Each February, the Centers for Disease Control and Prevention, along with multiple professional organizations, releases an updated Recommended Child and Adolescent Immunization Schedule.

Recent years have seen fewer changes in the vaccine schedule, mostly with adjustments based on products coming on or off the market, and sometimes with slight changes in recommendations. This year is no different, with mostly minor changes in store. As most practitioners know, having quick access to the tables that accompany the recommendations is always handy. Table 1 contains the typical, recommended immunization schedule. Table 2 contains the catch-up provisions, and Table 3 provides guidance on vaccines for special circumstances and for children with specific medical conditions.
 

2021 childhood and adolescent immunization schedule

One update is a recommendation that patients with egg allergies who had symptoms more extensive than hives should receive the influenza vaccine in a medical setting where severe allergic reactions or anaphylaxis can be recognized and treated, with the exclusion of two specific preparations, Flublok and Flucelvax.

In regard to the live attenuated influenza vaccine (LAIV), there are several points of reinforcement. First, the nomenclature has generally been changed to “LAIV4” throughout the document because only quadrivalent preparations are available. There are specific recommendations that patients should not receive LAIV4 if they recently took antiviral medication for influenza, with “lockout” periods lasting from 2 days to 17 days, depending on the antiviral preparation used. In addition, there is an emphasis on not using LAIV4 for children younger than 2 years.

Two updates to the meningococcal group B vaccine are worth reviewing. The first is that children aged 10 years or older with complement deficiency, complement inhibitor use, or asplenia should receive a meningitis B booster dose beginning 1 year after completion of the primary series, with boosters thereafter every 2 or 3 years as long as that patient remains at greater risk. Another recommendation for patients 10 years or older is that, even if they have received a primary series of meningitis B vaccines, they should receive a booster dose in the setting of an outbreak if it has been 1 year or more since completion of their primary series.

Recommendations have generally been relaxed for tetanus prophylaxis in older children, indicating that individuals requiring tetanus prophylaxis or their 10-year tetanus booster after receipt of at least one Tdap vaccine can receive either tetanus-diphtheria toxoid or Tdap.
 

COVID-19 vaccines

Although childhood vaccination against COVID-19 is still currently limited to adolescents involved in clinical trials, pediatricians surely are getting peppered with questions from parents about whether they should be vaccinated and what to make of the recent reports about allergic reactions. Fortunately, there are several resources for pediatricians. First, two reports point out that true anaphylactic reactions to COVID-19 vaccines appear quite rare. The reported data on Pfizer-developed mRNA vaccine demonstrated an anaphylaxis rate of approximately 2 cases per 1 million doses administered. Among the 21 recipients who experienced anaphylaxis (out of over 11 million total doses administered), fully one third had a history of anaphylaxis episodes. The report also reviews vaccine reactions that were reported but were not classified as anaphylaxis, pointing out that when reporting vaccine reactions, we should be very careful in the nomenclature we use.

Reporting on the Moderna mRNA vaccine showed anaphylaxis rates of about 2.5 per 1 million doses, with 50% of the recipients who experienced true anaphylaxis having a history of anaphylaxis. Most of those who experienced anaphylaxis (90% in the Moderna group and 86% in the Pfizer group) exhibited symptoms of anaphylaxis within 30 minutes of receiving the vaccine. The take-home point, and the current CDC recommendation, is that many individuals, even those with a history of anaphylaxis, can still receive COVID-19 vaccines. The rates of observed anaphylaxis after COVID vaccination are far below population rates of a history of allergy or severe allergic reactions. When coupled with an estimated mortality rate of 0.5%-1% for SARS-CoV-2 disease, that CDC recommends that we encourage people, even those with severe allergies, to get vaccinated.

One clear caveat is that individuals with a history of severe anaphylaxis, and even those concerned about allergies, should be observed for a longer period after vaccination (at least 30 minutes) than the 15 minutes recommended for the general population. In addition, individuals with a specific anaphylactic reaction or severe allergic reaction to any injectable vaccine should confer with an immunologist before considering vaccination.

Another useful resource is a column published by the American Medical Association that walks through some talking points for providers when discussing whether a patient should receive COVID-19 vaccination. Advice is offered on answering patient questions about which preparation to get, what side effects to watch for, and how to report an adverse reaction. Providers are reminded to urge patients to complete whichever series they begin (get that second dose!), and that they currently should not have to pay for a vaccine. FAQ resource pages are available for patients and health care providers.
 

More vaccine news: HPV and influenza

Meanwhile, published vaccine reports provide evidence from the field to demonstrate the benefits of vaccination. A study published in the New England Journal of Medicine reported on the effectiveness of human papillomavirus (HPV) vaccine in a Swedish cohort. The report evaluated females aged between 10 and 30 years beginning in 2006 and followed them through 2017, comparing rates of invasive cervical cancer among the group who received one or more HPV vaccine doses with the group who receive none. Even without adjustment, the raw rate of invasive cervical cancer in the vaccinated group was half of that in the unvaccinated group. After full adjustment, some populations experienced incident rate ratios that were greater than 80% reduced. The largest reduction, and therefore the biggest benefit, was among those who received the HPV vaccine before age 17.

A report from the United States looking at the 2018-2019 influenza season demonstrated a vaccine effectiveness rate against hospitalization of 41% and 51% against any ED visit related to influenza. The authors note that there was considerable drift in the influenza A type that appeared late in the influenza season, reducing the overall effectiveness, but that the vaccine was still largely effective.

William T. Basco Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.

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

Each February, the Centers for Disease Control and Prevention, along with multiple professional organizations, releases an updated Recommended Child and Adolescent Immunization Schedule.

Recent years have seen fewer changes in the vaccine schedule, mostly with adjustments based on products coming on or off the market, and sometimes with slight changes in recommendations. This year is no different, with mostly minor changes in store. As most practitioners know, having quick access to the tables that accompany the recommendations is always handy. Table 1 contains the typical, recommended immunization schedule. Table 2 contains the catch-up provisions, and Table 3 provides guidance on vaccines for special circumstances and for children with specific medical conditions.
 

2021 childhood and adolescent immunization schedule

One update is a recommendation that patients with egg allergies who had symptoms more extensive than hives should receive the influenza vaccine in a medical setting where severe allergic reactions or anaphylaxis can be recognized and treated, with the exclusion of two specific preparations, Flublok and Flucelvax.

In regard to the live attenuated influenza vaccine (LAIV), there are several points of reinforcement. First, the nomenclature has generally been changed to “LAIV4” throughout the document because only quadrivalent preparations are available. There are specific recommendations that patients should not receive LAIV4 if they recently took antiviral medication for influenza, with “lockout” periods lasting from 2 days to 17 days, depending on the antiviral preparation used. In addition, there is an emphasis on not using LAIV4 for children younger than 2 years.

Two updates to the meningococcal group B vaccine are worth reviewing. The first is that children aged 10 years or older with complement deficiency, complement inhibitor use, or asplenia should receive a meningitis B booster dose beginning 1 year after completion of the primary series, with boosters thereafter every 2 or 3 years as long as that patient remains at greater risk. Another recommendation for patients 10 years or older is that, even if they have received a primary series of meningitis B vaccines, they should receive a booster dose in the setting of an outbreak if it has been 1 year or more since completion of their primary series.

Recommendations have generally been relaxed for tetanus prophylaxis in older children, indicating that individuals requiring tetanus prophylaxis or their 10-year tetanus booster after receipt of at least one Tdap vaccine can receive either tetanus-diphtheria toxoid or Tdap.
 

COVID-19 vaccines

Although childhood vaccination against COVID-19 is still currently limited to adolescents involved in clinical trials, pediatricians surely are getting peppered with questions from parents about whether they should be vaccinated and what to make of the recent reports about allergic reactions. Fortunately, there are several resources for pediatricians. First, two reports point out that true anaphylactic reactions to COVID-19 vaccines appear quite rare. The reported data on Pfizer-developed mRNA vaccine demonstrated an anaphylaxis rate of approximately 2 cases per 1 million doses administered. Among the 21 recipients who experienced anaphylaxis (out of over 11 million total doses administered), fully one third had a history of anaphylaxis episodes. The report also reviews vaccine reactions that were reported but were not classified as anaphylaxis, pointing out that when reporting vaccine reactions, we should be very careful in the nomenclature we use.

Reporting on the Moderna mRNA vaccine showed anaphylaxis rates of about 2.5 per 1 million doses, with 50% of the recipients who experienced true anaphylaxis having a history of anaphylaxis. Most of those who experienced anaphylaxis (90% in the Moderna group and 86% in the Pfizer group) exhibited symptoms of anaphylaxis within 30 minutes of receiving the vaccine. The take-home point, and the current CDC recommendation, is that many individuals, even those with a history of anaphylaxis, can still receive COVID-19 vaccines. The rates of observed anaphylaxis after COVID vaccination are far below population rates of a history of allergy or severe allergic reactions. When coupled with an estimated mortality rate of 0.5%-1% for SARS-CoV-2 disease, that CDC recommends that we encourage people, even those with severe allergies, to get vaccinated.

One clear caveat is that individuals with a history of severe anaphylaxis, and even those concerned about allergies, should be observed for a longer period after vaccination (at least 30 minutes) than the 15 minutes recommended for the general population. In addition, individuals with a specific anaphylactic reaction or severe allergic reaction to any injectable vaccine should confer with an immunologist before considering vaccination.

Another useful resource is a column published by the American Medical Association that walks through some talking points for providers when discussing whether a patient should receive COVID-19 vaccination. Advice is offered on answering patient questions about which preparation to get, what side effects to watch for, and how to report an adverse reaction. Providers are reminded to urge patients to complete whichever series they begin (get that second dose!), and that they currently should not have to pay for a vaccine. FAQ resource pages are available for patients and health care providers.
 

More vaccine news: HPV and influenza

Meanwhile, published vaccine reports provide evidence from the field to demonstrate the benefits of vaccination. A study published in the New England Journal of Medicine reported on the effectiveness of human papillomavirus (HPV) vaccine in a Swedish cohort. The report evaluated females aged between 10 and 30 years beginning in 2006 and followed them through 2017, comparing rates of invasive cervical cancer among the group who received one or more HPV vaccine doses with the group who receive none. Even without adjustment, the raw rate of invasive cervical cancer in the vaccinated group was half of that in the unvaccinated group. After full adjustment, some populations experienced incident rate ratios that were greater than 80% reduced. The largest reduction, and therefore the biggest benefit, was among those who received the HPV vaccine before age 17.

A report from the United States looking at the 2018-2019 influenza season demonstrated a vaccine effectiveness rate against hospitalization of 41% and 51% against any ED visit related to influenza. The authors note that there was considerable drift in the influenza A type that appeared late in the influenza season, reducing the overall effectiveness, but that the vaccine was still largely effective.

William T. Basco Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.

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

Each February, the Centers for Disease Control and Prevention, along with multiple professional organizations, releases an updated Recommended Child and Adolescent Immunization Schedule.

Recent years have seen fewer changes in the vaccine schedule, mostly with adjustments based on products coming on or off the market, and sometimes with slight changes in recommendations. This year is no different, with mostly minor changes in store. As most practitioners know, having quick access to the tables that accompany the recommendations is always handy. Table 1 contains the typical, recommended immunization schedule. Table 2 contains the catch-up provisions, and Table 3 provides guidance on vaccines for special circumstances and for children with specific medical conditions.
 

2021 childhood and adolescent immunization schedule

One update is a recommendation that patients with egg allergies who had symptoms more extensive than hives should receive the influenza vaccine in a medical setting where severe allergic reactions or anaphylaxis can be recognized and treated, with the exclusion of two specific preparations, Flublok and Flucelvax.

In regard to the live attenuated influenza vaccine (LAIV), there are several points of reinforcement. First, the nomenclature has generally been changed to “LAIV4” throughout the document because only quadrivalent preparations are available. There are specific recommendations that patients should not receive LAIV4 if they recently took antiviral medication for influenza, with “lockout” periods lasting from 2 days to 17 days, depending on the antiviral preparation used. In addition, there is an emphasis on not using LAIV4 for children younger than 2 years.

Two updates to the meningococcal group B vaccine are worth reviewing. The first is that children aged 10 years or older with complement deficiency, complement inhibitor use, or asplenia should receive a meningitis B booster dose beginning 1 year after completion of the primary series, with boosters thereafter every 2 or 3 years as long as that patient remains at greater risk. Another recommendation for patients 10 years or older is that, even if they have received a primary series of meningitis B vaccines, they should receive a booster dose in the setting of an outbreak if it has been 1 year or more since completion of their primary series.

Recommendations have generally been relaxed for tetanus prophylaxis in older children, indicating that individuals requiring tetanus prophylaxis or their 10-year tetanus booster after receipt of at least one Tdap vaccine can receive either tetanus-diphtheria toxoid or Tdap.
 

COVID-19 vaccines

Although childhood vaccination against COVID-19 is still currently limited to adolescents involved in clinical trials, pediatricians surely are getting peppered with questions from parents about whether they should be vaccinated and what to make of the recent reports about allergic reactions. Fortunately, there are several resources for pediatricians. First, two reports point out that true anaphylactic reactions to COVID-19 vaccines appear quite rare. The reported data on Pfizer-developed mRNA vaccine demonstrated an anaphylaxis rate of approximately 2 cases per 1 million doses administered. Among the 21 recipients who experienced anaphylaxis (out of over 11 million total doses administered), fully one third had a history of anaphylaxis episodes. The report also reviews vaccine reactions that were reported but were not classified as anaphylaxis, pointing out that when reporting vaccine reactions, we should be very careful in the nomenclature we use.

Reporting on the Moderna mRNA vaccine showed anaphylaxis rates of about 2.5 per 1 million doses, with 50% of the recipients who experienced true anaphylaxis having a history of anaphylaxis. Most of those who experienced anaphylaxis (90% in the Moderna group and 86% in the Pfizer group) exhibited symptoms of anaphylaxis within 30 minutes of receiving the vaccine. The take-home point, and the current CDC recommendation, is that many individuals, even those with a history of anaphylaxis, can still receive COVID-19 vaccines. The rates of observed anaphylaxis after COVID vaccination are far below population rates of a history of allergy or severe allergic reactions. When coupled with an estimated mortality rate of 0.5%-1% for SARS-CoV-2 disease, that CDC recommends that we encourage people, even those with severe allergies, to get vaccinated.

One clear caveat is that individuals with a history of severe anaphylaxis, and even those concerned about allergies, should be observed for a longer period after vaccination (at least 30 minutes) than the 15 minutes recommended for the general population. In addition, individuals with a specific anaphylactic reaction or severe allergic reaction to any injectable vaccine should confer with an immunologist before considering vaccination.

Another useful resource is a column published by the American Medical Association that walks through some talking points for providers when discussing whether a patient should receive COVID-19 vaccination. Advice is offered on answering patient questions about which preparation to get, what side effects to watch for, and how to report an adverse reaction. Providers are reminded to urge patients to complete whichever series they begin (get that second dose!), and that they currently should not have to pay for a vaccine. FAQ resource pages are available for patients and health care providers.
 

More vaccine news: HPV and influenza

Meanwhile, published vaccine reports provide evidence from the field to demonstrate the benefits of vaccination. A study published in the New England Journal of Medicine reported on the effectiveness of human papillomavirus (HPV) vaccine in a Swedish cohort. The report evaluated females aged between 10 and 30 years beginning in 2006 and followed them through 2017, comparing rates of invasive cervical cancer among the group who received one or more HPV vaccine doses with the group who receive none. Even without adjustment, the raw rate of invasive cervical cancer in the vaccinated group was half of that in the unvaccinated group. After full adjustment, some populations experienced incident rate ratios that were greater than 80% reduced. The largest reduction, and therefore the biggest benefit, was among those who received the HPV vaccine before age 17.

A report from the United States looking at the 2018-2019 influenza season demonstrated a vaccine effectiveness rate against hospitalization of 41% and 51% against any ED visit related to influenza. The authors note that there was considerable drift in the influenza A type that appeared late in the influenza season, reducing the overall effectiveness, but that the vaccine was still largely effective.

William T. Basco Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.

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

Events of the past year have taken a huge toll on the happiness, wellness, and lifestyles of many, but especially those in the health care field, including psychiatrists.

olm26250/Thinkstock

The newly released Medscape Psychiatrist Lifestyle, Happiness & Burnout Report 2021 reveals how psychiatrists are coping with burnout and trying to maintain personal wellness, and how they view their workplaces and their futures amid the ongoing COVID-19 pandemic.

Before the pandemic hit in March 2020, 84% of psychiatrists who responded to the survey reported being happy outside of work, similar to the percentage (82%) of physicians overall.

But as the pandemic has worn on, feelings have shifted, and there are clear signs of strain on those in the health care field. Now, just over half (55%) of psychiatrists say they are happy outside of work, similar to the percentage (58%) of physicians overall.

Perhaps not surprising given the specific challenges of COVID-19, infectious disease physicians, pulmonologists, rheumatologists, and intensivists currently rank lowest in happiness outside of work.
 

Anxiety, depression, burnout

With the ongoing COVID-19 pandemic, more than three quarters (77%) of psychiatrists surveyed report experiencing some degree of anxiety about their future, the same percentage as for physicians overall.

This year, more psychiatrists reported being either burned out or burned out and depressed (41% vs. 35% last year). About two-thirds of psychiatrists said burnout has had at least a moderate impact on their lives; 5% consider the impact so severe that they are thinking of leaving medicine altogether.

The majority of burned-out psychiatrists (63%) said they felt that way even before the pandemic began; for about one-third (37%), burnout set in after the pandemic began.

The top factor contributing to burnout among psychiatrists is too many bureaucratic tasks (62%), followed by lack of respect from colleagues in the workplace (39%) and spending too many hours at work (37%).

Psychiatrists’ top tactic to cope with burnout is talking with family or friends (53%), followed by isolating themselves from others (51%), sleeping (45%), and exercising (43%); 42% said they eat junk food to cope; 35% play music; and 25% drink alcohol.

Most psychiatrists (63%) suffering burnout and/or depression don’t plan on seeking professional help. About one-third are currently seeking help or plan to do so, the highest proportion among all specialties.

Considering their symptoms not severe enough (57%) and feeling that they could deal with the problem on their own (41%) are the top reasons for not seeking professional help; 36% said they were too busy to get help, and 17% said they didn’t want to risk disclosing a problem.

Fifteen percent of psychiatrists who are burned out, depressed, or both have contemplated suicide, and 2% have attempted suicide.
 

Striving for work-life balance

Work-life balance is the most pressing workplace issue for 45% of psychiatrists, and 44% would sacrifice some of their salary for better work-life balance. These figures are about the same for physicians overall.

Forty-seven percent of psychiatrists take 3-4 weeks of vacation each year; 16% take 5 or more weeks. In this there was no change from last year’s report.

About one-third (35%) of psychiatrists generally make time to focus on their own well-being, the same proportion as physicians overall.

About two-thirds (68%) of psychiatrists exercise two or more times per week. Half of psychiatrists said they are currently trying to lose weight; about one-quarter are trying to maintain their current weight.

About one-quarter (26%) of psychiatrists said they do not drink alcohol at all; 17% have five or more drinks per week.

Most psychiatrists are currently in a committed relationship, with 81% either married or living with a partner. Among psychiatrists who are married or living with a partner, 43% are with someone who also works in medicine. About 81% of psychiatrists say their marriages are very good or good. These percentages are similar to those of physicians overall (85%).

Most psychiatrists (58%) spend up to 10 hours per week online for personal reasons; 82% spend this amount of time online each week for work.

It’s likely that the amount of time spent online for work will increase, given the pandemic-fueled surge in telemedicine. Yet even when their personal and professional Internet use are combined, psychiatrists, on average, spend far less time online than the nearly 7 hours per day of the average Internet user, according to recent data.

Findings from the latest happiness, wellness, and lifestyle survey are based on 12,339 Medscape member physicians practicing in the United States who completed an online survey conducted between Aug. 30 and Nov. 5, 2020.

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

Events of the past year have taken a huge toll on the happiness, wellness, and lifestyles of many, but especially those in the health care field, including psychiatrists.

olm26250/Thinkstock

The newly released Medscape Psychiatrist Lifestyle, Happiness & Burnout Report 2021 reveals how psychiatrists are coping with burnout and trying to maintain personal wellness, and how they view their workplaces and their futures amid the ongoing COVID-19 pandemic.

Before the pandemic hit in March 2020, 84% of psychiatrists who responded to the survey reported being happy outside of work, similar to the percentage (82%) of physicians overall.

But as the pandemic has worn on, feelings have shifted, and there are clear signs of strain on those in the health care field. Now, just over half (55%) of psychiatrists say they are happy outside of work, similar to the percentage (58%) of physicians overall.

Perhaps not surprising given the specific challenges of COVID-19, infectious disease physicians, pulmonologists, rheumatologists, and intensivists currently rank lowest in happiness outside of work.
 

Anxiety, depression, burnout

With the ongoing COVID-19 pandemic, more than three quarters (77%) of psychiatrists surveyed report experiencing some degree of anxiety about their future, the same percentage as for physicians overall.

This year, more psychiatrists reported being either burned out or burned out and depressed (41% vs. 35% last year). About two-thirds of psychiatrists said burnout has had at least a moderate impact on their lives; 5% consider the impact so severe that they are thinking of leaving medicine altogether.

The majority of burned-out psychiatrists (63%) said they felt that way even before the pandemic began; for about one-third (37%), burnout set in after the pandemic began.

The top factor contributing to burnout among psychiatrists is too many bureaucratic tasks (62%), followed by lack of respect from colleagues in the workplace (39%) and spending too many hours at work (37%).

Psychiatrists’ top tactic to cope with burnout is talking with family or friends (53%), followed by isolating themselves from others (51%), sleeping (45%), and exercising (43%); 42% said they eat junk food to cope; 35% play music; and 25% drink alcohol.

Most psychiatrists (63%) suffering burnout and/or depression don’t plan on seeking professional help. About one-third are currently seeking help or plan to do so, the highest proportion among all specialties.

Considering their symptoms not severe enough (57%) and feeling that they could deal with the problem on their own (41%) are the top reasons for not seeking professional help; 36% said they were too busy to get help, and 17% said they didn’t want to risk disclosing a problem.

Fifteen percent of psychiatrists who are burned out, depressed, or both have contemplated suicide, and 2% have attempted suicide.
 

Striving for work-life balance

Work-life balance is the most pressing workplace issue for 45% of psychiatrists, and 44% would sacrifice some of their salary for better work-life balance. These figures are about the same for physicians overall.

Forty-seven percent of psychiatrists take 3-4 weeks of vacation each year; 16% take 5 or more weeks. In this there was no change from last year’s report.

About one-third (35%) of psychiatrists generally make time to focus on their own well-being, the same proportion as physicians overall.

About two-thirds (68%) of psychiatrists exercise two or more times per week. Half of psychiatrists said they are currently trying to lose weight; about one-quarter are trying to maintain their current weight.

About one-quarter (26%) of psychiatrists said they do not drink alcohol at all; 17% have five or more drinks per week.

Most psychiatrists are currently in a committed relationship, with 81% either married or living with a partner. Among psychiatrists who are married or living with a partner, 43% are with someone who also works in medicine. About 81% of psychiatrists say their marriages are very good or good. These percentages are similar to those of physicians overall (85%).

Most psychiatrists (58%) spend up to 10 hours per week online for personal reasons; 82% spend this amount of time online each week for work.

It’s likely that the amount of time spent online for work will increase, given the pandemic-fueled surge in telemedicine. Yet even when their personal and professional Internet use are combined, psychiatrists, on average, spend far less time online than the nearly 7 hours per day of the average Internet user, according to recent data.

Findings from the latest happiness, wellness, and lifestyle survey are based on 12,339 Medscape member physicians practicing in the United States who completed an online survey conducted between Aug. 30 and Nov. 5, 2020.

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

Events of the past year have taken a huge toll on the happiness, wellness, and lifestyles of many, but especially those in the health care field, including psychiatrists.

olm26250/Thinkstock

The newly released Medscape Psychiatrist Lifestyle, Happiness & Burnout Report 2021 reveals how psychiatrists are coping with burnout and trying to maintain personal wellness, and how they view their workplaces and their futures amid the ongoing COVID-19 pandemic.

Before the pandemic hit in March 2020, 84% of psychiatrists who responded to the survey reported being happy outside of work, similar to the percentage (82%) of physicians overall.

But as the pandemic has worn on, feelings have shifted, and there are clear signs of strain on those in the health care field. Now, just over half (55%) of psychiatrists say they are happy outside of work, similar to the percentage (58%) of physicians overall.

Perhaps not surprising given the specific challenges of COVID-19, infectious disease physicians, pulmonologists, rheumatologists, and intensivists currently rank lowest in happiness outside of work.
 

Anxiety, depression, burnout

With the ongoing COVID-19 pandemic, more than three quarters (77%) of psychiatrists surveyed report experiencing some degree of anxiety about their future, the same percentage as for physicians overall.

This year, more psychiatrists reported being either burned out or burned out and depressed (41% vs. 35% last year). About two-thirds of psychiatrists said burnout has had at least a moderate impact on their lives; 5% consider the impact so severe that they are thinking of leaving medicine altogether.

The majority of burned-out psychiatrists (63%) said they felt that way even before the pandemic began; for about one-third (37%), burnout set in after the pandemic began.

The top factor contributing to burnout among psychiatrists is too many bureaucratic tasks (62%), followed by lack of respect from colleagues in the workplace (39%) and spending too many hours at work (37%).

Psychiatrists’ top tactic to cope with burnout is talking with family or friends (53%), followed by isolating themselves from others (51%), sleeping (45%), and exercising (43%); 42% said they eat junk food to cope; 35% play music; and 25% drink alcohol.

Most psychiatrists (63%) suffering burnout and/or depression don’t plan on seeking professional help. About one-third are currently seeking help or plan to do so, the highest proportion among all specialties.

Considering their symptoms not severe enough (57%) and feeling that they could deal with the problem on their own (41%) are the top reasons for not seeking professional help; 36% said they were too busy to get help, and 17% said they didn’t want to risk disclosing a problem.

Fifteen percent of psychiatrists who are burned out, depressed, or both have contemplated suicide, and 2% have attempted suicide.
 

Striving for work-life balance

Work-life balance is the most pressing workplace issue for 45% of psychiatrists, and 44% would sacrifice some of their salary for better work-life balance. These figures are about the same for physicians overall.

Forty-seven percent of psychiatrists take 3-4 weeks of vacation each year; 16% take 5 or more weeks. In this there was no change from last year’s report.

About one-third (35%) of psychiatrists generally make time to focus on their own well-being, the same proportion as physicians overall.

About two-thirds (68%) of psychiatrists exercise two or more times per week. Half of psychiatrists said they are currently trying to lose weight; about one-quarter are trying to maintain their current weight.

About one-quarter (26%) of psychiatrists said they do not drink alcohol at all; 17% have five or more drinks per week.

Most psychiatrists are currently in a committed relationship, with 81% either married or living with a partner. Among psychiatrists who are married or living with a partner, 43% are with someone who also works in medicine. About 81% of psychiatrists say their marriages are very good or good. These percentages are similar to those of physicians overall (85%).

Most psychiatrists (58%) spend up to 10 hours per week online for personal reasons; 82% spend this amount of time online each week for work.

It’s likely that the amount of time spent online for work will increase, given the pandemic-fueled surge in telemedicine. Yet even when their personal and professional Internet use are combined, psychiatrists, on average, spend far less time online than the nearly 7 hours per day of the average Internet user, according to recent data.

Findings from the latest happiness, wellness, and lifestyle survey are based on 12,339 Medscape member physicians practicing in the United States who completed an online survey conducted between Aug. 30 and Nov. 5, 2020.

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

Endometriosis, which affects 1 in 10 women, is one of the most common conditions that gynecologists treat. It is known to cause pain, pelvic adhesive disease, endometriotic cyst formation, and infertility. However, even more sinister, it also increases a woman’s risk for the development of epithelial ovarian cancer (known as endometriosis-associated ovarian cancer or EAOC). A woman with endometriosis has a two- to threefold increased risk of developing epithelial ovarian cancer, compared with nonaffected women.¹ This risk appears to be concentrated in the premenopausal age group, particularly the fifth decade of life. After menopause their risk of developing cancer returns to a baseline level.

EAOC classically presents as clear cell or endometrioid adenocarcinomas, rather than high-grade serous carcinomas. However, low-grade serous carcinomas are also frequently observed in this cohort.^2,3 Unlike high-grade serous carcinoma, EAOC is more likely to be diagnosed at an early stage, with the majority at stage I or II, and prognosis is better. After matching for age and stage with cases of high-grade serous carcinoma, there is improved disease-free and overall survival observed among cases of EAOC of clear cell and endometrioid histologic cell types.⁴ The phenomenon of dual primaries (synchronous endometrial and ovarian cancer) occurs more frequently in EAOC than it does in patients with nonendometriosis-related high-grade serous cancer (25% vs. 4%).

The genomics of these endometriosis-associated cancers are quite distinct. Similar to benign endometriosis implants, EAOC is associated with genomic mutations in ARID1A, PIK3CA, and PTEN, as well as progesterone resistance.^1,2 Multiple studies have shown that the adjacent eutopic endometrium carries similar gene mutations as those found in both benign endometriotic implants and EAOC.² This may explain the higher incidence (twofold) of endometrial cancer in patients with endometriosis as well as the increased incidence of dual ovarian and endometrial cancer primaries.

Just as there are multiple theories regarding the mechanism of benign endometriosis, we have theories rather than conclusions regarding the origins of EAOC. One such theory is that it develops from malignant transformation in an existing endometriotic cyst.⁵ Endometriotic cysts provide an iron-rich environment which promotes reactive oxygen species that promote carcinogenesis by inducing gene mutations and epigenetic alterations. However, if prolonged exposure to oxidative stress within endometriotic cysts were to be the cause for EAOC, we would expect to see a progressively increasing incidence of ovarian cancer over time in patients with expectantly managed cysts. However, in cases of expectant management, an initial, early, increased risk for cancer within the first 5 years is followed by a subsequent decreasing incidence over time.⁶ This early incidence spike suggests that some endometriotic cysts may have been misclassified as benign, then rapidly declare themselves as malignant during the observation period rather than a transformation into malignancy from a benign endometrioma over time.

An alternative, and favored, theory for the origins of EAOC are that endometrial cells with carcinogenic genomic alterations reflux through the fallopian tubes during menstruation and settle onto the ovarian epithelium which itself is damaged from recent ovulation thus providing an environment that is highly suitable for oncogenesis.² Genomic analyses of both the eutopic endometrium and malignant cells in patients with EAOC have shown that both tissues contain the same genomic alterations.¹ Given that menstruation, including retrograde menstruation, ends after menopause, this mechanism supports the observation that EAOC is predominantly a malignancy of premenopausal women. Additionally, salpingectomy and hysterectomy confers a protective effect on the development of EAOC, theoretically by preventing the retrograde transfer of these mutant progenitor endometrial cells. Furthermore, the factors that increase the number of menstrual cycles (such as an early age of menarche and delayed or nonchildbearing states) increases the risk for EAOC and factors that inhibit menstruation, such as oral contraceptive pill use, appear to decrease its risk.

EAOC most commonly arises in the ovary, and not in the deep endometriosis implants of adjacent pelvic structures (such as the anterior and posterior cul de sac and pelvic peritoneum). It is suggested that the ovary itself provides a uniquely favorable environment for carcinogenesis. As stated above, it is hypothesized that refluxed endometrial cells, carrying important progenitor mutations, may become trapped in the tissues of traumatized ovarian epithelium, ripe with inflammatory changes, post ovulation.² This microenvironment may promote the development of malignancy.

Given these theories and their supporting evidence, how can we attempt to reduce the incidence of this cancer for our patients with endometriosis? Despite their increased risk for ovarian and endometrial cancers, current recommendations do not support routine cancer screening in women with endometriosis.⁷ However, risk-mitigation strategies can still be pursued. Hormonal contraceptives to decrease ovulation and menstrual cycling are protective against ovarian cancer and are also helpful in mitigating the symptoms of endometriosis. While removal of endometriotic cysts may not, in and of itself, be a strategy to prevent EAOC, it is still generally recommended because these cysts are commonly a source of pain and infertility. While they do not appear to undergo malignant transformation, it can be difficult to definitively rule out an early ovarian cancer in these complex ovarian cysts, particularly as they are often associated with tumor marker abnormalities such as elevations in CA 125. Therefore, if surgical excision of an endometriotic cyst is not performed, it should be closely followed for at least 5 years to ensure it is a benign structure. If surgery is pursued and ovarian preservation is desired, removal of the fallopian tubes and uterus can help mitigate the risk for EAOC.⁸

Endometriosis is a morbid condition for many young women. In addition to causing pain and infertility it increases a woman’s risk for ovarian and endometrial cancer, particularly ovarian clear cell, endometrioid, and low-grade serous cancers and synchronous endometrial and ovarian cancers. Endometriotic cysts should be removed or closely monitored, and clinicians should discuss treatment options that minimize frequency of ovulation and menstruation events as a preventative strategy.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Endocrinology. 2019;160(3):626-38.

2. Cancers. 2020;12(6):1676.

3. Lancet Oncol. 2012;13:385-94.

4. Gynecol Oncol. 2014;132(3):760-6.

5. Redox Rep. 2016;21:119-26.

6. Int. J Clin Oncol. 2020;25:51-8.

7. Hum Reprod. 2013;28:1552-68.

8. J Natl Cancer Inst. 2019;111:1097-103.

Endometriosis, which affects 1 in 10 women, is one of the most common conditions that gynecologists treat. It is known to cause pain, pelvic adhesive disease, endometriotic cyst formation, and infertility. However, even more sinister, it also increases a woman’s risk for the development of epithelial ovarian cancer (known as endometriosis-associated ovarian cancer or EAOC). A woman with endometriosis has a two- to threefold increased risk of developing epithelial ovarian cancer, compared with nonaffected women.¹ This risk appears to be concentrated in the premenopausal age group, particularly the fifth decade of life. After menopause their risk of developing cancer returns to a baseline level.

EAOC classically presents as clear cell or endometrioid adenocarcinomas, rather than high-grade serous carcinomas. However, low-grade serous carcinomas are also frequently observed in this cohort.^2,3 Unlike high-grade serous carcinoma, EAOC is more likely to be diagnosed at an early stage, with the majority at stage I or II, and prognosis is better. After matching for age and stage with cases of high-grade serous carcinoma, there is improved disease-free and overall survival observed among cases of EAOC of clear cell and endometrioid histologic cell types.⁴ The phenomenon of dual primaries (synchronous endometrial and ovarian cancer) occurs more frequently in EAOC than it does in patients with nonendometriosis-related high-grade serous cancer (25% vs. 4%).

The genomics of these endometriosis-associated cancers are quite distinct. Similar to benign endometriosis implants, EAOC is associated with genomic mutations in ARID1A, PIK3CA, and PTEN, as well as progesterone resistance.^1,2 Multiple studies have shown that the adjacent eutopic endometrium carries similar gene mutations as those found in both benign endometriotic implants and EAOC.² This may explain the higher incidence (twofold) of endometrial cancer in patients with endometriosis as well as the increased incidence of dual ovarian and endometrial cancer primaries.

Just as there are multiple theories regarding the mechanism of benign endometriosis, we have theories rather than conclusions regarding the origins of EAOC. One such theory is that it develops from malignant transformation in an existing endometriotic cyst.⁵ Endometriotic cysts provide an iron-rich environment which promotes reactive oxygen species that promote carcinogenesis by inducing gene mutations and epigenetic alterations. However, if prolonged exposure to oxidative stress within endometriotic cysts were to be the cause for EAOC, we would expect to see a progressively increasing incidence of ovarian cancer over time in patients with expectantly managed cysts. However, in cases of expectant management, an initial, early, increased risk for cancer within the first 5 years is followed by a subsequent decreasing incidence over time.⁶ This early incidence spike suggests that some endometriotic cysts may have been misclassified as benign, then rapidly declare themselves as malignant during the observation period rather than a transformation into malignancy from a benign endometrioma over time.

An alternative, and favored, theory for the origins of EAOC are that endometrial cells with carcinogenic genomic alterations reflux through the fallopian tubes during menstruation and settle onto the ovarian epithelium which itself is damaged from recent ovulation thus providing an environment that is highly suitable for oncogenesis.² Genomic analyses of both the eutopic endometrium and malignant cells in patients with EAOC have shown that both tissues contain the same genomic alterations.¹ Given that menstruation, including retrograde menstruation, ends after menopause, this mechanism supports the observation that EAOC is predominantly a malignancy of premenopausal women. Additionally, salpingectomy and hysterectomy confers a protective effect on the development of EAOC, theoretically by preventing the retrograde transfer of these mutant progenitor endometrial cells. Furthermore, the factors that increase the number of menstrual cycles (such as an early age of menarche and delayed or nonchildbearing states) increases the risk for EAOC and factors that inhibit menstruation, such as oral contraceptive pill use, appear to decrease its risk.

EAOC most commonly arises in the ovary, and not in the deep endometriosis implants of adjacent pelvic structures (such as the anterior and posterior cul de sac and pelvic peritoneum). It is suggested that the ovary itself provides a uniquely favorable environment for carcinogenesis. As stated above, it is hypothesized that refluxed endometrial cells, carrying important progenitor mutations, may become trapped in the tissues of traumatized ovarian epithelium, ripe with inflammatory changes, post ovulation.² This microenvironment may promote the development of malignancy.

Given these theories and their supporting evidence, how can we attempt to reduce the incidence of this cancer for our patients with endometriosis? Despite their increased risk for ovarian and endometrial cancers, current recommendations do not support routine cancer screening in women with endometriosis.⁷ However, risk-mitigation strategies can still be pursued. Hormonal contraceptives to decrease ovulation and menstrual cycling are protective against ovarian cancer and are also helpful in mitigating the symptoms of endometriosis. While removal of endometriotic cysts may not, in and of itself, be a strategy to prevent EAOC, it is still generally recommended because these cysts are commonly a source of pain and infertility. While they do not appear to undergo malignant transformation, it can be difficult to definitively rule out an early ovarian cancer in these complex ovarian cysts, particularly as they are often associated with tumor marker abnormalities such as elevations in CA 125. Therefore, if surgical excision of an endometriotic cyst is not performed, it should be closely followed for at least 5 years to ensure it is a benign structure. If surgery is pursued and ovarian preservation is desired, removal of the fallopian tubes and uterus can help mitigate the risk for EAOC.⁸

Endometriosis is a morbid condition for many young women. In addition to causing pain and infertility it increases a woman’s risk for ovarian and endometrial cancer, particularly ovarian clear cell, endometrioid, and low-grade serous cancers and synchronous endometrial and ovarian cancers. Endometriotic cysts should be removed or closely monitored, and clinicians should discuss treatment options that minimize frequency of ovulation and menstruation events as a preventative strategy.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Endocrinology. 2019;160(3):626-38.

2. Cancers. 2020;12(6):1676.

3. Lancet Oncol. 2012;13:385-94.

4. Gynecol Oncol. 2014;132(3):760-6.

5. Redox Rep. 2016;21:119-26.

6. Int. J Clin Oncol. 2020;25:51-8.

7. Hum Reprod. 2013;28:1552-68.

8. J Natl Cancer Inst. 2019;111:1097-103.

Endometriosis, which affects 1 in 10 women, is one of the most common conditions that gynecologists treat. It is known to cause pain, pelvic adhesive disease, endometriotic cyst formation, and infertility. However, even more sinister, it also increases a woman’s risk for the development of epithelial ovarian cancer (known as endometriosis-associated ovarian cancer or EAOC). A woman with endometriosis has a two- to threefold increased risk of developing epithelial ovarian cancer, compared with nonaffected women.¹ This risk appears to be concentrated in the premenopausal age group, particularly the fifth decade of life. After menopause their risk of developing cancer returns to a baseline level.

EAOC classically presents as clear cell or endometrioid adenocarcinomas, rather than high-grade serous carcinomas. However, low-grade serous carcinomas are also frequently observed in this cohort.^2,3 Unlike high-grade serous carcinoma, EAOC is more likely to be diagnosed at an early stage, with the majority at stage I or II, and prognosis is better. After matching for age and stage with cases of high-grade serous carcinoma, there is improved disease-free and overall survival observed among cases of EAOC of clear cell and endometrioid histologic cell types.⁴ The phenomenon of dual primaries (synchronous endometrial and ovarian cancer) occurs more frequently in EAOC than it does in patients with nonendometriosis-related high-grade serous cancer (25% vs. 4%).

The genomics of these endometriosis-associated cancers are quite distinct. Similar to benign endometriosis implants, EAOC is associated with genomic mutations in ARID1A, PIK3CA, and PTEN, as well as progesterone resistance.^1,2 Multiple studies have shown that the adjacent eutopic endometrium carries similar gene mutations as those found in both benign endometriotic implants and EAOC.² This may explain the higher incidence (twofold) of endometrial cancer in patients with endometriosis as well as the increased incidence of dual ovarian and endometrial cancer primaries.

Just as there are multiple theories regarding the mechanism of benign endometriosis, we have theories rather than conclusions regarding the origins of EAOC. One such theory is that it develops from malignant transformation in an existing endometriotic cyst.⁵ Endometriotic cysts provide an iron-rich environment which promotes reactive oxygen species that promote carcinogenesis by inducing gene mutations and epigenetic alterations. However, if prolonged exposure to oxidative stress within endometriotic cysts were to be the cause for EAOC, we would expect to see a progressively increasing incidence of ovarian cancer over time in patients with expectantly managed cysts. However, in cases of expectant management, an initial, early, increased risk for cancer within the first 5 years is followed by a subsequent decreasing incidence over time.⁶ This early incidence spike suggests that some endometriotic cysts may have been misclassified as benign, then rapidly declare themselves as malignant during the observation period rather than a transformation into malignancy from a benign endometrioma over time.

An alternative, and favored, theory for the origins of EAOC are that endometrial cells with carcinogenic genomic alterations reflux through the fallopian tubes during menstruation and settle onto the ovarian epithelium which itself is damaged from recent ovulation thus providing an environment that is highly suitable for oncogenesis.² Genomic analyses of both the eutopic endometrium and malignant cells in patients with EAOC have shown that both tissues contain the same genomic alterations.¹ Given that menstruation, including retrograde menstruation, ends after menopause, this mechanism supports the observation that EAOC is predominantly a malignancy of premenopausal women. Additionally, salpingectomy and hysterectomy confers a protective effect on the development of EAOC, theoretically by preventing the retrograde transfer of these mutant progenitor endometrial cells. Furthermore, the factors that increase the number of menstrual cycles (such as an early age of menarche and delayed or nonchildbearing states) increases the risk for EAOC and factors that inhibit menstruation, such as oral contraceptive pill use, appear to decrease its risk.

EAOC most commonly arises in the ovary, and not in the deep endometriosis implants of adjacent pelvic structures (such as the anterior and posterior cul de sac and pelvic peritoneum). It is suggested that the ovary itself provides a uniquely favorable environment for carcinogenesis. As stated above, it is hypothesized that refluxed endometrial cells, carrying important progenitor mutations, may become trapped in the tissues of traumatized ovarian epithelium, ripe with inflammatory changes, post ovulation.² This microenvironment may promote the development of malignancy.

Given these theories and their supporting evidence, how can we attempt to reduce the incidence of this cancer for our patients with endometriosis? Despite their increased risk for ovarian and endometrial cancers, current recommendations do not support routine cancer screening in women with endometriosis.⁷ However, risk-mitigation strategies can still be pursued. Hormonal contraceptives to decrease ovulation and menstrual cycling are protective against ovarian cancer and are also helpful in mitigating the symptoms of endometriosis. While removal of endometriotic cysts may not, in and of itself, be a strategy to prevent EAOC, it is still generally recommended because these cysts are commonly a source of pain and infertility. While they do not appear to undergo malignant transformation, it can be difficult to definitively rule out an early ovarian cancer in these complex ovarian cysts, particularly as they are often associated with tumor marker abnormalities such as elevations in CA 125. Therefore, if surgical excision of an endometriotic cyst is not performed, it should be closely followed for at least 5 years to ensure it is a benign structure. If surgery is pursued and ovarian preservation is desired, removal of the fallopian tubes and uterus can help mitigate the risk for EAOC.⁸

Endometriosis is a morbid condition for many young women. In addition to causing pain and infertility it increases a woman’s risk for ovarian and endometrial cancer, particularly ovarian clear cell, endometrioid, and low-grade serous cancers and synchronous endometrial and ovarian cancers. Endometriotic cysts should be removed or closely monitored, and clinicians should discuss treatment options that minimize frequency of ovulation and menstruation events as a preventative strategy.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Endocrinology. 2019;160(3):626-38.

2. Cancers. 2020;12(6):1676.

3. Lancet Oncol. 2012;13:385-94.

4. Gynecol Oncol. 2014;132(3):760-6.

5. Redox Rep. 2016;21:119-26.

6. Int. J Clin Oncol. 2020;25:51-8.

7. Hum Reprod. 2013;28:1552-68.

8. J Natl Cancer Inst. 2019;111:1097-103.

The fifth consecutive week with a decline has the number of new COVID-19 cases in children at its lowest level since late October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New child cases totaled 70,640 for the week of Feb. 12-18, down from 99,000 the previous week, making for the lowest count since the week of Oct. 23-29, when 61,000 cases were reported, the AAP and CHA said in their weekly COVID-19 report.

The cumulative number of COVID-19 cases in children is now just over 3.1 million, which represents 13.1% of cases among all ages in the United States, based on data gathered from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

More children in California (439,000) have been infected than in any other state, while Illinois (176,000), Florida (145,000), Tennessee (137,000), Arizona (127,000), Ohio (121,000), and Pennsylvania (111,000) are the only other states with more than 100,000 cases, the AAP/CHA report shows.

Proportionally, the children of Wyoming have been hardest hit: Pediatric cases represent 19.4% of all cases in the state. The other four states with proportions of 18% or more are Alaska, Vermont, South Carolina, and Tennessee. Cumulative rates, however, tell a somewhat different story, as North Dakota leads with just over 8,500 cases per 100,000 children, followed by Tennessee (7,700 per 100,000) and Rhode Island (7,000 per 100,000), the AAP and CHA said.

Deaths in children, which had not been following the trend of fewer new cases over the last few weeks, dropped below double digits for the first time in a month. The six deaths that occurred during the week of Feb. 12-18 bring the total to 247 since the start of the pandemic in the 43 states, along with New York City and Guam, that are reporting such data, according to the report.

[email protected]

The fifth consecutive week with a decline has the number of new COVID-19 cases in children at its lowest level since late October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New child cases totaled 70,640 for the week of Feb. 12-18, down from 99,000 the previous week, making for the lowest count since the week of Oct. 23-29, when 61,000 cases were reported, the AAP and CHA said in their weekly COVID-19 report.

The cumulative number of COVID-19 cases in children is now just over 3.1 million, which represents 13.1% of cases among all ages in the United States, based on data gathered from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

More children in California (439,000) have been infected than in any other state, while Illinois (176,000), Florida (145,000), Tennessee (137,000), Arizona (127,000), Ohio (121,000), and Pennsylvania (111,000) are the only other states with more than 100,000 cases, the AAP/CHA report shows.

Proportionally, the children of Wyoming have been hardest hit: Pediatric cases represent 19.4% of all cases in the state. The other four states with proportions of 18% or more are Alaska, Vermont, South Carolina, and Tennessee. Cumulative rates, however, tell a somewhat different story, as North Dakota leads with just over 8,500 cases per 100,000 children, followed by Tennessee (7,700 per 100,000) and Rhode Island (7,000 per 100,000), the AAP and CHA said.

Deaths in children, which had not been following the trend of fewer new cases over the last few weeks, dropped below double digits for the first time in a month. The six deaths that occurred during the week of Feb. 12-18 bring the total to 247 since the start of the pandemic in the 43 states, along with New York City and Guam, that are reporting such data, according to the report.

[email protected]

The fifth consecutive week with a decline has the number of new COVID-19 cases in children at its lowest level since late October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New child cases totaled 70,640 for the week of Feb. 12-18, down from 99,000 the previous week, making for the lowest count since the week of Oct. 23-29, when 61,000 cases were reported, the AAP and CHA said in their weekly COVID-19 report.

The cumulative number of COVID-19 cases in children is now just over 3.1 million, which represents 13.1% of cases among all ages in the United States, based on data gathered from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

More children in California (439,000) have been infected than in any other state, while Illinois (176,000), Florida (145,000), Tennessee (137,000), Arizona (127,000), Ohio (121,000), and Pennsylvania (111,000) are the only other states with more than 100,000 cases, the AAP/CHA report shows.

Proportionally, the children of Wyoming have been hardest hit: Pediatric cases represent 19.4% of all cases in the state. The other four states with proportions of 18% or more are Alaska, Vermont, South Carolina, and Tennessee. Cumulative rates, however, tell a somewhat different story, as North Dakota leads with just over 8,500 cases per 100,000 children, followed by Tennessee (7,700 per 100,000) and Rhode Island (7,000 per 100,000), the AAP and CHA said.

Deaths in children, which had not been following the trend of fewer new cases over the last few weeks, dropped below double digits for the first time in a month. The six deaths that occurred during the week of Feb. 12-18 bring the total to 247 since the start of the pandemic in the 43 states, along with New York City and Guam, that are reporting such data, according to the report.

[email protected]

An obese 64-year-old man with type 2 diabetes presents with redness and warmth of his lower left leg.

He noticed discomfort today and saw that his left lower leg had redness and was warm. He does not recall scratches or injury to his leg. He has not had fever or chills. He has no other symptoms. His diabetes has been well controlled with diet and metformin.

On exam, his blood pressure is 120/70, pulse is 80, temperature is 37 degrees Celsius.

In the left lower extremity, the patient had 1+ edema at the ankle, with a 14-cm x 20-cm warm, erythematous area just above the ankle and extending proximally.

His labs found an HCT of 44 and a WBC of 12,000. What do you recommend?
 

A) Vascular duplex exam

B) 1st generation cephalosporin

C) 1st generation cephalosporin + TMP/Sulfa

D) Oral clindamycin

E) IV vancomycin

This patient has cellulitis and should receive a beta lactam antibiotic, which will have the best coverage and lowest minimal inhibitory concentration for the likely organism, beta hemolytic streptococci. Clindamycin would likely work, but it has greater side effects. This patient does not need coverage for methicillin-resistant staphylococcus aureus (MRSA). I know many of you, if not most, know this, but I want to go through relevant data and formal recommendations, because of a recent call I received from a patient.

My patient had a full body rash after receiving cephalexin + TMP/sulfa [trimethoprim-sulfamethoxazole] treatment for cellulitis. In recent years the addition of TMP/sulfa to strep treatment to also cover MRSA has become popular, especially in emergency department and urgent care settings.

Moran and colleagues studied cephalexin + TMP/sulfa vs. cephalexin and placebo in patients with uncomplicated cellulitis.¹ The outcome measured was clinical cure, and there was no difference between groups; clinical cure occurred in 182 (83.5%) of 218 participants in the cephalexin plus TMP/sulfa group vs. 165 (85.5%) of 193 in the cephalexin group (difference, −2.0%; 95% confidence interval, −9.7% to 5.7%; P = .50).

Jeng and colleagues studied patients admitted for a cellulitis, and evaluated the patients’ response to beta-lactam antibiotics.² Patients had acute and convalescent serologies for beta hemolytic strep. Almost all evaluable patients with positive strep studies (97%) responded to beta-lactams, and 21 of 23 (91%) with negative studies responded to beta-lactams (overall response rate 95%). This study was done during a time of high MRSA prevalence.

The most recent Infectious Diseases Society of America guidelines for skin and soft tissue infections, recommend oral penicillin, cephalexin, dicloxacillin, or clindamycin for mild cellulitis, and IV equivalent if patients have moderate cellulitis.³ If abscesses are present, then drainage is recommended and MRSA coverage. Kamath and colleagues reported on how closely guidelines for skin and soft tissue infections were followed.⁴ In patients with mild cellulitis, only 36% received guideline-suggested antibiotics. The most common antibiotic prescribed that was outside the guidelines was trimethoprim-sulfamethoxazole.
 

Myth: Cellulitis treatment should include MRSA coverage.

My advice: Stick with beta-lactam antibiotics, unless an abscess is present. There is no need to add MRSA coverage for initial treatment of mild to moderate cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Moran GJ et al. Effect of cephalexin plus trimethoprim-sulfamethoxazole vs. cephalexin alone on clinical cure of uncomplicated cellulitis: A randomized clinical trial. JAMA 2017 May 23;317(20):2088-96.

2. Jeng Arthur et al. The role of beta-hemolytic streptococci in causing diffuse, nonculturable cellulitis. Medicine. 2010;July;89(4):217-26.

3. Stevens DL et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10-e52.

4. Kamath RS et al. Guidelines vs. actual management of skin and soft tissue infections in the emergency department. Open Forum Infect Dis. 2018 Jan 12;5(1):ofx188.
 

An obese 64-year-old man with type 2 diabetes presents with redness and warmth of his lower left leg.

He noticed discomfort today and saw that his left lower leg had redness and was warm. He does not recall scratches or injury to his leg. He has not had fever or chills. He has no other symptoms. His diabetes has been well controlled with diet and metformin.

On exam, his blood pressure is 120/70, pulse is 80, temperature is 37 degrees Celsius.

In the left lower extremity, the patient had 1+ edema at the ankle, with a 14-cm x 20-cm warm, erythematous area just above the ankle and extending proximally.

His labs found an HCT of 44 and a WBC of 12,000. What do you recommend?
 

A) Vascular duplex exam

B) 1st generation cephalosporin

C) 1st generation cephalosporin + TMP/Sulfa

D) Oral clindamycin

E) IV vancomycin

This patient has cellulitis and should receive a beta lactam antibiotic, which will have the best coverage and lowest minimal inhibitory concentration for the likely organism, beta hemolytic streptococci. Clindamycin would likely work, but it has greater side effects. This patient does not need coverage for methicillin-resistant staphylococcus aureus (MRSA). I know many of you, if not most, know this, but I want to go through relevant data and formal recommendations, because of a recent call I received from a patient.

My patient had a full body rash after receiving cephalexin + TMP/sulfa [trimethoprim-sulfamethoxazole] treatment for cellulitis. In recent years the addition of TMP/sulfa to strep treatment to also cover MRSA has become popular, especially in emergency department and urgent care settings.

Moran and colleagues studied cephalexin + TMP/sulfa vs. cephalexin and placebo in patients with uncomplicated cellulitis.¹ The outcome measured was clinical cure, and there was no difference between groups; clinical cure occurred in 182 (83.5%) of 218 participants in the cephalexin plus TMP/sulfa group vs. 165 (85.5%) of 193 in the cephalexin group (difference, −2.0%; 95% confidence interval, −9.7% to 5.7%; P = .50).

Jeng and colleagues studied patients admitted for a cellulitis, and evaluated the patients’ response to beta-lactam antibiotics.² Patients had acute and convalescent serologies for beta hemolytic strep. Almost all evaluable patients with positive strep studies (97%) responded to beta-lactams, and 21 of 23 (91%) with negative studies responded to beta-lactams (overall response rate 95%). This study was done during a time of high MRSA prevalence.

The most recent Infectious Diseases Society of America guidelines for skin and soft tissue infections, recommend oral penicillin, cephalexin, dicloxacillin, or clindamycin for mild cellulitis, and IV equivalent if patients have moderate cellulitis.³ If abscesses are present, then drainage is recommended and MRSA coverage. Kamath and colleagues reported on how closely guidelines for skin and soft tissue infections were followed.⁴ In patients with mild cellulitis, only 36% received guideline-suggested antibiotics. The most common antibiotic prescribed that was outside the guidelines was trimethoprim-sulfamethoxazole.
 

Myth: Cellulitis treatment should include MRSA coverage.

My advice: Stick with beta-lactam antibiotics, unless an abscess is present. There is no need to add MRSA coverage for initial treatment of mild to moderate cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Moran GJ et al. Effect of cephalexin plus trimethoprim-sulfamethoxazole vs. cephalexin alone on clinical cure of uncomplicated cellulitis: A randomized clinical trial. JAMA 2017 May 23;317(20):2088-96.

2. Jeng Arthur et al. The role of beta-hemolytic streptococci in causing diffuse, nonculturable cellulitis. Medicine. 2010;July;89(4):217-26.

3. Stevens DL et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10-e52.

4. Kamath RS et al. Guidelines vs. actual management of skin and soft tissue infections in the emergency department. Open Forum Infect Dis. 2018 Jan 12;5(1):ofx188.
 

An obese 64-year-old man with type 2 diabetes presents with redness and warmth of his lower left leg.

He noticed discomfort today and saw that his left lower leg had redness and was warm. He does not recall scratches or injury to his leg. He has not had fever or chills. He has no other symptoms. His diabetes has been well controlled with diet and metformin.

On exam, his blood pressure is 120/70, pulse is 80, temperature is 37 degrees Celsius.

In the left lower extremity, the patient had 1+ edema at the ankle, with a 14-cm x 20-cm warm, erythematous area just above the ankle and extending proximally.

His labs found an HCT of 44 and a WBC of 12,000. What do you recommend?
 

A) Vascular duplex exam

B) 1st generation cephalosporin

C) 1st generation cephalosporin + TMP/Sulfa

D) Oral clindamycin

E) IV vancomycin

This patient has cellulitis and should receive a beta lactam antibiotic, which will have the best coverage and lowest minimal inhibitory concentration for the likely organism, beta hemolytic streptococci. Clindamycin would likely work, but it has greater side effects. This patient does not need coverage for methicillin-resistant staphylococcus aureus (MRSA). I know many of you, if not most, know this, but I want to go through relevant data and formal recommendations, because of a recent call I received from a patient.

My patient had a full body rash after receiving cephalexin + TMP/sulfa [trimethoprim-sulfamethoxazole] treatment for cellulitis. In recent years the addition of TMP/sulfa to strep treatment to also cover MRSA has become popular, especially in emergency department and urgent care settings.

Moran and colleagues studied cephalexin + TMP/sulfa vs. cephalexin and placebo in patients with uncomplicated cellulitis.¹ The outcome measured was clinical cure, and there was no difference between groups; clinical cure occurred in 182 (83.5%) of 218 participants in the cephalexin plus TMP/sulfa group vs. 165 (85.5%) of 193 in the cephalexin group (difference, −2.0%; 95% confidence interval, −9.7% to 5.7%; P = .50).

Jeng and colleagues studied patients admitted for a cellulitis, and evaluated the patients’ response to beta-lactam antibiotics.² Patients had acute and convalescent serologies for beta hemolytic strep. Almost all evaluable patients with positive strep studies (97%) responded to beta-lactams, and 21 of 23 (91%) with negative studies responded to beta-lactams (overall response rate 95%). This study was done during a time of high MRSA prevalence.

The most recent Infectious Diseases Society of America guidelines for skin and soft tissue infections, recommend oral penicillin, cephalexin, dicloxacillin, or clindamycin for mild cellulitis, and IV equivalent if patients have moderate cellulitis.³ If abscesses are present, then drainage is recommended and MRSA coverage. Kamath and colleagues reported on how closely guidelines for skin and soft tissue infections were followed.⁴ In patients with mild cellulitis, only 36% received guideline-suggested antibiotics. The most common antibiotic prescribed that was outside the guidelines was trimethoprim-sulfamethoxazole.
 

Myth: Cellulitis treatment should include MRSA coverage.

My advice: Stick with beta-lactam antibiotics, unless an abscess is present. There is no need to add MRSA coverage for initial treatment of mild to moderate cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Moran GJ et al. Effect of cephalexin plus trimethoprim-sulfamethoxazole vs. cephalexin alone on clinical cure of uncomplicated cellulitis: A randomized clinical trial. JAMA 2017 May 23;317(20):2088-96.

2. Jeng Arthur et al. The role of beta-hemolytic streptococci in causing diffuse, nonculturable cellulitis. Medicine. 2010;July;89(4):217-26.

3. Stevens DL et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10-e52.

4. Kamath RS et al. Guidelines vs. actual management of skin and soft tissue infections in the emergency department. Open Forum Infect Dis. 2018 Jan 12;5(1):ofx188.
 

Electronic health record (EHR) implementations involve long downtimes, which are an under-recognized patient safety risk, as clinicians are forced to switch to completely manual, paper-based, and important unfamiliar workflows to care for their acutely ill patients, said Subha Airan-Javia, MD, FAMIA, a hospitalist at the University of Pennsylvania, Philadelphia.

“In this setting, we discovered an unanticipated benefit of our tool [Carelign, initially built to digitize the handoff process] as a clinical resource during EHR downtime, giving clinicians access to critical data as well as an electronic platform to collaborate as a team around the care of their patients,” she said.

There are two important takeaways from their study on this issue. “The first is that Carelign was able to give clinicians access to clinical data that would otherwise have been unavailable, including vitals, labs, medications, care plans and care team assignments,” Dr. Airan-Javia said. “This undoubtedly mitigated patient safety risks during the EHR downtime.” 

The second: “As many clinicians know, any change in workflow, even for a few hours, can make providing a high level of patient care very difficult,” she added. “During a downtime without a tool like Carelign, clinicians have to rely on paper and bedside charts, writing notes on paper and then re-typing them into the EHR when it is back up. This adds to the already excessive amount of administrative work that is burning clinicians out.” Using a tool like Carelign means no such loss in efficiency.  

“A tool like Carelign, particularly because it is something that can be used without having to integrate it with the EHR, can put some control back into a hospitalist’s hands, to have a say in their workflow,” Dr. Airan-Javia said. “In a world where EHRs are designed to optimize billing, it can be game-changer to have a tool like Carelign that was created by a practicing clinician, for clinicians. Anyone interested in this area is welcome to reach out to me at [email protected] for collaboration or more information.”
 

Reference

1. Airan-Javia SL, et al. Mind the gap: Revolutionizing the EHR downtime experience with an interoperable workflow tool. Abstract published at Hospital Medicine 2019, March 24-27, National Harbor, Md. Abstract 380. https://www.shmabstracts.com/abstract/mind-the-gap-revolutionizing-the-ehr-downtime-experience-with-an-interoperable-workflow-tool/. Accessed Dec 11, 2019.

Electronic health record (EHR) implementations involve long downtimes, which are an under-recognized patient safety risk, as clinicians are forced to switch to completely manual, paper-based, and important unfamiliar workflows to care for their acutely ill patients, said Subha Airan-Javia, MD, FAMIA, a hospitalist at the University of Pennsylvania, Philadelphia.

“In this setting, we discovered an unanticipated benefit of our tool [Carelign, initially built to digitize the handoff process] as a clinical resource during EHR downtime, giving clinicians access to critical data as well as an electronic platform to collaborate as a team around the care of their patients,” she said.

There are two important takeaways from their study on this issue. “The first is that Carelign was able to give clinicians access to clinical data that would otherwise have been unavailable, including vitals, labs, medications, care plans and care team assignments,” Dr. Airan-Javia said. “This undoubtedly mitigated patient safety risks during the EHR downtime.” 

The second: “As many clinicians know, any change in workflow, even for a few hours, can make providing a high level of patient care very difficult,” she added. “During a downtime without a tool like Carelign, clinicians have to rely on paper and bedside charts, writing notes on paper and then re-typing them into the EHR when it is back up. This adds to the already excessive amount of administrative work that is burning clinicians out.” Using a tool like Carelign means no such loss in efficiency.  

“A tool like Carelign, particularly because it is something that can be used without having to integrate it with the EHR, can put some control back into a hospitalist’s hands, to have a say in their workflow,” Dr. Airan-Javia said. “In a world where EHRs are designed to optimize billing, it can be game-changer to have a tool like Carelign that was created by a practicing clinician, for clinicians. Anyone interested in this area is welcome to reach out to me at [email protected] for collaboration or more information.”
 

Reference

1. Airan-Javia SL, et al. Mind the gap: Revolutionizing the EHR downtime experience with an interoperable workflow tool. Abstract published at Hospital Medicine 2019, March 24-27, National Harbor, Md. Abstract 380. https://www.shmabstracts.com/abstract/mind-the-gap-revolutionizing-the-ehr-downtime-experience-with-an-interoperable-workflow-tool/. Accessed Dec 11, 2019.

Electronic health record (EHR) implementations involve long downtimes, which are an under-recognized patient safety risk, as clinicians are forced to switch to completely manual, paper-based, and important unfamiliar workflows to care for their acutely ill patients, said Subha Airan-Javia, MD, FAMIA, a hospitalist at the University of Pennsylvania, Philadelphia.

“In this setting, we discovered an unanticipated benefit of our tool [Carelign, initially built to digitize the handoff process] as a clinical resource during EHR downtime, giving clinicians access to critical data as well as an electronic platform to collaborate as a team around the care of their patients,” she said.

There are two important takeaways from their study on this issue. “The first is that Carelign was able to give clinicians access to clinical data that would otherwise have been unavailable, including vitals, labs, medications, care plans and care team assignments,” Dr. Airan-Javia said. “This undoubtedly mitigated patient safety risks during the EHR downtime.” 

The second: “As many clinicians know, any change in workflow, even for a few hours, can make providing a high level of patient care very difficult,” she added. “During a downtime without a tool like Carelign, clinicians have to rely on paper and bedside charts, writing notes on paper and then re-typing them into the EHR when it is back up. This adds to the already excessive amount of administrative work that is burning clinicians out.” Using a tool like Carelign means no such loss in efficiency.  

“A tool like Carelign, particularly because it is something that can be used without having to integrate it with the EHR, can put some control back into a hospitalist’s hands, to have a say in their workflow,” Dr. Airan-Javia said. “In a world where EHRs are designed to optimize billing, it can be game-changer to have a tool like Carelign that was created by a practicing clinician, for clinicians. Anyone interested in this area is welcome to reach out to me at [email protected] for collaboration or more information.”
 

Reference

1. Airan-Javia SL, et al. Mind the gap: Revolutionizing the EHR downtime experience with an interoperable workflow tool. Abstract published at Hospital Medicine 2019, March 24-27, National Harbor, Md. Abstract 380. https://www.shmabstracts.com/abstract/mind-the-gap-revolutionizing-the-ehr-downtime-experience-with-an-interoperable-workflow-tool/. Accessed Dec 11, 2019.

The Food and Drug Administration on Feb. 22 updated its October 2020 guidance for manufacturers developing COVID-19 vaccines, diagnostics, and treatments in the wake of circulating SARS-CoV-2 variants.

The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.

Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
 

Tailoring may be necessary

Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.

In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.

Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.

Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
 

Variants and testing

The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.

The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.

However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
 

Updated guidance for therapeutics

The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.

“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”

While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.

The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”

Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”

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

The Food and Drug Administration on Feb. 22 updated its October 2020 guidance for manufacturers developing COVID-19 vaccines, diagnostics, and treatments in the wake of circulating SARS-CoV-2 variants.

The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.

Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
 

Tailoring may be necessary

Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.

In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.

Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.

Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
 

Variants and testing

The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.

The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.

However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
 

Updated guidance for therapeutics

The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.

“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”

While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.

The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”

Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”

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

The Food and Drug Administration on Feb. 22 updated its October 2020 guidance for manufacturers developing COVID-19 vaccines, diagnostics, and treatments in the wake of circulating SARS-CoV-2 variants.

The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.

Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
 

Tailoring may be necessary

Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.

In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.

Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.

Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
 

Variants and testing

The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.

The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.

However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
 

Updated guidance for therapeutics

The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.

“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”

While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.

The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”

Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”

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

More than half of respondents to a recent survey looking at how the COVID-19 pandemic has affected people with psoriasis or psoriatic arthritis (PsA) said that they had avoided seeking medical care in person with a doctor or at a hospital.

Courtesy National Psoriasis Foundation

Moreover, around a quarter had their appointment with a rheumatologist canceled, rescheduled, or conducted virtually. Another 1 in 10 had their treatment plan disrupted, and 6% had to change or stop treatment entirely.

The mental health impact of living with these conditions during the pandemic was also notable, said Rachael Manion, the executive director of the Canadian Association of Psoriasis Patients (CAPP), which conducted the survey in collaboration with the Canadian Psoriasis Network (CPN) and Unmasking Psoriasis.

“It’s important to know that there have been a lot of different impacts of the pandemic on people living with psoriatic arthritis and psoriasis. Mental health in particular has had a really big hit as a result,” she said at the Canadian Arthritis Research Conference: Research with Impact.

“About half of the people who responded to our survey noted that their mental health was ‘worse’ or ‘much worse’ during the pandemic,” she said at the meeting, which was sponsored by the Arthritis Society, the Canadian Rheumatology Association, and Canada’s Institute of Musculoskeletal Health and Arthritis. Anxiety and feelings of isolation were reported by a respective 57% and 58% of respondents, and 40% reported depression.

“We can compare that to our earlier information around depression,” Ms. Manion said, which showed that, prior to the pandemic, 24% of people with psoriasis and 23% of those with PsA had said they experienced depression.

“What I found alarming looking at these results was that about a third of people were experiencing despair. Now that’s a really big, scary, overwhelming emotion that has a lot of burden on your mental health,” Ms. Manion said.

Despite the substantial effects on mental health, only 29% of respondents said they had been able to access mental health services during the pandemic.

To look at the impact of the COVID-19 pandemic on the psoriasis and PsA community in Canada, three patient advocacy groups – CAPP, CPN, and Unmasking Psoriasis – codeveloped a survey to look at the disease experience before and after the start of the COVID-19 pandemic. The survey was performed once, with 830 respondents providing information on their lives with psoriasis or PsA in the months before the start of the pandemic and at the time they were surveyed in September and October 2020.

Most of the survey respondents lived in Ontario, Quebec, British Columbia, or Alberta, although other provinces or territories were represented. Almost all respondents (96%) had psoriasis, and 60% also had PsA.

Pre-COVID, nearly half (49%) of patients said that they had not been seen by a rheumatologist, and 39% had not seen a dermatologist for treatment. Asked why, 56% and 27%, respectively, had not been referred, 9% and 15% said they had no specialist located nearby, and 7% and 10% stated that the wait list was too long.

“This tells us that there’s a lot more work that can be done and a lot more education of general practitioners and family medicine professionals about the benefits and the value of specialized care for psoriatic arthritis,” Ms. Manion suggested.

Before the pandemic, joint pain was occurring in 88% of patients, stiffness in 71%, and joint swelling in 67%. Disease flares or sudden periods of worsening occurred on a daily basis for 17%, and around one in five (21%) experienced multiple flares every month.

Prepandemic data also highlighted the negative impact that living with psoriasis or PsA has on people’s ability to sleep, interactions and intimacy with others, and on their school or work lives.

During the pandemic, around a quarter (26%) of respondents said they had worse or much worse access to employment, as well as its benefits such as a stable income (24%). A minority of respondent also described worse access to prescription medication (15%) and over-the-counter medication (13%).

“There are all kinds of things going on for patients in our community: changes to their work, changes to their drug coverage, their ability to sleep and sleep well, their mental health, and their ability to access care and treatments as part of their disease management,” Ms. Manion said.

Her final message to health care professionals was: “I just want to encourage you to continue to check in with your patients about what their experiences have been during the pandemic, and to really consider those impacts as you’re working with them to manage their disease.”

The survey received funding support from AbbVie, Bausch Health, Boehringer Ingelheim, Janssen, LEO Pharma, and Novartis.

More than half of respondents to a recent survey looking at how the COVID-19 pandemic has affected people with psoriasis or psoriatic arthritis (PsA) said that they had avoided seeking medical care in person with a doctor or at a hospital.

Courtesy National Psoriasis Foundation

Moreover, around a quarter had their appointment with a rheumatologist canceled, rescheduled, or conducted virtually. Another 1 in 10 had their treatment plan disrupted, and 6% had to change or stop treatment entirely.

The mental health impact of living with these conditions during the pandemic was also notable, said Rachael Manion, the executive director of the Canadian Association of Psoriasis Patients (CAPP), which conducted the survey in collaboration with the Canadian Psoriasis Network (CPN) and Unmasking Psoriasis.

“It’s important to know that there have been a lot of different impacts of the pandemic on people living with psoriatic arthritis and psoriasis. Mental health in particular has had a really big hit as a result,” she said at the Canadian Arthritis Research Conference: Research with Impact.

“About half of the people who responded to our survey noted that their mental health was ‘worse’ or ‘much worse’ during the pandemic,” she said at the meeting, which was sponsored by the Arthritis Society, the Canadian Rheumatology Association, and Canada’s Institute of Musculoskeletal Health and Arthritis. Anxiety and feelings of isolation were reported by a respective 57% and 58% of respondents, and 40% reported depression.

“We can compare that to our earlier information around depression,” Ms. Manion said, which showed that, prior to the pandemic, 24% of people with psoriasis and 23% of those with PsA had said they experienced depression.

“What I found alarming looking at these results was that about a third of people were experiencing despair. Now that’s a really big, scary, overwhelming emotion that has a lot of burden on your mental health,” Ms. Manion said.

Despite the substantial effects on mental health, only 29% of respondents said they had been able to access mental health services during the pandemic.

To look at the impact of the COVID-19 pandemic on the psoriasis and PsA community in Canada, three patient advocacy groups – CAPP, CPN, and Unmasking Psoriasis – codeveloped a survey to look at the disease experience before and after the start of the COVID-19 pandemic. The survey was performed once, with 830 respondents providing information on their lives with psoriasis or PsA in the months before the start of the pandemic and at the time they were surveyed in September and October 2020.

Most of the survey respondents lived in Ontario, Quebec, British Columbia, or Alberta, although other provinces or territories were represented. Almost all respondents (96%) had psoriasis, and 60% also had PsA.

Pre-COVID, nearly half (49%) of patients said that they had not been seen by a rheumatologist, and 39% had not seen a dermatologist for treatment. Asked why, 56% and 27%, respectively, had not been referred, 9% and 15% said they had no specialist located nearby, and 7% and 10% stated that the wait list was too long.

“This tells us that there’s a lot more work that can be done and a lot more education of general practitioners and family medicine professionals about the benefits and the value of specialized care for psoriatic arthritis,” Ms. Manion suggested.

Before the pandemic, joint pain was occurring in 88% of patients, stiffness in 71%, and joint swelling in 67%. Disease flares or sudden periods of worsening occurred on a daily basis for 17%, and around one in five (21%) experienced multiple flares every month.

Prepandemic data also highlighted the negative impact that living with psoriasis or PsA has on people’s ability to sleep, interactions and intimacy with others, and on their school or work lives.

During the pandemic, around a quarter (26%) of respondents said they had worse or much worse access to employment, as well as its benefits such as a stable income (24%). A minority of respondent also described worse access to prescription medication (15%) and over-the-counter medication (13%).

“There are all kinds of things going on for patients in our community: changes to their work, changes to their drug coverage, their ability to sleep and sleep well, their mental health, and their ability to access care and treatments as part of their disease management,” Ms. Manion said.

Her final message to health care professionals was: “I just want to encourage you to continue to check in with your patients about what their experiences have been during the pandemic, and to really consider those impacts as you’re working with them to manage their disease.”

The survey received funding support from AbbVie, Bausch Health, Boehringer Ingelheim, Janssen, LEO Pharma, and Novartis.

More than half of respondents to a recent survey looking at how the COVID-19 pandemic has affected people with psoriasis or psoriatic arthritis (PsA) said that they had avoided seeking medical care in person with a doctor or at a hospital.

Courtesy National Psoriasis Foundation

Moreover, around a quarter had their appointment with a rheumatologist canceled, rescheduled, or conducted virtually. Another 1 in 10 had their treatment plan disrupted, and 6% had to change or stop treatment entirely.

The mental health impact of living with these conditions during the pandemic was also notable, said Rachael Manion, the executive director of the Canadian Association of Psoriasis Patients (CAPP), which conducted the survey in collaboration with the Canadian Psoriasis Network (CPN) and Unmasking Psoriasis.

“It’s important to know that there have been a lot of different impacts of the pandemic on people living with psoriatic arthritis and psoriasis. Mental health in particular has had a really big hit as a result,” she said at the Canadian Arthritis Research Conference: Research with Impact.

“About half of the people who responded to our survey noted that their mental health was ‘worse’ or ‘much worse’ during the pandemic,” she said at the meeting, which was sponsored by the Arthritis Society, the Canadian Rheumatology Association, and Canada’s Institute of Musculoskeletal Health and Arthritis. Anxiety and feelings of isolation were reported by a respective 57% and 58% of respondents, and 40% reported depression.

“We can compare that to our earlier information around depression,” Ms. Manion said, which showed that, prior to the pandemic, 24% of people with psoriasis and 23% of those with PsA had said they experienced depression.

“What I found alarming looking at these results was that about a third of people were experiencing despair. Now that’s a really big, scary, overwhelming emotion that has a lot of burden on your mental health,” Ms. Manion said.

Despite the substantial effects on mental health, only 29% of respondents said they had been able to access mental health services during the pandemic.

To look at the impact of the COVID-19 pandemic on the psoriasis and PsA community in Canada, three patient advocacy groups – CAPP, CPN, and Unmasking Psoriasis – codeveloped a survey to look at the disease experience before and after the start of the COVID-19 pandemic. The survey was performed once, with 830 respondents providing information on their lives with psoriasis or PsA in the months before the start of the pandemic and at the time they were surveyed in September and October 2020.

Most of the survey respondents lived in Ontario, Quebec, British Columbia, or Alberta, although other provinces or territories were represented. Almost all respondents (96%) had psoriasis, and 60% also had PsA.

Pre-COVID, nearly half (49%) of patients said that they had not been seen by a rheumatologist, and 39% had not seen a dermatologist for treatment. Asked why, 56% and 27%, respectively, had not been referred, 9% and 15% said they had no specialist located nearby, and 7% and 10% stated that the wait list was too long.

“This tells us that there’s a lot more work that can be done and a lot more education of general practitioners and family medicine professionals about the benefits and the value of specialized care for psoriatic arthritis,” Ms. Manion suggested.

Before the pandemic, joint pain was occurring in 88% of patients, stiffness in 71%, and joint swelling in 67%. Disease flares or sudden periods of worsening occurred on a daily basis for 17%, and around one in five (21%) experienced multiple flares every month.

Prepandemic data also highlighted the negative impact that living with psoriasis or PsA has on people’s ability to sleep, interactions and intimacy with others, and on their school or work lives.

During the pandemic, around a quarter (26%) of respondents said they had worse or much worse access to employment, as well as its benefits such as a stable income (24%). A minority of respondent also described worse access to prescription medication (15%) and over-the-counter medication (13%).

“There are all kinds of things going on for patients in our community: changes to their work, changes to their drug coverage, their ability to sleep and sleep well, their mental health, and their ability to access care and treatments as part of their disease management,” Ms. Manion said.

Her final message to health care professionals was: “I just want to encourage you to continue to check in with your patients about what their experiences have been during the pandemic, and to really consider those impacts as you’re working with them to manage their disease.”

The survey received funding support from AbbVie, Bausch Health, Boehringer Ingelheim, Janssen, LEO Pharma, and Novartis.

The hospital and postdischarge course of patients diagnosed with type 2 myocardial infarction, triggered when myocardial oxygen demand outstrips supply, differs in telling ways from those with the more common atherothrombotic type 1 MI, suggests a new registry analysis that aims to lift a cloud of confusion surrounding their management.

The observational study of more than 250,000 patients with either form of MI, said to be the largest of its kind, points to widespread unfamiliarity with distinctions between the two, and the diagnostic and therapeutic implications of misclassification. It suggests, in particular, that type 2 MI may be grossly underdiagnosed and undertreated.

The minority of patients with type 2 MI were more likely female and to have heart failure (HF), renal disease, valve disease, or atrial fibrillation, and less likely to have a lipid disorder, compared with those with type 1 MI. They were one-fifth as likely to be referred for coronary angiography and 20 times less likely to undergo revascularization.

Indeed, only about 2% of the type 2 cohort ultimately underwent percutaneous coronary intervention (PCI) or coronary bypass surgery (CABG). Yet the analysis suggests that cardiovascular risk climbs regardless of MI type and that in patients with type 2 MI, coronary revascularization might well cut the risk of death in half over the short term.

There were also disparities in clinical outcomes in the analysis, based on data from the final 3 months of 2017 in the Nationwide Readmissions Database, which reportedly documents almost 60% of hospitalizations in the United States.

For example, those with type 1 or type 2 MI – as characterized in the then-current third Universal Definition of Myocardial Infarction and today’s UDMI-4 – were comparably at risk for both 30-day all-cause readmission and HF readmission. But type 2 patients were less likely to die in the hospital or be readmitted within 30 days for recurrent MI.
 

Revascularization uncertainty

Importantly, the study’s 3-month observation period immediately followed the debut of a code specifically for type 2 MI in the ICD-10-CM system.

Type 2 accounted for about 15% of MIs during that period, the percentage climbing sharply from the first to the third month. That suggests clinicians were still getting used to the code during the early weeks, “undercoding” for type-2 MI at first but less so after some experience, Cian P. McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston, said in an interview.

“I can imagine that as people become more aware of the coding, using it more often, the proportion of type 2 MI relative to the total MI cases will probably be much higher,” said McCarthy, lead author on the study published online Feb. 15, 2021, in the Journal of the American College of Cardiology.

What had been understood about type 2 MI came largely from single-center studies, he said. This “first national study of type-2 MI in the United States” sought to determine whether such findings are hospital specific or “representative of what people are doing nationally.”

The new analysis largely confirms that patients with type 2 MI are typically burdened with multiple comorbidities, Dr. McCarthy said, but also suggests that type 2 often was, and likely still is, incorrectly classified as type 1. So, it was “surprising” that they were rarely referred for angiography. “Only 1 in 50 received revascularization.”

Those diagnosed with type-2 MI were far less likely to receive coronary angiography (10.9% vs. 57.3%), PCI (1.7% vs. 38.5%), or CABG (0.4% vs. 7.8%) (P < .001 for all three differences), the report noted.

That, Dr. McCarthy said, “clearly shows that clinicians are uncertain about whether revascularization is beneficial” in type 2 MI.
 

Coding not in sync with UDMI

If there is confusion in practice about differentiating type 2 from type 1 MI, it likely has multiple sources, and one may be inconsistencies in how the UDMI and relevant ICD codes are applied in practice.

For example, the coding mandate is always to classify ST-segment elevation MI and non-STEMI as type 1, yet UDMI-4 itself states that a type 2 MI may be either STEMI or non-STEMI, noted Dr. McCarthy, as well as an editorial accompanying the report.

“It also can be difficult at times to distinguish type 2 MI from the diagnosis of myocardial injury,” both of which are partly defined by elevated cardiac troponin (cTn), adds the editorial, from Kristian Thygesen, MD, DSc, Aarhus (Denmark) University Hospital, Aarhus, Denmark, and Allan S. Jaffe, MD, Mayo Clinic, Rochester, Minn.

Crucially, but potentially sometimes overlooked, a diagnosis of infarction requires evidence of ischemia along with the biomarker elevation, whereas myocardial injury is defined by raised cTn without evidence of ischemia. Yet there is no ICD-10-CM code for “nonischemic myocardial injury,” Dr. Thygesen and Dr. Jaffe observed.

“Instead, the new ICD-10-CM coding includes a proxy called ‘non-MI troponin elevation due to an underlying cause,’ ” they wrote. “Unfortunately, although some have advocated using this code for myocardial injury, it is not specific for an elevated cTn value and could represent any abnormal laboratory measurements.” The code could be “misleading” and thus worsen the potential for miscoding and “misattribution of MI diagnoses.”

In the current study, 84.6% of the cohort were classified with type 1 MI, 14.8% with type 2, and 0.6% with both types. Of those with type 1 MI, 22.1% had STEMI, 76.4% had non-STEMI with the remainder “unspecified.”

“I think the introduction of ICD codes for type-2 MI is helpful in that we can study type 2 MI more broadly, across institutions, and try and get a better sense of its outcomes and how these patients are treated,” Dr. McCarthy said. But the coding system’s deficiencies may often lead to misclassification of patients. Especially, patients with type 2 STEMI may be miscoded as having type-1 STEMI, and those with only myocardial injury may be miscoded as having type 2 MI.
 

Most type 2 MI is a complication

A profile of patients with type 2 MI may be helpful for making distinctions. The analysis showed that, compared with patients with type 1 MI, they were slightly but significantly older and more likely to have clinical depression, alcohol or other substance abuse disorder, and to be female. They also had more heart failure (27.9% vs. 10.9%), kidney disease (35.7% vs. 25.7%), atrial fibrillation (31% vs. 21%), and anemia (26% vs. 18.9%) (P < .001 for all differences).

Type 2 patients were less likely to have CV risk factors usually associated with plaque instability and atherothrombosis, including a history of smoking, dyslipidemia, MI, PCI, or CABG (P < .001 for all differences), the group noted.

Of the 37,765 patients with type 2 MI, 91% received the diagnosis as secondary to another condition, including sepsis in 24.5%, hypertension in 16.9%, arrhythmias in 6.1%, respiratory failure in 4.3%, and pneumonia in 2.8% of cases.

In multivariate analyses, patients with type 2 MI, compared with type 1, showed lower risks of in-hospital death and readmission for MI within 30 days. Their 30-day risks of readmission from any cause and from MI were similar.

In-hospital mortality was lower for patients with type 2 MI who underwent revascularization, compared with those who did not, “but they were a very select, small proportion of the patient group. I would say there are probably unmeasured confounders,” Dr. McCarthy said.

“There’s a real kind of equipoise, so I think we desperately need a trial to guide us on whether revascularization is beneficial.”

Dr. McCarthy has disclosed no relevant financial relationships. Dr. Thygesen disclosed no relevant financial relationships. Dr. Jaffe disclosed serving as a consultant for Abbott, Roche, Siemens, Beckman-Coulter, Radiometer, ET Healthcare, Sphingotec, Brava, Quidel, Amgen, Novartis, and Medscape for educational activities.
 

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

The hospital and postdischarge course of patients diagnosed with type 2 myocardial infarction, triggered when myocardial oxygen demand outstrips supply, differs in telling ways from those with the more common atherothrombotic type 1 MI, suggests a new registry analysis that aims to lift a cloud of confusion surrounding their management.

The observational study of more than 250,000 patients with either form of MI, said to be the largest of its kind, points to widespread unfamiliarity with distinctions between the two, and the diagnostic and therapeutic implications of misclassification. It suggests, in particular, that type 2 MI may be grossly underdiagnosed and undertreated.

The minority of patients with type 2 MI were more likely female and to have heart failure (HF), renal disease, valve disease, or atrial fibrillation, and less likely to have a lipid disorder, compared with those with type 1 MI. They were one-fifth as likely to be referred for coronary angiography and 20 times less likely to undergo revascularization.

Indeed, only about 2% of the type 2 cohort ultimately underwent percutaneous coronary intervention (PCI) or coronary bypass surgery (CABG). Yet the analysis suggests that cardiovascular risk climbs regardless of MI type and that in patients with type 2 MI, coronary revascularization might well cut the risk of death in half over the short term.

There were also disparities in clinical outcomes in the analysis, based on data from the final 3 months of 2017 in the Nationwide Readmissions Database, which reportedly documents almost 60% of hospitalizations in the United States.

For example, those with type 1 or type 2 MI – as characterized in the then-current third Universal Definition of Myocardial Infarction and today’s UDMI-4 – were comparably at risk for both 30-day all-cause readmission and HF readmission. But type 2 patients were less likely to die in the hospital or be readmitted within 30 days for recurrent MI.
 

Revascularization uncertainty

Importantly, the study’s 3-month observation period immediately followed the debut of a code specifically for type 2 MI in the ICD-10-CM system.

Type 2 accounted for about 15% of MIs during that period, the percentage climbing sharply from the first to the third month. That suggests clinicians were still getting used to the code during the early weeks, “undercoding” for type-2 MI at first but less so after some experience, Cian P. McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston, said in an interview.

“I can imagine that as people become more aware of the coding, using it more often, the proportion of type 2 MI relative to the total MI cases will probably be much higher,” said McCarthy, lead author on the study published online Feb. 15, 2021, in the Journal of the American College of Cardiology.

What had been understood about type 2 MI came largely from single-center studies, he said. This “first national study of type-2 MI in the United States” sought to determine whether such findings are hospital specific or “representative of what people are doing nationally.”

The new analysis largely confirms that patients with type 2 MI are typically burdened with multiple comorbidities, Dr. McCarthy said, but also suggests that type 2 often was, and likely still is, incorrectly classified as type 1. So, it was “surprising” that they were rarely referred for angiography. “Only 1 in 50 received revascularization.”

Those diagnosed with type-2 MI were far less likely to receive coronary angiography (10.9% vs. 57.3%), PCI (1.7% vs. 38.5%), or CABG (0.4% vs. 7.8%) (P < .001 for all three differences), the report noted.

That, Dr. McCarthy said, “clearly shows that clinicians are uncertain about whether revascularization is beneficial” in type 2 MI.
 

Coding not in sync with UDMI

If there is confusion in practice about differentiating type 2 from type 1 MI, it likely has multiple sources, and one may be inconsistencies in how the UDMI and relevant ICD codes are applied in practice.

For example, the coding mandate is always to classify ST-segment elevation MI and non-STEMI as type 1, yet UDMI-4 itself states that a type 2 MI may be either STEMI or non-STEMI, noted Dr. McCarthy, as well as an editorial accompanying the report.

“It also can be difficult at times to distinguish type 2 MI from the diagnosis of myocardial injury,” both of which are partly defined by elevated cardiac troponin (cTn), adds the editorial, from Kristian Thygesen, MD, DSc, Aarhus (Denmark) University Hospital, Aarhus, Denmark, and Allan S. Jaffe, MD, Mayo Clinic, Rochester, Minn.

Crucially, but potentially sometimes overlooked, a diagnosis of infarction requires evidence of ischemia along with the biomarker elevation, whereas myocardial injury is defined by raised cTn without evidence of ischemia. Yet there is no ICD-10-CM code for “nonischemic myocardial injury,” Dr. Thygesen and Dr. Jaffe observed.

“Instead, the new ICD-10-CM coding includes a proxy called ‘non-MI troponin elevation due to an underlying cause,’ ” they wrote. “Unfortunately, although some have advocated using this code for myocardial injury, it is not specific for an elevated cTn value and could represent any abnormal laboratory measurements.” The code could be “misleading” and thus worsen the potential for miscoding and “misattribution of MI diagnoses.”

In the current study, 84.6% of the cohort were classified with type 1 MI, 14.8% with type 2, and 0.6% with both types. Of those with type 1 MI, 22.1% had STEMI, 76.4% had non-STEMI with the remainder “unspecified.”

“I think the introduction of ICD codes for type-2 MI is helpful in that we can study type 2 MI more broadly, across institutions, and try and get a better sense of its outcomes and how these patients are treated,” Dr. McCarthy said. But the coding system’s deficiencies may often lead to misclassification of patients. Especially, patients with type 2 STEMI may be miscoded as having type-1 STEMI, and those with only myocardial injury may be miscoded as having type 2 MI.
 

Most type 2 MI is a complication

A profile of patients with type 2 MI may be helpful for making distinctions. The analysis showed that, compared with patients with type 1 MI, they were slightly but significantly older and more likely to have clinical depression, alcohol or other substance abuse disorder, and to be female. They also had more heart failure (27.9% vs. 10.9%), kidney disease (35.7% vs. 25.7%), atrial fibrillation (31% vs. 21%), and anemia (26% vs. 18.9%) (P < .001 for all differences).

Type 2 patients were less likely to have CV risk factors usually associated with plaque instability and atherothrombosis, including a history of smoking, dyslipidemia, MI, PCI, or CABG (P < .001 for all differences), the group noted.

Of the 37,765 patients with type 2 MI, 91% received the diagnosis as secondary to another condition, including sepsis in 24.5%, hypertension in 16.9%, arrhythmias in 6.1%, respiratory failure in 4.3%, and pneumonia in 2.8% of cases.

In multivariate analyses, patients with type 2 MI, compared with type 1, showed lower risks of in-hospital death and readmission for MI within 30 days. Their 30-day risks of readmission from any cause and from MI were similar.

In-hospital mortality was lower for patients with type 2 MI who underwent revascularization, compared with those who did not, “but they were a very select, small proportion of the patient group. I would say there are probably unmeasured confounders,” Dr. McCarthy said.

“There’s a real kind of equipoise, so I think we desperately need a trial to guide us on whether revascularization is beneficial.”

Dr. McCarthy has disclosed no relevant financial relationships. Dr. Thygesen disclosed no relevant financial relationships. Dr. Jaffe disclosed serving as a consultant for Abbott, Roche, Siemens, Beckman-Coulter, Radiometer, ET Healthcare, Sphingotec, Brava, Quidel, Amgen, Novartis, and Medscape for educational activities.
 

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

The hospital and postdischarge course of patients diagnosed with type 2 myocardial infarction, triggered when myocardial oxygen demand outstrips supply, differs in telling ways from those with the more common atherothrombotic type 1 MI, suggests a new registry analysis that aims to lift a cloud of confusion surrounding their management.

The observational study of more than 250,000 patients with either form of MI, said to be the largest of its kind, points to widespread unfamiliarity with distinctions between the two, and the diagnostic and therapeutic implications of misclassification. It suggests, in particular, that type 2 MI may be grossly underdiagnosed and undertreated.

The minority of patients with type 2 MI were more likely female and to have heart failure (HF), renal disease, valve disease, or atrial fibrillation, and less likely to have a lipid disorder, compared with those with type 1 MI. They were one-fifth as likely to be referred for coronary angiography and 20 times less likely to undergo revascularization.

Indeed, only about 2% of the type 2 cohort ultimately underwent percutaneous coronary intervention (PCI) or coronary bypass surgery (CABG). Yet the analysis suggests that cardiovascular risk climbs regardless of MI type and that in patients with type 2 MI, coronary revascularization might well cut the risk of death in half over the short term.

There were also disparities in clinical outcomes in the analysis, based on data from the final 3 months of 2017 in the Nationwide Readmissions Database, which reportedly documents almost 60% of hospitalizations in the United States.

For example, those with type 1 or type 2 MI – as characterized in the then-current third Universal Definition of Myocardial Infarction and today’s UDMI-4 – were comparably at risk for both 30-day all-cause readmission and HF readmission. But type 2 patients were less likely to die in the hospital or be readmitted within 30 days for recurrent MI.
 

Revascularization uncertainty

Importantly, the study’s 3-month observation period immediately followed the debut of a code specifically for type 2 MI in the ICD-10-CM system.

Type 2 accounted for about 15% of MIs during that period, the percentage climbing sharply from the first to the third month. That suggests clinicians were still getting used to the code during the early weeks, “undercoding” for type-2 MI at first but less so after some experience, Cian P. McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston, said in an interview.

“I can imagine that as people become more aware of the coding, using it more often, the proportion of type 2 MI relative to the total MI cases will probably be much higher,” said McCarthy, lead author on the study published online Feb. 15, 2021, in the Journal of the American College of Cardiology.

What had been understood about type 2 MI came largely from single-center studies, he said. This “first national study of type-2 MI in the United States” sought to determine whether such findings are hospital specific or “representative of what people are doing nationally.”

The new analysis largely confirms that patients with type 2 MI are typically burdened with multiple comorbidities, Dr. McCarthy said, but also suggests that type 2 often was, and likely still is, incorrectly classified as type 1. So, it was “surprising” that they were rarely referred for angiography. “Only 1 in 50 received revascularization.”

Those diagnosed with type-2 MI were far less likely to receive coronary angiography (10.9% vs. 57.3%), PCI (1.7% vs. 38.5%), or CABG (0.4% vs. 7.8%) (P < .001 for all three differences), the report noted.

That, Dr. McCarthy said, “clearly shows that clinicians are uncertain about whether revascularization is beneficial” in type 2 MI.
 

Coding not in sync with UDMI

If there is confusion in practice about differentiating type 2 from type 1 MI, it likely has multiple sources, and one may be inconsistencies in how the UDMI and relevant ICD codes are applied in practice.

For example, the coding mandate is always to classify ST-segment elevation MI and non-STEMI as type 1, yet UDMI-4 itself states that a type 2 MI may be either STEMI or non-STEMI, noted Dr. McCarthy, as well as an editorial accompanying the report.

“It also can be difficult at times to distinguish type 2 MI from the diagnosis of myocardial injury,” both of which are partly defined by elevated cardiac troponin (cTn), adds the editorial, from Kristian Thygesen, MD, DSc, Aarhus (Denmark) University Hospital, Aarhus, Denmark, and Allan S. Jaffe, MD, Mayo Clinic, Rochester, Minn.

Crucially, but potentially sometimes overlooked, a diagnosis of infarction requires evidence of ischemia along with the biomarker elevation, whereas myocardial injury is defined by raised cTn without evidence of ischemia. Yet there is no ICD-10-CM code for “nonischemic myocardial injury,” Dr. Thygesen and Dr. Jaffe observed.

“Instead, the new ICD-10-CM coding includes a proxy called ‘non-MI troponin elevation due to an underlying cause,’ ” they wrote. “Unfortunately, although some have advocated using this code for myocardial injury, it is not specific for an elevated cTn value and could represent any abnormal laboratory measurements.” The code could be “misleading” and thus worsen the potential for miscoding and “misattribution of MI diagnoses.”

In the current study, 84.6% of the cohort were classified with type 1 MI, 14.8% with type 2, and 0.6% with both types. Of those with type 1 MI, 22.1% had STEMI, 76.4% had non-STEMI with the remainder “unspecified.”

“I think the introduction of ICD codes for type-2 MI is helpful in that we can study type 2 MI more broadly, across institutions, and try and get a better sense of its outcomes and how these patients are treated,” Dr. McCarthy said. But the coding system’s deficiencies may often lead to misclassification of patients. Especially, patients with type 2 STEMI may be miscoded as having type-1 STEMI, and those with only myocardial injury may be miscoded as having type 2 MI.
 

Most type 2 MI is a complication

A profile of patients with type 2 MI may be helpful for making distinctions. The analysis showed that, compared with patients with type 1 MI, they were slightly but significantly older and more likely to have clinical depression, alcohol or other substance abuse disorder, and to be female. They also had more heart failure (27.9% vs. 10.9%), kidney disease (35.7% vs. 25.7%), atrial fibrillation (31% vs. 21%), and anemia (26% vs. 18.9%) (P < .001 for all differences).

Type 2 patients were less likely to have CV risk factors usually associated with plaque instability and atherothrombosis, including a history of smoking, dyslipidemia, MI, PCI, or CABG (P < .001 for all differences), the group noted.

Of the 37,765 patients with type 2 MI, 91% received the diagnosis as secondary to another condition, including sepsis in 24.5%, hypertension in 16.9%, arrhythmias in 6.1%, respiratory failure in 4.3%, and pneumonia in 2.8% of cases.

In multivariate analyses, patients with type 2 MI, compared with type 1, showed lower risks of in-hospital death and readmission for MI within 30 days. Their 30-day risks of readmission from any cause and from MI were similar.

In-hospital mortality was lower for patients with type 2 MI who underwent revascularization, compared with those who did not, “but they were a very select, small proportion of the patient group. I would say there are probably unmeasured confounders,” Dr. McCarthy said.

“There’s a real kind of equipoise, so I think we desperately need a trial to guide us on whether revascularization is beneficial.”

Dr. McCarthy has disclosed no relevant financial relationships. Dr. Thygesen disclosed no relevant financial relationships. Dr. Jaffe disclosed serving as a consultant for Abbott, Roche, Siemens, Beckman-Coulter, Radiometer, ET Healthcare, Sphingotec, Brava, Quidel, Amgen, Novartis, and Medscape for educational activities.
 

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

Positive findings from frozen sections of a first temporal artery biopsy can effectively identify giant cell arteritis, ruling out in those cases the need to perform a second biopsy on the contralateral side and arguing against the use of simultaneous bilateral biopsies, according to results from a retrospective study of nearly 800 patients who underwent the procedure at the Mayo Clinic during 2010-2018.

Nephron/Wikimedia Commons

Although temporal artery biopsy (TAB) remains the standard diagnostic test for giant cell arteritis (GCA), second TAB procedures are often performed in patients with a high level of suspicion for GCA, which may result in unnecessary treatments and complications, Devon A. Cohen, MD, of the Mayo Clinic, Rochester, Minn., and colleagues wrote. (Dr. Cohen is now a clinical fellow in ophthalmology at the Massachusetts Eye and Ear Infirmary.)

At the Mayo Clinic, TAB specimens are first examined with frozen sections at the time of the biopsy; this process, followed within days by formalin-fixed tissue permanent sections, is unique to Mayo. “A frozen section–guided sequential TAB is commonly performed, with the results of the first biopsy obtained within minutes, which determines the need for evaluation of the contralateral side,” the researchers said. However, the use of frozen sections to evaluate patients with GCA has not been well studied.

In a retrospective cohort study published in JAMA Ophthalmology, the researchers identified TAB patients aged 40 years and older who underwent TAB procedures between Jan. 1, 2010, and Dec. 1, 2018, at the Mayo Clinic. The average age of the patients was 72 years, and 41% were men.
 

Strong positive predictions from frozen sections

The researchers analyzed 1,162 TABs from 795 patients using frozen and permanent histologic sections.

Overall, 119 patients (15.0%) and 138 TABs had positive permanent section findings, and 103 (86.6%) of these patients also had positive frozen section findings, including 4 false positives and 20 false negatives. The frozen section specificity and sensitivity was 99.4% and 83.2%, respectively, for detecting inflammation suggestive of GCA, and the positive and negative predictive values were 96.1% and 96.6%, respectively. Positive and negative likelihood ratios for frozen section were 140.6 and 0.17, respectively.

In a multivariate analysis, the odds of a positive permanent section TAB significantly increased with age (odds ratio, 1.04), vision loss (OR, 2.72), diplopia (OR, 3.33), headache (OR, 2.32), weight loss (OR, 2.37), and anorexia (OR, 5.65).

A total of 60 patients underwent bilateral TABs, and 307 patients underwent bilateral frozen section–guided sequential TABs; the discordance rates based on permanent sections were 5.0% and 5.5%, respectively.

Those discordance rates are “an important result applying to everyone working with patients suspected for GCA,” Patricia Chévez-Barrios, MD, of Houston Methodist Hospital, wrote in an accompanying editorial. “This is on the low end of what was previously published (3%-40%) and supports the relative low need for bilateral synchronous TAB for the diagnosis of GCA.”

A key issue in GCA diagnosis is the need to confirm inflammation, Dr. Chévez-Barrios said. “The surgeon must obtain a significant portion of the artery, and the pathologist should review several sections and levels of the tissue to confidently say whether there is inflammation or no.”
 

Frozen sections can spare patients from second procedures

The findings suggest a role for frozen section to help to determine whether a unilateral or bilateral simultaneous TAB should be performed, the study authors noted.

“If the frozen section is positive on the first TAB, a contralateral TAB is deferred, given the very low false-positive rate (0.6%). However, if the frozen section does not align with the permanent section result, in particular if the frozen section is positive but permanent section is negative, the patient returns for a TAB on the contralateral side if the GCA suspicion remains high,” they said.

The use of frozen sections requires ideal conditions in order to be effective, Dr. Chévez-Barrios said. The Mayo Clinic approach “is only possible because of their appropriate hospital setting, the training of the histotechnologists, and the experience of the pathologists interpreting the stains and sections. For most pathology laboratories outside of the Mayo Clinic, frozen sections on arteries are the exception and are used only in specific scenarios.”

In addition, the American College of Rheumatology recommends that patients with a high suspicion of GCA should begin corticosteroids as soon as laboratory studies are obtained; “As a result, if a TAB is performed after treatment begins, the typical active pattern of inflammation in the artery changes,” Dr. Chévez-Barrios said. “This further challenges the diagnosis in a frozen section setting because of the need for immunohistochemistry.” Although frozen sections are feasible in specialized settings such as the Mayo Clinic, most patients receive adequate diagnosis and treatment based on permanent sections.

The study findings were limited by several factors including the use of data from patients at a single center and the unique setup of the Mayo Clinic to perform rapid processing of frozen sections, the researchers noted.

“Additionally, we acknowledge that there is controversy regarding the clinical interpretation of healed arteritis. At our institution, healed arteritis is interpreted in the context of patient clinical characteristics and radiographic findings, which may differ from other institutions and may impact the results of this study,” they said.

Overall, the results support the potential of frozen sections in guiding TAB, although “more studies with a comparative analysis of laboratory results, clinical symptoms, and patient demographic characteristics between positive and negative frozen and permanent TAB results are needed to confirm our findings,” they concluded.

The study received no outside funding. One author reported receiving grants from Eli Lilly and Kiniksa Pharmaceuticals as well as personal fees from Genentech-Roche and Sanofi. Dr. Chévez-Barrios had no financial conflicts to disclose.

Positive findings from frozen sections of a first temporal artery biopsy can effectively identify giant cell arteritis, ruling out in those cases the need to perform a second biopsy on the contralateral side and arguing against the use of simultaneous bilateral biopsies, according to results from a retrospective study of nearly 800 patients who underwent the procedure at the Mayo Clinic during 2010-2018.

Nephron/Wikimedia Commons

Although temporal artery biopsy (TAB) remains the standard diagnostic test for giant cell arteritis (GCA), second TAB procedures are often performed in patients with a high level of suspicion for GCA, which may result in unnecessary treatments and complications, Devon A. Cohen, MD, of the Mayo Clinic, Rochester, Minn., and colleagues wrote. (Dr. Cohen is now a clinical fellow in ophthalmology at the Massachusetts Eye and Ear Infirmary.)

At the Mayo Clinic, TAB specimens are first examined with frozen sections at the time of the biopsy; this process, followed within days by formalin-fixed tissue permanent sections, is unique to Mayo. “A frozen section–guided sequential TAB is commonly performed, with the results of the first biopsy obtained within minutes, which determines the need for evaluation of the contralateral side,” the researchers said. However, the use of frozen sections to evaluate patients with GCA has not been well studied.

In a retrospective cohort study published in JAMA Ophthalmology, the researchers identified TAB patients aged 40 years and older who underwent TAB procedures between Jan. 1, 2010, and Dec. 1, 2018, at the Mayo Clinic. The average age of the patients was 72 years, and 41% were men.
 

Strong positive predictions from frozen sections

The researchers analyzed 1,162 TABs from 795 patients using frozen and permanent histologic sections.

Overall, 119 patients (15.0%) and 138 TABs had positive permanent section findings, and 103 (86.6%) of these patients also had positive frozen section findings, including 4 false positives and 20 false negatives. The frozen section specificity and sensitivity was 99.4% and 83.2%, respectively, for detecting inflammation suggestive of GCA, and the positive and negative predictive values were 96.1% and 96.6%, respectively. Positive and negative likelihood ratios for frozen section were 140.6 and 0.17, respectively.

In a multivariate analysis, the odds of a positive permanent section TAB significantly increased with age (odds ratio, 1.04), vision loss (OR, 2.72), diplopia (OR, 3.33), headache (OR, 2.32), weight loss (OR, 2.37), and anorexia (OR, 5.65).

A total of 60 patients underwent bilateral TABs, and 307 patients underwent bilateral frozen section–guided sequential TABs; the discordance rates based on permanent sections were 5.0% and 5.5%, respectively.

Those discordance rates are “an important result applying to everyone working with patients suspected for GCA,” Patricia Chévez-Barrios, MD, of Houston Methodist Hospital, wrote in an accompanying editorial. “This is on the low end of what was previously published (3%-40%) and supports the relative low need for bilateral synchronous TAB for the diagnosis of GCA.”

A key issue in GCA diagnosis is the need to confirm inflammation, Dr. Chévez-Barrios said. “The surgeon must obtain a significant portion of the artery, and the pathologist should review several sections and levels of the tissue to confidently say whether there is inflammation or no.”
 

Frozen sections can spare patients from second procedures

The findings suggest a role for frozen section to help to determine whether a unilateral or bilateral simultaneous TAB should be performed, the study authors noted.

“If the frozen section is positive on the first TAB, a contralateral TAB is deferred, given the very low false-positive rate (0.6%). However, if the frozen section does not align with the permanent section result, in particular if the frozen section is positive but permanent section is negative, the patient returns for a TAB on the contralateral side if the GCA suspicion remains high,” they said.

The use of frozen sections requires ideal conditions in order to be effective, Dr. Chévez-Barrios said. The Mayo Clinic approach “is only possible because of their appropriate hospital setting, the training of the histotechnologists, and the experience of the pathologists interpreting the stains and sections. For most pathology laboratories outside of the Mayo Clinic, frozen sections on arteries are the exception and are used only in specific scenarios.”

In addition, the American College of Rheumatology recommends that patients with a high suspicion of GCA should begin corticosteroids as soon as laboratory studies are obtained; “As a result, if a TAB is performed after treatment begins, the typical active pattern of inflammation in the artery changes,” Dr. Chévez-Barrios said. “This further challenges the diagnosis in a frozen section setting because of the need for immunohistochemistry.” Although frozen sections are feasible in specialized settings such as the Mayo Clinic, most patients receive adequate diagnosis and treatment based on permanent sections.

The study findings were limited by several factors including the use of data from patients at a single center and the unique setup of the Mayo Clinic to perform rapid processing of frozen sections, the researchers noted.

“Additionally, we acknowledge that there is controversy regarding the clinical interpretation of healed arteritis. At our institution, healed arteritis is interpreted in the context of patient clinical characteristics and radiographic findings, which may differ from other institutions and may impact the results of this study,” they said.

Overall, the results support the potential of frozen sections in guiding TAB, although “more studies with a comparative analysis of laboratory results, clinical symptoms, and patient demographic characteristics between positive and negative frozen and permanent TAB results are needed to confirm our findings,” they concluded.

The study received no outside funding. One author reported receiving grants from Eli Lilly and Kiniksa Pharmaceuticals as well as personal fees from Genentech-Roche and Sanofi. Dr. Chévez-Barrios had no financial conflicts to disclose.

Positive findings from frozen sections of a first temporal artery biopsy can effectively identify giant cell arteritis, ruling out in those cases the need to perform a second biopsy on the contralateral side and arguing against the use of simultaneous bilateral biopsies, according to results from a retrospective study of nearly 800 patients who underwent the procedure at the Mayo Clinic during 2010-2018.

Nephron/Wikimedia Commons

Although temporal artery biopsy (TAB) remains the standard diagnostic test for giant cell arteritis (GCA), second TAB procedures are often performed in patients with a high level of suspicion for GCA, which may result in unnecessary treatments and complications, Devon A. Cohen, MD, of the Mayo Clinic, Rochester, Minn., and colleagues wrote. (Dr. Cohen is now a clinical fellow in ophthalmology at the Massachusetts Eye and Ear Infirmary.)

At the Mayo Clinic, TAB specimens are first examined with frozen sections at the time of the biopsy; this process, followed within days by formalin-fixed tissue permanent sections, is unique to Mayo. “A frozen section–guided sequential TAB is commonly performed, with the results of the first biopsy obtained within minutes, which determines the need for evaluation of the contralateral side,” the researchers said. However, the use of frozen sections to evaluate patients with GCA has not been well studied.

In a retrospective cohort study published in JAMA Ophthalmology, the researchers identified TAB patients aged 40 years and older who underwent TAB procedures between Jan. 1, 2010, and Dec. 1, 2018, at the Mayo Clinic. The average age of the patients was 72 years, and 41% were men.
 

Strong positive predictions from frozen sections

The researchers analyzed 1,162 TABs from 795 patients using frozen and permanent histologic sections.

Overall, 119 patients (15.0%) and 138 TABs had positive permanent section findings, and 103 (86.6%) of these patients also had positive frozen section findings, including 4 false positives and 20 false negatives. The frozen section specificity and sensitivity was 99.4% and 83.2%, respectively, for detecting inflammation suggestive of GCA, and the positive and negative predictive values were 96.1% and 96.6%, respectively. Positive and negative likelihood ratios for frozen section were 140.6 and 0.17, respectively.

In a multivariate analysis, the odds of a positive permanent section TAB significantly increased with age (odds ratio, 1.04), vision loss (OR, 2.72), diplopia (OR, 3.33), headache (OR, 2.32), weight loss (OR, 2.37), and anorexia (OR, 5.65).

A total of 60 patients underwent bilateral TABs, and 307 patients underwent bilateral frozen section–guided sequential TABs; the discordance rates based on permanent sections were 5.0% and 5.5%, respectively.

Those discordance rates are “an important result applying to everyone working with patients suspected for GCA,” Patricia Chévez-Barrios, MD, of Houston Methodist Hospital, wrote in an accompanying editorial. “This is on the low end of what was previously published (3%-40%) and supports the relative low need for bilateral synchronous TAB for the diagnosis of GCA.”

A key issue in GCA diagnosis is the need to confirm inflammation, Dr. Chévez-Barrios said. “The surgeon must obtain a significant portion of the artery, and the pathologist should review several sections and levels of the tissue to confidently say whether there is inflammation or no.”
 

Frozen sections can spare patients from second procedures

The findings suggest a role for frozen section to help to determine whether a unilateral or bilateral simultaneous TAB should be performed, the study authors noted.

“If the frozen section is positive on the first TAB, a contralateral TAB is deferred, given the very low false-positive rate (0.6%). However, if the frozen section does not align with the permanent section result, in particular if the frozen section is positive but permanent section is negative, the patient returns for a TAB on the contralateral side if the GCA suspicion remains high,” they said.

The use of frozen sections requires ideal conditions in order to be effective, Dr. Chévez-Barrios said. The Mayo Clinic approach “is only possible because of their appropriate hospital setting, the training of the histotechnologists, and the experience of the pathologists interpreting the stains and sections. For most pathology laboratories outside of the Mayo Clinic, frozen sections on arteries are the exception and are used only in specific scenarios.”

In addition, the American College of Rheumatology recommends that patients with a high suspicion of GCA should begin corticosteroids as soon as laboratory studies are obtained; “As a result, if a TAB is performed after treatment begins, the typical active pattern of inflammation in the artery changes,” Dr. Chévez-Barrios said. “This further challenges the diagnosis in a frozen section setting because of the need for immunohistochemistry.” Although frozen sections are feasible in specialized settings such as the Mayo Clinic, most patients receive adequate diagnosis and treatment based on permanent sections.

The study findings were limited by several factors including the use of data from patients at a single center and the unique setup of the Mayo Clinic to perform rapid processing of frozen sections, the researchers noted.

“Additionally, we acknowledge that there is controversy regarding the clinical interpretation of healed arteritis. At our institution, healed arteritis is interpreted in the context of patient clinical characteristics and radiographic findings, which may differ from other institutions and may impact the results of this study,” they said.

Overall, the results support the potential of frozen sections in guiding TAB, although “more studies with a comparative analysis of laboratory results, clinical symptoms, and patient demographic characteristics between positive and negative frozen and permanent TAB results are needed to confirm our findings,” they concluded.

The study received no outside funding. One author reported receiving grants from Eli Lilly and Kiniksa Pharmaceuticals as well as personal fees from Genentech-Roche and Sanofi. Dr. Chévez-Barrios had no financial conflicts to disclose.