Analysis boosts fluvoxamine for COVID, but what’s the evidence?

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There’s a strong likelihood that the antidepressant fluvoxamine (Luvox) may moderately lower rates of hospitalization caused by COVID-19 in unvaccinated patients, a new systematic review and meta-analysis has found. But outside experts differ over whether the evidence from just three studies is strong enough to warrant adding the drug to the COVID-19 armamentarium.

The report, published online in JAMA Network Open, looked at three studies and estimated that the drug could reduce the relative risk of hospitalization by around 25% (likelihood of moderate effect, 81.6%-91.8%), depending on the type of analysis used.

“This research might be valuable, but the jury remains out until several other adequately powered and designed trials are completed,” said infectious disease specialist Carl J. Fichtenbaum, MD, of the University of Cincinnati, who’s familiar with the findings. “I’m not sure how useful this is given we have several antiviral agents available. Why would we choose this over Paxlovid, remdesivir, or molnupiravir?”

According to Dr. Fichtenbaum, researchers began focusing on fluvoxamine after case reports about patients improving while on the medication. This led to further interest, he said, boosted by the drug’s known ability to dampen the immune system.

A Silicon Valley investor and antivaccine activist named Steve Kirsch has been pushing the drug along with the debunked treatment hydroxychloroquine. He’s accused the government of a cover-up of fluvoxamine’s worth, according to MIT Technology Review, and he wrote a commentary that referred to the drug as “the fast, easy, safe, simple, low-cost solution to COVID that works 100% of the time that nobody wants to talk about.”

For the new analysis, researchers examined three randomized clinical trials with a total of 2,196 participants. The most extensive trial, the TOGETHER study in Brazil (n = 1,497), focused on an unusual outcome: It linked the drug to a 32% reduction in relative risk of patients with COVID-19 being hospitalized in an ED for fewer than 6 hours or transferred to a tertiary hospital because of the disease.

Another study, the STOP COVID 2 trial in the United States and Canada (n = 547), was stopped because too few patients could be recruited to provide useful results. The initial phase of this trial, STOP COVID 1 (n = 152), was also included in the analysis.

All participants in the three studies were unvaccinated. Their median age was 46-50 years, 55%-72% were women, and 44%-56% were obese. Most were multiracial due to the high number of participants from Brazil.

“In the Bayesian analyses, the pooled risk ratio in favor of fluvoxamine was 0.78 (95% confidence interval, 0.58-1.08) for the weakly neutral prior and 0.73 (95% CI, 0.53-1.01) for the moderately optimistic prior,” the researchers reported, referring to a reduction in risk of hospitalization. “In the frequentist meta-analysis, the pooled risk ratio in favor of fluvoxamine was 0.75 (95% CI, 0.58-0.97; I2, 0.2%).”

Two of the authors of the new analysis were also coauthors of the TOGETHER trial and both STOP COVID trials.

Corresponding author Emily G. McDonald, MD, division of experimental medicine at McGill University, Montreal, said in an interview that the findings show fluvoxamine “very likely reduces hospitalization in high-risk outpatient adults with COVID-19. This effect varies depending on your baseline risk of developing complications in the first place.”

Dr. McDonald added that “fluvoxamine is an option to reduce hospitalizations in high-risk adults. It is likely effective, is inexpensive, and has a long safety track record.” She also noted that “not all countries have access to Paxlovid, and some people have drug interactions that preclude its use. Existing monoclonals are not effective with newer variants.”

The drug’s apparent anti-inflammatory properties seem to be key, she said. According to her, the next steps should be “testing lower doses to see if they remain effective, following patients long term to see what impact there is on long COVID symptoms, testing related medications in the drug class to see if they also show an effect, and testing in vaccinated people and with newer variants.”

In an interview, biostatistician James Watson, PhD, of the Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand, and Nuffield department of medicine, University of Oxford, England, said the findings of the analysis are “not overwhelming data.”

He noted the TOGETHER study’s unusual focus on ED visits that latest fewer than 6 hours, which he described as “not a very objective endpoint.” The new meta-analysis focused instead on “outcome data on emergency department visits lasting more than 24 hours and used this as a more representative proxy for hospital admission than an ED visit alone.”

Dr. Fichtenbaum also highlighted the odd endpoint. “Most of us would have chosen something like use of oxygen, requirement for ventilation, or death,” he said. “There are many reasons why people go to the ED. This endpoint is not very strong.”

He also noted that the three studies “are very different in design and endpoints.”

Jeffrey S. Morris, PhD, a biostatistician at the University of Pennsylvania, Philadelphia, offered a different perspective about the findings in an interview. “There’s good evidence that it helps some,” he said, and may reduce hospitalizations by 10%. “If the pill is super cheap and toxicity is very acceptable, it’s not adding additional risk. Most clinicians would say that: ‘If I’m reducing risk by 10%, it’s worthwhile.’ ”

No funding was reported. Two authors report having a patent application filed by Washington University for methods of treating COVID-19 during the conduct of the study. Dr. Watson is an investigator for studies analyzing antiviral drugs and Prozac as COVID-19 treatments. Dr. Fichtenbaum and Dr. Morris disclosed no relevant financial relationships.

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

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There’s a strong likelihood that the antidepressant fluvoxamine (Luvox) may moderately lower rates of hospitalization caused by COVID-19 in unvaccinated patients, a new systematic review and meta-analysis has found. But outside experts differ over whether the evidence from just three studies is strong enough to warrant adding the drug to the COVID-19 armamentarium.

The report, published online in JAMA Network Open, looked at three studies and estimated that the drug could reduce the relative risk of hospitalization by around 25% (likelihood of moderate effect, 81.6%-91.8%), depending on the type of analysis used.

“This research might be valuable, but the jury remains out until several other adequately powered and designed trials are completed,” said infectious disease specialist Carl J. Fichtenbaum, MD, of the University of Cincinnati, who’s familiar with the findings. “I’m not sure how useful this is given we have several antiviral agents available. Why would we choose this over Paxlovid, remdesivir, or molnupiravir?”

According to Dr. Fichtenbaum, researchers began focusing on fluvoxamine after case reports about patients improving while on the medication. This led to further interest, he said, boosted by the drug’s known ability to dampen the immune system.

A Silicon Valley investor and antivaccine activist named Steve Kirsch has been pushing the drug along with the debunked treatment hydroxychloroquine. He’s accused the government of a cover-up of fluvoxamine’s worth, according to MIT Technology Review, and he wrote a commentary that referred to the drug as “the fast, easy, safe, simple, low-cost solution to COVID that works 100% of the time that nobody wants to talk about.”

For the new analysis, researchers examined three randomized clinical trials with a total of 2,196 participants. The most extensive trial, the TOGETHER study in Brazil (n = 1,497), focused on an unusual outcome: It linked the drug to a 32% reduction in relative risk of patients with COVID-19 being hospitalized in an ED for fewer than 6 hours or transferred to a tertiary hospital because of the disease.

Another study, the STOP COVID 2 trial in the United States and Canada (n = 547), was stopped because too few patients could be recruited to provide useful results. The initial phase of this trial, STOP COVID 1 (n = 152), was also included in the analysis.

All participants in the three studies were unvaccinated. Their median age was 46-50 years, 55%-72% were women, and 44%-56% were obese. Most were multiracial due to the high number of participants from Brazil.

“In the Bayesian analyses, the pooled risk ratio in favor of fluvoxamine was 0.78 (95% confidence interval, 0.58-1.08) for the weakly neutral prior and 0.73 (95% CI, 0.53-1.01) for the moderately optimistic prior,” the researchers reported, referring to a reduction in risk of hospitalization. “In the frequentist meta-analysis, the pooled risk ratio in favor of fluvoxamine was 0.75 (95% CI, 0.58-0.97; I2, 0.2%).”

Two of the authors of the new analysis were also coauthors of the TOGETHER trial and both STOP COVID trials.

Corresponding author Emily G. McDonald, MD, division of experimental medicine at McGill University, Montreal, said in an interview that the findings show fluvoxamine “very likely reduces hospitalization in high-risk outpatient adults with COVID-19. This effect varies depending on your baseline risk of developing complications in the first place.”

Dr. McDonald added that “fluvoxamine is an option to reduce hospitalizations in high-risk adults. It is likely effective, is inexpensive, and has a long safety track record.” She also noted that “not all countries have access to Paxlovid, and some people have drug interactions that preclude its use. Existing monoclonals are not effective with newer variants.”

The drug’s apparent anti-inflammatory properties seem to be key, she said. According to her, the next steps should be “testing lower doses to see if they remain effective, following patients long term to see what impact there is on long COVID symptoms, testing related medications in the drug class to see if they also show an effect, and testing in vaccinated people and with newer variants.”

In an interview, biostatistician James Watson, PhD, of the Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand, and Nuffield department of medicine, University of Oxford, England, said the findings of the analysis are “not overwhelming data.”

He noted the TOGETHER study’s unusual focus on ED visits that latest fewer than 6 hours, which he described as “not a very objective endpoint.” The new meta-analysis focused instead on “outcome data on emergency department visits lasting more than 24 hours and used this as a more representative proxy for hospital admission than an ED visit alone.”

Dr. Fichtenbaum also highlighted the odd endpoint. “Most of us would have chosen something like use of oxygen, requirement for ventilation, or death,” he said. “There are many reasons why people go to the ED. This endpoint is not very strong.”

He also noted that the three studies “are very different in design and endpoints.”

Jeffrey S. Morris, PhD, a biostatistician at the University of Pennsylvania, Philadelphia, offered a different perspective about the findings in an interview. “There’s good evidence that it helps some,” he said, and may reduce hospitalizations by 10%. “If the pill is super cheap and toxicity is very acceptable, it’s not adding additional risk. Most clinicians would say that: ‘If I’m reducing risk by 10%, it’s worthwhile.’ ”

No funding was reported. Two authors report having a patent application filed by Washington University for methods of treating COVID-19 during the conduct of the study. Dr. Watson is an investigator for studies analyzing antiviral drugs and Prozac as COVID-19 treatments. Dr. Fichtenbaum and Dr. Morris disclosed no relevant financial relationships.

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

 

There’s a strong likelihood that the antidepressant fluvoxamine (Luvox) may moderately lower rates of hospitalization caused by COVID-19 in unvaccinated patients, a new systematic review and meta-analysis has found. But outside experts differ over whether the evidence from just three studies is strong enough to warrant adding the drug to the COVID-19 armamentarium.

The report, published online in JAMA Network Open, looked at three studies and estimated that the drug could reduce the relative risk of hospitalization by around 25% (likelihood of moderate effect, 81.6%-91.8%), depending on the type of analysis used.

“This research might be valuable, but the jury remains out until several other adequately powered and designed trials are completed,” said infectious disease specialist Carl J. Fichtenbaum, MD, of the University of Cincinnati, who’s familiar with the findings. “I’m not sure how useful this is given we have several antiviral agents available. Why would we choose this over Paxlovid, remdesivir, or molnupiravir?”

According to Dr. Fichtenbaum, researchers began focusing on fluvoxamine after case reports about patients improving while on the medication. This led to further interest, he said, boosted by the drug’s known ability to dampen the immune system.

A Silicon Valley investor and antivaccine activist named Steve Kirsch has been pushing the drug along with the debunked treatment hydroxychloroquine. He’s accused the government of a cover-up of fluvoxamine’s worth, according to MIT Technology Review, and he wrote a commentary that referred to the drug as “the fast, easy, safe, simple, low-cost solution to COVID that works 100% of the time that nobody wants to talk about.”

For the new analysis, researchers examined three randomized clinical trials with a total of 2,196 participants. The most extensive trial, the TOGETHER study in Brazil (n = 1,497), focused on an unusual outcome: It linked the drug to a 32% reduction in relative risk of patients with COVID-19 being hospitalized in an ED for fewer than 6 hours or transferred to a tertiary hospital because of the disease.

Another study, the STOP COVID 2 trial in the United States and Canada (n = 547), was stopped because too few patients could be recruited to provide useful results. The initial phase of this trial, STOP COVID 1 (n = 152), was also included in the analysis.

All participants in the three studies were unvaccinated. Their median age was 46-50 years, 55%-72% were women, and 44%-56% were obese. Most were multiracial due to the high number of participants from Brazil.

“In the Bayesian analyses, the pooled risk ratio in favor of fluvoxamine was 0.78 (95% confidence interval, 0.58-1.08) for the weakly neutral prior and 0.73 (95% CI, 0.53-1.01) for the moderately optimistic prior,” the researchers reported, referring to a reduction in risk of hospitalization. “In the frequentist meta-analysis, the pooled risk ratio in favor of fluvoxamine was 0.75 (95% CI, 0.58-0.97; I2, 0.2%).”

Two of the authors of the new analysis were also coauthors of the TOGETHER trial and both STOP COVID trials.

Corresponding author Emily G. McDonald, MD, division of experimental medicine at McGill University, Montreal, said in an interview that the findings show fluvoxamine “very likely reduces hospitalization in high-risk outpatient adults with COVID-19. This effect varies depending on your baseline risk of developing complications in the first place.”

Dr. McDonald added that “fluvoxamine is an option to reduce hospitalizations in high-risk adults. It is likely effective, is inexpensive, and has a long safety track record.” She also noted that “not all countries have access to Paxlovid, and some people have drug interactions that preclude its use. Existing monoclonals are not effective with newer variants.”

The drug’s apparent anti-inflammatory properties seem to be key, she said. According to her, the next steps should be “testing lower doses to see if they remain effective, following patients long term to see what impact there is on long COVID symptoms, testing related medications in the drug class to see if they also show an effect, and testing in vaccinated people and with newer variants.”

In an interview, biostatistician James Watson, PhD, of the Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand, and Nuffield department of medicine, University of Oxford, England, said the findings of the analysis are “not overwhelming data.”

He noted the TOGETHER study’s unusual focus on ED visits that latest fewer than 6 hours, which he described as “not a very objective endpoint.” The new meta-analysis focused instead on “outcome data on emergency department visits lasting more than 24 hours and used this as a more representative proxy for hospital admission than an ED visit alone.”

Dr. Fichtenbaum also highlighted the odd endpoint. “Most of us would have chosen something like use of oxygen, requirement for ventilation, or death,” he said. “There are many reasons why people go to the ED. This endpoint is not very strong.”

He also noted that the three studies “are very different in design and endpoints.”

Jeffrey S. Morris, PhD, a biostatistician at the University of Pennsylvania, Philadelphia, offered a different perspective about the findings in an interview. “There’s good evidence that it helps some,” he said, and may reduce hospitalizations by 10%. “If the pill is super cheap and toxicity is very acceptable, it’s not adding additional risk. Most clinicians would say that: ‘If I’m reducing risk by 10%, it’s worthwhile.’ ”

No funding was reported. Two authors report having a patent application filed by Washington University for methods of treating COVID-19 during the conduct of the study. Dr. Watson is an investigator for studies analyzing antiviral drugs and Prozac as COVID-19 treatments. Dr. Fichtenbaum and Dr. Morris disclosed no relevant financial relationships.

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

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COVID cases rising in about half of states

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Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

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

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Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

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

Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

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

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Study finds discrepancies in biopsy decisions, diagnoses based on skin type

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Among dermatology residents and attending dermatologists, rates of diagnostic accuracy and appropriate biopsy recommendations were significantly lower for patients with skin of color, compared with White patients, new research shows.

“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.

Dr. Loren Krueger
Loren Krueger, MD, assistant professor in the Department of Dermatology, Emory University. Atlanta


Disparities in dermatologic care among Black patients, compared with White patients, have been well documented. Recent evidence includes a 2020 study that showed significant shortcomings among medical students in correctly diagnosing squamous cell carcinoma, urticaria, and atopic dermatitis for patients with skin of color.

“It’s no secret that our images do not accurately or in the right quantity include skin of color,” Dr. Krueger said. “Yet few papers talk about how these biases actually impact our care. Importantly, this study demonstrates that diagnostic bias develops as early as the medical student level.”

To further investigate the role of skin color in the assessment of neoplastic and inflammatory skin conditions and decisions to perform biopsy, Dr. Krueger and her colleagues surveyed 144 dermatology residents and attending dermatologists to evaluate their clinical decisionmaking skills in assessing skin conditions for patients with lighter skin and those with darker skin. Almost 80% (113) provided complete responses and were included in the study.

For the survey, participants were shown photos of 10 neoplastic and 10 inflammatory skin conditions. Each image was matched in lighter (skin types I-II) and darker (skin types IV-VI) skinned patients in random order. Participants were asked to identify the suspected underlying etiology (neoplastic–benign, neoplastic–malignant, papulosquamous, lichenoid, infectious, bullous, or no suspected etiology) and whether they would choose to perform biopsy for the pictured condition.

Overall, their responses showed a slightly higher probability of recommending a biopsy for patients with skin types IV-V (odds ratio, 1.18; P = .054).

However, respondents were more than twice as likely to recommend a biopsy for benign neoplasms for patients with skin of color, compared with those with lighter skin types (OR, 2.57; P < .0001). They were significantly less likely to recommend a biopsy for a malignant neoplasm for patients with skin of color (OR, 0.42; P < .0001).

In addition, the correct etiology was much more commonly missed in diagnosing patients with skin of color, even after adjusting for years in dermatology practice (OR, 0.569; P < .0001).

Conversely, respondents were significantly less likely to recommend a biopsy for benign neoplasms and were more likely to recommend a biopsy for malignant neoplasms among White patients. Etiology was more commonly correct.



The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.

Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.

And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.

Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.

“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”

Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.

Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.

In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”

The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”

The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.

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

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Among dermatology residents and attending dermatologists, rates of diagnostic accuracy and appropriate biopsy recommendations were significantly lower for patients with skin of color, compared with White patients, new research shows.

“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.

Dr. Loren Krueger
Loren Krueger, MD, assistant professor in the Department of Dermatology, Emory University. Atlanta


Disparities in dermatologic care among Black patients, compared with White patients, have been well documented. Recent evidence includes a 2020 study that showed significant shortcomings among medical students in correctly diagnosing squamous cell carcinoma, urticaria, and atopic dermatitis for patients with skin of color.

“It’s no secret that our images do not accurately or in the right quantity include skin of color,” Dr. Krueger said. “Yet few papers talk about how these biases actually impact our care. Importantly, this study demonstrates that diagnostic bias develops as early as the medical student level.”

To further investigate the role of skin color in the assessment of neoplastic and inflammatory skin conditions and decisions to perform biopsy, Dr. Krueger and her colleagues surveyed 144 dermatology residents and attending dermatologists to evaluate their clinical decisionmaking skills in assessing skin conditions for patients with lighter skin and those with darker skin. Almost 80% (113) provided complete responses and were included in the study.

For the survey, participants were shown photos of 10 neoplastic and 10 inflammatory skin conditions. Each image was matched in lighter (skin types I-II) and darker (skin types IV-VI) skinned patients in random order. Participants were asked to identify the suspected underlying etiology (neoplastic–benign, neoplastic–malignant, papulosquamous, lichenoid, infectious, bullous, or no suspected etiology) and whether they would choose to perform biopsy for the pictured condition.

Overall, their responses showed a slightly higher probability of recommending a biopsy for patients with skin types IV-V (odds ratio, 1.18; P = .054).

However, respondents were more than twice as likely to recommend a biopsy for benign neoplasms for patients with skin of color, compared with those with lighter skin types (OR, 2.57; P < .0001). They were significantly less likely to recommend a biopsy for a malignant neoplasm for patients with skin of color (OR, 0.42; P < .0001).

In addition, the correct etiology was much more commonly missed in diagnosing patients with skin of color, even after adjusting for years in dermatology practice (OR, 0.569; P < .0001).

Conversely, respondents were significantly less likely to recommend a biopsy for benign neoplasms and were more likely to recommend a biopsy for malignant neoplasms among White patients. Etiology was more commonly correct.



The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.

Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.

And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.

Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.

“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”

Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.

Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.

In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”

The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”

The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.

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

Among dermatology residents and attending dermatologists, rates of diagnostic accuracy and appropriate biopsy recommendations were significantly lower for patients with skin of color, compared with White patients, new research shows.

“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.

Dr. Loren Krueger
Loren Krueger, MD, assistant professor in the Department of Dermatology, Emory University. Atlanta


Disparities in dermatologic care among Black patients, compared with White patients, have been well documented. Recent evidence includes a 2020 study that showed significant shortcomings among medical students in correctly diagnosing squamous cell carcinoma, urticaria, and atopic dermatitis for patients with skin of color.

“It’s no secret that our images do not accurately or in the right quantity include skin of color,” Dr. Krueger said. “Yet few papers talk about how these biases actually impact our care. Importantly, this study demonstrates that diagnostic bias develops as early as the medical student level.”

To further investigate the role of skin color in the assessment of neoplastic and inflammatory skin conditions and decisions to perform biopsy, Dr. Krueger and her colleagues surveyed 144 dermatology residents and attending dermatologists to evaluate their clinical decisionmaking skills in assessing skin conditions for patients with lighter skin and those with darker skin. Almost 80% (113) provided complete responses and were included in the study.

For the survey, participants were shown photos of 10 neoplastic and 10 inflammatory skin conditions. Each image was matched in lighter (skin types I-II) and darker (skin types IV-VI) skinned patients in random order. Participants were asked to identify the suspected underlying etiology (neoplastic–benign, neoplastic–malignant, papulosquamous, lichenoid, infectious, bullous, or no suspected etiology) and whether they would choose to perform biopsy for the pictured condition.

Overall, their responses showed a slightly higher probability of recommending a biopsy for patients with skin types IV-V (odds ratio, 1.18; P = .054).

However, respondents were more than twice as likely to recommend a biopsy for benign neoplasms for patients with skin of color, compared with those with lighter skin types (OR, 2.57; P < .0001). They were significantly less likely to recommend a biopsy for a malignant neoplasm for patients with skin of color (OR, 0.42; P < .0001).

In addition, the correct etiology was much more commonly missed in diagnosing patients with skin of color, even after adjusting for years in dermatology practice (OR, 0.569; P < .0001).

Conversely, respondents were significantly less likely to recommend a biopsy for benign neoplasms and were more likely to recommend a biopsy for malignant neoplasms among White patients. Etiology was more commonly correct.



The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.

Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.

And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.

Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.

“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”

Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.

Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.

In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”

The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”

The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.

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

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Ulcerating Nodule on the Foot

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Ulcerating Nodule on the Foot

The Diagnosis: Perforating Rheumatoid Nodule

Perforating rheumatoid nodule (RN) is a variant of RN that demonstrates necrobiotic material extruding through the epidermis via the process of transepidermal elimination.1 The necrobiotic material contains fibrin and often harbors karyorrhectic debris. The pathogenesis of RN remains unclear; possible mechanisms include a small vessel vasculitis or mechanical trauma inciting a localized aggregation of inflammatory products and rheumatoid factor complexes. This induces macrophage activation, fibrin deposition, and necrosis.2 The majority of patients with RNs have detectable rheumatoid factor and anticyclic citrullinated protein in the blood.3 Rheumatoid nodules are the most common cutaneous manifestations of rheumatoid arthritis (RA) and will develop in 30% to 40% of RA patients.4,5 They typically are associated with advanced RA but may precede the onset of clinically severe RA in 5% to 10% of patients.5 Rheumatoid nodules generally range in size from 2 mm to 5 cm and are slightly more prevalent in men than in women. They present as firm painless masses typically on the extensor surfaces of the hands and olecranon process but can occur over any tendinous or ligamentlike structure.6,7 Perforating RNs are most common on areas subjected to pressure or repeated trauma, such as the sacrum.

The diagnosis usually is clinical; however, in cases of diagnostic uncertainty, RN can be distinguished by its histologic appearance. Rheumatoid nodules demonstrate granulomatous palisading necrobiosis with a central zone of highly eosinophilic fibrinoid necrobiosis surrounded by palisading mononuclear cells and an outer zone of granulation tissue. There may be a mixed chronic inflammatory infiltrate predominantly composed of lymphocytes and histiocytes in the background.

Rheumatoid nodules typically do not require treatment; however, perforation is known to increase the risk for infection, and surgical excision generally is indicated for prophylaxis against infection, though nodules may recur in the excision area.1,3,8 Alternatively, disease-modifying antirheumatic drugs and intralesional corticosteroids may effectively reduce the size of RNs. The differential diagnosis for perforating RNs includes epithelioid sarcoma, perforating granuloma annulare, necrobiotic xanthogranuloma, and necrobiosis lipoidica.

Epithelioid sarcoma is a malignant soft tissue tumor typically found on the upper extremities of adolescent or young adult males. They usually present as hard tender nodules that commonly ulcerate. Epithelioid sarcoma makes up less than 1% of soft tissue sarcomas.9 Although rare, they present a diagnostic pitfall, as the histology may mimic an inflammatory palisaded granulomatous dermatitis similar to RN and granuloma annulare, thus a high index of suspicion is required to not overlook this aggressive malignancy. Histology is typified by nodular aggregates of epithelioid cells with abundant eosinophilic cytoplasm and often with central zones of necrosis (Figure 1). Epithelioid sarcoma displays immunoreactivity to cytokeratin, CD34, and epithelial membrane antigen, but loss of integrase interactor 1 expression. Cytologic abnormalities such as pleomorphism and hyperchromatism can be helpful in distinguishing between epithelioid sarcoma and RN.

Epithelioid sarcoma. Nodular pattern with central necrosis and dense hyalinized collagen deposits surrounded by a palisading inflammatory infiltrate
FIGURE 1. Epithelioid sarcoma. Nodular pattern with central necrosis and dense hyalinized collagen deposits surrounded by a palisading inflammatory infiltrate (H&E, original magnification ×100).

Perforating granuloma annulare is a rare subtype of granuloma annulare that presents with flesh- to red-colored papules that develop central crust or scale. Perforating granuloma annulare composes approximately 5% of granuloma annulare cases. Perforating granuloma annulare can develop on any region of the body but has an affinity for the extensor surfaces of the extremities. It most frequently occurs in young women and rarely presents as a single lesion.10 Granuloma annulare typically is not associated with joint pain, and thus it differs from most cases of RNs. Histologically, it presents with an inflammatory palisading granuloma. There may be overlying epidermal thinning or parakeratosis, which can progress to perforation and extrusion of necrobiotic material. In comparison with RN, perforating granuloma annulare displays mucin deposition in the necrobiotic zones in lieu of fibrin (Figure 2).10,11

Perforating granuloma annulare
FIGURE 2. Perforating granuloma annulare. Zones of necrobiosis surrounded by palisading macrophages and lymphocytes (H&E, original magnification ×400).

Necrobiotic xanthogranuloma is a rare chronic form of non-Langerhans histiocytosis that characteristically presents with yellow or violaceous indurated plaques and nodules in a periorbital distribution. It often is associated with monoclonal gammopathy of IgG-κ. Lesions will ulcerate in 40% to 50% of patients.12 The mean age at presentation is in the sixth decade of life, and it is moderately predominant in females.13 Histopathology demonstrates palisading granulomatous formations with a lymphoplasmacytic infiltrate and zones of necrobiosis in the mid dermis extending into the panniculus. Characteristic histologic features that are variably present in necrobiotic xanthogranuloma but typically absent in RN include neutrophilic debris, cholesterol clefts, and Touton or foreign body giant cells (Figure 3).13

Necrobiotic xanthogranuloma
FIGURE 3. Necrobiotic xanthogranuloma. Focal areas of necrobiotic collagen with abundant cholesterol clefts and giant cells (H&E, original magnification ×40).

Necrobiosis lipoidica is a rare chronic granulomatous disease characterized by well-demarcated, atrophic, yellow-brown plaques on the pretibial surfaces. It typically presents in the third decade of life in women, and most cases are associated with diabetes mellitus types 1 or 2 or autoimmune conditions.14 Necrobiosis lipoidica begins as asymptomatic papules that enlarge progressively over months to years. They can become pruritic or painful and often develop ulceration. Histopathology shows horizontal zones of palisading histiocytes with intervening necrobiosis. An inflammatory infiltrate containing plasma cells also may be present (Figure 4).

Necrobiosis lipoidica
FIGURE 4. Necrobiosis lipoidica. Horizontal zones of palisading histiocytes with intervening necrobiosis and an inflammatory infiltrate (H&E, original magnification ×20).
References
  1. Horn RT Jr, Goette DK. Perforating rheumatoid nodule. Arch Dermatol. 1982;118:696-697.
  2. Tilstra JS, Lienesch DW. Rheumatoid nodules. Dermatol Clin. 2015;33:361-371. doi:10.1016/j.det.2015.03.004
  3. Kaye BR, Kaye RL, Bobrove A. Rheumatoid nodules. review of the spectrum of associated conditions and proposal of a new classification, with a report of four seronegative cases. Am J Med. 1984;76:279-292. doi:10.1016/0002-9343(84)90787-3
  4. Nyhäll-Wåhlin BM, Jacobsson LT, Petersson IF, et al; BARFOT study group. Smoking is a strong risk factor for rheumatoid nodules in early rheumatoid arthritis. Ann Rheum Dis. 2006;65:601-606. doi:10.1136/ard.2005.039172
  5. Turesson C, O’Fallon WM, Crowson CS, et al. Occurrence of extraarticular disease manifestations is associated with excess mortality in a community-based cohort of patients with rheumatoid arthritis. J Rheumatol. 2002;29:62-67.
  6. Bang S, Kim Y, Jang K, et al. Clinicopathologic features of rheumatoid nodules: a retrospective analysis. Clin Rheumatol. 2019;38:3041-3048. doi:10.1007/s10067-019-04668-1
  7. Chaganti S, Joshy S, Hariharan K, et al. Rheumatoid nodule presenting as Morton’s neuroma. J Orthop Traumatol. 2013;14:219-222. doi:10.1007/s10195-012-0215-x
  8. Sayah A, English JC 3rd. Rheumatoid arthritis: a review of the cutaneous manifestations. J Am Acad Dermatol. 2005;53:191-209; quiz 210-212. doi:10.1016/j.jaad.2004.07.023
  9. de Visscher SA, van Ginkel RJ, Wobbes T, et al. Epithelioid sarcoma: still an only surgically curable disease. Cancer. 2006;107:606-612. doi:10.1002/cncr.22037
  10. Penas PF, Jones-Caballero M, Fraga J, et al. Perforating granuloma annulare. Int J Dermatol. 1997;36:340-348. doi:10.1046 /j.1365-4362.1997.00047.x
  11. Gale M, Gilbert E, Blumenthal D. Isolated rheumatoid nodules: a diagnostic dilemma. Case Rep Med. 2015;2015:352352. doi:10.1155/2015/352352
  12. Wood AJ, Wagner MV, Abbott JJ, et al. Necrobiotic xanthogranuloma: a review of 17 cases with emphasis on clinical and pathologic correlation. Arch Dermatol. 2009;145:279-284. doi:10.1001 /archdermatol.2008.583
  13. Nelson CA, Zhong CS, Hashemi DA, et al. A multicenter crosssectional study and systematic review of necrobiotic xanthogranuloma with proposed diagnostic criteria. JAMA Dermatol. 2020;156:270-279. doi:10.1001/jamadermatol.2019.4221
  14. Sibbald C, Reid S, Alavi A. Necrobiosis lipoidica. Dermatol Clin. 2015;33:343-360. doi:10.1016/j.det.2015.03.003
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Mr. Horeczko and Dr. Cardis are from the School of Medicine, Georgetown University, Washington, DC. Dr. Steinberg is from the Center for Wound Healing, Medstar Georgetown University Hospital. Dr. Cardis also is from the Department of Dermatology, Medstar Washington Hospital Center/Georgetown University Hospital.

The authors report no conflict of interest.

Correspondence: Michael A. Cardis, MD, 5530 Wisconsin Ave, Chevy Chase, MD 20815 ([email protected]).

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Mr. Horeczko and Dr. Cardis are from the School of Medicine, Georgetown University, Washington, DC. Dr. Steinberg is from the Center for Wound Healing, Medstar Georgetown University Hospital. Dr. Cardis also is from the Department of Dermatology, Medstar Washington Hospital Center/Georgetown University Hospital.

The authors report no conflict of interest.

Correspondence: Michael A. Cardis, MD, 5530 Wisconsin Ave, Chevy Chase, MD 20815 ([email protected]).

Author and Disclosure Information

Mr. Horeczko and Dr. Cardis are from the School of Medicine, Georgetown University, Washington, DC. Dr. Steinberg is from the Center for Wound Healing, Medstar Georgetown University Hospital. Dr. Cardis also is from the Department of Dermatology, Medstar Washington Hospital Center/Georgetown University Hospital.

The authors report no conflict of interest.

Correspondence: Michael A. Cardis, MD, 5530 Wisconsin Ave, Chevy Chase, MD 20815 ([email protected]).

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The Diagnosis: Perforating Rheumatoid Nodule

Perforating rheumatoid nodule (RN) is a variant of RN that demonstrates necrobiotic material extruding through the epidermis via the process of transepidermal elimination.1 The necrobiotic material contains fibrin and often harbors karyorrhectic debris. The pathogenesis of RN remains unclear; possible mechanisms include a small vessel vasculitis or mechanical trauma inciting a localized aggregation of inflammatory products and rheumatoid factor complexes. This induces macrophage activation, fibrin deposition, and necrosis.2 The majority of patients with RNs have detectable rheumatoid factor and anticyclic citrullinated protein in the blood.3 Rheumatoid nodules are the most common cutaneous manifestations of rheumatoid arthritis (RA) and will develop in 30% to 40% of RA patients.4,5 They typically are associated with advanced RA but may precede the onset of clinically severe RA in 5% to 10% of patients.5 Rheumatoid nodules generally range in size from 2 mm to 5 cm and are slightly more prevalent in men than in women. They present as firm painless masses typically on the extensor surfaces of the hands and olecranon process but can occur over any tendinous or ligamentlike structure.6,7 Perforating RNs are most common on areas subjected to pressure or repeated trauma, such as the sacrum.

The diagnosis usually is clinical; however, in cases of diagnostic uncertainty, RN can be distinguished by its histologic appearance. Rheumatoid nodules demonstrate granulomatous palisading necrobiosis with a central zone of highly eosinophilic fibrinoid necrobiosis surrounded by palisading mononuclear cells and an outer zone of granulation tissue. There may be a mixed chronic inflammatory infiltrate predominantly composed of lymphocytes and histiocytes in the background.

Rheumatoid nodules typically do not require treatment; however, perforation is known to increase the risk for infection, and surgical excision generally is indicated for prophylaxis against infection, though nodules may recur in the excision area.1,3,8 Alternatively, disease-modifying antirheumatic drugs and intralesional corticosteroids may effectively reduce the size of RNs. The differential diagnosis for perforating RNs includes epithelioid sarcoma, perforating granuloma annulare, necrobiotic xanthogranuloma, and necrobiosis lipoidica.

Epithelioid sarcoma is a malignant soft tissue tumor typically found on the upper extremities of adolescent or young adult males. They usually present as hard tender nodules that commonly ulcerate. Epithelioid sarcoma makes up less than 1% of soft tissue sarcomas.9 Although rare, they present a diagnostic pitfall, as the histology may mimic an inflammatory palisaded granulomatous dermatitis similar to RN and granuloma annulare, thus a high index of suspicion is required to not overlook this aggressive malignancy. Histology is typified by nodular aggregates of epithelioid cells with abundant eosinophilic cytoplasm and often with central zones of necrosis (Figure 1). Epithelioid sarcoma displays immunoreactivity to cytokeratin, CD34, and epithelial membrane antigen, but loss of integrase interactor 1 expression. Cytologic abnormalities such as pleomorphism and hyperchromatism can be helpful in distinguishing between epithelioid sarcoma and RN.

Epithelioid sarcoma. Nodular pattern with central necrosis and dense hyalinized collagen deposits surrounded by a palisading inflammatory infiltrate
FIGURE 1. Epithelioid sarcoma. Nodular pattern with central necrosis and dense hyalinized collagen deposits surrounded by a palisading inflammatory infiltrate (H&E, original magnification ×100).

Perforating granuloma annulare is a rare subtype of granuloma annulare that presents with flesh- to red-colored papules that develop central crust or scale. Perforating granuloma annulare composes approximately 5% of granuloma annulare cases. Perforating granuloma annulare can develop on any region of the body but has an affinity for the extensor surfaces of the extremities. It most frequently occurs in young women and rarely presents as a single lesion.10 Granuloma annulare typically is not associated with joint pain, and thus it differs from most cases of RNs. Histologically, it presents with an inflammatory palisading granuloma. There may be overlying epidermal thinning or parakeratosis, which can progress to perforation and extrusion of necrobiotic material. In comparison with RN, perforating granuloma annulare displays mucin deposition in the necrobiotic zones in lieu of fibrin (Figure 2).10,11

Perforating granuloma annulare
FIGURE 2. Perforating granuloma annulare. Zones of necrobiosis surrounded by palisading macrophages and lymphocytes (H&E, original magnification ×400).

Necrobiotic xanthogranuloma is a rare chronic form of non-Langerhans histiocytosis that characteristically presents with yellow or violaceous indurated plaques and nodules in a periorbital distribution. It often is associated with monoclonal gammopathy of IgG-κ. Lesions will ulcerate in 40% to 50% of patients.12 The mean age at presentation is in the sixth decade of life, and it is moderately predominant in females.13 Histopathology demonstrates palisading granulomatous formations with a lymphoplasmacytic infiltrate and zones of necrobiosis in the mid dermis extending into the panniculus. Characteristic histologic features that are variably present in necrobiotic xanthogranuloma but typically absent in RN include neutrophilic debris, cholesterol clefts, and Touton or foreign body giant cells (Figure 3).13

Necrobiotic xanthogranuloma
FIGURE 3. Necrobiotic xanthogranuloma. Focal areas of necrobiotic collagen with abundant cholesterol clefts and giant cells (H&E, original magnification ×40).

Necrobiosis lipoidica is a rare chronic granulomatous disease characterized by well-demarcated, atrophic, yellow-brown plaques on the pretibial surfaces. It typically presents in the third decade of life in women, and most cases are associated with diabetes mellitus types 1 or 2 or autoimmune conditions.14 Necrobiosis lipoidica begins as asymptomatic papules that enlarge progressively over months to years. They can become pruritic or painful and often develop ulceration. Histopathology shows horizontal zones of palisading histiocytes with intervening necrobiosis. An inflammatory infiltrate containing plasma cells also may be present (Figure 4).

Necrobiosis lipoidica
FIGURE 4. Necrobiosis lipoidica. Horizontal zones of palisading histiocytes with intervening necrobiosis and an inflammatory infiltrate (H&E, original magnification ×20).

The Diagnosis: Perforating Rheumatoid Nodule

Perforating rheumatoid nodule (RN) is a variant of RN that demonstrates necrobiotic material extruding through the epidermis via the process of transepidermal elimination.1 The necrobiotic material contains fibrin and often harbors karyorrhectic debris. The pathogenesis of RN remains unclear; possible mechanisms include a small vessel vasculitis or mechanical trauma inciting a localized aggregation of inflammatory products and rheumatoid factor complexes. This induces macrophage activation, fibrin deposition, and necrosis.2 The majority of patients with RNs have detectable rheumatoid factor and anticyclic citrullinated protein in the blood.3 Rheumatoid nodules are the most common cutaneous manifestations of rheumatoid arthritis (RA) and will develop in 30% to 40% of RA patients.4,5 They typically are associated with advanced RA but may precede the onset of clinically severe RA in 5% to 10% of patients.5 Rheumatoid nodules generally range in size from 2 mm to 5 cm and are slightly more prevalent in men than in women. They present as firm painless masses typically on the extensor surfaces of the hands and olecranon process but can occur over any tendinous or ligamentlike structure.6,7 Perforating RNs are most common on areas subjected to pressure or repeated trauma, such as the sacrum.

The diagnosis usually is clinical; however, in cases of diagnostic uncertainty, RN can be distinguished by its histologic appearance. Rheumatoid nodules demonstrate granulomatous palisading necrobiosis with a central zone of highly eosinophilic fibrinoid necrobiosis surrounded by palisading mononuclear cells and an outer zone of granulation tissue. There may be a mixed chronic inflammatory infiltrate predominantly composed of lymphocytes and histiocytes in the background.

Rheumatoid nodules typically do not require treatment; however, perforation is known to increase the risk for infection, and surgical excision generally is indicated for prophylaxis against infection, though nodules may recur in the excision area.1,3,8 Alternatively, disease-modifying antirheumatic drugs and intralesional corticosteroids may effectively reduce the size of RNs. The differential diagnosis for perforating RNs includes epithelioid sarcoma, perforating granuloma annulare, necrobiotic xanthogranuloma, and necrobiosis lipoidica.

Epithelioid sarcoma is a malignant soft tissue tumor typically found on the upper extremities of adolescent or young adult males. They usually present as hard tender nodules that commonly ulcerate. Epithelioid sarcoma makes up less than 1% of soft tissue sarcomas.9 Although rare, they present a diagnostic pitfall, as the histology may mimic an inflammatory palisaded granulomatous dermatitis similar to RN and granuloma annulare, thus a high index of suspicion is required to not overlook this aggressive malignancy. Histology is typified by nodular aggregates of epithelioid cells with abundant eosinophilic cytoplasm and often with central zones of necrosis (Figure 1). Epithelioid sarcoma displays immunoreactivity to cytokeratin, CD34, and epithelial membrane antigen, but loss of integrase interactor 1 expression. Cytologic abnormalities such as pleomorphism and hyperchromatism can be helpful in distinguishing between epithelioid sarcoma and RN.

Epithelioid sarcoma. Nodular pattern with central necrosis and dense hyalinized collagen deposits surrounded by a palisading inflammatory infiltrate
FIGURE 1. Epithelioid sarcoma. Nodular pattern with central necrosis and dense hyalinized collagen deposits surrounded by a palisading inflammatory infiltrate (H&E, original magnification ×100).

Perforating granuloma annulare is a rare subtype of granuloma annulare that presents with flesh- to red-colored papules that develop central crust or scale. Perforating granuloma annulare composes approximately 5% of granuloma annulare cases. Perforating granuloma annulare can develop on any region of the body but has an affinity for the extensor surfaces of the extremities. It most frequently occurs in young women and rarely presents as a single lesion.10 Granuloma annulare typically is not associated with joint pain, and thus it differs from most cases of RNs. Histologically, it presents with an inflammatory palisading granuloma. There may be overlying epidermal thinning or parakeratosis, which can progress to perforation and extrusion of necrobiotic material. In comparison with RN, perforating granuloma annulare displays mucin deposition in the necrobiotic zones in lieu of fibrin (Figure 2).10,11

Perforating granuloma annulare
FIGURE 2. Perforating granuloma annulare. Zones of necrobiosis surrounded by palisading macrophages and lymphocytes (H&E, original magnification ×400).

Necrobiotic xanthogranuloma is a rare chronic form of non-Langerhans histiocytosis that characteristically presents with yellow or violaceous indurated plaques and nodules in a periorbital distribution. It often is associated with monoclonal gammopathy of IgG-κ. Lesions will ulcerate in 40% to 50% of patients.12 The mean age at presentation is in the sixth decade of life, and it is moderately predominant in females.13 Histopathology demonstrates palisading granulomatous formations with a lymphoplasmacytic infiltrate and zones of necrobiosis in the mid dermis extending into the panniculus. Characteristic histologic features that are variably present in necrobiotic xanthogranuloma but typically absent in RN include neutrophilic debris, cholesterol clefts, and Touton or foreign body giant cells (Figure 3).13

Necrobiotic xanthogranuloma
FIGURE 3. Necrobiotic xanthogranuloma. Focal areas of necrobiotic collagen with abundant cholesterol clefts and giant cells (H&E, original magnification ×40).

Necrobiosis lipoidica is a rare chronic granulomatous disease characterized by well-demarcated, atrophic, yellow-brown plaques on the pretibial surfaces. It typically presents in the third decade of life in women, and most cases are associated with diabetes mellitus types 1 or 2 or autoimmune conditions.14 Necrobiosis lipoidica begins as asymptomatic papules that enlarge progressively over months to years. They can become pruritic or painful and often develop ulceration. Histopathology shows horizontal zones of palisading histiocytes with intervening necrobiosis. An inflammatory infiltrate containing plasma cells also may be present (Figure 4).

Necrobiosis lipoidica
FIGURE 4. Necrobiosis lipoidica. Horizontal zones of palisading histiocytes with intervening necrobiosis and an inflammatory infiltrate (H&E, original magnification ×20).
References
  1. Horn RT Jr, Goette DK. Perforating rheumatoid nodule. Arch Dermatol. 1982;118:696-697.
  2. Tilstra JS, Lienesch DW. Rheumatoid nodules. Dermatol Clin. 2015;33:361-371. doi:10.1016/j.det.2015.03.004
  3. Kaye BR, Kaye RL, Bobrove A. Rheumatoid nodules. review of the spectrum of associated conditions and proposal of a new classification, with a report of four seronegative cases. Am J Med. 1984;76:279-292. doi:10.1016/0002-9343(84)90787-3
  4. Nyhäll-Wåhlin BM, Jacobsson LT, Petersson IF, et al; BARFOT study group. Smoking is a strong risk factor for rheumatoid nodules in early rheumatoid arthritis. Ann Rheum Dis. 2006;65:601-606. doi:10.1136/ard.2005.039172
  5. Turesson C, O’Fallon WM, Crowson CS, et al. Occurrence of extraarticular disease manifestations is associated with excess mortality in a community-based cohort of patients with rheumatoid arthritis. J Rheumatol. 2002;29:62-67.
  6. Bang S, Kim Y, Jang K, et al. Clinicopathologic features of rheumatoid nodules: a retrospective analysis. Clin Rheumatol. 2019;38:3041-3048. doi:10.1007/s10067-019-04668-1
  7. Chaganti S, Joshy S, Hariharan K, et al. Rheumatoid nodule presenting as Morton’s neuroma. J Orthop Traumatol. 2013;14:219-222. doi:10.1007/s10195-012-0215-x
  8. Sayah A, English JC 3rd. Rheumatoid arthritis: a review of the cutaneous manifestations. J Am Acad Dermatol. 2005;53:191-209; quiz 210-212. doi:10.1016/j.jaad.2004.07.023
  9. de Visscher SA, van Ginkel RJ, Wobbes T, et al. Epithelioid sarcoma: still an only surgically curable disease. Cancer. 2006;107:606-612. doi:10.1002/cncr.22037
  10. Penas PF, Jones-Caballero M, Fraga J, et al. Perforating granuloma annulare. Int J Dermatol. 1997;36:340-348. doi:10.1046 /j.1365-4362.1997.00047.x
  11. Gale M, Gilbert E, Blumenthal D. Isolated rheumatoid nodules: a diagnostic dilemma. Case Rep Med. 2015;2015:352352. doi:10.1155/2015/352352
  12. Wood AJ, Wagner MV, Abbott JJ, et al. Necrobiotic xanthogranuloma: a review of 17 cases with emphasis on clinical and pathologic correlation. Arch Dermatol. 2009;145:279-284. doi:10.1001 /archdermatol.2008.583
  13. Nelson CA, Zhong CS, Hashemi DA, et al. A multicenter crosssectional study and systematic review of necrobiotic xanthogranuloma with proposed diagnostic criteria. JAMA Dermatol. 2020;156:270-279. doi:10.1001/jamadermatol.2019.4221
  14. Sibbald C, Reid S, Alavi A. Necrobiosis lipoidica. Dermatol Clin. 2015;33:343-360. doi:10.1016/j.det.2015.03.003
References
  1. Horn RT Jr, Goette DK. Perforating rheumatoid nodule. Arch Dermatol. 1982;118:696-697.
  2. Tilstra JS, Lienesch DW. Rheumatoid nodules. Dermatol Clin. 2015;33:361-371. doi:10.1016/j.det.2015.03.004
  3. Kaye BR, Kaye RL, Bobrove A. Rheumatoid nodules. review of the spectrum of associated conditions and proposal of a new classification, with a report of four seronegative cases. Am J Med. 1984;76:279-292. doi:10.1016/0002-9343(84)90787-3
  4. Nyhäll-Wåhlin BM, Jacobsson LT, Petersson IF, et al; BARFOT study group. Smoking is a strong risk factor for rheumatoid nodules in early rheumatoid arthritis. Ann Rheum Dis. 2006;65:601-606. doi:10.1136/ard.2005.039172
  5. Turesson C, O’Fallon WM, Crowson CS, et al. Occurrence of extraarticular disease manifestations is associated with excess mortality in a community-based cohort of patients with rheumatoid arthritis. J Rheumatol. 2002;29:62-67.
  6. Bang S, Kim Y, Jang K, et al. Clinicopathologic features of rheumatoid nodules: a retrospective analysis. Clin Rheumatol. 2019;38:3041-3048. doi:10.1007/s10067-019-04668-1
  7. Chaganti S, Joshy S, Hariharan K, et al. Rheumatoid nodule presenting as Morton’s neuroma. J Orthop Traumatol. 2013;14:219-222. doi:10.1007/s10195-012-0215-x
  8. Sayah A, English JC 3rd. Rheumatoid arthritis: a review of the cutaneous manifestations. J Am Acad Dermatol. 2005;53:191-209; quiz 210-212. doi:10.1016/j.jaad.2004.07.023
  9. de Visscher SA, van Ginkel RJ, Wobbes T, et al. Epithelioid sarcoma: still an only surgically curable disease. Cancer. 2006;107:606-612. doi:10.1002/cncr.22037
  10. Penas PF, Jones-Caballero M, Fraga J, et al. Perforating granuloma annulare. Int J Dermatol. 1997;36:340-348. doi:10.1046 /j.1365-4362.1997.00047.x
  11. Gale M, Gilbert E, Blumenthal D. Isolated rheumatoid nodules: a diagnostic dilemma. Case Rep Med. 2015;2015:352352. doi:10.1155/2015/352352
  12. Wood AJ, Wagner MV, Abbott JJ, et al. Necrobiotic xanthogranuloma: a review of 17 cases with emphasis on clinical and pathologic correlation. Arch Dermatol. 2009;145:279-284. doi:10.1001 /archdermatol.2008.583
  13. Nelson CA, Zhong CS, Hashemi DA, et al. A multicenter crosssectional study and systematic review of necrobiotic xanthogranuloma with proposed diagnostic criteria. JAMA Dermatol. 2020;156:270-279. doi:10.1001/jamadermatol.2019.4221
  14. Sibbald C, Reid S, Alavi A. Necrobiosis lipoidica. Dermatol Clin. 2015;33:343-360. doi:10.1016/j.det.2015.03.003
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A 59-year-old woman with a history of joint pain presented with a foot nodule that developed over the course of 2 years. Physical examination revealed a firm, mobile, mildly tender, 3-cm, deep red nodule on the dorsal aspect of the left foot (top [inset]) with an overlying central epidermal defect and thick keratinaceous debris. The remainder of the physical examination was unremarkable. Empiric treatments with oral antibiotics and intralesional corticosteroids were unsuccessful. Incisional biopsy was performed for histologic review, and tissue culture studies were negative.

H&E, original magnification ×20; inset, clinical image of the foot.
H&E, original magnification ×20; inset, clinical image of the foot.

H&E, original magnification ×200.
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TNF inhibitor treatment models promote personalized care in ankylosing spondylitis

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A small number of patient and physician-reported outcomes, as well as laboratory and clinical factors, may help to predict the response of patients with ankylosing spondylitis (AS) to treatment with tumor necrosis factor (TNF) inhibitors when they have never taken them before, according to an analysis of data from nearly 2,000 individuals in 10 clinical trials.

TNF inhibitors are recommended for patients with AS whose symptoms persist despite use of NSAIDs, Runsheng Wang, MD, adjunct assistant professor at Columbia University Medical Center, New York, and a practicing rheumatologist at Garden State Rheumatology Consultants, Union, N.J., and colleagues wrote. Randomized, controlled clinical trials have shown that TNF inhibitors are effective in treating AS, but approximately half of patients fail to achieve notable improvement, which suggests the need for a predictive model.

“In clinical practice, before starting a treatment, physicians and patients want to know how likely a patient would be to respond to the treatment, particularly when more than one treatment option is available,” Dr. Wang said in an interview. “In this study, we developed predictive models that can potentially answer this question.”

The results suggest that the models in the study can be used to personalize clinical decision-making for patients with AS, whether to promote confidence in choosing a TNF inhibitor or to terminate treatment in nonresponders who had a higher probability of nonresponse at baseline, the researchers wrote. Similar models for other biologic treatments can help prioritize treatment options.

The predictive models are practical for clinical use because the variables in the reduced models – can be collected easily during patient visits, Dr. Wang explained. However, data from clinical practice are needed to further validate the study findings.

In a retrospective cohort study published in JAMA Network Open, the researchers analyzed data from 10 randomized, controlled clinical trials of TNF inhibitor treatment in patients with active AS conducted during 2002-2016. The study population included 1,899 adults with active AS who received an originator TNF inhibitor for at least 12 weeks, and the training set included 1,207 individuals. In the training set, the mean age of the participants was 39 years, and 75% were men.

The outcomes included major response and no response based on change in AS Disease Activity Score (ASDAS) from baseline to 12 weeks, and the researchers used machine-learning algorithms to estimate the probability of major response or no response. Major response was defined as a decrease in ASDAS of 2.0 or greater; no response was defined as a decrease in ASDAS of less than 1.1.



In the training set, a total of 407 patients (33.7%) had a major response, and 414 (34.3%) had no response.

The key features in the full, 21-variable model that increased the probability of a major response were higher C-reactive protein (CRP) levels, higher patient global assessment (PGA) of disease activity, and Bath AS Disease Activity Index (BASDAI) question 2 scores. (Question 2 asks for the overall level of back, hip, or neck pain associated with AS.) The probability of a major response decreased with higher body mass index and Bath AS Functional Index (BASFI) scores.

The key features in the model that increased the probability of no response were older age and higher BASFI scores. The probability of no response decreased with higher CRP levels, higher BASDAI question 2 scores, and higher PGA scores.

Overall, the researchers found that models using smaller subsets of variables (three or five variables in total) that would be easier to gather clinically yielded similar predictive performance.

The models were externally validated in a testing set of 692 individuals. Baseline characteristics were similar in the testing and training sets. In the testing set, the full models demonstrated moderate to high accuracy of 0.71 in the random forest model for major response and 0.76 in the random forest model for no response, with similar results in the reduced models.

At a prevalence of 25% for major response, the positive predictive values (PPVs) for random forest and logistic regression models ranged from 0.49 to 0.60, and the negative predictive values (NPVs) ranged from 0.82 to 0.84. At a prevalence of 25% for no response, PPVs ranged from 0.61 to 0.77, and NPVs ranged from 0.81 to 0.83.

The study findings were limited by several factors including the lack of data on smoking, which has been linked both to shorter treatment adherence and worse response to TNF inhibitors; the inclusion of only TNF inhibitor–naive patients; and the exclusion of NSAIDs from the models, the researchers wrote.

Dr. Wang disclosed support from the Rheumatology Research Foundation. The study’s two other authors disclosed receiving support from the Intramural Research Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The study was based on an analysis of data from AbbVie and Pfizer that were made available through Vivli.

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A small number of patient and physician-reported outcomes, as well as laboratory and clinical factors, may help to predict the response of patients with ankylosing spondylitis (AS) to treatment with tumor necrosis factor (TNF) inhibitors when they have never taken them before, according to an analysis of data from nearly 2,000 individuals in 10 clinical trials.

TNF inhibitors are recommended for patients with AS whose symptoms persist despite use of NSAIDs, Runsheng Wang, MD, adjunct assistant professor at Columbia University Medical Center, New York, and a practicing rheumatologist at Garden State Rheumatology Consultants, Union, N.J., and colleagues wrote. Randomized, controlled clinical trials have shown that TNF inhibitors are effective in treating AS, but approximately half of patients fail to achieve notable improvement, which suggests the need for a predictive model.

“In clinical practice, before starting a treatment, physicians and patients want to know how likely a patient would be to respond to the treatment, particularly when more than one treatment option is available,” Dr. Wang said in an interview. “In this study, we developed predictive models that can potentially answer this question.”

The results suggest that the models in the study can be used to personalize clinical decision-making for patients with AS, whether to promote confidence in choosing a TNF inhibitor or to terminate treatment in nonresponders who had a higher probability of nonresponse at baseline, the researchers wrote. Similar models for other biologic treatments can help prioritize treatment options.

The predictive models are practical for clinical use because the variables in the reduced models – can be collected easily during patient visits, Dr. Wang explained. However, data from clinical practice are needed to further validate the study findings.

In a retrospective cohort study published in JAMA Network Open, the researchers analyzed data from 10 randomized, controlled clinical trials of TNF inhibitor treatment in patients with active AS conducted during 2002-2016. The study population included 1,899 adults with active AS who received an originator TNF inhibitor for at least 12 weeks, and the training set included 1,207 individuals. In the training set, the mean age of the participants was 39 years, and 75% were men.

The outcomes included major response and no response based on change in AS Disease Activity Score (ASDAS) from baseline to 12 weeks, and the researchers used machine-learning algorithms to estimate the probability of major response or no response. Major response was defined as a decrease in ASDAS of 2.0 or greater; no response was defined as a decrease in ASDAS of less than 1.1.



In the training set, a total of 407 patients (33.7%) had a major response, and 414 (34.3%) had no response.

The key features in the full, 21-variable model that increased the probability of a major response were higher C-reactive protein (CRP) levels, higher patient global assessment (PGA) of disease activity, and Bath AS Disease Activity Index (BASDAI) question 2 scores. (Question 2 asks for the overall level of back, hip, or neck pain associated with AS.) The probability of a major response decreased with higher body mass index and Bath AS Functional Index (BASFI) scores.

The key features in the model that increased the probability of no response were older age and higher BASFI scores. The probability of no response decreased with higher CRP levels, higher BASDAI question 2 scores, and higher PGA scores.

Overall, the researchers found that models using smaller subsets of variables (three or five variables in total) that would be easier to gather clinically yielded similar predictive performance.

The models were externally validated in a testing set of 692 individuals. Baseline characteristics were similar in the testing and training sets. In the testing set, the full models demonstrated moderate to high accuracy of 0.71 in the random forest model for major response and 0.76 in the random forest model for no response, with similar results in the reduced models.

At a prevalence of 25% for major response, the positive predictive values (PPVs) for random forest and logistic regression models ranged from 0.49 to 0.60, and the negative predictive values (NPVs) ranged from 0.82 to 0.84. At a prevalence of 25% for no response, PPVs ranged from 0.61 to 0.77, and NPVs ranged from 0.81 to 0.83.

The study findings were limited by several factors including the lack of data on smoking, which has been linked both to shorter treatment adherence and worse response to TNF inhibitors; the inclusion of only TNF inhibitor–naive patients; and the exclusion of NSAIDs from the models, the researchers wrote.

Dr. Wang disclosed support from the Rheumatology Research Foundation. The study’s two other authors disclosed receiving support from the Intramural Research Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The study was based on an analysis of data from AbbVie and Pfizer that were made available through Vivli.

A small number of patient and physician-reported outcomes, as well as laboratory and clinical factors, may help to predict the response of patients with ankylosing spondylitis (AS) to treatment with tumor necrosis factor (TNF) inhibitors when they have never taken them before, according to an analysis of data from nearly 2,000 individuals in 10 clinical trials.

TNF inhibitors are recommended for patients with AS whose symptoms persist despite use of NSAIDs, Runsheng Wang, MD, adjunct assistant professor at Columbia University Medical Center, New York, and a practicing rheumatologist at Garden State Rheumatology Consultants, Union, N.J., and colleagues wrote. Randomized, controlled clinical trials have shown that TNF inhibitors are effective in treating AS, but approximately half of patients fail to achieve notable improvement, which suggests the need for a predictive model.

“In clinical practice, before starting a treatment, physicians and patients want to know how likely a patient would be to respond to the treatment, particularly when more than one treatment option is available,” Dr. Wang said in an interview. “In this study, we developed predictive models that can potentially answer this question.”

The results suggest that the models in the study can be used to personalize clinical decision-making for patients with AS, whether to promote confidence in choosing a TNF inhibitor or to terminate treatment in nonresponders who had a higher probability of nonresponse at baseline, the researchers wrote. Similar models for other biologic treatments can help prioritize treatment options.

The predictive models are practical for clinical use because the variables in the reduced models – can be collected easily during patient visits, Dr. Wang explained. However, data from clinical practice are needed to further validate the study findings.

In a retrospective cohort study published in JAMA Network Open, the researchers analyzed data from 10 randomized, controlled clinical trials of TNF inhibitor treatment in patients with active AS conducted during 2002-2016. The study population included 1,899 adults with active AS who received an originator TNF inhibitor for at least 12 weeks, and the training set included 1,207 individuals. In the training set, the mean age of the participants was 39 years, and 75% were men.

The outcomes included major response and no response based on change in AS Disease Activity Score (ASDAS) from baseline to 12 weeks, and the researchers used machine-learning algorithms to estimate the probability of major response or no response. Major response was defined as a decrease in ASDAS of 2.0 or greater; no response was defined as a decrease in ASDAS of less than 1.1.



In the training set, a total of 407 patients (33.7%) had a major response, and 414 (34.3%) had no response.

The key features in the full, 21-variable model that increased the probability of a major response were higher C-reactive protein (CRP) levels, higher patient global assessment (PGA) of disease activity, and Bath AS Disease Activity Index (BASDAI) question 2 scores. (Question 2 asks for the overall level of back, hip, or neck pain associated with AS.) The probability of a major response decreased with higher body mass index and Bath AS Functional Index (BASFI) scores.

The key features in the model that increased the probability of no response were older age and higher BASFI scores. The probability of no response decreased with higher CRP levels, higher BASDAI question 2 scores, and higher PGA scores.

Overall, the researchers found that models using smaller subsets of variables (three or five variables in total) that would be easier to gather clinically yielded similar predictive performance.

The models were externally validated in a testing set of 692 individuals. Baseline characteristics were similar in the testing and training sets. In the testing set, the full models demonstrated moderate to high accuracy of 0.71 in the random forest model for major response and 0.76 in the random forest model for no response, with similar results in the reduced models.

At a prevalence of 25% for major response, the positive predictive values (PPVs) for random forest and logistic regression models ranged from 0.49 to 0.60, and the negative predictive values (NPVs) ranged from 0.82 to 0.84. At a prevalence of 25% for no response, PPVs ranged from 0.61 to 0.77, and NPVs ranged from 0.81 to 0.83.

The study findings were limited by several factors including the lack of data on smoking, which has been linked both to shorter treatment adherence and worse response to TNF inhibitors; the inclusion of only TNF inhibitor–naive patients; and the exclusion of NSAIDs from the models, the researchers wrote.

Dr. Wang disclosed support from the Rheumatology Research Foundation. The study’s two other authors disclosed receiving support from the Intramural Research Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The study was based on an analysis of data from AbbVie and Pfizer that were made available through Vivli.

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Adolescents are undertested for STIs

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Approximately 20% of sexually active high schoolers reported testing for a sexually transmitted infection in the previous year, based on data from 2,501 respondents to the 2019 national Youth Risk Behavior Survey.

Data suggest that half of all new STIs in the United States occur in youth aged 15-24 years, and that 25% of sexually active young women in the United States have an STI, wrote Nicole Liddon, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues.

Although organizations including the American Academy of Pediatrics and the U.S. Preventive Services Task Force recommend varying degrees of routine STI screening for adolescents, data on the prevalence of testing in this population are limited, the researchers said.

However, the addition in 2019 of a question on STI testing to the national Youth Risk Behavior Survey (YRBS) provided an opportunity to assess prevalence of STI testing, identify potential barriers, and increase screening rates, they wrote.

In a study published in Pediatrics, the researchers reviewed data from the 2019 national YRBS, an anonymous survey administered biannually to public and private high school students across the United States.

The study population included 2,501 individuals who reported sexual activity with at least one person during the 3 months prior to the survey.

Overall, 20.4% of the respondents reported being tested for an STI in the previous year, including significantly more females than males (26.1% vs. 13.7%).

The prevalence of testing among females was not significantly different according to race/ethnicity, sexual identity, or the sex of sexual contacts, but the prevalence increased with age; 12.6%, 22.8%, 28.5%, and 36.9% for females aged 15 years and younger, 16 years, 17 years, and 18 years, respectively.

Among males, no significant differences in STI testing were noted according to race/ethnicity, age, sexual identity, or sex of sexual contacts.

The researchers also analyzed prevalence of STI tested based on sexual behaviors. Among female students, the prevalence of STI testing was higher among those who reported the following behaviors, compared with those who did not: nonuse of condoms at last sexual intercourse (34.1% vs. 18.2%), substance use at last sexual intercourse (32.0% vs. 24.7%), and having four or more lifetime sex partners (31.9% vs. 24.7%).

Among male students, the prevalence of STI testing was higher among those who reported the following behaviors, compared with those who did not: sex before age 13 years (27.1% vs. 12.1%), having two or more recent sex partners (22.4% vs. 10.4%), having four or more lifetime sex partners (22.3% vs. 9.5%), and substance use at last sexual intercourse (19.2% vs. 12.1%).

The low prevalence of STI testing in teens has become more urgent in the wake of the coronavirus pandemic, the researchers wrote. “These prevalence estimates were derived before the possible profound impacts of the pandemic on adolescent sexual behavior and access to and use of health care services.”

Current guidelines allow health care providers the options for opt-out STI screening as a strategy to improve screening rates and testing; however, this option does not eliminate the need for conversations with adolescent patients about sexual activity, they emphasized.

The study findings were limited by several other factors including the inability to directly assess adherence to screening recommendations specifically, the inability to determine whether low testing rates resulted from limited access to health care or missed screening opportunities at visits, and the inclusion only of high school students but not out-of-school youth who may have more limited access to testing.

However, the results highlight the need to improve STI testing services for adolescents, and to address barriers at the individual and clinic level, they said. The addition of a question about past-year STI testing to the 2019 and future YRBS survey will promote ongoing monitoring of efforts to increase testing rates.

 

 

Teen sexual health goes beyond testing

The current study shows that routine testing for STIs according to published guidelines is low, Cynthia Holland-Hall, MD, and Andrea E. Bonny, MD, of Nationwide Children’s Hospital and Ohio State University, both in Columbus, wrote in an accompanying editorial.

Notably, sexually active females and males who had sex with male partners, two groups for whom annual testing is specifically recommended by multiple organizations, had testing rates of less than 30%, they said. The authors highlighted the study’s lack of information on which specific barriers, such as lack of access to the health care system, lack of knowledge, and fear of disclosure, contributed to overall low rates of testing.

However, STI testing is only one element of sexual and reproductive health care. Although opt-out testing may improve detection rates, the editorialists emphasized the need for patient-provider conversations about sex, citing recent studies showing that adolescents who spent some time alone with providers were more likely to receive sexual and reproductive health (SRH) services in the past year.

“Resources such as confidentiality policies, checklists, and written screening tools may facilitate SRH discussions,” Dr. Holland-Hall and Dr. Bonny said. “With a little practice, respect, and intention, a caring provider can take the awkward out of discussing sexual health but must not opt out of the conversation.”
 

Privacy and time issues exacerbate low testing rates

The current study is especially important at this time because many adolescents have likely missed well visits, and therefore important STI screens, because of disruptions caused by the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“I was surprised that the rate of screening was only one in five,” said Dr. Kinsella. “I knew it would be suboptimal, but not that low.”

According to Dr. Kinsella, there are two major barriers to increasing STI testing in adolescents in primary care. One barrier is that insurance companies will often state on the bill what the testing was for, which will lead to an uncomfortable conversation at a later date for the adolescent and parent when the bill arrives in the mail. A second barrier is when to test during a visit,. “If we obtain urine samples on all adolescents and many of them are not sexually active, we are wasting a lot of time in the short visit to obtain urine,” she explained. “If testing is scheduled for the end of the visit, they often leave without providing a urine sample.”

Overall, the study is an important reminder to general pediatricians about STI testing for sexually active teens, she emphasized. 

The study received no outside funding. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

 


 

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Approximately 20% of sexually active high schoolers reported testing for a sexually transmitted infection in the previous year, based on data from 2,501 respondents to the 2019 national Youth Risk Behavior Survey.

Data suggest that half of all new STIs in the United States occur in youth aged 15-24 years, and that 25% of sexually active young women in the United States have an STI, wrote Nicole Liddon, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues.

Although organizations including the American Academy of Pediatrics and the U.S. Preventive Services Task Force recommend varying degrees of routine STI screening for adolescents, data on the prevalence of testing in this population are limited, the researchers said.

However, the addition in 2019 of a question on STI testing to the national Youth Risk Behavior Survey (YRBS) provided an opportunity to assess prevalence of STI testing, identify potential barriers, and increase screening rates, they wrote.

In a study published in Pediatrics, the researchers reviewed data from the 2019 national YRBS, an anonymous survey administered biannually to public and private high school students across the United States.

The study population included 2,501 individuals who reported sexual activity with at least one person during the 3 months prior to the survey.

Overall, 20.4% of the respondents reported being tested for an STI in the previous year, including significantly more females than males (26.1% vs. 13.7%).

The prevalence of testing among females was not significantly different according to race/ethnicity, sexual identity, or the sex of sexual contacts, but the prevalence increased with age; 12.6%, 22.8%, 28.5%, and 36.9% for females aged 15 years and younger, 16 years, 17 years, and 18 years, respectively.

Among males, no significant differences in STI testing were noted according to race/ethnicity, age, sexual identity, or sex of sexual contacts.

The researchers also analyzed prevalence of STI tested based on sexual behaviors. Among female students, the prevalence of STI testing was higher among those who reported the following behaviors, compared with those who did not: nonuse of condoms at last sexual intercourse (34.1% vs. 18.2%), substance use at last sexual intercourse (32.0% vs. 24.7%), and having four or more lifetime sex partners (31.9% vs. 24.7%).

Among male students, the prevalence of STI testing was higher among those who reported the following behaviors, compared with those who did not: sex before age 13 years (27.1% vs. 12.1%), having two or more recent sex partners (22.4% vs. 10.4%), having four or more lifetime sex partners (22.3% vs. 9.5%), and substance use at last sexual intercourse (19.2% vs. 12.1%).

The low prevalence of STI testing in teens has become more urgent in the wake of the coronavirus pandemic, the researchers wrote. “These prevalence estimates were derived before the possible profound impacts of the pandemic on adolescent sexual behavior and access to and use of health care services.”

Current guidelines allow health care providers the options for opt-out STI screening as a strategy to improve screening rates and testing; however, this option does not eliminate the need for conversations with adolescent patients about sexual activity, they emphasized.

The study findings were limited by several other factors including the inability to directly assess adherence to screening recommendations specifically, the inability to determine whether low testing rates resulted from limited access to health care or missed screening opportunities at visits, and the inclusion only of high school students but not out-of-school youth who may have more limited access to testing.

However, the results highlight the need to improve STI testing services for adolescents, and to address barriers at the individual and clinic level, they said. The addition of a question about past-year STI testing to the 2019 and future YRBS survey will promote ongoing monitoring of efforts to increase testing rates.

 

 

Teen sexual health goes beyond testing

The current study shows that routine testing for STIs according to published guidelines is low, Cynthia Holland-Hall, MD, and Andrea E. Bonny, MD, of Nationwide Children’s Hospital and Ohio State University, both in Columbus, wrote in an accompanying editorial.

Notably, sexually active females and males who had sex with male partners, two groups for whom annual testing is specifically recommended by multiple organizations, had testing rates of less than 30%, they said. The authors highlighted the study’s lack of information on which specific barriers, such as lack of access to the health care system, lack of knowledge, and fear of disclosure, contributed to overall low rates of testing.

However, STI testing is only one element of sexual and reproductive health care. Although opt-out testing may improve detection rates, the editorialists emphasized the need for patient-provider conversations about sex, citing recent studies showing that adolescents who spent some time alone with providers were more likely to receive sexual and reproductive health (SRH) services in the past year.

“Resources such as confidentiality policies, checklists, and written screening tools may facilitate SRH discussions,” Dr. Holland-Hall and Dr. Bonny said. “With a little practice, respect, and intention, a caring provider can take the awkward out of discussing sexual health but must not opt out of the conversation.”
 

Privacy and time issues exacerbate low testing rates

The current study is especially important at this time because many adolescents have likely missed well visits, and therefore important STI screens, because of disruptions caused by the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“I was surprised that the rate of screening was only one in five,” said Dr. Kinsella. “I knew it would be suboptimal, but not that low.”

According to Dr. Kinsella, there are two major barriers to increasing STI testing in adolescents in primary care. One barrier is that insurance companies will often state on the bill what the testing was for, which will lead to an uncomfortable conversation at a later date for the adolescent and parent when the bill arrives in the mail. A second barrier is when to test during a visit,. “If we obtain urine samples on all adolescents and many of them are not sexually active, we are wasting a lot of time in the short visit to obtain urine,” she explained. “If testing is scheduled for the end of the visit, they often leave without providing a urine sample.”

Overall, the study is an important reminder to general pediatricians about STI testing for sexually active teens, she emphasized. 

The study received no outside funding. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

 


 

 

Approximately 20% of sexually active high schoolers reported testing for a sexually transmitted infection in the previous year, based on data from 2,501 respondents to the 2019 national Youth Risk Behavior Survey.

Data suggest that half of all new STIs in the United States occur in youth aged 15-24 years, and that 25% of sexually active young women in the United States have an STI, wrote Nicole Liddon, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues.

Although organizations including the American Academy of Pediatrics and the U.S. Preventive Services Task Force recommend varying degrees of routine STI screening for adolescents, data on the prevalence of testing in this population are limited, the researchers said.

However, the addition in 2019 of a question on STI testing to the national Youth Risk Behavior Survey (YRBS) provided an opportunity to assess prevalence of STI testing, identify potential barriers, and increase screening rates, they wrote.

In a study published in Pediatrics, the researchers reviewed data from the 2019 national YRBS, an anonymous survey administered biannually to public and private high school students across the United States.

The study population included 2,501 individuals who reported sexual activity with at least one person during the 3 months prior to the survey.

Overall, 20.4% of the respondents reported being tested for an STI in the previous year, including significantly more females than males (26.1% vs. 13.7%).

The prevalence of testing among females was not significantly different according to race/ethnicity, sexual identity, or the sex of sexual contacts, but the prevalence increased with age; 12.6%, 22.8%, 28.5%, and 36.9% for females aged 15 years and younger, 16 years, 17 years, and 18 years, respectively.

Among males, no significant differences in STI testing were noted according to race/ethnicity, age, sexual identity, or sex of sexual contacts.

The researchers also analyzed prevalence of STI tested based on sexual behaviors. Among female students, the prevalence of STI testing was higher among those who reported the following behaviors, compared with those who did not: nonuse of condoms at last sexual intercourse (34.1% vs. 18.2%), substance use at last sexual intercourse (32.0% vs. 24.7%), and having four or more lifetime sex partners (31.9% vs. 24.7%).

Among male students, the prevalence of STI testing was higher among those who reported the following behaviors, compared with those who did not: sex before age 13 years (27.1% vs. 12.1%), having two or more recent sex partners (22.4% vs. 10.4%), having four or more lifetime sex partners (22.3% vs. 9.5%), and substance use at last sexual intercourse (19.2% vs. 12.1%).

The low prevalence of STI testing in teens has become more urgent in the wake of the coronavirus pandemic, the researchers wrote. “These prevalence estimates were derived before the possible profound impacts of the pandemic on adolescent sexual behavior and access to and use of health care services.”

Current guidelines allow health care providers the options for opt-out STI screening as a strategy to improve screening rates and testing; however, this option does not eliminate the need for conversations with adolescent patients about sexual activity, they emphasized.

The study findings were limited by several other factors including the inability to directly assess adherence to screening recommendations specifically, the inability to determine whether low testing rates resulted from limited access to health care or missed screening opportunities at visits, and the inclusion only of high school students but not out-of-school youth who may have more limited access to testing.

However, the results highlight the need to improve STI testing services for adolescents, and to address barriers at the individual and clinic level, they said. The addition of a question about past-year STI testing to the 2019 and future YRBS survey will promote ongoing monitoring of efforts to increase testing rates.

 

 

Teen sexual health goes beyond testing

The current study shows that routine testing for STIs according to published guidelines is low, Cynthia Holland-Hall, MD, and Andrea E. Bonny, MD, of Nationwide Children’s Hospital and Ohio State University, both in Columbus, wrote in an accompanying editorial.

Notably, sexually active females and males who had sex with male partners, two groups for whom annual testing is specifically recommended by multiple organizations, had testing rates of less than 30%, they said. The authors highlighted the study’s lack of information on which specific barriers, such as lack of access to the health care system, lack of knowledge, and fear of disclosure, contributed to overall low rates of testing.

However, STI testing is only one element of sexual and reproductive health care. Although opt-out testing may improve detection rates, the editorialists emphasized the need for patient-provider conversations about sex, citing recent studies showing that adolescents who spent some time alone with providers were more likely to receive sexual and reproductive health (SRH) services in the past year.

“Resources such as confidentiality policies, checklists, and written screening tools may facilitate SRH discussions,” Dr. Holland-Hall and Dr. Bonny said. “With a little practice, respect, and intention, a caring provider can take the awkward out of discussing sexual health but must not opt out of the conversation.”
 

Privacy and time issues exacerbate low testing rates

The current study is especially important at this time because many adolescents have likely missed well visits, and therefore important STI screens, because of disruptions caused by the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“I was surprised that the rate of screening was only one in five,” said Dr. Kinsella. “I knew it would be suboptimal, but not that low.”

According to Dr. Kinsella, there are two major barriers to increasing STI testing in adolescents in primary care. One barrier is that insurance companies will often state on the bill what the testing was for, which will lead to an uncomfortable conversation at a later date for the adolescent and parent when the bill arrives in the mail. A second barrier is when to test during a visit,. “If we obtain urine samples on all adolescents and many of them are not sexually active, we are wasting a lot of time in the short visit to obtain urine,” she explained. “If testing is scheduled for the end of the visit, they often leave without providing a urine sample.”

Overall, the study is an important reminder to general pediatricians about STI testing for sexually active teens, she emphasized. 

The study received no outside funding. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

 


 

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Rapper sings about living with sickle cell disease

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MANCHESTER, ENGLAND – A London-based rapper known for his gospel-inspired music has now given a voice to patients with sickle cell disease. He is using one of his music videos to raise awareness and educate health care professionals about living with the condition.

Alidor Gaspar, also known as A Star, composed the song Hidden Pain about his experience of living with sickle cell disease, and he created a video posted on YouTube that shows him in a hospital bed, writhing in pain.

One important aim of the video, he says, is to help educate health care professionals, some of whom have not come across this condition, he explained at a session during the annual meeting of the British Society for Haematology, held recently in Manchester, England.

“It’s kind of frustrating to feel like your safe space, when you’re in front of doctors and nurses and paramedics who are supposed to know what it is and react with treatment, [and they] don’t know what it is,” Mr. Gaspar said.

He recalled an occasion in which he was experiencing a crisis, and his wife called for an ambulance. The paramedics arrived and his wife asked them for “gas and air and morphine, and they were, like, no, we don’t want to give that to him.” She tried to explain that he has sickle cell disease, but the paramedics had not heard of the condition and were suspicious that the request for morphine was a sign of drug addiction.

Mr. Gaspar expressed his frustration over “constantly having to prove that you have something serious enough to need the treatment you are asking for.”

At the meeting, Mr. Gaspar was talking on the stage with hematologist Dr. Stephen Hibbs from Barts Health NHS Trust, London.

Mr. Gaspar explained that it took years before he eventually reached “a point where I understood that it’s something that affects me and affects many other people, and I didn’t want to hide it any more.”

Sickle cell disease, which occurs primarily in people of Afro-Caribbean background, is a taboo subject in his community, Mr. Gaspar elaborated in an interview.

The condition has been associated with a great deal of stigma, with young sufferers traditionally seen as “demonically possessed,” he commented.

“So there was always a shameful aspect around it when it came to African families speaking about it, especially back in Africa.”

But after his parents came to the United Kingdom, he was able to “do his research and understand that it’s just genetics.”

This knowledge, Mr. Gaspar said, “takes away the spiritual aspect” and allows people to “have the conversation about sickle cell with potential partners” and ask them to find out their genotype, which in turn helps to “break down the barriers and the stigma.”

Mr. Gaspar emphasizes that there is much more work still to do.

In the video, he appeals to the Black community to make blood donations.

He said that something that “haunts” him is that currently, only 1% of Black people in the United Kingdom give blood, “so I really want the song to move my community to take a step forward and make that difference.”

He has been in contact with NHS Blood and Transplant, which provides blood and transplantation service to the National Health Service. They “really liked” the song, Mr. Gaspar said, and helped him get access to a hospital ward in University College Hospital, London, for the video.

“I really wanted to make a video that made people uncomfortable when watching it,” he said. It shows him hospitalized for pain and breathlessness and recalling having to use a Zimmer frame at the age of 25.

“This is a side of sickle cell that normally people don’t know,” he said.

Since releasing the song and the video, Mr. Gaspar says he has been contacted by many fellow patients. They have told him that he is now their “voice”; when they are asked how the condition affects them, “they can show someone the Hidden Pain video and say: This is how it feels.”

Clinicians have also approached him, asking if they can show his video to illustrate to patients and their families how having the condition may affect their lives.
 

 

 

Preventable deaths

At the meeting, Dr. Hibbs highlighted the 2021 report No One’s Listening, which was issued by the Sickle Cell Society following an inquiry into avoidable deaths and failures of care for sickle cell patients.

The inquiry, published by an All-Party Parliamentary group, found “serious care failings” in acute services and evidence of attitudes underpinned by racism. There was evidence of substandard care for sickle cell patients who were admitted to general wards or to hospital accident and emergency departments, as well as low awareness of the condition among health care professionals.

The report noted that the care failings have led to patient deaths, some which could have been prevented, and that there have been many “near misses.”

Many patients with sickle cell disease said they are “not being listened to” or are not being understood, especially during that vulnerable period when they are “in a crisis.”

Mr. Gaspar said that the report, and also the deaths, really struck a chord with him and many in his community. “We felt like that was us. ... We’ve all been in that same position where we’ve been misunderstood and not heard by nurses, doctors, or paramedics.”

He emphasized the need for awareness of the condition and the need for timely treatment. Just 3 weeks ago, Mr. Gaspar attended the funeral of one of his friends who is in the Hidden Pain video, a fellow sickle cell disease patient, who died at 30 years of age.
 

Ignorance about the condition ‘all too common’

The lack of awareness about sickle cell disease, even among health care professionals, is “all too common,” says Dr. Subarna Chakravorty, consultant pediatric hematologist, King’s College Hospital, London.

Even in London, where there is a large Black community and the teaching hospitals have world-class expertise, patients with sickle cell disease are “still facing a lot of problems with knowledge” among health care professionals, she said in an interview.

“Often people are having to speak for their own condition; which is fine, except that sometimes they are not believed,” she commented.

“On the one hand, you rely on the patient to provide information about their disease, and then when you receive it, you don’t do anything about it. So [they’re] between a rock and a hard place.”
 

Why are sickle cell patients treated in this way?

For Dr. Chakravorty, there is “a lot to be said about racism and disparities” in treating patients “as morphine-seekers, opiate addicts, even in children.”

“So we really need to improve the knowledge and perceptions among nonspecialist staff,” she said, “and even among specialists.”

Mr. Gaspar aims to help with this effort and hopes that his song and video will be useful to health care professionals. Sickle cell disease “needs to be spoken about,” and more doctors and nurses need to “know what it is,” he said.

He said it is a relief to encounter health care professionals who are knowledgeable about his condition. There have been times when he has been “having a crisis at home, calling the ambulance, and the paramedic comes and says: ‘Mr. Gaspar, you have sickle cell...we believe that you usually have gas and air and morphine, is that correct?’”

“That gives me a sense of peace, to know that I don’t have to fight my case or convince someone I have sickle cell, and I need to start treatment. They already know.”

No relevant financial relationships have been disclosed.

 

 

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

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MANCHESTER, ENGLAND – A London-based rapper known for his gospel-inspired music has now given a voice to patients with sickle cell disease. He is using one of his music videos to raise awareness and educate health care professionals about living with the condition.

Alidor Gaspar, also known as A Star, composed the song Hidden Pain about his experience of living with sickle cell disease, and he created a video posted on YouTube that shows him in a hospital bed, writhing in pain.

One important aim of the video, he says, is to help educate health care professionals, some of whom have not come across this condition, he explained at a session during the annual meeting of the British Society for Haematology, held recently in Manchester, England.

“It’s kind of frustrating to feel like your safe space, when you’re in front of doctors and nurses and paramedics who are supposed to know what it is and react with treatment, [and they] don’t know what it is,” Mr. Gaspar said.

He recalled an occasion in which he was experiencing a crisis, and his wife called for an ambulance. The paramedics arrived and his wife asked them for “gas and air and morphine, and they were, like, no, we don’t want to give that to him.” She tried to explain that he has sickle cell disease, but the paramedics had not heard of the condition and were suspicious that the request for morphine was a sign of drug addiction.

Mr. Gaspar expressed his frustration over “constantly having to prove that you have something serious enough to need the treatment you are asking for.”

At the meeting, Mr. Gaspar was talking on the stage with hematologist Dr. Stephen Hibbs from Barts Health NHS Trust, London.

Mr. Gaspar explained that it took years before he eventually reached “a point where I understood that it’s something that affects me and affects many other people, and I didn’t want to hide it any more.”

Sickle cell disease, which occurs primarily in people of Afro-Caribbean background, is a taboo subject in his community, Mr. Gaspar elaborated in an interview.

The condition has been associated with a great deal of stigma, with young sufferers traditionally seen as “demonically possessed,” he commented.

“So there was always a shameful aspect around it when it came to African families speaking about it, especially back in Africa.”

But after his parents came to the United Kingdom, he was able to “do his research and understand that it’s just genetics.”

This knowledge, Mr. Gaspar said, “takes away the spiritual aspect” and allows people to “have the conversation about sickle cell with potential partners” and ask them to find out their genotype, which in turn helps to “break down the barriers and the stigma.”

Mr. Gaspar emphasizes that there is much more work still to do.

In the video, he appeals to the Black community to make blood donations.

He said that something that “haunts” him is that currently, only 1% of Black people in the United Kingdom give blood, “so I really want the song to move my community to take a step forward and make that difference.”

He has been in contact with NHS Blood and Transplant, which provides blood and transplantation service to the National Health Service. They “really liked” the song, Mr. Gaspar said, and helped him get access to a hospital ward in University College Hospital, London, for the video.

“I really wanted to make a video that made people uncomfortable when watching it,” he said. It shows him hospitalized for pain and breathlessness and recalling having to use a Zimmer frame at the age of 25.

“This is a side of sickle cell that normally people don’t know,” he said.

Since releasing the song and the video, Mr. Gaspar says he has been contacted by many fellow patients. They have told him that he is now their “voice”; when they are asked how the condition affects them, “they can show someone the Hidden Pain video and say: This is how it feels.”

Clinicians have also approached him, asking if they can show his video to illustrate to patients and their families how having the condition may affect their lives.
 

 

 

Preventable deaths

At the meeting, Dr. Hibbs highlighted the 2021 report No One’s Listening, which was issued by the Sickle Cell Society following an inquiry into avoidable deaths and failures of care for sickle cell patients.

The inquiry, published by an All-Party Parliamentary group, found “serious care failings” in acute services and evidence of attitudes underpinned by racism. There was evidence of substandard care for sickle cell patients who were admitted to general wards or to hospital accident and emergency departments, as well as low awareness of the condition among health care professionals.

The report noted that the care failings have led to patient deaths, some which could have been prevented, and that there have been many “near misses.”

Many patients with sickle cell disease said they are “not being listened to” or are not being understood, especially during that vulnerable period when they are “in a crisis.”

Mr. Gaspar said that the report, and also the deaths, really struck a chord with him and many in his community. “We felt like that was us. ... We’ve all been in that same position where we’ve been misunderstood and not heard by nurses, doctors, or paramedics.”

He emphasized the need for awareness of the condition and the need for timely treatment. Just 3 weeks ago, Mr. Gaspar attended the funeral of one of his friends who is in the Hidden Pain video, a fellow sickle cell disease patient, who died at 30 years of age.
 

Ignorance about the condition ‘all too common’

The lack of awareness about sickle cell disease, even among health care professionals, is “all too common,” says Dr. Subarna Chakravorty, consultant pediatric hematologist, King’s College Hospital, London.

Even in London, where there is a large Black community and the teaching hospitals have world-class expertise, patients with sickle cell disease are “still facing a lot of problems with knowledge” among health care professionals, she said in an interview.

“Often people are having to speak for their own condition; which is fine, except that sometimes they are not believed,” she commented.

“On the one hand, you rely on the patient to provide information about their disease, and then when you receive it, you don’t do anything about it. So [they’re] between a rock and a hard place.”
 

Why are sickle cell patients treated in this way?

For Dr. Chakravorty, there is “a lot to be said about racism and disparities” in treating patients “as morphine-seekers, opiate addicts, even in children.”

“So we really need to improve the knowledge and perceptions among nonspecialist staff,” she said, “and even among specialists.”

Mr. Gaspar aims to help with this effort and hopes that his song and video will be useful to health care professionals. Sickle cell disease “needs to be spoken about,” and more doctors and nurses need to “know what it is,” he said.

He said it is a relief to encounter health care professionals who are knowledgeable about his condition. There have been times when he has been “having a crisis at home, calling the ambulance, and the paramedic comes and says: ‘Mr. Gaspar, you have sickle cell...we believe that you usually have gas and air and morphine, is that correct?’”

“That gives me a sense of peace, to know that I don’t have to fight my case or convince someone I have sickle cell, and I need to start treatment. They already know.”

No relevant financial relationships have been disclosed.

 

 

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

 

MANCHESTER, ENGLAND – A London-based rapper known for his gospel-inspired music has now given a voice to patients with sickle cell disease. He is using one of his music videos to raise awareness and educate health care professionals about living with the condition.

Alidor Gaspar, also known as A Star, composed the song Hidden Pain about his experience of living with sickle cell disease, and he created a video posted on YouTube that shows him in a hospital bed, writhing in pain.

One important aim of the video, he says, is to help educate health care professionals, some of whom have not come across this condition, he explained at a session during the annual meeting of the British Society for Haematology, held recently in Manchester, England.

“It’s kind of frustrating to feel like your safe space, when you’re in front of doctors and nurses and paramedics who are supposed to know what it is and react with treatment, [and they] don’t know what it is,” Mr. Gaspar said.

He recalled an occasion in which he was experiencing a crisis, and his wife called for an ambulance. The paramedics arrived and his wife asked them for “gas and air and morphine, and they were, like, no, we don’t want to give that to him.” She tried to explain that he has sickle cell disease, but the paramedics had not heard of the condition and were suspicious that the request for morphine was a sign of drug addiction.

Mr. Gaspar expressed his frustration over “constantly having to prove that you have something serious enough to need the treatment you are asking for.”

At the meeting, Mr. Gaspar was talking on the stage with hematologist Dr. Stephen Hibbs from Barts Health NHS Trust, London.

Mr. Gaspar explained that it took years before he eventually reached “a point where I understood that it’s something that affects me and affects many other people, and I didn’t want to hide it any more.”

Sickle cell disease, which occurs primarily in people of Afro-Caribbean background, is a taboo subject in his community, Mr. Gaspar elaborated in an interview.

The condition has been associated with a great deal of stigma, with young sufferers traditionally seen as “demonically possessed,” he commented.

“So there was always a shameful aspect around it when it came to African families speaking about it, especially back in Africa.”

But after his parents came to the United Kingdom, he was able to “do his research and understand that it’s just genetics.”

This knowledge, Mr. Gaspar said, “takes away the spiritual aspect” and allows people to “have the conversation about sickle cell with potential partners” and ask them to find out their genotype, which in turn helps to “break down the barriers and the stigma.”

Mr. Gaspar emphasizes that there is much more work still to do.

In the video, he appeals to the Black community to make blood donations.

He said that something that “haunts” him is that currently, only 1% of Black people in the United Kingdom give blood, “so I really want the song to move my community to take a step forward and make that difference.”

He has been in contact with NHS Blood and Transplant, which provides blood and transplantation service to the National Health Service. They “really liked” the song, Mr. Gaspar said, and helped him get access to a hospital ward in University College Hospital, London, for the video.

“I really wanted to make a video that made people uncomfortable when watching it,” he said. It shows him hospitalized for pain and breathlessness and recalling having to use a Zimmer frame at the age of 25.

“This is a side of sickle cell that normally people don’t know,” he said.

Since releasing the song and the video, Mr. Gaspar says he has been contacted by many fellow patients. They have told him that he is now their “voice”; when they are asked how the condition affects them, “they can show someone the Hidden Pain video and say: This is how it feels.”

Clinicians have also approached him, asking if they can show his video to illustrate to patients and their families how having the condition may affect their lives.
 

 

 

Preventable deaths

At the meeting, Dr. Hibbs highlighted the 2021 report No One’s Listening, which was issued by the Sickle Cell Society following an inquiry into avoidable deaths and failures of care for sickle cell patients.

The inquiry, published by an All-Party Parliamentary group, found “serious care failings” in acute services and evidence of attitudes underpinned by racism. There was evidence of substandard care for sickle cell patients who were admitted to general wards or to hospital accident and emergency departments, as well as low awareness of the condition among health care professionals.

The report noted that the care failings have led to patient deaths, some which could have been prevented, and that there have been many “near misses.”

Many patients with sickle cell disease said they are “not being listened to” or are not being understood, especially during that vulnerable period when they are “in a crisis.”

Mr. Gaspar said that the report, and also the deaths, really struck a chord with him and many in his community. “We felt like that was us. ... We’ve all been in that same position where we’ve been misunderstood and not heard by nurses, doctors, or paramedics.”

He emphasized the need for awareness of the condition and the need for timely treatment. Just 3 weeks ago, Mr. Gaspar attended the funeral of one of his friends who is in the Hidden Pain video, a fellow sickle cell disease patient, who died at 30 years of age.
 

Ignorance about the condition ‘all too common’

The lack of awareness about sickle cell disease, even among health care professionals, is “all too common,” says Dr. Subarna Chakravorty, consultant pediatric hematologist, King’s College Hospital, London.

Even in London, where there is a large Black community and the teaching hospitals have world-class expertise, patients with sickle cell disease are “still facing a lot of problems with knowledge” among health care professionals, she said in an interview.

“Often people are having to speak for their own condition; which is fine, except that sometimes they are not believed,” she commented.

“On the one hand, you rely on the patient to provide information about their disease, and then when you receive it, you don’t do anything about it. So [they’re] between a rock and a hard place.”
 

Why are sickle cell patients treated in this way?

For Dr. Chakravorty, there is “a lot to be said about racism and disparities” in treating patients “as morphine-seekers, opiate addicts, even in children.”

“So we really need to improve the knowledge and perceptions among nonspecialist staff,” she said, “and even among specialists.”

Mr. Gaspar aims to help with this effort and hopes that his song and video will be useful to health care professionals. Sickle cell disease “needs to be spoken about,” and more doctors and nurses need to “know what it is,” he said.

He said it is a relief to encounter health care professionals who are knowledgeable about his condition. There have been times when he has been “having a crisis at home, calling the ambulance, and the paramedic comes and says: ‘Mr. Gaspar, you have sickle cell...we believe that you usually have gas and air and morphine, is that correct?’”

“That gives me a sense of peace, to know that I don’t have to fight my case or convince someone I have sickle cell, and I need to start treatment. They already know.”

No relevant financial relationships have been disclosed.

 

 

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

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Infectious disease pop quiz: Clinical challenge #22 for the ObGyn

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In a pregnant woman who has a life-threatening allergy to penicillin, what is the most appropriate treatment for syphilis?

Continue to the answer...

 

 

 

 

This patient should be admitted to the hospital and rapidly desensitized to penicillin. She then can be treated with the appropriate dose of penicillin, given her stage of syphilis. Of note, in the future, the patient’s allergy to penicillin will return, despite the brief period of desensitization.

References
  1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
  2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
Author and Disclosure Information

Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.

The authors report no financial relationships relevant to this article.

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Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.

The authors report no financial relationships relevant to this article.

Author and Disclosure Information

Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.

The authors report no financial relationships relevant to this article.

In a pregnant woman who has a life-threatening allergy to penicillin, what is the most appropriate treatment for syphilis?

Continue to the answer...

 

 

 

 

This patient should be admitted to the hospital and rapidly desensitized to penicillin. She then can be treated with the appropriate dose of penicillin, given her stage of syphilis. Of note, in the future, the patient’s allergy to penicillin will return, despite the brief period of desensitization.

In a pregnant woman who has a life-threatening allergy to penicillin, what is the most appropriate treatment for syphilis?

Continue to the answer...

 

 

 

 

This patient should be admitted to the hospital and rapidly desensitized to penicillin. She then can be treated with the appropriate dose of penicillin, given her stage of syphilis. Of note, in the future, the patient’s allergy to penicillin will return, despite the brief period of desensitization.

References
  1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
  2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
References
  1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
  2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
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Suing patients: Medical, ethical, and legal considerations

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Although it is common to read about patients suing their hospitals, there has been increasing public and political attention given to hospitals suing their patients to collect unpaid hospital bills. KH’s story began with an emergency appendectomy. She did not have health insurance to cover the $14,000 hospital bill. The family was unable to pay the bill, and the nonprofit hospital sued them for that bill, plus some additional expenses (totaling about $17,000), plus interest was accumulating at 9% per year. The hospital won a judgment, and it garnished the husband’s pay (10% of after-taxes pay, in this case) and placed a lien on the family’s home. Years later—because of interest and additional hospital bills—the family had paid $20,000, but still owed $26,000.1

The extent of the problem

This is neither a hypothetical case nor a rare event. Studies and press reports have noted dozens of examples of hospital collection excesses. One study found that unpaid medical bill lawsuits increased by 37% in Wisconsin between 2001 and 2018, with 5% of hospitals accounting for 25% of the lawsuits.2 Another report found almost “31,000 civil cases filed by 139 hospitals in 26 New York counties from 2015 to 2019.”3 Similar to the Wisconsin report, a small number of health care providers accounted for the majority of lawsuits. In another example, one Missouri nonprofit hospital, Heartland (rebranded “Mosaic”), created its own for-profit debt collection agency (Northwest Financial Services), which filed 11,000 lawsuits from 2009 to 2013, resulting in 6,000 wage garnishments.1 The Wall Street Journal, among others, has reported for years on the difficulties created by lawsuits against patients.4 Axios and Johns Hopkins reported that “medical debt comprises 58% of all debt collections in the United States.” And although some collection actions declined early in the pandemic, it did not appear to last.5,6

Inconsistent collection policies. Collection policies vary greatly from hospital to hospital, with an increasing number of hospitals demanding up-front payments (before services). Many of these health care institutions persuade patients to put medical debt on their credit cards, sometimes as part of an up-front (before service) process.7 If using a standard credit card, this comes with a very high interest rate. There are some special health-related credit cards, such as CareCredit, that generally have better interest rates. These cards offer no-interest short-term loans, with significant interest for longer-term loans. Thus, failure to repay the full amount when due means that the “deferred interest” (about 27%) must be paid.8 Also any of the problems patients have repaying a credit card (or other loan), of course, are no longer directly related to the hospital. These “indirect collections” still burden patients with medical debt.

Where you go matters. Because there is no common collection policy or practice among hospitals, choosing the wrong hospital may result in a lawsuit. A careful study of lawsuits for medical debt or garnishments related to that debt in 2017 in Virginia showed how being treated at certain hospitals dramatically changed the odds of wage garnishment for unpaid bills.9 It revealed that 29,286 hospital lawsuits were filed to collect medical debt—9,232 of which were wage garnishments (the most aggressive form of debt collection). Five hospitals alone accounted for the majority of garnishments in the state. Notably, nonprofit hospitals accounted for 71% of the garnishment cases. On the other hand, about 50% of the hospitals in the study did not file any lawsuits to garnish wages for medical debt.9

Why is there so much hospital debt?

One would think the Affordable Care Act (ACA) and other reforms would mean fewer people do not have health insurance—and the problems experienced by the patient in the case above. Indeed, the number of insured has increased in the United States, including through the expansion of Medi­caid. Nonetheless, in 2020, the Census Bureau reported that 28 million people did not have health insurance for any part of the year; that figure would be higher if those who had insurance for only part of the year were included.10

One reason for medical debt is the very high level of “under” insurance—that is, even with health insurance, copays for significant medical bills exceed what the patient can pay. Nearly half of adults (excluding the elderly) were enrolled in high-deductible health plans (in 2017).11 Among most employment-based plans, deductibles and co-pays have been going up for a decade.12 Overall, 20% of employer-provided plans had deductibles in excess of $3,000 ($5,000 for families).13 Of course, many families do not have anywhere near the resources to pay high deductibles, and that represents likely medical debt. The more modest copays of Medicare (often 20%) can be enough to push some elderly individuals beyond their capacity to pay.

“Out-of-network” care also may result in large hospital charges—and debt. Emergency care, for example, may be sought from the closest provider, even though out of network, and the insurance company may refuse to pay the charges. Another surprise form of billing is when a health care insurance company tentatively approves coverage and then after the patient receives care, determines it was unnecessary. In that case, even in-network charges may be denied, with the patient left to pay all the charges.

Continue to: How medical debt affects patients...

 

 

How medical debt affects patients

For patients, medical debt places pressure on their financial circumstances. Bankruptcy has a profound financial impact, and approximately two-thirds of bankruptcies are related to medical care costs and debt, including “indirect collection.”14 Even when the financial effect is not so devastating, it is often substantial, as the above case demonstrated. In a 2018 survey, almost 30% of those with health insurance had medical debts in some form of collection action, and 25% of those individuals said they did not know they owed the money.15 The same survey found that 20% of respondents had medical debt that adversely affected their credit scores and access to credit.15

At work, although employers are not supposed to treat employees adversely because of garnishment, some employers may not adhere to that rule. Furthermore, employees may believe or be concerned that the very existence of garnishment may penalize them at their current job or make it difficult to move to a better one.16

Lastly, patients with medical debt may be reluctant to seek needed medical care. They may be concerned about adding more medical debt or embarrassed or afraid that they would not be welcome at the hospital where they owe money.7

Public perception of hospitals

Lawsuits against patients also have a negative effect on hospitals—and it is not limited to the relatively few institutions that file many of these lawsuits each year. Press reports about lawsuits against patients garner great public interest and anger, and this tarnishes the image of heath care facilities in general because many people often do not distinguish the actions of a few institutions.

The sensitivity of health care organizations to bad publicity from debt collection practices was seen in a follow-up study of the previously discussed Virginia data. In the year following this report, there was a 59% decrease in the number of lawsuits filed, including a 66% decrease in garnishments.17 Eleven hospitals in the state that had been filing debt lawsuits stopped doing so.17

Medical debt: The obligation of nonprofit hospitals

The response seen in the Virginia follow-up study may also reflect well-founded concern from board members about political consequences and even taxation problems. The majority of hospitals, including those in these studies, are nonprofit institutions with an Internal Revenue Service (IRS) 501(c)(3) “tax-exempt” status. (Note, “nonprofit” does not mean that the organization does not make a profit, but that the profit does not accrue to individuals.) The “nonprofit” status is usually granted by states, but the federal tax-exempt status is granted by the IRS. This status exempts the institutions from paying most federal taxes, and (perhaps most importantly) qualifies donors to receive tax deductions (and similar benefits) for donations made to these hospitals. This important tax treatment is granted based on the theory that their services are so valuable to the public that advancing their work through the tax exemption ultimately benefits the public more than the tax revenue would.

In return for these benefits, the organization has obligations to work in the public interest. For years, hospitals have been criticized for not providing sufficient public benefits (compared, for example, with for-profit hospitals) to justify the tax exemption. That criticism caused the IRS to begin requiring a special Form 990, Schedule H, which is attached to the usual 501(c)(3) informational tax return, “to provide information on the activities and policies of, and community benefit provided by, its hospital facilities and other non-hospital health care facilities.”18 Part III of Schedule H asks, in part, about bad debt and collection practices.

Then the ACA Section 501(r) enhanced the obligation of nonprofit health facilities to provide charitable care in two ways. First, they must have, and make available, policies to provide free and discounted care; and second, they cannot sue for payment until they make an individualized determination as to whether the patient should have received discounted care or financial assistance.19

Thus aggressive collection practices (which should include “indirect collection”) invite special scrutiny by local officials and the IRS. In the longer-term, concern that tax-exempt hospitals are not truly operating in the public interest is undoubtedly amplified by these aggressive debt collection practices. How can a hospital claim it is truly operating in the public interest when it sues dozens of modest-income individuals each year?

Regulating medical debt and its collection

The No Surprises Act

In December 2020, Congress adopted the No Surprises Act to address some of the problems of patient debt.20 Among other things, the act protects patients “from receiving surprise medical bills when they receive most emergency services,” or when they are in an in-network hospital but receive services from out-of-network providers (such as anesthesia and radiology).21 Several states also have similar legislation, so the federal law specifically states that where state laws are more protective of patients, the state’s higher protections apply, and vice versa. The act took effect on January 1, 2022, though there is an “interim final” regulation that will be subject to change, and there is already litigation over those regulations.22 The real complexity of the rules will arise through the regulations, which are likely to change several times over the next few years. To help with this, the American Medical Association has an extensive toolkit for health care providers.23

Continue to: Additional regulations...

 

 

Additional regulations

Both the federal government and most states are likely to take additional action to reduce hospital debt lawsuits. Some proposals sound simple enough but would have significant complications. For example, governments could prohibit all lawsuits that collect hospital debt.7 Such a regulation would mean that paying hospital debts would essentially become optional. Imagine the millionaire who does not want to pay a $25,000 hospital charge; or patients with other debts who would pay those off before the hospital debt. The regulation might have income or asset limits on debt collection lawsuits and the like, but it quickly becomes complicated. Furthermore, to protect themselves, hospitals would undoubtedly become much more aggressive about requiring up-front payments—which would force the debt or prepayment onto credit cards or similar debt obligations that are not subject to the no collection lawsuit rule.

Public reporting. The follow-up study in Virginia17 suggests that requiring public reporting of the number of cases filed by or on behalf of (directly or indirectly) each hospital may help. Hospitals would, of course, have incentives to make their figures look better, perhaps by selling the debt to an agency that would be able to file suit in its name rather than the hospital’s name. These might be little more than indirect collections. For reporting purposes, any form of transferring debt might be considered filing a lawsuit. The problem, noted earlier, about requiring prepayment or credit cards would also exist.

Get the board involved. A different approach would be to ensure that a hospital’s board of trustees is involved in setting and overseeing debt collection policies. For example, the law might require boards to annually consider and adopt specific debt collection practices—including indirect collection efforts. Boards should already be doing something similar to this, but regulation might be an inexpensive way to ensure it is done—and in a manner consistent with the organization’s values. Another suggestion is to require the board to approve any legal action against specific patients.7 By making sure this is not just another item on the consent agenda, the oversight would probably reduce automatic debt collection processes.

Expand IRS reporting requirements for nonprofits. Indeed, for nonprofit hospitals with 501(c)(3) obligations, the Form 990, Schedule H already provides some information about collection actions and uncompensated care, and this is enhanced by the ACA Section 501(r). These could be expanded and perhaps include “indirect” collections. The IRS could “flag” hospitals with high total litigation and similar collection actions, and ask the hospital to provide a detailed explanation for each action and how it was consistent with the obligation to serve the public (thereby justifying the exempt taxation status, an idea proposed by the US Government Accountability Office in 2020).24

Ensure the hospital’s actions reflect their mission and values

Hospitals are created to provide medical care for people and to improve the human condition. Those who lead them should, and generally do, share that purpose. The apparent collection policies that have garnered negative public attention suggest that some of these institutions have lost focus of their ultimate mission and values. The boards and executives of these health care institutions, as well as the medical professionals and attorneys who serve them, should be continuously guided by those values.

Important decisions—including collection and prepayment processes—reflect the values of the institution. Failure to ensure these procedures are in line with the organization’s mission is an embarrassment to all health care facilities, including the majority of hospitals that do not engage in these aggressive collection practices. Not addressing these issues will likely result in political and legal action—blunt and inefficient instruments—to limit what the public sees as wrongdoing. ●

References

 

  1. Kiel P. From the E.R. to the courtroom: how nonprofit hospitals are seizing patients’ wages. ProPublica. December 19, 2014. Accessed March 21, 2022. https://www.propublica.org/article/how-nonprofit-hospitals-are-seizing-patients-wages
  2. Cooper Z, Han J, Mahoney N. Hospital lawsuits over unpaid bills increased by 37 percent in Wisconsin from 2001 to 2018. Health Affairs. 2021;40:1830-1835. Accessed March 21, 2022. https://www.healthaffairs.org/doi/full/10.1377 /hlthaff.2021.01130
  3. LaMantia J. New York hospitals have filed thousands of lawsuits against patients. Modern Healthcare. March 13, 2020. Accessed March 21, 2022. https://www.modernhealthcare .com/legal/new-york-hospitals-have-filed-thousands -lawsuits-against-patients
  4. Armour S. When patients can’t pay, many hospitals are suing. Wall Street Journal. June 25, 2019. Accessed March 21, 2022. https://www.wsj.com/articles/nonprofit-hospitals-criticized-for-debt-collection-tactics-11561467600
  5. McGhee M, Chase W. How America’s top hospitals hound patients with predatory billing. Axios. Accessed March 21, 2022. https://www.axios.com/hospital-billing
  6. Owens C. Public spotlight on hospital lawsuits may slow them down. June 14, 2021. Accessed March 22, 2022. https:// www.axios.com/hospital-lawsuits-slowing-down-media -35ce395a-9fe3-4b23-b815-d7b06cce2773.html
  7. Buck ID. When hospitals sue patients. Hastings L.J. 2022;73:191-232, at 209-211. Accessed March 21, 2022. https:// repository.uchastings.edu/cgi/viewcontent.cgi?article =3961&context=hastings_law_journal
  8. Lagasse J. Healthcare turns to zero-interest loans to give patients a better reason to pay. Healthcare Finance. May 3, 2017. Accessed March 21, 2022. https://www.healthcarefinancenews.com/news/healthcare-turns-zero-interest-loans-give-patients-better-reason-pay#:~:text=Zero%2Dinterest%20loans%20are%20finding,of%20the%20patient%2Dprovider%20relationship.
  9. Bruhn WE, Rutkow L, Wang P, et al. Prevalence and characteristics of Virginia hospitals suing patients and garnishing wages for unpaid medical bills. JAMA. 2019;322:691-692. doi:10.1001/jama.2019.9144
  10. Keisler-Starkey K, Bunch LN. Health insurance coverage in the United States: 2020. September 14, 2021. United States Census Bureau Current Population Reports, P60-274. US Government Publishing Office; September 2021. Accessed March 21, 2022. https://www.census.gov/content/dam /Census/library/publications/2021/demo/p60-274.pdf
  11. Cohen RA, Zammitti EP. High-deductible health plan enrollment among adults aged 18-64 with employment-based insurance coverage. NCHS Data Brief, No. 317. August 2018. Accessed March 21, 2022. https://www.cdc.gov/nchs/data/databriefs/db317.pdf
  12. Kaiser Family Foundation. Employer health benefits: 2020 summary of findings. Accessed March 21, 2022. https://www.kff.org/report-section/ehbs-2020-summary-of-findings/
  13. Picchi A. Higher health insurance deductibles a sickening trend for Americans. CBS NEWS. June 13, 2019. Accessed March 21, 2022. https://www.cbsnews.com/news/high-health-insurance-deductibles-a-sickening-trend-thats -causing-financial-hardship/
  14. Himmelstein DU, Lawless RM, Thorne D, Foohey P, Woolhandler S. Medical bankruptcy: still common despite the Affordable Care Act. Am J Public Health. 2019;109:431-433. doi:10.2105/AJPH.2018.304901
  15. Rosato D. What medical debt does to your credit score. Consumer Reports. July 26, 2018. Accessed March 21, 2022. https://www.consumerreports.org/credit-scores-reports/what-medical-debt-does-to-your-credit-score/
  16. State laws on wage garnishments. Nolo web site. https://www.nolo.com/legal-encyclopedia/free-books/employee-rights-book/chapter2-9.html. Accessed April 1, 2022.
  17. Patruzo JGR, Hashim F, Dun C, et al. Trends in hospital lawsuits filed against patients for unpaid bills following published research about their activity. JAMA Network Open. 2021;4:e2121926. doi:10.1001/jamanetworkopen.2021.21926
  18. About Schedule H (Form 990), hospitals. IRS. Updated June 10, 2021. Accessed March 21, 2022. https://www.irs.gov/forms-pubs/about-schedule-h-form-990
  19. Requirements for 501(c)(3) hospitals under the Affordable Care Act – Section 501(r). Updated September 9, 2021. Accessed March 21, 2022. https://www.irs.gov/charities-non-profits/charitable-organizations/requirements-for-501c3-hospitals-under-the-affordable-care-act-section-501r
  20. Pub. L. No. 116-260, 134 Stat. 1182, Division BB, § 109.
  21. Fact sheet. No Surprises: understand your rights against surprise medical bills. Centers for Medicare and Medicaid Services. January 3, 2022. Accessed March 21, 2022. https://www.cms.gov/newsroom/fact-sheets/no-surprises-understand-your-rights-against-surprise-medical-bills
  22. Implementation of the No Surprises Act. Accessed March 21, 2022. https://www.ama-assn.org/delivering-care/patient-support-advocacy/implementation-no-surprises-act
  23. American Medical Association. Toolkit for physicians: preparing for implementation of the No Surprises Act. January 2022. Accessed March 21, 2022. https://www.ama-assn.org/system/files/ama-nsa-toolkit.pdf
  24. US Government Accountability Office. Tax administration: opportunities exist to improve oversight of hospitals’ taxexempt status. September 2020. Accessed March 21, 2022. https://www.gao.gov/assets/gao-20-679.pdf
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Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.

The authors report no financial relationships related to this article.

 

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Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.

The authors report no financial relationships related to this article.

 

Author and Disclosure Information

Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Academic Division Director, Reproductive Endocrinology and Infertility, Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors.

Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.

The authors report no financial relationships related to this article.

 

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Although it is common to read about patients suing their hospitals, there has been increasing public and political attention given to hospitals suing their patients to collect unpaid hospital bills. KH’s story began with an emergency appendectomy. She did not have health insurance to cover the $14,000 hospital bill. The family was unable to pay the bill, and the nonprofit hospital sued them for that bill, plus some additional expenses (totaling about $17,000), plus interest was accumulating at 9% per year. The hospital won a judgment, and it garnished the husband’s pay (10% of after-taxes pay, in this case) and placed a lien on the family’s home. Years later—because of interest and additional hospital bills—the family had paid $20,000, but still owed $26,000.1

The extent of the problem

This is neither a hypothetical case nor a rare event. Studies and press reports have noted dozens of examples of hospital collection excesses. One study found that unpaid medical bill lawsuits increased by 37% in Wisconsin between 2001 and 2018, with 5% of hospitals accounting for 25% of the lawsuits.2 Another report found almost “31,000 civil cases filed by 139 hospitals in 26 New York counties from 2015 to 2019.”3 Similar to the Wisconsin report, a small number of health care providers accounted for the majority of lawsuits. In another example, one Missouri nonprofit hospital, Heartland (rebranded “Mosaic”), created its own for-profit debt collection agency (Northwest Financial Services), which filed 11,000 lawsuits from 2009 to 2013, resulting in 6,000 wage garnishments.1 The Wall Street Journal, among others, has reported for years on the difficulties created by lawsuits against patients.4 Axios and Johns Hopkins reported that “medical debt comprises 58% of all debt collections in the United States.” And although some collection actions declined early in the pandemic, it did not appear to last.5,6

Inconsistent collection policies. Collection policies vary greatly from hospital to hospital, with an increasing number of hospitals demanding up-front payments (before services). Many of these health care institutions persuade patients to put medical debt on their credit cards, sometimes as part of an up-front (before service) process.7 If using a standard credit card, this comes with a very high interest rate. There are some special health-related credit cards, such as CareCredit, that generally have better interest rates. These cards offer no-interest short-term loans, with significant interest for longer-term loans. Thus, failure to repay the full amount when due means that the “deferred interest” (about 27%) must be paid.8 Also any of the problems patients have repaying a credit card (or other loan), of course, are no longer directly related to the hospital. These “indirect collections” still burden patients with medical debt.

Where you go matters. Because there is no common collection policy or practice among hospitals, choosing the wrong hospital may result in a lawsuit. A careful study of lawsuits for medical debt or garnishments related to that debt in 2017 in Virginia showed how being treated at certain hospitals dramatically changed the odds of wage garnishment for unpaid bills.9 It revealed that 29,286 hospital lawsuits were filed to collect medical debt—9,232 of which were wage garnishments (the most aggressive form of debt collection). Five hospitals alone accounted for the majority of garnishments in the state. Notably, nonprofit hospitals accounted for 71% of the garnishment cases. On the other hand, about 50% of the hospitals in the study did not file any lawsuits to garnish wages for medical debt.9

Why is there so much hospital debt?

One would think the Affordable Care Act (ACA) and other reforms would mean fewer people do not have health insurance—and the problems experienced by the patient in the case above. Indeed, the number of insured has increased in the United States, including through the expansion of Medi­caid. Nonetheless, in 2020, the Census Bureau reported that 28 million people did not have health insurance for any part of the year; that figure would be higher if those who had insurance for only part of the year were included.10

One reason for medical debt is the very high level of “under” insurance—that is, even with health insurance, copays for significant medical bills exceed what the patient can pay. Nearly half of adults (excluding the elderly) were enrolled in high-deductible health plans (in 2017).11 Among most employment-based plans, deductibles and co-pays have been going up for a decade.12 Overall, 20% of employer-provided plans had deductibles in excess of $3,000 ($5,000 for families).13 Of course, many families do not have anywhere near the resources to pay high deductibles, and that represents likely medical debt. The more modest copays of Medicare (often 20%) can be enough to push some elderly individuals beyond their capacity to pay.

“Out-of-network” care also may result in large hospital charges—and debt. Emergency care, for example, may be sought from the closest provider, even though out of network, and the insurance company may refuse to pay the charges. Another surprise form of billing is when a health care insurance company tentatively approves coverage and then after the patient receives care, determines it was unnecessary. In that case, even in-network charges may be denied, with the patient left to pay all the charges.

Continue to: How medical debt affects patients...

 

 

How medical debt affects patients

For patients, medical debt places pressure on their financial circumstances. Bankruptcy has a profound financial impact, and approximately two-thirds of bankruptcies are related to medical care costs and debt, including “indirect collection.”14 Even when the financial effect is not so devastating, it is often substantial, as the above case demonstrated. In a 2018 survey, almost 30% of those with health insurance had medical debts in some form of collection action, and 25% of those individuals said they did not know they owed the money.15 The same survey found that 20% of respondents had medical debt that adversely affected their credit scores and access to credit.15

At work, although employers are not supposed to treat employees adversely because of garnishment, some employers may not adhere to that rule. Furthermore, employees may believe or be concerned that the very existence of garnishment may penalize them at their current job or make it difficult to move to a better one.16

Lastly, patients with medical debt may be reluctant to seek needed medical care. They may be concerned about adding more medical debt or embarrassed or afraid that they would not be welcome at the hospital where they owe money.7

Public perception of hospitals

Lawsuits against patients also have a negative effect on hospitals—and it is not limited to the relatively few institutions that file many of these lawsuits each year. Press reports about lawsuits against patients garner great public interest and anger, and this tarnishes the image of heath care facilities in general because many people often do not distinguish the actions of a few institutions.

The sensitivity of health care organizations to bad publicity from debt collection practices was seen in a follow-up study of the previously discussed Virginia data. In the year following this report, there was a 59% decrease in the number of lawsuits filed, including a 66% decrease in garnishments.17 Eleven hospitals in the state that had been filing debt lawsuits stopped doing so.17

Medical debt: The obligation of nonprofit hospitals

The response seen in the Virginia follow-up study may also reflect well-founded concern from board members about political consequences and even taxation problems. The majority of hospitals, including those in these studies, are nonprofit institutions with an Internal Revenue Service (IRS) 501(c)(3) “tax-exempt” status. (Note, “nonprofit” does not mean that the organization does not make a profit, but that the profit does not accrue to individuals.) The “nonprofit” status is usually granted by states, but the federal tax-exempt status is granted by the IRS. This status exempts the institutions from paying most federal taxes, and (perhaps most importantly) qualifies donors to receive tax deductions (and similar benefits) for donations made to these hospitals. This important tax treatment is granted based on the theory that their services are so valuable to the public that advancing their work through the tax exemption ultimately benefits the public more than the tax revenue would.

In return for these benefits, the organization has obligations to work in the public interest. For years, hospitals have been criticized for not providing sufficient public benefits (compared, for example, with for-profit hospitals) to justify the tax exemption. That criticism caused the IRS to begin requiring a special Form 990, Schedule H, which is attached to the usual 501(c)(3) informational tax return, “to provide information on the activities and policies of, and community benefit provided by, its hospital facilities and other non-hospital health care facilities.”18 Part III of Schedule H asks, in part, about bad debt and collection practices.

Then the ACA Section 501(r) enhanced the obligation of nonprofit health facilities to provide charitable care in two ways. First, they must have, and make available, policies to provide free and discounted care; and second, they cannot sue for payment until they make an individualized determination as to whether the patient should have received discounted care or financial assistance.19

Thus aggressive collection practices (which should include “indirect collection”) invite special scrutiny by local officials and the IRS. In the longer-term, concern that tax-exempt hospitals are not truly operating in the public interest is undoubtedly amplified by these aggressive debt collection practices. How can a hospital claim it is truly operating in the public interest when it sues dozens of modest-income individuals each year?

Regulating medical debt and its collection

The No Surprises Act

In December 2020, Congress adopted the No Surprises Act to address some of the problems of patient debt.20 Among other things, the act protects patients “from receiving surprise medical bills when they receive most emergency services,” or when they are in an in-network hospital but receive services from out-of-network providers (such as anesthesia and radiology).21 Several states also have similar legislation, so the federal law specifically states that where state laws are more protective of patients, the state’s higher protections apply, and vice versa. The act took effect on January 1, 2022, though there is an “interim final” regulation that will be subject to change, and there is already litigation over those regulations.22 The real complexity of the rules will arise through the regulations, which are likely to change several times over the next few years. To help with this, the American Medical Association has an extensive toolkit for health care providers.23

Continue to: Additional regulations...

 

 

Additional regulations

Both the federal government and most states are likely to take additional action to reduce hospital debt lawsuits. Some proposals sound simple enough but would have significant complications. For example, governments could prohibit all lawsuits that collect hospital debt.7 Such a regulation would mean that paying hospital debts would essentially become optional. Imagine the millionaire who does not want to pay a $25,000 hospital charge; or patients with other debts who would pay those off before the hospital debt. The regulation might have income or asset limits on debt collection lawsuits and the like, but it quickly becomes complicated. Furthermore, to protect themselves, hospitals would undoubtedly become much more aggressive about requiring up-front payments—which would force the debt or prepayment onto credit cards or similar debt obligations that are not subject to the no collection lawsuit rule.

Public reporting. The follow-up study in Virginia17 suggests that requiring public reporting of the number of cases filed by or on behalf of (directly or indirectly) each hospital may help. Hospitals would, of course, have incentives to make their figures look better, perhaps by selling the debt to an agency that would be able to file suit in its name rather than the hospital’s name. These might be little more than indirect collections. For reporting purposes, any form of transferring debt might be considered filing a lawsuit. The problem, noted earlier, about requiring prepayment or credit cards would also exist.

Get the board involved. A different approach would be to ensure that a hospital’s board of trustees is involved in setting and overseeing debt collection policies. For example, the law might require boards to annually consider and adopt specific debt collection practices—including indirect collection efforts. Boards should already be doing something similar to this, but regulation might be an inexpensive way to ensure it is done—and in a manner consistent with the organization’s values. Another suggestion is to require the board to approve any legal action against specific patients.7 By making sure this is not just another item on the consent agenda, the oversight would probably reduce automatic debt collection processes.

Expand IRS reporting requirements for nonprofits. Indeed, for nonprofit hospitals with 501(c)(3) obligations, the Form 990, Schedule H already provides some information about collection actions and uncompensated care, and this is enhanced by the ACA Section 501(r). These could be expanded and perhaps include “indirect” collections. The IRS could “flag” hospitals with high total litigation and similar collection actions, and ask the hospital to provide a detailed explanation for each action and how it was consistent with the obligation to serve the public (thereby justifying the exempt taxation status, an idea proposed by the US Government Accountability Office in 2020).24

Ensure the hospital’s actions reflect their mission and values

Hospitals are created to provide medical care for people and to improve the human condition. Those who lead them should, and generally do, share that purpose. The apparent collection policies that have garnered negative public attention suggest that some of these institutions have lost focus of their ultimate mission and values. The boards and executives of these health care institutions, as well as the medical professionals and attorneys who serve them, should be continuously guided by those values.

Important decisions—including collection and prepayment processes—reflect the values of the institution. Failure to ensure these procedures are in line with the organization’s mission is an embarrassment to all health care facilities, including the majority of hospitals that do not engage in these aggressive collection practices. Not addressing these issues will likely result in political and legal action—blunt and inefficient instruments—to limit what the public sees as wrongdoing. ●

 

 

Although it is common to read about patients suing their hospitals, there has been increasing public and political attention given to hospitals suing their patients to collect unpaid hospital bills. KH’s story began with an emergency appendectomy. She did not have health insurance to cover the $14,000 hospital bill. The family was unable to pay the bill, and the nonprofit hospital sued them for that bill, plus some additional expenses (totaling about $17,000), plus interest was accumulating at 9% per year. The hospital won a judgment, and it garnished the husband’s pay (10% of after-taxes pay, in this case) and placed a lien on the family’s home. Years later—because of interest and additional hospital bills—the family had paid $20,000, but still owed $26,000.1

The extent of the problem

This is neither a hypothetical case nor a rare event. Studies and press reports have noted dozens of examples of hospital collection excesses. One study found that unpaid medical bill lawsuits increased by 37% in Wisconsin between 2001 and 2018, with 5% of hospitals accounting for 25% of the lawsuits.2 Another report found almost “31,000 civil cases filed by 139 hospitals in 26 New York counties from 2015 to 2019.”3 Similar to the Wisconsin report, a small number of health care providers accounted for the majority of lawsuits. In another example, one Missouri nonprofit hospital, Heartland (rebranded “Mosaic”), created its own for-profit debt collection agency (Northwest Financial Services), which filed 11,000 lawsuits from 2009 to 2013, resulting in 6,000 wage garnishments.1 The Wall Street Journal, among others, has reported for years on the difficulties created by lawsuits against patients.4 Axios and Johns Hopkins reported that “medical debt comprises 58% of all debt collections in the United States.” And although some collection actions declined early in the pandemic, it did not appear to last.5,6

Inconsistent collection policies. Collection policies vary greatly from hospital to hospital, with an increasing number of hospitals demanding up-front payments (before services). Many of these health care institutions persuade patients to put medical debt on their credit cards, sometimes as part of an up-front (before service) process.7 If using a standard credit card, this comes with a very high interest rate. There are some special health-related credit cards, such as CareCredit, that generally have better interest rates. These cards offer no-interest short-term loans, with significant interest for longer-term loans. Thus, failure to repay the full amount when due means that the “deferred interest” (about 27%) must be paid.8 Also any of the problems patients have repaying a credit card (or other loan), of course, are no longer directly related to the hospital. These “indirect collections” still burden patients with medical debt.

Where you go matters. Because there is no common collection policy or practice among hospitals, choosing the wrong hospital may result in a lawsuit. A careful study of lawsuits for medical debt or garnishments related to that debt in 2017 in Virginia showed how being treated at certain hospitals dramatically changed the odds of wage garnishment for unpaid bills.9 It revealed that 29,286 hospital lawsuits were filed to collect medical debt—9,232 of which were wage garnishments (the most aggressive form of debt collection). Five hospitals alone accounted for the majority of garnishments in the state. Notably, nonprofit hospitals accounted for 71% of the garnishment cases. On the other hand, about 50% of the hospitals in the study did not file any lawsuits to garnish wages for medical debt.9

Why is there so much hospital debt?

One would think the Affordable Care Act (ACA) and other reforms would mean fewer people do not have health insurance—and the problems experienced by the patient in the case above. Indeed, the number of insured has increased in the United States, including through the expansion of Medi­caid. Nonetheless, in 2020, the Census Bureau reported that 28 million people did not have health insurance for any part of the year; that figure would be higher if those who had insurance for only part of the year were included.10

One reason for medical debt is the very high level of “under” insurance—that is, even with health insurance, copays for significant medical bills exceed what the patient can pay. Nearly half of adults (excluding the elderly) were enrolled in high-deductible health plans (in 2017).11 Among most employment-based plans, deductibles and co-pays have been going up for a decade.12 Overall, 20% of employer-provided plans had deductibles in excess of $3,000 ($5,000 for families).13 Of course, many families do not have anywhere near the resources to pay high deductibles, and that represents likely medical debt. The more modest copays of Medicare (often 20%) can be enough to push some elderly individuals beyond their capacity to pay.

“Out-of-network” care also may result in large hospital charges—and debt. Emergency care, for example, may be sought from the closest provider, even though out of network, and the insurance company may refuse to pay the charges. Another surprise form of billing is when a health care insurance company tentatively approves coverage and then after the patient receives care, determines it was unnecessary. In that case, even in-network charges may be denied, with the patient left to pay all the charges.

Continue to: How medical debt affects patients...

 

 

How medical debt affects patients

For patients, medical debt places pressure on their financial circumstances. Bankruptcy has a profound financial impact, and approximately two-thirds of bankruptcies are related to medical care costs and debt, including “indirect collection.”14 Even when the financial effect is not so devastating, it is often substantial, as the above case demonstrated. In a 2018 survey, almost 30% of those with health insurance had medical debts in some form of collection action, and 25% of those individuals said they did not know they owed the money.15 The same survey found that 20% of respondents had medical debt that adversely affected their credit scores and access to credit.15

At work, although employers are not supposed to treat employees adversely because of garnishment, some employers may not adhere to that rule. Furthermore, employees may believe or be concerned that the very existence of garnishment may penalize them at their current job or make it difficult to move to a better one.16

Lastly, patients with medical debt may be reluctant to seek needed medical care. They may be concerned about adding more medical debt or embarrassed or afraid that they would not be welcome at the hospital where they owe money.7

Public perception of hospitals

Lawsuits against patients also have a negative effect on hospitals—and it is not limited to the relatively few institutions that file many of these lawsuits each year. Press reports about lawsuits against patients garner great public interest and anger, and this tarnishes the image of heath care facilities in general because many people often do not distinguish the actions of a few institutions.

The sensitivity of health care organizations to bad publicity from debt collection practices was seen in a follow-up study of the previously discussed Virginia data. In the year following this report, there was a 59% decrease in the number of lawsuits filed, including a 66% decrease in garnishments.17 Eleven hospitals in the state that had been filing debt lawsuits stopped doing so.17

Medical debt: The obligation of nonprofit hospitals

The response seen in the Virginia follow-up study may also reflect well-founded concern from board members about political consequences and even taxation problems. The majority of hospitals, including those in these studies, are nonprofit institutions with an Internal Revenue Service (IRS) 501(c)(3) “tax-exempt” status. (Note, “nonprofit” does not mean that the organization does not make a profit, but that the profit does not accrue to individuals.) The “nonprofit” status is usually granted by states, but the federal tax-exempt status is granted by the IRS. This status exempts the institutions from paying most federal taxes, and (perhaps most importantly) qualifies donors to receive tax deductions (and similar benefits) for donations made to these hospitals. This important tax treatment is granted based on the theory that their services are so valuable to the public that advancing their work through the tax exemption ultimately benefits the public more than the tax revenue would.

In return for these benefits, the organization has obligations to work in the public interest. For years, hospitals have been criticized for not providing sufficient public benefits (compared, for example, with for-profit hospitals) to justify the tax exemption. That criticism caused the IRS to begin requiring a special Form 990, Schedule H, which is attached to the usual 501(c)(3) informational tax return, “to provide information on the activities and policies of, and community benefit provided by, its hospital facilities and other non-hospital health care facilities.”18 Part III of Schedule H asks, in part, about bad debt and collection practices.

Then the ACA Section 501(r) enhanced the obligation of nonprofit health facilities to provide charitable care in two ways. First, they must have, and make available, policies to provide free and discounted care; and second, they cannot sue for payment until they make an individualized determination as to whether the patient should have received discounted care or financial assistance.19

Thus aggressive collection practices (which should include “indirect collection”) invite special scrutiny by local officials and the IRS. In the longer-term, concern that tax-exempt hospitals are not truly operating in the public interest is undoubtedly amplified by these aggressive debt collection practices. How can a hospital claim it is truly operating in the public interest when it sues dozens of modest-income individuals each year?

Regulating medical debt and its collection

The No Surprises Act

In December 2020, Congress adopted the No Surprises Act to address some of the problems of patient debt.20 Among other things, the act protects patients “from receiving surprise medical bills when they receive most emergency services,” or when they are in an in-network hospital but receive services from out-of-network providers (such as anesthesia and radiology).21 Several states also have similar legislation, so the federal law specifically states that where state laws are more protective of patients, the state’s higher protections apply, and vice versa. The act took effect on January 1, 2022, though there is an “interim final” regulation that will be subject to change, and there is already litigation over those regulations.22 The real complexity of the rules will arise through the regulations, which are likely to change several times over the next few years. To help with this, the American Medical Association has an extensive toolkit for health care providers.23

Continue to: Additional regulations...

 

 

Additional regulations

Both the federal government and most states are likely to take additional action to reduce hospital debt lawsuits. Some proposals sound simple enough but would have significant complications. For example, governments could prohibit all lawsuits that collect hospital debt.7 Such a regulation would mean that paying hospital debts would essentially become optional. Imagine the millionaire who does not want to pay a $25,000 hospital charge; or patients with other debts who would pay those off before the hospital debt. The regulation might have income or asset limits on debt collection lawsuits and the like, but it quickly becomes complicated. Furthermore, to protect themselves, hospitals would undoubtedly become much more aggressive about requiring up-front payments—which would force the debt or prepayment onto credit cards or similar debt obligations that are not subject to the no collection lawsuit rule.

Public reporting. The follow-up study in Virginia17 suggests that requiring public reporting of the number of cases filed by or on behalf of (directly or indirectly) each hospital may help. Hospitals would, of course, have incentives to make their figures look better, perhaps by selling the debt to an agency that would be able to file suit in its name rather than the hospital’s name. These might be little more than indirect collections. For reporting purposes, any form of transferring debt might be considered filing a lawsuit. The problem, noted earlier, about requiring prepayment or credit cards would also exist.

Get the board involved. A different approach would be to ensure that a hospital’s board of trustees is involved in setting and overseeing debt collection policies. For example, the law might require boards to annually consider and adopt specific debt collection practices—including indirect collection efforts. Boards should already be doing something similar to this, but regulation might be an inexpensive way to ensure it is done—and in a manner consistent with the organization’s values. Another suggestion is to require the board to approve any legal action against specific patients.7 By making sure this is not just another item on the consent agenda, the oversight would probably reduce automatic debt collection processes.

Expand IRS reporting requirements for nonprofits. Indeed, for nonprofit hospitals with 501(c)(3) obligations, the Form 990, Schedule H already provides some information about collection actions and uncompensated care, and this is enhanced by the ACA Section 501(r). These could be expanded and perhaps include “indirect” collections. The IRS could “flag” hospitals with high total litigation and similar collection actions, and ask the hospital to provide a detailed explanation for each action and how it was consistent with the obligation to serve the public (thereby justifying the exempt taxation status, an idea proposed by the US Government Accountability Office in 2020).24

Ensure the hospital’s actions reflect their mission and values

Hospitals are created to provide medical care for people and to improve the human condition. Those who lead them should, and generally do, share that purpose. The apparent collection policies that have garnered negative public attention suggest that some of these institutions have lost focus of their ultimate mission and values. The boards and executives of these health care institutions, as well as the medical professionals and attorneys who serve them, should be continuously guided by those values.

Important decisions—including collection and prepayment processes—reflect the values of the institution. Failure to ensure these procedures are in line with the organization’s mission is an embarrassment to all health care facilities, including the majority of hospitals that do not engage in these aggressive collection practices. Not addressing these issues will likely result in political and legal action—blunt and inefficient instruments—to limit what the public sees as wrongdoing. ●

References

 

  1. Kiel P. From the E.R. to the courtroom: how nonprofit hospitals are seizing patients’ wages. ProPublica. December 19, 2014. Accessed March 21, 2022. https://www.propublica.org/article/how-nonprofit-hospitals-are-seizing-patients-wages
  2. Cooper Z, Han J, Mahoney N. Hospital lawsuits over unpaid bills increased by 37 percent in Wisconsin from 2001 to 2018. Health Affairs. 2021;40:1830-1835. Accessed March 21, 2022. https://www.healthaffairs.org/doi/full/10.1377 /hlthaff.2021.01130
  3. LaMantia J. New York hospitals have filed thousands of lawsuits against patients. Modern Healthcare. March 13, 2020. Accessed March 21, 2022. https://www.modernhealthcare .com/legal/new-york-hospitals-have-filed-thousands -lawsuits-against-patients
  4. Armour S. When patients can’t pay, many hospitals are suing. Wall Street Journal. June 25, 2019. Accessed March 21, 2022. https://www.wsj.com/articles/nonprofit-hospitals-criticized-for-debt-collection-tactics-11561467600
  5. McGhee M, Chase W. How America’s top hospitals hound patients with predatory billing. Axios. Accessed March 21, 2022. https://www.axios.com/hospital-billing
  6. Owens C. Public spotlight on hospital lawsuits may slow them down. June 14, 2021. Accessed March 22, 2022. https:// www.axios.com/hospital-lawsuits-slowing-down-media -35ce395a-9fe3-4b23-b815-d7b06cce2773.html
  7. Buck ID. When hospitals sue patients. Hastings L.J. 2022;73:191-232, at 209-211. Accessed March 21, 2022. https:// repository.uchastings.edu/cgi/viewcontent.cgi?article =3961&context=hastings_law_journal
  8. Lagasse J. Healthcare turns to zero-interest loans to give patients a better reason to pay. Healthcare Finance. May 3, 2017. Accessed March 21, 2022. https://www.healthcarefinancenews.com/news/healthcare-turns-zero-interest-loans-give-patients-better-reason-pay#:~:text=Zero%2Dinterest%20loans%20are%20finding,of%20the%20patient%2Dprovider%20relationship.
  9. Bruhn WE, Rutkow L, Wang P, et al. Prevalence and characteristics of Virginia hospitals suing patients and garnishing wages for unpaid medical bills. JAMA. 2019;322:691-692. doi:10.1001/jama.2019.9144
  10. Keisler-Starkey K, Bunch LN. Health insurance coverage in the United States: 2020. September 14, 2021. United States Census Bureau Current Population Reports, P60-274. US Government Publishing Office; September 2021. Accessed March 21, 2022. https://www.census.gov/content/dam /Census/library/publications/2021/demo/p60-274.pdf
  11. Cohen RA, Zammitti EP. High-deductible health plan enrollment among adults aged 18-64 with employment-based insurance coverage. NCHS Data Brief, No. 317. August 2018. Accessed March 21, 2022. https://www.cdc.gov/nchs/data/databriefs/db317.pdf
  12. Kaiser Family Foundation. Employer health benefits: 2020 summary of findings. Accessed March 21, 2022. https://www.kff.org/report-section/ehbs-2020-summary-of-findings/
  13. Picchi A. Higher health insurance deductibles a sickening trend for Americans. CBS NEWS. June 13, 2019. Accessed March 21, 2022. https://www.cbsnews.com/news/high-health-insurance-deductibles-a-sickening-trend-thats -causing-financial-hardship/
  14. Himmelstein DU, Lawless RM, Thorne D, Foohey P, Woolhandler S. Medical bankruptcy: still common despite the Affordable Care Act. Am J Public Health. 2019;109:431-433. doi:10.2105/AJPH.2018.304901
  15. Rosato D. What medical debt does to your credit score. Consumer Reports. July 26, 2018. Accessed March 21, 2022. https://www.consumerreports.org/credit-scores-reports/what-medical-debt-does-to-your-credit-score/
  16. State laws on wage garnishments. Nolo web site. https://www.nolo.com/legal-encyclopedia/free-books/employee-rights-book/chapter2-9.html. Accessed April 1, 2022.
  17. Patruzo JGR, Hashim F, Dun C, et al. Trends in hospital lawsuits filed against patients for unpaid bills following published research about their activity. JAMA Network Open. 2021;4:e2121926. doi:10.1001/jamanetworkopen.2021.21926
  18. About Schedule H (Form 990), hospitals. IRS. Updated June 10, 2021. Accessed March 21, 2022. https://www.irs.gov/forms-pubs/about-schedule-h-form-990
  19. Requirements for 501(c)(3) hospitals under the Affordable Care Act – Section 501(r). Updated September 9, 2021. Accessed March 21, 2022. https://www.irs.gov/charities-non-profits/charitable-organizations/requirements-for-501c3-hospitals-under-the-affordable-care-act-section-501r
  20. Pub. L. No. 116-260, 134 Stat. 1182, Division BB, § 109.
  21. Fact sheet. No Surprises: understand your rights against surprise medical bills. Centers for Medicare and Medicaid Services. January 3, 2022. Accessed March 21, 2022. https://www.cms.gov/newsroom/fact-sheets/no-surprises-understand-your-rights-against-surprise-medical-bills
  22. Implementation of the No Surprises Act. Accessed March 21, 2022. https://www.ama-assn.org/delivering-care/patient-support-advocacy/implementation-no-surprises-act
  23. American Medical Association. Toolkit for physicians: preparing for implementation of the No Surprises Act. January 2022. Accessed March 21, 2022. https://www.ama-assn.org/system/files/ama-nsa-toolkit.pdf
  24. US Government Accountability Office. Tax administration: opportunities exist to improve oversight of hospitals’ taxexempt status. September 2020. Accessed March 21, 2022. https://www.gao.gov/assets/gao-20-679.pdf
References

 

  1. Kiel P. From the E.R. to the courtroom: how nonprofit hospitals are seizing patients’ wages. ProPublica. December 19, 2014. Accessed March 21, 2022. https://www.propublica.org/article/how-nonprofit-hospitals-are-seizing-patients-wages
  2. Cooper Z, Han J, Mahoney N. Hospital lawsuits over unpaid bills increased by 37 percent in Wisconsin from 2001 to 2018. Health Affairs. 2021;40:1830-1835. Accessed March 21, 2022. https://www.healthaffairs.org/doi/full/10.1377 /hlthaff.2021.01130
  3. LaMantia J. New York hospitals have filed thousands of lawsuits against patients. Modern Healthcare. March 13, 2020. Accessed March 21, 2022. https://www.modernhealthcare .com/legal/new-york-hospitals-have-filed-thousands -lawsuits-against-patients
  4. Armour S. When patients can’t pay, many hospitals are suing. Wall Street Journal. June 25, 2019. Accessed March 21, 2022. https://www.wsj.com/articles/nonprofit-hospitals-criticized-for-debt-collection-tactics-11561467600
  5. McGhee M, Chase W. How America’s top hospitals hound patients with predatory billing. Axios. Accessed March 21, 2022. https://www.axios.com/hospital-billing
  6. Owens C. Public spotlight on hospital lawsuits may slow them down. June 14, 2021. Accessed March 22, 2022. https:// www.axios.com/hospital-lawsuits-slowing-down-media -35ce395a-9fe3-4b23-b815-d7b06cce2773.html
  7. Buck ID. When hospitals sue patients. Hastings L.J. 2022;73:191-232, at 209-211. Accessed March 21, 2022. https:// repository.uchastings.edu/cgi/viewcontent.cgi?article =3961&context=hastings_law_journal
  8. Lagasse J. Healthcare turns to zero-interest loans to give patients a better reason to pay. Healthcare Finance. May 3, 2017. Accessed March 21, 2022. https://www.healthcarefinancenews.com/news/healthcare-turns-zero-interest-loans-give-patients-better-reason-pay#:~:text=Zero%2Dinterest%20loans%20are%20finding,of%20the%20patient%2Dprovider%20relationship.
  9. Bruhn WE, Rutkow L, Wang P, et al. Prevalence and characteristics of Virginia hospitals suing patients and garnishing wages for unpaid medical bills. JAMA. 2019;322:691-692. doi:10.1001/jama.2019.9144
  10. Keisler-Starkey K, Bunch LN. Health insurance coverage in the United States: 2020. September 14, 2021. United States Census Bureau Current Population Reports, P60-274. US Government Publishing Office; September 2021. Accessed March 21, 2022. https://www.census.gov/content/dam /Census/library/publications/2021/demo/p60-274.pdf
  11. Cohen RA, Zammitti EP. High-deductible health plan enrollment among adults aged 18-64 with employment-based insurance coverage. NCHS Data Brief, No. 317. August 2018. Accessed March 21, 2022. https://www.cdc.gov/nchs/data/databriefs/db317.pdf
  12. Kaiser Family Foundation. Employer health benefits: 2020 summary of findings. Accessed March 21, 2022. https://www.kff.org/report-section/ehbs-2020-summary-of-findings/
  13. Picchi A. Higher health insurance deductibles a sickening trend for Americans. CBS NEWS. June 13, 2019. Accessed March 21, 2022. https://www.cbsnews.com/news/high-health-insurance-deductibles-a-sickening-trend-thats -causing-financial-hardship/
  14. Himmelstein DU, Lawless RM, Thorne D, Foohey P, Woolhandler S. Medical bankruptcy: still common despite the Affordable Care Act. Am J Public Health. 2019;109:431-433. doi:10.2105/AJPH.2018.304901
  15. Rosato D. What medical debt does to your credit score. Consumer Reports. July 26, 2018. Accessed March 21, 2022. https://www.consumerreports.org/credit-scores-reports/what-medical-debt-does-to-your-credit-score/
  16. State laws on wage garnishments. Nolo web site. https://www.nolo.com/legal-encyclopedia/free-books/employee-rights-book/chapter2-9.html. Accessed April 1, 2022.
  17. Patruzo JGR, Hashim F, Dun C, et al. Trends in hospital lawsuits filed against patients for unpaid bills following published research about their activity. JAMA Network Open. 2021;4:e2121926. doi:10.1001/jamanetworkopen.2021.21926
  18. About Schedule H (Form 990), hospitals. IRS. Updated June 10, 2021. Accessed March 21, 2022. https://www.irs.gov/forms-pubs/about-schedule-h-form-990
  19. Requirements for 501(c)(3) hospitals under the Affordable Care Act – Section 501(r). Updated September 9, 2021. Accessed March 21, 2022. https://www.irs.gov/charities-non-profits/charitable-organizations/requirements-for-501c3-hospitals-under-the-affordable-care-act-section-501r
  20. Pub. L. No. 116-260, 134 Stat. 1182, Division BB, § 109.
  21. Fact sheet. No Surprises: understand your rights against surprise medical bills. Centers for Medicare and Medicaid Services. January 3, 2022. Accessed March 21, 2022. https://www.cms.gov/newsroom/fact-sheets/no-surprises-understand-your-rights-against-surprise-medical-bills
  22. Implementation of the No Surprises Act. Accessed March 21, 2022. https://www.ama-assn.org/delivering-care/patient-support-advocacy/implementation-no-surprises-act
  23. American Medical Association. Toolkit for physicians: preparing for implementation of the No Surprises Act. January 2022. Accessed March 21, 2022. https://www.ama-assn.org/system/files/ama-nsa-toolkit.pdf
  24. US Government Accountability Office. Tax administration: opportunities exist to improve oversight of hospitals’ taxexempt status. September 2020. Accessed March 21, 2022. https://www.gao.gov/assets/gao-20-679.pdf
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Infectious disease pop quiz: Clinical challenges for the ObGyn

Article Type
Changed

 

 

In this question-and-answer article (the third in a series), our objective is to re­inforce for the clinician several practical points of management for common infectious diseases. The principal references for the answers to the questions are 2 textbook chapters written by Dr. Duff.1,2 Other pertinent references are included in the text.

21. What prophylactic antibiotic should be administered intrapartum to a pregnant woman who is colonized with group B streptococci but who has a mild allergy to penicillin?

In this situation, the drug of choice is intravenous cefazolin, 2 g initially then 1 g every 8 hours until delivery. For patients with a severe allergy to penicillin, the drugs of choice are either clindamycin, 900 mg intravenously every 8 hours (if sensitivity of the organism is confirmed), or vancomycin, 20 mg/kg intravenously every 8 hours (maximum of 2 g per single dose).

22. In a pregnant woman who has a life-threatening allergy to penicillin, what is the most appropriate treatment for syphilis?

This patient should be admitted to the hospital and rapidly desensitized to penicillin. She then can be treated with the appropriate dose of penicillin, given her stage of syphilis. Of note, in the future, the patient’s allergy to penicillin will return, despite the brief period of desensitization.

 

23. What are the most common organisms that cause chorioamnionitis and puerperal endometritis?

Chorioamnionitis and puerperal endometritis are polymicrobial, mixed aerobic-anaerobic infections. The dominant organisms are anaerobic gram-negative bacilli (Bacteroides and Prevotella species); anaerobic gram-positive cocci (Peptococcus species and Peptostreptococcus species); aerobic gram-negative bacilli (principally, Escherichia coli, Klebsiella pneumoniae, and Proteus species); and aerobic gram-positive cocci (enterococci, staphylococci, and group B streptococci). ●

References
  1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
  2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
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Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology,University of Florida College of Medicine, Gainesville.

 

The authors report no financial relationships relevant to this article.

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Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology,University of Florida College of Medicine, Gainesville.

 

The authors report no financial relationships relevant to this article.

Author and Disclosure Information

Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology,University of Florida College of Medicine, Gainesville.

 

The authors report no financial relationships relevant to this article.

Article PDF
Article PDF

 

 

In this question-and-answer article (the third in a series), our objective is to re­inforce for the clinician several practical points of management for common infectious diseases. The principal references for the answers to the questions are 2 textbook chapters written by Dr. Duff.1,2 Other pertinent references are included in the text.

21. What prophylactic antibiotic should be administered intrapartum to a pregnant woman who is colonized with group B streptococci but who has a mild allergy to penicillin?

In this situation, the drug of choice is intravenous cefazolin, 2 g initially then 1 g every 8 hours until delivery. For patients with a severe allergy to penicillin, the drugs of choice are either clindamycin, 900 mg intravenously every 8 hours (if sensitivity of the organism is confirmed), or vancomycin, 20 mg/kg intravenously every 8 hours (maximum of 2 g per single dose).

22. In a pregnant woman who has a life-threatening allergy to penicillin, what is the most appropriate treatment for syphilis?

This patient should be admitted to the hospital and rapidly desensitized to penicillin. She then can be treated with the appropriate dose of penicillin, given her stage of syphilis. Of note, in the future, the patient’s allergy to penicillin will return, despite the brief period of desensitization.

 

23. What are the most common organisms that cause chorioamnionitis and puerperal endometritis?

Chorioamnionitis and puerperal endometritis are polymicrobial, mixed aerobic-anaerobic infections. The dominant organisms are anaerobic gram-negative bacilli (Bacteroides and Prevotella species); anaerobic gram-positive cocci (Peptococcus species and Peptostreptococcus species); aerobic gram-negative bacilli (principally, Escherichia coli, Klebsiella pneumoniae, and Proteus species); and aerobic gram-positive cocci (enterococci, staphylococci, and group B streptococci). ●

 

 

In this question-and-answer article (the third in a series), our objective is to re­inforce for the clinician several practical points of management for common infectious diseases. The principal references for the answers to the questions are 2 textbook chapters written by Dr. Duff.1,2 Other pertinent references are included in the text.

21. What prophylactic antibiotic should be administered intrapartum to a pregnant woman who is colonized with group B streptococci but who has a mild allergy to penicillin?

In this situation, the drug of choice is intravenous cefazolin, 2 g initially then 1 g every 8 hours until delivery. For patients with a severe allergy to penicillin, the drugs of choice are either clindamycin, 900 mg intravenously every 8 hours (if sensitivity of the organism is confirmed), or vancomycin, 20 mg/kg intravenously every 8 hours (maximum of 2 g per single dose).

22. In a pregnant woman who has a life-threatening allergy to penicillin, what is the most appropriate treatment for syphilis?

This patient should be admitted to the hospital and rapidly desensitized to penicillin. She then can be treated with the appropriate dose of penicillin, given her stage of syphilis. Of note, in the future, the patient’s allergy to penicillin will return, despite the brief period of desensitization.

 

23. What are the most common organisms that cause chorioamnionitis and puerperal endometritis?

Chorioamnionitis and puerperal endometritis are polymicrobial, mixed aerobic-anaerobic infections. The dominant organisms are anaerobic gram-negative bacilli (Bacteroides and Prevotella species); anaerobic gram-positive cocci (Peptococcus species and Peptostreptococcus species); aerobic gram-negative bacilli (principally, Escherichia coli, Klebsiella pneumoniae, and Proteus species); and aerobic gram-positive cocci (enterococci, staphylococci, and group B streptococci). ●

References
  1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
  2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
References
  1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
  2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
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