Background: Antibiotic therapy is considered the standard of care for acute uncomplicated diverticulitis. Over the past decade, randomized clinical trials have suggested that treatment with antibiotics may be noninferior to observation with supportive care; however, there have not been any blinded, placebo-controlled trials to provide high-quality evidence.

Notably, though this study was adequately powered to detect differences in length of stay, it was not powered to detect differences in clinical outcomes, including death or the need for surgery. The exclusion of patients with language barriers raises concerns regarding the generalizability of the results.

Bottom line: Antibiotic therapy does not decrease length of hospital stay when compared with placebo for patients with acute uncomplicated diverticulitis.

Citation: Jaung R et al. Antibiotics do not reduce length of hospital stay for uncomplicated diverticulitis in a pragmatic double-blind randomized trial. Clin Gastroenterol Hepatol. 2020 Mar;S1542-3565(20):30426-2. doi: 10.1016/j.cgh.2020.03.049.

Dr. Elyahu is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Antibiotic therapy is considered the standard of care for acute uncomplicated diverticulitis. Over the past decade, randomized clinical trials have suggested that treatment with antibiotics may be noninferior to observation with supportive care; however, there have not been any blinded, placebo-controlled trials to provide high-quality evidence.

Notably, though this study was adequately powered to detect differences in length of stay, it was not powered to detect differences in clinical outcomes, including death or the need for surgery. The exclusion of patients with language barriers raises concerns regarding the generalizability of the results.

Bottom line: Antibiotic therapy does not decrease length of hospital stay when compared with placebo for patients with acute uncomplicated diverticulitis.

Citation: Jaung R et al. Antibiotics do not reduce length of hospital stay for uncomplicated diverticulitis in a pragmatic double-blind randomized trial. Clin Gastroenterol Hepatol. 2020 Mar;S1542-3565(20):30426-2. doi: 10.1016/j.cgh.2020.03.049.

Dr. Elyahu is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Antibiotic therapy is considered the standard of care for acute uncomplicated diverticulitis. Over the past decade, randomized clinical trials have suggested that treatment with antibiotics may be noninferior to observation with supportive care; however, there have not been any blinded, placebo-controlled trials to provide high-quality evidence.

Notably, though this study was adequately powered to detect differences in length of stay, it was not powered to detect differences in clinical outcomes, including death or the need for surgery. The exclusion of patients with language barriers raises concerns regarding the generalizability of the results.

Bottom line: Antibiotic therapy does not decrease length of hospital stay when compared with placebo for patients with acute uncomplicated diverticulitis.

Citation: Jaung R et al. Antibiotics do not reduce length of hospital stay for uncomplicated diverticulitis in a pragmatic double-blind randomized trial. Clin Gastroenterol Hepatol. 2020 Mar;S1542-3565(20):30426-2. doi: 10.1016/j.cgh.2020.03.049.

Dr. Elyahu is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

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

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

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

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

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

A new analysis of over 22,000 mastectomy patients confirms what smaller studies have indicated: Patients who undergo nipple-sparing mastectomy have overall and disease-free survival similar to that of those who receive a total mastectomy.

When nipple-sparing mastectomy was introduced, many experts felt uneasy about opting for the less invasive procedure, recalled Rosa Hwang, MD, associate medical director for breast surgery at MD Anderson Cancer Center in Houston. “The concern was leaving all this skin,” said Dr. Hwang. “Are you going to leave cancer behind” and increase the risk of local recurrence?

Over the past 2 decades, the number of patients undergoing nipple-sparing mastectomy increased and, in turn, studies began to demonstrate the safety of the procedure.

However, large analyses evaluating long-term outcomes – namely, overall survival and breast cancer-specific survival – of nipple-sparing mastectomy were still lacking.

The latest study, published online Nov. 20 in Annals of Surgical Oncology, compared the long-term prognosis and survival benefits of nipple-sparing to total mastectomy in thousands of women. The analysis, which pulled data from the SEER cancer database, included 5,765 patients who underwent the nipple-sparing procedure and 17,289 patients who had a total mastectomy.

The authors found that overall survival and breast cancer–specific survival were similar for women undergoing nipple-sparing mastectomy and those receiving a total mastectomy. In fact, over the long-term, the nipple-sparing group slightly edged out the total mastectomy group in overall survival (94.61% vs. 93% at 5 years and 86.34% vs. 83.48% at 10 years, respectively) and in breast cancer-specific survival rates (96.16% vs. 95.74% at 5 years, and 92.2% vs. 91.37% at 10 years). The differences, however, were not significant.

The study also found that certain subgroups – including White women, women over age 46, those with a median household income of $70,000 or more, hormone receptor-positive, and HER2 negative – had significantly better overall survival rate with the nipple-sparing procedure (P < .05). However, the authors noted, the survival advantage in the nipple-sparing group did not extend to breast cancer–specific survival.

Dr. Hwang, who was not involved in the current analysis, said the significant overall survival result in the subgroup analysis was surprising because “there’s no biological reason why one would expect that to be true.”  

Given that the subgroups did not demonstrate better breast cancer–specific survival, Dr. Hwang believes the overall survival finding may have more to do with comorbidities, which the study did not account for, than type of mastectomy.

When choosing who is eligible for a nipple-sparing mastectomy, “We’re more selective,” Dr. Hwang said. For instance, patients with uncontrolled diabetes or who smoke are unlikely to be candidates. “So, I think it’s possible that medical comorbidities and medical conditions between these groups [were] different.”

According to the authors, coding inconsistencies represent another possible weakness of the study. From 1998 to 2010, “the term ‘nipple-sparing mastectomy’ was coded as a [total mastectomy] with the ‘subcutaneous mastectomy’ code.” It’s possible that some patients receiving the nipple-sparing procedure before 2011 were not appropriately coded in the current study.

Moving forward, a large prospective study that includes comorbidities would be helpful, but overall the study helps validate that “nipple-sparing mastectomy is a safe operation for selected patients,” Dr. Hwang said. 

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

A new analysis of over 22,000 mastectomy patients confirms what smaller studies have indicated: Patients who undergo nipple-sparing mastectomy have overall and disease-free survival similar to that of those who receive a total mastectomy.

When nipple-sparing mastectomy was introduced, many experts felt uneasy about opting for the less invasive procedure, recalled Rosa Hwang, MD, associate medical director for breast surgery at MD Anderson Cancer Center in Houston. “The concern was leaving all this skin,” said Dr. Hwang. “Are you going to leave cancer behind” and increase the risk of local recurrence?

Over the past 2 decades, the number of patients undergoing nipple-sparing mastectomy increased and, in turn, studies began to demonstrate the safety of the procedure.

However, large analyses evaluating long-term outcomes – namely, overall survival and breast cancer-specific survival – of nipple-sparing mastectomy were still lacking.

The latest study, published online Nov. 20 in Annals of Surgical Oncology, compared the long-term prognosis and survival benefits of nipple-sparing to total mastectomy in thousands of women. The analysis, which pulled data from the SEER cancer database, included 5,765 patients who underwent the nipple-sparing procedure and 17,289 patients who had a total mastectomy.

The authors found that overall survival and breast cancer–specific survival were similar for women undergoing nipple-sparing mastectomy and those receiving a total mastectomy. In fact, over the long-term, the nipple-sparing group slightly edged out the total mastectomy group in overall survival (94.61% vs. 93% at 5 years and 86.34% vs. 83.48% at 10 years, respectively) and in breast cancer-specific survival rates (96.16% vs. 95.74% at 5 years, and 92.2% vs. 91.37% at 10 years). The differences, however, were not significant.

The study also found that certain subgroups – including White women, women over age 46, those with a median household income of $70,000 or more, hormone receptor-positive, and HER2 negative – had significantly better overall survival rate with the nipple-sparing procedure (P < .05). However, the authors noted, the survival advantage in the nipple-sparing group did not extend to breast cancer–specific survival.

Dr. Hwang, who was not involved in the current analysis, said the significant overall survival result in the subgroup analysis was surprising because “there’s no biological reason why one would expect that to be true.”  

Given that the subgroups did not demonstrate better breast cancer–specific survival, Dr. Hwang believes the overall survival finding may have more to do with comorbidities, which the study did not account for, than type of mastectomy.

When choosing who is eligible for a nipple-sparing mastectomy, “We’re more selective,” Dr. Hwang said. For instance, patients with uncontrolled diabetes or who smoke are unlikely to be candidates. “So, I think it’s possible that medical comorbidities and medical conditions between these groups [were] different.”

According to the authors, coding inconsistencies represent another possible weakness of the study. From 1998 to 2010, “the term ‘nipple-sparing mastectomy’ was coded as a [total mastectomy] with the ‘subcutaneous mastectomy’ code.” It’s possible that some patients receiving the nipple-sparing procedure before 2011 were not appropriately coded in the current study.

Moving forward, a large prospective study that includes comorbidities would be helpful, but overall the study helps validate that “nipple-sparing mastectomy is a safe operation for selected patients,” Dr. Hwang said. 

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

A new analysis of over 22,000 mastectomy patients confirms what smaller studies have indicated: Patients who undergo nipple-sparing mastectomy have overall and disease-free survival similar to that of those who receive a total mastectomy.

When nipple-sparing mastectomy was introduced, many experts felt uneasy about opting for the less invasive procedure, recalled Rosa Hwang, MD, associate medical director for breast surgery at MD Anderson Cancer Center in Houston. “The concern was leaving all this skin,” said Dr. Hwang. “Are you going to leave cancer behind” and increase the risk of local recurrence?

Over the past 2 decades, the number of patients undergoing nipple-sparing mastectomy increased and, in turn, studies began to demonstrate the safety of the procedure.

However, large analyses evaluating long-term outcomes – namely, overall survival and breast cancer-specific survival – of nipple-sparing mastectomy were still lacking.

The latest study, published online Nov. 20 in Annals of Surgical Oncology, compared the long-term prognosis and survival benefits of nipple-sparing to total mastectomy in thousands of women. The analysis, which pulled data from the SEER cancer database, included 5,765 patients who underwent the nipple-sparing procedure and 17,289 patients who had a total mastectomy.

The authors found that overall survival and breast cancer–specific survival were similar for women undergoing nipple-sparing mastectomy and those receiving a total mastectomy. In fact, over the long-term, the nipple-sparing group slightly edged out the total mastectomy group in overall survival (94.61% vs. 93% at 5 years and 86.34% vs. 83.48% at 10 years, respectively) and in breast cancer-specific survival rates (96.16% vs. 95.74% at 5 years, and 92.2% vs. 91.37% at 10 years). The differences, however, were not significant.

The study also found that certain subgroups – including White women, women over age 46, those with a median household income of $70,000 or more, hormone receptor-positive, and HER2 negative – had significantly better overall survival rate with the nipple-sparing procedure (P < .05). However, the authors noted, the survival advantage in the nipple-sparing group did not extend to breast cancer–specific survival.

Dr. Hwang, who was not involved in the current analysis, said the significant overall survival result in the subgroup analysis was surprising because “there’s no biological reason why one would expect that to be true.”  

Given that the subgroups did not demonstrate better breast cancer–specific survival, Dr. Hwang believes the overall survival finding may have more to do with comorbidities, which the study did not account for, than type of mastectomy.

When choosing who is eligible for a nipple-sparing mastectomy, “We’re more selective,” Dr. Hwang said. For instance, patients with uncontrolled diabetes or who smoke are unlikely to be candidates. “So, I think it’s possible that medical comorbidities and medical conditions between these groups [were] different.”

According to the authors, coding inconsistencies represent another possible weakness of the study. From 1998 to 2010, “the term ‘nipple-sparing mastectomy’ was coded as a [total mastectomy] with the ‘subcutaneous mastectomy’ code.” It’s possible that some patients receiving the nipple-sparing procedure before 2011 were not appropriately coded in the current study.

Moving forward, a large prospective study that includes comorbidities would be helpful, but overall the study helps validate that “nipple-sparing mastectomy is a safe operation for selected patients,” Dr. Hwang said. 

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

It could be argued that hospital medicine in the United States was made vital by a major infectious disease epidemic – the HIV/AIDS crisis – said Emily Gottenborg, MD, a hospitalist and program director of hospitalist training at the University of Colorado at Denver, Aurora. Certainly, it was born out of the need for change, for physicians who could coordinate complex patient care plans and serve as the “quarterbacks” of the hospital. “As a result, we have always been very nimble and ready to embrace change,” said Dr. Gottenborg.

That hospitalist-honed agility and penchant for innovation has proven to be invaluable during the current COVID-19 pandemic as hospital medicine–focused residency programs have been forced to pivot quickly and modify their agendas. From managing the pandemic’s impact on residents’ day-to-day experiences, to carefully balancing educational needs and goals, program leaders have worked tirelessly to ensure that residents continue to receive excellent training.

The overarching theme across U.S.-based residency programs is that the educational changes and challenges during the COVID-19 pandemic have often been one and the same.
 

Service versus education

At the beginning of the pandemic, trainees at the University of Pittsburgh Medical Center were limited in seeing COVID patients in order to curb exposure. But now that COVID appears to be the new normal, “I think the question becomes: ‘How do we incorporate our trainees to take care of COVID patients since it seems it will be staying around for a while?’ ” said Rachna Rawal, MD, a hospitalist and clinical assistant professor of medicine at UPMC.

Mark Bolster ©UPMC All rights reserved.

This dilemma highlights the conflict between service and education. Residents have been motivated and eager to help, which has been beneficial whenever there is a surge. “At the same time, you want to preserve their education, and it’s a very difficult balance at times,” said Dr. Rawal. It’s also challenging to figure out the safest way for residents to see patients, as well as how to include medical students, since interns and residents serve as important educational resources for them.

Keeping trainees involved with daily virtual conferences rather than in-person interactions raises the question of whether or not the engagement is equivalent. “It’s harder to keep them accountable when they’re not in person, but it’s also not worth the risk given the COVID numbers at times,” Dr. Rawal said. The goal has become to make sure residents stay safe while still feeling that they are getting a good education.
 

A balancing act

“I think early on, there was a lot of pride in what we were doing, that we were on the front line managing this thing that was emerging,” said Daniel Ricotta, MD, a hospitalist and associate program director of the internal medicine residency at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston. “And now I think people are starting to feel a little bit weary.”

It has been demanding trying to manage ongoing educational needs through this time. “At the end of the day, residents are still trainees and have to be trained and educated. They’re not just worker bees taking care of patients,” Dr. Ricotta said. Residents need a well-rounded clinical experience – “they can’t just take care of COVID patients and then be able to graduate as general internists,” he said – but that becomes onerous when the hospital is full of patients with COVID.

Along with balancing residents’ clinical immersion, Dr. Ricotta said there has been the challenge of doing “the content-based teaching from didactics that occur in the context of clinical work, but are somewhat separated when you need to limit the number of people in the rooms and try to keep as many people at home as possible when they’re not taking care of patients in order to limit their level of risk.” Adjusting and readjusting both of these aspects has had a major impact on residents’ day-to-day education.

“A big part of residency is community,” noted Dr. Ricotta, but the sense of community has been disrupted because some of the bonding experiences residents used to do outside the hospital to build that community have necessarily gone by the wayside. This particularly affects interns from around the country who are meeting each other for the first time. “We actually had a normal intern orientation this year, but last year, when everything was virtual, we were trying to find ways to bridge relationships in a way that was safe and socially distanced,” he said.
 

Improving quality

UC Denver is unique in that they have a 3-year program specifically for hospital medicine residents, said Dr. Gottenborg. Right away, “our residents rose to the challenge and wanted to be part of the workforce that helps care for this critical population of [COVID] patients.” The residents were able to run the ICUs and take care of COVID patients, but in exchange, they had to give up some of their elective rotation time.

One aspect of the UC Denver hospital medicine residency program is participation in projects that focus on how to improve the health care system. Over the past year, the residents worked on one project in particular that focused on restructuring the guidelines for consulting physical therapists. Since many patients end up needing a physical therapist for a variety of reasons, a full hospital puts increased strain on their workload, making their time more precious.

“[The project] forced us to think about the right criteria to consult them,” explained Dr. Gottenborg. “We cut down essentially all the inappropriate consults to PT, opening their time. That project was driven by how the residents were experiencing the pandemic in the hospital.”
 

Learning to adapt

“The training environment during this pandemic has been tumultuous for both our residents and medical students,” said Alan M. Hall, MD, associate professor of internal medicine and pediatrics and assistant dean of curriculum integration at the University of Kentucky, Lexington. Along with treating patients with COVID-19, he said trainees have also had to cope with anxiety about getting the virus themselves or inadvertently bringing it home to their families.

Like most medical schools, University of Kentucky students were shifted away from clinical rotations and into alternative and online education for a time. When they returned to in-person education, the students were initially restricted from seeing patients with confirmed or suspected COVID-19 in order to reduce their personal risk and to conserve personal protective equipment.

This especially impacted certain rotations, such as pediatrics. Because respiratory symptoms are common in this population, students were greatly limited in the number of new patients they could see. Now they are given the option to see patients with COVID-19 if they want to.

“Our residents have had to adapt to seemingly endless changes during this pandemic,” Dr. Hall said. For example, at the beginning of the surge, the internal medicine residents trained for a completely new clinical model, though this ultimately never needed to be implemented. Then they had to adjust to extremely high census numbers that continue to have an effect on almost all of their rotations.

Conversely, the pediatrics residents saw far fewer inpatients last winter than they typically would. This made it more difficult for them to feel comfortable when census numbers increased with common diagnoses like bronchiolitis. “However, those respiratory viruses that were hibernating last winter caused an unusual and challenging summer surge,” Dr. Hall said.

The biggest challenge though “is knowing that there is not a perfect solution for this global pandemic’s effect on medical education,” said Dr. Hall. “We can’t possibly perfectly balance the safety of our learners and their families with the dangers of COVID-19.”
 

Leadership discussions

As a residency program leader, Dr. Ricotta said there are conversations about multiple topics, including maintaining a safe learning environment; providing important aspects of residency training; whether to go back to full in-person teaching, keep doing virtual teaching, or implement a hybrid model; and how to help residents understand the balance between their personal and professional lives, especially in terms of safety.

“They have to their lives outside of the hospital, but we also are trying to instill ... what their responsibility is to society, to their patients, and to each other,” said Dr. Ricotta.

A more recent discussion has been about how to manage the COVID vaccine boosters. “We can’t have everyone getting vaccines at the same time because they might have symptoms afterward, and then be out sick – you’re missing half your workforce,” Dr. Ricotta said. But staggering residents’ booster shots created yet another dilemma around deciding who received the booster sooner rather than later.

The biggest consideration for Dr. Gottenborg’s leadership team was deciding whether to use their residents to help with the COVID surges or keep them in a traditional residency experience. While the residents wanted to be part of the pandemic response, there were many factors to consider. Ultimately, they came up with a balance between the amount of time residents should spend taking care of COVID patients while also assuring that they leave the program with all the skills and experiences they need.

Though Dr. Hall works more closely with medical students than residents, he sees the challenges and effects as being similar. Creating harmony between a safe learning environment and students’ educational goals has been the topic of endless discussions. This includes decisions as to whether or not students should be involved in person in certain activities such as large classroom didactics, written exams, seeing patients in clinical settings, and small group discussions.
 

Recruitment effects

When it comes to recruiting during a global pandemic, the experiences and predictions are mixed. Dr. Hall believes virtual interviews are making recruitment easier, but in turn, the fact that they are virtual also makes it harder for the applicant to get a good feel for the program and the people involved in it.

Dr. Ricotta reported that recruitment numbers have been fairly steady at Beth Israel Deaconess over the last few years. “In addition to the critical care physicians, hospital medicine was really the front line of this pandemic and so in some ways, we gained some recognition that we may not have had otherwise,” said Dr. Ricotta. He believes this has the benefit of attracting some residents, but at the same time, it could potentially scare others away from what they perceive as a demanding, grueling job. “I think it has been mixed. It’s dependent on the person.”

At UC Denver, Dr. Gottenborg said they are seeing a rapid rise in the number of applications and interest in their programs. Still, “I think this could go both ways,” she acknowledged. With the focus on hospital medicine in the media, medical students are more aware of the specialty and what it involves. “I think the sense of mission is really exemplified and everyone is talking about it,” she said. This is evident in the arrival this summer of the first new class of interns since the pandemic. “They’re incredibly passionate about the work,” said Dr. Gottenborg.

However, there is also the notable increase in physician burnout since the pandemic started. That this has been regularly featured in the media leaves Dr. Gottenborg to wonder if prospective residents will shy away from hospital medicine because they believe it is an area that leads to burnout. “I hope that’s not the case,” she said.

“I would actually argue [recruitment] is easier,” said Dr. Rawal. Like Dr. Hall, she sees virtual interviews as a big benefit to prospective trainees because they don’t have to spend a large amount of money on travel, food, and other expenses like they did before, a welcome relief for residents with significant debt. “I think that is one very big positive from the pandemic,” she said. Her trainees were advised to make a final list and consider going to see the top two or three in person, but “at this point, there’s really no expectation to go see all 15 places that you look into.”

Dr. Rawal also pointed out that recruitment is affected by whether or not trainees are expected to see COVID patients. “I know in some places they aren’t and in some places they are, so it just depends on where you are and what you’re looking for,” she said.
 

Shifts in education

It remains to be seen if all the educational changes will be permanent, though it appears that many will remain. Dr. Hall hopes that virtual visits to provide care to patients who have difficulty getting to physical clinics will continue to be a focus for hospital medicine trainees. “For medical students, I think this will allow us to better assess what content can best be delivered in person, synchronously online, or asynchronously through recorded content,” he said.

Dr. Ricotta predicts that virtual conferences will become more pervasive as academic hospitals continue to acquire more community hospitals, especially for grand rounds. “The virtual teaching that occurred in the residency program because it’s required by the [Accreditation Council for Graduate Medical Education] has, I think, informed how academic centers do ongoing faculty development, professional development, and obviously education for the residents,” Dr. Ricotta said. “I think virtual teaching is here to stay.” This includes telehealth training, which had not been a widespread part of residency education before now.

Trainees have been given tools to handle high patient censuses and learned a whole new set of communication skills, thanks to the pandemic, said Dr. Rawal. There has been a focus on learning how to advocate for the vaccine, along with education on situations like how to have conversations with patients who don’t believe they have COVID, even when their tests are positive. “Learning to handle these situations and still be a physician and provide appropriate care regardless of the patient’s views is very important. This is not something I learned in my training because it never came up,” she said.

Dr. Gottenborg has been impressed by the resident workforce’s response across all specialties throughout these difficult days. “They were universally ready to dive in and work long hours and care for these very sick patients and ultimately share their experiences so that we could do it better as these patients continue to flow through our systems,” she said. “It has been very invigorating.”

The pandemic has also put a spotlight on the importance of being flexible, as well as various problems with how health care systems operate, “which, for people in our field, gets us both excited and gives us a lot of work to do,” said Dr. Gottenborg. “Our residents see that and feel that and will hopefully continue to hold that torch in hospital medicine.”

In spite of everything, Dr. Rawal believes this is an exhilarating time to be a trainee. “They’re getting an opportunity that none of us got. Usually, when policies are made, we really don’t see the immediate impact.” But with recent mandates like masks and social distancing, “the rate of change that they get to see things happen is exciting. They’re going to be a very exciting group of physicians.”

It could be argued that hospital medicine in the United States was made vital by a major infectious disease epidemic – the HIV/AIDS crisis – said Emily Gottenborg, MD, a hospitalist and program director of hospitalist training at the University of Colorado at Denver, Aurora. Certainly, it was born out of the need for change, for physicians who could coordinate complex patient care plans and serve as the “quarterbacks” of the hospital. “As a result, we have always been very nimble and ready to embrace change,” said Dr. Gottenborg.

That hospitalist-honed agility and penchant for innovation has proven to be invaluable during the current COVID-19 pandemic as hospital medicine–focused residency programs have been forced to pivot quickly and modify their agendas. From managing the pandemic’s impact on residents’ day-to-day experiences, to carefully balancing educational needs and goals, program leaders have worked tirelessly to ensure that residents continue to receive excellent training.

The overarching theme across U.S.-based residency programs is that the educational changes and challenges during the COVID-19 pandemic have often been one and the same.
 

Service versus education

At the beginning of the pandemic, trainees at the University of Pittsburgh Medical Center were limited in seeing COVID patients in order to curb exposure. But now that COVID appears to be the new normal, “I think the question becomes: ‘How do we incorporate our trainees to take care of COVID patients since it seems it will be staying around for a while?’ ” said Rachna Rawal, MD, a hospitalist and clinical assistant professor of medicine at UPMC.

Mark Bolster ©UPMC All rights reserved.

This dilemma highlights the conflict between service and education. Residents have been motivated and eager to help, which has been beneficial whenever there is a surge. “At the same time, you want to preserve their education, and it’s a very difficult balance at times,” said Dr. Rawal. It’s also challenging to figure out the safest way for residents to see patients, as well as how to include medical students, since interns and residents serve as important educational resources for them.

Keeping trainees involved with daily virtual conferences rather than in-person interactions raises the question of whether or not the engagement is equivalent. “It’s harder to keep them accountable when they’re not in person, but it’s also not worth the risk given the COVID numbers at times,” Dr. Rawal said. The goal has become to make sure residents stay safe while still feeling that they are getting a good education.
 

A balancing act

“I think early on, there was a lot of pride in what we were doing, that we were on the front line managing this thing that was emerging,” said Daniel Ricotta, MD, a hospitalist and associate program director of the internal medicine residency at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston. “And now I think people are starting to feel a little bit weary.”

It has been demanding trying to manage ongoing educational needs through this time. “At the end of the day, residents are still trainees and have to be trained and educated. They’re not just worker bees taking care of patients,” Dr. Ricotta said. Residents need a well-rounded clinical experience – “they can’t just take care of COVID patients and then be able to graduate as general internists,” he said – but that becomes onerous when the hospital is full of patients with COVID.

Along with balancing residents’ clinical immersion, Dr. Ricotta said there has been the challenge of doing “the content-based teaching from didactics that occur in the context of clinical work, but are somewhat separated when you need to limit the number of people in the rooms and try to keep as many people at home as possible when they’re not taking care of patients in order to limit their level of risk.” Adjusting and readjusting both of these aspects has had a major impact on residents’ day-to-day education.

“A big part of residency is community,” noted Dr. Ricotta, but the sense of community has been disrupted because some of the bonding experiences residents used to do outside the hospital to build that community have necessarily gone by the wayside. This particularly affects interns from around the country who are meeting each other for the first time. “We actually had a normal intern orientation this year, but last year, when everything was virtual, we were trying to find ways to bridge relationships in a way that was safe and socially distanced,” he said.
 

Improving quality

UC Denver is unique in that they have a 3-year program specifically for hospital medicine residents, said Dr. Gottenborg. Right away, “our residents rose to the challenge and wanted to be part of the workforce that helps care for this critical population of [COVID] patients.” The residents were able to run the ICUs and take care of COVID patients, but in exchange, they had to give up some of their elective rotation time.

One aspect of the UC Denver hospital medicine residency program is participation in projects that focus on how to improve the health care system. Over the past year, the residents worked on one project in particular that focused on restructuring the guidelines for consulting physical therapists. Since many patients end up needing a physical therapist for a variety of reasons, a full hospital puts increased strain on their workload, making their time more precious.

“[The project] forced us to think about the right criteria to consult them,” explained Dr. Gottenborg. “We cut down essentially all the inappropriate consults to PT, opening their time. That project was driven by how the residents were experiencing the pandemic in the hospital.”
 

Learning to adapt

“The training environment during this pandemic has been tumultuous for both our residents and medical students,” said Alan M. Hall, MD, associate professor of internal medicine and pediatrics and assistant dean of curriculum integration at the University of Kentucky, Lexington. Along with treating patients with COVID-19, he said trainees have also had to cope with anxiety about getting the virus themselves or inadvertently bringing it home to their families.

Like most medical schools, University of Kentucky students were shifted away from clinical rotations and into alternative and online education for a time. When they returned to in-person education, the students were initially restricted from seeing patients with confirmed or suspected COVID-19 in order to reduce their personal risk and to conserve personal protective equipment.

This especially impacted certain rotations, such as pediatrics. Because respiratory symptoms are common in this population, students were greatly limited in the number of new patients they could see. Now they are given the option to see patients with COVID-19 if they want to.

“Our residents have had to adapt to seemingly endless changes during this pandemic,” Dr. Hall said. For example, at the beginning of the surge, the internal medicine residents trained for a completely new clinical model, though this ultimately never needed to be implemented. Then they had to adjust to extremely high census numbers that continue to have an effect on almost all of their rotations.

Conversely, the pediatrics residents saw far fewer inpatients last winter than they typically would. This made it more difficult for them to feel comfortable when census numbers increased with common diagnoses like bronchiolitis. “However, those respiratory viruses that were hibernating last winter caused an unusual and challenging summer surge,” Dr. Hall said.

The biggest challenge though “is knowing that there is not a perfect solution for this global pandemic’s effect on medical education,” said Dr. Hall. “We can’t possibly perfectly balance the safety of our learners and their families with the dangers of COVID-19.”
 

Leadership discussions

As a residency program leader, Dr. Ricotta said there are conversations about multiple topics, including maintaining a safe learning environment; providing important aspects of residency training; whether to go back to full in-person teaching, keep doing virtual teaching, or implement a hybrid model; and how to help residents understand the balance between their personal and professional lives, especially in terms of safety.

“They have to their lives outside of the hospital, but we also are trying to instill ... what their responsibility is to society, to their patients, and to each other,” said Dr. Ricotta.

A more recent discussion has been about how to manage the COVID vaccine boosters. “We can’t have everyone getting vaccines at the same time because they might have symptoms afterward, and then be out sick – you’re missing half your workforce,” Dr. Ricotta said. But staggering residents’ booster shots created yet another dilemma around deciding who received the booster sooner rather than later.

The biggest consideration for Dr. Gottenborg’s leadership team was deciding whether to use their residents to help with the COVID surges or keep them in a traditional residency experience. While the residents wanted to be part of the pandemic response, there were many factors to consider. Ultimately, they came up with a balance between the amount of time residents should spend taking care of COVID patients while also assuring that they leave the program with all the skills and experiences they need.

Though Dr. Hall works more closely with medical students than residents, he sees the challenges and effects as being similar. Creating harmony between a safe learning environment and students’ educational goals has been the topic of endless discussions. This includes decisions as to whether or not students should be involved in person in certain activities such as large classroom didactics, written exams, seeing patients in clinical settings, and small group discussions.
 

Recruitment effects

When it comes to recruiting during a global pandemic, the experiences and predictions are mixed. Dr. Hall believes virtual interviews are making recruitment easier, but in turn, the fact that they are virtual also makes it harder for the applicant to get a good feel for the program and the people involved in it.

Dr. Ricotta reported that recruitment numbers have been fairly steady at Beth Israel Deaconess over the last few years. “In addition to the critical care physicians, hospital medicine was really the front line of this pandemic and so in some ways, we gained some recognition that we may not have had otherwise,” said Dr. Ricotta. He believes this has the benefit of attracting some residents, but at the same time, it could potentially scare others away from what they perceive as a demanding, grueling job. “I think it has been mixed. It’s dependent on the person.”

At UC Denver, Dr. Gottenborg said they are seeing a rapid rise in the number of applications and interest in their programs. Still, “I think this could go both ways,” she acknowledged. With the focus on hospital medicine in the media, medical students are more aware of the specialty and what it involves. “I think the sense of mission is really exemplified and everyone is talking about it,” she said. This is evident in the arrival this summer of the first new class of interns since the pandemic. “They’re incredibly passionate about the work,” said Dr. Gottenborg.

However, there is also the notable increase in physician burnout since the pandemic started. That this has been regularly featured in the media leaves Dr. Gottenborg to wonder if prospective residents will shy away from hospital medicine because they believe it is an area that leads to burnout. “I hope that’s not the case,” she said.

“I would actually argue [recruitment] is easier,” said Dr. Rawal. Like Dr. Hall, she sees virtual interviews as a big benefit to prospective trainees because they don’t have to spend a large amount of money on travel, food, and other expenses like they did before, a welcome relief for residents with significant debt. “I think that is one very big positive from the pandemic,” she said. Her trainees were advised to make a final list and consider going to see the top two or three in person, but “at this point, there’s really no expectation to go see all 15 places that you look into.”

Dr. Rawal also pointed out that recruitment is affected by whether or not trainees are expected to see COVID patients. “I know in some places they aren’t and in some places they are, so it just depends on where you are and what you’re looking for,” she said.
 

Shifts in education

It remains to be seen if all the educational changes will be permanent, though it appears that many will remain. Dr. Hall hopes that virtual visits to provide care to patients who have difficulty getting to physical clinics will continue to be a focus for hospital medicine trainees. “For medical students, I think this will allow us to better assess what content can best be delivered in person, synchronously online, or asynchronously through recorded content,” he said.

Dr. Ricotta predicts that virtual conferences will become more pervasive as academic hospitals continue to acquire more community hospitals, especially for grand rounds. “The virtual teaching that occurred in the residency program because it’s required by the [Accreditation Council for Graduate Medical Education] has, I think, informed how academic centers do ongoing faculty development, professional development, and obviously education for the residents,” Dr. Ricotta said. “I think virtual teaching is here to stay.” This includes telehealth training, which had not been a widespread part of residency education before now.

Trainees have been given tools to handle high patient censuses and learned a whole new set of communication skills, thanks to the pandemic, said Dr. Rawal. There has been a focus on learning how to advocate for the vaccine, along with education on situations like how to have conversations with patients who don’t believe they have COVID, even when their tests are positive. “Learning to handle these situations and still be a physician and provide appropriate care regardless of the patient’s views is very important. This is not something I learned in my training because it never came up,” she said.

Dr. Gottenborg has been impressed by the resident workforce’s response across all specialties throughout these difficult days. “They were universally ready to dive in and work long hours and care for these very sick patients and ultimately share their experiences so that we could do it better as these patients continue to flow through our systems,” she said. “It has been very invigorating.”

The pandemic has also put a spotlight on the importance of being flexible, as well as various problems with how health care systems operate, “which, for people in our field, gets us both excited and gives us a lot of work to do,” said Dr. Gottenborg. “Our residents see that and feel that and will hopefully continue to hold that torch in hospital medicine.”

In spite of everything, Dr. Rawal believes this is an exhilarating time to be a trainee. “They’re getting an opportunity that none of us got. Usually, when policies are made, we really don’t see the immediate impact.” But with recent mandates like masks and social distancing, “the rate of change that they get to see things happen is exciting. They’re going to be a very exciting group of physicians.”

It could be argued that hospital medicine in the United States was made vital by a major infectious disease epidemic – the HIV/AIDS crisis – said Emily Gottenborg, MD, a hospitalist and program director of hospitalist training at the University of Colorado at Denver, Aurora. Certainly, it was born out of the need for change, for physicians who could coordinate complex patient care plans and serve as the “quarterbacks” of the hospital. “As a result, we have always been very nimble and ready to embrace change,” said Dr. Gottenborg.

That hospitalist-honed agility and penchant for innovation has proven to be invaluable during the current COVID-19 pandemic as hospital medicine–focused residency programs have been forced to pivot quickly and modify their agendas. From managing the pandemic’s impact on residents’ day-to-day experiences, to carefully balancing educational needs and goals, program leaders have worked tirelessly to ensure that residents continue to receive excellent training.

The overarching theme across U.S.-based residency programs is that the educational changes and challenges during the COVID-19 pandemic have often been one and the same.
 

Service versus education

At the beginning of the pandemic, trainees at the University of Pittsburgh Medical Center were limited in seeing COVID patients in order to curb exposure. But now that COVID appears to be the new normal, “I think the question becomes: ‘How do we incorporate our trainees to take care of COVID patients since it seems it will be staying around for a while?’ ” said Rachna Rawal, MD, a hospitalist and clinical assistant professor of medicine at UPMC.

Mark Bolster ©UPMC All rights reserved.

This dilemma highlights the conflict between service and education. Residents have been motivated and eager to help, which has been beneficial whenever there is a surge. “At the same time, you want to preserve their education, and it’s a very difficult balance at times,” said Dr. Rawal. It’s also challenging to figure out the safest way for residents to see patients, as well as how to include medical students, since interns and residents serve as important educational resources for them.

Keeping trainees involved with daily virtual conferences rather than in-person interactions raises the question of whether or not the engagement is equivalent. “It’s harder to keep them accountable when they’re not in person, but it’s also not worth the risk given the COVID numbers at times,” Dr. Rawal said. The goal has become to make sure residents stay safe while still feeling that they are getting a good education.
 

A balancing act

“I think early on, there was a lot of pride in what we were doing, that we were on the front line managing this thing that was emerging,” said Daniel Ricotta, MD, a hospitalist and associate program director of the internal medicine residency at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston. “And now I think people are starting to feel a little bit weary.”

It has been demanding trying to manage ongoing educational needs through this time. “At the end of the day, residents are still trainees and have to be trained and educated. They’re not just worker bees taking care of patients,” Dr. Ricotta said. Residents need a well-rounded clinical experience – “they can’t just take care of COVID patients and then be able to graduate as general internists,” he said – but that becomes onerous when the hospital is full of patients with COVID.

Along with balancing residents’ clinical immersion, Dr. Ricotta said there has been the challenge of doing “the content-based teaching from didactics that occur in the context of clinical work, but are somewhat separated when you need to limit the number of people in the rooms and try to keep as many people at home as possible when they’re not taking care of patients in order to limit their level of risk.” Adjusting and readjusting both of these aspects has had a major impact on residents’ day-to-day education.

“A big part of residency is community,” noted Dr. Ricotta, but the sense of community has been disrupted because some of the bonding experiences residents used to do outside the hospital to build that community have necessarily gone by the wayside. This particularly affects interns from around the country who are meeting each other for the first time. “We actually had a normal intern orientation this year, but last year, when everything was virtual, we were trying to find ways to bridge relationships in a way that was safe and socially distanced,” he said.
 

Improving quality

UC Denver is unique in that they have a 3-year program specifically for hospital medicine residents, said Dr. Gottenborg. Right away, “our residents rose to the challenge and wanted to be part of the workforce that helps care for this critical population of [COVID] patients.” The residents were able to run the ICUs and take care of COVID patients, but in exchange, they had to give up some of their elective rotation time.

One aspect of the UC Denver hospital medicine residency program is participation in projects that focus on how to improve the health care system. Over the past year, the residents worked on one project in particular that focused on restructuring the guidelines for consulting physical therapists. Since many patients end up needing a physical therapist for a variety of reasons, a full hospital puts increased strain on their workload, making their time more precious.

“[The project] forced us to think about the right criteria to consult them,” explained Dr. Gottenborg. “We cut down essentially all the inappropriate consults to PT, opening their time. That project was driven by how the residents were experiencing the pandemic in the hospital.”
 

Learning to adapt

“The training environment during this pandemic has been tumultuous for both our residents and medical students,” said Alan M. Hall, MD, associate professor of internal medicine and pediatrics and assistant dean of curriculum integration at the University of Kentucky, Lexington. Along with treating patients with COVID-19, he said trainees have also had to cope with anxiety about getting the virus themselves or inadvertently bringing it home to their families.

Like most medical schools, University of Kentucky students were shifted away from clinical rotations and into alternative and online education for a time. When they returned to in-person education, the students were initially restricted from seeing patients with confirmed or suspected COVID-19 in order to reduce their personal risk and to conserve personal protective equipment.

This especially impacted certain rotations, such as pediatrics. Because respiratory symptoms are common in this population, students were greatly limited in the number of new patients they could see. Now they are given the option to see patients with COVID-19 if they want to.

“Our residents have had to adapt to seemingly endless changes during this pandemic,” Dr. Hall said. For example, at the beginning of the surge, the internal medicine residents trained for a completely new clinical model, though this ultimately never needed to be implemented. Then they had to adjust to extremely high census numbers that continue to have an effect on almost all of their rotations.

Conversely, the pediatrics residents saw far fewer inpatients last winter than they typically would. This made it more difficult for them to feel comfortable when census numbers increased with common diagnoses like bronchiolitis. “However, those respiratory viruses that were hibernating last winter caused an unusual and challenging summer surge,” Dr. Hall said.

The biggest challenge though “is knowing that there is not a perfect solution for this global pandemic’s effect on medical education,” said Dr. Hall. “We can’t possibly perfectly balance the safety of our learners and their families with the dangers of COVID-19.”
 

Leadership discussions

As a residency program leader, Dr. Ricotta said there are conversations about multiple topics, including maintaining a safe learning environment; providing important aspects of residency training; whether to go back to full in-person teaching, keep doing virtual teaching, or implement a hybrid model; and how to help residents understand the balance between their personal and professional lives, especially in terms of safety.

“They have to their lives outside of the hospital, but we also are trying to instill ... what their responsibility is to society, to their patients, and to each other,” said Dr. Ricotta.

A more recent discussion has been about how to manage the COVID vaccine boosters. “We can’t have everyone getting vaccines at the same time because they might have symptoms afterward, and then be out sick – you’re missing half your workforce,” Dr. Ricotta said. But staggering residents’ booster shots created yet another dilemma around deciding who received the booster sooner rather than later.

The biggest consideration for Dr. Gottenborg’s leadership team was deciding whether to use their residents to help with the COVID surges or keep them in a traditional residency experience. While the residents wanted to be part of the pandemic response, there were many factors to consider. Ultimately, they came up with a balance between the amount of time residents should spend taking care of COVID patients while also assuring that they leave the program with all the skills and experiences they need.

Though Dr. Hall works more closely with medical students than residents, he sees the challenges and effects as being similar. Creating harmony between a safe learning environment and students’ educational goals has been the topic of endless discussions. This includes decisions as to whether or not students should be involved in person in certain activities such as large classroom didactics, written exams, seeing patients in clinical settings, and small group discussions.
 

Recruitment effects

When it comes to recruiting during a global pandemic, the experiences and predictions are mixed. Dr. Hall believes virtual interviews are making recruitment easier, but in turn, the fact that they are virtual also makes it harder for the applicant to get a good feel for the program and the people involved in it.

Dr. Ricotta reported that recruitment numbers have been fairly steady at Beth Israel Deaconess over the last few years. “In addition to the critical care physicians, hospital medicine was really the front line of this pandemic and so in some ways, we gained some recognition that we may not have had otherwise,” said Dr. Ricotta. He believes this has the benefit of attracting some residents, but at the same time, it could potentially scare others away from what they perceive as a demanding, grueling job. “I think it has been mixed. It’s dependent on the person.”

At UC Denver, Dr. Gottenborg said they are seeing a rapid rise in the number of applications and interest in their programs. Still, “I think this could go both ways,” she acknowledged. With the focus on hospital medicine in the media, medical students are more aware of the specialty and what it involves. “I think the sense of mission is really exemplified and everyone is talking about it,” she said. This is evident in the arrival this summer of the first new class of interns since the pandemic. “They’re incredibly passionate about the work,” said Dr. Gottenborg.

However, there is also the notable increase in physician burnout since the pandemic started. That this has been regularly featured in the media leaves Dr. Gottenborg to wonder if prospective residents will shy away from hospital medicine because they believe it is an area that leads to burnout. “I hope that’s not the case,” she said.

“I would actually argue [recruitment] is easier,” said Dr. Rawal. Like Dr. Hall, she sees virtual interviews as a big benefit to prospective trainees because they don’t have to spend a large amount of money on travel, food, and other expenses like they did before, a welcome relief for residents with significant debt. “I think that is one very big positive from the pandemic,” she said. Her trainees were advised to make a final list and consider going to see the top two or three in person, but “at this point, there’s really no expectation to go see all 15 places that you look into.”

Dr. Rawal also pointed out that recruitment is affected by whether or not trainees are expected to see COVID patients. “I know in some places they aren’t and in some places they are, so it just depends on where you are and what you’re looking for,” she said.
 

Shifts in education

It remains to be seen if all the educational changes will be permanent, though it appears that many will remain. Dr. Hall hopes that virtual visits to provide care to patients who have difficulty getting to physical clinics will continue to be a focus for hospital medicine trainees. “For medical students, I think this will allow us to better assess what content can best be delivered in person, synchronously online, or asynchronously through recorded content,” he said.

Dr. Ricotta predicts that virtual conferences will become more pervasive as academic hospitals continue to acquire more community hospitals, especially for grand rounds. “The virtual teaching that occurred in the residency program because it’s required by the [Accreditation Council for Graduate Medical Education] has, I think, informed how academic centers do ongoing faculty development, professional development, and obviously education for the residents,” Dr. Ricotta said. “I think virtual teaching is here to stay.” This includes telehealth training, which had not been a widespread part of residency education before now.

Trainees have been given tools to handle high patient censuses and learned a whole new set of communication skills, thanks to the pandemic, said Dr. Rawal. There has been a focus on learning how to advocate for the vaccine, along with education on situations like how to have conversations with patients who don’t believe they have COVID, even when their tests are positive. “Learning to handle these situations and still be a physician and provide appropriate care regardless of the patient’s views is very important. This is not something I learned in my training because it never came up,” she said.

Dr. Gottenborg has been impressed by the resident workforce’s response across all specialties throughout these difficult days. “They were universally ready to dive in and work long hours and care for these very sick patients and ultimately share their experiences so that we could do it better as these patients continue to flow through our systems,” she said. “It has been very invigorating.”

The pandemic has also put a spotlight on the importance of being flexible, as well as various problems with how health care systems operate, “which, for people in our field, gets us both excited and gives us a lot of work to do,” said Dr. Gottenborg. “Our residents see that and feel that and will hopefully continue to hold that torch in hospital medicine.”

In spite of everything, Dr. Rawal believes this is an exhilarating time to be a trainee. “They’re getting an opportunity that none of us got. Usually, when policies are made, we really don’t see the immediate impact.” But with recent mandates like masks and social distancing, “the rate of change that they get to see things happen is exciting. They’re going to be a very exciting group of physicians.”

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Childhood autism rates are at the highest level since the Centers for Disease Control and Prevention began tracking the disorder in 2000, new data released Dec. 2 show.

The increase likely reflects improvements in diagnosis and identification of autism spectrum disorder (ASD), not an increase in incidence, study authors with the CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network told this news organization.

Using a new surveillance methodology, researchers found that 2.3% of 8-year-olds in communities in 11 states across the United States had an autism diagnosis in 2018, up from 1.9% in 2016.

A separate report on early identification in 4-year-olds shows that children born in 2014 were 50% more likely to receive an autism diagnosis or ASD special education classification by 48 months of age than those born in 2010, signaling improved early diagnosis.

Taken together, the data suggest efforts to raise awareness about autism are working, though researchers were quick to say much work remains.

“It was not surprising to me and in fact it was reassuring that the number of children diagnosed with autism is higher and is actually approaching prevalence of autism that has been noted in some national surveys of parents,” Stuart Shapira, MD, PhD, associate director for science in CDC’s National Center on Birth Defects and Developmental Disability, told this news organization.

“It means we’re doing a better job of identifying children, which helps to get them into services earlier so they can achieve their best developmental outcome.”

The studies, published online in Morbidity and Mortality Weekly Report, are the first to use a new ASD surveillance protocol that relies on ASD diagnosis or special education classification and billing codes and eliminates comprehensive records analysis by trained clinician reviewers.

Racial disparities

The updated methodology was less labor intensive and reduced the time it took to produce the report, but it is not without its critics, who claim the new protocol will undercount the number of children with ASD.

Created in 2000 and funded by the CDC, the ADDM Network is the only surveillance program in the United States that tracks the number and characteristics of children with ASD in multiple communities in the U.S.

When ADDM released its first report in 2007 from six states and based on data from the year 2000, ASD prevalence was 6.7 per 1,000 children, or 1 in 150 children.

In the latest report, which includes data from 2018, the autism prevalence rate across 11 states was 23.0 per 1,000 children, or 1 in 44 children.

That rate is closer to reported autism prevalence from the National Survey of Children’s Health and the National Health Interview Survey, both of which rely on parent-reported ASD diagnoses.

For the report, researchers analyzed medical and special education records of 220,281 children who were born in 2010 in Arizona, Arkansas, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, Tennessee, Utah, and Wisconsin.

Children were counted as having autism if their records included an ASD diagnosis, a special education classification of ASD, or an ASD International Classification of Diseases (ICD) code. A total of 5,058 children met those criteria.

Rates of ASD ranged from a low of 1.7% in Missouri to 3.9% in California and were 4.2 times higher in boys than in girls. Just under half of the children with ASD were evaluated by age 36 months.

Although the overall ASD prevalence was similar among White, Black, Hispanic, and Asian/Pacific Islander children, the report highlighted a number of other racial disparities overall and in individual states.

For example, among those with ASD and data on cognitive ability, 35.2% had an intelligence quotient score of 70 or lower. Black children with ASD were far more likely to have an IQ of 70 or less (49.8%) than Hispanic (33.1%) or White (29.7%) children.

“The persistent disparities in co-occurring intellectual disabilities in children with autism is something that we continue to see and suggests that we need to better understand exactly what’s happening,” Matthew Maenner, PhD, an epidemiologist and autism surveillance team lead with the CDC’s National Center on Birth Defects and Developmental Disabilities, told this news organization.

Another long-standing trend observed again in the new report on prevalence among 8-year-olds is low ASD prevalence among Hispanic children. While the overall estimate showed similar autism rates, a closer review of state-level data reveals a different picture.

“In almost half of the sites, Hispanic children were less likely to be identified as having ASD,” he said. “This gets lost if you look only at the overall estimate.”

New methodology

When ADDM released its first report in 2007, autism diagnosis was widely inadequate in the United States. Relying on only confirmed ASD diagnoses would significantly underestimate the number of children with the disorder, so the CDC added “active case finding” to the protocol.

Trained clinician reviewers analyzed individual notes from medical and educational records for every 8-year-old in ADDM Network sites, looking for evidence of characteristics and behaviors associated with autism. The process was labor- and time-intensive and took up to 4 years to complete.

In 2018, the CDC began investigating ways to speed the process and came up with the strategy used in the latest report. The new protocol was faster, easier, and less expensive. Although he says cost was never the deciding factor, Dr. Maenner acknowledges that had they stuck with the original protocol, they would have been forced to reduce the number of ADDM Network sites.

Dr. Maenner argues that a comparison of the two protocols shows the new method doesn’t compromise accuracy and may actually capture children who lacked the medical or educational records the previous protocol required for a count. But not everyone agrees.

“I thought the point was to be as accurate and complete as possible in doing the surveillance,” Walter Zahorodny, PhD, associate professor of pediatrics at Rutgers University, New Brunswick, N.J., and principal investigator of the New Jersey ADDM Network site, told this news organization. “In states where there’s a high detail of information in records, like New Jersey, it’s going to underestimate the count.”

Dr. Zahorodny says the latest data prove his point. In 2016, under the old methodology, ASD prevalence was 3.1% in the state. In 2018, under the new protocol, prevalence was 2.84%, a decrease of about 20% that Dr. Zahorodny pins squarely on the elimination of ADDM clinical reviewers.

But New Jersey is the only state that participated in both the 2016 and 2018 surveillance periods to report a decrease in ASD prevalence. The other eight states all found autism rates in their states went up.

Sydney Pettygrove, PhD, associate professor of public health and pediatrics at the University of Arizona, Tucson, and a principal investigator for the ADDM site in Arizona, told this news organization that when she first learned the CDC was rolling out a new methodology, she and other investigators were concerned.

“People were really upset. I was really upset,” she said. “I had formed an opinion based on the earlier data that this would not be a good idea.”

In 2000, when ASD surveillance began in Arizona, nearly 30% of children identified by ADDM clinical reviewers as having autism had no mention of the disorder in their records. Today, that percentage is closer to 5%.

“In 2000 it would have been catastrophic to try to estimate the prevalence of autism with the new protocol,” said Dr. Pettygrove. As it turns out, under the new protocol, prevalence rates in Arizona increased from 16.0 per 1,000 children in 2016 to 24.9 in 2018.

Built-in bias eliminated?

In addition to speeding up the process, the new methodology might have other benefits as well. Under the old ADDM surveillance protocol, children who lacked certain medical or educational records did not meet the ASD case definition and weren’t counted.

A 2019 study showed that this disproportionately affected Black and Hispanic children, who had significantly less access to health care professionals than White children.

As a result, “the old methodology had a bias built into it,” Maureen Durkin, PhD, DrPH, coauthor of that study and chair of population health sciences at the University of Wisconsin–Madison and principal investigator for the ADDM site in Wisconsin, told this news organization.

“Clinician reviewers ended up putting these children in the ‘suspected ASD’ category because they couldn’t call it a case under the case definition,” Dr. Durkin said. “There was a fairly large percentage of suspected cases and a disproportionate number of those kids were children of color.”

Although she can’t say for sure, Dr. Durkin said it’s possible the new protocol could eliminate some of that bias.

CDC researchers also attribute the new method to an expanded study of early diagnosis among 4-year-olds. In previous years, only a handful of the ADDM Network sites participating in the 8-year-old surveillance project also studied early diagnosis in 4-year-olds.

This year, all 11 sites took part in the early diagnosis analysis, tripling the number of children included in the analysis. That made it possible to include, for the first time, Asian/Pacific Islander children in this analysis.

In the past, ASD prevalence has trended higher in White children, compared with other racial groups. The new data found that ASD prevalence among 4-year-olds was significantly lower in White children (12.9 per 1,000 children) than in Black, Hispanic, or Asian/Pacific Islander children (16.6, 21.1, and 22.7 per 1,000, respectively). Prevalence in American Indian/Alaska Native children was the lowest among all racial groups (11.5 per 1,000).

It’s the first time researchers have seen this pattern in any ADDM report, Kelly Shaw, PhD, lead author of that study and an epidemiologist with the National Center on Birth Defects and Developmental Disability at the CDC, told this news organization.

These data don’t provide clues about the potential cause of that disparity, Dr. Shaw said. It’s likely an indication of better identification of ASD in those communities, she said, and not a sign of increased incidence of autism among Black, Hispanic, or Asian/Pacific Islander children.

“We don’t have any evidence to suggest or expect that autism would be increasing differentially among groups,” Dr. Shaw said.

The data suggest “we are making some progress but there certainly is still room for improvement,” Dr. Shaw said.

Study authors report no conflicts of interest.

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

Childhood autism rates are at the highest level since the Centers for Disease Control and Prevention began tracking the disorder in 2000, new data released Dec. 2 show.

The increase likely reflects improvements in diagnosis and identification of autism spectrum disorder (ASD), not an increase in incidence, study authors with the CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network told this news organization.

Using a new surveillance methodology, researchers found that 2.3% of 8-year-olds in communities in 11 states across the United States had an autism diagnosis in 2018, up from 1.9% in 2016.

A separate report on early identification in 4-year-olds shows that children born in 2014 were 50% more likely to receive an autism diagnosis or ASD special education classification by 48 months of age than those born in 2010, signaling improved early diagnosis.

Taken together, the data suggest efforts to raise awareness about autism are working, though researchers were quick to say much work remains.

“It was not surprising to me and in fact it was reassuring that the number of children diagnosed with autism is higher and is actually approaching prevalence of autism that has been noted in some national surveys of parents,” Stuart Shapira, MD, PhD, associate director for science in CDC’s National Center on Birth Defects and Developmental Disability, told this news organization.

“It means we’re doing a better job of identifying children, which helps to get them into services earlier so they can achieve their best developmental outcome.”

The studies, published online in Morbidity and Mortality Weekly Report, are the first to use a new ASD surveillance protocol that relies on ASD diagnosis or special education classification and billing codes and eliminates comprehensive records analysis by trained clinician reviewers.

Racial disparities

The updated methodology was less labor intensive and reduced the time it took to produce the report, but it is not without its critics, who claim the new protocol will undercount the number of children with ASD.

Created in 2000 and funded by the CDC, the ADDM Network is the only surveillance program in the United States that tracks the number and characteristics of children with ASD in multiple communities in the U.S.

When ADDM released its first report in 2007 from six states and based on data from the year 2000, ASD prevalence was 6.7 per 1,000 children, or 1 in 150 children.

In the latest report, which includes data from 2018, the autism prevalence rate across 11 states was 23.0 per 1,000 children, or 1 in 44 children.

That rate is closer to reported autism prevalence from the National Survey of Children’s Health and the National Health Interview Survey, both of which rely on parent-reported ASD diagnoses.

For the report, researchers analyzed medical and special education records of 220,281 children who were born in 2010 in Arizona, Arkansas, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, Tennessee, Utah, and Wisconsin.

Children were counted as having autism if their records included an ASD diagnosis, a special education classification of ASD, or an ASD International Classification of Diseases (ICD) code. A total of 5,058 children met those criteria.

Rates of ASD ranged from a low of 1.7% in Missouri to 3.9% in California and were 4.2 times higher in boys than in girls. Just under half of the children with ASD were evaluated by age 36 months.

Although the overall ASD prevalence was similar among White, Black, Hispanic, and Asian/Pacific Islander children, the report highlighted a number of other racial disparities overall and in individual states.

For example, among those with ASD and data on cognitive ability, 35.2% had an intelligence quotient score of 70 or lower. Black children with ASD were far more likely to have an IQ of 70 or less (49.8%) than Hispanic (33.1%) or White (29.7%) children.

“The persistent disparities in co-occurring intellectual disabilities in children with autism is something that we continue to see and suggests that we need to better understand exactly what’s happening,” Matthew Maenner, PhD, an epidemiologist and autism surveillance team lead with the CDC’s National Center on Birth Defects and Developmental Disabilities, told this news organization.

Another long-standing trend observed again in the new report on prevalence among 8-year-olds is low ASD prevalence among Hispanic children. While the overall estimate showed similar autism rates, a closer review of state-level data reveals a different picture.

“In almost half of the sites, Hispanic children were less likely to be identified as having ASD,” he said. “This gets lost if you look only at the overall estimate.”

New methodology

When ADDM released its first report in 2007, autism diagnosis was widely inadequate in the United States. Relying on only confirmed ASD diagnoses would significantly underestimate the number of children with the disorder, so the CDC added “active case finding” to the protocol.

Trained clinician reviewers analyzed individual notes from medical and educational records for every 8-year-old in ADDM Network sites, looking for evidence of characteristics and behaviors associated with autism. The process was labor- and time-intensive and took up to 4 years to complete.

In 2018, the CDC began investigating ways to speed the process and came up with the strategy used in the latest report. The new protocol was faster, easier, and less expensive. Although he says cost was never the deciding factor, Dr. Maenner acknowledges that had they stuck with the original protocol, they would have been forced to reduce the number of ADDM Network sites.

Dr. Maenner argues that a comparison of the two protocols shows the new method doesn’t compromise accuracy and may actually capture children who lacked the medical or educational records the previous protocol required for a count. But not everyone agrees.

“I thought the point was to be as accurate and complete as possible in doing the surveillance,” Walter Zahorodny, PhD, associate professor of pediatrics at Rutgers University, New Brunswick, N.J., and principal investigator of the New Jersey ADDM Network site, told this news organization. “In states where there’s a high detail of information in records, like New Jersey, it’s going to underestimate the count.”

Dr. Zahorodny says the latest data prove his point. In 2016, under the old methodology, ASD prevalence was 3.1% in the state. In 2018, under the new protocol, prevalence was 2.84%, a decrease of about 20% that Dr. Zahorodny pins squarely on the elimination of ADDM clinical reviewers.

But New Jersey is the only state that participated in both the 2016 and 2018 surveillance periods to report a decrease in ASD prevalence. The other eight states all found autism rates in their states went up.

Sydney Pettygrove, PhD, associate professor of public health and pediatrics at the University of Arizona, Tucson, and a principal investigator for the ADDM site in Arizona, told this news organization that when she first learned the CDC was rolling out a new methodology, she and other investigators were concerned.

“People were really upset. I was really upset,” she said. “I had formed an opinion based on the earlier data that this would not be a good idea.”

In 2000, when ASD surveillance began in Arizona, nearly 30% of children identified by ADDM clinical reviewers as having autism had no mention of the disorder in their records. Today, that percentage is closer to 5%.

“In 2000 it would have been catastrophic to try to estimate the prevalence of autism with the new protocol,” said Dr. Pettygrove. As it turns out, under the new protocol, prevalence rates in Arizona increased from 16.0 per 1,000 children in 2016 to 24.9 in 2018.

Built-in bias eliminated?

In addition to speeding up the process, the new methodology might have other benefits as well. Under the old ADDM surveillance protocol, children who lacked certain medical or educational records did not meet the ASD case definition and weren’t counted.

A 2019 study showed that this disproportionately affected Black and Hispanic children, who had significantly less access to health care professionals than White children.

As a result, “the old methodology had a bias built into it,” Maureen Durkin, PhD, DrPH, coauthor of that study and chair of population health sciences at the University of Wisconsin–Madison and principal investigator for the ADDM site in Wisconsin, told this news organization.

“Clinician reviewers ended up putting these children in the ‘suspected ASD’ category because they couldn’t call it a case under the case definition,” Dr. Durkin said. “There was a fairly large percentage of suspected cases and a disproportionate number of those kids were children of color.”

Although she can’t say for sure, Dr. Durkin said it’s possible the new protocol could eliminate some of that bias.

CDC researchers also attribute the new method to an expanded study of early diagnosis among 4-year-olds. In previous years, only a handful of the ADDM Network sites participating in the 8-year-old surveillance project also studied early diagnosis in 4-year-olds.

This year, all 11 sites took part in the early diagnosis analysis, tripling the number of children included in the analysis. That made it possible to include, for the first time, Asian/Pacific Islander children in this analysis.

In the past, ASD prevalence has trended higher in White children, compared with other racial groups. The new data found that ASD prevalence among 4-year-olds was significantly lower in White children (12.9 per 1,000 children) than in Black, Hispanic, or Asian/Pacific Islander children (16.6, 21.1, and 22.7 per 1,000, respectively). Prevalence in American Indian/Alaska Native children was the lowest among all racial groups (11.5 per 1,000).

It’s the first time researchers have seen this pattern in any ADDM report, Kelly Shaw, PhD, lead author of that study and an epidemiologist with the National Center on Birth Defects and Developmental Disability at the CDC, told this news organization.

These data don’t provide clues about the potential cause of that disparity, Dr. Shaw said. It’s likely an indication of better identification of ASD in those communities, she said, and not a sign of increased incidence of autism among Black, Hispanic, or Asian/Pacific Islander children.

“We don’t have any evidence to suggest or expect that autism would be increasing differentially among groups,” Dr. Shaw said.

The data suggest “we are making some progress but there certainly is still room for improvement,” Dr. Shaw said.

Study authors report no conflicts of interest.

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

Childhood autism rates are at the highest level since the Centers for Disease Control and Prevention began tracking the disorder in 2000, new data released Dec. 2 show.

The increase likely reflects improvements in diagnosis and identification of autism spectrum disorder (ASD), not an increase in incidence, study authors with the CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network told this news organization.

Using a new surveillance methodology, researchers found that 2.3% of 8-year-olds in communities in 11 states across the United States had an autism diagnosis in 2018, up from 1.9% in 2016.

A separate report on early identification in 4-year-olds shows that children born in 2014 were 50% more likely to receive an autism diagnosis or ASD special education classification by 48 months of age than those born in 2010, signaling improved early diagnosis.

Taken together, the data suggest efforts to raise awareness about autism are working, though researchers were quick to say much work remains.

“It was not surprising to me and in fact it was reassuring that the number of children diagnosed with autism is higher and is actually approaching prevalence of autism that has been noted in some national surveys of parents,” Stuart Shapira, MD, PhD, associate director for science in CDC’s National Center on Birth Defects and Developmental Disability, told this news organization.

“It means we’re doing a better job of identifying children, which helps to get them into services earlier so they can achieve their best developmental outcome.”

The studies, published online in Morbidity and Mortality Weekly Report, are the first to use a new ASD surveillance protocol that relies on ASD diagnosis or special education classification and billing codes and eliminates comprehensive records analysis by trained clinician reviewers.

Racial disparities

The updated methodology was less labor intensive and reduced the time it took to produce the report, but it is not without its critics, who claim the new protocol will undercount the number of children with ASD.

Created in 2000 and funded by the CDC, the ADDM Network is the only surveillance program in the United States that tracks the number and characteristics of children with ASD in multiple communities in the U.S.

When ADDM released its first report in 2007 from six states and based on data from the year 2000, ASD prevalence was 6.7 per 1,000 children, or 1 in 150 children.

In the latest report, which includes data from 2018, the autism prevalence rate across 11 states was 23.0 per 1,000 children, or 1 in 44 children.

That rate is closer to reported autism prevalence from the National Survey of Children’s Health and the National Health Interview Survey, both of which rely on parent-reported ASD diagnoses.

For the report, researchers analyzed medical and special education records of 220,281 children who were born in 2010 in Arizona, Arkansas, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, Tennessee, Utah, and Wisconsin.

Children were counted as having autism if their records included an ASD diagnosis, a special education classification of ASD, or an ASD International Classification of Diseases (ICD) code. A total of 5,058 children met those criteria.

Rates of ASD ranged from a low of 1.7% in Missouri to 3.9% in California and were 4.2 times higher in boys than in girls. Just under half of the children with ASD were evaluated by age 36 months.

Although the overall ASD prevalence was similar among White, Black, Hispanic, and Asian/Pacific Islander children, the report highlighted a number of other racial disparities overall and in individual states.

For example, among those with ASD and data on cognitive ability, 35.2% had an intelligence quotient score of 70 or lower. Black children with ASD were far more likely to have an IQ of 70 or less (49.8%) than Hispanic (33.1%) or White (29.7%) children.

“The persistent disparities in co-occurring intellectual disabilities in children with autism is something that we continue to see and suggests that we need to better understand exactly what’s happening,” Matthew Maenner, PhD, an epidemiologist and autism surveillance team lead with the CDC’s National Center on Birth Defects and Developmental Disabilities, told this news organization.

Another long-standing trend observed again in the new report on prevalence among 8-year-olds is low ASD prevalence among Hispanic children. While the overall estimate showed similar autism rates, a closer review of state-level data reveals a different picture.

“In almost half of the sites, Hispanic children were less likely to be identified as having ASD,” he said. “This gets lost if you look only at the overall estimate.”

New methodology

When ADDM released its first report in 2007, autism diagnosis was widely inadequate in the United States. Relying on only confirmed ASD diagnoses would significantly underestimate the number of children with the disorder, so the CDC added “active case finding” to the protocol.

Trained clinician reviewers analyzed individual notes from medical and educational records for every 8-year-old in ADDM Network sites, looking for evidence of characteristics and behaviors associated with autism. The process was labor- and time-intensive and took up to 4 years to complete.

In 2018, the CDC began investigating ways to speed the process and came up with the strategy used in the latest report. The new protocol was faster, easier, and less expensive. Although he says cost was never the deciding factor, Dr. Maenner acknowledges that had they stuck with the original protocol, they would have been forced to reduce the number of ADDM Network sites.

Dr. Maenner argues that a comparison of the two protocols shows the new method doesn’t compromise accuracy and may actually capture children who lacked the medical or educational records the previous protocol required for a count. But not everyone agrees.

“I thought the point was to be as accurate and complete as possible in doing the surveillance,” Walter Zahorodny, PhD, associate professor of pediatrics at Rutgers University, New Brunswick, N.J., and principal investigator of the New Jersey ADDM Network site, told this news organization. “In states where there’s a high detail of information in records, like New Jersey, it’s going to underestimate the count.”

Dr. Zahorodny says the latest data prove his point. In 2016, under the old methodology, ASD prevalence was 3.1% in the state. In 2018, under the new protocol, prevalence was 2.84%, a decrease of about 20% that Dr. Zahorodny pins squarely on the elimination of ADDM clinical reviewers.

But New Jersey is the only state that participated in both the 2016 and 2018 surveillance periods to report a decrease in ASD prevalence. The other eight states all found autism rates in their states went up.

Sydney Pettygrove, PhD, associate professor of public health and pediatrics at the University of Arizona, Tucson, and a principal investigator for the ADDM site in Arizona, told this news organization that when she first learned the CDC was rolling out a new methodology, she and other investigators were concerned.

“People were really upset. I was really upset,” she said. “I had formed an opinion based on the earlier data that this would not be a good idea.”

In 2000, when ASD surveillance began in Arizona, nearly 30% of children identified by ADDM clinical reviewers as having autism had no mention of the disorder in their records. Today, that percentage is closer to 5%.

“In 2000 it would have been catastrophic to try to estimate the prevalence of autism with the new protocol,” said Dr. Pettygrove. As it turns out, under the new protocol, prevalence rates in Arizona increased from 16.0 per 1,000 children in 2016 to 24.9 in 2018.

Built-in bias eliminated?

In addition to speeding up the process, the new methodology might have other benefits as well. Under the old ADDM surveillance protocol, children who lacked certain medical or educational records did not meet the ASD case definition and weren’t counted.

A 2019 study showed that this disproportionately affected Black and Hispanic children, who had significantly less access to health care professionals than White children.

As a result, “the old methodology had a bias built into it,” Maureen Durkin, PhD, DrPH, coauthor of that study and chair of population health sciences at the University of Wisconsin–Madison and principal investigator for the ADDM site in Wisconsin, told this news organization.

“Clinician reviewers ended up putting these children in the ‘suspected ASD’ category because they couldn’t call it a case under the case definition,” Dr. Durkin said. “There was a fairly large percentage of suspected cases and a disproportionate number of those kids were children of color.”

Although she can’t say for sure, Dr. Durkin said it’s possible the new protocol could eliminate some of that bias.

CDC researchers also attribute the new method to an expanded study of early diagnosis among 4-year-olds. In previous years, only a handful of the ADDM Network sites participating in the 8-year-old surveillance project also studied early diagnosis in 4-year-olds.

This year, all 11 sites took part in the early diagnosis analysis, tripling the number of children included in the analysis. That made it possible to include, for the first time, Asian/Pacific Islander children in this analysis.

In the past, ASD prevalence has trended higher in White children, compared with other racial groups. The new data found that ASD prevalence among 4-year-olds was significantly lower in White children (12.9 per 1,000 children) than in Black, Hispanic, or Asian/Pacific Islander children (16.6, 21.1, and 22.7 per 1,000, respectively). Prevalence in American Indian/Alaska Native children was the lowest among all racial groups (11.5 per 1,000).

It’s the first time researchers have seen this pattern in any ADDM report, Kelly Shaw, PhD, lead author of that study and an epidemiologist with the National Center on Birth Defects and Developmental Disability at the CDC, told this news organization.

These data don’t provide clues about the potential cause of that disparity, Dr. Shaw said. It’s likely an indication of better identification of ASD in those communities, she said, and not a sign of increased incidence of autism among Black, Hispanic, or Asian/Pacific Islander children.

“We don’t have any evidence to suggest or expect that autism would be increasing differentially among groups,” Dr. Shaw said.

The data suggest “we are making some progress but there certainly is still room for improvement,” Dr. Shaw said.

Study authors report no conflicts of interest.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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