initial vaccine rollout,” they noted, “these differences have fortunately narrowed over time, particularly for Hispanic individuals, though they do still persist in the Black population,” according to a recent report.
 

BMI trajectories during first year of life

In utero exposure to COVID-19 has been linked to fetal/neonatal morbidity and mortality, including stillbirth, preterm birth, preeclampsia, and gestational hypertension, but less is known about infant outcomes during the first year of life.

The researchers aimed to compare weight, length, and BMI trajectories over the first year of life in infants with, versus without, in utero exposure to COVID-19.

They identified 149 infants with in utero exposure to COVID-19 and 127 unexposed infants; all were born between March 30, 2020, and May 30, 2021, to mothers who participated in the Mass General Brigham COVID-19 Perinatal Biorepository.

The study excluded infants whose mothers received the vaccine (n = 5) or who had unclear vaccination status during pregnancy (n = 4) to reduce sample heterogeneity.

At the time of the study, few women had received the COVID-19 vaccine because vaccines were approved by the Food and Drug Administration for emergency use in December 2020 and the CDC recommended them for all pregnant women much later, in August 2021.

The researchers examined the weight, length, and BMI of the infants at birth, and at 2, 6, and 12 months, standardized using World Health Organization (WHO) growth charts.

Compared with mothers who did not have COVID-19 during pregnancy, those who had COVID-19 were younger (mean age, 32 vs. 34 years) and had a higher earliest BMI during pregnancy (29 vs. 26 kg/m²) and greater parity (previous births, excluding the index pregnancy, 1.2 vs. 0.9), and they were more likely to be Hispanic or Black and less likely to have private insurance.

Compared with infants exposed to COVID-19 in utero, infants who were not exposed were more likely to be male (47% vs. 55%).

Both infant groups were equally likely to be breastfed (90%).

Compared with the unexposed infants, infants born to mothers with prenatal COVID-19 had lower BMI z-scores at birth (effect size, −0.35; P = .03) and greater gain in BMI z-scores from birth to 12 months (effect size, 0.53; P = .03), but they had similar length at birth and over 12 months, after adjustment for maternal age at delivery, ethnicity, parity, insurance status, and earliest BMI during pregnancy, as well as infant sex, date of birth, and if applicable, history of breastfeeding.

The study received funding from the National Institutes of Health, Harvard Nutrition Obesity Research Center, Boston Area Diabetes Endocrinology Research Centers, American Heart Association, and Simons Foundation. Ms. Ockene has reported no relevant financial relationships. Dr. Edlow has reported being a consultant for Mirvie and receiving research funding from Merck outside the study. Dr. Fourman has reported serving as a consultant and receiving grant funding to her institution from Amryt outside the study. Disclosures for the other authors are listed with the article.

Court cases show that physicians continually underestimate their liability in supervising nurse practitioners (NPs) and physician assistants (PAs).

Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.

Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.

Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.

“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.

In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
 

Yet more states are removing supervision requirements

With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.

“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”

*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.

In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”

As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.

The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.

The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.

However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.

Court cases in which supervising physician was found liable

There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.

Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.

“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.

A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.

When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.

The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.

Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of  Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.

The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.

When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.

The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
 

Different standards for expert witnesses

In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.

These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.

Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
 

Supervision pointers from a physician

Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.

Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.

“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
 

Collaborating with autonomous NPs

Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.

At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”

The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
 

Conclusion

Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.

Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.

*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.

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

Court cases show that physicians continually underestimate their liability in supervising nurse practitioners (NPs) and physician assistants (PAs).

Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.

Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.

Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.

“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.

In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
 

Yet more states are removing supervision requirements

With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.

“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”

*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.

In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”

As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.

The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.

The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.

However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.

Court cases in which supervising physician was found liable

There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.

Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.

“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.

A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.

When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.

The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.

Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of  Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.

The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.

When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.

The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
 

Different standards for expert witnesses

In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.

These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.

Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
 

Supervision pointers from a physician

Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.

Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.

“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
 

Collaborating with autonomous NPs

Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.

At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”

The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
 

Conclusion

Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.

Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.

*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.

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

Court cases show that physicians continually underestimate their liability in supervising nurse practitioners (NPs) and physician assistants (PAs).

Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.

Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.

Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.

“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.

In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
 

Yet more states are removing supervision requirements

With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.

“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”

*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.

In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”

As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.

The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.

The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.

However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.

Court cases in which supervising physician was found liable

There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.

Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.

“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.

A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.

When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.

The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.

Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of  Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.

The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.

When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.

The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
 

Different standards for expert witnesses

In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.

These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.

Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
 

Supervision pointers from a physician

Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.

Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.

“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
 

Collaborating with autonomous NPs

Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.

At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”

The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
 

Conclusion

Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.

Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.

*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.

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