Pulmonology

It’s back to school time, and some may be wondering what the current availability of vaccines may mean and the effects of the ever-changing COVID-19 guidelines on their children’s education and day-to-day experiences as students this year.

Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.

The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.

The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.

As older children may be heading to college, it is important

to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.

Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
 

Monkeypox

We now have a new health concern for this school year.

Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.

Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:

• sexual activity with those with lesions consistent with monkeypox;
• sharing eating and drinking utensils; and
• sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.

Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.

Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.

At the time of this article, CDC guidance recommends the vaccine against monkeypox for:

• those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
• those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
• those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
• those whose jobs may expose them to monkeypox.

Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.

Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.

Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.

As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.

Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

It’s back to school time, and some may be wondering what the current availability of vaccines may mean and the effects of the ever-changing COVID-19 guidelines on their children’s education and day-to-day experiences as students this year.

Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.

The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.

The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.

As older children may be heading to college, it is important

to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.

Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
 

Monkeypox

We now have a new health concern for this school year.

Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.

Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:

• sexual activity with those with lesions consistent with monkeypox;
• sharing eating and drinking utensils; and
• sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.

Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.

Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.

At the time of this article, CDC guidance recommends the vaccine against monkeypox for:

• those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
• those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
• those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
• those whose jobs may expose them to monkeypox.

Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.

Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.

Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.

As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.

Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

It’s back to school time, and some may be wondering what the current availability of vaccines may mean and the effects of the ever-changing COVID-19 guidelines on their children’s education and day-to-day experiences as students this year.

Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.

The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.

The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.

As older children may be heading to college, it is important

to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.

Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
 

Monkeypox

We now have a new health concern for this school year.

Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.

Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:

• sexual activity with those with lesions consistent with monkeypox;
• sharing eating and drinking utensils; and
• sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.

Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.

Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.

At the time of this article, CDC guidance recommends the vaccine against monkeypox for:

• those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
• those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
• those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
• those whose jobs may expose them to monkeypox.

Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.

Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.

Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.

As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.

Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

Adults who quit smoking significantly reduced their risk for mortality from pneumonia; the risk decreased even more with added years of not smoking, according to data from nearly 95,000 individuals.

Smoking is associated with an increased risk for pneumonia, but the extent to which smoking cessation reduces this risk long-term has not been explored, wrote Tomomi Kihara, MD, PhD, of the University of Tsukuba, Japan, and colleagues on behalf of the Japan Collaborative Cohort.

In the Japan Collaborative Cohort Study for Evaluation of Cancer Risk, known as the JACC Study, a community-based cohort of 110,585 individuals aged 40-79 years participated in health screening exams and self-administered questionnaires that included information about smoking. Other findings from the study have been previously published.

In the current study published in Preventive Medicine, the researchers reviewed data from 94,972 JACC participants who provided data about smoking status, including 59,514 never-smokers, 10,554 former smokers, and 24,904 current smokers. The mean age of the participants was 57 years; 57% were women.

The respondents were divided into groups based on years of smoking cessation: 0-1 year, 2-4 years, 5-9 years, 10-14 years, and 15 or more years. The primary endpoint was an underlying cause of death from pneumonia.

Over a median follow-up period of 19 years, 1,806 participants (1,115 men and 691 women) died of pneumonia.

In a multivariate analysis, the hazard ratio for those who quit smoking, compared with current smokers, was 1.02 for 0-1 year of smoking cessation, 0.92 for 2-4 years, 0.95 for 5-9 years, 0.71 for 10-14 years, and 0.63 (0.48-0.83) for 15 or more years. The HR for never smokers was 0.50. The analysis adjusted for competing risk for death without pneumonia in the study population.

Most of the benefits of smoking cessation occurred after 10-14 years, the researchers wrote in their discussion of the findings, and smoking cessation of 10 years or more resulted in risk for death from pneumonia similar to that of never-smokers.

“To our knowledge, no previous studies have examined the association between years of smoking cessation and pneumonia in a general population,” they added.

The study findings were limited by several factors, including the use of data on smoking and smoking cessation at baseline as well as a lack of data on the use of tobacco products other than cigarettes, although alternative tobacco products are rarely used in Japan, the researchers noted. Other limitations include the use of pneumonia mortality as an endpoint, which could have ignored the impact of smoking cessation on less severe pneumonia, and the inability to clarify the association between smoking cessation and pneumonia mortality by sex because of the small number of female former smokers. However, the results were strengthened by the large sample size and long observation period, they said.

“The present study provides empirical evidence that smoking cessation may lead to a decline in the risk of mortality from pneumonia,” and supports smoking cessation as a preventive measure, the researchers concluded.

The study was supported by the Japanese Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare, Health and Labor Sciences; and an Intramural Research Fund for Cardiovascular Diseases of National Cerebral and Cardiovascular Center. The researchers had no financial conflicts to disclose.

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

Adults who quit smoking significantly reduced their risk for mortality from pneumonia; the risk decreased even more with added years of not smoking, according to data from nearly 95,000 individuals.

Smoking is associated with an increased risk for pneumonia, but the extent to which smoking cessation reduces this risk long-term has not been explored, wrote Tomomi Kihara, MD, PhD, of the University of Tsukuba, Japan, and colleagues on behalf of the Japan Collaborative Cohort.

In the Japan Collaborative Cohort Study for Evaluation of Cancer Risk, known as the JACC Study, a community-based cohort of 110,585 individuals aged 40-79 years participated in health screening exams and self-administered questionnaires that included information about smoking. Other findings from the study have been previously published.

In the current study published in Preventive Medicine, the researchers reviewed data from 94,972 JACC participants who provided data about smoking status, including 59,514 never-smokers, 10,554 former smokers, and 24,904 current smokers. The mean age of the participants was 57 years; 57% were women.

The respondents were divided into groups based on years of smoking cessation: 0-1 year, 2-4 years, 5-9 years, 10-14 years, and 15 or more years. The primary endpoint was an underlying cause of death from pneumonia.

Over a median follow-up period of 19 years, 1,806 participants (1,115 men and 691 women) died of pneumonia.

In a multivariate analysis, the hazard ratio for those who quit smoking, compared with current smokers, was 1.02 for 0-1 year of smoking cessation, 0.92 for 2-4 years, 0.95 for 5-9 years, 0.71 for 10-14 years, and 0.63 (0.48-0.83) for 15 or more years. The HR for never smokers was 0.50. The analysis adjusted for competing risk for death without pneumonia in the study population.

Most of the benefits of smoking cessation occurred after 10-14 years, the researchers wrote in their discussion of the findings, and smoking cessation of 10 years or more resulted in risk for death from pneumonia similar to that of never-smokers.

“To our knowledge, no previous studies have examined the association between years of smoking cessation and pneumonia in a general population,” they added.

The study findings were limited by several factors, including the use of data on smoking and smoking cessation at baseline as well as a lack of data on the use of tobacco products other than cigarettes, although alternative tobacco products are rarely used in Japan, the researchers noted. Other limitations include the use of pneumonia mortality as an endpoint, which could have ignored the impact of smoking cessation on less severe pneumonia, and the inability to clarify the association between smoking cessation and pneumonia mortality by sex because of the small number of female former smokers. However, the results were strengthened by the large sample size and long observation period, they said.

“The present study provides empirical evidence that smoking cessation may lead to a decline in the risk of mortality from pneumonia,” and supports smoking cessation as a preventive measure, the researchers concluded.

The study was supported by the Japanese Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare, Health and Labor Sciences; and an Intramural Research Fund for Cardiovascular Diseases of National Cerebral and Cardiovascular Center. The researchers had no financial conflicts to disclose.

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

Adults who quit smoking significantly reduced their risk for mortality from pneumonia; the risk decreased even more with added years of not smoking, according to data from nearly 95,000 individuals.

Smoking is associated with an increased risk for pneumonia, but the extent to which smoking cessation reduces this risk long-term has not been explored, wrote Tomomi Kihara, MD, PhD, of the University of Tsukuba, Japan, and colleagues on behalf of the Japan Collaborative Cohort.

In the Japan Collaborative Cohort Study for Evaluation of Cancer Risk, known as the JACC Study, a community-based cohort of 110,585 individuals aged 40-79 years participated in health screening exams and self-administered questionnaires that included information about smoking. Other findings from the study have been previously published.

In the current study published in Preventive Medicine, the researchers reviewed data from 94,972 JACC participants who provided data about smoking status, including 59,514 never-smokers, 10,554 former smokers, and 24,904 current smokers. The mean age of the participants was 57 years; 57% were women.

The respondents were divided into groups based on years of smoking cessation: 0-1 year, 2-4 years, 5-9 years, 10-14 years, and 15 or more years. The primary endpoint was an underlying cause of death from pneumonia.

Over a median follow-up period of 19 years, 1,806 participants (1,115 men and 691 women) died of pneumonia.

In a multivariate analysis, the hazard ratio for those who quit smoking, compared with current smokers, was 1.02 for 0-1 year of smoking cessation, 0.92 for 2-4 years, 0.95 for 5-9 years, 0.71 for 10-14 years, and 0.63 (0.48-0.83) for 15 or more years. The HR for never smokers was 0.50. The analysis adjusted for competing risk for death without pneumonia in the study population.

Most of the benefits of smoking cessation occurred after 10-14 years, the researchers wrote in their discussion of the findings, and smoking cessation of 10 years or more resulted in risk for death from pneumonia similar to that of never-smokers.

“To our knowledge, no previous studies have examined the association between years of smoking cessation and pneumonia in a general population,” they added.

The study findings were limited by several factors, including the use of data on smoking and smoking cessation at baseline as well as a lack of data on the use of tobacco products other than cigarettes, although alternative tobacco products are rarely used in Japan, the researchers noted. Other limitations include the use of pneumonia mortality as an endpoint, which could have ignored the impact of smoking cessation on less severe pneumonia, and the inability to clarify the association between smoking cessation and pneumonia mortality by sex because of the small number of female former smokers. However, the results were strengthened by the large sample size and long observation period, they said.

“The present study provides empirical evidence that smoking cessation may lead to a decline in the risk of mortality from pneumonia,” and supports smoking cessation as a preventive measure, the researchers concluded.

The study was supported by the Japanese Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare, Health and Labor Sciences; and an Intramural Research Fund for Cardiovascular Diseases of National Cerebral and Cardiovascular Center. The researchers had no financial conflicts to disclose.

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

For about the past year, Priya Goel, MD, can be seen cruising around the island of Manhattan as she makes her way between visits to some of New York City’s most treasured residents: a small but essential group of patients born before the Empire State Building scraped the sky and the old Yankee Stadium had become the House That Ruth Built.

Dr. Goel, a family physician, works for Heal, a national home health care company that primarily serves people older than 65. Her practice has 10 patients older than 100 – the oldest is a 108-year-old man – whom she visits monthly.
 

The gray wave

Dr. Goel’s charges are among America’s latest baby boom – babies born a century ago, that is.

Between 1980 and 2019, the share of American centenarians, those aged 100 and up, grew faster than the total population. In 2019, 100,322 persons in the United States were at least 100 years old – more than triple the 1980 figure of 32,194, according to the U.S. Administration on Aging. By 2060, experts predict, the U.S. centenarian population will reach nearly 600,000.

Although some of the ultra-aged live in nursing homes, many continue to live independently. They require both routine and acute medical care. So, what does it take to be a physician for a centenarian?

Dr. Goel, who is in her mid-30s and could well be the great-granddaughter of some of her patients, urged her colleagues not to stereotype patients on the basis of age.

“You have to consider their functional and cognitive abilities, their ability to understand disease processes and make decisions for themselves,” Dr. Goel said. “Age is just one factor in the grand scheme of things.”

Visiting patients in their homes provides her with insights into how well they’re doing, including the safety of their environments and the depth of their social networks.

New York City has its peculiar demands. Heal provides Dr. Goel with a driver who chauffeurs her to her patient visits. She takes notes between stops.

“The idea is to have these patients remain in an environment where they’re comfortable, in surroundings where they’ve grown up or lived for many years,” she said. “A lot of them are in elevator buildings and they are wheelchair-bound or bed-bound and they physically can’t leave.”

She said she gets a far different view of the patient than does an office-based physician.

“When you go into their home, it’s very personal. You’re seeing what their daily environment is like, what their diet is like. You can see their food on the counter. You can see the level of hygiene,” Dr. Goel said. “You get to see their social support. Are their kids involved? Are they hoarding? Stuff that they wouldn’t just necessarily disclose but on a visit you get to see going into the home. It’s an extra layer of understanding that patient.”

Dr. Goel contrasted home care from care in a nursing home, where the patients are seen daily. On the basis of her observations, she decides whether to see her patients every month or every 3 months.

She applies this strategy to everyone from age 60 to over 100.
 

Tracking a growing group

Since 1995, geriatrician Thomas Perls, MD, has directed the New England Centenarian Study at Boston University. The study, largely funded by the National Institute on Aging, has enrolled 2,599 centenarian persons and 700 of their offspring. At any given time in the study, about 10% of the centenarians are alive. The study has a high mortality rate.

The people in Dr. Perls’s study range in age, but they top out at 119, the third oldest person ever in the world. Most centenarians are women.

“When we first began the study in 1995, the prevalence of centenarians in the United States was about 1 per 10,000 in the population,” Perls told this news organization. “And now, that prevalence has doubled to 1 per 5,000.”

Even if no one has achieved the record of Methuselah, the Biblical patriarch who was purported to have lived to the age of 969, some people always have lived into their 90s and beyond. Dr. Perls attributed the increase in longevity to control at the turn of the 20th century of typhoid fever, diphtheria, and other infectious diseases with effective public health measures, including the availability of clean water and improvement in socioeconomic conditions.

“Infant mortality just plummeted. So, come around 1915, 1920, we were no longer losing a quarter of our population to these diseases. That meant a quarter more of the population could age into adulthood and middle age,” he said. “A certain component of that group was, therefore, able to continue to age to a very, very old age.”

Other advances, such as antibiotics and vaccinations in the 1960s; the availability in the 1970s of much better detection and effective treatment of high blood pressure; the recognition of the harms of smoking; and much more effective treatment of cardiovascular disease and cancer have allowed many people who would have otherwise died in their 70s and 80s to live much longer. “I think what this means is that there is a substantial proportion of the population that has the biology to get to 100,” Dr. Perls said.

Perls said the Latino population and Blacks have a better track record than Whites in reaching the 100-year milestone. “The average life expectancy might be lower in these populations because of socioeconomic factors, but if they are able to get to around their early 80s, compared to Whites, their ability to get to 100 is actually better,” he said.

Asians fare best when it comes to longevity. While around 1% of White women in the United States live to 100, 10% of Asian women in Hong Kong hit that mark.

“I think some of that is better environment and health habits in Hong Kong than in the United States,” Dr. Perls said. “I think another piece may be a genetic advantage in East Asians. We’re looking into that.”

Dr. Perls said he agreed with Dr. Goel that health care providers and the lay public should not make assumptions on the basis of age alone as to how a person is doing. “People can age so very differently from one another,” he said.

Up to about age 90, the vast majority of those differences are determined by our health behaviors, such as smoking, alcohol use, exercise, sleep, the effect of our diets on weight, and access to good health care, including regular screening for problems such as high blood pressure, diabetes, and cancer. “People who are able to do everything right generally add healthy years to their lives, while those who do not have shorter life expectancies and longer periods of chronic diseases,” Dr. Perls said.

Paying diligent attention to these behaviors over the long run can have a huge payoff.

Dr. Perls’s team has found that to live beyond age 90 and on into the early 100s, protective genes can play a strong role. These genes help slow aging and decrease one’s risk for aging-related diseases. Centenarians usually have a history of aging very slowly and greatly delaying aging-related diseases and disability toward the ends of their lives.

Centenarians are the antithesis of the misguided belief that the older you get, the sicker you get. Quite the opposite occurs. For Dr. Perls, “the older you get, the healthier you’ve been.”
 

MD bias against the elderly?

Care of elderly patients is becoming essential in the practice of primary care physicians – but not all of them enjoy the work.

To be effective, physicians who treat centenarians must get a better idea of the individual patient’s functional status and comorbidities. “You absolutely cannot make assumptions on age alone,” Dr. Perls said.

The so-called “normal” temperature, 98.6° F, can spell trouble for centenarians and other very old patients, warned Natalie Baker, DNP, CRNP, an associate professor of nursing at the University of Alabama, Birmingham, and president of the 3,000-member Gerontological Advanced Practice Nurses Association.

“We have to be very cognizant of what we call a typical presentation of disease or illness and that a very subtle change in an older adult can signal a serious infection or illness,” Dr. Baker said. “If your patient has a high fever, that is a potential problem.”

The average temperature of an older adult is lower than the accepted 98.6° F, and their body’s response to an infection is slow to exhibit an increase in temperature, Dr. Baker said. “When treating centenarians, clinicians must be cognizant of other subtle signs of infection, such as decreased appetite or change in mentation,” she cautioned.

A decline in appetite or insomnia may be a subtle sign that these patients need to be evaluated, she added.
 

COVID-19 and centenarians

Three-quarters of the 1 million U.S. deaths from COVID-19 occurred in people aged 65 and older. However, Dr. Perls said centenarians may be a special subpopulation when it comes to COVID.

The Japanese Health Ministry, which follows the large centenarian population in that country, noted a marked jump in the number of centenarians during the pandemic – although the reasons for the increase aren’t clear.

Centenarians may be a bit different. Dr. Perls said some evidence suggests that the over-100 crowd may have better immune systems than younger people. “Part of the trick of getting to 100 is having a pretty good immune system,” he said.
 

Don’t mess with success

“There is no need at that point for us to try to alter their diet to what we think it might be,” Dr. Baker said. “There’s no need to start with diabetic education. They may tell you their secret is a shot of vodka every day. Why should we stop it at that age? Accept their lifestyles, because they’ve done something right to get to that age.”

Opinions differ on how to approach screening for centenarians.

Dr. Goel said guidelines for routine screening, such as colonoscopies, mammograms, and PAP smears, drop off for patients starting at 75. Dr. Perls said this strategy stems from the belief that people will die from other things first, so screening is no longer needed. Dr. Perls said he disagrees with this approach.

“Again, we can’t base our screening and health care decisions on age alone. If I have an independently functioning and robust 95-year-old man in my office, you can be sure I am going to continue recommending regular screening for colon cancer and other screenings that are normal for people who are 30 years younger,” he said.

Justin Zaghi, MD, chief medical officer at Heal, said screening patients in their late 90s and 100s for cancer generally doesn’t make sense except in some rare circumstances in which the cancer would be unlikely to be a cause of death. “However, if we are talking about screening for fall risks, hearing difficulties, poor vision, pain, and malnutrition, those screenings still absolutely make sense for patients in their late 90s and 100s,” Dr. Zaghi said.

One high-functioning 104-year-old patient of Dr. Perls underwent a total hip replacement for a hip fracture and is faring well. “Obviously, if she had end-stage dementia, we’d do everything to keep the person comfortable, or if they had medical problems that made surgery too high risk, then you don’t do it,” he said. “But if they’re otherwise, I would proceed.”
 

Avoid the ED

Dr. Goel said doctors should avoid sending patients to the emergency department, an often chaotic place that is especially unfriendly to centenarians and the very old. “Sometimes I’ve seen older patients who are being rushed to the ER, and I ask, What are the goals of care?” she said.

Clinicians caring for seniors should keep in mind that infections can cause seniors to appear confused – and this may lead the clinician to think the patient has dementia. Or, Dr. Goel said, a patient with dementia may suddenly experience much worse dementia.

“In either case, you want to make sure you’re not dealing with any underlying infection, like urinary tract infection, or pneumonia brewing, or skin infections,” she said. “Their skin is so much frailer. You want to make sure there are no bedsores.”

She has had patients whose children report that their usually placid centenarian parents are suddenly acting out. “We’ll do a urinary test and it definitely shows a urinary tract infection. You want to make sure you’re not missing out on something else before you attribute it to dementia,” she said.

Environmental changes, such as moving a patient to a new room in a hospital setting, can trigger an acute mental status change, such as delirium, she added. Helping older patients feel in control as much as possible is important.

“You want to make sure you’re orienting them to the time of day. Make sure they get up at the same time, go to bed at the same time, have clocks and calendars present – just making sure that they feel like they’re still in control of their body and their day,” she said.

Physicians should be aware of potential depression in these patients, whose experience of loss – an unavoidable consequence of outliving family and friends – can result in problems with sleep and diet, as well as a sense of social isolation.

Neal Flomenbaum, MD, professor and emergency physician-in-chief emeritus, New York–Presbyterian/Weill Cornell Medical Center in New York, said sometimes the best thing for these very elderly patients is to “get them in and out of ED as quickly as possible, and do what you can diagnostically.”

He noted that EDs have been making accommodations to serve the elderly, such as using LEDs that replicate outdoor lighting conditions, as well as providing seniors with separate rooms with glass doors to protect them from noise, separate air handlers to prevent infections, and adequate space for visitors.

These patients often are subject to trauma from falls.

“The bones don’t heal as well as in younger people, and treating their comorbidities is essential. Once they have trouble with one area and they’re lying in bed and can’t move much, they can get bedsores,” Dr. Flomenbaum said. “In the hospital, they are vulnerable to infections. So, you’re thinking of all of these things at the same time and how to treat them appropriately and then get them out of the hospital as soon as possible with whatever care that they need in their own homes if at all possible.”

“I always err on the side of less is more,” Dr. Goel said. “Obviously, if there is something – if they have a cough, they need an x-ray. That’s very basic. We want to take care of that. Give them the antibiotic if they need that. But rushing them in and out of the hospital doesn’t add to their quality of life.”

Dr. Flomenbaum, a pioneer in geriatric emergency medicine, says physicians need to be aware that centenarians and other very old patients don’t present the same way as younger adults.

He began to notice more than 20 years ago that every night, patients would turn up in his ED who were in their late 90s into their 100s. Some would come in with what their children identified as sudden-onset dementia – they didn’t know their own names and couldn’t identify their kids. They didn’t know the time or day. Dr. Flomenbaum said the children often asked whether their parents should enter a nursing home.

“And I’d say, ‘Not so fast. Well, let’s take a look at this.’ You don’t develop that kind of dementia overnight. It usually takes a while,” he said.

He said he ordered complete blood cell counts and oxygen saturation tests that frequently turned out to be abnormal. They didn’t have a fever, and infiltrates initially weren’t seen on chest x-rays.

With rehydration and supplemental oxygen, their symptoms started to improve, and it became obvious that the symptoms were not of dementia but of pneumonia, and that they required antibiotics, Dr. Flomenbaum said.
 

Dementia dilemma

Too often, on the basis of age, doctors assume patients have dementia or other cognitive impairments.

“What a shock and a surprise when doctors actually talk to folks and do a neurocognitive screen and find they’re just fine,” Dr. Perls said.

The decline in hearing and vision can lead to a misdiagnosis of cognitive impairment because the patients are not able to hear what you’re asking them. “It’s really important that the person can hear you – whether you use an amplifying device or they have hearing aids, that’s critical,” he said. “You just have to be a good doctor.”

Often the physical toll of aging exacerbates social difficulties. Poor hearing, for example, can accelerate cognitive impairment and cause people to interact less often, and less meaningfully, with their environment. For some, wearing hearing aids seems demeaning – until they hear what they’ve been missing.

“I get them to wear their hearing aids and, lo and behold, they’re a whole new person because they’re now able to take in their environment and interact with others,” Dr. Perls said.

Dr. Flomenbaum said alcohol abuse and drug reactions can cause delirium, which, unlike dementia, is potentially reversible. Yet many physicians cannot reliably differentiate between dementia and delirium, he added.

The geriatric specialists talk about the lessons they’ve learned and the gratification they get from caring for centenarians.

“I have come to realize the importance of family, of having a close circle, whether that’s through friends or neighbors,” Dr. Goel said. “This work is very rewarding because, if it wasn’t for homebound organizations, how would these people get care or get access to care?”

For Dr. Baker, a joy of the job is hearing centenarians share their life stories.

“I love to hear their stories about how they’ve overcome adversity, living through the depression and living through different wars,” she said. “I love talking to veterans, and I think that oftentimes, we do not value our older adults in our society as we should. Sometimes they are dismissed because they move slowly or are hard to communicate with due to hearing deficits. But they are, I think, a very important part of our lives.”
 

‘They’ve already won’

Most centenarians readily offer the secrets to their longevity. Aline Jacobsohn, of Boca Raton, Fla., is no different.

Ms. Jacobsohn, who will be 101 in October, thinks a diet of small portions of fish, vegetables, and fruit, which she has followed since her husband Leo died in 1982, has helped keep her healthy. She eats lots of salmon and herring and is a fan of spinach sautéed with olive oil. “The only thing I don’t eat is meat,” the trim and active Ms. Jacobsohn said in a recent interview over Zoom.

Her other secret: “Doctors. I like to stay away from them as much as possible.”

Shari Rosenbaum, MD, Jacobsohn’s internist, doesn’t dismiss that approach. She uses a version of it when managing her three centenarian patients, the oldest of whom is 103.

“Let them smoke! Let them drink! They’re happy. It’s not causing harm. Let them eat cake! They’ve already won,” said Dr. Rosenbaum, who is affiliated with Boca Raton–based MDVIP, a national membership-based network of 1,100 primary care physicians serving 368,000 patients. Of those, nearly 460 are centenarians.

“You’re not preventing those problems in this population,” she said. “They’re here to enjoy every moment that they have, and they might as well.”

Dr. Rosenbaum sees a divergence in her patients – those who will reach very old age, and those who won’t – starting in their 60s.

“The centenarians don’t have medical problems,” she said. “They don’t get cancer. They don’t get diabetes. Some of them take good care of themselves. Some don’t take such good care of themselves. But they are all optimists. They all see the glass half full. They all participate in life. They all have excellent support systems. They have good genes, a positive attitude toward life, and a strong social network.”

Ms. Jacobsohn – whose surname at the time was Bakst – grew up in Frankfurt am Main, Germany, during the rise of the Nazi regime. The family fled to Columbia in 1938, where she met and eventually married her husband, Leo, who ran a business importing clocks and watches in Cali.

In 1989, the Jacobsohns and their three children moved to south Florida to escape the dangers of kidnappings and ransoms posed by the drug cartels.

Ms. Jacobsohn agreed that she appears to have longevity genes – “good stock,” she calls it. “My mother died 23 days before she was 100. My grandmother lived till 99, almost 100,” she said.

Two years ago, she donated her car to a charity and stopped driving in the interest of her own safety and that of other drivers and pedestrians.

Ms. Jacobsohn has a strong support system. Two of her children live nearby and visit her nearly every day. A live-in companion helps her with the activities of daily life, including preparing meals.

Ms. Jacobsohn plays bridge regularly, and well. “I’m sorry to say that I’m a very good bridge player,” she said, frankly. “How is it possible that I’ve played bridge so well and then I don’t remember what I had for lunch yesterday?”

She reads, mainly a diet of history but occasionally novels, too. “They have to be engaging,” she said.

The loss of loved ones is an inevitable part of very old age. Her husband of 47 years died of emphysema, and one of her sons died in his 70s of prostate cancer.

She knows well the fate that awaits us all and accepts it philosophically.

“It’s a very normal thing that people die. You don’t live forever. So, whenever it comes, it’s okay. Enough is enough. Dayenu,” she said, using the Hebrew word for, “It would have been enough” – a favorite in the Passover Seder celebrating the ancient Jews’ liberation from slavery in Egypt.

Ms. Jacobsohn sang the song and then took a reporter on a Zoom tour of her tidy home and her large flower garden featuring Cattleya orchids from Colombia.

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

For about the past year, Priya Goel, MD, can be seen cruising around the island of Manhattan as she makes her way between visits to some of New York City’s most treasured residents: a small but essential group of patients born before the Empire State Building scraped the sky and the old Yankee Stadium had become the House That Ruth Built.

Dr. Goel, a family physician, works for Heal, a national home health care company that primarily serves people older than 65. Her practice has 10 patients older than 100 – the oldest is a 108-year-old man – whom she visits monthly.
 

The gray wave

Dr. Goel’s charges are among America’s latest baby boom – babies born a century ago, that is.

Between 1980 and 2019, the share of American centenarians, those aged 100 and up, grew faster than the total population. In 2019, 100,322 persons in the United States were at least 100 years old – more than triple the 1980 figure of 32,194, according to the U.S. Administration on Aging. By 2060, experts predict, the U.S. centenarian population will reach nearly 600,000.

Although some of the ultra-aged live in nursing homes, many continue to live independently. They require both routine and acute medical care. So, what does it take to be a physician for a centenarian?

Dr. Goel, who is in her mid-30s and could well be the great-granddaughter of some of her patients, urged her colleagues not to stereotype patients on the basis of age.

“You have to consider their functional and cognitive abilities, their ability to understand disease processes and make decisions for themselves,” Dr. Goel said. “Age is just one factor in the grand scheme of things.”

Visiting patients in their homes provides her with insights into how well they’re doing, including the safety of their environments and the depth of their social networks.

New York City has its peculiar demands. Heal provides Dr. Goel with a driver who chauffeurs her to her patient visits. She takes notes between stops.

“The idea is to have these patients remain in an environment where they’re comfortable, in surroundings where they’ve grown up or lived for many years,” she said. “A lot of them are in elevator buildings and they are wheelchair-bound or bed-bound and they physically can’t leave.”

She said she gets a far different view of the patient than does an office-based physician.

“When you go into their home, it’s very personal. You’re seeing what their daily environment is like, what their diet is like. You can see their food on the counter. You can see the level of hygiene,” Dr. Goel said. “You get to see their social support. Are their kids involved? Are they hoarding? Stuff that they wouldn’t just necessarily disclose but on a visit you get to see going into the home. It’s an extra layer of understanding that patient.”

Dr. Goel contrasted home care from care in a nursing home, where the patients are seen daily. On the basis of her observations, she decides whether to see her patients every month or every 3 months.

She applies this strategy to everyone from age 60 to over 100.
 

Tracking a growing group

Since 1995, geriatrician Thomas Perls, MD, has directed the New England Centenarian Study at Boston University. The study, largely funded by the National Institute on Aging, has enrolled 2,599 centenarian persons and 700 of their offspring. At any given time in the study, about 10% of the centenarians are alive. The study has a high mortality rate.

The people in Dr. Perls’s study range in age, but they top out at 119, the third oldest person ever in the world. Most centenarians are women.

“When we first began the study in 1995, the prevalence of centenarians in the United States was about 1 per 10,000 in the population,” Perls told this news organization. “And now, that prevalence has doubled to 1 per 5,000.”

Even if no one has achieved the record of Methuselah, the Biblical patriarch who was purported to have lived to the age of 969, some people always have lived into their 90s and beyond. Dr. Perls attributed the increase in longevity to control at the turn of the 20th century of typhoid fever, diphtheria, and other infectious diseases with effective public health measures, including the availability of clean water and improvement in socioeconomic conditions.

“Infant mortality just plummeted. So, come around 1915, 1920, we were no longer losing a quarter of our population to these diseases. That meant a quarter more of the population could age into adulthood and middle age,” he said. “A certain component of that group was, therefore, able to continue to age to a very, very old age.”

Other advances, such as antibiotics and vaccinations in the 1960s; the availability in the 1970s of much better detection and effective treatment of high blood pressure; the recognition of the harms of smoking; and much more effective treatment of cardiovascular disease and cancer have allowed many people who would have otherwise died in their 70s and 80s to live much longer. “I think what this means is that there is a substantial proportion of the population that has the biology to get to 100,” Dr. Perls said.

Perls said the Latino population and Blacks have a better track record than Whites in reaching the 100-year milestone. “The average life expectancy might be lower in these populations because of socioeconomic factors, but if they are able to get to around their early 80s, compared to Whites, their ability to get to 100 is actually better,” he said.

Asians fare best when it comes to longevity. While around 1% of White women in the United States live to 100, 10% of Asian women in Hong Kong hit that mark.

“I think some of that is better environment and health habits in Hong Kong than in the United States,” Dr. Perls said. “I think another piece may be a genetic advantage in East Asians. We’re looking into that.”

Dr. Perls said he agreed with Dr. Goel that health care providers and the lay public should not make assumptions on the basis of age alone as to how a person is doing. “People can age so very differently from one another,” he said.

Up to about age 90, the vast majority of those differences are determined by our health behaviors, such as smoking, alcohol use, exercise, sleep, the effect of our diets on weight, and access to good health care, including regular screening for problems such as high blood pressure, diabetes, and cancer. “People who are able to do everything right generally add healthy years to their lives, while those who do not have shorter life expectancies and longer periods of chronic diseases,” Dr. Perls said.

Paying diligent attention to these behaviors over the long run can have a huge payoff.

Dr. Perls’s team has found that to live beyond age 90 and on into the early 100s, protective genes can play a strong role. These genes help slow aging and decrease one’s risk for aging-related diseases. Centenarians usually have a history of aging very slowly and greatly delaying aging-related diseases and disability toward the ends of their lives.

Centenarians are the antithesis of the misguided belief that the older you get, the sicker you get. Quite the opposite occurs. For Dr. Perls, “the older you get, the healthier you’ve been.”
 

MD bias against the elderly?

Care of elderly patients is becoming essential in the practice of primary care physicians – but not all of them enjoy the work.

To be effective, physicians who treat centenarians must get a better idea of the individual patient’s functional status and comorbidities. “You absolutely cannot make assumptions on age alone,” Dr. Perls said.

The so-called “normal” temperature, 98.6° F, can spell trouble for centenarians and other very old patients, warned Natalie Baker, DNP, CRNP, an associate professor of nursing at the University of Alabama, Birmingham, and president of the 3,000-member Gerontological Advanced Practice Nurses Association.

“We have to be very cognizant of what we call a typical presentation of disease or illness and that a very subtle change in an older adult can signal a serious infection or illness,” Dr. Baker said. “If your patient has a high fever, that is a potential problem.”

The average temperature of an older adult is lower than the accepted 98.6° F, and their body’s response to an infection is slow to exhibit an increase in temperature, Dr. Baker said. “When treating centenarians, clinicians must be cognizant of other subtle signs of infection, such as decreased appetite or change in mentation,” she cautioned.

A decline in appetite or insomnia may be a subtle sign that these patients need to be evaluated, she added.
 

COVID-19 and centenarians

Three-quarters of the 1 million U.S. deaths from COVID-19 occurred in people aged 65 and older. However, Dr. Perls said centenarians may be a special subpopulation when it comes to COVID.

The Japanese Health Ministry, which follows the large centenarian population in that country, noted a marked jump in the number of centenarians during the pandemic – although the reasons for the increase aren’t clear.

Centenarians may be a bit different. Dr. Perls said some evidence suggests that the over-100 crowd may have better immune systems than younger people. “Part of the trick of getting to 100 is having a pretty good immune system,” he said.
 

Don’t mess with success

“There is no need at that point for us to try to alter their diet to what we think it might be,” Dr. Baker said. “There’s no need to start with diabetic education. They may tell you their secret is a shot of vodka every day. Why should we stop it at that age? Accept their lifestyles, because they’ve done something right to get to that age.”

Opinions differ on how to approach screening for centenarians.

Dr. Goel said guidelines for routine screening, such as colonoscopies, mammograms, and PAP smears, drop off for patients starting at 75. Dr. Perls said this strategy stems from the belief that people will die from other things first, so screening is no longer needed. Dr. Perls said he disagrees with this approach.

“Again, we can’t base our screening and health care decisions on age alone. If I have an independently functioning and robust 95-year-old man in my office, you can be sure I am going to continue recommending regular screening for colon cancer and other screenings that are normal for people who are 30 years younger,” he said.

Justin Zaghi, MD, chief medical officer at Heal, said screening patients in their late 90s and 100s for cancer generally doesn’t make sense except in some rare circumstances in which the cancer would be unlikely to be a cause of death. “However, if we are talking about screening for fall risks, hearing difficulties, poor vision, pain, and malnutrition, those screenings still absolutely make sense for patients in their late 90s and 100s,” Dr. Zaghi said.

One high-functioning 104-year-old patient of Dr. Perls underwent a total hip replacement for a hip fracture and is faring well. “Obviously, if she had end-stage dementia, we’d do everything to keep the person comfortable, or if they had medical problems that made surgery too high risk, then you don’t do it,” he said. “But if they’re otherwise, I would proceed.”
 

Avoid the ED

Dr. Goel said doctors should avoid sending patients to the emergency department, an often chaotic place that is especially unfriendly to centenarians and the very old. “Sometimes I’ve seen older patients who are being rushed to the ER, and I ask, What are the goals of care?” she said.

Clinicians caring for seniors should keep in mind that infections can cause seniors to appear confused – and this may lead the clinician to think the patient has dementia. Or, Dr. Goel said, a patient with dementia may suddenly experience much worse dementia.

“In either case, you want to make sure you’re not dealing with any underlying infection, like urinary tract infection, or pneumonia brewing, or skin infections,” she said. “Their skin is so much frailer. You want to make sure there are no bedsores.”

She has had patients whose children report that their usually placid centenarian parents are suddenly acting out. “We’ll do a urinary test and it definitely shows a urinary tract infection. You want to make sure you’re not missing out on something else before you attribute it to dementia,” she said.

Environmental changes, such as moving a patient to a new room in a hospital setting, can trigger an acute mental status change, such as delirium, she added. Helping older patients feel in control as much as possible is important.

“You want to make sure you’re orienting them to the time of day. Make sure they get up at the same time, go to bed at the same time, have clocks and calendars present – just making sure that they feel like they’re still in control of their body and their day,” she said.

Physicians should be aware of potential depression in these patients, whose experience of loss – an unavoidable consequence of outliving family and friends – can result in problems with sleep and diet, as well as a sense of social isolation.

Neal Flomenbaum, MD, professor and emergency physician-in-chief emeritus, New York–Presbyterian/Weill Cornell Medical Center in New York, said sometimes the best thing for these very elderly patients is to “get them in and out of ED as quickly as possible, and do what you can diagnostically.”

He noted that EDs have been making accommodations to serve the elderly, such as using LEDs that replicate outdoor lighting conditions, as well as providing seniors with separate rooms with glass doors to protect them from noise, separate air handlers to prevent infections, and adequate space for visitors.

These patients often are subject to trauma from falls.

“The bones don’t heal as well as in younger people, and treating their comorbidities is essential. Once they have trouble with one area and they’re lying in bed and can’t move much, they can get bedsores,” Dr. Flomenbaum said. “In the hospital, they are vulnerable to infections. So, you’re thinking of all of these things at the same time and how to treat them appropriately and then get them out of the hospital as soon as possible with whatever care that they need in their own homes if at all possible.”

“I always err on the side of less is more,” Dr. Goel said. “Obviously, if there is something – if they have a cough, they need an x-ray. That’s very basic. We want to take care of that. Give them the antibiotic if they need that. But rushing them in and out of the hospital doesn’t add to their quality of life.”

Dr. Flomenbaum, a pioneer in geriatric emergency medicine, says physicians need to be aware that centenarians and other very old patients don’t present the same way as younger adults.

He began to notice more than 20 years ago that every night, patients would turn up in his ED who were in their late 90s into their 100s. Some would come in with what their children identified as sudden-onset dementia – they didn’t know their own names and couldn’t identify their kids. They didn’t know the time or day. Dr. Flomenbaum said the children often asked whether their parents should enter a nursing home.

“And I’d say, ‘Not so fast. Well, let’s take a look at this.’ You don’t develop that kind of dementia overnight. It usually takes a while,” he said.

He said he ordered complete blood cell counts and oxygen saturation tests that frequently turned out to be abnormal. They didn’t have a fever, and infiltrates initially weren’t seen on chest x-rays.

With rehydration and supplemental oxygen, their symptoms started to improve, and it became obvious that the symptoms were not of dementia but of pneumonia, and that they required antibiotics, Dr. Flomenbaum said.
 

Dementia dilemma

Too often, on the basis of age, doctors assume patients have dementia or other cognitive impairments.

“What a shock and a surprise when doctors actually talk to folks and do a neurocognitive screen and find they’re just fine,” Dr. Perls said.

The decline in hearing and vision can lead to a misdiagnosis of cognitive impairment because the patients are not able to hear what you’re asking them. “It’s really important that the person can hear you – whether you use an amplifying device or they have hearing aids, that’s critical,” he said. “You just have to be a good doctor.”

Often the physical toll of aging exacerbates social difficulties. Poor hearing, for example, can accelerate cognitive impairment and cause people to interact less often, and less meaningfully, with their environment. For some, wearing hearing aids seems demeaning – until they hear what they’ve been missing.

“I get them to wear their hearing aids and, lo and behold, they’re a whole new person because they’re now able to take in their environment and interact with others,” Dr. Perls said.

Dr. Flomenbaum said alcohol abuse and drug reactions can cause delirium, which, unlike dementia, is potentially reversible. Yet many physicians cannot reliably differentiate between dementia and delirium, he added.

The geriatric specialists talk about the lessons they’ve learned and the gratification they get from caring for centenarians.

“I have come to realize the importance of family, of having a close circle, whether that’s through friends or neighbors,” Dr. Goel said. “This work is very rewarding because, if it wasn’t for homebound organizations, how would these people get care or get access to care?”

For Dr. Baker, a joy of the job is hearing centenarians share their life stories.

“I love to hear their stories about how they’ve overcome adversity, living through the depression and living through different wars,” she said. “I love talking to veterans, and I think that oftentimes, we do not value our older adults in our society as we should. Sometimes they are dismissed because they move slowly or are hard to communicate with due to hearing deficits. But they are, I think, a very important part of our lives.”
 

‘They’ve already won’

Most centenarians readily offer the secrets to their longevity. Aline Jacobsohn, of Boca Raton, Fla., is no different.

Ms. Jacobsohn, who will be 101 in October, thinks a diet of small portions of fish, vegetables, and fruit, which she has followed since her husband Leo died in 1982, has helped keep her healthy. She eats lots of salmon and herring and is a fan of spinach sautéed with olive oil. “The only thing I don’t eat is meat,” the trim and active Ms. Jacobsohn said in a recent interview over Zoom.

Her other secret: “Doctors. I like to stay away from them as much as possible.”

Shari Rosenbaum, MD, Jacobsohn’s internist, doesn’t dismiss that approach. She uses a version of it when managing her three centenarian patients, the oldest of whom is 103.

“Let them smoke! Let them drink! They’re happy. It’s not causing harm. Let them eat cake! They’ve already won,” said Dr. Rosenbaum, who is affiliated with Boca Raton–based MDVIP, a national membership-based network of 1,100 primary care physicians serving 368,000 patients. Of those, nearly 460 are centenarians.

“You’re not preventing those problems in this population,” she said. “They’re here to enjoy every moment that they have, and they might as well.”

Dr. Rosenbaum sees a divergence in her patients – those who will reach very old age, and those who won’t – starting in their 60s.

“The centenarians don’t have medical problems,” she said. “They don’t get cancer. They don’t get diabetes. Some of them take good care of themselves. Some don’t take such good care of themselves. But they are all optimists. They all see the glass half full. They all participate in life. They all have excellent support systems. They have good genes, a positive attitude toward life, and a strong social network.”

Ms. Jacobsohn – whose surname at the time was Bakst – grew up in Frankfurt am Main, Germany, during the rise of the Nazi regime. The family fled to Columbia in 1938, where she met and eventually married her husband, Leo, who ran a business importing clocks and watches in Cali.

In 1989, the Jacobsohns and their three children moved to south Florida to escape the dangers of kidnappings and ransoms posed by the drug cartels.

Ms. Jacobsohn agreed that she appears to have longevity genes – “good stock,” she calls it. “My mother died 23 days before she was 100. My grandmother lived till 99, almost 100,” she said.

Two years ago, she donated her car to a charity and stopped driving in the interest of her own safety and that of other drivers and pedestrians.

Ms. Jacobsohn has a strong support system. Two of her children live nearby and visit her nearly every day. A live-in companion helps her with the activities of daily life, including preparing meals.

Ms. Jacobsohn plays bridge regularly, and well. “I’m sorry to say that I’m a very good bridge player,” she said, frankly. “How is it possible that I’ve played bridge so well and then I don’t remember what I had for lunch yesterday?”

She reads, mainly a diet of history but occasionally novels, too. “They have to be engaging,” she said.

The loss of loved ones is an inevitable part of very old age. Her husband of 47 years died of emphysema, and one of her sons died in his 70s of prostate cancer.

She knows well the fate that awaits us all and accepts it philosophically.

“It’s a very normal thing that people die. You don’t live forever. So, whenever it comes, it’s okay. Enough is enough. Dayenu,” she said, using the Hebrew word for, “It would have been enough” – a favorite in the Passover Seder celebrating the ancient Jews’ liberation from slavery in Egypt.

Ms. Jacobsohn sang the song and then took a reporter on a Zoom tour of her tidy home and her large flower garden featuring Cattleya orchids from Colombia.

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

For about the past year, Priya Goel, MD, can be seen cruising around the island of Manhattan as she makes her way between visits to some of New York City’s most treasured residents: a small but essential group of patients born before the Empire State Building scraped the sky and the old Yankee Stadium had become the House That Ruth Built.

Dr. Goel, a family physician, works for Heal, a national home health care company that primarily serves people older than 65. Her practice has 10 patients older than 100 – the oldest is a 108-year-old man – whom she visits monthly.
 

The gray wave

Dr. Goel’s charges are among America’s latest baby boom – babies born a century ago, that is.

Between 1980 and 2019, the share of American centenarians, those aged 100 and up, grew faster than the total population. In 2019, 100,322 persons in the United States were at least 100 years old – more than triple the 1980 figure of 32,194, according to the U.S. Administration on Aging. By 2060, experts predict, the U.S. centenarian population will reach nearly 600,000.

Although some of the ultra-aged live in nursing homes, many continue to live independently. They require both routine and acute medical care. So, what does it take to be a physician for a centenarian?

Dr. Goel, who is in her mid-30s and could well be the great-granddaughter of some of her patients, urged her colleagues not to stereotype patients on the basis of age.

“You have to consider their functional and cognitive abilities, their ability to understand disease processes and make decisions for themselves,” Dr. Goel said. “Age is just one factor in the grand scheme of things.”

Visiting patients in their homes provides her with insights into how well they’re doing, including the safety of their environments and the depth of their social networks.

New York City has its peculiar demands. Heal provides Dr. Goel with a driver who chauffeurs her to her patient visits. She takes notes between stops.

“The idea is to have these patients remain in an environment where they’re comfortable, in surroundings where they’ve grown up or lived for many years,” she said. “A lot of them are in elevator buildings and they are wheelchair-bound or bed-bound and they physically can’t leave.”

She said she gets a far different view of the patient than does an office-based physician.

“When you go into their home, it’s very personal. You’re seeing what their daily environment is like, what their diet is like. You can see their food on the counter. You can see the level of hygiene,” Dr. Goel said. “You get to see their social support. Are their kids involved? Are they hoarding? Stuff that they wouldn’t just necessarily disclose but on a visit you get to see going into the home. It’s an extra layer of understanding that patient.”

Dr. Goel contrasted home care from care in a nursing home, where the patients are seen daily. On the basis of her observations, she decides whether to see her patients every month or every 3 months.

She applies this strategy to everyone from age 60 to over 100.
 

Tracking a growing group

Since 1995, geriatrician Thomas Perls, MD, has directed the New England Centenarian Study at Boston University. The study, largely funded by the National Institute on Aging, has enrolled 2,599 centenarian persons and 700 of their offspring. At any given time in the study, about 10% of the centenarians are alive. The study has a high mortality rate.

The people in Dr. Perls’s study range in age, but they top out at 119, the third oldest person ever in the world. Most centenarians are women.

“When we first began the study in 1995, the prevalence of centenarians in the United States was about 1 per 10,000 in the population,” Perls told this news organization. “And now, that prevalence has doubled to 1 per 5,000.”

Even if no one has achieved the record of Methuselah, the Biblical patriarch who was purported to have lived to the age of 969, some people always have lived into their 90s and beyond. Dr. Perls attributed the increase in longevity to control at the turn of the 20th century of typhoid fever, diphtheria, and other infectious diseases with effective public health measures, including the availability of clean water and improvement in socioeconomic conditions.

“Infant mortality just plummeted. So, come around 1915, 1920, we were no longer losing a quarter of our population to these diseases. That meant a quarter more of the population could age into adulthood and middle age,” he said. “A certain component of that group was, therefore, able to continue to age to a very, very old age.”

Other advances, such as antibiotics and vaccinations in the 1960s; the availability in the 1970s of much better detection and effective treatment of high blood pressure; the recognition of the harms of smoking; and much more effective treatment of cardiovascular disease and cancer have allowed many people who would have otherwise died in their 70s and 80s to live much longer. “I think what this means is that there is a substantial proportion of the population that has the biology to get to 100,” Dr. Perls said.

Perls said the Latino population and Blacks have a better track record than Whites in reaching the 100-year milestone. “The average life expectancy might be lower in these populations because of socioeconomic factors, but if they are able to get to around their early 80s, compared to Whites, their ability to get to 100 is actually better,” he said.

Asians fare best when it comes to longevity. While around 1% of White women in the United States live to 100, 10% of Asian women in Hong Kong hit that mark.

“I think some of that is better environment and health habits in Hong Kong than in the United States,” Dr. Perls said. “I think another piece may be a genetic advantage in East Asians. We’re looking into that.”

Dr. Perls said he agreed with Dr. Goel that health care providers and the lay public should not make assumptions on the basis of age alone as to how a person is doing. “People can age so very differently from one another,” he said.

Up to about age 90, the vast majority of those differences are determined by our health behaviors, such as smoking, alcohol use, exercise, sleep, the effect of our diets on weight, and access to good health care, including regular screening for problems such as high blood pressure, diabetes, and cancer. “People who are able to do everything right generally add healthy years to their lives, while those who do not have shorter life expectancies and longer periods of chronic diseases,” Dr. Perls said.

Paying diligent attention to these behaviors over the long run can have a huge payoff.

Dr. Perls’s team has found that to live beyond age 90 and on into the early 100s, protective genes can play a strong role. These genes help slow aging and decrease one’s risk for aging-related diseases. Centenarians usually have a history of aging very slowly and greatly delaying aging-related diseases and disability toward the ends of their lives.

Centenarians are the antithesis of the misguided belief that the older you get, the sicker you get. Quite the opposite occurs. For Dr. Perls, “the older you get, the healthier you’ve been.”
 

MD bias against the elderly?

Care of elderly patients is becoming essential in the practice of primary care physicians – but not all of them enjoy the work.

To be effective, physicians who treat centenarians must get a better idea of the individual patient’s functional status and comorbidities. “You absolutely cannot make assumptions on age alone,” Dr. Perls said.

The so-called “normal” temperature, 98.6° F, can spell trouble for centenarians and other very old patients, warned Natalie Baker, DNP, CRNP, an associate professor of nursing at the University of Alabama, Birmingham, and president of the 3,000-member Gerontological Advanced Practice Nurses Association.

“We have to be very cognizant of what we call a typical presentation of disease or illness and that a very subtle change in an older adult can signal a serious infection or illness,” Dr. Baker said. “If your patient has a high fever, that is a potential problem.”

The average temperature of an older adult is lower than the accepted 98.6° F, and their body’s response to an infection is slow to exhibit an increase in temperature, Dr. Baker said. “When treating centenarians, clinicians must be cognizant of other subtle signs of infection, such as decreased appetite or change in mentation,” she cautioned.

A decline in appetite or insomnia may be a subtle sign that these patients need to be evaluated, she added.
 

COVID-19 and centenarians

Three-quarters of the 1 million U.S. deaths from COVID-19 occurred in people aged 65 and older. However, Dr. Perls said centenarians may be a special subpopulation when it comes to COVID.

The Japanese Health Ministry, which follows the large centenarian population in that country, noted a marked jump in the number of centenarians during the pandemic – although the reasons for the increase aren’t clear.

Centenarians may be a bit different. Dr. Perls said some evidence suggests that the over-100 crowd may have better immune systems than younger people. “Part of the trick of getting to 100 is having a pretty good immune system,” he said.
 

Don’t mess with success

“There is no need at that point for us to try to alter their diet to what we think it might be,” Dr. Baker said. “There’s no need to start with diabetic education. They may tell you their secret is a shot of vodka every day. Why should we stop it at that age? Accept their lifestyles, because they’ve done something right to get to that age.”

Opinions differ on how to approach screening for centenarians.

Dr. Goel said guidelines for routine screening, such as colonoscopies, mammograms, and PAP smears, drop off for patients starting at 75. Dr. Perls said this strategy stems from the belief that people will die from other things first, so screening is no longer needed. Dr. Perls said he disagrees with this approach.

“Again, we can’t base our screening and health care decisions on age alone. If I have an independently functioning and robust 95-year-old man in my office, you can be sure I am going to continue recommending regular screening for colon cancer and other screenings that are normal for people who are 30 years younger,” he said.

Justin Zaghi, MD, chief medical officer at Heal, said screening patients in their late 90s and 100s for cancer generally doesn’t make sense except in some rare circumstances in which the cancer would be unlikely to be a cause of death. “However, if we are talking about screening for fall risks, hearing difficulties, poor vision, pain, and malnutrition, those screenings still absolutely make sense for patients in their late 90s and 100s,” Dr. Zaghi said.

One high-functioning 104-year-old patient of Dr. Perls underwent a total hip replacement for a hip fracture and is faring well. “Obviously, if she had end-stage dementia, we’d do everything to keep the person comfortable, or if they had medical problems that made surgery too high risk, then you don’t do it,” he said. “But if they’re otherwise, I would proceed.”
 

Avoid the ED

Dr. Goel said doctors should avoid sending patients to the emergency department, an often chaotic place that is especially unfriendly to centenarians and the very old. “Sometimes I’ve seen older patients who are being rushed to the ER, and I ask, What are the goals of care?” she said.

Clinicians caring for seniors should keep in mind that infections can cause seniors to appear confused – and this may lead the clinician to think the patient has dementia. Or, Dr. Goel said, a patient with dementia may suddenly experience much worse dementia.

“In either case, you want to make sure you’re not dealing with any underlying infection, like urinary tract infection, or pneumonia brewing, or skin infections,” she said. “Their skin is so much frailer. You want to make sure there are no bedsores.”

She has had patients whose children report that their usually placid centenarian parents are suddenly acting out. “We’ll do a urinary test and it definitely shows a urinary tract infection. You want to make sure you’re not missing out on something else before you attribute it to dementia,” she said.

Environmental changes, such as moving a patient to a new room in a hospital setting, can trigger an acute mental status change, such as delirium, she added. Helping older patients feel in control as much as possible is important.

“You want to make sure you’re orienting them to the time of day. Make sure they get up at the same time, go to bed at the same time, have clocks and calendars present – just making sure that they feel like they’re still in control of their body and their day,” she said.

Physicians should be aware of potential depression in these patients, whose experience of loss – an unavoidable consequence of outliving family and friends – can result in problems with sleep and diet, as well as a sense of social isolation.

Neal Flomenbaum, MD, professor and emergency physician-in-chief emeritus, New York–Presbyterian/Weill Cornell Medical Center in New York, said sometimes the best thing for these very elderly patients is to “get them in and out of ED as quickly as possible, and do what you can diagnostically.”

He noted that EDs have been making accommodations to serve the elderly, such as using LEDs that replicate outdoor lighting conditions, as well as providing seniors with separate rooms with glass doors to protect them from noise, separate air handlers to prevent infections, and adequate space for visitors.

These patients often are subject to trauma from falls.

“The bones don’t heal as well as in younger people, and treating their comorbidities is essential. Once they have trouble with one area and they’re lying in bed and can’t move much, they can get bedsores,” Dr. Flomenbaum said. “In the hospital, they are vulnerable to infections. So, you’re thinking of all of these things at the same time and how to treat them appropriately and then get them out of the hospital as soon as possible with whatever care that they need in their own homes if at all possible.”

“I always err on the side of less is more,” Dr. Goel said. “Obviously, if there is something – if they have a cough, they need an x-ray. That’s very basic. We want to take care of that. Give them the antibiotic if they need that. But rushing them in and out of the hospital doesn’t add to their quality of life.”

Dr. Flomenbaum, a pioneer in geriatric emergency medicine, says physicians need to be aware that centenarians and other very old patients don’t present the same way as younger adults.

He began to notice more than 20 years ago that every night, patients would turn up in his ED who were in their late 90s into their 100s. Some would come in with what their children identified as sudden-onset dementia – they didn’t know their own names and couldn’t identify their kids. They didn’t know the time or day. Dr. Flomenbaum said the children often asked whether their parents should enter a nursing home.

“And I’d say, ‘Not so fast. Well, let’s take a look at this.’ You don’t develop that kind of dementia overnight. It usually takes a while,” he said.

He said he ordered complete blood cell counts and oxygen saturation tests that frequently turned out to be abnormal. They didn’t have a fever, and infiltrates initially weren’t seen on chest x-rays.

With rehydration and supplemental oxygen, their symptoms started to improve, and it became obvious that the symptoms were not of dementia but of pneumonia, and that they required antibiotics, Dr. Flomenbaum said.
 

Dementia dilemma

Too often, on the basis of age, doctors assume patients have dementia or other cognitive impairments.

“What a shock and a surprise when doctors actually talk to folks and do a neurocognitive screen and find they’re just fine,” Dr. Perls said.

The decline in hearing and vision can lead to a misdiagnosis of cognitive impairment because the patients are not able to hear what you’re asking them. “It’s really important that the person can hear you – whether you use an amplifying device or they have hearing aids, that’s critical,” he said. “You just have to be a good doctor.”

Often the physical toll of aging exacerbates social difficulties. Poor hearing, for example, can accelerate cognitive impairment and cause people to interact less often, and less meaningfully, with their environment. For some, wearing hearing aids seems demeaning – until they hear what they’ve been missing.

“I get them to wear their hearing aids and, lo and behold, they’re a whole new person because they’re now able to take in their environment and interact with others,” Dr. Perls said.

Dr. Flomenbaum said alcohol abuse and drug reactions can cause delirium, which, unlike dementia, is potentially reversible. Yet many physicians cannot reliably differentiate between dementia and delirium, he added.

The geriatric specialists talk about the lessons they’ve learned and the gratification they get from caring for centenarians.

“I have come to realize the importance of family, of having a close circle, whether that’s through friends or neighbors,” Dr. Goel said. “This work is very rewarding because, if it wasn’t for homebound organizations, how would these people get care or get access to care?”

For Dr. Baker, a joy of the job is hearing centenarians share their life stories.

“I love to hear their stories about how they’ve overcome adversity, living through the depression and living through different wars,” she said. “I love talking to veterans, and I think that oftentimes, we do not value our older adults in our society as we should. Sometimes they are dismissed because they move slowly or are hard to communicate with due to hearing deficits. But they are, I think, a very important part of our lives.”
 

‘They’ve already won’

Most centenarians readily offer the secrets to their longevity. Aline Jacobsohn, of Boca Raton, Fla., is no different.

Ms. Jacobsohn, who will be 101 in October, thinks a diet of small portions of fish, vegetables, and fruit, which she has followed since her husband Leo died in 1982, has helped keep her healthy. She eats lots of salmon and herring and is a fan of spinach sautéed with olive oil. “The only thing I don’t eat is meat,” the trim and active Ms. Jacobsohn said in a recent interview over Zoom.

Her other secret: “Doctors. I like to stay away from them as much as possible.”

Shari Rosenbaum, MD, Jacobsohn’s internist, doesn’t dismiss that approach. She uses a version of it when managing her three centenarian patients, the oldest of whom is 103.

“Let them smoke! Let them drink! They’re happy. It’s not causing harm. Let them eat cake! They’ve already won,” said Dr. Rosenbaum, who is affiliated with Boca Raton–based MDVIP, a national membership-based network of 1,100 primary care physicians serving 368,000 patients. Of those, nearly 460 are centenarians.

“You’re not preventing those problems in this population,” she said. “They’re here to enjoy every moment that they have, and they might as well.”

Dr. Rosenbaum sees a divergence in her patients – those who will reach very old age, and those who won’t – starting in their 60s.

“The centenarians don’t have medical problems,” she said. “They don’t get cancer. They don’t get diabetes. Some of them take good care of themselves. Some don’t take such good care of themselves. But they are all optimists. They all see the glass half full. They all participate in life. They all have excellent support systems. They have good genes, a positive attitude toward life, and a strong social network.”

Ms. Jacobsohn – whose surname at the time was Bakst – grew up in Frankfurt am Main, Germany, during the rise of the Nazi regime. The family fled to Columbia in 1938, where she met and eventually married her husband, Leo, who ran a business importing clocks and watches in Cali.

In 1989, the Jacobsohns and their three children moved to south Florida to escape the dangers of kidnappings and ransoms posed by the drug cartels.

Ms. Jacobsohn agreed that she appears to have longevity genes – “good stock,” she calls it. “My mother died 23 days before she was 100. My grandmother lived till 99, almost 100,” she said.

Two years ago, she donated her car to a charity and stopped driving in the interest of her own safety and that of other drivers and pedestrians.

Ms. Jacobsohn has a strong support system. Two of her children live nearby and visit her nearly every day. A live-in companion helps her with the activities of daily life, including preparing meals.

Ms. Jacobsohn plays bridge regularly, and well. “I’m sorry to say that I’m a very good bridge player,” she said, frankly. “How is it possible that I’ve played bridge so well and then I don’t remember what I had for lunch yesterday?”

She reads, mainly a diet of history but occasionally novels, too. “They have to be engaging,” she said.

The loss of loved ones is an inevitable part of very old age. Her husband of 47 years died of emphysema, and one of her sons died in his 70s of prostate cancer.

She knows well the fate that awaits us all and accepts it philosophically.

“It’s a very normal thing that people die. You don’t live forever. So, whenever it comes, it’s okay. Enough is enough. Dayenu,” she said, using the Hebrew word for, “It would have been enough” – a favorite in the Passover Seder celebrating the ancient Jews’ liberation from slavery in Egypt.

Ms. Jacobsohn sang the song and then took a reporter on a Zoom tour of her tidy home and her large flower garden featuring Cattleya orchids from Colombia.

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

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

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

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

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

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

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

Lung disease as an adverse effect of the targeted cancer drug trastuzumab deruxtecan (T-DXd, Enhertu) is not negligible, although the benefit-to-risk relationship with use of the drug is still positive, say researchers who report a review of early clinical trials with the drug.

T-DXd is a monoclonal antibody that targets HER2. It is approved for use in HER2-positive breast, gastric, and lung cancers.

In the new study, investigators analyzed data from early clinical trials that involved patients with advanced cancers who had been heavily pretreated. They found an incidence of just over 15% for interstitial lung disease (ILD)/pneumonitis associated with the drug. Most patients (77.4%) had grade 1 or 2 ILD, but 2.2% of patients had grade 5 ILD.

“Interstitial lung disease is a known risk factor in patients treated with antibody conjugates for cancer,” commented lead author Charles Powell, MD, Icahn School of Medicine at Mount Sinai, New York. This adverse effect can lead to lung fibrosis and can become severe, life threatening, and even fatal, the authors warned.

The authors also discussed management of the event, which involves corticosteroids, and recommended that any patient who develops ILD of grade 3 or higher be hospitalized.

Close monitoring and proactive management may reduce the risk of ILD, they suggested.

Indeed, the incidence of this adverse effect was lower in a later phase 3 trial of the drug (10.5% in the DESTINY-Breast03 trial) and that the adverse events were less severe in this patient population (none of these events were of grade 4 or 5).

“Increased knowledge ... and implementation of ILD/pneumonitis monitoring, diagnosis, and management guidelines” may have resulted in this adverse effect being identified early and treated before it progressed, they commented.

ILD is highlighted in a boxed warning on the product label.

The study was published online in ESMO Open.

In their review, the investigators evaluated nine early-stage monotherapy clinical trials (phases 1 and 2) involving a total of 1,150 patients (breast cancer, 44.3%; gastric cancer, 25.6%; lung cancer, 17.7%; colorectal cancer, 9.3%, other cancers, 3.0%).

These patients had advanced cancer and had been heavily pretreated with a median of four prior lines of therapy. They received one or more doses of at least 5.4 mg/kg of T-DXd.

Nearly half of the cohort were treated for more than 6 months. A total of 276 potential ILD/pneumonitis events were sent for adjudication; of those, 85% were adjudicated as ILD/pneumonitis.

The overall incidence of adjudicated ILD/pneumonitis events was 15.4%; most were low-grade events. Some 87% of patients experienced their first ILD event within 12 months of treatment. The median time to experiencing an ILD/pneumonitis event was 5.4 months.

Some of the patients who developed grade 1 ILD/pneumonitis were treated and the adverse event resolved. These patients were then rechallenged with the drug. Only 3 of the 47 rechallenged patients experienced recurrence of ILD/pneumonitis, the authors noted.

“Rechallenge with T-DXd after complete resolution of grade 1 events is possible and warrants further investigation,” they commented. They cautioned, however, that rechallenge is not recommended for all patients, at least not for those with grade 2 or higher ILD/pneumonitis.

Overall, the authors concluded that the “benefit-risk of T-DXd treatment is positive,” but they warned that some patients may be at increased risk of developing ILD/pneumonitis

Baseline factors that increase the risk of developing an ILD/pneumonitis event include the following: being younger than 65 years, receiving a T-DXd dose of more than6.4 mg/kg, having a baseline oxygen saturation level of less than 95%, having moderate to severe renal impairment, and having lung comorbidities. In addition, patients who had initially been diagnosed with cancer more than 4 years before receiving the drug were at higher risk of developing ILD/pneumonitis.

“Using learnings from the early clinical trials experience, physician education and patient management protocols were revised and disseminated by the study sponsors [and] more recent trial data in earlier lines of therapy has demonstrated lower rates of ILD events, suggesting close monitoring and proactive management of ILD/pneumonitis is warranted for all patients,” Dr. Powell said in a statement.

The T-DXd clinical trials were sponsored by AstraZeneca and Daiichi Sankyo. Dr. Powell has received fees from Daiichi Sankyo, AstraZeneca, and Voluntis.

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

Lung disease as an adverse effect of the targeted cancer drug trastuzumab deruxtecan (T-DXd, Enhertu) is not negligible, although the benefit-to-risk relationship with use of the drug is still positive, say researchers who report a review of early clinical trials with the drug.

T-DXd is a monoclonal antibody that targets HER2. It is approved for use in HER2-positive breast, gastric, and lung cancers.

In the new study, investigators analyzed data from early clinical trials that involved patients with advanced cancers who had been heavily pretreated. They found an incidence of just over 15% for interstitial lung disease (ILD)/pneumonitis associated with the drug. Most patients (77.4%) had grade 1 or 2 ILD, but 2.2% of patients had grade 5 ILD.

“Interstitial lung disease is a known risk factor in patients treated with antibody conjugates for cancer,” commented lead author Charles Powell, MD, Icahn School of Medicine at Mount Sinai, New York. This adverse effect can lead to lung fibrosis and can become severe, life threatening, and even fatal, the authors warned.

The authors also discussed management of the event, which involves corticosteroids, and recommended that any patient who develops ILD of grade 3 or higher be hospitalized.

Close monitoring and proactive management may reduce the risk of ILD, they suggested.

Indeed, the incidence of this adverse effect was lower in a later phase 3 trial of the drug (10.5% in the DESTINY-Breast03 trial) and that the adverse events were less severe in this patient population (none of these events were of grade 4 or 5).

“Increased knowledge ... and implementation of ILD/pneumonitis monitoring, diagnosis, and management guidelines” may have resulted in this adverse effect being identified early and treated before it progressed, they commented.

ILD is highlighted in a boxed warning on the product label.

The study was published online in ESMO Open.

In their review, the investigators evaluated nine early-stage monotherapy clinical trials (phases 1 and 2) involving a total of 1,150 patients (breast cancer, 44.3%; gastric cancer, 25.6%; lung cancer, 17.7%; colorectal cancer, 9.3%, other cancers, 3.0%).

These patients had advanced cancer and had been heavily pretreated with a median of four prior lines of therapy. They received one or more doses of at least 5.4 mg/kg of T-DXd.

Nearly half of the cohort were treated for more than 6 months. A total of 276 potential ILD/pneumonitis events were sent for adjudication; of those, 85% were adjudicated as ILD/pneumonitis.

The overall incidence of adjudicated ILD/pneumonitis events was 15.4%; most were low-grade events. Some 87% of patients experienced their first ILD event within 12 months of treatment. The median time to experiencing an ILD/pneumonitis event was 5.4 months.

Some of the patients who developed grade 1 ILD/pneumonitis were treated and the adverse event resolved. These patients were then rechallenged with the drug. Only 3 of the 47 rechallenged patients experienced recurrence of ILD/pneumonitis, the authors noted.

“Rechallenge with T-DXd after complete resolution of grade 1 events is possible and warrants further investigation,” they commented. They cautioned, however, that rechallenge is not recommended for all patients, at least not for those with grade 2 or higher ILD/pneumonitis.

Overall, the authors concluded that the “benefit-risk of T-DXd treatment is positive,” but they warned that some patients may be at increased risk of developing ILD/pneumonitis

Baseline factors that increase the risk of developing an ILD/pneumonitis event include the following: being younger than 65 years, receiving a T-DXd dose of more than6.4 mg/kg, having a baseline oxygen saturation level of less than 95%, having moderate to severe renal impairment, and having lung comorbidities. In addition, patients who had initially been diagnosed with cancer more than 4 years before receiving the drug were at higher risk of developing ILD/pneumonitis.

“Using learnings from the early clinical trials experience, physician education and patient management protocols were revised and disseminated by the study sponsors [and] more recent trial data in earlier lines of therapy has demonstrated lower rates of ILD events, suggesting close monitoring and proactive management of ILD/pneumonitis is warranted for all patients,” Dr. Powell said in a statement.

The T-DXd clinical trials were sponsored by AstraZeneca and Daiichi Sankyo. Dr. Powell has received fees from Daiichi Sankyo, AstraZeneca, and Voluntis.

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

Lung disease as an adverse effect of the targeted cancer drug trastuzumab deruxtecan (T-DXd, Enhertu) is not negligible, although the benefit-to-risk relationship with use of the drug is still positive, say researchers who report a review of early clinical trials with the drug.

T-DXd is a monoclonal antibody that targets HER2. It is approved for use in HER2-positive breast, gastric, and lung cancers.

In the new study, investigators analyzed data from early clinical trials that involved patients with advanced cancers who had been heavily pretreated. They found an incidence of just over 15% for interstitial lung disease (ILD)/pneumonitis associated with the drug. Most patients (77.4%) had grade 1 or 2 ILD, but 2.2% of patients had grade 5 ILD.

“Interstitial lung disease is a known risk factor in patients treated with antibody conjugates for cancer,” commented lead author Charles Powell, MD, Icahn School of Medicine at Mount Sinai, New York. This adverse effect can lead to lung fibrosis and can become severe, life threatening, and even fatal, the authors warned.

The authors also discussed management of the event, which involves corticosteroids, and recommended that any patient who develops ILD of grade 3 or higher be hospitalized.

Close monitoring and proactive management may reduce the risk of ILD, they suggested.

Indeed, the incidence of this adverse effect was lower in a later phase 3 trial of the drug (10.5% in the DESTINY-Breast03 trial) and that the adverse events were less severe in this patient population (none of these events were of grade 4 or 5).

“Increased knowledge ... and implementation of ILD/pneumonitis monitoring, diagnosis, and management guidelines” may have resulted in this adverse effect being identified early and treated before it progressed, they commented.

ILD is highlighted in a boxed warning on the product label.

The study was published online in ESMO Open.

In their review, the investigators evaluated nine early-stage monotherapy clinical trials (phases 1 and 2) involving a total of 1,150 patients (breast cancer, 44.3%; gastric cancer, 25.6%; lung cancer, 17.7%; colorectal cancer, 9.3%, other cancers, 3.0%).

These patients had advanced cancer and had been heavily pretreated with a median of four prior lines of therapy. They received one or more doses of at least 5.4 mg/kg of T-DXd.

Nearly half of the cohort were treated for more than 6 months. A total of 276 potential ILD/pneumonitis events were sent for adjudication; of those, 85% were adjudicated as ILD/pneumonitis.

The overall incidence of adjudicated ILD/pneumonitis events was 15.4%; most were low-grade events. Some 87% of patients experienced their first ILD event within 12 months of treatment. The median time to experiencing an ILD/pneumonitis event was 5.4 months.

Some of the patients who developed grade 1 ILD/pneumonitis were treated and the adverse event resolved. These patients were then rechallenged with the drug. Only 3 of the 47 rechallenged patients experienced recurrence of ILD/pneumonitis, the authors noted.

“Rechallenge with T-DXd after complete resolution of grade 1 events is possible and warrants further investigation,” they commented. They cautioned, however, that rechallenge is not recommended for all patients, at least not for those with grade 2 or higher ILD/pneumonitis.

Overall, the authors concluded that the “benefit-risk of T-DXd treatment is positive,” but they warned that some patients may be at increased risk of developing ILD/pneumonitis

Baseline factors that increase the risk of developing an ILD/pneumonitis event include the following: being younger than 65 years, receiving a T-DXd dose of more than6.4 mg/kg, having a baseline oxygen saturation level of less than 95%, having moderate to severe renal impairment, and having lung comorbidities. In addition, patients who had initially been diagnosed with cancer more than 4 years before receiving the drug were at higher risk of developing ILD/pneumonitis.

“Using learnings from the early clinical trials experience, physician education and patient management protocols were revised and disseminated by the study sponsors [and] more recent trial data in earlier lines of therapy has demonstrated lower rates of ILD events, suggesting close monitoring and proactive management of ILD/pneumonitis is warranted for all patients,” Dr. Powell said in a statement.

The T-DXd clinical trials were sponsored by AstraZeneca and Daiichi Sankyo. Dr. Powell has received fees from Daiichi Sankyo, AstraZeneca, and Voluntis.

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

The Association for the Advancement of Blood and Biotherapies has released clinical practice guidelines for using COVID-19 convalescent plasma (CCP) in hospital and outpatient settings.

In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”

The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:

• Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
• CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
• CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
• Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
• The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)

Multiple guidelines for use of CCP are similar

In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.

They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.

The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.

The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.

“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.

“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.

Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”

One strong recommendation

Dr. Barrett pointed out that four of the five recommendations are rated “weak.”

“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”

She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.

“That clinical bottom line is what most clinicians will look for,” she said.

“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”

The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.

The Association for the Advancement of Blood and Biotherapies has released clinical practice guidelines for using COVID-19 convalescent plasma (CCP) in hospital and outpatient settings.

In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”

The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:

• Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
• CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
• CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
• Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
• The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)

Multiple guidelines for use of CCP are similar

In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.

They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.

The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.

The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.

“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.

“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.

Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”

One strong recommendation

Dr. Barrett pointed out that four of the five recommendations are rated “weak.”

“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”

She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.

“That clinical bottom line is what most clinicians will look for,” she said.

“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”

The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.

The Association for the Advancement of Blood and Biotherapies has released clinical practice guidelines for using COVID-19 convalescent plasma (CCP) in hospital and outpatient settings.

In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”

The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:

• Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
• CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
• CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
• Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
• The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)

Multiple guidelines for use of CCP are similar

In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.

They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.

The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.

The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.

“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.

“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.

Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”

One strong recommendation

Dr. Barrett pointed out that four of the five recommendations are rated “weak.”

“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”

She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.

“That clinical bottom line is what most clinicians will look for,” she said.

“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”

The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

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

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

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

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

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