Journal of Clinical Outcomes Management

A study published in May in The Lancet journal eClinicalMedicine reports that breathomics testing is one step closer to becoming a reality as a lung cancer screening tool.

The tool was successfully used to identify, in 84 patients, 16 lung cancer–related carcinogenic volatile compounds (VOCs), such as aldehydes, hydrocarbons, ketones, carboxylic acids, and furan – some of which are compounds used in the production of common household goods, such as furniture, carpeting, and wood floors.

“The test is anticipated to be highlighted for primary screening of lung cancer but not the final diagnosis,” according to study authors who were led by Peiyu Wang, MD, PhD, chair of social medicine and health at Peking (China) University.

While early diagnosis and treatment are critical for improving lung cancer survival, early detection of lung cancer is challenging because of the lack of clinical manifestations and specific biomarkers. Annual CT scans are costly and include radiation exposure, Dr. Wang and his associates wrote.

Breathomics testing is considered a promising method for detection and screening for lung cancer. It has been under study for years and in 2014, researchers from Belgium published a review in Cancer Epidemiology Biomarkers and Prevention documenting the use of VOCs as early diagnostic or prognostic biomarkers for mesothelioma.

Lung cancer breath biomarkers identified in various studies have been highly heterogeneous because of differing sample collection methods, varying patient conditions, testing environments, and analysis methods. As a result, there currently is no breathomics test for lung cancer screening, Dr. Wang said in an interview.

In terms of its potential as a lung cancer screening tool, “Clinicians may introduce this test for people with high risk for lung cancer, such as elderly smokers, or people with suspected symptoms. It may also be introduced for young populations with subjective or objective needs to screen for lung cancer. As the proportion of lung adenocarcinoma in nonsmoking young women is increasing, the test may be a good method for lung cancer screening in this population,” Dr. Wang said.

After adjusting for age, sex, smoking, and comorbidities, researchers found elevated levels for 16 VOCs in patients with lung cancer. A diagnostic model including the 16 VOCs achieved an area under the curve of 0.952, sensitivity of 89.2%, specificity of 89.1%, and accuracy of 89.1% in lung cancer diagnosis. A model including the top eight VOCs achieved an area under the curve of 0.931, sensitivity of 86.0%, specificity of 87.2%, and accuracy of 86.9%.

After selecting 28 VOCs as candidates through a literature review, Dr. Wang and associates conducted a prospective discovery study from Sept. 1 to Dec. 31, 2020, using high-pressure photon ionization time-of-flight mass spectrometry to evaluate their performance for lung cancer diagnosis. The validation study included 157 lung cancer patients (mean age 57.0 years; 54.1 percent female) and 368 volunteers (mean age 44.5 years; 31.3% female).

“The external validation confirmed good performance of these biomarkers in lung cancer detection,” the researchers stated. It helped, they added, to solve the heterogeneity among published studies, establishing both 16 VOCs and 8 VOCS for lung cancer screening.

The authors stated that a large gap exists between breathomics research and clinical practices in lung cancer detection and screening. While the validated 16 VOCs, mainly aldehydes and hydrocarbon, showed potential for promoting this lung cancer screening strategy, more scientific studies are warranted to investigate the underlying mechanisms of identified lung cancer VOCs.

Dr. Wang declared no competing interests.

A study published in May in The Lancet journal eClinicalMedicine reports that breathomics testing is one step closer to becoming a reality as a lung cancer screening tool.

The tool was successfully used to identify, in 84 patients, 16 lung cancer–related carcinogenic volatile compounds (VOCs), such as aldehydes, hydrocarbons, ketones, carboxylic acids, and furan – some of which are compounds used in the production of common household goods, such as furniture, carpeting, and wood floors.

“The test is anticipated to be highlighted for primary screening of lung cancer but not the final diagnosis,” according to study authors who were led by Peiyu Wang, MD, PhD, chair of social medicine and health at Peking (China) University.

While early diagnosis and treatment are critical for improving lung cancer survival, early detection of lung cancer is challenging because of the lack of clinical manifestations and specific biomarkers. Annual CT scans are costly and include radiation exposure, Dr. Wang and his associates wrote.

Breathomics testing is considered a promising method for detection and screening for lung cancer. It has been under study for years and in 2014, researchers from Belgium published a review in Cancer Epidemiology Biomarkers and Prevention documenting the use of VOCs as early diagnostic or prognostic biomarkers for mesothelioma.

Lung cancer breath biomarkers identified in various studies have been highly heterogeneous because of differing sample collection methods, varying patient conditions, testing environments, and analysis methods. As a result, there currently is no breathomics test for lung cancer screening, Dr. Wang said in an interview.

In terms of its potential as a lung cancer screening tool, “Clinicians may introduce this test for people with high risk for lung cancer, such as elderly smokers, or people with suspected symptoms. It may also be introduced for young populations with subjective or objective needs to screen for lung cancer. As the proportion of lung adenocarcinoma in nonsmoking young women is increasing, the test may be a good method for lung cancer screening in this population,” Dr. Wang said.

After adjusting for age, sex, smoking, and comorbidities, researchers found elevated levels for 16 VOCs in patients with lung cancer. A diagnostic model including the 16 VOCs achieved an area under the curve of 0.952, sensitivity of 89.2%, specificity of 89.1%, and accuracy of 89.1% in lung cancer diagnosis. A model including the top eight VOCs achieved an area under the curve of 0.931, sensitivity of 86.0%, specificity of 87.2%, and accuracy of 86.9%.

After selecting 28 VOCs as candidates through a literature review, Dr. Wang and associates conducted a prospective discovery study from Sept. 1 to Dec. 31, 2020, using high-pressure photon ionization time-of-flight mass spectrometry to evaluate their performance for lung cancer diagnosis. The validation study included 157 lung cancer patients (mean age 57.0 years; 54.1 percent female) and 368 volunteers (mean age 44.5 years; 31.3% female).

“The external validation confirmed good performance of these biomarkers in lung cancer detection,” the researchers stated. It helped, they added, to solve the heterogeneity among published studies, establishing both 16 VOCs and 8 VOCS for lung cancer screening.

The authors stated that a large gap exists between breathomics research and clinical practices in lung cancer detection and screening. While the validated 16 VOCs, mainly aldehydes and hydrocarbon, showed potential for promoting this lung cancer screening strategy, more scientific studies are warranted to investigate the underlying mechanisms of identified lung cancer VOCs.

Dr. Wang declared no competing interests.

A study published in May in The Lancet journal eClinicalMedicine reports that breathomics testing is one step closer to becoming a reality as a lung cancer screening tool.

The tool was successfully used to identify, in 84 patients, 16 lung cancer–related carcinogenic volatile compounds (VOCs), such as aldehydes, hydrocarbons, ketones, carboxylic acids, and furan – some of which are compounds used in the production of common household goods, such as furniture, carpeting, and wood floors.

“The test is anticipated to be highlighted for primary screening of lung cancer but not the final diagnosis,” according to study authors who were led by Peiyu Wang, MD, PhD, chair of social medicine and health at Peking (China) University.

While early diagnosis and treatment are critical for improving lung cancer survival, early detection of lung cancer is challenging because of the lack of clinical manifestations and specific biomarkers. Annual CT scans are costly and include radiation exposure, Dr. Wang and his associates wrote.

Breathomics testing is considered a promising method for detection and screening for lung cancer. It has been under study for years and in 2014, researchers from Belgium published a review in Cancer Epidemiology Biomarkers and Prevention documenting the use of VOCs as early diagnostic or prognostic biomarkers for mesothelioma.

Lung cancer breath biomarkers identified in various studies have been highly heterogeneous because of differing sample collection methods, varying patient conditions, testing environments, and analysis methods. As a result, there currently is no breathomics test for lung cancer screening, Dr. Wang said in an interview.

In terms of its potential as a lung cancer screening tool, “Clinicians may introduce this test for people with high risk for lung cancer, such as elderly smokers, or people with suspected symptoms. It may also be introduced for young populations with subjective or objective needs to screen for lung cancer. As the proportion of lung adenocarcinoma in nonsmoking young women is increasing, the test may be a good method for lung cancer screening in this population,” Dr. Wang said.

After adjusting for age, sex, smoking, and comorbidities, researchers found elevated levels for 16 VOCs in patients with lung cancer. A diagnostic model including the 16 VOCs achieved an area under the curve of 0.952, sensitivity of 89.2%, specificity of 89.1%, and accuracy of 89.1% in lung cancer diagnosis. A model including the top eight VOCs achieved an area under the curve of 0.931, sensitivity of 86.0%, specificity of 87.2%, and accuracy of 86.9%.

After selecting 28 VOCs as candidates through a literature review, Dr. Wang and associates conducted a prospective discovery study from Sept. 1 to Dec. 31, 2020, using high-pressure photon ionization time-of-flight mass spectrometry to evaluate their performance for lung cancer diagnosis. The validation study included 157 lung cancer patients (mean age 57.0 years; 54.1 percent female) and 368 volunteers (mean age 44.5 years; 31.3% female).

“The external validation confirmed good performance of these biomarkers in lung cancer detection,” the researchers stated. It helped, they added, to solve the heterogeneity among published studies, establishing both 16 VOCs and 8 VOCS for lung cancer screening.

The authors stated that a large gap exists between breathomics research and clinical practices in lung cancer detection and screening. While the validated 16 VOCs, mainly aldehydes and hydrocarbon, showed potential for promoting this lung cancer screening strategy, more scientific studies are warranted to investigate the underlying mechanisms of identified lung cancer VOCs.

Dr. Wang declared no competing interests.

The combination of hearing loss and vision loss is linked to an eightfold increased risk of cognitive impairment, new research shows.

Investigators analyzed data on more than 5 million U.S. seniors. Adjusted results show that participants with hearing impairment alone had more than twice the odds of also having cognitive impairment, while those with vision impairment alone had more than triple the odds of cognitive impairment.

However, those with dual sensory impairment (DSI) had an eightfold higher risk for cognitive impairment.

In addition, half of the participants with DSI also had cognitive impairment. Of those with cognitive impairment, 16% had DSI, compared with only about 2% of their peers without cognitive impairment.

“The findings of the present study may inform interventions that can support older people with concurrent sensory impairment and cognitive impairment,” said lead author Esme Fuller-Thomson, PhD, professor, Factor-Inwentash Faculty of Social Work, University of Toronto.

“Special attention, in particular, should be given to those aged 65-74 who have serious hearing and/or vision impairment [because], if the relationship with dementia is found to be causal, such interventions can potentially mitigate the development of cognitive impairment,” said Dr. Fuller-Thomson, who is also director of the Institute for Life Course and Aging and a professor in the department of family and community medicine and faculty of nursing, all at the University of Toronto.

The findings were published online in the Journal of Alzheimer’s Disease  Reports.
 

Sensory isolation

Hearing and vision impairment increase with age; it is estimated that one-third of U.S. adults between the ages of 65 and 74 experience hearing loss, and 4% experience vision impairment, the investigators note.

“The link between dual hearing loss and seeing loss and mental health problems such as depression and social isolation have been well researched, but we were very interested in the link between dual sensory loss and cognitive problems,” Dr. Fuller-Thomson said.

Additionally, “there have been several studies in the past decade linking hearing loss to dementia and cognitive decline, but less attention has been paid to cognitive problems among those with DSI, despite this group being particularly isolated,” she said. Existing research into DSI suggests an association with cognitive decline; the current investigators sought to expand on this previous work.

To do so, they used merged data from 10 consecutive waves from 2008 to 2017 of the American Community Survey (ACS), which was conducted by the U.S. Census Bureau. The ACS is a nationally representative sample of 3.5 million randomly selected U.S. addresses and includes community-dwelling adults and those residing in institutional settings.

Participants aged 65 or older (n = 5,405,135; 56.4% women) were asked yes/no questions regarding serious cognitive impairment, hearing impairment, and vision impairment. A proxy, such as a family member or nursing home staff member, provided answers for individuals not capable of self-report.

Potential confounding variables included age, race/ethnicity, sex, education, and household income.
 

Potential mechanisms

Results showed that, among those with cognitive impairment, there was a higher prevalence of hearing impairment, vision impairment, and DSI than among their peers without cognitive impairment; in addition, a lower percentage of these persons had no sensory impairment (P < .001).

The prevalence of DSI climbed with age, from 1.5% for respondents aged 65-74 years to 2.6% for those aged 75-84 and to 10.8% in those 85 years and older.

Individuals with higher levels of poverty also had higher levels of DSI. Among those who had not completed high school, the prevalence of DSI was higher, compared with high school or university graduates (6.3% vs. 3.1% and 1.85, respectively).

After controlling for age, race, education, and income, the researchers found “substantially” higher odds of cognitive impairment in those with vs. those without sensory impairments.

“The magnitude of the odds of cognitive impairment by sensory impairment was greatest for the youngest cohort (age 65-74) and lowest for the oldest cohort (age 85+),” the investigators wrote. Among participants in the youngest cohort, there was a “dose-response relationship” for those with hearing impairment only, visual impairment only, and DSI.

Because the study was observational, it “does not provide sufficient information to determine the reasons behind the observed link between sensory loss and cognitive problems,” Dr. Fuller-Thomson said. However, there are “several potential causal mechanisms [that] warrant future research.”

The “sensory deprivation hypothesis” suggests that DSI could cause cognitive deterioration because of decreased auditory and visual input. The “resource allocation hypothesis” posits that hearing- or vision-impaired older adults “may use more cognitive resources to accommodate for sensory deficits, allocating fewer cognitive resources for higher-order memory processes,” the researchers wrote. Hearing impairment “may also lead to social disengagement among older adults, hastening cognitive decline due to isolation and lack of stimulation,” they added.

Reverse causality is also possible. In the “cognitive load on perception” hypothesis, cognitive decline may lead to declines in hearing and vision because of “decreased resources for sensory processing.”

In addition, the association may be noncausal. “The ‘common cause hypothesis’ theorizes that sensory impairment and cognitive impairment may be due to shared age-related degeneration of the central nervous system ... or frailty,” Dr. Fuller-Thomson said.
 

Parallel findings

The results are similar to those from a study conducted by Phillip Hwang, PhD, of the department of anatomy and neurobiology, Boston University, and colleagues that was published online in JAMA Network Open.

They analyzed data on 8 years of follow-up of 2,927 participants in the Cardiovascular Health Study (mean age, 74.6 years; 58.2% women).

Compared with no sensory impairment, DSI was associated with increased risk for all-cause dementia and Alzheimer’s disease, but not with vascular dementia.

“Future work in health care guidelines could consider incorporating screening of sensory impairment in older adults as part of risk assessment for dementia,” Nicholas Reed, AuD, and Esther Oh, MD, PhD, both of Johns Hopkins University, Baltimore, wrote in an accompanying editorial.
 

Accurate testing

Commenting on both studies, Heather Whitson, MD, professor of medicine (geriatrics) and ophthalmology and director at the Duke University Center for the Study of Aging and Human Development, Durham, N.C., said both “add further strength to the evidence base, which has really converged in the last few years to support that there is a link between sensory health and cognitive health.”

However, “we still don’t know whether hearing/vision loss causes cognitive decline, though there are plausible ways that sensory loss could affect cognitive abilities like memory, language, and executive function,” she said

Dr. Whitson, who was not involved with the research, is also codirector of the Duke/University of North Carolina Alzheimer’s Disease Research Center at Duke University, Durham, N.C., and the Durham VA Medical Center.

“The big question is whether we can improve patients’ cognitive performance by treating or accommodating their sensory impairments,” she said. “If safe and feasible things like hearing aids or cataract surgery improve cognitive health, even a little bit, it would be a huge benefit to society, because sensory loss is very common, and there are many treatment options,” Dr. Whitson added.

Dr. Fuller-Thomson emphasized that practitioners should “consider the full impact of sensory impairment on cognitive testing methods, as both auditory and visual testing methods may fail to take hearing and vision impairment into account.”

Thus, “when performing cognitive tests on older adults with sensory impairments, practitioners should ensure they are communicating audibly and/or using visual speech cues for hearing-impaired individuals, eliminating items from cognitive tests that rely on vision for those who are visually impaired, and using physical cues for individuals with hearing or dual sensory impairment, as this can help increase the accuracy of testing and prevent confounding,” she said.

The study by Fuller-Thomson et al. was funded by a donation from Janis Rotman. Its investigators have reported no relevant financial relationships. The study by Hwang et al. was funded by contracts from the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging. Dr. Hwang reports no relevant financial relationships. The other investigators’ disclosures are listed in the original article. Dr. Reed received grants from the National Institute on Aging during the conduct of the study and has served on the advisory board of Neosensory outside the submitted work. Dr. Oh and Dr. Whitson report no relevant financial relationships.

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

The combination of hearing loss and vision loss is linked to an eightfold increased risk of cognitive impairment, new research shows.

Investigators analyzed data on more than 5 million U.S. seniors. Adjusted results show that participants with hearing impairment alone had more than twice the odds of also having cognitive impairment, while those with vision impairment alone had more than triple the odds of cognitive impairment.

However, those with dual sensory impairment (DSI) had an eightfold higher risk for cognitive impairment.

In addition, half of the participants with DSI also had cognitive impairment. Of those with cognitive impairment, 16% had DSI, compared with only about 2% of their peers without cognitive impairment.

“The findings of the present study may inform interventions that can support older people with concurrent sensory impairment and cognitive impairment,” said lead author Esme Fuller-Thomson, PhD, professor, Factor-Inwentash Faculty of Social Work, University of Toronto.

“Special attention, in particular, should be given to those aged 65-74 who have serious hearing and/or vision impairment [because], if the relationship with dementia is found to be causal, such interventions can potentially mitigate the development of cognitive impairment,” said Dr. Fuller-Thomson, who is also director of the Institute for Life Course and Aging and a professor in the department of family and community medicine and faculty of nursing, all at the University of Toronto.

The findings were published online in the Journal of Alzheimer’s Disease  Reports.
 

Sensory isolation

Hearing and vision impairment increase with age; it is estimated that one-third of U.S. adults between the ages of 65 and 74 experience hearing loss, and 4% experience vision impairment, the investigators note.

“The link between dual hearing loss and seeing loss and mental health problems such as depression and social isolation have been well researched, but we were very interested in the link between dual sensory loss and cognitive problems,” Dr. Fuller-Thomson said.

Additionally, “there have been several studies in the past decade linking hearing loss to dementia and cognitive decline, but less attention has been paid to cognitive problems among those with DSI, despite this group being particularly isolated,” she said. Existing research into DSI suggests an association with cognitive decline; the current investigators sought to expand on this previous work.

To do so, they used merged data from 10 consecutive waves from 2008 to 2017 of the American Community Survey (ACS), which was conducted by the U.S. Census Bureau. The ACS is a nationally representative sample of 3.5 million randomly selected U.S. addresses and includes community-dwelling adults and those residing in institutional settings.

Participants aged 65 or older (n = 5,405,135; 56.4% women) were asked yes/no questions regarding serious cognitive impairment, hearing impairment, and vision impairment. A proxy, such as a family member or nursing home staff member, provided answers for individuals not capable of self-report.

Potential confounding variables included age, race/ethnicity, sex, education, and household income.
 

Potential mechanisms

Results showed that, among those with cognitive impairment, there was a higher prevalence of hearing impairment, vision impairment, and DSI than among their peers without cognitive impairment; in addition, a lower percentage of these persons had no sensory impairment (P < .001).

The prevalence of DSI climbed with age, from 1.5% for respondents aged 65-74 years to 2.6% for those aged 75-84 and to 10.8% in those 85 years and older.

Individuals with higher levels of poverty also had higher levels of DSI. Among those who had not completed high school, the prevalence of DSI was higher, compared with high school or university graduates (6.3% vs. 3.1% and 1.85, respectively).

After controlling for age, race, education, and income, the researchers found “substantially” higher odds of cognitive impairment in those with vs. those without sensory impairments.

“The magnitude of the odds of cognitive impairment by sensory impairment was greatest for the youngest cohort (age 65-74) and lowest for the oldest cohort (age 85+),” the investigators wrote. Among participants in the youngest cohort, there was a “dose-response relationship” for those with hearing impairment only, visual impairment only, and DSI.

Because the study was observational, it “does not provide sufficient information to determine the reasons behind the observed link between sensory loss and cognitive problems,” Dr. Fuller-Thomson said. However, there are “several potential causal mechanisms [that] warrant future research.”

The “sensory deprivation hypothesis” suggests that DSI could cause cognitive deterioration because of decreased auditory and visual input. The “resource allocation hypothesis” posits that hearing- or vision-impaired older adults “may use more cognitive resources to accommodate for sensory deficits, allocating fewer cognitive resources for higher-order memory processes,” the researchers wrote. Hearing impairment “may also lead to social disengagement among older adults, hastening cognitive decline due to isolation and lack of stimulation,” they added.

Reverse causality is also possible. In the “cognitive load on perception” hypothesis, cognitive decline may lead to declines in hearing and vision because of “decreased resources for sensory processing.”

In addition, the association may be noncausal. “The ‘common cause hypothesis’ theorizes that sensory impairment and cognitive impairment may be due to shared age-related degeneration of the central nervous system ... or frailty,” Dr. Fuller-Thomson said.
 

Parallel findings

The results are similar to those from a study conducted by Phillip Hwang, PhD, of the department of anatomy and neurobiology, Boston University, and colleagues that was published online in JAMA Network Open.

They analyzed data on 8 years of follow-up of 2,927 participants in the Cardiovascular Health Study (mean age, 74.6 years; 58.2% women).

Compared with no sensory impairment, DSI was associated with increased risk for all-cause dementia and Alzheimer’s disease, but not with vascular dementia.

“Future work in health care guidelines could consider incorporating screening of sensory impairment in older adults as part of risk assessment for dementia,” Nicholas Reed, AuD, and Esther Oh, MD, PhD, both of Johns Hopkins University, Baltimore, wrote in an accompanying editorial.
 

Accurate testing

Commenting on both studies, Heather Whitson, MD, professor of medicine (geriatrics) and ophthalmology and director at the Duke University Center for the Study of Aging and Human Development, Durham, N.C., said both “add further strength to the evidence base, which has really converged in the last few years to support that there is a link between sensory health and cognitive health.”

However, “we still don’t know whether hearing/vision loss causes cognitive decline, though there are plausible ways that sensory loss could affect cognitive abilities like memory, language, and executive function,” she said

Dr. Whitson, who was not involved with the research, is also codirector of the Duke/University of North Carolina Alzheimer’s Disease Research Center at Duke University, Durham, N.C., and the Durham VA Medical Center.

“The big question is whether we can improve patients’ cognitive performance by treating or accommodating their sensory impairments,” she said. “If safe and feasible things like hearing aids or cataract surgery improve cognitive health, even a little bit, it would be a huge benefit to society, because sensory loss is very common, and there are many treatment options,” Dr. Whitson added.

Dr. Fuller-Thomson emphasized that practitioners should “consider the full impact of sensory impairment on cognitive testing methods, as both auditory and visual testing methods may fail to take hearing and vision impairment into account.”

Thus, “when performing cognitive tests on older adults with sensory impairments, practitioners should ensure they are communicating audibly and/or using visual speech cues for hearing-impaired individuals, eliminating items from cognitive tests that rely on vision for those who are visually impaired, and using physical cues for individuals with hearing or dual sensory impairment, as this can help increase the accuracy of testing and prevent confounding,” she said.

The study by Fuller-Thomson et al. was funded by a donation from Janis Rotman. Its investigators have reported no relevant financial relationships. The study by Hwang et al. was funded by contracts from the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging. Dr. Hwang reports no relevant financial relationships. The other investigators’ disclosures are listed in the original article. Dr. Reed received grants from the National Institute on Aging during the conduct of the study and has served on the advisory board of Neosensory outside the submitted work. Dr. Oh and Dr. Whitson report no relevant financial relationships.

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

The combination of hearing loss and vision loss is linked to an eightfold increased risk of cognitive impairment, new research shows.

Investigators analyzed data on more than 5 million U.S. seniors. Adjusted results show that participants with hearing impairment alone had more than twice the odds of also having cognitive impairment, while those with vision impairment alone had more than triple the odds of cognitive impairment.

However, those with dual sensory impairment (DSI) had an eightfold higher risk for cognitive impairment.

In addition, half of the participants with DSI also had cognitive impairment. Of those with cognitive impairment, 16% had DSI, compared with only about 2% of their peers without cognitive impairment.

“The findings of the present study may inform interventions that can support older people with concurrent sensory impairment and cognitive impairment,” said lead author Esme Fuller-Thomson, PhD, professor, Factor-Inwentash Faculty of Social Work, University of Toronto.

“Special attention, in particular, should be given to those aged 65-74 who have serious hearing and/or vision impairment [because], if the relationship with dementia is found to be causal, such interventions can potentially mitigate the development of cognitive impairment,” said Dr. Fuller-Thomson, who is also director of the Institute for Life Course and Aging and a professor in the department of family and community medicine and faculty of nursing, all at the University of Toronto.

The findings were published online in the Journal of Alzheimer’s Disease  Reports.
 

Sensory isolation

Hearing and vision impairment increase with age; it is estimated that one-third of U.S. adults between the ages of 65 and 74 experience hearing loss, and 4% experience vision impairment, the investigators note.

“The link between dual hearing loss and seeing loss and mental health problems such as depression and social isolation have been well researched, but we were very interested in the link between dual sensory loss and cognitive problems,” Dr. Fuller-Thomson said.

Additionally, “there have been several studies in the past decade linking hearing loss to dementia and cognitive decline, but less attention has been paid to cognitive problems among those with DSI, despite this group being particularly isolated,” she said. Existing research into DSI suggests an association with cognitive decline; the current investigators sought to expand on this previous work.

To do so, they used merged data from 10 consecutive waves from 2008 to 2017 of the American Community Survey (ACS), which was conducted by the U.S. Census Bureau. The ACS is a nationally representative sample of 3.5 million randomly selected U.S. addresses and includes community-dwelling adults and those residing in institutional settings.

Participants aged 65 or older (n = 5,405,135; 56.4% women) were asked yes/no questions regarding serious cognitive impairment, hearing impairment, and vision impairment. A proxy, such as a family member or nursing home staff member, provided answers for individuals not capable of self-report.

Potential confounding variables included age, race/ethnicity, sex, education, and household income.
 

Potential mechanisms

Results showed that, among those with cognitive impairment, there was a higher prevalence of hearing impairment, vision impairment, and DSI than among their peers without cognitive impairment; in addition, a lower percentage of these persons had no sensory impairment (P < .001).

The prevalence of DSI climbed with age, from 1.5% for respondents aged 65-74 years to 2.6% for those aged 75-84 and to 10.8% in those 85 years and older.

Individuals with higher levels of poverty also had higher levels of DSI. Among those who had not completed high school, the prevalence of DSI was higher, compared with high school or university graduates (6.3% vs. 3.1% and 1.85, respectively).

After controlling for age, race, education, and income, the researchers found “substantially” higher odds of cognitive impairment in those with vs. those without sensory impairments.

“The magnitude of the odds of cognitive impairment by sensory impairment was greatest for the youngest cohort (age 65-74) and lowest for the oldest cohort (age 85+),” the investigators wrote. Among participants in the youngest cohort, there was a “dose-response relationship” for those with hearing impairment only, visual impairment only, and DSI.

Because the study was observational, it “does not provide sufficient information to determine the reasons behind the observed link between sensory loss and cognitive problems,” Dr. Fuller-Thomson said. However, there are “several potential causal mechanisms [that] warrant future research.”

The “sensory deprivation hypothesis” suggests that DSI could cause cognitive deterioration because of decreased auditory and visual input. The “resource allocation hypothesis” posits that hearing- or vision-impaired older adults “may use more cognitive resources to accommodate for sensory deficits, allocating fewer cognitive resources for higher-order memory processes,” the researchers wrote. Hearing impairment “may also lead to social disengagement among older adults, hastening cognitive decline due to isolation and lack of stimulation,” they added.

Reverse causality is also possible. In the “cognitive load on perception” hypothesis, cognitive decline may lead to declines in hearing and vision because of “decreased resources for sensory processing.”

In addition, the association may be noncausal. “The ‘common cause hypothesis’ theorizes that sensory impairment and cognitive impairment may be due to shared age-related degeneration of the central nervous system ... or frailty,” Dr. Fuller-Thomson said.
 

Parallel findings

The results are similar to those from a study conducted by Phillip Hwang, PhD, of the department of anatomy and neurobiology, Boston University, and colleagues that was published online in JAMA Network Open.

They analyzed data on 8 years of follow-up of 2,927 participants in the Cardiovascular Health Study (mean age, 74.6 years; 58.2% women).

Compared with no sensory impairment, DSI was associated with increased risk for all-cause dementia and Alzheimer’s disease, but not with vascular dementia.

“Future work in health care guidelines could consider incorporating screening of sensory impairment in older adults as part of risk assessment for dementia,” Nicholas Reed, AuD, and Esther Oh, MD, PhD, both of Johns Hopkins University, Baltimore, wrote in an accompanying editorial.
 

Accurate testing

Commenting on both studies, Heather Whitson, MD, professor of medicine (geriatrics) and ophthalmology and director at the Duke University Center for the Study of Aging and Human Development, Durham, N.C., said both “add further strength to the evidence base, which has really converged in the last few years to support that there is a link between sensory health and cognitive health.”

However, “we still don’t know whether hearing/vision loss causes cognitive decline, though there are plausible ways that sensory loss could affect cognitive abilities like memory, language, and executive function,” she said

Dr. Whitson, who was not involved with the research, is also codirector of the Duke/University of North Carolina Alzheimer’s Disease Research Center at Duke University, Durham, N.C., and the Durham VA Medical Center.

“The big question is whether we can improve patients’ cognitive performance by treating or accommodating their sensory impairments,” she said. “If safe and feasible things like hearing aids or cataract surgery improve cognitive health, even a little bit, it would be a huge benefit to society, because sensory loss is very common, and there are many treatment options,” Dr. Whitson added.

Dr. Fuller-Thomson emphasized that practitioners should “consider the full impact of sensory impairment on cognitive testing methods, as both auditory and visual testing methods may fail to take hearing and vision impairment into account.”

Thus, “when performing cognitive tests on older adults with sensory impairments, practitioners should ensure they are communicating audibly and/or using visual speech cues for hearing-impaired individuals, eliminating items from cognitive tests that rely on vision for those who are visually impaired, and using physical cues for individuals with hearing or dual sensory impairment, as this can help increase the accuracy of testing and prevent confounding,” she said.

The study by Fuller-Thomson et al. was funded by a donation from Janis Rotman. Its investigators have reported no relevant financial relationships. The study by Hwang et al. was funded by contracts from the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging. Dr. Hwang reports no relevant financial relationships. The other investigators’ disclosures are listed in the original article. Dr. Reed received grants from the National Institute on Aging during the conduct of the study and has served on the advisory board of Neosensory outside the submitted work. Dr. Oh and Dr. Whitson report no relevant financial relationships.

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

Immunotherapy with nivolumab (Opdivo) is now approved in the United States for first-line use in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The new approval for the drug, a programmed cell death–ligand-1 inhibitor, is for use in this patient population regardless of PD-L1 status.

The indication also specifies that nivolumab is to be used together with chemotherapy (with a fluoropyrimidine- and platinum-containing regimen) or in combination with ipilimumab (Yervoy), an immunotherapy with a different mechanism of action.

“Today’s approvals bring two first-line immunotherapy-based treatment options at once ... to newly diagnosed patients with unresectable advanced or metastatic ESCC,” commented Adam Lenkowsky, a senior vice president at Bristol-Myers Squibb, which makes both nivolumab and ipilimumab.

The approval of the new indication by the Food and Drug Administration was based on improved survival shown in the phase 3 CheckMate-648 trial, which involved nearly 1,000 patients. The trial had three arms and compared nivolumab plus chemotherapy (n = 321) and nivolumab plus ipilimumab (n = 324) with chemotherapy alone (n = 324).

The results showed improved survival with both nivolumab combinations compared with chemotherapy (fluorouracil and cisplatin) alone. Overall survival was improved both in all randomized patients (a secondary endpoint) and in patients whose tumors expressed PD-L1 (≥ 1%), the primary endpoint.

For the combination of nivolumab plus chemotherapy, median overall survival was 13.2 versus 10.7 months, compared with chemotherapy alone in all randomized patients, and 15.4 versus 9.1 months in patients whose tumors express PD-L1 (≥ 1%).

For the combination of nivolumab plus ipilimumab, median overall survival was 12.8 versus 10.7 months with chemotherapy alone in all randomized patients and 13.7 versus 9.1 months in patients whose tumors express PD-L1 (≥ 1%).

However, progression-free survival did not reach statistical significance in any group.

“Unresectable advanced or metastatic ESCC is a challenging disease, and there’s a need for additional treatment options that may extend survival in the first-line setting,” commented Jaffer A. Ajani, MD, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center, Houston. He was also the lead U.S. investigator for CheckMate-648 and, in a company press release, said the “two nivolumab-based combinations showed a survival benefit compared to chemotherapy alone, offering new treatment options regardless of PD-L1 status.”

Results from the trial were presented at the 2021 annual meeting of the American Society of Clinical Oncology. At that time, trial investigator Ian Chau, MD, a consultant medical oncologist at the Royal Marsden Hospital in Sutton, England, told attendees that “nivolumab plus chemotherapy and nivolumab plus ipilimumab each represent a new potential first-line standard of care for patients with advanced ESCC.”

Commenting on that presentation, Samuel J. Klempner, MD, a gastrointestinal medical oncologist at the Massachusetts General Hospital Cancer Center, Boston, noted that the “prospect of a chemo-free regimen for advanced ESCC with the well-studied combination of ipilimumab and nivolumab would represent a welcome addition to our treatment armamentarium.”
 

No new safety signals

Dr. Chau noted there were no new safety signals with either of the immunotherapies.

Nivolumab and/or chemotherapy were discontinued in 39% of patients and delayed in 71% of patients for an adverse reaction.

Nivolumab and/or ipilimumab were discontinued in 23% of patients and delayed in 46% of patients for an adverse reaction.

The manufacturer cautioned that immunotherapy with nivolumab with or without ipilimumab has been associated with severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions, and infusion-related reactions.

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

Immunotherapy with nivolumab (Opdivo) is now approved in the United States for first-line use in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The new approval for the drug, a programmed cell death–ligand-1 inhibitor, is for use in this patient population regardless of PD-L1 status.

The indication also specifies that nivolumab is to be used together with chemotherapy (with a fluoropyrimidine- and platinum-containing regimen) or in combination with ipilimumab (Yervoy), an immunotherapy with a different mechanism of action.

“Today’s approvals bring two first-line immunotherapy-based treatment options at once ... to newly diagnosed patients with unresectable advanced or metastatic ESCC,” commented Adam Lenkowsky, a senior vice president at Bristol-Myers Squibb, which makes both nivolumab and ipilimumab.

The approval of the new indication by the Food and Drug Administration was based on improved survival shown in the phase 3 CheckMate-648 trial, which involved nearly 1,000 patients. The trial had three arms and compared nivolumab plus chemotherapy (n = 321) and nivolumab plus ipilimumab (n = 324) with chemotherapy alone (n = 324).

The results showed improved survival with both nivolumab combinations compared with chemotherapy (fluorouracil and cisplatin) alone. Overall survival was improved both in all randomized patients (a secondary endpoint) and in patients whose tumors expressed PD-L1 (≥ 1%), the primary endpoint.

For the combination of nivolumab plus chemotherapy, median overall survival was 13.2 versus 10.7 months, compared with chemotherapy alone in all randomized patients, and 15.4 versus 9.1 months in patients whose tumors express PD-L1 (≥ 1%).

For the combination of nivolumab plus ipilimumab, median overall survival was 12.8 versus 10.7 months with chemotherapy alone in all randomized patients and 13.7 versus 9.1 months in patients whose tumors express PD-L1 (≥ 1%).

However, progression-free survival did not reach statistical significance in any group.

“Unresectable advanced or metastatic ESCC is a challenging disease, and there’s a need for additional treatment options that may extend survival in the first-line setting,” commented Jaffer A. Ajani, MD, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center, Houston. He was also the lead U.S. investigator for CheckMate-648 and, in a company press release, said the “two nivolumab-based combinations showed a survival benefit compared to chemotherapy alone, offering new treatment options regardless of PD-L1 status.”

Results from the trial were presented at the 2021 annual meeting of the American Society of Clinical Oncology. At that time, trial investigator Ian Chau, MD, a consultant medical oncologist at the Royal Marsden Hospital in Sutton, England, told attendees that “nivolumab plus chemotherapy and nivolumab plus ipilimumab each represent a new potential first-line standard of care for patients with advanced ESCC.”

Commenting on that presentation, Samuel J. Klempner, MD, a gastrointestinal medical oncologist at the Massachusetts General Hospital Cancer Center, Boston, noted that the “prospect of a chemo-free regimen for advanced ESCC with the well-studied combination of ipilimumab and nivolumab would represent a welcome addition to our treatment armamentarium.”
 

No new safety signals

Dr. Chau noted there were no new safety signals with either of the immunotherapies.

Nivolumab and/or chemotherapy were discontinued in 39% of patients and delayed in 71% of patients for an adverse reaction.

Nivolumab and/or ipilimumab were discontinued in 23% of patients and delayed in 46% of patients for an adverse reaction.

The manufacturer cautioned that immunotherapy with nivolumab with or without ipilimumab has been associated with severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions, and infusion-related reactions.

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

Immunotherapy with nivolumab (Opdivo) is now approved in the United States for first-line use in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The new approval for the drug, a programmed cell death–ligand-1 inhibitor, is for use in this patient population regardless of PD-L1 status.

The indication also specifies that nivolumab is to be used together with chemotherapy (with a fluoropyrimidine- and platinum-containing regimen) or in combination with ipilimumab (Yervoy), an immunotherapy with a different mechanism of action.

“Today’s approvals bring two first-line immunotherapy-based treatment options at once ... to newly diagnosed patients with unresectable advanced or metastatic ESCC,” commented Adam Lenkowsky, a senior vice president at Bristol-Myers Squibb, which makes both nivolumab and ipilimumab.

The approval of the new indication by the Food and Drug Administration was based on improved survival shown in the phase 3 CheckMate-648 trial, which involved nearly 1,000 patients. The trial had three arms and compared nivolumab plus chemotherapy (n = 321) and nivolumab plus ipilimumab (n = 324) with chemotherapy alone (n = 324).

The results showed improved survival with both nivolumab combinations compared with chemotherapy (fluorouracil and cisplatin) alone. Overall survival was improved both in all randomized patients (a secondary endpoint) and in patients whose tumors expressed PD-L1 (≥ 1%), the primary endpoint.

For the combination of nivolumab plus chemotherapy, median overall survival was 13.2 versus 10.7 months, compared with chemotherapy alone in all randomized patients, and 15.4 versus 9.1 months in patients whose tumors express PD-L1 (≥ 1%).

For the combination of nivolumab plus ipilimumab, median overall survival was 12.8 versus 10.7 months with chemotherapy alone in all randomized patients and 13.7 versus 9.1 months in patients whose tumors express PD-L1 (≥ 1%).

However, progression-free survival did not reach statistical significance in any group.

“Unresectable advanced or metastatic ESCC is a challenging disease, and there’s a need for additional treatment options that may extend survival in the first-line setting,” commented Jaffer A. Ajani, MD, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center, Houston. He was also the lead U.S. investigator for CheckMate-648 and, in a company press release, said the “two nivolumab-based combinations showed a survival benefit compared to chemotherapy alone, offering new treatment options regardless of PD-L1 status.”

Results from the trial were presented at the 2021 annual meeting of the American Society of Clinical Oncology. At that time, trial investigator Ian Chau, MD, a consultant medical oncologist at the Royal Marsden Hospital in Sutton, England, told attendees that “nivolumab plus chemotherapy and nivolumab plus ipilimumab each represent a new potential first-line standard of care for patients with advanced ESCC.”

Commenting on that presentation, Samuel J. Klempner, MD, a gastrointestinal medical oncologist at the Massachusetts General Hospital Cancer Center, Boston, noted that the “prospect of a chemo-free regimen for advanced ESCC with the well-studied combination of ipilimumab and nivolumab would represent a welcome addition to our treatment armamentarium.”
 

No new safety signals

Dr. Chau noted there were no new safety signals with either of the immunotherapies.

Nivolumab and/or chemotherapy were discontinued in 39% of patients and delayed in 71% of patients for an adverse reaction.

Nivolumab and/or ipilimumab were discontinued in 23% of patients and delayed in 46% of patients for an adverse reaction.

The manufacturer cautioned that immunotherapy with nivolumab with or without ipilimumab has been associated with severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions, and infusion-related reactions.

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

NEW ORLEANS – Patients experiencing brain fog and other persistent symptoms of long COVID show significant deficits on neuropsychiatric testing that correspond with prior acute COVID-19 infection, adding to mounting evidence of the significant toll the chronic condition can have on mental health.

“Many clinicians have observed the symptoms we describe in this study, however this report is among the first which identify the specific deficits using neuropsychological testing to better characterize the syndrome,” Sean T. Lynch, MD, first author of a study on the issue presented at the annual meeting of the American Psychiatric Association, said in an interview.

Dr. Lynch, of the department of psychiatry, Westchester Medical Center Health System, Valhalla, N.Y., and his colleagues enrolled 60 participants who had experienced acute COVID-19 disease 6-8 months earlier and had undergone neuropsychological, psychiatric, medical, functional, and quality-of-life assessments. Results from the study were published online in the Journal of the Academy of Consultation–Liaison Psychiatry (2022 Jan 25. doi: 10.1016/j.jaclp.2022.01.003).

Among the study participants, 32 were seeking treatment for brain fog in a clinical program for survivors of COVID-19, while the remaining 28 were part of an ongoing longitudinal investigation of neuropsychological, medical, and psychiatric sequelae of COVID-19, but were not seeking care for the persistent symptoms.

Assessments for neurocognitive impairment included a battery of tests used in infectious and other diseases, including the Test of Premorbid Function, the Patient Assessment of Own Function, the Trail Making Test parts A and B, the Stroop Color and Word Test, and others.

Overall, the battery of assessments showed that 37 (62%) of participants had neuropsychological test impairment, with results below the 16th percentile in two tests, while 16 (27%) showed scores indicative of severe impairment (below the second percentile in at least one test and below the 16th percentile in one test).

Those reporting brain fog had scores that were even lower than expected on tests of attention, processing speed, memory, and executive function. And among those reporting brain fog, significantly more had scores reflecting severe impairment compared with the controls (38% vs. 14%; P < .04).

“Based on what we’ve observed in our patients and what others have previously reported, we did expect to find some impairment in this study sample,” Dr. Lynch noted.

“However, we were surprised to find that 27% of the study sample had extremely low neuropsychological test scores, meaning that they scored at least two standard deviations below the expected score on at least one neuropsychological test based on their age and level of education.”

The brain fog group also reported significantly higher levels of depression, fatigue, PTSD, and functional difficulties, and lower quality of life.

Severe impairment on the neuropsychological tests correlated with the extent of acute COVID-19 symptoms, as well as depression scores, number of medical comorbidities, and subjective cognitive complaints.

An analysis of serum levels of the inflammatory markers among 50 of the 60 participants showed that 45% of the patients had an elevated IL-6, 20% had elevated TNF-alpha, and 41% had elevated CRP, compared with reference ranges.

IL-6 levels were found to correlate with acute COVID-19 symptoms, the number of medical comorbidities, fatigue, and measures of executive function, while C-reactive protein (CRP) correlated with current COVID-19 symptoms and depression scores.

In terms of clinical factors that might predict low neuropsychological test scores, Dr. Lynch noted that the “markers that we found to be significant included severity of acute COVID-19 illness, current post-COVID-19 symptoms, measures of depression and anxiety, level of fatigue, and number of medical comorbidities.”

Dr. Lynch noted that the ongoing study will include up to 18-month follow-ups that are currently underway. “The [follow-ups] will examine if symptoms improve over time and evaluate if any intervention that took place was successful,” he said.


 

Survey supports findings

The detrimental effects of mental health symptoms in long COVID were further supported in another study at the APA meeting, an online survey of 787 survivors of acute COVID-19.

In the community survey, presented by Michael Van Ameringen, MD, a professor in the department of psychiatry and behavioral neurosciences at McMaster University, in Hamilton, Ont., all respondents (100%) reported having persistent symptoms of the virus, and as many as 68% indicated that they had not returned to normal functioning, despite only 15% of the respondents having been hospitalized with COVID-19.

A large proportion showed significant depression, anxiety, and posttraumatic stress disorder (PTSD), and the most commonly reported persistent symptoms were fatigue in 75.9% of respondents, brain fog in 67.9%, concentration difficulties in 61.1%, and weakness in 51.2%.

As many as 88.2% of patients said they experienced persistent neurocognitive symptoms, with poor memory and concentration; 56% reported problems with word finding; and 54.1% had slowed thinking.

The respondents showed high rates of anxiety (41.7%) as well as depression (61.4%) as determined by scores above 9 on the Generalized Anxiety Disorder–7 (GAD-7) and Patient Health Questionnaires (PHQ-9).

As many as 40.5% of respondents showed probable PTSD, with scores above 30 on the PTSD checklist (PCL-5). Their mean resilience score on the Brief Resilient Coping Scale was 13.5, suggesting low resilience.

Among the respondents, 43.3% said they had received past treatment for mental health, while 33.5% were currently receiving mental health treatment.

Dr. Van Ameringen noted the important limitation of the study being an online survey with no control group, but said the responses nevertheless raise the question of the role of prior psychiatric disorders in long COVID.

“In our sample, 40% of respondents had a past psychiatric history, so you wonder if that also makes you vulnerable to long COVID,” he said in an interview.

“About a third were getting psychiatric help, but I think the more impaired you are, the more likely you are to seek help.”

Those who were hospitalized with COVID-19 were at a higher risk of PTSD compared with those not hospitalized (P < .001), as were those under the age of 30 (P < .05) or between 31 and 50 vs. over 50 (P < .01).

Dr. Van Ameringen noted that the survey’s high rate of subjects who had not returned to normal functioning was especially striking.

“This is not a minor issue – these are people who are no longer functioning in society,” he said.
 

In pandemics, the brain tends to be ‘overlooked’

Further addressing the neurological effects of COVID-19 at the APA meeting, Avindra Nath, MD, clinical director of the National Institutes of Neurologic Disorders and Stroke in Bethesda, Md., noted that the persisting cognitive and psychiatric symptoms after illness, such as brain fog and depression and anxiety, are not necessarily unique to COVID-19.

“We have seen this before,” he said. “There have been at least seven or eight human coronaviruses, and the interesting thing is each one affects the brain and causes neurological complications.”

The effects are classified differently and have slightly different receptors, “but the consequences are the same.”

Of note, however, research published in The Lancet Psychiatry (2021 May. doi: 10.1016/S2215-0366[21]00084-5) revealed that symptoms such as dementia, mood, and anxiety are significantly higher after COVID-19 compared with other respiratory infections, with the differences increasing at 180 days since the index event.

Dr. Nath noted that, over the decades, he has observed that in pandemics “the brain tends to get overlooked.” He explained that “what can be most important in the end is what happened in the brain, because those are the things that really cause the long-term consequences.”

“These patients are depressed; they have dementia, they have brain fog, and even now that we recognize these issues, we haven’t done a very good job of studying them,” he said. “There’s so much we still don’t know, and a lot of patients are left with these symptoms and nowhere to go.”

Dr. Lynch, Dr. Van Ameringen, and Dr. Nath had no disclosures to report.

NEW ORLEANS – Patients experiencing brain fog and other persistent symptoms of long COVID show significant deficits on neuropsychiatric testing that correspond with prior acute COVID-19 infection, adding to mounting evidence of the significant toll the chronic condition can have on mental health.

“Many clinicians have observed the symptoms we describe in this study, however this report is among the first which identify the specific deficits using neuropsychological testing to better characterize the syndrome,” Sean T. Lynch, MD, first author of a study on the issue presented at the annual meeting of the American Psychiatric Association, said in an interview.

Dr. Lynch, of the department of psychiatry, Westchester Medical Center Health System, Valhalla, N.Y., and his colleagues enrolled 60 participants who had experienced acute COVID-19 disease 6-8 months earlier and had undergone neuropsychological, psychiatric, medical, functional, and quality-of-life assessments. Results from the study were published online in the Journal of the Academy of Consultation–Liaison Psychiatry (2022 Jan 25. doi: 10.1016/j.jaclp.2022.01.003).

Among the study participants, 32 were seeking treatment for brain fog in a clinical program for survivors of COVID-19, while the remaining 28 were part of an ongoing longitudinal investigation of neuropsychological, medical, and psychiatric sequelae of COVID-19, but were not seeking care for the persistent symptoms.

Assessments for neurocognitive impairment included a battery of tests used in infectious and other diseases, including the Test of Premorbid Function, the Patient Assessment of Own Function, the Trail Making Test parts A and B, the Stroop Color and Word Test, and others.

Overall, the battery of assessments showed that 37 (62%) of participants had neuropsychological test impairment, with results below the 16th percentile in two tests, while 16 (27%) showed scores indicative of severe impairment (below the second percentile in at least one test and below the 16th percentile in one test).

Those reporting brain fog had scores that were even lower than expected on tests of attention, processing speed, memory, and executive function. And among those reporting brain fog, significantly more had scores reflecting severe impairment compared with the controls (38% vs. 14%; P < .04).

“Based on what we’ve observed in our patients and what others have previously reported, we did expect to find some impairment in this study sample,” Dr. Lynch noted.

“However, we were surprised to find that 27% of the study sample had extremely low neuropsychological test scores, meaning that they scored at least two standard deviations below the expected score on at least one neuropsychological test based on their age and level of education.”

The brain fog group also reported significantly higher levels of depression, fatigue, PTSD, and functional difficulties, and lower quality of life.

Severe impairment on the neuropsychological tests correlated with the extent of acute COVID-19 symptoms, as well as depression scores, number of medical comorbidities, and subjective cognitive complaints.

An analysis of serum levels of the inflammatory markers among 50 of the 60 participants showed that 45% of the patients had an elevated IL-6, 20% had elevated TNF-alpha, and 41% had elevated CRP, compared with reference ranges.

IL-6 levels were found to correlate with acute COVID-19 symptoms, the number of medical comorbidities, fatigue, and measures of executive function, while C-reactive protein (CRP) correlated with current COVID-19 symptoms and depression scores.

In terms of clinical factors that might predict low neuropsychological test scores, Dr. Lynch noted that the “markers that we found to be significant included severity of acute COVID-19 illness, current post-COVID-19 symptoms, measures of depression and anxiety, level of fatigue, and number of medical comorbidities.”

Dr. Lynch noted that the ongoing study will include up to 18-month follow-ups that are currently underway. “The [follow-ups] will examine if symptoms improve over time and evaluate if any intervention that took place was successful,” he said.


 

Survey supports findings

The detrimental effects of mental health symptoms in long COVID were further supported in another study at the APA meeting, an online survey of 787 survivors of acute COVID-19.

In the community survey, presented by Michael Van Ameringen, MD, a professor in the department of psychiatry and behavioral neurosciences at McMaster University, in Hamilton, Ont., all respondents (100%) reported having persistent symptoms of the virus, and as many as 68% indicated that they had not returned to normal functioning, despite only 15% of the respondents having been hospitalized with COVID-19.

A large proportion showed significant depression, anxiety, and posttraumatic stress disorder (PTSD), and the most commonly reported persistent symptoms were fatigue in 75.9% of respondents, brain fog in 67.9%, concentration difficulties in 61.1%, and weakness in 51.2%.

As many as 88.2% of patients said they experienced persistent neurocognitive symptoms, with poor memory and concentration; 56% reported problems with word finding; and 54.1% had slowed thinking.

The respondents showed high rates of anxiety (41.7%) as well as depression (61.4%) as determined by scores above 9 on the Generalized Anxiety Disorder–7 (GAD-7) and Patient Health Questionnaires (PHQ-9).

As many as 40.5% of respondents showed probable PTSD, with scores above 30 on the PTSD checklist (PCL-5). Their mean resilience score on the Brief Resilient Coping Scale was 13.5, suggesting low resilience.

Among the respondents, 43.3% said they had received past treatment for mental health, while 33.5% were currently receiving mental health treatment.

Dr. Van Ameringen noted the important limitation of the study being an online survey with no control group, but said the responses nevertheless raise the question of the role of prior psychiatric disorders in long COVID.

“In our sample, 40% of respondents had a past psychiatric history, so you wonder if that also makes you vulnerable to long COVID,” he said in an interview.

“About a third were getting psychiatric help, but I think the more impaired you are, the more likely you are to seek help.”

Those who were hospitalized with COVID-19 were at a higher risk of PTSD compared with those not hospitalized (P < .001), as were those under the age of 30 (P < .05) or between 31 and 50 vs. over 50 (P < .01).

Dr. Van Ameringen noted that the survey’s high rate of subjects who had not returned to normal functioning was especially striking.

“This is not a minor issue – these are people who are no longer functioning in society,” he said.
 

In pandemics, the brain tends to be ‘overlooked’

Further addressing the neurological effects of COVID-19 at the APA meeting, Avindra Nath, MD, clinical director of the National Institutes of Neurologic Disorders and Stroke in Bethesda, Md., noted that the persisting cognitive and psychiatric symptoms after illness, such as brain fog and depression and anxiety, are not necessarily unique to COVID-19.

“We have seen this before,” he said. “There have been at least seven or eight human coronaviruses, and the interesting thing is each one affects the brain and causes neurological complications.”

The effects are classified differently and have slightly different receptors, “but the consequences are the same.”

Of note, however, research published in The Lancet Psychiatry (2021 May. doi: 10.1016/S2215-0366[21]00084-5) revealed that symptoms such as dementia, mood, and anxiety are significantly higher after COVID-19 compared with other respiratory infections, with the differences increasing at 180 days since the index event.

Dr. Nath noted that, over the decades, he has observed that in pandemics “the brain tends to get overlooked.” He explained that “what can be most important in the end is what happened in the brain, because those are the things that really cause the long-term consequences.”

“These patients are depressed; they have dementia, they have brain fog, and even now that we recognize these issues, we haven’t done a very good job of studying them,” he said. “There’s so much we still don’t know, and a lot of patients are left with these symptoms and nowhere to go.”

Dr. Lynch, Dr. Van Ameringen, and Dr. Nath had no disclosures to report.

NEW ORLEANS – Patients experiencing brain fog and other persistent symptoms of long COVID show significant deficits on neuropsychiatric testing that correspond with prior acute COVID-19 infection, adding to mounting evidence of the significant toll the chronic condition can have on mental health.

“Many clinicians have observed the symptoms we describe in this study, however this report is among the first which identify the specific deficits using neuropsychological testing to better characterize the syndrome,” Sean T. Lynch, MD, first author of a study on the issue presented at the annual meeting of the American Psychiatric Association, said in an interview.

Dr. Lynch, of the department of psychiatry, Westchester Medical Center Health System, Valhalla, N.Y., and his colleagues enrolled 60 participants who had experienced acute COVID-19 disease 6-8 months earlier and had undergone neuropsychological, psychiatric, medical, functional, and quality-of-life assessments. Results from the study were published online in the Journal of the Academy of Consultation–Liaison Psychiatry (2022 Jan 25. doi: 10.1016/j.jaclp.2022.01.003).

Among the study participants, 32 were seeking treatment for brain fog in a clinical program for survivors of COVID-19, while the remaining 28 were part of an ongoing longitudinal investigation of neuropsychological, medical, and psychiatric sequelae of COVID-19, but were not seeking care for the persistent symptoms.

Assessments for neurocognitive impairment included a battery of tests used in infectious and other diseases, including the Test of Premorbid Function, the Patient Assessment of Own Function, the Trail Making Test parts A and B, the Stroop Color and Word Test, and others.

Overall, the battery of assessments showed that 37 (62%) of participants had neuropsychological test impairment, with results below the 16th percentile in two tests, while 16 (27%) showed scores indicative of severe impairment (below the second percentile in at least one test and below the 16th percentile in one test).

Those reporting brain fog had scores that were even lower than expected on tests of attention, processing speed, memory, and executive function. And among those reporting brain fog, significantly more had scores reflecting severe impairment compared with the controls (38% vs. 14%; P < .04).

“Based on what we’ve observed in our patients and what others have previously reported, we did expect to find some impairment in this study sample,” Dr. Lynch noted.

“However, we were surprised to find that 27% of the study sample had extremely low neuropsychological test scores, meaning that they scored at least two standard deviations below the expected score on at least one neuropsychological test based on their age and level of education.”

The brain fog group also reported significantly higher levels of depression, fatigue, PTSD, and functional difficulties, and lower quality of life.

Severe impairment on the neuropsychological tests correlated with the extent of acute COVID-19 symptoms, as well as depression scores, number of medical comorbidities, and subjective cognitive complaints.

An analysis of serum levels of the inflammatory markers among 50 of the 60 participants showed that 45% of the patients had an elevated IL-6, 20% had elevated TNF-alpha, and 41% had elevated CRP, compared with reference ranges.

IL-6 levels were found to correlate with acute COVID-19 symptoms, the number of medical comorbidities, fatigue, and measures of executive function, while C-reactive protein (CRP) correlated with current COVID-19 symptoms and depression scores.

In terms of clinical factors that might predict low neuropsychological test scores, Dr. Lynch noted that the “markers that we found to be significant included severity of acute COVID-19 illness, current post-COVID-19 symptoms, measures of depression and anxiety, level of fatigue, and number of medical comorbidities.”

Dr. Lynch noted that the ongoing study will include up to 18-month follow-ups that are currently underway. “The [follow-ups] will examine if symptoms improve over time and evaluate if any intervention that took place was successful,” he said.


 

Survey supports findings

The detrimental effects of mental health symptoms in long COVID were further supported in another study at the APA meeting, an online survey of 787 survivors of acute COVID-19.

In the community survey, presented by Michael Van Ameringen, MD, a professor in the department of psychiatry and behavioral neurosciences at McMaster University, in Hamilton, Ont., all respondents (100%) reported having persistent symptoms of the virus, and as many as 68% indicated that they had not returned to normal functioning, despite only 15% of the respondents having been hospitalized with COVID-19.

A large proportion showed significant depression, anxiety, and posttraumatic stress disorder (PTSD), and the most commonly reported persistent symptoms were fatigue in 75.9% of respondents, brain fog in 67.9%, concentration difficulties in 61.1%, and weakness in 51.2%.

As many as 88.2% of patients said they experienced persistent neurocognitive symptoms, with poor memory and concentration; 56% reported problems with word finding; and 54.1% had slowed thinking.

The respondents showed high rates of anxiety (41.7%) as well as depression (61.4%) as determined by scores above 9 on the Generalized Anxiety Disorder–7 (GAD-7) and Patient Health Questionnaires (PHQ-9).

As many as 40.5% of respondents showed probable PTSD, with scores above 30 on the PTSD checklist (PCL-5). Their mean resilience score on the Brief Resilient Coping Scale was 13.5, suggesting low resilience.

Among the respondents, 43.3% said they had received past treatment for mental health, while 33.5% were currently receiving mental health treatment.

Dr. Van Ameringen noted the important limitation of the study being an online survey with no control group, but said the responses nevertheless raise the question of the role of prior psychiatric disorders in long COVID.

“In our sample, 40% of respondents had a past psychiatric history, so you wonder if that also makes you vulnerable to long COVID,” he said in an interview.

“About a third were getting psychiatric help, but I think the more impaired you are, the more likely you are to seek help.”

Those who were hospitalized with COVID-19 were at a higher risk of PTSD compared with those not hospitalized (P < .001), as were those under the age of 30 (P < .05) or between 31 and 50 vs. over 50 (P < .01).

Dr. Van Ameringen noted that the survey’s high rate of subjects who had not returned to normal functioning was especially striking.

“This is not a minor issue – these are people who are no longer functioning in society,” he said.
 

In pandemics, the brain tends to be ‘overlooked’

Further addressing the neurological effects of COVID-19 at the APA meeting, Avindra Nath, MD, clinical director of the National Institutes of Neurologic Disorders and Stroke in Bethesda, Md., noted that the persisting cognitive and psychiatric symptoms after illness, such as brain fog and depression and anxiety, are not necessarily unique to COVID-19.

“We have seen this before,” he said. “There have been at least seven or eight human coronaviruses, and the interesting thing is each one affects the brain and causes neurological complications.”

The effects are classified differently and have slightly different receptors, “but the consequences are the same.”

Of note, however, research published in The Lancet Psychiatry (2021 May. doi: 10.1016/S2215-0366[21]00084-5) revealed that symptoms such as dementia, mood, and anxiety are significantly higher after COVID-19 compared with other respiratory infections, with the differences increasing at 180 days since the index event.

Dr. Nath noted that, over the decades, he has observed that in pandemics “the brain tends to get overlooked.” He explained that “what can be most important in the end is what happened in the brain, because those are the things that really cause the long-term consequences.”

“These patients are depressed; they have dementia, they have brain fog, and even now that we recognize these issues, we haven’t done a very good job of studying them,” he said. “There’s so much we still don’t know, and a lot of patients are left with these symptoms and nowhere to go.”

Dr. Lynch, Dr. Van Ameringen, and Dr. Nath had no disclosures to report.

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Headache medicine expert Joel Saper, MD once saw the formation of the United Council for Neurologic Subspecialties as a sign of progress in the field. In 2005, he even helped write their first certification exam for headache medicine.

Now he’s calling fraud.

After Dr. Saper’s initial 10-year certification expired, he paid $1,800 to take a recertification test. Passing this, he earned another decade of diplomate status; or so he thought, until a couple years later, when he received word from the UCNS.

“They were changing the rules,” Dr. Saper said in an interview. “The 10-year certificate was no longer valid. You had to go through another process.”

That process, known as continuous certification, has become the new standard among medical boards. In contrast with a more conventional recertification process that depends upon high-fee, high-stakes exams taken years apart, continuous certification typically involves a relatively small annual fee coupled with online reading and assessments designed to ensure familiarity with advances in the field.

It’s not just the physicians that need to study up. Medical boards are under pressure to ensure that they are maintaining retention, a potentially challenging task with approximately 200 medical certifying boards in the United States competing for attention, and in some cases, credibility.

Pivots to new systems of recertification have been a particular flash point among physicians. In 2015, a Newsweek article described how a group of “nationally known physicians revolted against the American Board of Internal Medicine” after the board “attempted to expand its program for recertifying doctors, adding boatloads of requirements and fees to be paid by physicians.”

In response, ABIM attacked both the journalist and Newsweek, citing a conflict of interest (the journalist was married to a doctor). The journalist went on to uncover some uncomfortable statistics, including the fact that, over a 5-year period, the ABIM Foundation lost $39.8 million while paying senior administrators $125.7 million. Such revelations have likely added to a collective skepticism about medical boards and their motives.
 

The changing landscape of recertification

According to Brenda Riggott, executive director of the UCNS, the switch to continuous certification was driven by a need to keep up with new standards.

“We really found the landscape of maintaining medical certifications in general was changing,” Ms. Riggott said, highlighting how the UCNS “evaluated 13 different continuous certification models being administered by medical boards” before settling upon the present model.

Continuous certification with the UCNS now requires a $175 annual fee. Each year, diplomates read 10 journal articles, then take a 25-question online quiz to demonstrate their understanding.

“It’s really about patient care,” Ms. Riggott said in an interview. “Medicine changes rapidly. And there are a lot of advances. Evaluating that once a decade is really not enough to verify that somebody is maintaining their skills, their knowledge.”

Dr. Saper, a clinical professor of neurology at Michigan State University, East Lansing, and founder-director of the Michigan Head Pain and Neurological Institute, Ann Arbor, had no inherent qualm with transitioning to this newer process, but he did take umbrage at its execution, since his UCNS certificate still had about 7 years until expiry.

He said the UCNS should have honored existing certificates through their stated duration, citing precedent set by the American Academy of Neurology. When the AAN transitioned from lifetime board certification to a periodic recertification process, they honored the lifetime status of those who already held it, according to Dr. Saper.

“[The AAN] looked at those of us who had been boarded under the premise that we were going to be lifetime boarded ... and they said: ‘We’re going to grandfather you ... because that was the rule under which you took your initial exams.’ ... That’s what UCNS should have done,” Dr. Saper said.
 

A compromise

Under pressure from Dr. Saper and others, UCNS compromised by endorsing 10-year diplomates until the 5-year mark.

Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and the editor-in-chief of Neurology Reviews, was among those who spoke up, only to see the duration of his certification cut in half.

“UCNS obviously realized that they had been wrong,” Dr. Rapoport said, referring to the compromise they made.

At the 5-year mark, physicians who didn’t adopt the new system were deleted from the UCNS online database, eliminating “the only way the public would know whether or not we were certified. This was after UCNS told us we would stay on the list with a note next to our name suggesting our certification was incomplete. They did not care that this might have hurt our reputations,” Dr. Rapoport said.

“To this day, no refunds, partial or full, have been given for the $1,800 we paid for the privilege of sitting for the exam, or for our time studying, or for the expenses accrued from canceling a day in the office and traveling to a testing center,” Dr. Rapoport said. “I did not want the money back; I wanted the certification promised to me. Since they have removed my name from this list, they do owe me the $1,800. They say they do not return their fees if you fail. How about if you pass and they remove you from their list?”

Yet he went on to make clear that the real issue is the principle of the matter. “This is not about money,” Dr. Rapoport said. “This is about what is fair and right.”

“The UCNS issued me a certificate for 10 years of certification in headache medicine; it is unethical and unlawful to break that contract and grant me only 5 years. Worse, they removed my name as though I do not exist. Along with Dr. Saper, I was one of the doctors that spent time and effort to advance headache medicine from October 1979, when I became a headache specialist, to today. I supported the principles of UCNS and took the first exam. I became the President of the International Headache Society and traveled the world promoting headache medicine; and this is how I am treated. Who can respect this type of certification, or this organization?”

Dr. Saper agreed: “It’s not about the money. It’s about the commitment. It’s very fraudulent.”

After the UCNS decision, Dr. Rapoport and Dr. Saper sought legal counsel, but ultimately decided not to sue the UCNS because of the lengthy process it would entail and the cost, estimated to be over $100,000.

“Our lawyers said: ‘It’s going to be years to get through it. You’ll probably win in the end, because it was fraudulent behavior,’ ” Dr. Saper said.
 

A different viewpoint

Ms. Riggott offered a different viewpoint: Nobody was guaranteed 10 years of certification.

“People do not pay for certification [from the UCNS],” Ms. Riggott said. “They pay to sit for an exam. It’s an exam administration fee. That can be construed as: ‘They paid for 10 years.’ They did not. They paid to sit for an exam. There are people who pay for an exam, and they don’t pass it, and they’re not certified. They don’t get a refund. That’s just the way high-stakes certification exams go.”

Dr. Saper and Dr. Rapoport see it differently. “The inherent reason any of us sit for an exam is to get certified.” Dr. Rapoport added. “Ms. Riggott is not being honest. There was an implied contract that if we passed, we would be granted a 10-year certification because that was what we did previously and that is what they told us would happen. Why would they have sent me this nice certificate for 10 more years of certification if she were telling the truth?”

Courtesy Dr. Alan M. Rapoport

Profits over promises

Dr. Rapoport estimates that many other neurologists had their certificates cut short and were dropped from this official list, some of them eminent members of the field, including David Watson, MD, professor and chair of neurology at West Virginia University Rockefeller Neuroscience Institute, Morgantown, and Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University.

“It is troubling when the organizations charged with maintaining the integrity of our specialization do not act with integrity,” Dr. Watson said. “The UCNS chose profits over promises and has refused to meaningfully engage with those of us whom they have wronged. What was once a point of pride for me (being in the second class of certified headache medicine diplomates) has become a meaningless piece of paper. This makes me sad.”

Dr. Cowan said the UCNS actions angered him while affirming his lifelong skepticism of clubs. “I was very sorry, but not surprised, to see the UCNS change the rules when the opportunity to make more money presented itself, and not surprised they did not honor their contracts. UCNS is just another scam like Best Doctors in the US and similar hypes. Neither are worth another dime of my money nor the time spent discussing them. One thing more: I have no quarrel with efforts to encourage keeping up with the field, although no one I know needs codification or direction as to which articles should be read. My outrage comes when responsible behavior is used as an excuse to line the pockets of dishonest, immoral individuals. I’m done.”

According to Ms. Riggott, the UCNS continuous certification process continues to evolve based on feedback from diplomates. She noted that “change is hard,” although the challenges of the transition appear to be paying off. “Initial retention for continuing certification is much higher than we would have expected from a high-stakes recertification exam,” she said. “So we are very, very happy about that.”
 

Proprietary tests drive revenue

According to Katie Collins, executive director of the National Board of Physicians and Surgeons, proprietary tests are a key revenue driver for medical boards, casting doubt on their educational motives.

“This isn’t really about maintaining their education, it’s really about having control over what they learn,” Ms. Collins said. “And unfortunately, physicians no longer have control over what they learn.”

NBPAS was formed largely in response to physicians dissatisfied with this situation. For $189 every 2 years, plus $25 for a paper certificate, NBPAS recertifies doctors originally credentialed by the American Board of Medical Specialties or the American Osteopathic Association.

Instead of making physicians take proprietary tests, NBPAS requires them to earn 50 hours of Accreditation Council for Continuing Medical Education–accredited CME every 2 years. Physicians can select where they seek this credit, giving them the agency to “pick and choose where they want to learn more,” Ms. Collins said, noting that this allows physicians to address personal knowledge gaps, instead of mastering the prescriptive lessons issued by other boards.

While this benefits physicians, Ms. Collins added, it also reduces the bottom line.

NBPAS is a “true 501(c)(3),” she said. “We have money for rainy days, but certainly not millions. We don’t have anything close to a million in savings.” Most medical boards are making millions on top of their services, she said. “That’s not for me to rein in, but it’s for me to point out.”

Noah Rosen, MD, associate professor of neurology and psychiatry at Northwell Health, Great Neck, N.Y., and former UCNS board member, said the UCNS was not motivated by money when they decided to switch to continuous recertification.

“The UCNS budget is publicly available,” Dr. Rosen said in an interview. “This is not a money-making organization,” he added, noting that the UCNS has “been basically operating on a breakeven budget,” and that certification “is not really a money-making proposition.”

Public IRS filings from 2019 and 2020 suggest a slightly different picture. In 2019, the UCNS reported net income of $72,256. In 2020, the inaugural year of the continuous certification program, net income jumped almost fivefold to $349,108. Over the same period, total assets held by the UCNS rose from $1.97 million to $2.37 million.

For comparison, NBPAS controls approximately $500,000 in total assets. The ABIM? Just shy of $72 million.
 

Recertification highlights a generational gap

Dr. Rosen, who was not a voting board member when the UCNS decided to switch to continuous certification, suggested that the transition could have been handled more effectively.

“I think Dr. Rapoport speaks to the frustration of how they made the transition, and that it could have been done in a way that recognizes people that held the certificate in a better way,” Dr. Rosen said.

He said that the departure of Dr. Rapoport and other neurologists from the UCNS points to another trend in the certification space. “I do think it brings up a deeper issue: What’s the value of certification? Dr. Rapoport and other people have brought up the question: What actually does this certificate bring you, if it’s not recognized by the federal government, and actually is not recognized by a lot of state governments, as well, as an official certification?”

He said the answer could depend on age.

“There seems to be a difference between younger people entering into the field and people that are more established in the field already,” Dr. Rosen said. “Younger people entering the field, they see certification as a distinction, something that separates them from the experiences and maybe every other neurologist.”

Ms. Collins independently pointed out the same generational gap. She noted that when the ABMS changed their maintenance model from lifelong to periodic in 2000, approximately 60% of their physicians had to change with the times, while the remainder did not.

“They grandfathered the other 40% – the older, probably more Caucasian male physicians,” she said. “It’s just the field. It’s evolved, it’s become more diverse. They created a divide in the physician community about what is the best means to maintain your board.”

In response to these comments, and despite his negative experiences with the UCNS, Dr. Rapoport emphasized that he still places high value on subspecialty certification.

“I care a lot about certification and that is why I decided to study for and take the only exam offered at the time,” he said, “I do not need it to continue my practice in headache medicine. No one asks me if I am certified in headache medicine. My patients are referred to me because of my reputation. But I have always sought the highest level of certification I could get. What UCNS has done is to cheapen the value of their certification.”

Dr. Rosen and Ms. Collins highlighted the other side of the same conclusion: For younger physicians, board certifications are more of a career consideration than they are for older physicians, as they could mean the difference between landing or losing a job.

“The American Board of Medical Specialties and [their] 24 member boards have really woven board certification into a requirement for employment for hospital privileges and for reimbursement,” Ms. Collins said.

And so, the practical value of board certification may depend most on the tenure of the person holding paper.

“I have not gone back to get any further certification [from the UCNS],” Dr. Saper said.

Even if his name has been removed from the UCNS register, he pointed out that his printed certificate still shows it’s valid until October 31st, 2026: “If anybody asks: ‘Are you certified?’ I say: ‘Here’s my certificate.’ ”

Courtesy Joel R. Saper, MD

Headache medicine expert Joel Saper, MD once saw the formation of the United Council for Neurologic Subspecialties as a sign of progress in the field. In 2005, he even helped write their first certification exam for headache medicine.

Now he’s calling fraud.

After Dr. Saper’s initial 10-year certification expired, he paid $1,800 to take a recertification test. Passing this, he earned another decade of diplomate status; or so he thought, until a couple years later, when he received word from the UCNS.

“They were changing the rules,” Dr. Saper said in an interview. “The 10-year certificate was no longer valid. You had to go through another process.”

That process, known as continuous certification, has become the new standard among medical boards. In contrast with a more conventional recertification process that depends upon high-fee, high-stakes exams taken years apart, continuous certification typically involves a relatively small annual fee coupled with online reading and assessments designed to ensure familiarity with advances in the field.

It’s not just the physicians that need to study up. Medical boards are under pressure to ensure that they are maintaining retention, a potentially challenging task with approximately 200 medical certifying boards in the United States competing for attention, and in some cases, credibility.

Pivots to new systems of recertification have been a particular flash point among physicians. In 2015, a Newsweek article described how a group of “nationally known physicians revolted against the American Board of Internal Medicine” after the board “attempted to expand its program for recertifying doctors, adding boatloads of requirements and fees to be paid by physicians.”

In response, ABIM attacked both the journalist and Newsweek, citing a conflict of interest (the journalist was married to a doctor). The journalist went on to uncover some uncomfortable statistics, including the fact that, over a 5-year period, the ABIM Foundation lost $39.8 million while paying senior administrators $125.7 million. Such revelations have likely added to a collective skepticism about medical boards and their motives.
 

The changing landscape of recertification

According to Brenda Riggott, executive director of the UCNS, the switch to continuous certification was driven by a need to keep up with new standards.

“We really found the landscape of maintaining medical certifications in general was changing,” Ms. Riggott said, highlighting how the UCNS “evaluated 13 different continuous certification models being administered by medical boards” before settling upon the present model.

Continuous certification with the UCNS now requires a $175 annual fee. Each year, diplomates read 10 journal articles, then take a 25-question online quiz to demonstrate their understanding.

“It’s really about patient care,” Ms. Riggott said in an interview. “Medicine changes rapidly. And there are a lot of advances. Evaluating that once a decade is really not enough to verify that somebody is maintaining their skills, their knowledge.”

Dr. Saper, a clinical professor of neurology at Michigan State University, East Lansing, and founder-director of the Michigan Head Pain and Neurological Institute, Ann Arbor, had no inherent qualm with transitioning to this newer process, but he did take umbrage at its execution, since his UCNS certificate still had about 7 years until expiry.

He said the UCNS should have honored existing certificates through their stated duration, citing precedent set by the American Academy of Neurology. When the AAN transitioned from lifetime board certification to a periodic recertification process, they honored the lifetime status of those who already held it, according to Dr. Saper.

“[The AAN] looked at those of us who had been boarded under the premise that we were going to be lifetime boarded ... and they said: ‘We’re going to grandfather you ... because that was the rule under which you took your initial exams.’ ... That’s what UCNS should have done,” Dr. Saper said.
 

A compromise

Under pressure from Dr. Saper and others, UCNS compromised by endorsing 10-year diplomates until the 5-year mark.

Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and the editor-in-chief of Neurology Reviews, was among those who spoke up, only to see the duration of his certification cut in half.

“UCNS obviously realized that they had been wrong,” Dr. Rapoport said, referring to the compromise they made.

At the 5-year mark, physicians who didn’t adopt the new system were deleted from the UCNS online database, eliminating “the only way the public would know whether or not we were certified. This was after UCNS told us we would stay on the list with a note next to our name suggesting our certification was incomplete. They did not care that this might have hurt our reputations,” Dr. Rapoport said.

“To this day, no refunds, partial or full, have been given for the $1,800 we paid for the privilege of sitting for the exam, or for our time studying, or for the expenses accrued from canceling a day in the office and traveling to a testing center,” Dr. Rapoport said. “I did not want the money back; I wanted the certification promised to me. Since they have removed my name from this list, they do owe me the $1,800. They say they do not return their fees if you fail. How about if you pass and they remove you from their list?”

Yet he went on to make clear that the real issue is the principle of the matter. “This is not about money,” Dr. Rapoport said. “This is about what is fair and right.”

“The UCNS issued me a certificate for 10 years of certification in headache medicine; it is unethical and unlawful to break that contract and grant me only 5 years. Worse, they removed my name as though I do not exist. Along with Dr. Saper, I was one of the doctors that spent time and effort to advance headache medicine from October 1979, when I became a headache specialist, to today. I supported the principles of UCNS and took the first exam. I became the President of the International Headache Society and traveled the world promoting headache medicine; and this is how I am treated. Who can respect this type of certification, or this organization?”

Dr. Saper agreed: “It’s not about the money. It’s about the commitment. It’s very fraudulent.”

After the UCNS decision, Dr. Rapoport and Dr. Saper sought legal counsel, but ultimately decided not to sue the UCNS because of the lengthy process it would entail and the cost, estimated to be over $100,000.

“Our lawyers said: ‘It’s going to be years to get through it. You’ll probably win in the end, because it was fraudulent behavior,’ ” Dr. Saper said.
 

A different viewpoint

Ms. Riggott offered a different viewpoint: Nobody was guaranteed 10 years of certification.

“People do not pay for certification [from the UCNS],” Ms. Riggott said. “They pay to sit for an exam. It’s an exam administration fee. That can be construed as: ‘They paid for 10 years.’ They did not. They paid to sit for an exam. There are people who pay for an exam, and they don’t pass it, and they’re not certified. They don’t get a refund. That’s just the way high-stakes certification exams go.”

Dr. Saper and Dr. Rapoport see it differently. “The inherent reason any of us sit for an exam is to get certified.” Dr. Rapoport added. “Ms. Riggott is not being honest. There was an implied contract that if we passed, we would be granted a 10-year certification because that was what we did previously and that is what they told us would happen. Why would they have sent me this nice certificate for 10 more years of certification if she were telling the truth?”

Courtesy Dr. Alan M. Rapoport

Profits over promises

Dr. Rapoport estimates that many other neurologists had their certificates cut short and were dropped from this official list, some of them eminent members of the field, including David Watson, MD, professor and chair of neurology at West Virginia University Rockefeller Neuroscience Institute, Morgantown, and Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University.

“It is troubling when the organizations charged with maintaining the integrity of our specialization do not act with integrity,” Dr. Watson said. “The UCNS chose profits over promises and has refused to meaningfully engage with those of us whom they have wronged. What was once a point of pride for me (being in the second class of certified headache medicine diplomates) has become a meaningless piece of paper. This makes me sad.”

Dr. Cowan said the UCNS actions angered him while affirming his lifelong skepticism of clubs. “I was very sorry, but not surprised, to see the UCNS change the rules when the opportunity to make more money presented itself, and not surprised they did not honor their contracts. UCNS is just another scam like Best Doctors in the US and similar hypes. Neither are worth another dime of my money nor the time spent discussing them. One thing more: I have no quarrel with efforts to encourage keeping up with the field, although no one I know needs codification or direction as to which articles should be read. My outrage comes when responsible behavior is used as an excuse to line the pockets of dishonest, immoral individuals. I’m done.”

According to Ms. Riggott, the UCNS continuous certification process continues to evolve based on feedback from diplomates. She noted that “change is hard,” although the challenges of the transition appear to be paying off. “Initial retention for continuing certification is much higher than we would have expected from a high-stakes recertification exam,” she said. “So we are very, very happy about that.”
 

Proprietary tests drive revenue

According to Katie Collins, executive director of the National Board of Physicians and Surgeons, proprietary tests are a key revenue driver for medical boards, casting doubt on their educational motives.

“This isn’t really about maintaining their education, it’s really about having control over what they learn,” Ms. Collins said. “And unfortunately, physicians no longer have control over what they learn.”

NBPAS was formed largely in response to physicians dissatisfied with this situation. For $189 every 2 years, plus $25 for a paper certificate, NBPAS recertifies doctors originally credentialed by the American Board of Medical Specialties or the American Osteopathic Association.

Instead of making physicians take proprietary tests, NBPAS requires them to earn 50 hours of Accreditation Council for Continuing Medical Education–accredited CME every 2 years. Physicians can select where they seek this credit, giving them the agency to “pick and choose where they want to learn more,” Ms. Collins said, noting that this allows physicians to address personal knowledge gaps, instead of mastering the prescriptive lessons issued by other boards.

While this benefits physicians, Ms. Collins added, it also reduces the bottom line.

NBPAS is a “true 501(c)(3),” she said. “We have money for rainy days, but certainly not millions. We don’t have anything close to a million in savings.” Most medical boards are making millions on top of their services, she said. “That’s not for me to rein in, but it’s for me to point out.”

Noah Rosen, MD, associate professor of neurology and psychiatry at Northwell Health, Great Neck, N.Y., and former UCNS board member, said the UCNS was not motivated by money when they decided to switch to continuous recertification.

“The UCNS budget is publicly available,” Dr. Rosen said in an interview. “This is not a money-making organization,” he added, noting that the UCNS has “been basically operating on a breakeven budget,” and that certification “is not really a money-making proposition.”

Public IRS filings from 2019 and 2020 suggest a slightly different picture. In 2019, the UCNS reported net income of $72,256. In 2020, the inaugural year of the continuous certification program, net income jumped almost fivefold to $349,108. Over the same period, total assets held by the UCNS rose from $1.97 million to $2.37 million.

For comparison, NBPAS controls approximately $500,000 in total assets. The ABIM? Just shy of $72 million.
 

Recertification highlights a generational gap

Dr. Rosen, who was not a voting board member when the UCNS decided to switch to continuous certification, suggested that the transition could have been handled more effectively.

“I think Dr. Rapoport speaks to the frustration of how they made the transition, and that it could have been done in a way that recognizes people that held the certificate in a better way,” Dr. Rosen said.

He said that the departure of Dr. Rapoport and other neurologists from the UCNS points to another trend in the certification space. “I do think it brings up a deeper issue: What’s the value of certification? Dr. Rapoport and other people have brought up the question: What actually does this certificate bring you, if it’s not recognized by the federal government, and actually is not recognized by a lot of state governments, as well, as an official certification?”

He said the answer could depend on age.

“There seems to be a difference between younger people entering into the field and people that are more established in the field already,” Dr. Rosen said. “Younger people entering the field, they see certification as a distinction, something that separates them from the experiences and maybe every other neurologist.”

Ms. Collins independently pointed out the same generational gap. She noted that when the ABMS changed their maintenance model from lifelong to periodic in 2000, approximately 60% of their physicians had to change with the times, while the remainder did not.

“They grandfathered the other 40% – the older, probably more Caucasian male physicians,” she said. “It’s just the field. It’s evolved, it’s become more diverse. They created a divide in the physician community about what is the best means to maintain your board.”

In response to these comments, and despite his negative experiences with the UCNS, Dr. Rapoport emphasized that he still places high value on subspecialty certification.

“I care a lot about certification and that is why I decided to study for and take the only exam offered at the time,” he said, “I do not need it to continue my practice in headache medicine. No one asks me if I am certified in headache medicine. My patients are referred to me because of my reputation. But I have always sought the highest level of certification I could get. What UCNS has done is to cheapen the value of their certification.”

Dr. Rosen and Ms. Collins highlighted the other side of the same conclusion: For younger physicians, board certifications are more of a career consideration than they are for older physicians, as they could mean the difference between landing or losing a job.

“The American Board of Medical Specialties and [their] 24 member boards have really woven board certification into a requirement for employment for hospital privileges and for reimbursement,” Ms. Collins said.

And so, the practical value of board certification may depend most on the tenure of the person holding paper.

“I have not gone back to get any further certification [from the UCNS],” Dr. Saper said.

Even if his name has been removed from the UCNS register, he pointed out that his printed certificate still shows it’s valid until October 31st, 2026: “If anybody asks: ‘Are you certified?’ I say: ‘Here’s my certificate.’ ”

Courtesy Joel R. Saper, MD

Headache medicine expert Joel Saper, MD once saw the formation of the United Council for Neurologic Subspecialties as a sign of progress in the field. In 2005, he even helped write their first certification exam for headache medicine.

Now he’s calling fraud.

After Dr. Saper’s initial 10-year certification expired, he paid $1,800 to take a recertification test. Passing this, he earned another decade of diplomate status; or so he thought, until a couple years later, when he received word from the UCNS.

“They were changing the rules,” Dr. Saper said in an interview. “The 10-year certificate was no longer valid. You had to go through another process.”

That process, known as continuous certification, has become the new standard among medical boards. In contrast with a more conventional recertification process that depends upon high-fee, high-stakes exams taken years apart, continuous certification typically involves a relatively small annual fee coupled with online reading and assessments designed to ensure familiarity with advances in the field.

It’s not just the physicians that need to study up. Medical boards are under pressure to ensure that they are maintaining retention, a potentially challenging task with approximately 200 medical certifying boards in the United States competing for attention, and in some cases, credibility.

Pivots to new systems of recertification have been a particular flash point among physicians. In 2015, a Newsweek article described how a group of “nationally known physicians revolted against the American Board of Internal Medicine” after the board “attempted to expand its program for recertifying doctors, adding boatloads of requirements and fees to be paid by physicians.”

In response, ABIM attacked both the journalist and Newsweek, citing a conflict of interest (the journalist was married to a doctor). The journalist went on to uncover some uncomfortable statistics, including the fact that, over a 5-year period, the ABIM Foundation lost $39.8 million while paying senior administrators $125.7 million. Such revelations have likely added to a collective skepticism about medical boards and their motives.
 

The changing landscape of recertification

According to Brenda Riggott, executive director of the UCNS, the switch to continuous certification was driven by a need to keep up with new standards.

“We really found the landscape of maintaining medical certifications in general was changing,” Ms. Riggott said, highlighting how the UCNS “evaluated 13 different continuous certification models being administered by medical boards” before settling upon the present model.

Continuous certification with the UCNS now requires a $175 annual fee. Each year, diplomates read 10 journal articles, then take a 25-question online quiz to demonstrate their understanding.

“It’s really about patient care,” Ms. Riggott said in an interview. “Medicine changes rapidly. And there are a lot of advances. Evaluating that once a decade is really not enough to verify that somebody is maintaining their skills, their knowledge.”

Dr. Saper, a clinical professor of neurology at Michigan State University, East Lansing, and founder-director of the Michigan Head Pain and Neurological Institute, Ann Arbor, had no inherent qualm with transitioning to this newer process, but he did take umbrage at its execution, since his UCNS certificate still had about 7 years until expiry.

He said the UCNS should have honored existing certificates through their stated duration, citing precedent set by the American Academy of Neurology. When the AAN transitioned from lifetime board certification to a periodic recertification process, they honored the lifetime status of those who already held it, according to Dr. Saper.

“[The AAN] looked at those of us who had been boarded under the premise that we were going to be lifetime boarded ... and they said: ‘We’re going to grandfather you ... because that was the rule under which you took your initial exams.’ ... That’s what UCNS should have done,” Dr. Saper said.
 

A compromise

Under pressure from Dr. Saper and others, UCNS compromised by endorsing 10-year diplomates until the 5-year mark.

Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and the editor-in-chief of Neurology Reviews, was among those who spoke up, only to see the duration of his certification cut in half.

“UCNS obviously realized that they had been wrong,” Dr. Rapoport said, referring to the compromise they made.

At the 5-year mark, physicians who didn’t adopt the new system were deleted from the UCNS online database, eliminating “the only way the public would know whether or not we were certified. This was after UCNS told us we would stay on the list with a note next to our name suggesting our certification was incomplete. They did not care that this might have hurt our reputations,” Dr. Rapoport said.

“To this day, no refunds, partial or full, have been given for the $1,800 we paid for the privilege of sitting for the exam, or for our time studying, or for the expenses accrued from canceling a day in the office and traveling to a testing center,” Dr. Rapoport said. “I did not want the money back; I wanted the certification promised to me. Since they have removed my name from this list, they do owe me the $1,800. They say they do not return their fees if you fail. How about if you pass and they remove you from their list?”

Yet he went on to make clear that the real issue is the principle of the matter. “This is not about money,” Dr. Rapoport said. “This is about what is fair and right.”

“The UCNS issued me a certificate for 10 years of certification in headache medicine; it is unethical and unlawful to break that contract and grant me only 5 years. Worse, they removed my name as though I do not exist. Along with Dr. Saper, I was one of the doctors that spent time and effort to advance headache medicine from October 1979, when I became a headache specialist, to today. I supported the principles of UCNS and took the first exam. I became the President of the International Headache Society and traveled the world promoting headache medicine; and this is how I am treated. Who can respect this type of certification, or this organization?”

Dr. Saper agreed: “It’s not about the money. It’s about the commitment. It’s very fraudulent.”

After the UCNS decision, Dr. Rapoport and Dr. Saper sought legal counsel, but ultimately decided not to sue the UCNS because of the lengthy process it would entail and the cost, estimated to be over $100,000.

“Our lawyers said: ‘It’s going to be years to get through it. You’ll probably win in the end, because it was fraudulent behavior,’ ” Dr. Saper said.
 

A different viewpoint

Ms. Riggott offered a different viewpoint: Nobody was guaranteed 10 years of certification.

“People do not pay for certification [from the UCNS],” Ms. Riggott said. “They pay to sit for an exam. It’s an exam administration fee. That can be construed as: ‘They paid for 10 years.’ They did not. They paid to sit for an exam. There are people who pay for an exam, and they don’t pass it, and they’re not certified. They don’t get a refund. That’s just the way high-stakes certification exams go.”

Dr. Saper and Dr. Rapoport see it differently. “The inherent reason any of us sit for an exam is to get certified.” Dr. Rapoport added. “Ms. Riggott is not being honest. There was an implied contract that if we passed, we would be granted a 10-year certification because that was what we did previously and that is what they told us would happen. Why would they have sent me this nice certificate for 10 more years of certification if she were telling the truth?”

Courtesy Dr. Alan M. Rapoport

Profits over promises

Dr. Rapoport estimates that many other neurologists had their certificates cut short and were dropped from this official list, some of them eminent members of the field, including David Watson, MD, professor and chair of neurology at West Virginia University Rockefeller Neuroscience Institute, Morgantown, and Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University.

“It is troubling when the organizations charged with maintaining the integrity of our specialization do not act with integrity,” Dr. Watson said. “The UCNS chose profits over promises and has refused to meaningfully engage with those of us whom they have wronged. What was once a point of pride for me (being in the second class of certified headache medicine diplomates) has become a meaningless piece of paper. This makes me sad.”

Dr. Cowan said the UCNS actions angered him while affirming his lifelong skepticism of clubs. “I was very sorry, but not surprised, to see the UCNS change the rules when the opportunity to make more money presented itself, and not surprised they did not honor their contracts. UCNS is just another scam like Best Doctors in the US and similar hypes. Neither are worth another dime of my money nor the time spent discussing them. One thing more: I have no quarrel with efforts to encourage keeping up with the field, although no one I know needs codification or direction as to which articles should be read. My outrage comes when responsible behavior is used as an excuse to line the pockets of dishonest, immoral individuals. I’m done.”

According to Ms. Riggott, the UCNS continuous certification process continues to evolve based on feedback from diplomates. She noted that “change is hard,” although the challenges of the transition appear to be paying off. “Initial retention for continuing certification is much higher than we would have expected from a high-stakes recertification exam,” she said. “So we are very, very happy about that.”
 

Proprietary tests drive revenue

According to Katie Collins, executive director of the National Board of Physicians and Surgeons, proprietary tests are a key revenue driver for medical boards, casting doubt on their educational motives.

“This isn’t really about maintaining their education, it’s really about having control over what they learn,” Ms. Collins said. “And unfortunately, physicians no longer have control over what they learn.”

NBPAS was formed largely in response to physicians dissatisfied with this situation. For $189 every 2 years, plus $25 for a paper certificate, NBPAS recertifies doctors originally credentialed by the American Board of Medical Specialties or the American Osteopathic Association.

Instead of making physicians take proprietary tests, NBPAS requires them to earn 50 hours of Accreditation Council for Continuing Medical Education–accredited CME every 2 years. Physicians can select where they seek this credit, giving them the agency to “pick and choose where they want to learn more,” Ms. Collins said, noting that this allows physicians to address personal knowledge gaps, instead of mastering the prescriptive lessons issued by other boards.

While this benefits physicians, Ms. Collins added, it also reduces the bottom line.

NBPAS is a “true 501(c)(3),” she said. “We have money for rainy days, but certainly not millions. We don’t have anything close to a million in savings.” Most medical boards are making millions on top of their services, she said. “That’s not for me to rein in, but it’s for me to point out.”

Noah Rosen, MD, associate professor of neurology and psychiatry at Northwell Health, Great Neck, N.Y., and former UCNS board member, said the UCNS was not motivated by money when they decided to switch to continuous recertification.

“The UCNS budget is publicly available,” Dr. Rosen said in an interview. “This is not a money-making organization,” he added, noting that the UCNS has “been basically operating on a breakeven budget,” and that certification “is not really a money-making proposition.”

Public IRS filings from 2019 and 2020 suggest a slightly different picture. In 2019, the UCNS reported net income of $72,256. In 2020, the inaugural year of the continuous certification program, net income jumped almost fivefold to $349,108. Over the same period, total assets held by the UCNS rose from $1.97 million to $2.37 million.

For comparison, NBPAS controls approximately $500,000 in total assets. The ABIM? Just shy of $72 million.
 

Recertification highlights a generational gap

Dr. Rosen, who was not a voting board member when the UCNS decided to switch to continuous certification, suggested that the transition could have been handled more effectively.

“I think Dr. Rapoport speaks to the frustration of how they made the transition, and that it could have been done in a way that recognizes people that held the certificate in a better way,” Dr. Rosen said.

He said that the departure of Dr. Rapoport and other neurologists from the UCNS points to another trend in the certification space. “I do think it brings up a deeper issue: What’s the value of certification? Dr. Rapoport and other people have brought up the question: What actually does this certificate bring you, if it’s not recognized by the federal government, and actually is not recognized by a lot of state governments, as well, as an official certification?”

He said the answer could depend on age.

“There seems to be a difference between younger people entering into the field and people that are more established in the field already,” Dr. Rosen said. “Younger people entering the field, they see certification as a distinction, something that separates them from the experiences and maybe every other neurologist.”

Ms. Collins independently pointed out the same generational gap. She noted that when the ABMS changed their maintenance model from lifelong to periodic in 2000, approximately 60% of their physicians had to change with the times, while the remainder did not.

“They grandfathered the other 40% – the older, probably more Caucasian male physicians,” she said. “It’s just the field. It’s evolved, it’s become more diverse. They created a divide in the physician community about what is the best means to maintain your board.”

In response to these comments, and despite his negative experiences with the UCNS, Dr. Rapoport emphasized that he still places high value on subspecialty certification.

“I care a lot about certification and that is why I decided to study for and take the only exam offered at the time,” he said, “I do not need it to continue my practice in headache medicine. No one asks me if I am certified in headache medicine. My patients are referred to me because of my reputation. But I have always sought the highest level of certification I could get. What UCNS has done is to cheapen the value of their certification.”

Dr. Rosen and Ms. Collins highlighted the other side of the same conclusion: For younger physicians, board certifications are more of a career consideration than they are for older physicians, as they could mean the difference between landing or losing a job.

“The American Board of Medical Specialties and [their] 24 member boards have really woven board certification into a requirement for employment for hospital privileges and for reimbursement,” Ms. Collins said.

And so, the practical value of board certification may depend most on the tenure of the person holding paper.

“I have not gone back to get any further certification [from the UCNS],” Dr. Saper said.

Even if his name has been removed from the UCNS register, he pointed out that his printed certificate still shows it’s valid until October 31st, 2026: “If anybody asks: ‘Are you certified?’ I say: ‘Here’s my certificate.’ ”

Courtesy Joel R. Saper, MD

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

Moderate consumption of coffee, with or without sugar, is associated with a reduced risk of death, according to prospective cohort study.

Among more than 170,000 people in the United Kingdom, those who drank about two to four cups of coffee a day, with or without sugar, had a lower rate of death than those who didn’t drink coffee, reported lead author Dan Liu, MD, of the department of epidemiology at Southern Medical University, Guangzhou, China.

“Previous observational studies have suggested an association between coffee intake and reduced risk for death, but they did not distinguish between coffee consumed with sugar or artificial sweeteners and coffee consumed without,” Dr. Liu, who is also of the department of public health and preventive medicine, Jinan University, Guangzhou, China, and colleagues wrote in Annals of Internal Medicine.

To learn more, the investigators turned to the UK Biobank, which recruited approximately half a million participants in the United Kingdom between 2006 and 2010 to undergo a variety of questionnaires, interviews, physical measurements, and medical tests. Out of this group, 171,616 participants completed at least one dietary questionnaire and met the criteria for the present study, including lack of cancer or cardiovascular disease upon enrollment.

Results from these questionnaires showed that 55.4% of participants drank coffee without any sweetener, 14.3% drank coffee with sugar, 6.1% drank coffee with artificial sweetener, and 24.2% did not drink coffee at all. Coffee drinkers were further sorted into groups based on how many cups of coffee they drank per day.
 

Coffee drinkers were significantly less likely to die from any cause

Over the course of about 7 years, 3,177 of the participants died, including 1,725 who died from cancer and 628 who died from cardiovascular disease.

After accounting for other factors that might impact risk of death, like lifestyle choices, the investigators found that coffee drinkers were significantly less likely to die from any cause, cardiovascular disease, or cancer, than those who didn’t drink coffee at all. This benefit was observed across types of coffee, including ground, instant, and decaffeinated varieties. The protective effects of coffee were most apparent in people who drank about two to four cups a day, among whom death was about 30% less likely, regardless of whether they added sugar to their coffee or not. Individuals who drank coffee with artificial sweetener did not live significantly longer than those who drank no coffee at all; however, the investigators suggested that this result may have been skewed by higher rates of negative health factors, such as obesity and hypertension, in the artificial sweetener group.

Dr. Liu and colleagues noted that their findings align with previous studies linking coffee consumption with survival. Like those other studies, the present data revealed a “U-shaped” benefit curve, in which moderate coffee consumption was associated with longer life, whereas low or no consumption and high consumption were not.
 

Experts caution against drinking sweetened beverages despite new findings

Although the present findings suggested that adding sugar did not eliminate the health benefits of coffee, Dr. Liu and colleagues still cautioned against sweetened beverages, citing widely known associations between sugar consumption and poor health.

In an accompanying editorial, Christina C. Wee, MD, MPH, deputy editor of Annals of Internal Medicine, pointed out a key detail from the data: the amount of sugar added to coffee in the U.K. study may be dwarfed by the amount consumed by some coffee drinkers across the pond.

“The average dose of added sugar per cup of sweetened coffee [in the study] was only a little over a teaspoon, or about 4 grams,” Dr. Wee wrote. “This is a far cry from the 15 grams of sugar in an 8-ounce cup of caramel macchiato at a popular U.S. coffee chain.”

Still, Dr. Wee, an associate professor of medicine at Harvard Medical School, Boston, and director of the obesity research program in the division of general medicine at Beth Israel Deaconess Medical Center, Boston, suggested that your typical coffee drinker can feel safe in their daily habit.

“The evidence does not suggest a need for most coffee drinkers – particularly those who drink it with no or modest amounts of sugar – to eliminate coffee,” she wrote. “So drink up – but it would be prudent to avoid too many caramel macchiatos while more evidence brews.”

Estefanía Toledo, MD, MPH, PhD, of the department of preventive medicine and public health at the University of Navarra, Pamplona, Spain, offered a similar takeaway.

Courtesy University of Navarra

“For those who enjoy drinking coffee, are not pregnant or lactating, and do not have special health conditions, coffee consumption could be considered part of a healthy lifestyle,” Dr. Toledo said in a written comment. “I would recommend adding as little sugar as possible to coffee until more evidence has been accrued.”

Dr. Toledo, who previously published a study showing a link between coffee and extended survival, noted that moderate coffee consumption has “repeatedly” been associated with lower rates of “several chronic diseases” and death, but there still isn’t enough evidence to recommend coffee for those who don’t already drink it.

More long-term research is needed, Dr. Toledo said, ideally with studies comparing changes in coffee consumption and health outcomes over time. These may not be forthcoming, however, as such trials are “not easy and feasible to conduct.”

David Kao, MD, assistant professor of medicine-cardiology and medical director of the school of medicine at the University of Colorado at Denver, Aurora, said that the study conducted by Dr. Liu and colleagues is a “very well-executed analysis” that strengthens our confidence in the safety of long-term coffee consumption, even for patients with heart disease.

Dr. Kao, who recently published an analysis showing that higher coffee intake is associated with a lower risk of heart failure, refrained from advising anyone to up their coffee quota.

“I remain cautious about stating too strongly that people should increase coffee intake purely to improve survival,” Dr. Kao said in a written comment. “That said, it does not appear harmful to increase it some, until you drink consistently more than six to seven cups per day.”

The study was supported by the National Natural Science Foundation of China, the Young Elite Scientist Sponsorship Program by CAST, the Guangdong Basic and Applied Basic Research Foundation, and others. Dr. Toledo and Dr. Kao disclosed no relevant conflicts of interest.

Moderate consumption of coffee, with or without sugar, is associated with a reduced risk of death, according to prospective cohort study.

Among more than 170,000 people in the United Kingdom, those who drank about two to four cups of coffee a day, with or without sugar, had a lower rate of death than those who didn’t drink coffee, reported lead author Dan Liu, MD, of the department of epidemiology at Southern Medical University, Guangzhou, China.

“Previous observational studies have suggested an association between coffee intake and reduced risk for death, but they did not distinguish between coffee consumed with sugar or artificial sweeteners and coffee consumed without,” Dr. Liu, who is also of the department of public health and preventive medicine, Jinan University, Guangzhou, China, and colleagues wrote in Annals of Internal Medicine.

To learn more, the investigators turned to the UK Biobank, which recruited approximately half a million participants in the United Kingdom between 2006 and 2010 to undergo a variety of questionnaires, interviews, physical measurements, and medical tests. Out of this group, 171,616 participants completed at least one dietary questionnaire and met the criteria for the present study, including lack of cancer or cardiovascular disease upon enrollment.

Results from these questionnaires showed that 55.4% of participants drank coffee without any sweetener, 14.3% drank coffee with sugar, 6.1% drank coffee with artificial sweetener, and 24.2% did not drink coffee at all. Coffee drinkers were further sorted into groups based on how many cups of coffee they drank per day.
 

Coffee drinkers were significantly less likely to die from any cause

Over the course of about 7 years, 3,177 of the participants died, including 1,725 who died from cancer and 628 who died from cardiovascular disease.

After accounting for other factors that might impact risk of death, like lifestyle choices, the investigators found that coffee drinkers were significantly less likely to die from any cause, cardiovascular disease, or cancer, than those who didn’t drink coffee at all. This benefit was observed across types of coffee, including ground, instant, and decaffeinated varieties. The protective effects of coffee were most apparent in people who drank about two to four cups a day, among whom death was about 30% less likely, regardless of whether they added sugar to their coffee or not. Individuals who drank coffee with artificial sweetener did not live significantly longer than those who drank no coffee at all; however, the investigators suggested that this result may have been skewed by higher rates of negative health factors, such as obesity and hypertension, in the artificial sweetener group.

Dr. Liu and colleagues noted that their findings align with previous studies linking coffee consumption with survival. Like those other studies, the present data revealed a “U-shaped” benefit curve, in which moderate coffee consumption was associated with longer life, whereas low or no consumption and high consumption were not.
 

Experts caution against drinking sweetened beverages despite new findings

Although the present findings suggested that adding sugar did not eliminate the health benefits of coffee, Dr. Liu and colleagues still cautioned against sweetened beverages, citing widely known associations between sugar consumption and poor health.

In an accompanying editorial, Christina C. Wee, MD, MPH, deputy editor of Annals of Internal Medicine, pointed out a key detail from the data: the amount of sugar added to coffee in the U.K. study may be dwarfed by the amount consumed by some coffee drinkers across the pond.

“The average dose of added sugar per cup of sweetened coffee [in the study] was only a little over a teaspoon, or about 4 grams,” Dr. Wee wrote. “This is a far cry from the 15 grams of sugar in an 8-ounce cup of caramel macchiato at a popular U.S. coffee chain.”

Still, Dr. Wee, an associate professor of medicine at Harvard Medical School, Boston, and director of the obesity research program in the division of general medicine at Beth Israel Deaconess Medical Center, Boston, suggested that your typical coffee drinker can feel safe in their daily habit.

“The evidence does not suggest a need for most coffee drinkers – particularly those who drink it with no or modest amounts of sugar – to eliminate coffee,” she wrote. “So drink up – but it would be prudent to avoid too many caramel macchiatos while more evidence brews.”

Estefanía Toledo, MD, MPH, PhD, of the department of preventive medicine and public health at the University of Navarra, Pamplona, Spain, offered a similar takeaway.

Courtesy University of Navarra

“For those who enjoy drinking coffee, are not pregnant or lactating, and do not have special health conditions, coffee consumption could be considered part of a healthy lifestyle,” Dr. Toledo said in a written comment. “I would recommend adding as little sugar as possible to coffee until more evidence has been accrued.”

Dr. Toledo, who previously published a study showing a link between coffee and extended survival, noted that moderate coffee consumption has “repeatedly” been associated with lower rates of “several chronic diseases” and death, but there still isn’t enough evidence to recommend coffee for those who don’t already drink it.

More long-term research is needed, Dr. Toledo said, ideally with studies comparing changes in coffee consumption and health outcomes over time. These may not be forthcoming, however, as such trials are “not easy and feasible to conduct.”

David Kao, MD, assistant professor of medicine-cardiology and medical director of the school of medicine at the University of Colorado at Denver, Aurora, said that the study conducted by Dr. Liu and colleagues is a “very well-executed analysis” that strengthens our confidence in the safety of long-term coffee consumption, even for patients with heart disease.

Dr. Kao, who recently published an analysis showing that higher coffee intake is associated with a lower risk of heart failure, refrained from advising anyone to up their coffee quota.

“I remain cautious about stating too strongly that people should increase coffee intake purely to improve survival,” Dr. Kao said in a written comment. “That said, it does not appear harmful to increase it some, until you drink consistently more than six to seven cups per day.”

The study was supported by the National Natural Science Foundation of China, the Young Elite Scientist Sponsorship Program by CAST, the Guangdong Basic and Applied Basic Research Foundation, and others. Dr. Toledo and Dr. Kao disclosed no relevant conflicts of interest.

Moderate consumption of coffee, with or without sugar, is associated with a reduced risk of death, according to prospective cohort study.

Among more than 170,000 people in the United Kingdom, those who drank about two to four cups of coffee a day, with or without sugar, had a lower rate of death than those who didn’t drink coffee, reported lead author Dan Liu, MD, of the department of epidemiology at Southern Medical University, Guangzhou, China.

“Previous observational studies have suggested an association between coffee intake and reduced risk for death, but they did not distinguish between coffee consumed with sugar or artificial sweeteners and coffee consumed without,” Dr. Liu, who is also of the department of public health and preventive medicine, Jinan University, Guangzhou, China, and colleagues wrote in Annals of Internal Medicine.

To learn more, the investigators turned to the UK Biobank, which recruited approximately half a million participants in the United Kingdom between 2006 and 2010 to undergo a variety of questionnaires, interviews, physical measurements, and medical tests. Out of this group, 171,616 participants completed at least one dietary questionnaire and met the criteria for the present study, including lack of cancer or cardiovascular disease upon enrollment.

Results from these questionnaires showed that 55.4% of participants drank coffee without any sweetener, 14.3% drank coffee with sugar, 6.1% drank coffee with artificial sweetener, and 24.2% did not drink coffee at all. Coffee drinkers were further sorted into groups based on how many cups of coffee they drank per day.
 

Coffee drinkers were significantly less likely to die from any cause

Over the course of about 7 years, 3,177 of the participants died, including 1,725 who died from cancer and 628 who died from cardiovascular disease.

After accounting for other factors that might impact risk of death, like lifestyle choices, the investigators found that coffee drinkers were significantly less likely to die from any cause, cardiovascular disease, or cancer, than those who didn’t drink coffee at all. This benefit was observed across types of coffee, including ground, instant, and decaffeinated varieties. The protective effects of coffee were most apparent in people who drank about two to four cups a day, among whom death was about 30% less likely, regardless of whether they added sugar to their coffee or not. Individuals who drank coffee with artificial sweetener did not live significantly longer than those who drank no coffee at all; however, the investigators suggested that this result may have been skewed by higher rates of negative health factors, such as obesity and hypertension, in the artificial sweetener group.

Dr. Liu and colleagues noted that their findings align with previous studies linking coffee consumption with survival. Like those other studies, the present data revealed a “U-shaped” benefit curve, in which moderate coffee consumption was associated with longer life, whereas low or no consumption and high consumption were not.
 

Experts caution against drinking sweetened beverages despite new findings

Although the present findings suggested that adding sugar did not eliminate the health benefits of coffee, Dr. Liu and colleagues still cautioned against sweetened beverages, citing widely known associations between sugar consumption and poor health.

In an accompanying editorial, Christina C. Wee, MD, MPH, deputy editor of Annals of Internal Medicine, pointed out a key detail from the data: the amount of sugar added to coffee in the U.K. study may be dwarfed by the amount consumed by some coffee drinkers across the pond.

“The average dose of added sugar per cup of sweetened coffee [in the study] was only a little over a teaspoon, or about 4 grams,” Dr. Wee wrote. “This is a far cry from the 15 grams of sugar in an 8-ounce cup of caramel macchiato at a popular U.S. coffee chain.”

Still, Dr. Wee, an associate professor of medicine at Harvard Medical School, Boston, and director of the obesity research program in the division of general medicine at Beth Israel Deaconess Medical Center, Boston, suggested that your typical coffee drinker can feel safe in their daily habit.

“The evidence does not suggest a need for most coffee drinkers – particularly those who drink it with no or modest amounts of sugar – to eliminate coffee,” she wrote. “So drink up – but it would be prudent to avoid too many caramel macchiatos while more evidence brews.”

Estefanía Toledo, MD, MPH, PhD, of the department of preventive medicine and public health at the University of Navarra, Pamplona, Spain, offered a similar takeaway.

Courtesy University of Navarra

“For those who enjoy drinking coffee, are not pregnant or lactating, and do not have special health conditions, coffee consumption could be considered part of a healthy lifestyle,” Dr. Toledo said in a written comment. “I would recommend adding as little sugar as possible to coffee until more evidence has been accrued.”

Dr. Toledo, who previously published a study showing a link between coffee and extended survival, noted that moderate coffee consumption has “repeatedly” been associated with lower rates of “several chronic diseases” and death, but there still isn’t enough evidence to recommend coffee for those who don’t already drink it.

More long-term research is needed, Dr. Toledo said, ideally with studies comparing changes in coffee consumption and health outcomes over time. These may not be forthcoming, however, as such trials are “not easy and feasible to conduct.”

David Kao, MD, assistant professor of medicine-cardiology and medical director of the school of medicine at the University of Colorado at Denver, Aurora, said that the study conducted by Dr. Liu and colleagues is a “very well-executed analysis” that strengthens our confidence in the safety of long-term coffee consumption, even for patients with heart disease.

Dr. Kao, who recently published an analysis showing that higher coffee intake is associated with a lower risk of heart failure, refrained from advising anyone to up their coffee quota.

“I remain cautious about stating too strongly that people should increase coffee intake purely to improve survival,” Dr. Kao said in a written comment. “That said, it does not appear harmful to increase it some, until you drink consistently more than six to seven cups per day.”

The study was supported by the National Natural Science Foundation of China, the Young Elite Scientist Sponsorship Program by CAST, the Guangdong Basic and Applied Basic Research Foundation, and others. Dr. Toledo and Dr. Kao disclosed no relevant conflicts of interest.

From Medically Home Group, Boston, MA.

Brick-and-mortar hospitals in the United States have historically been considered the dominant setting for providing care to patients. The coordination and delivery of care has previously been bound to physical hospitals largely because multidisciplinary services were only accessible in an individual location. While the fundamental make-up of these services remains unchanged, these services are now available in alternate settings. Some of these services include access to a patient care team, supplies, diagnostics, pharmacy, and advanced therapeutic interventions. Presently, the physical environment is becoming increasingly irrelevant as the core of what makes the traditional hospital—the professional staff, collaborative work processes, and the dynamics of the space—have all been translated into a modern digitally integrated environment. The elements necessary to providing safe, effective care in a physical hospital setting are now available in a patient’s home.

Impetus for the Model

As hospitals reconsider how and where they deliver patient care because of limited resources, the hospital-at-home model has gained significant momentum and interest. This model transforms a home into a hospital. The inpatient acute care episode is entirely substituted with an intensive at-home hospital admission enabled by technology, multidisciplinary teams, and ancillary services. Furthermore, patients requiring post-acute support can be transitioned to their next phase of care seamlessly. Given the nationwide nursing shortage, aging population, challenges uncovered by the COVID-19 pandemic, rising hospital costs, nurse/provider burnout related to challenging work environments, and capacity constraints, a shift toward the combination of virtual and in-home care is imperative. The hospital-at-home model has been associated with superior patient outcomes, including reduced risks of delirium, improved functional status, improved patient and family member satisfaction, reduced mortality, reduced readmissions, and significantly lower costs.¹ COVID-19 alone has unmasked major facility-based deficiencies and limitations of our health care system. While the pandemic is not the impetus for the hospital-at-home model, the extended stress of this event has created a unique opportunity to reimagine and transform our health care delivery system so that it is less fragmented and more flexible.

Nursing in the Model

Nursing is central to the hospital-at-home model. Virtual nurses provide meticulous care plan oversight, assessment, and documentation across in-home service providers, to ensure holistic, safe, transparent, and continuous progression toward care plan milestones. The virtual nurse monitors patients using in-home technology that is set up at the time of admission. Connecting with patients to verify social and medical needs, the virtual nurse advocates for their patients and uses these technologies to care and deploy on-demand hands-on services to the patient. Service providers such as paramedics, infusion nurses, or home health nurses may be deployed to provide services in the patient’s home. By bringing in supplies, therapeutics, and interdisciplinary team members, the capabilities of a brick-and-mortar hospital are replicated in the home. All actions that occur wherever the patient is receiving care are overseen by professional nursing staff; in short, virtual nurses are the equivalent of bedside nurses in the brick-and-mortar health care facilities.

Potential Benefits

There are many benefits to the hospital-at-home model (Table). This health care model can be particularly helpful for patients who require frequent admission to acute care facilities, and is well suited for patients with a range of conditions, including those with COVID-19, pneumonia, cellulitis, or congestive heart failure. This care model helps eliminate some of the stressors for patients who have chronic illnesses or other conditions that require frequent hospital admissions. Patients can independently recover at home and can also be surrounded by their loved ones and pets while recovering. This care approach additionally eliminates the risk of hospital-acquired infections and injuries. The hospital-at-home model allows for increased mobility,² as patients are familiar with their surroundings, resulting in reduced onset of delirium. Additionally, patients with improved mobility performance are less likely to experience negative health outcomes.³ There is less chance of sleep disruption as the patient is sleeping in their own bed—no unfamiliar roommate, no call bells or health care personnel frequently coming into the room. The in-home technology set up for remote patient monitoring is designed with the user in mind. Ease of use empowers the patient to collaborate with their care team on their own terms and center the priorities of themselves and their families.

Positive Outcomes

The hospital-at-home model is associated with positive outcomes. The authors of a systematic review identified 10 randomized controlled trials of hospital-at-home programs (with a total of 1372 patients), but were able to obtain data for only 5 of these trials (with a total of 844 patients).⁴ They found a 38% reduction in 6-month mortality for patients who received hospital care at home, as well as significantly higher patient satisfaction across a range of medical conditions, including patients with cellulitis and community-acquired pneumonia, as well as elderly patients with multiple medical conditions. The authors concluded that hospital care at home was less expensive than admission to an acute care hospital.⁴ Similarly, a meta-analysis done by Caplan et al⁵ that included 61 randomized controlled trials concluded that hospital at home is associated with reductions in mortality, readmission rates, and cost, and increases in patient and caregiver satisfaction. Levine et al² found reduced costs and utilization with home hospitalization compared to in-hospital care, as well as improved patient mobility status.

The home is the ideal place to empower patients and caregivers to engage in self-management.² Receiving hospital care at home eliminates the need for dealing with transportation arrangements, traffic, road tolls, and time/scheduling constraints, or finding care for a dependent family member, some of the many stressors that may be experienced by patients who require frequent trips to the hospital. For patients who may not be clinically suitable candidates for hospital at home, such as those requiring critical care intervention and support, the brick-and-mortar hospital is still the appropriate site of care. The hospital-at-home model helps prevent bed shortages in brick-and-mortar hospital settings by allowing hospital care at home for patients who meet preset criteria. These patients can be hospitalized in alternative locations such as their own homes or the residence of a friend. This helps increase health system capacity as well as resiliency.

In addition to expanding safe and appropriate treatment spaces, the hospital-at-home model helps increase access to care for patients during nonstandard hours, including weekends, holidays, or when the waiting time in the emergency room is painfully long. Furthermore, providing care in the home gives the clinical team valuable insight into the patient’s daily life and routine. Performing medication reconciliation with the medicine cabinet in sight and dietary education in a patient’s kitchen are powerful touch points.² For example, a patient with congestive heart failure who must undergo diuresis is much more likely to meet their care goals when their home diet is aligned with the treatment goal. By being able to see exactly what is in a patient’s pantry and fridge, the care team can create a much more tailored approach to sodium intake and fluid management. Providers can create and execute true patient-centric care as they gain direct insight into the patient’s lifestyle, which is clearly valuable when creating care plans for complex chronic health issues.

 

 

Challenges to Implementation and Scaling

Although there are clear benefits to hospital at home, how to best implement and scale this model presents a challenge. In addition to educating patients and families about this model of care, health care systems must expand their hospital-at-home programs and provide education about this model to clinical staff and trainees, and insurers must create reimbursement paradigms. Patients meeting eligibility criteria to enroll in hospital at home is the easiest hurdle, as hospital-at-home programs function best when they enroll and service as many patients as possible, including underserved populations.

Upfront Costs and Cost Savings

While there are upfront costs to set up technology and coordinate services, hospital at home also provides significant total cost savings when compared to coordination associated with brick-and-mortar admission. Hospital care accounts for about one-third of total medical expenditures and is a leading cause of debt.² Eliminating fixed hospital costs such as facility, overhead, and equipment costs through adoption of the hospital-at-home model can lead to a reduction in expenditures. It has been found that fewer laboratory and diagnostic tests are ordered for hospital-at-home patients when compared to similar patients in brick-and-mortar hospital settings, with comparable or better clinical patient outcomes.⁶ Furthermore, it is estimated that there are cost savings of 19% to 30% when compared to traditional inpatient care.⁶ Without legislative action, upon the end of the current COVID-19 public health emergency, the Centers for Medicare & Medicaid Service’s Acute Hospital Care at Home waiver will terminate. This could slow down scaling of the model.However, over the past 2 years there has been enough buy-in from major health systems and patients to continue the momentum of the model’s growth. When setting up a hospital-at-home program, it would be wise to consider a few factors: where in the hospital or health system entity structure the hospital-at-home program will reside, which existing resources can be leveraged within the hospital or health system, and what are the state or federal regulatory requirements for such a program. This type of program continues to fill gaps within the US health care system, meeting the needs of widely overlooked populations and increasing access to essential ancillary services.

Conclusion

It is time to consider our bias toward hospital-first options when managing the care needs of our patients. Health care providers have the option to advocate for holistic care, better experience, and better outcomes. Home-based options are safe, equitable, and patient-centric. Increased costs, consumerism, and technology have pushed us to think about alternative approaches to patient care delivery, and the pandemic created a unique opportunity to see just how far the health care system could stretch itself with capacity constraints, insufficient resources, and staff shortages. In light of new possibilities, it is time to reimagine and transform our health care delivery system so that it is unified, seamless, cohesive, and flexible.

Corresponding author: Payal Sharma, DNP, MSN, RN, FNP-BC, CBN; [email protected].

Disclosures: None reported.

From Medically Home Group, Boston, MA.

Brick-and-mortar hospitals in the United States have historically been considered the dominant setting for providing care to patients. The coordination and delivery of care has previously been bound to physical hospitals largely because multidisciplinary services were only accessible in an individual location. While the fundamental make-up of these services remains unchanged, these services are now available in alternate settings. Some of these services include access to a patient care team, supplies, diagnostics, pharmacy, and advanced therapeutic interventions. Presently, the physical environment is becoming increasingly irrelevant as the core of what makes the traditional hospital—the professional staff, collaborative work processes, and the dynamics of the space—have all been translated into a modern digitally integrated environment. The elements necessary to providing safe, effective care in a physical hospital setting are now available in a patient’s home.

Impetus for the Model

As hospitals reconsider how and where they deliver patient care because of limited resources, the hospital-at-home model has gained significant momentum and interest. This model transforms a home into a hospital. The inpatient acute care episode is entirely substituted with an intensive at-home hospital admission enabled by technology, multidisciplinary teams, and ancillary services. Furthermore, patients requiring post-acute support can be transitioned to their next phase of care seamlessly. Given the nationwide nursing shortage, aging population, challenges uncovered by the COVID-19 pandemic, rising hospital costs, nurse/provider burnout related to challenging work environments, and capacity constraints, a shift toward the combination of virtual and in-home care is imperative. The hospital-at-home model has been associated with superior patient outcomes, including reduced risks of delirium, improved functional status, improved patient and family member satisfaction, reduced mortality, reduced readmissions, and significantly lower costs.¹ COVID-19 alone has unmasked major facility-based deficiencies and limitations of our health care system. While the pandemic is not the impetus for the hospital-at-home model, the extended stress of this event has created a unique opportunity to reimagine and transform our health care delivery system so that it is less fragmented and more flexible.

Nursing in the Model

Nursing is central to the hospital-at-home model. Virtual nurses provide meticulous care plan oversight, assessment, and documentation across in-home service providers, to ensure holistic, safe, transparent, and continuous progression toward care plan milestones. The virtual nurse monitors patients using in-home technology that is set up at the time of admission. Connecting with patients to verify social and medical needs, the virtual nurse advocates for their patients and uses these technologies to care and deploy on-demand hands-on services to the patient. Service providers such as paramedics, infusion nurses, or home health nurses may be deployed to provide services in the patient’s home. By bringing in supplies, therapeutics, and interdisciplinary team members, the capabilities of a brick-and-mortar hospital are replicated in the home. All actions that occur wherever the patient is receiving care are overseen by professional nursing staff; in short, virtual nurses are the equivalent of bedside nurses in the brick-and-mortar health care facilities.

Potential Benefits

There are many benefits to the hospital-at-home model (Table). This health care model can be particularly helpful for patients who require frequent admission to acute care facilities, and is well suited for patients with a range of conditions, including those with COVID-19, pneumonia, cellulitis, or congestive heart failure. This care model helps eliminate some of the stressors for patients who have chronic illnesses or other conditions that require frequent hospital admissions. Patients can independently recover at home and can also be surrounded by their loved ones and pets while recovering. This care approach additionally eliminates the risk of hospital-acquired infections and injuries. The hospital-at-home model allows for increased mobility,² as patients are familiar with their surroundings, resulting in reduced onset of delirium. Additionally, patients with improved mobility performance are less likely to experience negative health outcomes.³ There is less chance of sleep disruption as the patient is sleeping in their own bed—no unfamiliar roommate, no call bells or health care personnel frequently coming into the room. The in-home technology set up for remote patient monitoring is designed with the user in mind. Ease of use empowers the patient to collaborate with their care team on their own terms and center the priorities of themselves and their families.

Positive Outcomes

The hospital-at-home model is associated with positive outcomes. The authors of a systematic review identified 10 randomized controlled trials of hospital-at-home programs (with a total of 1372 patients), but were able to obtain data for only 5 of these trials (with a total of 844 patients).⁴ They found a 38% reduction in 6-month mortality for patients who received hospital care at home, as well as significantly higher patient satisfaction across a range of medical conditions, including patients with cellulitis and community-acquired pneumonia, as well as elderly patients with multiple medical conditions. The authors concluded that hospital care at home was less expensive than admission to an acute care hospital.⁴ Similarly, a meta-analysis done by Caplan et al⁵ that included 61 randomized controlled trials concluded that hospital at home is associated with reductions in mortality, readmission rates, and cost, and increases in patient and caregiver satisfaction. Levine et al² found reduced costs and utilization with home hospitalization compared to in-hospital care, as well as improved patient mobility status.

The home is the ideal place to empower patients and caregivers to engage in self-management.² Receiving hospital care at home eliminates the need for dealing with transportation arrangements, traffic, road tolls, and time/scheduling constraints, or finding care for a dependent family member, some of the many stressors that may be experienced by patients who require frequent trips to the hospital. For patients who may not be clinically suitable candidates for hospital at home, such as those requiring critical care intervention and support, the brick-and-mortar hospital is still the appropriate site of care. The hospital-at-home model helps prevent bed shortages in brick-and-mortar hospital settings by allowing hospital care at home for patients who meet preset criteria. These patients can be hospitalized in alternative locations such as their own homes or the residence of a friend. This helps increase health system capacity as well as resiliency.

In addition to expanding safe and appropriate treatment spaces, the hospital-at-home model helps increase access to care for patients during nonstandard hours, including weekends, holidays, or when the waiting time in the emergency room is painfully long. Furthermore, providing care in the home gives the clinical team valuable insight into the patient’s daily life and routine. Performing medication reconciliation with the medicine cabinet in sight and dietary education in a patient’s kitchen are powerful touch points.² For example, a patient with congestive heart failure who must undergo diuresis is much more likely to meet their care goals when their home diet is aligned with the treatment goal. By being able to see exactly what is in a patient’s pantry and fridge, the care team can create a much more tailored approach to sodium intake and fluid management. Providers can create and execute true patient-centric care as they gain direct insight into the patient’s lifestyle, which is clearly valuable when creating care plans for complex chronic health issues.

 

 

Challenges to Implementation and Scaling

Although there are clear benefits to hospital at home, how to best implement and scale this model presents a challenge. In addition to educating patients and families about this model of care, health care systems must expand their hospital-at-home programs and provide education about this model to clinical staff and trainees, and insurers must create reimbursement paradigms. Patients meeting eligibility criteria to enroll in hospital at home is the easiest hurdle, as hospital-at-home programs function best when they enroll and service as many patients as possible, including underserved populations.

Upfront Costs and Cost Savings

While there are upfront costs to set up technology and coordinate services, hospital at home also provides significant total cost savings when compared to coordination associated with brick-and-mortar admission. Hospital care accounts for about one-third of total medical expenditures and is a leading cause of debt.² Eliminating fixed hospital costs such as facility, overhead, and equipment costs through adoption of the hospital-at-home model can lead to a reduction in expenditures. It has been found that fewer laboratory and diagnostic tests are ordered for hospital-at-home patients when compared to similar patients in brick-and-mortar hospital settings, with comparable or better clinical patient outcomes.⁶ Furthermore, it is estimated that there are cost savings of 19% to 30% when compared to traditional inpatient care.⁶ Without legislative action, upon the end of the current COVID-19 public health emergency, the Centers for Medicare & Medicaid Service’s Acute Hospital Care at Home waiver will terminate. This could slow down scaling of the model.However, over the past 2 years there has been enough buy-in from major health systems and patients to continue the momentum of the model’s growth. When setting up a hospital-at-home program, it would be wise to consider a few factors: where in the hospital or health system entity structure the hospital-at-home program will reside, which existing resources can be leveraged within the hospital or health system, and what are the state or federal regulatory requirements for such a program. This type of program continues to fill gaps within the US health care system, meeting the needs of widely overlooked populations and increasing access to essential ancillary services.

Conclusion

It is time to consider our bias toward hospital-first options when managing the care needs of our patients. Health care providers have the option to advocate for holistic care, better experience, and better outcomes. Home-based options are safe, equitable, and patient-centric. Increased costs, consumerism, and technology have pushed us to think about alternative approaches to patient care delivery, and the pandemic created a unique opportunity to see just how far the health care system could stretch itself with capacity constraints, insufficient resources, and staff shortages. In light of new possibilities, it is time to reimagine and transform our health care delivery system so that it is unified, seamless, cohesive, and flexible.

Corresponding author: Payal Sharma, DNP, MSN, RN, FNP-BC, CBN; [email protected].

Disclosures: None reported.

From Medically Home Group, Boston, MA.

Brick-and-mortar hospitals in the United States have historically been considered the dominant setting for providing care to patients. The coordination and delivery of care has previously been bound to physical hospitals largely because multidisciplinary services were only accessible in an individual location. While the fundamental make-up of these services remains unchanged, these services are now available in alternate settings. Some of these services include access to a patient care team, supplies, diagnostics, pharmacy, and advanced therapeutic interventions. Presently, the physical environment is becoming increasingly irrelevant as the core of what makes the traditional hospital—the professional staff, collaborative work processes, and the dynamics of the space—have all been translated into a modern digitally integrated environment. The elements necessary to providing safe, effective care in a physical hospital setting are now available in a patient’s home.

Impetus for the Model

As hospitals reconsider how and where they deliver patient care because of limited resources, the hospital-at-home model has gained significant momentum and interest. This model transforms a home into a hospital. The inpatient acute care episode is entirely substituted with an intensive at-home hospital admission enabled by technology, multidisciplinary teams, and ancillary services. Furthermore, patients requiring post-acute support can be transitioned to their next phase of care seamlessly. Given the nationwide nursing shortage, aging population, challenges uncovered by the COVID-19 pandemic, rising hospital costs, nurse/provider burnout related to challenging work environments, and capacity constraints, a shift toward the combination of virtual and in-home care is imperative. The hospital-at-home model has been associated with superior patient outcomes, including reduced risks of delirium, improved functional status, improved patient and family member satisfaction, reduced mortality, reduced readmissions, and significantly lower costs.¹ COVID-19 alone has unmasked major facility-based deficiencies and limitations of our health care system. While the pandemic is not the impetus for the hospital-at-home model, the extended stress of this event has created a unique opportunity to reimagine and transform our health care delivery system so that it is less fragmented and more flexible.

Nursing in the Model

Nursing is central to the hospital-at-home model. Virtual nurses provide meticulous care plan oversight, assessment, and documentation across in-home service providers, to ensure holistic, safe, transparent, and continuous progression toward care plan milestones. The virtual nurse monitors patients using in-home technology that is set up at the time of admission. Connecting with patients to verify social and medical needs, the virtual nurse advocates for their patients and uses these technologies to care and deploy on-demand hands-on services to the patient. Service providers such as paramedics, infusion nurses, or home health nurses may be deployed to provide services in the patient’s home. By bringing in supplies, therapeutics, and interdisciplinary team members, the capabilities of a brick-and-mortar hospital are replicated in the home. All actions that occur wherever the patient is receiving care are overseen by professional nursing staff; in short, virtual nurses are the equivalent of bedside nurses in the brick-and-mortar health care facilities.

Potential Benefits

There are many benefits to the hospital-at-home model (Table). This health care model can be particularly helpful for patients who require frequent admission to acute care facilities, and is well suited for patients with a range of conditions, including those with COVID-19, pneumonia, cellulitis, or congestive heart failure. This care model helps eliminate some of the stressors for patients who have chronic illnesses or other conditions that require frequent hospital admissions. Patients can independently recover at home and can also be surrounded by their loved ones and pets while recovering. This care approach additionally eliminates the risk of hospital-acquired infections and injuries. The hospital-at-home model allows for increased mobility,² as patients are familiar with their surroundings, resulting in reduced onset of delirium. Additionally, patients with improved mobility performance are less likely to experience negative health outcomes.³ There is less chance of sleep disruption as the patient is sleeping in their own bed—no unfamiliar roommate, no call bells or health care personnel frequently coming into the room. The in-home technology set up for remote patient monitoring is designed with the user in mind. Ease of use empowers the patient to collaborate with their care team on their own terms and center the priorities of themselves and their families.

Positive Outcomes

The hospital-at-home model is associated with positive outcomes. The authors of a systematic review identified 10 randomized controlled trials of hospital-at-home programs (with a total of 1372 patients), but were able to obtain data for only 5 of these trials (with a total of 844 patients).⁴ They found a 38% reduction in 6-month mortality for patients who received hospital care at home, as well as significantly higher patient satisfaction across a range of medical conditions, including patients with cellulitis and community-acquired pneumonia, as well as elderly patients with multiple medical conditions. The authors concluded that hospital care at home was less expensive than admission to an acute care hospital.⁴ Similarly, a meta-analysis done by Caplan et al⁵ that included 61 randomized controlled trials concluded that hospital at home is associated with reductions in mortality, readmission rates, and cost, and increases in patient and caregiver satisfaction. Levine et al² found reduced costs and utilization with home hospitalization compared to in-hospital care, as well as improved patient mobility status.

The home is the ideal place to empower patients and caregivers to engage in self-management.² Receiving hospital care at home eliminates the need for dealing with transportation arrangements, traffic, road tolls, and time/scheduling constraints, or finding care for a dependent family member, some of the many stressors that may be experienced by patients who require frequent trips to the hospital. For patients who may not be clinically suitable candidates for hospital at home, such as those requiring critical care intervention and support, the brick-and-mortar hospital is still the appropriate site of care. The hospital-at-home model helps prevent bed shortages in brick-and-mortar hospital settings by allowing hospital care at home for patients who meet preset criteria. These patients can be hospitalized in alternative locations such as their own homes or the residence of a friend. This helps increase health system capacity as well as resiliency.

In addition to expanding safe and appropriate treatment spaces, the hospital-at-home model helps increase access to care for patients during nonstandard hours, including weekends, holidays, or when the waiting time in the emergency room is painfully long. Furthermore, providing care in the home gives the clinical team valuable insight into the patient’s daily life and routine. Performing medication reconciliation with the medicine cabinet in sight and dietary education in a patient’s kitchen are powerful touch points.² For example, a patient with congestive heart failure who must undergo diuresis is much more likely to meet their care goals when their home diet is aligned with the treatment goal. By being able to see exactly what is in a patient’s pantry and fridge, the care team can create a much more tailored approach to sodium intake and fluid management. Providers can create and execute true patient-centric care as they gain direct insight into the patient’s lifestyle, which is clearly valuable when creating care plans for complex chronic health issues.

 

 

Challenges to Implementation and Scaling

Although there are clear benefits to hospital at home, how to best implement and scale this model presents a challenge. In addition to educating patients and families about this model of care, health care systems must expand their hospital-at-home programs and provide education about this model to clinical staff and trainees, and insurers must create reimbursement paradigms. Patients meeting eligibility criteria to enroll in hospital at home is the easiest hurdle, as hospital-at-home programs function best when they enroll and service as many patients as possible, including underserved populations.

Upfront Costs and Cost Savings

While there are upfront costs to set up technology and coordinate services, hospital at home also provides significant total cost savings when compared to coordination associated with brick-and-mortar admission. Hospital care accounts for about one-third of total medical expenditures and is a leading cause of debt.² Eliminating fixed hospital costs such as facility, overhead, and equipment costs through adoption of the hospital-at-home model can lead to a reduction in expenditures. It has been found that fewer laboratory and diagnostic tests are ordered for hospital-at-home patients when compared to similar patients in brick-and-mortar hospital settings, with comparable or better clinical patient outcomes.⁶ Furthermore, it is estimated that there are cost savings of 19% to 30% when compared to traditional inpatient care.⁶ Without legislative action, upon the end of the current COVID-19 public health emergency, the Centers for Medicare & Medicaid Service’s Acute Hospital Care at Home waiver will terminate. This could slow down scaling of the model.However, over the past 2 years there has been enough buy-in from major health systems and patients to continue the momentum of the model’s growth. When setting up a hospital-at-home program, it would be wise to consider a few factors: where in the hospital or health system entity structure the hospital-at-home program will reside, which existing resources can be leveraged within the hospital or health system, and what are the state or federal regulatory requirements for such a program. This type of program continues to fill gaps within the US health care system, meeting the needs of widely overlooked populations and increasing access to essential ancillary services.

Conclusion

It is time to consider our bias toward hospital-first options when managing the care needs of our patients. Health care providers have the option to advocate for holistic care, better experience, and better outcomes. Home-based options are safe, equitable, and patient-centric. Increased costs, consumerism, and technology have pushed us to think about alternative approaches to patient care delivery, and the pandemic created a unique opportunity to see just how far the health care system could stretch itself with capacity constraints, insufficient resources, and staff shortages. In light of new possibilities, it is time to reimagine and transform our health care delivery system so that it is unified, seamless, cohesive, and flexible.

Corresponding author: Payal Sharma, DNP, MSN, RN, FNP-BC, CBN; [email protected].

Disclosures: None reported.

The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.^1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.³ Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.⁴ Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.^5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.⁷

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.⁸ Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.⁹ It is essential to note that safety is rooted within the quality domain as a top priority in medicine.¹⁰ The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.¹¹ Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

Disclosures: None reported.

The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.^1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.³ Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.⁴ Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.^5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.⁷

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.⁸ Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.⁹ It is essential to note that safety is rooted within the quality domain as a top priority in medicine.¹⁰ The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.¹¹ Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

Disclosures: None reported.

The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.^1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.³ Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.⁴ Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.^5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.⁷

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.⁸ Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.⁹ It is essential to note that safety is rooted within the quality domain as a top priority in medicine.¹⁰ The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.¹¹ Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

Disclosures: None reported.