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The benefits of a triple fixed-dose inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta₂ agonist combination extend to patients with moderate as well as severe chronic obstructive pulmonary disease (COPD).

That’s according to investigators in the ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial (NCT02465567).

In a subanalysis of data on patients with moderate COPD who were enrolled in the comparison trial, the single-inhaler combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂ agonist (LABA) formoterol fumarate (BGF) showed benefits in terms of COPD exacerbations, lung function, symptoms, and quality-of-life compared with either of two dual therapy combinations (glycopyrrolate or budesonide with formoterol [GFF/BFF]).

“A moderate benefit:risk ratio was demonstrated in patients with moderate COPD, consistent with the results of the overall ETHOS population, indicating the results of the ETHOS study were not driven by patients with severe or very severe COPD,” wrote Gary T. Ferguson, MD, from the Pulmonary Research Institute of Southeast Michigan in Farmington Hills, and colleagues. Their poster was presented during the American Thoracic Society’s virtual international conference. (Abstract A2244).

As reported at ATS 2020, in the overall ETHOS population of 8,509 patients with moderate to very severe COPD the annual rate of moderate or severe COPD exacerbations was 1.08 and 1.07 for the triple combinations with 320-mcg and 160-mcg doses of budesonide, respectively, compared with 1.42 for glycopyrrolate-formoterol, and 1.24 for budesonide-formoterol.

Both triple combinations were significantly superior to the dual therapies for controlling exacerbations, Klaus F. Rabe, MD, PhD, of LungenClinic Grosshansdorf and Christian-Albrechts University Kiel (Germany), and colleagues found.
 

Subanalysis details

At the 2021 iteration of ATS, ETHOS investigator Dr. Ferguson and colleagues reported results for 613 patients with moderate COPD assigned to BGF 320 mcg, 604 assigned to BGF 160 mcg, 596 assigned to GFF, and 614 randomized to BFF.

Baseline demographic and clinical characteristics were similar among the groups, including age, sex, smoking status, mean COPD Assessment Test (CAT) score, mean blood eosinophil count, ICS use at screening, exacerbations in the previous year, mean postbronchodilator forced expiratory volume in 1 second (FEV₁) percentage of predicted, and mean postbronchodilator percentage reversibility.

A modified intention-to-treat (ITT) analysis showed that the rate of moderate or severe exacerbations over 52 weeks with BGF 320 mcg was 21% lower than with GFF (P = .0123), but only 4% lower than with BFF, a difference that was not statistically significant.

The BGF 160-mg dose was associated with a 30% reduction in exacerbations vs. GFF (P = .0002), and with a nonsignificant reduction of 15% compared with BFF.

­There was a numerical but not statistically significant improvement from baseline at week 24 in morning pre-dose trough FEV₁ between the BGF 320-mcg dose and GFF (difference 47 mL), and a significant improvement (90 mL) with BGF compared with BFF (P = .0006). The BGF 160-mcg dose was associated with a larger improvement (89 mL) compared with BFF (P = .0004) but not with GFF.

The FEV₁ area under the curve (AUC) of receiver operating characteristics from 0 to 4 hours was superior with BGF at both doses compared with both GFF and BFF.

Patients who used BGF 320 mcg also used significantly less rescue medication over 24 weeks compared with patients who used GFF (P < .0001) or BFF (P = .0001). There were no significant differences in rescue medication use between the BGF 160-mg dose and either of the dual therapy combinations.

Time to clinically important deterioration – defined as a greater than ­100 mL decrease in trough FEV₁, or a ­4 units increase in St. George’s Respiratory Questionnaire total score, or a treatment-emergent moderate/severe COPD exacerbation occurring up to week 52 – was significantly longer with the 320-mcg but not 160-mcg BGF dose compared with GFF (P = .0295) or BFF (P = .0172).
 

Safety

Treatment-emergent adverse events (TEAEs) occurred in about two-thirds of patients in each trial arm, although TEAEs related to study treatment were more common with the two triple-therapy combinations and with BFF than with GFF.

TEAEs leading to study discontinuation occurred in 5.5% of patients on BGF 320 mcg, 4% on BGF 160 mcg, 4.5% on GFF, and 3.2% on BFF.

Confirmed major adverse cardiovascular events occurred in 0.8% and 1.5% in the BGF 320- and 160-mcg groups, respectively, in 1.8% of patients in the GFF arm, and 1.5% in the BFF arm.

Confirmed pneumonia was seen in 2.6% of patients in each BGF arm, 2.2% in the GFF arm, and 3.6% in the BFF arm.
 

Selected population

In a comment, David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, noted that the enrollment criteria for ETHOS tended to skew the population toward patients with severe disease.

In the trial, all patients were receiving at least two inhaled maintenance therapies at the time of screening, and had a postbronchodilator ratio of FEV₁ to forced vital capacity of less than 0.7, with a postbronchodilator FEV₁ of 25%-65% of the predicted normal value. The patients all had a smoking history of at least 10 pack-years and a documented history of at least one moderate or severe COPD exacerbation in the year before screening.

“The question was whether they would see the same results in people with more moderate impairment, and the answer in this subanalysis is ‘yes.’ The findings weren’t identical between patients with severe and moderate disease, but there were similarities with what was seen in the overall ETHOS study,” he said.

The ETHOS Trial was supported by Pearl Therapeutics. Dr. Ferguson reported grants, personal fees, and nonfinancial support from AstraZeneca during the conduct of the study; and grants, fees, and nonfinancial support from Pearl and others. Dr. Mannino reports recruitment to an advisory board for AstraZeneca.

The benefits of a triple fixed-dose inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta₂ agonist combination extend to patients with moderate as well as severe chronic obstructive pulmonary disease (COPD).

That’s according to investigators in the ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial (NCT02465567).

In a subanalysis of data on patients with moderate COPD who were enrolled in the comparison trial, the single-inhaler combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂ agonist (LABA) formoterol fumarate (BGF) showed benefits in terms of COPD exacerbations, lung function, symptoms, and quality-of-life compared with either of two dual therapy combinations (glycopyrrolate or budesonide with formoterol [GFF/BFF]).

“A moderate benefit:risk ratio was demonstrated in patients with moderate COPD, consistent with the results of the overall ETHOS population, indicating the results of the ETHOS study were not driven by patients with severe or very severe COPD,” wrote Gary T. Ferguson, MD, from the Pulmonary Research Institute of Southeast Michigan in Farmington Hills, and colleagues. Their poster was presented during the American Thoracic Society’s virtual international conference. (Abstract A2244).

As reported at ATS 2020, in the overall ETHOS population of 8,509 patients with moderate to very severe COPD the annual rate of moderate or severe COPD exacerbations was 1.08 and 1.07 for the triple combinations with 320-mcg and 160-mcg doses of budesonide, respectively, compared with 1.42 for glycopyrrolate-formoterol, and 1.24 for budesonide-formoterol.

Both triple combinations were significantly superior to the dual therapies for controlling exacerbations, Klaus F. Rabe, MD, PhD, of LungenClinic Grosshansdorf and Christian-Albrechts University Kiel (Germany), and colleagues found.
 

Subanalysis details

At the 2021 iteration of ATS, ETHOS investigator Dr. Ferguson and colleagues reported results for 613 patients with moderate COPD assigned to BGF 320 mcg, 604 assigned to BGF 160 mcg, 596 assigned to GFF, and 614 randomized to BFF.

Baseline demographic and clinical characteristics were similar among the groups, including age, sex, smoking status, mean COPD Assessment Test (CAT) score, mean blood eosinophil count, ICS use at screening, exacerbations in the previous year, mean postbronchodilator forced expiratory volume in 1 second (FEV₁) percentage of predicted, and mean postbronchodilator percentage reversibility.

A modified intention-to-treat (ITT) analysis showed that the rate of moderate or severe exacerbations over 52 weeks with BGF 320 mcg was 21% lower than with GFF (P = .0123), but only 4% lower than with BFF, a difference that was not statistically significant.

The BGF 160-mg dose was associated with a 30% reduction in exacerbations vs. GFF (P = .0002), and with a nonsignificant reduction of 15% compared with BFF.

­There was a numerical but not statistically significant improvement from baseline at week 24 in morning pre-dose trough FEV₁ between the BGF 320-mcg dose and GFF (difference 47 mL), and a significant improvement (90 mL) with BGF compared with BFF (P = .0006). The BGF 160-mcg dose was associated with a larger improvement (89 mL) compared with BFF (P = .0004) but not with GFF.

The FEV₁ area under the curve (AUC) of receiver operating characteristics from 0 to 4 hours was superior with BGF at both doses compared with both GFF and BFF.

Patients who used BGF 320 mcg also used significantly less rescue medication over 24 weeks compared with patients who used GFF (P < .0001) or BFF (P = .0001). There were no significant differences in rescue medication use between the BGF 160-mg dose and either of the dual therapy combinations.

Time to clinically important deterioration – defined as a greater than ­100 mL decrease in trough FEV₁, or a ­4 units increase in St. George’s Respiratory Questionnaire total score, or a treatment-emergent moderate/severe COPD exacerbation occurring up to week 52 – was significantly longer with the 320-mcg but not 160-mcg BGF dose compared with GFF (P = .0295) or BFF (P = .0172).
 

Safety

Treatment-emergent adverse events (TEAEs) occurred in about two-thirds of patients in each trial arm, although TEAEs related to study treatment were more common with the two triple-therapy combinations and with BFF than with GFF.

TEAEs leading to study discontinuation occurred in 5.5% of patients on BGF 320 mcg, 4% on BGF 160 mcg, 4.5% on GFF, and 3.2% on BFF.

Confirmed major adverse cardiovascular events occurred in 0.8% and 1.5% in the BGF 320- and 160-mcg groups, respectively, in 1.8% of patients in the GFF arm, and 1.5% in the BFF arm.

Confirmed pneumonia was seen in 2.6% of patients in each BGF arm, 2.2% in the GFF arm, and 3.6% in the BFF arm.
 

Selected population

In a comment, David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, noted that the enrollment criteria for ETHOS tended to skew the population toward patients with severe disease.

In the trial, all patients were receiving at least two inhaled maintenance therapies at the time of screening, and had a postbronchodilator ratio of FEV₁ to forced vital capacity of less than 0.7, with a postbronchodilator FEV₁ of 25%-65% of the predicted normal value. The patients all had a smoking history of at least 10 pack-years and a documented history of at least one moderate or severe COPD exacerbation in the year before screening.

“The question was whether they would see the same results in people with more moderate impairment, and the answer in this subanalysis is ‘yes.’ The findings weren’t identical between patients with severe and moderate disease, but there were similarities with what was seen in the overall ETHOS study,” he said.

The ETHOS Trial was supported by Pearl Therapeutics. Dr. Ferguson reported grants, personal fees, and nonfinancial support from AstraZeneca during the conduct of the study; and grants, fees, and nonfinancial support from Pearl and others. Dr. Mannino reports recruitment to an advisory board for AstraZeneca.

The benefits of a triple fixed-dose inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta₂ agonist combination extend to patients with moderate as well as severe chronic obstructive pulmonary disease (COPD).

That’s according to investigators in the ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial (NCT02465567).

In a subanalysis of data on patients with moderate COPD who were enrolled in the comparison trial, the single-inhaler combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂ agonist (LABA) formoterol fumarate (BGF) showed benefits in terms of COPD exacerbations, lung function, symptoms, and quality-of-life compared with either of two dual therapy combinations (glycopyrrolate or budesonide with formoterol [GFF/BFF]).

“A moderate benefit:risk ratio was demonstrated in patients with moderate COPD, consistent with the results of the overall ETHOS population, indicating the results of the ETHOS study were not driven by patients with severe or very severe COPD,” wrote Gary T. Ferguson, MD, from the Pulmonary Research Institute of Southeast Michigan in Farmington Hills, and colleagues. Their poster was presented during the American Thoracic Society’s virtual international conference. (Abstract A2244).

As reported at ATS 2020, in the overall ETHOS population of 8,509 patients with moderate to very severe COPD the annual rate of moderate or severe COPD exacerbations was 1.08 and 1.07 for the triple combinations with 320-mcg and 160-mcg doses of budesonide, respectively, compared with 1.42 for glycopyrrolate-formoterol, and 1.24 for budesonide-formoterol.

Both triple combinations were significantly superior to the dual therapies for controlling exacerbations, Klaus F. Rabe, MD, PhD, of LungenClinic Grosshansdorf and Christian-Albrechts University Kiel (Germany), and colleagues found.
 

Subanalysis details

At the 2021 iteration of ATS, ETHOS investigator Dr. Ferguson and colleagues reported results for 613 patients with moderate COPD assigned to BGF 320 mcg, 604 assigned to BGF 160 mcg, 596 assigned to GFF, and 614 randomized to BFF.

Baseline demographic and clinical characteristics were similar among the groups, including age, sex, smoking status, mean COPD Assessment Test (CAT) score, mean blood eosinophil count, ICS use at screening, exacerbations in the previous year, mean postbronchodilator forced expiratory volume in 1 second (FEV₁) percentage of predicted, and mean postbronchodilator percentage reversibility.

A modified intention-to-treat (ITT) analysis showed that the rate of moderate or severe exacerbations over 52 weeks with BGF 320 mcg was 21% lower than with GFF (P = .0123), but only 4% lower than with BFF, a difference that was not statistically significant.

The BGF 160-mg dose was associated with a 30% reduction in exacerbations vs. GFF (P = .0002), and with a nonsignificant reduction of 15% compared with BFF.

­There was a numerical but not statistically significant improvement from baseline at week 24 in morning pre-dose trough FEV₁ between the BGF 320-mcg dose and GFF (difference 47 mL), and a significant improvement (90 mL) with BGF compared with BFF (P = .0006). The BGF 160-mcg dose was associated with a larger improvement (89 mL) compared with BFF (P = .0004) but not with GFF.

The FEV₁ area under the curve (AUC) of receiver operating characteristics from 0 to 4 hours was superior with BGF at both doses compared with both GFF and BFF.

Patients who used BGF 320 mcg also used significantly less rescue medication over 24 weeks compared with patients who used GFF (P < .0001) or BFF (P = .0001). There were no significant differences in rescue medication use between the BGF 160-mg dose and either of the dual therapy combinations.

Time to clinically important deterioration – defined as a greater than ­100 mL decrease in trough FEV₁, or a ­4 units increase in St. George’s Respiratory Questionnaire total score, or a treatment-emergent moderate/severe COPD exacerbation occurring up to week 52 – was significantly longer with the 320-mcg but not 160-mcg BGF dose compared with GFF (P = .0295) or BFF (P = .0172).
 

Safety

Treatment-emergent adverse events (TEAEs) occurred in about two-thirds of patients in each trial arm, although TEAEs related to study treatment were more common with the two triple-therapy combinations and with BFF than with GFF.

TEAEs leading to study discontinuation occurred in 5.5% of patients on BGF 320 mcg, 4% on BGF 160 mcg, 4.5% on GFF, and 3.2% on BFF.

Confirmed major adverse cardiovascular events occurred in 0.8% and 1.5% in the BGF 320- and 160-mcg groups, respectively, in 1.8% of patients in the GFF arm, and 1.5% in the BFF arm.

Confirmed pneumonia was seen in 2.6% of patients in each BGF arm, 2.2% in the GFF arm, and 3.6% in the BFF arm.
 

Selected population

In a comment, David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, noted that the enrollment criteria for ETHOS tended to skew the population toward patients with severe disease.

In the trial, all patients were receiving at least two inhaled maintenance therapies at the time of screening, and had a postbronchodilator ratio of FEV₁ to forced vital capacity of less than 0.7, with a postbronchodilator FEV₁ of 25%-65% of the predicted normal value. The patients all had a smoking history of at least 10 pack-years and a documented history of at least one moderate or severe COPD exacerbation in the year before screening.

“The question was whether they would see the same results in people with more moderate impairment, and the answer in this subanalysis is ‘yes.’ The findings weren’t identical between patients with severe and moderate disease, but there were similarities with what was seen in the overall ETHOS study,” he said.

The ETHOS Trial was supported by Pearl Therapeutics. Dr. Ferguson reported grants, personal fees, and nonfinancial support from AstraZeneca during the conduct of the study; and grants, fees, and nonfinancial support from Pearl and others. Dr. Mannino reports recruitment to an advisory board for AstraZeneca.

The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.

The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.

“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”

In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.

“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.

Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”

“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.

Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.

The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”

All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.

“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.

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

The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.

The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.

“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”

In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.

“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.

Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”

“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.

Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.

The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”

All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.

“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.

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

The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.

The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.

“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”

In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.

“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.

Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”

“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.

Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.

The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”

All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.

“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.

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

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

Sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with chronic obstructive pulmonary disease (COPD) may point to different criteria for diagnosing cardiac comorbidities in women and men, a retrospective analysis suggests.

Among 2,046 patients in the German COSYCONET (COPD and Systemic Consequences–Comorbidities Net) cohort, most functional parameters and comorbidities and several items on the COPD Assessment Test (CAT) differed significantly between men and women.

In addition, there were sex-specific differences in the association between symptoms and cardiac disease, Franziska C. Trudzinski, MD, from the University of Heidelberg (Germany), and colleagues reported.

(Note: Although the authors used the term “gender” to distinguish male from female, this news organization has used the term “sex” in this article to refer to biological attributes of individual patients rather than personal identity.)

“[Sex]-specific differences in COPD comprised not only differences in the level of symptoms, comorbidities, and functional alterations but also differences in their mutual relationships. This was reflected in different sets of predictors for cardiac disease,” they wrote in a thematic poster presented at the American Thoracic Society’s virtual international conference.
 

GOLD standard

The investigators conducted an analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease from the COSYCONET COPD cohort.

They looked at the patients’ clinical history, comorbidities, lung function, CAT scores, and modified Medical Research Council (mMRC) dyspnea score.

The authors used multivariate regression analysis to model potential sex-related differences in the relationship between symptoms in general and CAT items in particular, and the pattern of comorbidities and functional alterations.

They also performed logistic regression analyses to identify predictors for cardiac disease, defined as myocardial infarction, heart failure, or coronary artery disease. The analyses were controlled for age, body mass index (BMI), smoking status, mMRC, CAT items, and z scores of forced expiratory volume in 1 second/forced vital capacity ratio.

The investigators found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough (item 1), phlegm (item 2), and energy (item 8; P < .05 for all comparisons).

In logistic regression analysis, predictors for cardiac disease in men were energy (CAT item 8), mMRC score, smoking status, BMI, age, and spirometric lung function.

In women, however, only age was significantly predictive for cardiac disease.

“Our findings give hints how diagnostic information might be used differently in men and women,” Dr. Trudzinski and colleagues wrote.
 

Reassuring data

David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, said in an interview that sex differences in COPD presentation and severity are common.

“In general, men and women report symptoms differently. For example, women don’t report a whole lot of chronic bronchitis and phlegm, although they may have it,” he said, “whereas men may report less dyspnea. It varies, but in general we know that men and women, even with the same type of disease, report symptoms differently.”

Comorbidities also differ between the sexes, he noted. Women more frequently have osteoporosis, and men more frequently have heart disease, as borne out in the study. The prevalence of heart disease among patients in the study was approximately 2.5 times higher in men than women.

“It’s reassuring, because what we’re seeing is similar to what we’ve seen in other [studies] with regards to comorbidities,” he said.

The study was sponsored by Philipps University Marburg Medical Center, Germany. The authors and Dr. Mannino have reported no relevant financial relationships.

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

Sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with chronic obstructive pulmonary disease (COPD) may point to different criteria for diagnosing cardiac comorbidities in women and men, a retrospective analysis suggests.

Among 2,046 patients in the German COSYCONET (COPD and Systemic Consequences–Comorbidities Net) cohort, most functional parameters and comorbidities and several items on the COPD Assessment Test (CAT) differed significantly between men and women.

In addition, there were sex-specific differences in the association between symptoms and cardiac disease, Franziska C. Trudzinski, MD, from the University of Heidelberg (Germany), and colleagues reported.

(Note: Although the authors used the term “gender” to distinguish male from female, this news organization has used the term “sex” in this article to refer to biological attributes of individual patients rather than personal identity.)

“[Sex]-specific differences in COPD comprised not only differences in the level of symptoms, comorbidities, and functional alterations but also differences in their mutual relationships. This was reflected in different sets of predictors for cardiac disease,” they wrote in a thematic poster presented at the American Thoracic Society’s virtual international conference.
 

GOLD standard

The investigators conducted an analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease from the COSYCONET COPD cohort.

They looked at the patients’ clinical history, comorbidities, lung function, CAT scores, and modified Medical Research Council (mMRC) dyspnea score.

The authors used multivariate regression analysis to model potential sex-related differences in the relationship between symptoms in general and CAT items in particular, and the pattern of comorbidities and functional alterations.

They also performed logistic regression analyses to identify predictors for cardiac disease, defined as myocardial infarction, heart failure, or coronary artery disease. The analyses were controlled for age, body mass index (BMI), smoking status, mMRC, CAT items, and z scores of forced expiratory volume in 1 second/forced vital capacity ratio.

The investigators found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough (item 1), phlegm (item 2), and energy (item 8; P < .05 for all comparisons).

In logistic regression analysis, predictors for cardiac disease in men were energy (CAT item 8), mMRC score, smoking status, BMI, age, and spirometric lung function.

In women, however, only age was significantly predictive for cardiac disease.

“Our findings give hints how diagnostic information might be used differently in men and women,” Dr. Trudzinski and colleagues wrote.
 

Reassuring data

David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, said in an interview that sex differences in COPD presentation and severity are common.

“In general, men and women report symptoms differently. For example, women don’t report a whole lot of chronic bronchitis and phlegm, although they may have it,” he said, “whereas men may report less dyspnea. It varies, but in general we know that men and women, even with the same type of disease, report symptoms differently.”

Comorbidities also differ between the sexes, he noted. Women more frequently have osteoporosis, and men more frequently have heart disease, as borne out in the study. The prevalence of heart disease among patients in the study was approximately 2.5 times higher in men than women.

“It’s reassuring, because what we’re seeing is similar to what we’ve seen in other [studies] with regards to comorbidities,” he said.

The study was sponsored by Philipps University Marburg Medical Center, Germany. The authors and Dr. Mannino have reported no relevant financial relationships.

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

Sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with chronic obstructive pulmonary disease (COPD) may point to different criteria for diagnosing cardiac comorbidities in women and men, a retrospective analysis suggests.

Among 2,046 patients in the German COSYCONET (COPD and Systemic Consequences–Comorbidities Net) cohort, most functional parameters and comorbidities and several items on the COPD Assessment Test (CAT) differed significantly between men and women.

In addition, there were sex-specific differences in the association between symptoms and cardiac disease, Franziska C. Trudzinski, MD, from the University of Heidelberg (Germany), and colleagues reported.

(Note: Although the authors used the term “gender” to distinguish male from female, this news organization has used the term “sex” in this article to refer to biological attributes of individual patients rather than personal identity.)

“[Sex]-specific differences in COPD comprised not only differences in the level of symptoms, comorbidities, and functional alterations but also differences in their mutual relationships. This was reflected in different sets of predictors for cardiac disease,” they wrote in a thematic poster presented at the American Thoracic Society’s virtual international conference.
 

GOLD standard

The investigators conducted an analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease from the COSYCONET COPD cohort.

They looked at the patients’ clinical history, comorbidities, lung function, CAT scores, and modified Medical Research Council (mMRC) dyspnea score.

The authors used multivariate regression analysis to model potential sex-related differences in the relationship between symptoms in general and CAT items in particular, and the pattern of comorbidities and functional alterations.

They also performed logistic regression analyses to identify predictors for cardiac disease, defined as myocardial infarction, heart failure, or coronary artery disease. The analyses were controlled for age, body mass index (BMI), smoking status, mMRC, CAT items, and z scores of forced expiratory volume in 1 second/forced vital capacity ratio.

The investigators found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough (item 1), phlegm (item 2), and energy (item 8; P < .05 for all comparisons).

In logistic regression analysis, predictors for cardiac disease in men were energy (CAT item 8), mMRC score, smoking status, BMI, age, and spirometric lung function.

In women, however, only age was significantly predictive for cardiac disease.

“Our findings give hints how diagnostic information might be used differently in men and women,” Dr. Trudzinski and colleagues wrote.
 

Reassuring data

David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, said in an interview that sex differences in COPD presentation and severity are common.

“In general, men and women report symptoms differently. For example, women don’t report a whole lot of chronic bronchitis and phlegm, although they may have it,” he said, “whereas men may report less dyspnea. It varies, but in general we know that men and women, even with the same type of disease, report symptoms differently.”

Comorbidities also differ between the sexes, he noted. Women more frequently have osteoporosis, and men more frequently have heart disease, as borne out in the study. The prevalence of heart disease among patients in the study was approximately 2.5 times higher in men than women.

“It’s reassuring, because what we’re seeing is similar to what we’ve seen in other [studies] with regards to comorbidities,” he said.

The study was sponsored by Philipps University Marburg Medical Center, Germany. The authors and Dr. Mannino have reported no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

Infectious disease physicians are among the doctors carrying the largest burdens in the COVID-19 pandemic.

Perhaps not surprisingly, they were the specialists least likely to feel they were fairly compensated in the Medscape Infectious Diseases Physician Compensation Report 2021.

Only 44% said the pay was fair (down from 51% the prior year) compared with those at the high end – 79% in oncology, 69% in psychiatry, and 68% in plastic surgery who answered that way.

Income, which averaged $245,000, varied little from the previous year overall, according to the survey, but nearly one-third of ID physicians saw a decline in pay.

Again this year, ID physicians ranked near the bottom on the compensation spectrum. Pediatricians were lowest paid at $221,000. Plastic surgeons topped the chart at $526,000, followed by orthopedists at $511,000.

At the same time, the ID specialty is facing increasing shortages, a gap made even more visible in the pandemic. Medscape reported last year that nearly 80% of U.S. counties have no infectious disease specialists.

Thomas File Jr., MD, last year’s president of the Infectious Diseases Society of America, emphasized that COVID-19 is not the only threat that ID specialists have had to deal with or will have. He cited the threats that Zika and SARS posed in past years.

“COVID-19 illustrates the need for more trained ID specialists, because we know we’re going to be seeing more outbreaks in the future,” he said in an interview at the onset of the pandemic in March 2020.
 

Longer hours in pandemic

ID physicians’ hours generally increased during the pandemic, and they remain inflated by 8 hours per week (60 compared with 52 prepandemic) as the nation struggles to manage continuing COVID-19 infections. Physicians in critical care and public health and preventive medicine are seeing heavier workloads as well, by an average of 6-7 hours per week.

At the same time, ID physicians spent the most time of physicians in all specialties on paperwork and administrative tasks. Those tasks, which include electronic health record entry and clinical reading, took ID doctors 24.2 hours a week, more the twice the hours spent by those in anesthesiology (10.1), ophthalmology (10.3), and radiology (11.6).

The 24.2 hours was a substantial increase from the last report, when ID physicians said they spent 18.5 hours on the tasks.

The survey asked about the most challenging part of the job. ID physicians reported “long hours” as number one followed by “having so many rules and regulations.”

Only 4% said the danger or risk associated with treating COVID-19 patients was the most challenging part.

The top two aspects of their work they deemed most rewarding were “being very good at what I do” (chosen by 33%) and “knowing that I’m making the world a better place” (31%).
 

Patient volume up 17%

ID physicians reported seeing 78 patients per week in this report compared with 66 prepandemic, a 17% increase. Conversely, pediatricians saw an 18% drop in patient visits, followed by dermatologists, orthopedists and otolaryngologists (all down about 15%).

Despite the challenges and dissatisfaction with pay, the great majority of  ID physicians said they would choose both medicine (83%) and their specialty (89%, up from 85% last year) again.
 

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

Infectious disease physicians are among the doctors carrying the largest burdens in the COVID-19 pandemic.

Perhaps not surprisingly, they were the specialists least likely to feel they were fairly compensated in the Medscape Infectious Diseases Physician Compensation Report 2021.

Only 44% said the pay was fair (down from 51% the prior year) compared with those at the high end – 79% in oncology, 69% in psychiatry, and 68% in plastic surgery who answered that way.

Income, which averaged $245,000, varied little from the previous year overall, according to the survey, but nearly one-third of ID physicians saw a decline in pay.

Again this year, ID physicians ranked near the bottom on the compensation spectrum. Pediatricians were lowest paid at $221,000. Plastic surgeons topped the chart at $526,000, followed by orthopedists at $511,000.

At the same time, the ID specialty is facing increasing shortages, a gap made even more visible in the pandemic. Medscape reported last year that nearly 80% of U.S. counties have no infectious disease specialists.

Thomas File Jr., MD, last year’s president of the Infectious Diseases Society of America, emphasized that COVID-19 is not the only threat that ID specialists have had to deal with or will have. He cited the threats that Zika and SARS posed in past years.

“COVID-19 illustrates the need for more trained ID specialists, because we know we’re going to be seeing more outbreaks in the future,” he said in an interview at the onset of the pandemic in March 2020.
 

Longer hours in pandemic

ID physicians’ hours generally increased during the pandemic, and they remain inflated by 8 hours per week (60 compared with 52 prepandemic) as the nation struggles to manage continuing COVID-19 infections. Physicians in critical care and public health and preventive medicine are seeing heavier workloads as well, by an average of 6-7 hours per week.

At the same time, ID physicians spent the most time of physicians in all specialties on paperwork and administrative tasks. Those tasks, which include electronic health record entry and clinical reading, took ID doctors 24.2 hours a week, more the twice the hours spent by those in anesthesiology (10.1), ophthalmology (10.3), and radiology (11.6).

The 24.2 hours was a substantial increase from the last report, when ID physicians said they spent 18.5 hours on the tasks.

The survey asked about the most challenging part of the job. ID physicians reported “long hours” as number one followed by “having so many rules and regulations.”

Only 4% said the danger or risk associated with treating COVID-19 patients was the most challenging part.

The top two aspects of their work they deemed most rewarding were “being very good at what I do” (chosen by 33%) and “knowing that I’m making the world a better place” (31%).
 

Patient volume up 17%

ID physicians reported seeing 78 patients per week in this report compared with 66 prepandemic, a 17% increase. Conversely, pediatricians saw an 18% drop in patient visits, followed by dermatologists, orthopedists and otolaryngologists (all down about 15%).

Despite the challenges and dissatisfaction with pay, the great majority of  ID physicians said they would choose both medicine (83%) and their specialty (89%, up from 85% last year) again.
 

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

Infectious disease physicians are among the doctors carrying the largest burdens in the COVID-19 pandemic.

Perhaps not surprisingly, they were the specialists least likely to feel they were fairly compensated in the Medscape Infectious Diseases Physician Compensation Report 2021.

Only 44% said the pay was fair (down from 51% the prior year) compared with those at the high end – 79% in oncology, 69% in psychiatry, and 68% in plastic surgery who answered that way.

Income, which averaged $245,000, varied little from the previous year overall, according to the survey, but nearly one-third of ID physicians saw a decline in pay.

Again this year, ID physicians ranked near the bottom on the compensation spectrum. Pediatricians were lowest paid at $221,000. Plastic surgeons topped the chart at $526,000, followed by orthopedists at $511,000.

At the same time, the ID specialty is facing increasing shortages, a gap made even more visible in the pandemic. Medscape reported last year that nearly 80% of U.S. counties have no infectious disease specialists.

Thomas File Jr., MD, last year’s president of the Infectious Diseases Society of America, emphasized that COVID-19 is not the only threat that ID specialists have had to deal with or will have. He cited the threats that Zika and SARS posed in past years.

“COVID-19 illustrates the need for more trained ID specialists, because we know we’re going to be seeing more outbreaks in the future,” he said in an interview at the onset of the pandemic in March 2020.
 

Longer hours in pandemic

ID physicians’ hours generally increased during the pandemic, and they remain inflated by 8 hours per week (60 compared with 52 prepandemic) as the nation struggles to manage continuing COVID-19 infections. Physicians in critical care and public health and preventive medicine are seeing heavier workloads as well, by an average of 6-7 hours per week.

At the same time, ID physicians spent the most time of physicians in all specialties on paperwork and administrative tasks. Those tasks, which include electronic health record entry and clinical reading, took ID doctors 24.2 hours a week, more the twice the hours spent by those in anesthesiology (10.1), ophthalmology (10.3), and radiology (11.6).

The 24.2 hours was a substantial increase from the last report, when ID physicians said they spent 18.5 hours on the tasks.

The survey asked about the most challenging part of the job. ID physicians reported “long hours” as number one followed by “having so many rules and regulations.”

Only 4% said the danger or risk associated with treating COVID-19 patients was the most challenging part.

The top two aspects of their work they deemed most rewarding were “being very good at what I do” (chosen by 33%) and “knowing that I’m making the world a better place” (31%).
 

Patient volume up 17%

ID physicians reported seeing 78 patients per week in this report compared with 66 prepandemic, a 17% increase. Conversely, pediatricians saw an 18% drop in patient visits, followed by dermatologists, orthopedists and otolaryngologists (all down about 15%).

Despite the challenges and dissatisfaction with pay, the great majority of  ID physicians said they would choose both medicine (83%) and their specialty (89%, up from 85% last year) again.
 

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

GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.

AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.

“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
 

The trouble with using risk scores

A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.

“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.

He pointed out that low implementation may also stem from poorly defined clinical responsibilities.

“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”

To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.

Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
 

Google Maps for GI bleeding

“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”

In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.

Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.

“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
 

The road to clinical implementation

With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.

In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.

“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”

In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.

“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”

The investigators disclosed no relevant conflicts of interest.

GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.

AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.

“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
 

The trouble with using risk scores

A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.

“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.

He pointed out that low implementation may also stem from poorly defined clinical responsibilities.

“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”

To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.

Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
 

Google Maps for GI bleeding

“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”

In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.

Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.

“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
 

The road to clinical implementation

With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.

In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.

“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”

In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.

“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”

The investigators disclosed no relevant conflicts of interest.

GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.

AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.

“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
 

The trouble with using risk scores

A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.

“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.

He pointed out that low implementation may also stem from poorly defined clinical responsibilities.

“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”

To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.

Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
 

Google Maps for GI bleeding

“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”

In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.

Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.

“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
 

The road to clinical implementation

With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.

In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.

“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”

In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.

“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”

The investigators disclosed no relevant conflicts of interest.

The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.

The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.

The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .

The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.

“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.

“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.

“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
 

Road map to improve diversity, achieve allyship

The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.

The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.

The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.

It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.

The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.

“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.

“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.

The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.

It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.

The report also highlights additional opportunities to:

• improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
• identify and assist clinicians who experience mental health conditions, , or 
• emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
• increase privacy protections for patient data used in research
• maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
• perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
• expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry

The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.

The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.

This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.

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

The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.

The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.

The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .

The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.

“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.

“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.

“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
 

Road map to improve diversity, achieve allyship

The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.

The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.

The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.

It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.

The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.

“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.

“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.

The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.

It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.

The report also highlights additional opportunities to:

• improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
• identify and assist clinicians who experience mental health conditions, , or 
• emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
• increase privacy protections for patient data used in research
• maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
• perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
• expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry

The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.

The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.

This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.

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

The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.

The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.

The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .

The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.

“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.

“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.

“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
 

Road map to improve diversity, achieve allyship

The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.

The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.

The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.

It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.

The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.

“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.

“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.

The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.

It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.

The report also highlights additional opportunities to:

• improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
• identify and assist clinicians who experience mental health conditions, , or 
• emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
• increase privacy protections for patient data used in research
• maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
• perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
• expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry

The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.

The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.

This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.

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

The health disparities seen in today’s high rates of Black infant and maternal morbidity and mortality are rooted in health inequities and generational stress dating back centuries in the United States, but today’s obstetricians can make changes in their own practices to address this inequity, according to Haywood L. Brown, MD, professor of ob.gyn. and associate dean of diversity at the Morsani College of Medicine and vice president of institutional equity at the University of South Florida, Tampa.

Dr. Brown delivered his remarks during the Benson and Pamela Harer Seminar on History at the annual meeting of the American College of Obstetricians and Gynecologists on May 2. His talk focused on the origins of perinatal and maternal health inequities and how those original factors play out today in increased maternal and neonatal morbidity and mortality among Black women and their babies.

“Racial and ethnic disparities and inequity in maternal and child health are prevalent and persistent. We have to move beyond the documentation,” Dr. Brown told attendees. “We have to adopt uniform care standards, recognizing our own biases and understanding that the contribution of social determinants of health are important in the care and outcome of women. And we have to work on decreasing the stress of women who give birth.”

Evelyn Nicole Mitchell, MD, faculty chair of the ob.gyn. diversity and inclusion committee at the University of Southern California, found Dr. Brown’s talk compelling and hopes it opens the eyes of others who attended.

“You really have to understand the why behind the problems we have, and it really goes back to slavery and this historical distrust that’s been here from the beginning,” Dr. Mitchell said in an interview. “I hope this allows people to open their eyes and think about this situation from their patients’ shoes, to really put their guard down and explore, ‘how can I contribute to fixing this system that has been here from the beginning?’ I think a lot of people get defensive and think: ‘Oh, I’m not a racist. I just don’t want to talk about this,’ but it’s about a system being racist.” The question then, Dr. Mitchell said, is: “So how do I contribute to that system?”

Dr. Brown frequently returned to the theme of high stress levels in Black mothers contributing to poorer outcomes, such as preterm birth. That stress arises originally from the generational stress brought on by racism and oppression over the centuries but has been compounded by poverty, racial injustice, lack of access to adequate nutrition, lower education levels, environmental factors, and other determinants of health.

“The bottom line, as Dr. Brown said, is that we need to decrease the stress level of Black mothers giving birth,” Dr. Mitchell said. “How can I, as a provider, decrease the stress level of my patients? Well, No. 1, I can identify and eliminate implicit bias that I may harbor.”
 

Slavery husbandry laid the groundwork for today

The most surprising aspect of Dr. Brown’s lecture for Dr. Mitchell was the fact that enslaved women received a measure of protection that other enslaved people did not to “ensure that they were healthy and that they were able to reproduce in the future,” Dr. Mitchell said. “It was for the wrong reasons – to keep slavery going – but in a sense they were prioritizing Black women to take advantage of their reproductive capacity, compared to nowadays where Black women are facing severe disparities.”

To safeguard enslaved women’s fecundity, plantation owners attempted to reduce stressors in the women’s lives, such as allowing them to cohabitate with a husband and nuclear family, though sexual assault and abuse still occurred. The owners also tracked the enslaved girls’ menstrual cycles after menarche to maximize their “breeding” potential, especially between the ages of 15 and 24. Slave owners delegated older enslaved women as maternity caregivers and midwives, leading to the passing down of midwifery skills through generations of Black American women.

“Pregnant women received the best medical care on the plantation because of the premium placed on reproduction,” Dr. Brown said. Wealthier planters called in doctors for complicated deliveries, which provided J. Marian Sims the ability conduct surgical experiments on Betsey, Lucy, and Anarcha to treat vesicovaginal fistula since fistula “limited her ability to do the maximum work she could in the house or on the plantation,” Dr. Brown said.

After slavery ended, health care access did not improve for Black people. In 1920, there was approximately 1 Black physician for every 3,000 Black people, compared with 1 in 500 for the White population, and grannie midwives continued to be the primary birthing attendants for Black women. Over the next several decades, however, both maternal and infant mortality across all races began steeply dropping. Reasons for the drop included the incorporation of the American Board of Obstetrics and Gynecology in 1930, a shift from home births to hospital births, and the legalization of abortion, which led to an 89% decline in deaths from septic illegal abortions from 1950 to 1973.

Still, Black maternal and infant mortality remained higher than White, and the poverty gap further exacerbated outcomes.

“Substandard maternity care really is the origin of many of the Black maternal and infant morbidity and mortality” complications, such as low birth weight, small for gestational age, growth restriction, and intrauterine starvation, “which we now believe are the origin of things like hypertension, diabetes, and obesity,” Dr. Brown said.

Today, inequities persist because of the systemic racism throughout this history.

“As we talk about health disparities, prematurity, growth restriction, and maternal morbidity, the fetal origins for adult disease in diabetes and hypertension and obesity have generational implications over the last 400 years,” Dr. Brown said. “Generational stress and stresses in lack women from slavery to present times are some of the origins of the things that we see today, including segregation, economic inequities, eugenic sterilizations, the quality of education, and of course, systemic racism on health care access and quality.”

It is this long arc of history that Dr. Mitchell hopes attendees will begin to grasp.

“If you don’t understand all that and have that depth, there’s no way for you to truly understand the problems that are going on and how to solve them,” Dr. Mitchell said. She hopes that especially those who have been more “resistant to accepting these truths” can start to see the big picture. “Hopefully, they can look at it as a systemic problem and then focus on how they can change the system.”

Dr Brown is a contributor to UpToDate and the Merck Manual and serves on the advisory boards of Merck for Mothers Global Women’s Health and BabyScripts. Dr. Mitchell has no disclosures.

The health disparities seen in today’s high rates of Black infant and maternal morbidity and mortality are rooted in health inequities and generational stress dating back centuries in the United States, but today’s obstetricians can make changes in their own practices to address this inequity, according to Haywood L. Brown, MD, professor of ob.gyn. and associate dean of diversity at the Morsani College of Medicine and vice president of institutional equity at the University of South Florida, Tampa.

Dr. Brown delivered his remarks during the Benson and Pamela Harer Seminar on History at the annual meeting of the American College of Obstetricians and Gynecologists on May 2. His talk focused on the origins of perinatal and maternal health inequities and how those original factors play out today in increased maternal and neonatal morbidity and mortality among Black women and their babies.

“Racial and ethnic disparities and inequity in maternal and child health are prevalent and persistent. We have to move beyond the documentation,” Dr. Brown told attendees. “We have to adopt uniform care standards, recognizing our own biases and understanding that the contribution of social determinants of health are important in the care and outcome of women. And we have to work on decreasing the stress of women who give birth.”

Evelyn Nicole Mitchell, MD, faculty chair of the ob.gyn. diversity and inclusion committee at the University of Southern California, found Dr. Brown’s talk compelling and hopes it opens the eyes of others who attended.

“You really have to understand the why behind the problems we have, and it really goes back to slavery and this historical distrust that’s been here from the beginning,” Dr. Mitchell said in an interview. “I hope this allows people to open their eyes and think about this situation from their patients’ shoes, to really put their guard down and explore, ‘how can I contribute to fixing this system that has been here from the beginning?’ I think a lot of people get defensive and think: ‘Oh, I’m not a racist. I just don’t want to talk about this,’ but it’s about a system being racist.” The question then, Dr. Mitchell said, is: “So how do I contribute to that system?”

Dr. Brown frequently returned to the theme of high stress levels in Black mothers contributing to poorer outcomes, such as preterm birth. That stress arises originally from the generational stress brought on by racism and oppression over the centuries but has been compounded by poverty, racial injustice, lack of access to adequate nutrition, lower education levels, environmental factors, and other determinants of health.

“The bottom line, as Dr. Brown said, is that we need to decrease the stress level of Black mothers giving birth,” Dr. Mitchell said. “How can I, as a provider, decrease the stress level of my patients? Well, No. 1, I can identify and eliminate implicit bias that I may harbor.”
 

Slavery husbandry laid the groundwork for today

The most surprising aspect of Dr. Brown’s lecture for Dr. Mitchell was the fact that enslaved women received a measure of protection that other enslaved people did not to “ensure that they were healthy and that they were able to reproduce in the future,” Dr. Mitchell said. “It was for the wrong reasons – to keep slavery going – but in a sense they were prioritizing Black women to take advantage of their reproductive capacity, compared to nowadays where Black women are facing severe disparities.”

To safeguard enslaved women’s fecundity, plantation owners attempted to reduce stressors in the women’s lives, such as allowing them to cohabitate with a husband and nuclear family, though sexual assault and abuse still occurred. The owners also tracked the enslaved girls’ menstrual cycles after menarche to maximize their “breeding” potential, especially between the ages of 15 and 24. Slave owners delegated older enslaved women as maternity caregivers and midwives, leading to the passing down of midwifery skills through generations of Black American women.

“Pregnant women received the best medical care on the plantation because of the premium placed on reproduction,” Dr. Brown said. Wealthier planters called in doctors for complicated deliveries, which provided J. Marian Sims the ability conduct surgical experiments on Betsey, Lucy, and Anarcha to treat vesicovaginal fistula since fistula “limited her ability to do the maximum work she could in the house or on the plantation,” Dr. Brown said.

After slavery ended, health care access did not improve for Black people. In 1920, there was approximately 1 Black physician for every 3,000 Black people, compared with 1 in 500 for the White population, and grannie midwives continued to be the primary birthing attendants for Black women. Over the next several decades, however, both maternal and infant mortality across all races began steeply dropping. Reasons for the drop included the incorporation of the American Board of Obstetrics and Gynecology in 1930, a shift from home births to hospital births, and the legalization of abortion, which led to an 89% decline in deaths from septic illegal abortions from 1950 to 1973.

Still, Black maternal and infant mortality remained higher than White, and the poverty gap further exacerbated outcomes.

“Substandard maternity care really is the origin of many of the Black maternal and infant morbidity and mortality” complications, such as low birth weight, small for gestational age, growth restriction, and intrauterine starvation, “which we now believe are the origin of things like hypertension, diabetes, and obesity,” Dr. Brown said.

Today, inequities persist because of the systemic racism throughout this history.

“As we talk about health disparities, prematurity, growth restriction, and maternal morbidity, the fetal origins for adult disease in diabetes and hypertension and obesity have generational implications over the last 400 years,” Dr. Brown said. “Generational stress and stresses in lack women from slavery to present times are some of the origins of the things that we see today, including segregation, economic inequities, eugenic sterilizations, the quality of education, and of course, systemic racism on health care access and quality.”

It is this long arc of history that Dr. Mitchell hopes attendees will begin to grasp.

“If you don’t understand all that and have that depth, there’s no way for you to truly understand the problems that are going on and how to solve them,” Dr. Mitchell said. She hopes that especially those who have been more “resistant to accepting these truths” can start to see the big picture. “Hopefully, they can look at it as a systemic problem and then focus on how they can change the system.”

Dr Brown is a contributor to UpToDate and the Merck Manual and serves on the advisory boards of Merck for Mothers Global Women’s Health and BabyScripts. Dr. Mitchell has no disclosures.

The health disparities seen in today’s high rates of Black infant and maternal morbidity and mortality are rooted in health inequities and generational stress dating back centuries in the United States, but today’s obstetricians can make changes in their own practices to address this inequity, according to Haywood L. Brown, MD, professor of ob.gyn. and associate dean of diversity at the Morsani College of Medicine and vice president of institutional equity at the University of South Florida, Tampa.

Dr. Brown delivered his remarks during the Benson and Pamela Harer Seminar on History at the annual meeting of the American College of Obstetricians and Gynecologists on May 2. His talk focused on the origins of perinatal and maternal health inequities and how those original factors play out today in increased maternal and neonatal morbidity and mortality among Black women and their babies.

“Racial and ethnic disparities and inequity in maternal and child health are prevalent and persistent. We have to move beyond the documentation,” Dr. Brown told attendees. “We have to adopt uniform care standards, recognizing our own biases and understanding that the contribution of social determinants of health are important in the care and outcome of women. And we have to work on decreasing the stress of women who give birth.”

Evelyn Nicole Mitchell, MD, faculty chair of the ob.gyn. diversity and inclusion committee at the University of Southern California, found Dr. Brown’s talk compelling and hopes it opens the eyes of others who attended.

“You really have to understand the why behind the problems we have, and it really goes back to slavery and this historical distrust that’s been here from the beginning,” Dr. Mitchell said in an interview. “I hope this allows people to open their eyes and think about this situation from their patients’ shoes, to really put their guard down and explore, ‘how can I contribute to fixing this system that has been here from the beginning?’ I think a lot of people get defensive and think: ‘Oh, I’m not a racist. I just don’t want to talk about this,’ but it’s about a system being racist.” The question then, Dr. Mitchell said, is: “So how do I contribute to that system?”

Dr. Brown frequently returned to the theme of high stress levels in Black mothers contributing to poorer outcomes, such as preterm birth. That stress arises originally from the generational stress brought on by racism and oppression over the centuries but has been compounded by poverty, racial injustice, lack of access to adequate nutrition, lower education levels, environmental factors, and other determinants of health.

“The bottom line, as Dr. Brown said, is that we need to decrease the stress level of Black mothers giving birth,” Dr. Mitchell said. “How can I, as a provider, decrease the stress level of my patients? Well, No. 1, I can identify and eliminate implicit bias that I may harbor.”
 

Slavery husbandry laid the groundwork for today

The most surprising aspect of Dr. Brown’s lecture for Dr. Mitchell was the fact that enslaved women received a measure of protection that other enslaved people did not to “ensure that they were healthy and that they were able to reproduce in the future,” Dr. Mitchell said. “It was for the wrong reasons – to keep slavery going – but in a sense they were prioritizing Black women to take advantage of their reproductive capacity, compared to nowadays where Black women are facing severe disparities.”

To safeguard enslaved women’s fecundity, plantation owners attempted to reduce stressors in the women’s lives, such as allowing them to cohabitate with a husband and nuclear family, though sexual assault and abuse still occurred. The owners also tracked the enslaved girls’ menstrual cycles after menarche to maximize their “breeding” potential, especially between the ages of 15 and 24. Slave owners delegated older enslaved women as maternity caregivers and midwives, leading to the passing down of midwifery skills through generations of Black American women.

“Pregnant women received the best medical care on the plantation because of the premium placed on reproduction,” Dr. Brown said. Wealthier planters called in doctors for complicated deliveries, which provided J. Marian Sims the ability conduct surgical experiments on Betsey, Lucy, and Anarcha to treat vesicovaginal fistula since fistula “limited her ability to do the maximum work she could in the house or on the plantation,” Dr. Brown said.

After slavery ended, health care access did not improve for Black people. In 1920, there was approximately 1 Black physician for every 3,000 Black people, compared with 1 in 500 for the White population, and grannie midwives continued to be the primary birthing attendants for Black women. Over the next several decades, however, both maternal and infant mortality across all races began steeply dropping. Reasons for the drop included the incorporation of the American Board of Obstetrics and Gynecology in 1930, a shift from home births to hospital births, and the legalization of abortion, which led to an 89% decline in deaths from septic illegal abortions from 1950 to 1973.

Still, Black maternal and infant mortality remained higher than White, and the poverty gap further exacerbated outcomes.

“Substandard maternity care really is the origin of many of the Black maternal and infant morbidity and mortality” complications, such as low birth weight, small for gestational age, growth restriction, and intrauterine starvation, “which we now believe are the origin of things like hypertension, diabetes, and obesity,” Dr. Brown said.

Today, inequities persist because of the systemic racism throughout this history.

“As we talk about health disparities, prematurity, growth restriction, and maternal morbidity, the fetal origins for adult disease in diabetes and hypertension and obesity have generational implications over the last 400 years,” Dr. Brown said. “Generational stress and stresses in lack women from slavery to present times are some of the origins of the things that we see today, including segregation, economic inequities, eugenic sterilizations, the quality of education, and of course, systemic racism on health care access and quality.”

It is this long arc of history that Dr. Mitchell hopes attendees will begin to grasp.

“If you don’t understand all that and have that depth, there’s no way for you to truly understand the problems that are going on and how to solve them,” Dr. Mitchell said. She hopes that especially those who have been more “resistant to accepting these truths” can start to see the big picture. “Hopefully, they can look at it as a systemic problem and then focus on how they can change the system.”

Dr Brown is a contributor to UpToDate and the Merck Manual and serves on the advisory boards of Merck for Mothers Global Women’s Health and BabyScripts. Dr. Mitchell has no disclosures.

Just 1 week after it looked like the COVID-19 situation in children might be taking another turn for the worse, the number of new pediatric cases dropped to its lowest level since October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The week of May 7-13 saw just under 49,000 new cases reported in U.S. children, down from 72,000 the week before and the lowest number recorded since the week of Oct. 9-15, 2020, the AAP and CHA said in their weekly COVID-19 report. During the week of April 30 to May 6 – the same week Rhode Island reported a large backlog of cases and increased its total by 30% – the number of new cases went up slightly after 2 weeks of declines.

Other positive indicators come in the form of the proportion of cases occurring in children. The cumulative percentage of cases in children since the start of the pandemic remained at 14.0% for a second consecutive week, and the proportion of new cases in children held at 24.0% and did not increase for the first time in 6 weeks, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The total number of child COVID-19 cases reported in these jurisdictions is now up to 3.9 million, for a cumulative rate of 5,187 cases per 100,000 children in the United States. Among the states, total counts range from a low of 4,070 in Hawaii to 475,619 in California. Hawaii also has the lowest rate at 1,357 per 100,000 children, while the highest, 9,778 per 100,000, can be found in Rhode Island, the AAP and CHA said.

Deaths in children continue to accumulate at a relatively slow pace, with two more added during the week of May 7-13, bringing the total to 308 for the entire pandemic in 43 states, New York City, Puerto Rico, and Guam. Children’s share of the mortality burden is currently 0.06%, a figure that has not changed since mid-December, and the death rate for children with COVID-19 is 0.01%, according to the report.

Almost two-thirds (65%) of all deaths have occurred in just nine states – Arizona (31), California (21), Colorado (13), Georgia (10), Illinois (18), Maryland (10), Pennsylvania (10), Tennessee (10), and Texas (52) – and New York City (24), while eight states have not reported any deaths yet, the two groups said.

rfranki@mdedge.com

Just 1 week after it looked like the COVID-19 situation in children might be taking another turn for the worse, the number of new pediatric cases dropped to its lowest level since October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The week of May 7-13 saw just under 49,000 new cases reported in U.S. children, down from 72,000 the week before and the lowest number recorded since the week of Oct. 9-15, 2020, the AAP and CHA said in their weekly COVID-19 report. During the week of April 30 to May 6 – the same week Rhode Island reported a large backlog of cases and increased its total by 30% – the number of new cases went up slightly after 2 weeks of declines.

Other positive indicators come in the form of the proportion of cases occurring in children. The cumulative percentage of cases in children since the start of the pandemic remained at 14.0% for a second consecutive week, and the proportion of new cases in children held at 24.0% and did not increase for the first time in 6 weeks, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The total number of child COVID-19 cases reported in these jurisdictions is now up to 3.9 million, for a cumulative rate of 5,187 cases per 100,000 children in the United States. Among the states, total counts range from a low of 4,070 in Hawaii to 475,619 in California. Hawaii also has the lowest rate at 1,357 per 100,000 children, while the highest, 9,778 per 100,000, can be found in Rhode Island, the AAP and CHA said.

Deaths in children continue to accumulate at a relatively slow pace, with two more added during the week of May 7-13, bringing the total to 308 for the entire pandemic in 43 states, New York City, Puerto Rico, and Guam. Children’s share of the mortality burden is currently 0.06%, a figure that has not changed since mid-December, and the death rate for children with COVID-19 is 0.01%, according to the report.

Almost two-thirds (65%) of all deaths have occurred in just nine states – Arizona (31), California (21), Colorado (13), Georgia (10), Illinois (18), Maryland (10), Pennsylvania (10), Tennessee (10), and Texas (52) – and New York City (24), while eight states have not reported any deaths yet, the two groups said.

rfranki@mdedge.com

Just 1 week after it looked like the COVID-19 situation in children might be taking another turn for the worse, the number of new pediatric cases dropped to its lowest level since October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The week of May 7-13 saw just under 49,000 new cases reported in U.S. children, down from 72,000 the week before and the lowest number recorded since the week of Oct. 9-15, 2020, the AAP and CHA said in their weekly COVID-19 report. During the week of April 30 to May 6 – the same week Rhode Island reported a large backlog of cases and increased its total by 30% – the number of new cases went up slightly after 2 weeks of declines.

Other positive indicators come in the form of the proportion of cases occurring in children. The cumulative percentage of cases in children since the start of the pandemic remained at 14.0% for a second consecutive week, and the proportion of new cases in children held at 24.0% and did not increase for the first time in 6 weeks, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The total number of child COVID-19 cases reported in these jurisdictions is now up to 3.9 million, for a cumulative rate of 5,187 cases per 100,000 children in the United States. Among the states, total counts range from a low of 4,070 in Hawaii to 475,619 in California. Hawaii also has the lowest rate at 1,357 per 100,000 children, while the highest, 9,778 per 100,000, can be found in Rhode Island, the AAP and CHA said.

Deaths in children continue to accumulate at a relatively slow pace, with two more added during the week of May 7-13, bringing the total to 308 for the entire pandemic in 43 states, New York City, Puerto Rico, and Guam. Children’s share of the mortality burden is currently 0.06%, a figure that has not changed since mid-December, and the death rate for children with COVID-19 is 0.01%, according to the report.

Almost two-thirds (65%) of all deaths have occurred in just nine states – Arizona (31), California (21), Colorado (13), Georgia (10), Illinois (18), Maryland (10), Pennsylvania (10), Tennessee (10), and Texas (52) – and New York City (24), while eight states have not reported any deaths yet, the two groups said.

rfranki@mdedge.com