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New guidelines dispel myths about COVID-19 treatment
Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.
Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus.
Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.
The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
NIH updates treatment guidelines
A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.
Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.
In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.
In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
Hydroxychloroquine and casirivimab + imdevimab
One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.
Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.
Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.
Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.
Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus.
Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.
The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
NIH updates treatment guidelines
A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.
Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.
In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.
In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
Hydroxychloroquine and casirivimab + imdevimab
One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.
Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.
Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.
Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.
Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus.
Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.
The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
NIH updates treatment guidelines
A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.
Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.
In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.
In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
Hydroxychloroquine and casirivimab + imdevimab
One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.
Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.
Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.
Climate change: Dermatologists address impact on health, and mobilize to increase awareness
Climate change will increasingly affect the distribution and frequency of insect-borne diseases, cutaneous leishmaniasis, skin cancer, fungal diseases, and a host of other illnesses that have cutaneous manifestations or involve the skin – and dermatologists are being urged to be ready to diagnose clinical findings, counsel patients about risk mitigation, and decrease the carbon footprint of their practices and medical organizations.
“Climate change is not a far-off threat but an urgent health issue,” Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, wrote in an editorial with coauthor Mary Sun, a student at Icahn School of Medicine at Mount Sinai, New York. It was first published online in the British Journal of Dermatology last year, titled, “The climate emergency: Why should dermatologists care and how can they act?”.
. Some of the 150-plus members of the ERG have been writing about the dermatologic impacts of climate change – including content that filled the January issue of the International Journal of Women’s Dermatology – and speaking about the issues.
A session at the AAD’s virtual annual meeting in April will address climate change and dermatology – the second such session at an annual meeting – and the first two of three planned virtual symposia led by Dr. Rosenbach and his colleagues, have been hosted by the Association of Professors of Dermatology. The ERG encouraged the AAD’s adoption of a position statement in 2018 about climate change and dermatology and its membership in the Medical Society Consortium on Climate and Health.
“There’s been a lot of conversation in the medical community about the health effects of climate change, but most people leave out the skin,” said Mary L. Williams, MD, clinical professor of dermatology at the University of California, San Francisco, who is a cofounder and coleader with Dr. Rosenbach of the climate change ERG.
“That’s interesting because the skin is the most environmental of all our organs. Of course it will be impacted by all that’s going on,” she said. “We want to bring the dermatologic community and the wider medical community along with us [in appreciating and acting on this knowledge].”
Changing disease patterns
Dr. Rosenbach did not think much about how climate change could affect his patients and his clinical practice until he saw a severe case of hand, foot, and mouth disease in a hospitalized adult in Philadelphia about 10 years ago.
A presentation of the case at an infectious disease conference spurred discussion of how the preceding winters had been warmer and of correlations reported by researchers in China between the incidence of hand, foot, and mouth disease – historically a mild infection in children – and average temperature and other meteorological factors. “I knew about climate change, but I never knew we’d see different diseases in our clinical practice, or old diseases affecting new hosts,” Dr. Rosenbach said in an interview.
He pored over the literature to deepen his understanding of climate change science and the impact of climate change on medicine, and found an “emerging focus” on climate change in some medical journals, but “very little in dermatology.” In collaboration with Benjamin Kaffenberger, MD, a dermatologist at The Ohio State University, and colleagues, including an entomologist, Dr. Rosenbach wrote a review of publications relating to climate change and skin disease in North America.
Published in 2017 in the Journal of the American Academy of Dermatology, the review details how bacteria, viruses, fungi, and parasites are responding to changing weather patterns in North America, and why dermatologists should be able to recognize changing patterns of disease. Globalization plays a role in changing disease and vector patterns, but “climate change allows expansion of the natural range of pathogens, hosts, reservoirs, and vectors that allow diseases to appear in immunologically naive populations,” they wrote.
Patterns of infectious diseases with cutaneous manifestations are already changing. The geographic range of coccidioidomycosis, or valley fever, for instance, “has basically doubled in the Southwest U.S., extending up the entire West Coast,” Dr. Rosenbach said, as the result of longer dry seasons and more frequent wind storms that aerosolize the mycosis-causing, soil-dwelling fungal spores.
Lyme disease and associated tick-borne infections continue to expand northward as Ixodes tick vectors move and breed “exactly in sync with a warming world,” Dr. Rosenbach said. “We’re seeing Lyme in Philadelphia in February, whereas in the past we may not have seen it until May ... There are derms in Maine [whose patients have Lyme disease] who may never have seen a case before, and derms in Canada who are making diagnoses of Lyme [for the first time].”
And locally acquired cases of dengue are being reported in Hawaii, Texas, and Florida – and even North Carolina, according to a review of infectious diseases with cutaneous manifestations in the issue of the International Journal of Women’s Dermatology dedicated to climate change. As with Ixodes ticks, which transmit Lyme disease, rising temperatures lead to longer breeding seasons for Aedes mosquitoes, which transmit dengue. Increased endemicity of dengue is concerning because severe illness is significantly more likely in individuals previously infected with a different serotype.
“Dermatologists should be ready to identify and diagnose these mosquito-borne diseases that we think of as occurring in Central America or tropical regions,” Dr. Rosenbach said. “In my children’s lifetime there will be tropical diseases in New York, Philadelphia, Boston and other such places.”
In his articles and talks, Dr. Rosenbach lays out the science of climate change – for instance, the change in average global temperatures above preindustrial levels (an approximate 1° C rise) , the threshold beyond which the Earth will become less hospitable (1.5° C of warming according to United Nation’s Intergovernmental Panel on Climate Change), the current projections for future warming (an increase of about 3° Celsius by 2100), and the “gold-standard” level of scientific certainty that climate change is human-caused.
Mathematical climate modeling, he emphasized in the interview, can accurately project changes in infection rates. Researchers predicted 10 years ago in a published paper, for instance, that based on global warming patterns, the sand fly vector responsible for cutaneous leishmaniasis would live in the Southern United States and cause endemic infections within 10 years.
And in 2018, Dr. Rosenbach said, a paper in JAMA Dermatology described how more than half – 59% – of the cases of cutaneous leishmaniasis diagnosed in Texas were endemic, all occurring in people with no prior travel outside the United States.
Dr. Williams’ devotion to climate change and dermatology and to the climate change ERG was inspired in large part by Dr. Rosenbach’s 2017 paper in JAAD. She had long been concerned about climate change, she said, but “the review article was really the impetus for me to think, this is really within my specialty.”
Extreme weather events, and the climate-driven migration expected to increasingly occur, have clear relevance to dermatology, Dr. Williams said. “Often, the most vexing problems that people have when they’re forced out of their homes ... are dermatologic,” she said, like infections from contaminated waters after flooding and the spread of scabies and other communicable diseases due to crowding and unsanitary conditions.
But there are other less obvious ramifications of a changing climate that affect dermatology. Dr. Williams has delved into the literature on heat-related illness, for instance, and found that most research has been in the realm of sports medicine and military health. “Most of us don’t treat serious heat-related illnesses, but our skin is responsible for keeping us cool and there’s an important role for dermatologists to play in knowing how the skin does that and who is at risk for heat illness because the skin is unable to do the full job,” she said.
Research is needed to identify which medications can interfere with the skin’s thermoregulatory responses and put patients at risk, she noted. “And a lot of the work on sweat gland physiology is probably 30 years old now. We should bring to bear contemporary research techniques.”
Dermatology is also “in the early stages of understanding the role that air pollution plays in skin disease,” Dr. Williams said. “Most of the medical literature focuses on the effects of pollution on the lungs and in cardiovascular disease.”
There is evidence linking small particulate matter found in wood smoke and other air pollutants to exacerbations of atopic dermatitis and other inflammatory skin conditions, she noted, but mechanisms need to be explored and health disparities examined. “While we know that there are health disparities in terms of [exposure to] pollution and respiratory illness, we have no idea if this is the case with our skin diseases like atopic dermatitis,” said Dr. Williams.
In general, according to the AAD position statement, low-income and minority communities, in addition to the very young and the very old, “are and will continue to be disproportionately affected by climate change.”
Education and the carbon footprint
Viewing climate change as a social determinant of health (SDH ) – and integrating it into medical training as such – is a topic of active discussion. At UCSF, Sarah J. Coates, MD, a fellow in pediatric dermatology, is working with colleagues to integrate climate change into formal resident education. “We know that climate change affects housing, food security, migration ... and certain populations are and will be especially vulnerable,” she said in an interview. “The effects of climate change fit squarely into the social determinant of health curriculum that we’re building here.”
Dr. Coates began to appreciate the link between climate and infectious diseases – a topic she now writes and speaks about – when she saw several patients with coccidioidomycosis as a dermatology resident at UCSF and learned that the cases represented an epidemic in the Central Valley “resulting from several years of drought.”
Her medical school and residency training were otherwise devoid of any discussion of climate change. At UCSF and nearby Stanford (Calif.) University, this is no longer the case, she and Dr. Williams said. “The medical students here have been quite active and are requesting education,” noted Dr. Williams. “The desire to know more is coming from the bottom.”
Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, sees the same interest from physicians-in-training in the Boston area. They want education about climate science, the impact of climate changes on health and risk mitigation, and ways to reduce medicine’s carbon footprint. “We need to teach them and charge them to lead in their communities,” she said in an interview.
Dr. Maloney joined the AAD’s climate change resource group soon after its inception, having realized the urgency of climate change and feeling that she needed “to get passionate and not just do small things.” As a Mohs surgeon, she expects an “explosion” of skin cancer as temperatures and sun exposure continue to increase.
She urges dermatologists to work to decrease the carbon footprint of their practices and to advocate for local hospitals and other clinical institutions to do so. On the AAD website, members now have free access to tools provided by the nonprofit organization My Green Doctor for outpatient offices to lighten their carbon footprints in a cost-effective – or even cost-saving – manner.
Dr. Maloney’s institution has moved to automated lighting systems and the use of LED lights, she said, and has encouraged ride sharing (prior to the pandemic) and computer switch-offs at night. And in her practice, she and a colleague have been working to reduce the purchasing and use of disposable plastics.
Educating patients about the effects of climate change on the health of their skin is another of the missions listed in the AAD’s position statement, and it’s something that Dr. Coates is currently researching. “It seems similar to talking about other social determinants of health,” she said. “Saying to a patient, for instance, ‘we’ve had some really terrible wildfires lately. They’re getting worse as the seasons go on and we know that’s because of climate change. How do you think your current rash relates to the current air quality? How you think the air quality affects your skin?’ ”
Dr. Rosenbach emphasizes that physicians are a broadly trusted group. “I’d tell a patient, ‘you’re the fourth patient I’ve seen with Lyme – we think that’s because it’s been a warmer year due to climate change,’” he said. “I don’t think that bringing up climate change has ever been a source of friction.”
Climate change will increasingly affect the distribution and frequency of insect-borne diseases, cutaneous leishmaniasis, skin cancer, fungal diseases, and a host of other illnesses that have cutaneous manifestations or involve the skin – and dermatologists are being urged to be ready to diagnose clinical findings, counsel patients about risk mitigation, and decrease the carbon footprint of their practices and medical organizations.
“Climate change is not a far-off threat but an urgent health issue,” Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, wrote in an editorial with coauthor Mary Sun, a student at Icahn School of Medicine at Mount Sinai, New York. It was first published online in the British Journal of Dermatology last year, titled, “The climate emergency: Why should dermatologists care and how can they act?”.
. Some of the 150-plus members of the ERG have been writing about the dermatologic impacts of climate change – including content that filled the January issue of the International Journal of Women’s Dermatology – and speaking about the issues.
A session at the AAD’s virtual annual meeting in April will address climate change and dermatology – the second such session at an annual meeting – and the first two of three planned virtual symposia led by Dr. Rosenbach and his colleagues, have been hosted by the Association of Professors of Dermatology. The ERG encouraged the AAD’s adoption of a position statement in 2018 about climate change and dermatology and its membership in the Medical Society Consortium on Climate and Health.
“There’s been a lot of conversation in the medical community about the health effects of climate change, but most people leave out the skin,” said Mary L. Williams, MD, clinical professor of dermatology at the University of California, San Francisco, who is a cofounder and coleader with Dr. Rosenbach of the climate change ERG.
“That’s interesting because the skin is the most environmental of all our organs. Of course it will be impacted by all that’s going on,” she said. “We want to bring the dermatologic community and the wider medical community along with us [in appreciating and acting on this knowledge].”
Changing disease patterns
Dr. Rosenbach did not think much about how climate change could affect his patients and his clinical practice until he saw a severe case of hand, foot, and mouth disease in a hospitalized adult in Philadelphia about 10 years ago.
A presentation of the case at an infectious disease conference spurred discussion of how the preceding winters had been warmer and of correlations reported by researchers in China between the incidence of hand, foot, and mouth disease – historically a mild infection in children – and average temperature and other meteorological factors. “I knew about climate change, but I never knew we’d see different diseases in our clinical practice, or old diseases affecting new hosts,” Dr. Rosenbach said in an interview.
He pored over the literature to deepen his understanding of climate change science and the impact of climate change on medicine, and found an “emerging focus” on climate change in some medical journals, but “very little in dermatology.” In collaboration with Benjamin Kaffenberger, MD, a dermatologist at The Ohio State University, and colleagues, including an entomologist, Dr. Rosenbach wrote a review of publications relating to climate change and skin disease in North America.
Published in 2017 in the Journal of the American Academy of Dermatology, the review details how bacteria, viruses, fungi, and parasites are responding to changing weather patterns in North America, and why dermatologists should be able to recognize changing patterns of disease. Globalization plays a role in changing disease and vector patterns, but “climate change allows expansion of the natural range of pathogens, hosts, reservoirs, and vectors that allow diseases to appear in immunologically naive populations,” they wrote.
Patterns of infectious diseases with cutaneous manifestations are already changing. The geographic range of coccidioidomycosis, or valley fever, for instance, “has basically doubled in the Southwest U.S., extending up the entire West Coast,” Dr. Rosenbach said, as the result of longer dry seasons and more frequent wind storms that aerosolize the mycosis-causing, soil-dwelling fungal spores.
Lyme disease and associated tick-borne infections continue to expand northward as Ixodes tick vectors move and breed “exactly in sync with a warming world,” Dr. Rosenbach said. “We’re seeing Lyme in Philadelphia in February, whereas in the past we may not have seen it until May ... There are derms in Maine [whose patients have Lyme disease] who may never have seen a case before, and derms in Canada who are making diagnoses of Lyme [for the first time].”
And locally acquired cases of dengue are being reported in Hawaii, Texas, and Florida – and even North Carolina, according to a review of infectious diseases with cutaneous manifestations in the issue of the International Journal of Women’s Dermatology dedicated to climate change. As with Ixodes ticks, which transmit Lyme disease, rising temperatures lead to longer breeding seasons for Aedes mosquitoes, which transmit dengue. Increased endemicity of dengue is concerning because severe illness is significantly more likely in individuals previously infected with a different serotype.
“Dermatologists should be ready to identify and diagnose these mosquito-borne diseases that we think of as occurring in Central America or tropical regions,” Dr. Rosenbach said. “In my children’s lifetime there will be tropical diseases in New York, Philadelphia, Boston and other such places.”
In his articles and talks, Dr. Rosenbach lays out the science of climate change – for instance, the change in average global temperatures above preindustrial levels (an approximate 1° C rise) , the threshold beyond which the Earth will become less hospitable (1.5° C of warming according to United Nation’s Intergovernmental Panel on Climate Change), the current projections for future warming (an increase of about 3° Celsius by 2100), and the “gold-standard” level of scientific certainty that climate change is human-caused.
Mathematical climate modeling, he emphasized in the interview, can accurately project changes in infection rates. Researchers predicted 10 years ago in a published paper, for instance, that based on global warming patterns, the sand fly vector responsible for cutaneous leishmaniasis would live in the Southern United States and cause endemic infections within 10 years.
And in 2018, Dr. Rosenbach said, a paper in JAMA Dermatology described how more than half – 59% – of the cases of cutaneous leishmaniasis diagnosed in Texas were endemic, all occurring in people with no prior travel outside the United States.
Dr. Williams’ devotion to climate change and dermatology and to the climate change ERG was inspired in large part by Dr. Rosenbach’s 2017 paper in JAAD. She had long been concerned about climate change, she said, but “the review article was really the impetus for me to think, this is really within my specialty.”
Extreme weather events, and the climate-driven migration expected to increasingly occur, have clear relevance to dermatology, Dr. Williams said. “Often, the most vexing problems that people have when they’re forced out of their homes ... are dermatologic,” she said, like infections from contaminated waters after flooding and the spread of scabies and other communicable diseases due to crowding and unsanitary conditions.
But there are other less obvious ramifications of a changing climate that affect dermatology. Dr. Williams has delved into the literature on heat-related illness, for instance, and found that most research has been in the realm of sports medicine and military health. “Most of us don’t treat serious heat-related illnesses, but our skin is responsible for keeping us cool and there’s an important role for dermatologists to play in knowing how the skin does that and who is at risk for heat illness because the skin is unable to do the full job,” she said.
Research is needed to identify which medications can interfere with the skin’s thermoregulatory responses and put patients at risk, she noted. “And a lot of the work on sweat gland physiology is probably 30 years old now. We should bring to bear contemporary research techniques.”
Dermatology is also “in the early stages of understanding the role that air pollution plays in skin disease,” Dr. Williams said. “Most of the medical literature focuses on the effects of pollution on the lungs and in cardiovascular disease.”
There is evidence linking small particulate matter found in wood smoke and other air pollutants to exacerbations of atopic dermatitis and other inflammatory skin conditions, she noted, but mechanisms need to be explored and health disparities examined. “While we know that there are health disparities in terms of [exposure to] pollution and respiratory illness, we have no idea if this is the case with our skin diseases like atopic dermatitis,” said Dr. Williams.
In general, according to the AAD position statement, low-income and minority communities, in addition to the very young and the very old, “are and will continue to be disproportionately affected by climate change.”
Education and the carbon footprint
Viewing climate change as a social determinant of health (SDH ) – and integrating it into medical training as such – is a topic of active discussion. At UCSF, Sarah J. Coates, MD, a fellow in pediatric dermatology, is working with colleagues to integrate climate change into formal resident education. “We know that climate change affects housing, food security, migration ... and certain populations are and will be especially vulnerable,” she said in an interview. “The effects of climate change fit squarely into the social determinant of health curriculum that we’re building here.”
Dr. Coates began to appreciate the link between climate and infectious diseases – a topic she now writes and speaks about – when she saw several patients with coccidioidomycosis as a dermatology resident at UCSF and learned that the cases represented an epidemic in the Central Valley “resulting from several years of drought.”
Her medical school and residency training were otherwise devoid of any discussion of climate change. At UCSF and nearby Stanford (Calif.) University, this is no longer the case, she and Dr. Williams said. “The medical students here have been quite active and are requesting education,” noted Dr. Williams. “The desire to know more is coming from the bottom.”
Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, sees the same interest from physicians-in-training in the Boston area. They want education about climate science, the impact of climate changes on health and risk mitigation, and ways to reduce medicine’s carbon footprint. “We need to teach them and charge them to lead in their communities,” she said in an interview.
Dr. Maloney joined the AAD’s climate change resource group soon after its inception, having realized the urgency of climate change and feeling that she needed “to get passionate and not just do small things.” As a Mohs surgeon, she expects an “explosion” of skin cancer as temperatures and sun exposure continue to increase.
She urges dermatologists to work to decrease the carbon footprint of their practices and to advocate for local hospitals and other clinical institutions to do so. On the AAD website, members now have free access to tools provided by the nonprofit organization My Green Doctor for outpatient offices to lighten their carbon footprints in a cost-effective – or even cost-saving – manner.
Dr. Maloney’s institution has moved to automated lighting systems and the use of LED lights, she said, and has encouraged ride sharing (prior to the pandemic) and computer switch-offs at night. And in her practice, she and a colleague have been working to reduce the purchasing and use of disposable plastics.
Educating patients about the effects of climate change on the health of their skin is another of the missions listed in the AAD’s position statement, and it’s something that Dr. Coates is currently researching. “It seems similar to talking about other social determinants of health,” she said. “Saying to a patient, for instance, ‘we’ve had some really terrible wildfires lately. They’re getting worse as the seasons go on and we know that’s because of climate change. How do you think your current rash relates to the current air quality? How you think the air quality affects your skin?’ ”
Dr. Rosenbach emphasizes that physicians are a broadly trusted group. “I’d tell a patient, ‘you’re the fourth patient I’ve seen with Lyme – we think that’s because it’s been a warmer year due to climate change,’” he said. “I don’t think that bringing up climate change has ever been a source of friction.”
Climate change will increasingly affect the distribution and frequency of insect-borne diseases, cutaneous leishmaniasis, skin cancer, fungal diseases, and a host of other illnesses that have cutaneous manifestations or involve the skin – and dermatologists are being urged to be ready to diagnose clinical findings, counsel patients about risk mitigation, and decrease the carbon footprint of their practices and medical organizations.
“Climate change is not a far-off threat but an urgent health issue,” Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, wrote in an editorial with coauthor Mary Sun, a student at Icahn School of Medicine at Mount Sinai, New York. It was first published online in the British Journal of Dermatology last year, titled, “The climate emergency: Why should dermatologists care and how can they act?”.
. Some of the 150-plus members of the ERG have been writing about the dermatologic impacts of climate change – including content that filled the January issue of the International Journal of Women’s Dermatology – and speaking about the issues.
A session at the AAD’s virtual annual meeting in April will address climate change and dermatology – the second such session at an annual meeting – and the first two of three planned virtual symposia led by Dr. Rosenbach and his colleagues, have been hosted by the Association of Professors of Dermatology. The ERG encouraged the AAD’s adoption of a position statement in 2018 about climate change and dermatology and its membership in the Medical Society Consortium on Climate and Health.
“There’s been a lot of conversation in the medical community about the health effects of climate change, but most people leave out the skin,” said Mary L. Williams, MD, clinical professor of dermatology at the University of California, San Francisco, who is a cofounder and coleader with Dr. Rosenbach of the climate change ERG.
“That’s interesting because the skin is the most environmental of all our organs. Of course it will be impacted by all that’s going on,” she said. “We want to bring the dermatologic community and the wider medical community along with us [in appreciating and acting on this knowledge].”
Changing disease patterns
Dr. Rosenbach did not think much about how climate change could affect his patients and his clinical practice until he saw a severe case of hand, foot, and mouth disease in a hospitalized adult in Philadelphia about 10 years ago.
A presentation of the case at an infectious disease conference spurred discussion of how the preceding winters had been warmer and of correlations reported by researchers in China between the incidence of hand, foot, and mouth disease – historically a mild infection in children – and average temperature and other meteorological factors. “I knew about climate change, but I never knew we’d see different diseases in our clinical practice, or old diseases affecting new hosts,” Dr. Rosenbach said in an interview.
He pored over the literature to deepen his understanding of climate change science and the impact of climate change on medicine, and found an “emerging focus” on climate change in some medical journals, but “very little in dermatology.” In collaboration with Benjamin Kaffenberger, MD, a dermatologist at The Ohio State University, and colleagues, including an entomologist, Dr. Rosenbach wrote a review of publications relating to climate change and skin disease in North America.
Published in 2017 in the Journal of the American Academy of Dermatology, the review details how bacteria, viruses, fungi, and parasites are responding to changing weather patterns in North America, and why dermatologists should be able to recognize changing patterns of disease. Globalization plays a role in changing disease and vector patterns, but “climate change allows expansion of the natural range of pathogens, hosts, reservoirs, and vectors that allow diseases to appear in immunologically naive populations,” they wrote.
Patterns of infectious diseases with cutaneous manifestations are already changing. The geographic range of coccidioidomycosis, or valley fever, for instance, “has basically doubled in the Southwest U.S., extending up the entire West Coast,” Dr. Rosenbach said, as the result of longer dry seasons and more frequent wind storms that aerosolize the mycosis-causing, soil-dwelling fungal spores.
Lyme disease and associated tick-borne infections continue to expand northward as Ixodes tick vectors move and breed “exactly in sync with a warming world,” Dr. Rosenbach said. “We’re seeing Lyme in Philadelphia in February, whereas in the past we may not have seen it until May ... There are derms in Maine [whose patients have Lyme disease] who may never have seen a case before, and derms in Canada who are making diagnoses of Lyme [for the first time].”
And locally acquired cases of dengue are being reported in Hawaii, Texas, and Florida – and even North Carolina, according to a review of infectious diseases with cutaneous manifestations in the issue of the International Journal of Women’s Dermatology dedicated to climate change. As with Ixodes ticks, which transmit Lyme disease, rising temperatures lead to longer breeding seasons for Aedes mosquitoes, which transmit dengue. Increased endemicity of dengue is concerning because severe illness is significantly more likely in individuals previously infected with a different serotype.
“Dermatologists should be ready to identify and diagnose these mosquito-borne diseases that we think of as occurring in Central America or tropical regions,” Dr. Rosenbach said. “In my children’s lifetime there will be tropical diseases in New York, Philadelphia, Boston and other such places.”
In his articles and talks, Dr. Rosenbach lays out the science of climate change – for instance, the change in average global temperatures above preindustrial levels (an approximate 1° C rise) , the threshold beyond which the Earth will become less hospitable (1.5° C of warming according to United Nation’s Intergovernmental Panel on Climate Change), the current projections for future warming (an increase of about 3° Celsius by 2100), and the “gold-standard” level of scientific certainty that climate change is human-caused.
Mathematical climate modeling, he emphasized in the interview, can accurately project changes in infection rates. Researchers predicted 10 years ago in a published paper, for instance, that based on global warming patterns, the sand fly vector responsible for cutaneous leishmaniasis would live in the Southern United States and cause endemic infections within 10 years.
And in 2018, Dr. Rosenbach said, a paper in JAMA Dermatology described how more than half – 59% – of the cases of cutaneous leishmaniasis diagnosed in Texas were endemic, all occurring in people with no prior travel outside the United States.
Dr. Williams’ devotion to climate change and dermatology and to the climate change ERG was inspired in large part by Dr. Rosenbach’s 2017 paper in JAAD. She had long been concerned about climate change, she said, but “the review article was really the impetus for me to think, this is really within my specialty.”
Extreme weather events, and the climate-driven migration expected to increasingly occur, have clear relevance to dermatology, Dr. Williams said. “Often, the most vexing problems that people have when they’re forced out of their homes ... are dermatologic,” she said, like infections from contaminated waters after flooding and the spread of scabies and other communicable diseases due to crowding and unsanitary conditions.
But there are other less obvious ramifications of a changing climate that affect dermatology. Dr. Williams has delved into the literature on heat-related illness, for instance, and found that most research has been in the realm of sports medicine and military health. “Most of us don’t treat serious heat-related illnesses, but our skin is responsible for keeping us cool and there’s an important role for dermatologists to play in knowing how the skin does that and who is at risk for heat illness because the skin is unable to do the full job,” she said.
Research is needed to identify which medications can interfere with the skin’s thermoregulatory responses and put patients at risk, she noted. “And a lot of the work on sweat gland physiology is probably 30 years old now. We should bring to bear contemporary research techniques.”
Dermatology is also “in the early stages of understanding the role that air pollution plays in skin disease,” Dr. Williams said. “Most of the medical literature focuses on the effects of pollution on the lungs and in cardiovascular disease.”
There is evidence linking small particulate matter found in wood smoke and other air pollutants to exacerbations of atopic dermatitis and other inflammatory skin conditions, she noted, but mechanisms need to be explored and health disparities examined. “While we know that there are health disparities in terms of [exposure to] pollution and respiratory illness, we have no idea if this is the case with our skin diseases like atopic dermatitis,” said Dr. Williams.
In general, according to the AAD position statement, low-income and minority communities, in addition to the very young and the very old, “are and will continue to be disproportionately affected by climate change.”
Education and the carbon footprint
Viewing climate change as a social determinant of health (SDH ) – and integrating it into medical training as such – is a topic of active discussion. At UCSF, Sarah J. Coates, MD, a fellow in pediatric dermatology, is working with colleagues to integrate climate change into formal resident education. “We know that climate change affects housing, food security, migration ... and certain populations are and will be especially vulnerable,” she said in an interview. “The effects of climate change fit squarely into the social determinant of health curriculum that we’re building here.”
Dr. Coates began to appreciate the link between climate and infectious diseases – a topic she now writes and speaks about – when she saw several patients with coccidioidomycosis as a dermatology resident at UCSF and learned that the cases represented an epidemic in the Central Valley “resulting from several years of drought.”
Her medical school and residency training were otherwise devoid of any discussion of climate change. At UCSF and nearby Stanford (Calif.) University, this is no longer the case, she and Dr. Williams said. “The medical students here have been quite active and are requesting education,” noted Dr. Williams. “The desire to know more is coming from the bottom.”
Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, sees the same interest from physicians-in-training in the Boston area. They want education about climate science, the impact of climate changes on health and risk mitigation, and ways to reduce medicine’s carbon footprint. “We need to teach them and charge them to lead in their communities,” she said in an interview.
Dr. Maloney joined the AAD’s climate change resource group soon after its inception, having realized the urgency of climate change and feeling that she needed “to get passionate and not just do small things.” As a Mohs surgeon, she expects an “explosion” of skin cancer as temperatures and sun exposure continue to increase.
She urges dermatologists to work to decrease the carbon footprint of their practices and to advocate for local hospitals and other clinical institutions to do so. On the AAD website, members now have free access to tools provided by the nonprofit organization My Green Doctor for outpatient offices to lighten their carbon footprints in a cost-effective – or even cost-saving – manner.
Dr. Maloney’s institution has moved to automated lighting systems and the use of LED lights, she said, and has encouraged ride sharing (prior to the pandemic) and computer switch-offs at night. And in her practice, she and a colleague have been working to reduce the purchasing and use of disposable plastics.
Educating patients about the effects of climate change on the health of their skin is another of the missions listed in the AAD’s position statement, and it’s something that Dr. Coates is currently researching. “It seems similar to talking about other social determinants of health,” she said. “Saying to a patient, for instance, ‘we’ve had some really terrible wildfires lately. They’re getting worse as the seasons go on and we know that’s because of climate change. How do you think your current rash relates to the current air quality? How you think the air quality affects your skin?’ ”
Dr. Rosenbach emphasizes that physicians are a broadly trusted group. “I’d tell a patient, ‘you’re the fourth patient I’ve seen with Lyme – we think that’s because it’s been a warmer year due to climate change,’” he said. “I don’t think that bringing up climate change has ever been a source of friction.”
SNP chips deemed ‘extremely unreliable’ for identifying rare variants
In fact, SNP chips are “extremely unreliable for genotyping very rare pathogenic variants,” and a positive result for such a variant “is more likely to be wrong than right,” researchers reported in the BMJ.
The authors explained that SNP chips are “DNA microarrays that test genetic variation at many hundreds of thousands of specific locations across the genome.” Although SNP chips have proven accurate in identifying common variants, past reports have suggested that SNP chips perform poorly for genotyping rare variants.
To gain more insight, Caroline Wright, PhD, of the University of Exeter (England) and colleagues conducted a large study.
The researchers analyzed data on 49,908 people from the UK Biobank who had SNP chip and next-generation sequencing results, as well as an additional 21 people who purchased consumer genetic tests and shared their data online via the Personal Genome Project.
The researchers compared the SNP chip and sequencing results. They also selected rare pathogenic variants in BRCA1 and BRCA2 for detailed analysis of clinically actionable variants in the UK Biobank, and they assessed BRCA-related cancers in participants using cancer registry data.
Largest evaluation of SNP chips
SNP chips performed well for common variants, the researchers found. Sensitivity, specificity, positive-predictive value, and negative-predictive value all exceeded 99% for 108,574 common variants.
For rare variants, SNP chips performed poorly, with a positive-predictive value of 16% for variants with a frequency below 0.001% in the UK Biobank.
“The study provides the largest evaluation of the performance of SNP chips for genotyping genetic variants at different frequencies in the population, particularly focusing on very rare variants,” Dr. Wright said. “The biggest surprise was how poorly the SNP chips we evaluated performed for rare variants.”
Dr. Wright noted that there is an inherent problem built into using SNP chip technology to genotype very rare variants.
“The SNP chip technology relies on clustering data from multiple individuals in order to determine what genotype each individual has at a specific position in their genome,” Dr. Wright explained. “Although this method works very well for common variants, the rarer the variant, the harder it is to distinguish from experimental noise.”
False positives and cancer: ‘Don’t trust the results’
The researchers found that, for rare BRCA variants (frequency below 0.01%), SNP chips had a sensitivity of 34.6%, specificity of 98.3%, negative-predictive value of 99.9%, and positive-predictive value of 4.2%.
Rates of BRCA-related cancers in patients with positive SNP chip results were similar to rates in age-matched control subjects because “the vast majority of variants were false positives,” the researchers noted.
“If these variants are incorrectly genotyped – that is, false positives detected – a woman could be offered screening or even prophylactic surgery inappropriately when she is more likely to be at population background risk [for BRCA-related cancers],” Dr. Wright said.
“For very-rare-disease–causing genetic variants, don’t trust the results from SNP chips; for example, those from direct-to-consumer genetic tests. Never use them to guide clinical action without diagnostic validation,” she added.
Heather Hampel, a genetic counselor and researcher at the Ohio State University Comprehensive Cancer Center in Columbus, agreed.
“Positive results on SNP-based tests need to be confirmed by medical-grade genetic testing using a sequencing technology,” she said. “Negative results on an SNP- based test cannot be considered to rule out mutations in BRCA1/2 or other cancer-susceptibility genes, so individuals with strong personal and family histories of cancer should be seen by a genetic counselor to consider medical-grade genetic testing using a sequencing technology.”
Practicing oncologists can trust patients’ prior germline genetic test results if the testing was performed in a cancer genetics clinic, which uses sequencing-based technologies, Ms. Hampel noted.
“If the test was performed before 2013, there are likely new genes that have been discovered for which their patient was not tested, and repeat testing may be warranted,” Ms. Hampel said. “A referral to a cancer genetic counselor would be appropriate.”
Ms. Hampel disclosed relationships with Genome Medical, GI OnDemand, Invitae Genetics, and Promega. Dr. Wright and her coauthors disclosed no conflicts of interest. The group’s research was conducted using the UK Biobank and the University of Exeter High-Performance Computing, with funding from the Wellcome Trust and the National Institute for Health Research.
In fact, SNP chips are “extremely unreliable for genotyping very rare pathogenic variants,” and a positive result for such a variant “is more likely to be wrong than right,” researchers reported in the BMJ.
The authors explained that SNP chips are “DNA microarrays that test genetic variation at many hundreds of thousands of specific locations across the genome.” Although SNP chips have proven accurate in identifying common variants, past reports have suggested that SNP chips perform poorly for genotyping rare variants.
To gain more insight, Caroline Wright, PhD, of the University of Exeter (England) and colleagues conducted a large study.
The researchers analyzed data on 49,908 people from the UK Biobank who had SNP chip and next-generation sequencing results, as well as an additional 21 people who purchased consumer genetic tests and shared their data online via the Personal Genome Project.
The researchers compared the SNP chip and sequencing results. They also selected rare pathogenic variants in BRCA1 and BRCA2 for detailed analysis of clinically actionable variants in the UK Biobank, and they assessed BRCA-related cancers in participants using cancer registry data.
Largest evaluation of SNP chips
SNP chips performed well for common variants, the researchers found. Sensitivity, specificity, positive-predictive value, and negative-predictive value all exceeded 99% for 108,574 common variants.
For rare variants, SNP chips performed poorly, with a positive-predictive value of 16% for variants with a frequency below 0.001% in the UK Biobank.
“The study provides the largest evaluation of the performance of SNP chips for genotyping genetic variants at different frequencies in the population, particularly focusing on very rare variants,” Dr. Wright said. “The biggest surprise was how poorly the SNP chips we evaluated performed for rare variants.”
Dr. Wright noted that there is an inherent problem built into using SNP chip technology to genotype very rare variants.
“The SNP chip technology relies on clustering data from multiple individuals in order to determine what genotype each individual has at a specific position in their genome,” Dr. Wright explained. “Although this method works very well for common variants, the rarer the variant, the harder it is to distinguish from experimental noise.”
False positives and cancer: ‘Don’t trust the results’
The researchers found that, for rare BRCA variants (frequency below 0.01%), SNP chips had a sensitivity of 34.6%, specificity of 98.3%, negative-predictive value of 99.9%, and positive-predictive value of 4.2%.
Rates of BRCA-related cancers in patients with positive SNP chip results were similar to rates in age-matched control subjects because “the vast majority of variants were false positives,” the researchers noted.
“If these variants are incorrectly genotyped – that is, false positives detected – a woman could be offered screening or even prophylactic surgery inappropriately when she is more likely to be at population background risk [for BRCA-related cancers],” Dr. Wright said.
“For very-rare-disease–causing genetic variants, don’t trust the results from SNP chips; for example, those from direct-to-consumer genetic tests. Never use them to guide clinical action without diagnostic validation,” she added.
Heather Hampel, a genetic counselor and researcher at the Ohio State University Comprehensive Cancer Center in Columbus, agreed.
“Positive results on SNP-based tests need to be confirmed by medical-grade genetic testing using a sequencing technology,” she said. “Negative results on an SNP- based test cannot be considered to rule out mutations in BRCA1/2 or other cancer-susceptibility genes, so individuals with strong personal and family histories of cancer should be seen by a genetic counselor to consider medical-grade genetic testing using a sequencing technology.”
Practicing oncologists can trust patients’ prior germline genetic test results if the testing was performed in a cancer genetics clinic, which uses sequencing-based technologies, Ms. Hampel noted.
“If the test was performed before 2013, there are likely new genes that have been discovered for which their patient was not tested, and repeat testing may be warranted,” Ms. Hampel said. “A referral to a cancer genetic counselor would be appropriate.”
Ms. Hampel disclosed relationships with Genome Medical, GI OnDemand, Invitae Genetics, and Promega. Dr. Wright and her coauthors disclosed no conflicts of interest. The group’s research was conducted using the UK Biobank and the University of Exeter High-Performance Computing, with funding from the Wellcome Trust and the National Institute for Health Research.
In fact, SNP chips are “extremely unreliable for genotyping very rare pathogenic variants,” and a positive result for such a variant “is more likely to be wrong than right,” researchers reported in the BMJ.
The authors explained that SNP chips are “DNA microarrays that test genetic variation at many hundreds of thousands of specific locations across the genome.” Although SNP chips have proven accurate in identifying common variants, past reports have suggested that SNP chips perform poorly for genotyping rare variants.
To gain more insight, Caroline Wright, PhD, of the University of Exeter (England) and colleagues conducted a large study.
The researchers analyzed data on 49,908 people from the UK Biobank who had SNP chip and next-generation sequencing results, as well as an additional 21 people who purchased consumer genetic tests and shared their data online via the Personal Genome Project.
The researchers compared the SNP chip and sequencing results. They also selected rare pathogenic variants in BRCA1 and BRCA2 for detailed analysis of clinically actionable variants in the UK Biobank, and they assessed BRCA-related cancers in participants using cancer registry data.
Largest evaluation of SNP chips
SNP chips performed well for common variants, the researchers found. Sensitivity, specificity, positive-predictive value, and negative-predictive value all exceeded 99% for 108,574 common variants.
For rare variants, SNP chips performed poorly, with a positive-predictive value of 16% for variants with a frequency below 0.001% in the UK Biobank.
“The study provides the largest evaluation of the performance of SNP chips for genotyping genetic variants at different frequencies in the population, particularly focusing on very rare variants,” Dr. Wright said. “The biggest surprise was how poorly the SNP chips we evaluated performed for rare variants.”
Dr. Wright noted that there is an inherent problem built into using SNP chip technology to genotype very rare variants.
“The SNP chip technology relies on clustering data from multiple individuals in order to determine what genotype each individual has at a specific position in their genome,” Dr. Wright explained. “Although this method works very well for common variants, the rarer the variant, the harder it is to distinguish from experimental noise.”
False positives and cancer: ‘Don’t trust the results’
The researchers found that, for rare BRCA variants (frequency below 0.01%), SNP chips had a sensitivity of 34.6%, specificity of 98.3%, negative-predictive value of 99.9%, and positive-predictive value of 4.2%.
Rates of BRCA-related cancers in patients with positive SNP chip results were similar to rates in age-matched control subjects because “the vast majority of variants were false positives,” the researchers noted.
“If these variants are incorrectly genotyped – that is, false positives detected – a woman could be offered screening or even prophylactic surgery inappropriately when she is more likely to be at population background risk [for BRCA-related cancers],” Dr. Wright said.
“For very-rare-disease–causing genetic variants, don’t trust the results from SNP chips; for example, those from direct-to-consumer genetic tests. Never use them to guide clinical action without diagnostic validation,” she added.
Heather Hampel, a genetic counselor and researcher at the Ohio State University Comprehensive Cancer Center in Columbus, agreed.
“Positive results on SNP-based tests need to be confirmed by medical-grade genetic testing using a sequencing technology,” she said. “Negative results on an SNP- based test cannot be considered to rule out mutations in BRCA1/2 or other cancer-susceptibility genes, so individuals with strong personal and family histories of cancer should be seen by a genetic counselor to consider medical-grade genetic testing using a sequencing technology.”
Practicing oncologists can trust patients’ prior germline genetic test results if the testing was performed in a cancer genetics clinic, which uses sequencing-based technologies, Ms. Hampel noted.
“If the test was performed before 2013, there are likely new genes that have been discovered for which their patient was not tested, and repeat testing may be warranted,” Ms. Hampel said. “A referral to a cancer genetic counselor would be appropriate.”
Ms. Hampel disclosed relationships with Genome Medical, GI OnDemand, Invitae Genetics, and Promega. Dr. Wright and her coauthors disclosed no conflicts of interest. The group’s research was conducted using the UK Biobank and the University of Exeter High-Performance Computing, with funding from the Wellcome Trust and the National Institute for Health Research.
FROM BMJ
The skill set of the ‘pluripotent’ hospitalist
Editor’s note: National Hospitalist Day occurs the first Thursday in March annually, and serves to celebrate the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape. On National Hospitalist Day in 2021, SHM convened a virtual roundtable with a diverse group of hospitalists to discuss skill set, wellness, and other key issues for hospitalists. To listen to the entire roundtable discussion, visit this Explore The Space podcast episode.
A hospitalist isn’t just a physician who happens to work in a hospital. They are medical professionals with a robust skill set that they use both inside and outside the hospital setting. But what skill sets do hospitalists need to become successful in their careers? And what skill sets does a “pluripotent” hospitalist need in their armamentarium?
These were the issues discussed by participants of a virtual roundtable discussion on National Hospitalist Day – March 4, 2021 – as part of a joint effort of the Society of Hospital Medicine and the Explore the Space podcast.
Maylyn S. Martinez, MD, clinician-researcher and clinical associate at the University of Chicago, sees her hospitalist and research skill sets as two “buckets” of skills she can sort through, with diagnostic, knowledge-based care coordination, and interpersonal skills as lanes where she can focus and improve. “I’m always trying to work in, and sharpen, and find ways to get better at something in each of those every day,” she said.
For Anika Kumar, MD, FHM, pediatric editor of the Hospitalist and clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine, much of her work is focused on problem solving. “I approach that as: ‘How do I come up with my differential diagnosis, and how do I diagnose the patient?’ I think that the lanes are a little bit different, but there is some overlap.”
Adaptability is another important part of the skill set for the hospitalist, Ndidi Unaka, MD, MEd, associate professor in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center, said during the discussion. “I think we all really value teamwork, and we take on the role of being the coordinator and making sure things are getting done in a seamless and thoughtful manner. Communicating with families, communicating with our research team, communicating with primary care physicians. I think that is something we’re very used to doing, and I think we do it well. I think we don’t shy away from difficult conversations with consultants. And I think that’s what makes being a hospitalist so amazing.”
Achieving wellness as a hospitalist
Another topic discussed during the roundtable was “comprehensive care for the hospitalist” and how they can achieve a sense of wellness for themselves. Gurpreet Dhaliwal, MD, clinician-educator and professor of medicine at the University of California, San Francisco, said long-term satisfaction in one’s career is less about compensation and more about autonomy, mastery, and purpose.
“Autonomy is shrinking a little bit in health care. But if we connect to our purpose – ‘what are we doing here and how do we connect?’ – it’s either learning about patients and their stories, being with a team of people that you work with, that really builds that purpose,” he said.
Regarding mastery, there’s “tremendous joy if you’re in an environment where people value your mastery, whether it is working in a team or communicating or diagnosing or doing a procedure. If you think of setting up the work environment and those things are in place, I think a lot of wellness can actually happen at work, even though another component, of course, is balancing your life outside of work,” Dr. Dhaliwal said.
This may seem out of reach during COVID-19, but wellness is still achievable during the pandemic, Dr. Martinez said. Her time is spent 75% as a researcher and 25% as a clinician, which is her ideal balance. “I enjoy doing my research, doing my own statistics and writing grants and just learning about this problem that I’ve developed an interest in,” she said. “I just think that’s an important piece for people to focus on as far as health care for the hospitalist, is that there’s no no-one-size-fits-all, that’s for sure.”
Dr. Kumar noted that her clinical time gives her energy for nonclinical work. “I love my clinical time. It’s one of my favorite things that I do,” she said. Although she is tired at the end of the week, “I feel like I am not only giving back to my patients and my team, but I’m also giving back to myself and reminding myself why it is I do what I do every day,” she said.
Wellness for Dr. Unaka meant remembering what drew her to medicine. “It was definitely the opportunity to build strong relationships with patients and families,” she said. While these encounters can sometimes be heavy and stay with a hospitalist, “the fact that we’re in it with them is something that gives a lot of us purpose. I think that when I reflect on all of those things, I’m so happy that I’m in the role that I am.”
Unique skills during COVID-19
Mark Shapiro, MD, hospitalist and host of the roundtable and the Explore the Space podcast, also asked the panelists what skills they unexpectedly leveraged during the pandemic. Communication – with colleagues and with the community they serve – was a universal answer among the panelists.
“I learned – really from seeing some of our senior leaders here do it so well – the importance of being visible, particularly at a time when people were not together and more isolated,” Dr. Unaka said. “I think being able to be visible when you can, in order to deliver really complicated or tough news or communicate about uncertainty, for instance. Being here for our residents – many of our interns moved here sight unseen. I think they needed to feel like they had some sense of normalcy and a sense of community. I really learned how important it was to be visible, and available, and how important the little things mattered.”
Dr. Martinez said that worrying about her patients with COVID-19 in the hospital and the uncertainty around the disease kept her up at night. “I think we always have a hard time leaving work at work and getting a good night’s sleep. I just could not let go of worrying about these patients and having terrible insomnia, trying to leave work at work and I couldn’t – even after they were discharged.”
Dr. Shapiro said the skill he most needed to work on during the pandemic was his courage. “I remember the first time I took care of COVID patients. I was scared. I have no problems saying that out loud. That was a scary experience.”
The demeanor of the nurses on his unit, who had already seen patients with COVID-19, helped ground him during those moments and gave him the courage to move forward. “They’d already been doing it and they were the same. Same affect, same jokes, same everything,” he said. “That actually really helped, and I’ve leaned on that every time I’ve been back on our COVID service.”
Importance of mental health
The COVID-19 pandemic has also shined a light on the importance of mental health. “I think it is important to acknowledge that as hospitalists who have been out on the bleeding edge for a year, mental health is critically important, and we know that we face shortages in that space for the public at large and also for our profession,” Dr. Shapiro said.
When asked about what mental health and self-care looks like for her, Dr. Kumar referenced the need for exercise, meditation, and yoga. “My mental health was better knowing that the people closest to me – whether they be colleagues or friends or family – their mental health was also in a good place and they were also in a good place. And that helped to build me up,” she said.
Dr. Unaka called attention to the stigma around mental health, particularly among physicians, and the lack of resources to address the issue. “It’s a real problem,” she said. “I think it’s at a point where we as a profession need to advocate on behalf of each other and on behalf of our trainees. And honestly, I think we need to view mental health as just ‘health’ and stop separating it out in order for us to move to a place where people feel like they can access what they need without feeling shame about it.”
Editor’s note: National Hospitalist Day occurs the first Thursday in March annually, and serves to celebrate the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape. On National Hospitalist Day in 2021, SHM convened a virtual roundtable with a diverse group of hospitalists to discuss skill set, wellness, and other key issues for hospitalists. To listen to the entire roundtable discussion, visit this Explore The Space podcast episode.
A hospitalist isn’t just a physician who happens to work in a hospital. They are medical professionals with a robust skill set that they use both inside and outside the hospital setting. But what skill sets do hospitalists need to become successful in their careers? And what skill sets does a “pluripotent” hospitalist need in their armamentarium?
These were the issues discussed by participants of a virtual roundtable discussion on National Hospitalist Day – March 4, 2021 – as part of a joint effort of the Society of Hospital Medicine and the Explore the Space podcast.
Maylyn S. Martinez, MD, clinician-researcher and clinical associate at the University of Chicago, sees her hospitalist and research skill sets as two “buckets” of skills she can sort through, with diagnostic, knowledge-based care coordination, and interpersonal skills as lanes where she can focus and improve. “I’m always trying to work in, and sharpen, and find ways to get better at something in each of those every day,” she said.
For Anika Kumar, MD, FHM, pediatric editor of the Hospitalist and clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine, much of her work is focused on problem solving. “I approach that as: ‘How do I come up with my differential diagnosis, and how do I diagnose the patient?’ I think that the lanes are a little bit different, but there is some overlap.”
Adaptability is another important part of the skill set for the hospitalist, Ndidi Unaka, MD, MEd, associate professor in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center, said during the discussion. “I think we all really value teamwork, and we take on the role of being the coordinator and making sure things are getting done in a seamless and thoughtful manner. Communicating with families, communicating with our research team, communicating with primary care physicians. I think that is something we’re very used to doing, and I think we do it well. I think we don’t shy away from difficult conversations with consultants. And I think that’s what makes being a hospitalist so amazing.”
Achieving wellness as a hospitalist
Another topic discussed during the roundtable was “comprehensive care for the hospitalist” and how they can achieve a sense of wellness for themselves. Gurpreet Dhaliwal, MD, clinician-educator and professor of medicine at the University of California, San Francisco, said long-term satisfaction in one’s career is less about compensation and more about autonomy, mastery, and purpose.
“Autonomy is shrinking a little bit in health care. But if we connect to our purpose – ‘what are we doing here and how do we connect?’ – it’s either learning about patients and their stories, being with a team of people that you work with, that really builds that purpose,” he said.
Regarding mastery, there’s “tremendous joy if you’re in an environment where people value your mastery, whether it is working in a team or communicating or diagnosing or doing a procedure. If you think of setting up the work environment and those things are in place, I think a lot of wellness can actually happen at work, even though another component, of course, is balancing your life outside of work,” Dr. Dhaliwal said.
This may seem out of reach during COVID-19, but wellness is still achievable during the pandemic, Dr. Martinez said. Her time is spent 75% as a researcher and 25% as a clinician, which is her ideal balance. “I enjoy doing my research, doing my own statistics and writing grants and just learning about this problem that I’ve developed an interest in,” she said. “I just think that’s an important piece for people to focus on as far as health care for the hospitalist, is that there’s no no-one-size-fits-all, that’s for sure.”
Dr. Kumar noted that her clinical time gives her energy for nonclinical work. “I love my clinical time. It’s one of my favorite things that I do,” she said. Although she is tired at the end of the week, “I feel like I am not only giving back to my patients and my team, but I’m also giving back to myself and reminding myself why it is I do what I do every day,” she said.
Wellness for Dr. Unaka meant remembering what drew her to medicine. “It was definitely the opportunity to build strong relationships with patients and families,” she said. While these encounters can sometimes be heavy and stay with a hospitalist, “the fact that we’re in it with them is something that gives a lot of us purpose. I think that when I reflect on all of those things, I’m so happy that I’m in the role that I am.”
Unique skills during COVID-19
Mark Shapiro, MD, hospitalist and host of the roundtable and the Explore the Space podcast, also asked the panelists what skills they unexpectedly leveraged during the pandemic. Communication – with colleagues and with the community they serve – was a universal answer among the panelists.
“I learned – really from seeing some of our senior leaders here do it so well – the importance of being visible, particularly at a time when people were not together and more isolated,” Dr. Unaka said. “I think being able to be visible when you can, in order to deliver really complicated or tough news or communicate about uncertainty, for instance. Being here for our residents – many of our interns moved here sight unseen. I think they needed to feel like they had some sense of normalcy and a sense of community. I really learned how important it was to be visible, and available, and how important the little things mattered.”
Dr. Martinez said that worrying about her patients with COVID-19 in the hospital and the uncertainty around the disease kept her up at night. “I think we always have a hard time leaving work at work and getting a good night’s sleep. I just could not let go of worrying about these patients and having terrible insomnia, trying to leave work at work and I couldn’t – even after they were discharged.”
Dr. Shapiro said the skill he most needed to work on during the pandemic was his courage. “I remember the first time I took care of COVID patients. I was scared. I have no problems saying that out loud. That was a scary experience.”
The demeanor of the nurses on his unit, who had already seen patients with COVID-19, helped ground him during those moments and gave him the courage to move forward. “They’d already been doing it and they were the same. Same affect, same jokes, same everything,” he said. “That actually really helped, and I’ve leaned on that every time I’ve been back on our COVID service.”
Importance of mental health
The COVID-19 pandemic has also shined a light on the importance of mental health. “I think it is important to acknowledge that as hospitalists who have been out on the bleeding edge for a year, mental health is critically important, and we know that we face shortages in that space for the public at large and also for our profession,” Dr. Shapiro said.
When asked about what mental health and self-care looks like for her, Dr. Kumar referenced the need for exercise, meditation, and yoga. “My mental health was better knowing that the people closest to me – whether they be colleagues or friends or family – their mental health was also in a good place and they were also in a good place. And that helped to build me up,” she said.
Dr. Unaka called attention to the stigma around mental health, particularly among physicians, and the lack of resources to address the issue. “It’s a real problem,” she said. “I think it’s at a point where we as a profession need to advocate on behalf of each other and on behalf of our trainees. And honestly, I think we need to view mental health as just ‘health’ and stop separating it out in order for us to move to a place where people feel like they can access what they need without feeling shame about it.”
Editor’s note: National Hospitalist Day occurs the first Thursday in March annually, and serves to celebrate the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape. On National Hospitalist Day in 2021, SHM convened a virtual roundtable with a diverse group of hospitalists to discuss skill set, wellness, and other key issues for hospitalists. To listen to the entire roundtable discussion, visit this Explore The Space podcast episode.
A hospitalist isn’t just a physician who happens to work in a hospital. They are medical professionals with a robust skill set that they use both inside and outside the hospital setting. But what skill sets do hospitalists need to become successful in their careers? And what skill sets does a “pluripotent” hospitalist need in their armamentarium?
These were the issues discussed by participants of a virtual roundtable discussion on National Hospitalist Day – March 4, 2021 – as part of a joint effort of the Society of Hospital Medicine and the Explore the Space podcast.
Maylyn S. Martinez, MD, clinician-researcher and clinical associate at the University of Chicago, sees her hospitalist and research skill sets as two “buckets” of skills she can sort through, with diagnostic, knowledge-based care coordination, and interpersonal skills as lanes where she can focus and improve. “I’m always trying to work in, and sharpen, and find ways to get better at something in each of those every day,” she said.
For Anika Kumar, MD, FHM, pediatric editor of the Hospitalist and clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine, much of her work is focused on problem solving. “I approach that as: ‘How do I come up with my differential diagnosis, and how do I diagnose the patient?’ I think that the lanes are a little bit different, but there is some overlap.”
Adaptability is another important part of the skill set for the hospitalist, Ndidi Unaka, MD, MEd, associate professor in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center, said during the discussion. “I think we all really value teamwork, and we take on the role of being the coordinator and making sure things are getting done in a seamless and thoughtful manner. Communicating with families, communicating with our research team, communicating with primary care physicians. I think that is something we’re very used to doing, and I think we do it well. I think we don’t shy away from difficult conversations with consultants. And I think that’s what makes being a hospitalist so amazing.”
Achieving wellness as a hospitalist
Another topic discussed during the roundtable was “comprehensive care for the hospitalist” and how they can achieve a sense of wellness for themselves. Gurpreet Dhaliwal, MD, clinician-educator and professor of medicine at the University of California, San Francisco, said long-term satisfaction in one’s career is less about compensation and more about autonomy, mastery, and purpose.
“Autonomy is shrinking a little bit in health care. But if we connect to our purpose – ‘what are we doing here and how do we connect?’ – it’s either learning about patients and their stories, being with a team of people that you work with, that really builds that purpose,” he said.
Regarding mastery, there’s “tremendous joy if you’re in an environment where people value your mastery, whether it is working in a team or communicating or diagnosing or doing a procedure. If you think of setting up the work environment and those things are in place, I think a lot of wellness can actually happen at work, even though another component, of course, is balancing your life outside of work,” Dr. Dhaliwal said.
This may seem out of reach during COVID-19, but wellness is still achievable during the pandemic, Dr. Martinez said. Her time is spent 75% as a researcher and 25% as a clinician, which is her ideal balance. “I enjoy doing my research, doing my own statistics and writing grants and just learning about this problem that I’ve developed an interest in,” she said. “I just think that’s an important piece for people to focus on as far as health care for the hospitalist, is that there’s no no-one-size-fits-all, that’s for sure.”
Dr. Kumar noted that her clinical time gives her energy for nonclinical work. “I love my clinical time. It’s one of my favorite things that I do,” she said. Although she is tired at the end of the week, “I feel like I am not only giving back to my patients and my team, but I’m also giving back to myself and reminding myself why it is I do what I do every day,” she said.
Wellness for Dr. Unaka meant remembering what drew her to medicine. “It was definitely the opportunity to build strong relationships with patients and families,” she said. While these encounters can sometimes be heavy and stay with a hospitalist, “the fact that we’re in it with them is something that gives a lot of us purpose. I think that when I reflect on all of those things, I’m so happy that I’m in the role that I am.”
Unique skills during COVID-19
Mark Shapiro, MD, hospitalist and host of the roundtable and the Explore the Space podcast, also asked the panelists what skills they unexpectedly leveraged during the pandemic. Communication – with colleagues and with the community they serve – was a universal answer among the panelists.
“I learned – really from seeing some of our senior leaders here do it so well – the importance of being visible, particularly at a time when people were not together and more isolated,” Dr. Unaka said. “I think being able to be visible when you can, in order to deliver really complicated or tough news or communicate about uncertainty, for instance. Being here for our residents – many of our interns moved here sight unseen. I think they needed to feel like they had some sense of normalcy and a sense of community. I really learned how important it was to be visible, and available, and how important the little things mattered.”
Dr. Martinez said that worrying about her patients with COVID-19 in the hospital and the uncertainty around the disease kept her up at night. “I think we always have a hard time leaving work at work and getting a good night’s sleep. I just could not let go of worrying about these patients and having terrible insomnia, trying to leave work at work and I couldn’t – even after they were discharged.”
Dr. Shapiro said the skill he most needed to work on during the pandemic was his courage. “I remember the first time I took care of COVID patients. I was scared. I have no problems saying that out loud. That was a scary experience.”
The demeanor of the nurses on his unit, who had already seen patients with COVID-19, helped ground him during those moments and gave him the courage to move forward. “They’d already been doing it and they were the same. Same affect, same jokes, same everything,” he said. “That actually really helped, and I’ve leaned on that every time I’ve been back on our COVID service.”
Importance of mental health
The COVID-19 pandemic has also shined a light on the importance of mental health. “I think it is important to acknowledge that as hospitalists who have been out on the bleeding edge for a year, mental health is critically important, and we know that we face shortages in that space for the public at large and also for our profession,” Dr. Shapiro said.
When asked about what mental health and self-care looks like for her, Dr. Kumar referenced the need for exercise, meditation, and yoga. “My mental health was better knowing that the people closest to me – whether they be colleagues or friends or family – their mental health was also in a good place and they were also in a good place. And that helped to build me up,” she said.
Dr. Unaka called attention to the stigma around mental health, particularly among physicians, and the lack of resources to address the issue. “It’s a real problem,” she said. “I think it’s at a point where we as a profession need to advocate on behalf of each other and on behalf of our trainees. And honestly, I think we need to view mental health as just ‘health’ and stop separating it out in order for us to move to a place where people feel like they can access what they need without feeling shame about it.”
Virtual is the new real
Why did we fall short on maximizing telehealth’s value in the COVID-19 pandemic?
The COVID-19 pandemic catalyzed the transformation of Internet-based, remotely accessible innovative technologies. Internet-based customer service delivery technology was rapidly adopted and utilized by several services industries, but health care systems in most of the countries across the world faced unique challenges in adopting the technology for the delivery of health care services. The health care ecosystem of the United States was not immune to such challenges, and several significant barriers surfaced while the pandemic was underway.
Complexly structured, fragmented, unprepared, and overly burnt-out health systems in the United States arguably have fallen short of maximizing the value of telehealth in delivering safe, easily accessible, comprehensive, and cost-effective health care services. In this essay, we examine the reasons for such a suboptimal performance and discuss a few important strategies that may be useful in maximizing the value of telehealth value in several, appropriate health care services.
Hospitals and telehealth
Are hospitalists preparing ourselves “not to see” patients in a hospital-based health care delivery setting? If you have not yet started yet, now may be the right time! Yes, a certain percentage of doctor-patient encounters in hospital settings will remain virtual forever.
A well-established telehealth infrastructure is rarely found in most U.S. hospitals, although the COVID-19 pandemic has unexpectedly boosted the rapid growth of telehealth in the country.1 Public health emergency declarations in the United States in the face of the COVID-19 crisis have facilitated two important initiatives to restore health care delivery amidst formal and informal lockdowns that brought states to a grinding halt. These extend from expansion of virtual services, including telehealth, virtual check-ins, and e-visits, to the decision by the Department of Health & Human Services Office of Civil Rights to exercise enforcement discretion and waive penalties for the use of relatively inexpensive, non–public-facing mobile and other audiovisual technology tools.2
Hospital-based care in the United States taps nearly 33% of national health expenditure. An additional 30% of national health expenditure that is related to physicians, prescriptions, and other facilities is indirectly influenced by care delivered at health care facilities.3 Studies show that about 20% of ED visits could potentially be avoided via virtual urgent care offerings.4 A rapidly changing health care ecosystem is proving formidable for most hospital systems, and a test for their resilience and agility. Not just the implementation of telehealth is challenging, but getting it right is the key success factor.
Hospital-based telehealth
Expansion of telehealth coverage by the Centers for Medicare & Medicaid Services and most commercial payers did not quite ride the pandemic-induced momentum across the care continuum. Hospitals are lagging far behind ambulatory care in implementing telehealth. As illustrated in the “4-T Matrix” (see graphic) we would like to examine four key reasons for such a sluggish initial uptake and try to propose four important strategies that may help us to maximize the value created by telehealth technologies.
1. Timing
The health care system has always lagged far behind other service industries in terms of technology adaptation. Because of the unique nature of health care services, face-to-face interaction supersedes all other forms of communication. A rapidly evolving pandemic was not matched by simultaneous technology education for patients and providers. The enormous choice of hard-to-navigate telehealth tools; time and labor-intensive implementation; and uncertainty around payer, policy, and regulatory expectations might have precluded providers from the rapid adoption of telehealth in the hospital setting. Patients’ specific characteristics, such as the absence of technology-centered education, information, age, comorbidities, lack of technical literacy, and dependency on caregivers contributed to the suboptimal response from patients and families.
Deploying simple, ubiquitous, user-friendly, and technologically less challenging telehealth solutions may be a better approach to increase the adoption of such solutions by providers and patients. Hospitals need to develop and distribute telehealth user guides in all possible modes of communication. Provider-centric in-service sessions, workshops, and live support by “superuser teams” often work well in reducing end-user resistance.
2. Technical
Current electronic medical records vary widely in their features and offerings, and their ability to interact with third-party software and platforms. Dissatisfaction of end users with EMRs is well known, as is their likely relationship to burnout. Recent research continues to show a strong relationship between EMR usability and the odds of burnout among physicians.5 In the current climate, administrators and health informaticists have the responsibility to avoid adding increased burdens to end users.
Another issue is the limited connectivity in many remote/rural areas that would impact implementation of telehealth platforms. Studies indicate that 33% of rural Americans lack access to high-speed broadband Internet to support video visits.6 The recent successful implementation of telehealth across 530 providers in 75 ambulatory practices operated by Munson Healthcare, a rural health system in northern Michigan, sheds light on the technology’s enormous potential in providing safe access to rural populations.6,7
Privacy and safety of patient data is of paramount importance. According to a national poll on healthy aging by the University of Michigan in May 2019, targeting older adults, 47% of survey responders expressed difficulty using technology and 49% of survey responders were concerned about privacy.8 Use of certification and other tools offered by the Office of the National Coordinator for Health Information Technology would help reassure users, and the ability to capture and share images between providers would be of immense benefit in facilitating e-consults.
The need of the hour is redesigned work flow, to help providers adopt and use virtual care/telehealth efficiently. Work flow redesign must be coupled with technological advances to allow seamless integration of third-party telehealth platforms into existing EMR systems or built directly into EMRs. Use of quality metrics and analytical tools specific to telehealth would help measure the technology’s impact on patient care, outcomes, and end-user/provider experience.
3. Teams and training
Outcomes of health care interventions are often determined by the effectiveness of teams. Irrespective of how robust health care systems may have been initially, rapidly spreading infectious diseases like COVID-19 can quickly derail the system, bringing the workforce and patients to a breaking point.5 Decentralized, uncoordinated, and siloed efforts by individual teams across the care continuum were contributing factors for the partial success of telehealth care delivery pathways. The hospital systems with telehealth-ready teams at the start of the COVID-19 pandemic were so rare that the knowledge and technical training opportunities for innovators grew severalfold during the pandemic.
As per the American Medical Association, telehealth success is massively dependent on building the right team. Core, leadership, advisory, and implementation teams comprised of clinical representatives, end users, administrative personnel, executive members of the organization, technical experts, and payment/policy experts should be put together before implementing a telehealth strategy.9 Seamless integration of hospital-based care with ambulatory care via a telehealth platform is only complete when care managers are trained and deployed to fulfill the needs of a diverse group of patients. Deriving overall value from telehealth is only possible when there is a skill development, training and mentoring team put in place.
4. Thinking
In most U.S. hospitals, inpatient health care is equally distributed between nonprocedure and procedure-based services. Hospitals resorted to suspension of nonemergent procedures to mitigate the risk of spreading COVID-19. This was further compounded by many patients’ self-selection to defer care, an abrupt reduction in the influx of patients from the referral base because of suboptimally operating ambulatory care services, leading to low hospital occupancy.
Hospitals across the nation have gone through a massive short-term financial crunch and unfavorable cash-flow forecast, which prompted a paradoxical work-force reduction. While some argue that it may be akin to strategic myopia, the authors believed that such a response is strategically imperative to keep the hospital afloat. It is reasonable to attribute the paucity of innovation to constrained resources, and health systems are simply staying overly optimistic about “weathering the storm” and reverting soon to “business as usual.” The technological framework necessary for deploying a telehealth solution often comes with a price. Financially challenged hospital systems rarely exercise any capital-intensive activities. By contrast, telehealth adoption by ambulatory care can result in quicker resumption of patient care in community settings. A lack of operational and infrastructure synchrony between ambulatory and in-hospital systems has failed to capture telehealth-driven inpatient volume. For example, direct admissions from ambulatory telehealth referrals was a missed opportunity in several places. Referrals for labs, diagnostic tests, and other allied services could have helped hospitals offset their fixed costs. Similarly, work flows related to discharge and postdischarge follow up rarely embrace telehealth tools or telehealth care pathways. A brisk change in the health care ecosystem is partly responsible for this.
Digital strategy needs to be incorporated into business strategy. For the reasons already discussed, telehealth technology is not a “nice to have” anymore, but a “must have.” At present, providers are of the opinion that about 20% of their patient services can be delivered via a telehealth platform. Similar trends are observed among patients, as a new modality of access to care is increasingly beneficial to them. Telehealth must be incorporated in standardized hospital work flows. Use of telehealth for preoperative clearance will greatly minimize same-day surgery cancellations. Given the potential shortage in resources, telehealth adoption for inpatient consultations will help systems conserve personal protective equipment, minimize the risk of staff exposure to COVID-19, and improve efficiency.
Digital strategy also prompts the reengineering of care delivery.10 Excessive and unused physical capacity can be converted into digital care hubs. Health maintenance, prevention, health promotion, health education, and chronic disease management not only can serve a variety of patient groups but can also help address the “last-mile problem” in health care. A successful digital strategy usually has three important components – Commitment: Hospital leadership is committed to include digital transformation as a strategic objective; Cost: Digital strategy is added as a line item in the budget; and Control: Measurable metrics are put in place to monitor the performance, impact, and influence of the digital strategy.
Conclusion
For decades, most U.S. health systems occupied the periphery of technological transformation when compared to the rest of the service industry. While most health systems took a heroic approach to the adoption of telehealth during COVID-19, despite being unprepared, the need for a systematic telehealth deployment is far from being adequately fulfilled. The COVID-19 pandemic brought permanent changes to several business disciplines globally. Given the impact of the pandemic on the health and overall wellbeing of American society, the U.S. health care industry must leave no stone unturned in its quest for transformation.
Dr. Lingisetty is a hospitalist and physician executive at Baptist Health System, Little Rock, Ark, and is cofounder/president of SHM’s Arkansas chapter. Dr. Prasad is medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He is cochair of SHM’s IT Special Interest Group, sits on the HQPS committee, and is president of SHM’s Wisconsin chapter. Dr. Palabindala is the medical director, utilization management, and physician advisory services at the University of Mississippi Medical Center and an associate professor of medicine and academic hospitalist at the University of Mississippi, both in Jackson.
References
1. Finnegan M. “Telehealth booms amid COVID-19 crisis.” Computerworld. 2020 Apr 27. www.computerworld.com/article/3540315/telehealth-booms-amid-covid-19-crisis-virtual-care-is-here-to-stay.html. Accessed 2020 Sep 12.
2. Department of Health & Human Services. “OCR Announces Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency.” 2020 Mar 17. www.hhs.gov/about/news/2020/03/17/ocr-announces-notification-of-enforcement-discretion-for-telehealth-remote-communications-during-the-covid-19.html. Accessed 2020 Sep 12.
3. National Center for Health Statistics. “Health Expenditures.” www.cdc.gov/nchs/fastats/health-expenditures.htm. Accessed 2020 Sep 12.
4. Bestsennyy O et al. “Telehealth: A post–COVID-19 reality?” McKinsey & Company. 2020 May 29. www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality. Accessed 2020 Sep 12.
5. Melnick ER et al. The Association Between Perceived Electronic Health Record Usability and Professional Burnout Among U.S. Physicians. Mayo Clin Proc. 2020 March;95(3):476-87.
6. Hirko KA et al. Telehealth in response to the COVID-19 pandemic: Implications for rural health disparities. J Am Med Inform Assoc. 2020 Nov;27(11):1816-8. .
7. American Academy of Family Physicians. “Study Examines Telehealth, Rural Disparities in Pandemic.” 2020 July 30. www.aafp.org/news/practice-professional-issues/20200730ruraltelehealth.html. Accessed 2020 Dec 15.
8. Kurlander J et al. “Virtual Visits: Telehealth and Older Adults.” National Poll on Healthy Aging. 2019 Oct. hdl.handle.net/2027.42/151376.
9. American Medical Association. Telehealth Implementation Playbook. 2019. www.ama-assn.org/system/files/2020-04/ama-telehealth-implementation-playbook.pdf.
10. Smith AC et al. Telehealth for global emergencies: Implications for coronavirus disease 2019 (COVID-19). J Telemed Telecare. 2020 Jun;26(5):309-13.
Why did we fall short on maximizing telehealth’s value in the COVID-19 pandemic?
Why did we fall short on maximizing telehealth’s value in the COVID-19 pandemic?
The COVID-19 pandemic catalyzed the transformation of Internet-based, remotely accessible innovative technologies. Internet-based customer service delivery technology was rapidly adopted and utilized by several services industries, but health care systems in most of the countries across the world faced unique challenges in adopting the technology for the delivery of health care services. The health care ecosystem of the United States was not immune to such challenges, and several significant barriers surfaced while the pandemic was underway.
Complexly structured, fragmented, unprepared, and overly burnt-out health systems in the United States arguably have fallen short of maximizing the value of telehealth in delivering safe, easily accessible, comprehensive, and cost-effective health care services. In this essay, we examine the reasons for such a suboptimal performance and discuss a few important strategies that may be useful in maximizing the value of telehealth value in several, appropriate health care services.
Hospitals and telehealth
Are hospitalists preparing ourselves “not to see” patients in a hospital-based health care delivery setting? If you have not yet started yet, now may be the right time! Yes, a certain percentage of doctor-patient encounters in hospital settings will remain virtual forever.
A well-established telehealth infrastructure is rarely found in most U.S. hospitals, although the COVID-19 pandemic has unexpectedly boosted the rapid growth of telehealth in the country.1 Public health emergency declarations in the United States in the face of the COVID-19 crisis have facilitated two important initiatives to restore health care delivery amidst formal and informal lockdowns that brought states to a grinding halt. These extend from expansion of virtual services, including telehealth, virtual check-ins, and e-visits, to the decision by the Department of Health & Human Services Office of Civil Rights to exercise enforcement discretion and waive penalties for the use of relatively inexpensive, non–public-facing mobile and other audiovisual technology tools.2
Hospital-based care in the United States taps nearly 33% of national health expenditure. An additional 30% of national health expenditure that is related to physicians, prescriptions, and other facilities is indirectly influenced by care delivered at health care facilities.3 Studies show that about 20% of ED visits could potentially be avoided via virtual urgent care offerings.4 A rapidly changing health care ecosystem is proving formidable for most hospital systems, and a test for their resilience and agility. Not just the implementation of telehealth is challenging, but getting it right is the key success factor.
Hospital-based telehealth
Expansion of telehealth coverage by the Centers for Medicare & Medicaid Services and most commercial payers did not quite ride the pandemic-induced momentum across the care continuum. Hospitals are lagging far behind ambulatory care in implementing telehealth. As illustrated in the “4-T Matrix” (see graphic) we would like to examine four key reasons for such a sluggish initial uptake and try to propose four important strategies that may help us to maximize the value created by telehealth technologies.
1. Timing
The health care system has always lagged far behind other service industries in terms of technology adaptation. Because of the unique nature of health care services, face-to-face interaction supersedes all other forms of communication. A rapidly evolving pandemic was not matched by simultaneous technology education for patients and providers. The enormous choice of hard-to-navigate telehealth tools; time and labor-intensive implementation; and uncertainty around payer, policy, and regulatory expectations might have precluded providers from the rapid adoption of telehealth in the hospital setting. Patients’ specific characteristics, such as the absence of technology-centered education, information, age, comorbidities, lack of technical literacy, and dependency on caregivers contributed to the suboptimal response from patients and families.
Deploying simple, ubiquitous, user-friendly, and technologically less challenging telehealth solutions may be a better approach to increase the adoption of such solutions by providers and patients. Hospitals need to develop and distribute telehealth user guides in all possible modes of communication. Provider-centric in-service sessions, workshops, and live support by “superuser teams” often work well in reducing end-user resistance.
2. Technical
Current electronic medical records vary widely in their features and offerings, and their ability to interact with third-party software and platforms. Dissatisfaction of end users with EMRs is well known, as is their likely relationship to burnout. Recent research continues to show a strong relationship between EMR usability and the odds of burnout among physicians.5 In the current climate, administrators and health informaticists have the responsibility to avoid adding increased burdens to end users.
Another issue is the limited connectivity in many remote/rural areas that would impact implementation of telehealth platforms. Studies indicate that 33% of rural Americans lack access to high-speed broadband Internet to support video visits.6 The recent successful implementation of telehealth across 530 providers in 75 ambulatory practices operated by Munson Healthcare, a rural health system in northern Michigan, sheds light on the technology’s enormous potential in providing safe access to rural populations.6,7
Privacy and safety of patient data is of paramount importance. According to a national poll on healthy aging by the University of Michigan in May 2019, targeting older adults, 47% of survey responders expressed difficulty using technology and 49% of survey responders were concerned about privacy.8 Use of certification and other tools offered by the Office of the National Coordinator for Health Information Technology would help reassure users, and the ability to capture and share images between providers would be of immense benefit in facilitating e-consults.
The need of the hour is redesigned work flow, to help providers adopt and use virtual care/telehealth efficiently. Work flow redesign must be coupled with technological advances to allow seamless integration of third-party telehealth platforms into existing EMR systems or built directly into EMRs. Use of quality metrics and analytical tools specific to telehealth would help measure the technology’s impact on patient care, outcomes, and end-user/provider experience.
3. Teams and training
Outcomes of health care interventions are often determined by the effectiveness of teams. Irrespective of how robust health care systems may have been initially, rapidly spreading infectious diseases like COVID-19 can quickly derail the system, bringing the workforce and patients to a breaking point.5 Decentralized, uncoordinated, and siloed efforts by individual teams across the care continuum were contributing factors for the partial success of telehealth care delivery pathways. The hospital systems with telehealth-ready teams at the start of the COVID-19 pandemic were so rare that the knowledge and technical training opportunities for innovators grew severalfold during the pandemic.
As per the American Medical Association, telehealth success is massively dependent on building the right team. Core, leadership, advisory, and implementation teams comprised of clinical representatives, end users, administrative personnel, executive members of the organization, technical experts, and payment/policy experts should be put together before implementing a telehealth strategy.9 Seamless integration of hospital-based care with ambulatory care via a telehealth platform is only complete when care managers are trained and deployed to fulfill the needs of a diverse group of patients. Deriving overall value from telehealth is only possible when there is a skill development, training and mentoring team put in place.
4. Thinking
In most U.S. hospitals, inpatient health care is equally distributed between nonprocedure and procedure-based services. Hospitals resorted to suspension of nonemergent procedures to mitigate the risk of spreading COVID-19. This was further compounded by many patients’ self-selection to defer care, an abrupt reduction in the influx of patients from the referral base because of suboptimally operating ambulatory care services, leading to low hospital occupancy.
Hospitals across the nation have gone through a massive short-term financial crunch and unfavorable cash-flow forecast, which prompted a paradoxical work-force reduction. While some argue that it may be akin to strategic myopia, the authors believed that such a response is strategically imperative to keep the hospital afloat. It is reasonable to attribute the paucity of innovation to constrained resources, and health systems are simply staying overly optimistic about “weathering the storm” and reverting soon to “business as usual.” The technological framework necessary for deploying a telehealth solution often comes with a price. Financially challenged hospital systems rarely exercise any capital-intensive activities. By contrast, telehealth adoption by ambulatory care can result in quicker resumption of patient care in community settings. A lack of operational and infrastructure synchrony between ambulatory and in-hospital systems has failed to capture telehealth-driven inpatient volume. For example, direct admissions from ambulatory telehealth referrals was a missed opportunity in several places. Referrals for labs, diagnostic tests, and other allied services could have helped hospitals offset their fixed costs. Similarly, work flows related to discharge and postdischarge follow up rarely embrace telehealth tools or telehealth care pathways. A brisk change in the health care ecosystem is partly responsible for this.
Digital strategy needs to be incorporated into business strategy. For the reasons already discussed, telehealth technology is not a “nice to have” anymore, but a “must have.” At present, providers are of the opinion that about 20% of their patient services can be delivered via a telehealth platform. Similar trends are observed among patients, as a new modality of access to care is increasingly beneficial to them. Telehealth must be incorporated in standardized hospital work flows. Use of telehealth for preoperative clearance will greatly minimize same-day surgery cancellations. Given the potential shortage in resources, telehealth adoption for inpatient consultations will help systems conserve personal protective equipment, minimize the risk of staff exposure to COVID-19, and improve efficiency.
Digital strategy also prompts the reengineering of care delivery.10 Excessive and unused physical capacity can be converted into digital care hubs. Health maintenance, prevention, health promotion, health education, and chronic disease management not only can serve a variety of patient groups but can also help address the “last-mile problem” in health care. A successful digital strategy usually has three important components – Commitment: Hospital leadership is committed to include digital transformation as a strategic objective; Cost: Digital strategy is added as a line item in the budget; and Control: Measurable metrics are put in place to monitor the performance, impact, and influence of the digital strategy.
Conclusion
For decades, most U.S. health systems occupied the periphery of technological transformation when compared to the rest of the service industry. While most health systems took a heroic approach to the adoption of telehealth during COVID-19, despite being unprepared, the need for a systematic telehealth deployment is far from being adequately fulfilled. The COVID-19 pandemic brought permanent changes to several business disciplines globally. Given the impact of the pandemic on the health and overall wellbeing of American society, the U.S. health care industry must leave no stone unturned in its quest for transformation.
Dr. Lingisetty is a hospitalist and physician executive at Baptist Health System, Little Rock, Ark, and is cofounder/president of SHM’s Arkansas chapter. Dr. Prasad is medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He is cochair of SHM’s IT Special Interest Group, sits on the HQPS committee, and is president of SHM’s Wisconsin chapter. Dr. Palabindala is the medical director, utilization management, and physician advisory services at the University of Mississippi Medical Center and an associate professor of medicine and academic hospitalist at the University of Mississippi, both in Jackson.
References
1. Finnegan M. “Telehealth booms amid COVID-19 crisis.” Computerworld. 2020 Apr 27. www.computerworld.com/article/3540315/telehealth-booms-amid-covid-19-crisis-virtual-care-is-here-to-stay.html. Accessed 2020 Sep 12.
2. Department of Health & Human Services. “OCR Announces Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency.” 2020 Mar 17. www.hhs.gov/about/news/2020/03/17/ocr-announces-notification-of-enforcement-discretion-for-telehealth-remote-communications-during-the-covid-19.html. Accessed 2020 Sep 12.
3. National Center for Health Statistics. “Health Expenditures.” www.cdc.gov/nchs/fastats/health-expenditures.htm. Accessed 2020 Sep 12.
4. Bestsennyy O et al. “Telehealth: A post–COVID-19 reality?” McKinsey & Company. 2020 May 29. www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality. Accessed 2020 Sep 12.
5. Melnick ER et al. The Association Between Perceived Electronic Health Record Usability and Professional Burnout Among U.S. Physicians. Mayo Clin Proc. 2020 March;95(3):476-87.
6. Hirko KA et al. Telehealth in response to the COVID-19 pandemic: Implications for rural health disparities. J Am Med Inform Assoc. 2020 Nov;27(11):1816-8. .
7. American Academy of Family Physicians. “Study Examines Telehealth, Rural Disparities in Pandemic.” 2020 July 30. www.aafp.org/news/practice-professional-issues/20200730ruraltelehealth.html. Accessed 2020 Dec 15.
8. Kurlander J et al. “Virtual Visits: Telehealth and Older Adults.” National Poll on Healthy Aging. 2019 Oct. hdl.handle.net/2027.42/151376.
9. American Medical Association. Telehealth Implementation Playbook. 2019. www.ama-assn.org/system/files/2020-04/ama-telehealth-implementation-playbook.pdf.
10. Smith AC et al. Telehealth for global emergencies: Implications for coronavirus disease 2019 (COVID-19). J Telemed Telecare. 2020 Jun;26(5):309-13.
The COVID-19 pandemic catalyzed the transformation of Internet-based, remotely accessible innovative technologies. Internet-based customer service delivery technology was rapidly adopted and utilized by several services industries, but health care systems in most of the countries across the world faced unique challenges in adopting the technology for the delivery of health care services. The health care ecosystem of the United States was not immune to such challenges, and several significant barriers surfaced while the pandemic was underway.
Complexly structured, fragmented, unprepared, and overly burnt-out health systems in the United States arguably have fallen short of maximizing the value of telehealth in delivering safe, easily accessible, comprehensive, and cost-effective health care services. In this essay, we examine the reasons for such a suboptimal performance and discuss a few important strategies that may be useful in maximizing the value of telehealth value in several, appropriate health care services.
Hospitals and telehealth
Are hospitalists preparing ourselves “not to see” patients in a hospital-based health care delivery setting? If you have not yet started yet, now may be the right time! Yes, a certain percentage of doctor-patient encounters in hospital settings will remain virtual forever.
A well-established telehealth infrastructure is rarely found in most U.S. hospitals, although the COVID-19 pandemic has unexpectedly boosted the rapid growth of telehealth in the country.1 Public health emergency declarations in the United States in the face of the COVID-19 crisis have facilitated two important initiatives to restore health care delivery amidst formal and informal lockdowns that brought states to a grinding halt. These extend from expansion of virtual services, including telehealth, virtual check-ins, and e-visits, to the decision by the Department of Health & Human Services Office of Civil Rights to exercise enforcement discretion and waive penalties for the use of relatively inexpensive, non–public-facing mobile and other audiovisual technology tools.2
Hospital-based care in the United States taps nearly 33% of national health expenditure. An additional 30% of national health expenditure that is related to physicians, prescriptions, and other facilities is indirectly influenced by care delivered at health care facilities.3 Studies show that about 20% of ED visits could potentially be avoided via virtual urgent care offerings.4 A rapidly changing health care ecosystem is proving formidable for most hospital systems, and a test for their resilience and agility. Not just the implementation of telehealth is challenging, but getting it right is the key success factor.
Hospital-based telehealth
Expansion of telehealth coverage by the Centers for Medicare & Medicaid Services and most commercial payers did not quite ride the pandemic-induced momentum across the care continuum. Hospitals are lagging far behind ambulatory care in implementing telehealth. As illustrated in the “4-T Matrix” (see graphic) we would like to examine four key reasons for such a sluggish initial uptake and try to propose four important strategies that may help us to maximize the value created by telehealth technologies.
1. Timing
The health care system has always lagged far behind other service industries in terms of technology adaptation. Because of the unique nature of health care services, face-to-face interaction supersedes all other forms of communication. A rapidly evolving pandemic was not matched by simultaneous technology education for patients and providers. The enormous choice of hard-to-navigate telehealth tools; time and labor-intensive implementation; and uncertainty around payer, policy, and regulatory expectations might have precluded providers from the rapid adoption of telehealth in the hospital setting. Patients’ specific characteristics, such as the absence of technology-centered education, information, age, comorbidities, lack of technical literacy, and dependency on caregivers contributed to the suboptimal response from patients and families.
Deploying simple, ubiquitous, user-friendly, and technologically less challenging telehealth solutions may be a better approach to increase the adoption of such solutions by providers and patients. Hospitals need to develop and distribute telehealth user guides in all possible modes of communication. Provider-centric in-service sessions, workshops, and live support by “superuser teams” often work well in reducing end-user resistance.
2. Technical
Current electronic medical records vary widely in their features and offerings, and their ability to interact with third-party software and platforms. Dissatisfaction of end users with EMRs is well known, as is their likely relationship to burnout. Recent research continues to show a strong relationship between EMR usability and the odds of burnout among physicians.5 In the current climate, administrators and health informaticists have the responsibility to avoid adding increased burdens to end users.
Another issue is the limited connectivity in many remote/rural areas that would impact implementation of telehealth platforms. Studies indicate that 33% of rural Americans lack access to high-speed broadband Internet to support video visits.6 The recent successful implementation of telehealth across 530 providers in 75 ambulatory practices operated by Munson Healthcare, a rural health system in northern Michigan, sheds light on the technology’s enormous potential in providing safe access to rural populations.6,7
Privacy and safety of patient data is of paramount importance. According to a national poll on healthy aging by the University of Michigan in May 2019, targeting older adults, 47% of survey responders expressed difficulty using technology and 49% of survey responders were concerned about privacy.8 Use of certification and other tools offered by the Office of the National Coordinator for Health Information Technology would help reassure users, and the ability to capture and share images between providers would be of immense benefit in facilitating e-consults.
The need of the hour is redesigned work flow, to help providers adopt and use virtual care/telehealth efficiently. Work flow redesign must be coupled with technological advances to allow seamless integration of third-party telehealth platforms into existing EMR systems or built directly into EMRs. Use of quality metrics and analytical tools specific to telehealth would help measure the technology’s impact on patient care, outcomes, and end-user/provider experience.
3. Teams and training
Outcomes of health care interventions are often determined by the effectiveness of teams. Irrespective of how robust health care systems may have been initially, rapidly spreading infectious diseases like COVID-19 can quickly derail the system, bringing the workforce and patients to a breaking point.5 Decentralized, uncoordinated, and siloed efforts by individual teams across the care continuum were contributing factors for the partial success of telehealth care delivery pathways. The hospital systems with telehealth-ready teams at the start of the COVID-19 pandemic were so rare that the knowledge and technical training opportunities for innovators grew severalfold during the pandemic.
As per the American Medical Association, telehealth success is massively dependent on building the right team. Core, leadership, advisory, and implementation teams comprised of clinical representatives, end users, administrative personnel, executive members of the organization, technical experts, and payment/policy experts should be put together before implementing a telehealth strategy.9 Seamless integration of hospital-based care with ambulatory care via a telehealth platform is only complete when care managers are trained and deployed to fulfill the needs of a diverse group of patients. Deriving overall value from telehealth is only possible when there is a skill development, training and mentoring team put in place.
4. Thinking
In most U.S. hospitals, inpatient health care is equally distributed between nonprocedure and procedure-based services. Hospitals resorted to suspension of nonemergent procedures to mitigate the risk of spreading COVID-19. This was further compounded by many patients’ self-selection to defer care, an abrupt reduction in the influx of patients from the referral base because of suboptimally operating ambulatory care services, leading to low hospital occupancy.
Hospitals across the nation have gone through a massive short-term financial crunch and unfavorable cash-flow forecast, which prompted a paradoxical work-force reduction. While some argue that it may be akin to strategic myopia, the authors believed that such a response is strategically imperative to keep the hospital afloat. It is reasonable to attribute the paucity of innovation to constrained resources, and health systems are simply staying overly optimistic about “weathering the storm” and reverting soon to “business as usual.” The technological framework necessary for deploying a telehealth solution often comes with a price. Financially challenged hospital systems rarely exercise any capital-intensive activities. By contrast, telehealth adoption by ambulatory care can result in quicker resumption of patient care in community settings. A lack of operational and infrastructure synchrony between ambulatory and in-hospital systems has failed to capture telehealth-driven inpatient volume. For example, direct admissions from ambulatory telehealth referrals was a missed opportunity in several places. Referrals for labs, diagnostic tests, and other allied services could have helped hospitals offset their fixed costs. Similarly, work flows related to discharge and postdischarge follow up rarely embrace telehealth tools or telehealth care pathways. A brisk change in the health care ecosystem is partly responsible for this.
Digital strategy needs to be incorporated into business strategy. For the reasons already discussed, telehealth technology is not a “nice to have” anymore, but a “must have.” At present, providers are of the opinion that about 20% of their patient services can be delivered via a telehealth platform. Similar trends are observed among patients, as a new modality of access to care is increasingly beneficial to them. Telehealth must be incorporated in standardized hospital work flows. Use of telehealth for preoperative clearance will greatly minimize same-day surgery cancellations. Given the potential shortage in resources, telehealth adoption for inpatient consultations will help systems conserve personal protective equipment, minimize the risk of staff exposure to COVID-19, and improve efficiency.
Digital strategy also prompts the reengineering of care delivery.10 Excessive and unused physical capacity can be converted into digital care hubs. Health maintenance, prevention, health promotion, health education, and chronic disease management not only can serve a variety of patient groups but can also help address the “last-mile problem” in health care. A successful digital strategy usually has three important components – Commitment: Hospital leadership is committed to include digital transformation as a strategic objective; Cost: Digital strategy is added as a line item in the budget; and Control: Measurable metrics are put in place to monitor the performance, impact, and influence of the digital strategy.
Conclusion
For decades, most U.S. health systems occupied the periphery of technological transformation when compared to the rest of the service industry. While most health systems took a heroic approach to the adoption of telehealth during COVID-19, despite being unprepared, the need for a systematic telehealth deployment is far from being adequately fulfilled. The COVID-19 pandemic brought permanent changes to several business disciplines globally. Given the impact of the pandemic on the health and overall wellbeing of American society, the U.S. health care industry must leave no stone unturned in its quest for transformation.
Dr. Lingisetty is a hospitalist and physician executive at Baptist Health System, Little Rock, Ark, and is cofounder/president of SHM’s Arkansas chapter. Dr. Prasad is medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He is cochair of SHM’s IT Special Interest Group, sits on the HQPS committee, and is president of SHM’s Wisconsin chapter. Dr. Palabindala is the medical director, utilization management, and physician advisory services at the University of Mississippi Medical Center and an associate professor of medicine and academic hospitalist at the University of Mississippi, both in Jackson.
References
1. Finnegan M. “Telehealth booms amid COVID-19 crisis.” Computerworld. 2020 Apr 27. www.computerworld.com/article/3540315/telehealth-booms-amid-covid-19-crisis-virtual-care-is-here-to-stay.html. Accessed 2020 Sep 12.
2. Department of Health & Human Services. “OCR Announces Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency.” 2020 Mar 17. www.hhs.gov/about/news/2020/03/17/ocr-announces-notification-of-enforcement-discretion-for-telehealth-remote-communications-during-the-covid-19.html. Accessed 2020 Sep 12.
3. National Center for Health Statistics. “Health Expenditures.” www.cdc.gov/nchs/fastats/health-expenditures.htm. Accessed 2020 Sep 12.
4. Bestsennyy O et al. “Telehealth: A post–COVID-19 reality?” McKinsey & Company. 2020 May 29. www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality. Accessed 2020 Sep 12.
5. Melnick ER et al. The Association Between Perceived Electronic Health Record Usability and Professional Burnout Among U.S. Physicians. Mayo Clin Proc. 2020 March;95(3):476-87.
6. Hirko KA et al. Telehealth in response to the COVID-19 pandemic: Implications for rural health disparities. J Am Med Inform Assoc. 2020 Nov;27(11):1816-8. .
7. American Academy of Family Physicians. “Study Examines Telehealth, Rural Disparities in Pandemic.” 2020 July 30. www.aafp.org/news/practice-professional-issues/20200730ruraltelehealth.html. Accessed 2020 Dec 15.
8. Kurlander J et al. “Virtual Visits: Telehealth and Older Adults.” National Poll on Healthy Aging. 2019 Oct. hdl.handle.net/2027.42/151376.
9. American Medical Association. Telehealth Implementation Playbook. 2019. www.ama-assn.org/system/files/2020-04/ama-telehealth-implementation-playbook.pdf.
10. Smith AC et al. Telehealth for global emergencies: Implications for coronavirus disease 2019 (COVID-19). J Telemed Telecare. 2020 Jun;26(5):309-13.
‘Major update’ of BP guidance for kidney disease; treat to 120 mm Hg
The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”
This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.
The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.
In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.
“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.
The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
First, ‘take blood pressure well’
The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”
First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.
Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”
The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.
In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.
In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.
Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
Second, target 120, properly measured
“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.
“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.
“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.
“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
Still need individual treatment
Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.
“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.
“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.
“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”
“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
ACE inhibitors and ARBs beneficial in albuminuria, underused
“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.
“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”
Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.
“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
Public health implications
SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.
They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.
The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2 or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.
Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.
On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.
These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.
“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”
Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.
A version of this article first appeared on Medscape.com.
The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”
This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.
The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.
In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.
“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.
The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
First, ‘take blood pressure well’
The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”
First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.
Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”
The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.
In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.
In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.
Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
Second, target 120, properly measured
“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.
“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.
“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.
“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
Still need individual treatment
Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.
“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.
“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.
“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”
“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
ACE inhibitors and ARBs beneficial in albuminuria, underused
“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.
“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”
Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.
“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
Public health implications
SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.
They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.
The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2 or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.
Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.
On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.
These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.
“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”
Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.
A version of this article first appeared on Medscape.com.
The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”
This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.
The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.
In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.
“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.
The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
First, ‘take blood pressure well’
The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”
First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.
Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”
The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.
In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.
In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.
Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
Second, target 120, properly measured
“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.
“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.
“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.
“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
Still need individual treatment
Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.
“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.
“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.
“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”
“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
ACE inhibitors and ARBs beneficial in albuminuria, underused
“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.
“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”
Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.
“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
Public health implications
SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.
They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.
The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2 or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.
Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.
On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.
These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.
“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”
Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.
A version of this article first appeared on Medscape.com.
Hospitalist movers and shakers – March 2021
Vivek H. Murthy, MD, was named by President Joe Biden as his selection for Surgeon General of the United States. Dr. Murthy filled the same role from 2014-17 during President Barack Obama’s administration.
Dr. Murthy was a hospitalist and an instructor at Brigham and Women’s Hospital at Harvard Medical School prior to becoming surgeon general the first time. He also is the founder of Doctors for America.
David Tupponce, MD, recently was named the new president of Allegheny Health Network’s Grove City (Pa.) Medical Center. He takes over for interim president Allan Klapper, MD, who filled the position since August 2020.
Dr. Tupponce comes to Grove City Medical Center after a successful tenure as president of Central Maine Medical Center (Lewiston, Maine), where he grew its physician group and fine-tuned the hospital quality program. Prior to that, he was chief executive officer at Tenet Healthcare’s Abrazo Scottsdale (Ariz.) Campus and CEO at Paradise Valley Hospital (Phoenix, Ariz.).
Dr. Tupponce is familiar with western Pennsylvania, having earned a master’s degree in medical management from Carnegie Mellon University in Pittsburgh. He also was chief resident at the University of Pittsburgh Medical Center.
Malcolm Mar Fan, MD, has been elevated to medical director of the Hospitalist Group at Evangelical Community Hospital (Lewisburg, Pa.). In the newly established position, Dr. Mar Fan will oversee all operations for the facility’s hospitalist program.
Dr. Mar Fan has been a hospitalist at Evangelical since 2014 after completing his internist residency at Albert Einstein Medical Center in Philadelphia. He has played a major role on Evangelical’s Peri-operative Glucose Management Committee and its Informatics Committee for Impatient and Outpatient Electronic Health Records.
Lyon County (Kansas) recently announced that Ladun Oyenuga, MD, has been appointed as public health officer for the county. She began her tenure on January 1.
Dr. Oyenuga is a hospitalist at Newman Regional Health (Emporia, Kan.). She is a native of Nigeria and did her residency at Harlem (N.Y.) Hospital Center. She has been with Newman since 2017.
Cherese Mari Laulhere BirthCare Center (Long Beach, Calif.) recently announced the addition of an OB hospitalist program at Miller Children’s & Women’s Hospital. OB hospitalists, or laborists, care for women with obstetrical issues while in the hospital.
At Cherese Mari Laulhere, OB hospitalists will be on hand 24 hours a day to assist patients’ OB/GYNs or to fill in if the personal physician cannot get to the hospital quickly.
Hospitalists at Nationwide Children’s (Columbus, Ohio) are now providing care for children who are hospitalized at Adena Regional Medical Center (Chillicothe, Ohio).
It is an expansion of an ongoing partnership between the two hospitals. Adena and Nationwide Children’s have been working together in helping to care for children in the south central and southern Ohio region since 2011. Nationwide Children’s hospitalists will round in special care and the well-baby nursery at Adena, as well as provide education programs for Adena providers and staff.
MultiCare Health System (Tacoma, Wash.) has announced that it will expand its hospitalist program partnership with Sound Physicians, also based in Tacoma, to create a region-wide, cohesive group of providers. The goal is to help ensure efficient management of inpatient populations as a region instead of at the individual hospital level, and will allow MultiCare to implement standard tools, processes and regionwide best practices.
The hospitalist programs at Tacoma General Hospital, Allenmore Hospital and Covington Medical Center will transition to Sound Physicians on April 5, 2021. Sound hospitalists are already working at three other MultiCare facilities – Tacoma General Hospital, Allenmore Hospital, and Covington Medical Center.
Vivek H. Murthy, MD, was named by President Joe Biden as his selection for Surgeon General of the United States. Dr. Murthy filled the same role from 2014-17 during President Barack Obama’s administration.
Dr. Murthy was a hospitalist and an instructor at Brigham and Women’s Hospital at Harvard Medical School prior to becoming surgeon general the first time. He also is the founder of Doctors for America.
David Tupponce, MD, recently was named the new president of Allegheny Health Network’s Grove City (Pa.) Medical Center. He takes over for interim president Allan Klapper, MD, who filled the position since August 2020.
Dr. Tupponce comes to Grove City Medical Center after a successful tenure as president of Central Maine Medical Center (Lewiston, Maine), where he grew its physician group and fine-tuned the hospital quality program. Prior to that, he was chief executive officer at Tenet Healthcare’s Abrazo Scottsdale (Ariz.) Campus and CEO at Paradise Valley Hospital (Phoenix, Ariz.).
Dr. Tupponce is familiar with western Pennsylvania, having earned a master’s degree in medical management from Carnegie Mellon University in Pittsburgh. He also was chief resident at the University of Pittsburgh Medical Center.
Malcolm Mar Fan, MD, has been elevated to medical director of the Hospitalist Group at Evangelical Community Hospital (Lewisburg, Pa.). In the newly established position, Dr. Mar Fan will oversee all operations for the facility’s hospitalist program.
Dr. Mar Fan has been a hospitalist at Evangelical since 2014 after completing his internist residency at Albert Einstein Medical Center in Philadelphia. He has played a major role on Evangelical’s Peri-operative Glucose Management Committee and its Informatics Committee for Impatient and Outpatient Electronic Health Records.
Lyon County (Kansas) recently announced that Ladun Oyenuga, MD, has been appointed as public health officer for the county. She began her tenure on January 1.
Dr. Oyenuga is a hospitalist at Newman Regional Health (Emporia, Kan.). She is a native of Nigeria and did her residency at Harlem (N.Y.) Hospital Center. She has been with Newman since 2017.
Cherese Mari Laulhere BirthCare Center (Long Beach, Calif.) recently announced the addition of an OB hospitalist program at Miller Children’s & Women’s Hospital. OB hospitalists, or laborists, care for women with obstetrical issues while in the hospital.
At Cherese Mari Laulhere, OB hospitalists will be on hand 24 hours a day to assist patients’ OB/GYNs or to fill in if the personal physician cannot get to the hospital quickly.
Hospitalists at Nationwide Children’s (Columbus, Ohio) are now providing care for children who are hospitalized at Adena Regional Medical Center (Chillicothe, Ohio).
It is an expansion of an ongoing partnership between the two hospitals. Adena and Nationwide Children’s have been working together in helping to care for children in the south central and southern Ohio region since 2011. Nationwide Children’s hospitalists will round in special care and the well-baby nursery at Adena, as well as provide education programs for Adena providers and staff.
MultiCare Health System (Tacoma, Wash.) has announced that it will expand its hospitalist program partnership with Sound Physicians, also based in Tacoma, to create a region-wide, cohesive group of providers. The goal is to help ensure efficient management of inpatient populations as a region instead of at the individual hospital level, and will allow MultiCare to implement standard tools, processes and regionwide best practices.
The hospitalist programs at Tacoma General Hospital, Allenmore Hospital and Covington Medical Center will transition to Sound Physicians on April 5, 2021. Sound hospitalists are already working at three other MultiCare facilities – Tacoma General Hospital, Allenmore Hospital, and Covington Medical Center.
Vivek H. Murthy, MD, was named by President Joe Biden as his selection for Surgeon General of the United States. Dr. Murthy filled the same role from 2014-17 during President Barack Obama’s administration.
Dr. Murthy was a hospitalist and an instructor at Brigham and Women’s Hospital at Harvard Medical School prior to becoming surgeon general the first time. He also is the founder of Doctors for America.
David Tupponce, MD, recently was named the new president of Allegheny Health Network’s Grove City (Pa.) Medical Center. He takes over for interim president Allan Klapper, MD, who filled the position since August 2020.
Dr. Tupponce comes to Grove City Medical Center after a successful tenure as president of Central Maine Medical Center (Lewiston, Maine), where he grew its physician group and fine-tuned the hospital quality program. Prior to that, he was chief executive officer at Tenet Healthcare’s Abrazo Scottsdale (Ariz.) Campus and CEO at Paradise Valley Hospital (Phoenix, Ariz.).
Dr. Tupponce is familiar with western Pennsylvania, having earned a master’s degree in medical management from Carnegie Mellon University in Pittsburgh. He also was chief resident at the University of Pittsburgh Medical Center.
Malcolm Mar Fan, MD, has been elevated to medical director of the Hospitalist Group at Evangelical Community Hospital (Lewisburg, Pa.). In the newly established position, Dr. Mar Fan will oversee all operations for the facility’s hospitalist program.
Dr. Mar Fan has been a hospitalist at Evangelical since 2014 after completing his internist residency at Albert Einstein Medical Center in Philadelphia. He has played a major role on Evangelical’s Peri-operative Glucose Management Committee and its Informatics Committee for Impatient and Outpatient Electronic Health Records.
Lyon County (Kansas) recently announced that Ladun Oyenuga, MD, has been appointed as public health officer for the county. She began her tenure on January 1.
Dr. Oyenuga is a hospitalist at Newman Regional Health (Emporia, Kan.). She is a native of Nigeria and did her residency at Harlem (N.Y.) Hospital Center. She has been with Newman since 2017.
Cherese Mari Laulhere BirthCare Center (Long Beach, Calif.) recently announced the addition of an OB hospitalist program at Miller Children’s & Women’s Hospital. OB hospitalists, or laborists, care for women with obstetrical issues while in the hospital.
At Cherese Mari Laulhere, OB hospitalists will be on hand 24 hours a day to assist patients’ OB/GYNs or to fill in if the personal physician cannot get to the hospital quickly.
Hospitalists at Nationwide Children’s (Columbus, Ohio) are now providing care for children who are hospitalized at Adena Regional Medical Center (Chillicothe, Ohio).
It is an expansion of an ongoing partnership between the two hospitals. Adena and Nationwide Children’s have been working together in helping to care for children in the south central and southern Ohio region since 2011. Nationwide Children’s hospitalists will round in special care and the well-baby nursery at Adena, as well as provide education programs for Adena providers and staff.
MultiCare Health System (Tacoma, Wash.) has announced that it will expand its hospitalist program partnership with Sound Physicians, also based in Tacoma, to create a region-wide, cohesive group of providers. The goal is to help ensure efficient management of inpatient populations as a region instead of at the individual hospital level, and will allow MultiCare to implement standard tools, processes and regionwide best practices.
The hospitalist programs at Tacoma General Hospital, Allenmore Hospital and Covington Medical Center will transition to Sound Physicians on April 5, 2021. Sound hospitalists are already working at three other MultiCare facilities – Tacoma General Hospital, Allenmore Hospital, and Covington Medical Center.
Liver stiffness predicts hepatic events in NAFLD
Among patients with nonalcoholic fatty liver disease (NAFLD) and compensated advanced chronic liver disease, liver stiffness measurements (LSMs) are associated with risks of hepatic events, according to a retrospective analysis of more than 1,000 patients.
“[N]oninvasive markers that can predict liver disease severity and outcomes in patients with NAFLD and advanced fibrosis are a major unmet need,” wrote lead author Salvatore Petta, MD, of the University of Palermo, Italy, and colleagues. Their report is in Clinical Gastroenterology and Hepatology. “Data about the accuracy of LSM in the prediction of events in NAFLD, and especially in patients with NAFLD and F3-F4 fibrosis, are scarce.”
To address this knowledge gap, the investigators retrospectively analyzed data from 1,039 consecutive patients with NAFLD who had baseline LSMs of more than 10 kPa and/or histologically diagnosed F3-F4 fibrosis. Patients were prospectively recruited at 10 centers in 6 countries, then followed for a median of 35 months, ranging from 19 to 63 months.
All patients had their liver stiffness measured with an M or XL probe at baseline. In addition, approximately half of the patients (n = 533) had a follow-up measurement using the same method, generating a subgroup with changes in liver stiffness. “Improved” liver stiffness was defined as a decrease in LSM greater than 20% from baseline, “impaired” liver stiffness was defined as an increase in LSM greater than 20% from baseline, and “stable” liver stiffness was defined as a change falling between 20% lower and 20% higher than baseline.
At baseline, mean LSM was 17.6 kPa. Cox regression analysis revealed that baseline LSM was independently associated with HCC (hazard ratio, 1.03; 95% confidence interval, 1.00-1.04; P = .003), liver decompensation (HR, 1.03; 95% CI, 1.02-1.04; P < .001), and liver-related death (HR, 1.02; 95% CI, 1.00-1.03; P = .005), but not extrahepatic events.
According to the investigators, the association between LSM at baseline and risk of liver decompensation was maintained after adjustment for the severity of liver disease and for surrogate markers of portal hypertension, they noted. Furthermore, patients with a baseline LSM of at least 21 kPa – which indicates high risk of clinically significant portal hypertension (CSPH) – were at greater risk of liver decompensation than were those with an LSM less than 21 kPa (HR, 3.71; 95% CI, 1.89-6.78; P = .04).
In the subgroup with follow-up measurements, approximately half of the patients had an improved LSM (53.3%), while 27.2% had a stable LSM, and 19.5% had an impaired LSM, a pattern that was significantly associated with diabetes at baseline (P = .01).
“These data agree with the available literature identifying diabetes as a risk factor for liver disease progression and liver-related complications,” the investigators wrote.
Cox regression showed that, among those with follow-up LSM, changes in LSM were independently associated with HCC (HR, 1.72; 95% CI, 1.01-3.02; P = .04), liver decompensation (HR, 1.56; 95% CI, 1.05-2.51; P = . 04), liver-related mortality (HR, 1.96; 95% CI, 1.10-3.38; P = .02), and mortality of any cause (HR, 1.73; 95% CI, 1.11-2.69; P = .01).
These risks could be further stratified by level of change in liver stiffness, with greater impairment predicting greater risk: The crude rate of liver decompensation was 14.4% among those with impaired LSM, compared with 6.2% among those with stable LSM and 3.8% among those with LSM improvement. That said, the categories of changes in LSM were not predictive of decompensation among patients with high risk of CSPH at baseline; however, they remained predictive among those with low risk of CSPH at baseline.
“[T]his study … showed that an integrated assessment of baseline LSM or [changes in LSM] can help in stratifying the risk of development of liver-related complications and of both hepatic and overall mortality,” the investigators concluded. “These data, if further validated, could help personalize prognosis and follow-up in NAFLD with [compensated advanced chronic liver disease].”
The investigators disclosed relationships with AbbVie, Novo Nordisk, Gilead, and others.
Among patients with nonalcoholic fatty liver disease (NAFLD) and compensated advanced chronic liver disease, liver stiffness measurements (LSMs) are associated with risks of hepatic events, according to a retrospective analysis of more than 1,000 patients.
“[N]oninvasive markers that can predict liver disease severity and outcomes in patients with NAFLD and advanced fibrosis are a major unmet need,” wrote lead author Salvatore Petta, MD, of the University of Palermo, Italy, and colleagues. Their report is in Clinical Gastroenterology and Hepatology. “Data about the accuracy of LSM in the prediction of events in NAFLD, and especially in patients with NAFLD and F3-F4 fibrosis, are scarce.”
To address this knowledge gap, the investigators retrospectively analyzed data from 1,039 consecutive patients with NAFLD who had baseline LSMs of more than 10 kPa and/or histologically diagnosed F3-F4 fibrosis. Patients were prospectively recruited at 10 centers in 6 countries, then followed for a median of 35 months, ranging from 19 to 63 months.
All patients had their liver stiffness measured with an M or XL probe at baseline. In addition, approximately half of the patients (n = 533) had a follow-up measurement using the same method, generating a subgroup with changes in liver stiffness. “Improved” liver stiffness was defined as a decrease in LSM greater than 20% from baseline, “impaired” liver stiffness was defined as an increase in LSM greater than 20% from baseline, and “stable” liver stiffness was defined as a change falling between 20% lower and 20% higher than baseline.
At baseline, mean LSM was 17.6 kPa. Cox regression analysis revealed that baseline LSM was independently associated with HCC (hazard ratio, 1.03; 95% confidence interval, 1.00-1.04; P = .003), liver decompensation (HR, 1.03; 95% CI, 1.02-1.04; P < .001), and liver-related death (HR, 1.02; 95% CI, 1.00-1.03; P = .005), but not extrahepatic events.
According to the investigators, the association between LSM at baseline and risk of liver decompensation was maintained after adjustment for the severity of liver disease and for surrogate markers of portal hypertension, they noted. Furthermore, patients with a baseline LSM of at least 21 kPa – which indicates high risk of clinically significant portal hypertension (CSPH) – were at greater risk of liver decompensation than were those with an LSM less than 21 kPa (HR, 3.71; 95% CI, 1.89-6.78; P = .04).
In the subgroup with follow-up measurements, approximately half of the patients had an improved LSM (53.3%), while 27.2% had a stable LSM, and 19.5% had an impaired LSM, a pattern that was significantly associated with diabetes at baseline (P = .01).
“These data agree with the available literature identifying diabetes as a risk factor for liver disease progression and liver-related complications,” the investigators wrote.
Cox regression showed that, among those with follow-up LSM, changes in LSM were independently associated with HCC (HR, 1.72; 95% CI, 1.01-3.02; P = .04), liver decompensation (HR, 1.56; 95% CI, 1.05-2.51; P = . 04), liver-related mortality (HR, 1.96; 95% CI, 1.10-3.38; P = .02), and mortality of any cause (HR, 1.73; 95% CI, 1.11-2.69; P = .01).
These risks could be further stratified by level of change in liver stiffness, with greater impairment predicting greater risk: The crude rate of liver decompensation was 14.4% among those with impaired LSM, compared with 6.2% among those with stable LSM and 3.8% among those with LSM improvement. That said, the categories of changes in LSM were not predictive of decompensation among patients with high risk of CSPH at baseline; however, they remained predictive among those with low risk of CSPH at baseline.
“[T]his study … showed that an integrated assessment of baseline LSM or [changes in LSM] can help in stratifying the risk of development of liver-related complications and of both hepatic and overall mortality,” the investigators concluded. “These data, if further validated, could help personalize prognosis and follow-up in NAFLD with [compensated advanced chronic liver disease].”
The investigators disclosed relationships with AbbVie, Novo Nordisk, Gilead, and others.
Among patients with nonalcoholic fatty liver disease (NAFLD) and compensated advanced chronic liver disease, liver stiffness measurements (LSMs) are associated with risks of hepatic events, according to a retrospective analysis of more than 1,000 patients.
“[N]oninvasive markers that can predict liver disease severity and outcomes in patients with NAFLD and advanced fibrosis are a major unmet need,” wrote lead author Salvatore Petta, MD, of the University of Palermo, Italy, and colleagues. Their report is in Clinical Gastroenterology and Hepatology. “Data about the accuracy of LSM in the prediction of events in NAFLD, and especially in patients with NAFLD and F3-F4 fibrosis, are scarce.”
To address this knowledge gap, the investigators retrospectively analyzed data from 1,039 consecutive patients with NAFLD who had baseline LSMs of more than 10 kPa and/or histologically diagnosed F3-F4 fibrosis. Patients were prospectively recruited at 10 centers in 6 countries, then followed for a median of 35 months, ranging from 19 to 63 months.
All patients had their liver stiffness measured with an M or XL probe at baseline. In addition, approximately half of the patients (n = 533) had a follow-up measurement using the same method, generating a subgroup with changes in liver stiffness. “Improved” liver stiffness was defined as a decrease in LSM greater than 20% from baseline, “impaired” liver stiffness was defined as an increase in LSM greater than 20% from baseline, and “stable” liver stiffness was defined as a change falling between 20% lower and 20% higher than baseline.
At baseline, mean LSM was 17.6 kPa. Cox regression analysis revealed that baseline LSM was independently associated with HCC (hazard ratio, 1.03; 95% confidence interval, 1.00-1.04; P = .003), liver decompensation (HR, 1.03; 95% CI, 1.02-1.04; P < .001), and liver-related death (HR, 1.02; 95% CI, 1.00-1.03; P = .005), but not extrahepatic events.
According to the investigators, the association between LSM at baseline and risk of liver decompensation was maintained after adjustment for the severity of liver disease and for surrogate markers of portal hypertension, they noted. Furthermore, patients with a baseline LSM of at least 21 kPa – which indicates high risk of clinically significant portal hypertension (CSPH) – were at greater risk of liver decompensation than were those with an LSM less than 21 kPa (HR, 3.71; 95% CI, 1.89-6.78; P = .04).
In the subgroup with follow-up measurements, approximately half of the patients had an improved LSM (53.3%), while 27.2% had a stable LSM, and 19.5% had an impaired LSM, a pattern that was significantly associated with diabetes at baseline (P = .01).
“These data agree with the available literature identifying diabetes as a risk factor for liver disease progression and liver-related complications,” the investigators wrote.
Cox regression showed that, among those with follow-up LSM, changes in LSM were independently associated with HCC (HR, 1.72; 95% CI, 1.01-3.02; P = .04), liver decompensation (HR, 1.56; 95% CI, 1.05-2.51; P = . 04), liver-related mortality (HR, 1.96; 95% CI, 1.10-3.38; P = .02), and mortality of any cause (HR, 1.73; 95% CI, 1.11-2.69; P = .01).
These risks could be further stratified by level of change in liver stiffness, with greater impairment predicting greater risk: The crude rate of liver decompensation was 14.4% among those with impaired LSM, compared with 6.2% among those with stable LSM and 3.8% among those with LSM improvement. That said, the categories of changes in LSM were not predictive of decompensation among patients with high risk of CSPH at baseline; however, they remained predictive among those with low risk of CSPH at baseline.
“[T]his study … showed that an integrated assessment of baseline LSM or [changes in LSM] can help in stratifying the risk of development of liver-related complications and of both hepatic and overall mortality,” the investigators concluded. “These data, if further validated, could help personalize prognosis and follow-up in NAFLD with [compensated advanced chronic liver disease].”
The investigators disclosed relationships with AbbVie, Novo Nordisk, Gilead, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Close joint health monitoring essential with new hemophilia therapies
Novel therapies have transformed the treatment of hemophilia in recent decades, but these new approaches also raise new challenges for clinicians who monitor joint health in persons with hemophilia, a specialist said.
“Patient-reported outcomes should be combined with other, more objective outcome measures for joint health monitoring, and joint ultrasound is a promising tool for objective joint health monitoring, although, due to its relatively recent introduction in clinical practice, we lack objective data and standardization,” said Roberta Gualtierotti, MD, PhD, from the Università Degli Studi of Milan.
She reviewed the challenges and approaches to monitoring joint health in persons with hemophilia during the annual congress of the European Association for Haemophilia and Allied Disorders.
Over the last decades the target of hemophilia treatment has shifted from prolonging survival to improving joint health and quality of life, and care has improved with the introduction of novel therapies such as extended half-life replacement products, nonreplacement therapies, and gene therapy, she noted.
However, “due to different pharmacodynamics and pharmacokinetics profiles, the currently available therapies cannot be compared to each other on several levels,” Dr. Gualtierotti said.
Laboratory monitoring of replacement therapies with standard coagulation assays may be unreliable, and depending on the mechanism of action and type of administration of nonreplacement agents, patients may experience breakthrough bleeding, especially after traumatic injury, she said.
Until the specific noncoagulatory effects of factor VIII on bone and joint health is better understood, close monitoring of patients will be required, she added.
Outcome measures
Subjective measures of joint health include patient-reported bleeding rates and health-related quality of life. These are practical for home management, but patients may not be able to distinguish symptoms of acute joint bleeding from chronic arthritis pain, with the potential for either under- or overtreatment, and subjective reporting is likely to miss subclinical bleeding that can occur even when patients are on prophylaxis.
Health-related quality of life tools, whether generic or specific for hemophilia, are not sensitive to small improvements, and they are not always used in routine clinical practice.
Objective measures include physical examination with scoring according to the World Federation of Hemophilia (Gilbert Scale) score or Hemophilia Joint Health Score, but these measures have limited ability to identify early or subclinical joint abnormalities.
“Therefore, joint physical examination on its own is not a sufficient measure of treatment efficacy, and it should be used in combination with other tools more objective, such as imaging,” Dr. Gualtierotti said.
Get the picture?
Imaging with x-rays, MRI, and, recently in some centers, point-of-care ultrasound can provide clinicians with important real-time information about the joint stability and health.
Point-of-care ultrasound in particular offers promise as a practical tool, with no ionizing radiation and high sensitivity for synovial hyperplasia subclinical joint effusion. It’s relatively inexpensive, can be used to image multiple joints, and allows for ease of follow-up, she said. The technique requires specialized training, however, and there is a lack of prospective data about its utility in hemophilia.
Various ultrasound scoring systems have been proposed, and home-based ultrasound is currently being explored in several clinical trials, Dr. Gualtierotti noted.
Other avenues for remote joint health monitoring under consideration are serum or synovial biomarkers for joint bleeding and arthropathy that could be employed at bedside or at home, smartphone apps for breakthrough bleeding and patient-reported outcomes, and sensors for detecting abnormalities in gait that may signal joint dysfunction, she said.
Best practice
In the question-and-answer session following the talk, Fernando Zikan, MD, from the Federal University of Rio de Janeiro noted that, “in underdeveloped countries, we still find it very difficult to guide good practices for joint health control by the patient and family members. Which strategy do you think is fundamental for the patient to feel safe to notice changes in his body?”
“It would be useful to educate patients to come to the center whenever the patient has trauma and whenever an increase in his physical activity occurs. If this is far, a bedside ultrasound evaluation by the general practitioner could help avoid joint damage. Finally, a correct rehabilitation is fundamental,” Dr. Gualtierotti replied.
Asked by several others whether she used ultrasound in her daily practice, Dr. Gualtierotti said that “we use joint ultrasound in our clinical practice in the regular annual check-up examination and whenever the patient suspects and reports hemarthrosis.”
Dr. Gualtierotti reported participation in advisory boards for Biomarin, Pfizer, Bayer, and Takeda, and in educational seminars sponsored by Pfizer, Sobi, and Roche. She has received support for congress travel and/or attendance by Bayer and Pfizer. Dr. Zikan reported no relevant disclosures.
Novel therapies have transformed the treatment of hemophilia in recent decades, but these new approaches also raise new challenges for clinicians who monitor joint health in persons with hemophilia, a specialist said.
“Patient-reported outcomes should be combined with other, more objective outcome measures for joint health monitoring, and joint ultrasound is a promising tool for objective joint health monitoring, although, due to its relatively recent introduction in clinical practice, we lack objective data and standardization,” said Roberta Gualtierotti, MD, PhD, from the Università Degli Studi of Milan.
She reviewed the challenges and approaches to monitoring joint health in persons with hemophilia during the annual congress of the European Association for Haemophilia and Allied Disorders.
Over the last decades the target of hemophilia treatment has shifted from prolonging survival to improving joint health and quality of life, and care has improved with the introduction of novel therapies such as extended half-life replacement products, nonreplacement therapies, and gene therapy, she noted.
However, “due to different pharmacodynamics and pharmacokinetics profiles, the currently available therapies cannot be compared to each other on several levels,” Dr. Gualtierotti said.
Laboratory monitoring of replacement therapies with standard coagulation assays may be unreliable, and depending on the mechanism of action and type of administration of nonreplacement agents, patients may experience breakthrough bleeding, especially after traumatic injury, she said.
Until the specific noncoagulatory effects of factor VIII on bone and joint health is better understood, close monitoring of patients will be required, she added.
Outcome measures
Subjective measures of joint health include patient-reported bleeding rates and health-related quality of life. These are practical for home management, but patients may not be able to distinguish symptoms of acute joint bleeding from chronic arthritis pain, with the potential for either under- or overtreatment, and subjective reporting is likely to miss subclinical bleeding that can occur even when patients are on prophylaxis.
Health-related quality of life tools, whether generic or specific for hemophilia, are not sensitive to small improvements, and they are not always used in routine clinical practice.
Objective measures include physical examination with scoring according to the World Federation of Hemophilia (Gilbert Scale) score or Hemophilia Joint Health Score, but these measures have limited ability to identify early or subclinical joint abnormalities.
“Therefore, joint physical examination on its own is not a sufficient measure of treatment efficacy, and it should be used in combination with other tools more objective, such as imaging,” Dr. Gualtierotti said.
Get the picture?
Imaging with x-rays, MRI, and, recently in some centers, point-of-care ultrasound can provide clinicians with important real-time information about the joint stability and health.
Point-of-care ultrasound in particular offers promise as a practical tool, with no ionizing radiation and high sensitivity for synovial hyperplasia subclinical joint effusion. It’s relatively inexpensive, can be used to image multiple joints, and allows for ease of follow-up, she said. The technique requires specialized training, however, and there is a lack of prospective data about its utility in hemophilia.
Various ultrasound scoring systems have been proposed, and home-based ultrasound is currently being explored in several clinical trials, Dr. Gualtierotti noted.
Other avenues for remote joint health monitoring under consideration are serum or synovial biomarkers for joint bleeding and arthropathy that could be employed at bedside or at home, smartphone apps for breakthrough bleeding and patient-reported outcomes, and sensors for detecting abnormalities in gait that may signal joint dysfunction, she said.
Best practice
In the question-and-answer session following the talk, Fernando Zikan, MD, from the Federal University of Rio de Janeiro noted that, “in underdeveloped countries, we still find it very difficult to guide good practices for joint health control by the patient and family members. Which strategy do you think is fundamental for the patient to feel safe to notice changes in his body?”
“It would be useful to educate patients to come to the center whenever the patient has trauma and whenever an increase in his physical activity occurs. If this is far, a bedside ultrasound evaluation by the general practitioner could help avoid joint damage. Finally, a correct rehabilitation is fundamental,” Dr. Gualtierotti replied.
Asked by several others whether she used ultrasound in her daily practice, Dr. Gualtierotti said that “we use joint ultrasound in our clinical practice in the regular annual check-up examination and whenever the patient suspects and reports hemarthrosis.”
Dr. Gualtierotti reported participation in advisory boards for Biomarin, Pfizer, Bayer, and Takeda, and in educational seminars sponsored by Pfizer, Sobi, and Roche. She has received support for congress travel and/or attendance by Bayer and Pfizer. Dr. Zikan reported no relevant disclosures.
Novel therapies have transformed the treatment of hemophilia in recent decades, but these new approaches also raise new challenges for clinicians who monitor joint health in persons with hemophilia, a specialist said.
“Patient-reported outcomes should be combined with other, more objective outcome measures for joint health monitoring, and joint ultrasound is a promising tool for objective joint health monitoring, although, due to its relatively recent introduction in clinical practice, we lack objective data and standardization,” said Roberta Gualtierotti, MD, PhD, from the Università Degli Studi of Milan.
She reviewed the challenges and approaches to monitoring joint health in persons with hemophilia during the annual congress of the European Association for Haemophilia and Allied Disorders.
Over the last decades the target of hemophilia treatment has shifted from prolonging survival to improving joint health and quality of life, and care has improved with the introduction of novel therapies such as extended half-life replacement products, nonreplacement therapies, and gene therapy, she noted.
However, “due to different pharmacodynamics and pharmacokinetics profiles, the currently available therapies cannot be compared to each other on several levels,” Dr. Gualtierotti said.
Laboratory monitoring of replacement therapies with standard coagulation assays may be unreliable, and depending on the mechanism of action and type of administration of nonreplacement agents, patients may experience breakthrough bleeding, especially after traumatic injury, she said.
Until the specific noncoagulatory effects of factor VIII on bone and joint health is better understood, close monitoring of patients will be required, she added.
Outcome measures
Subjective measures of joint health include patient-reported bleeding rates and health-related quality of life. These are practical for home management, but patients may not be able to distinguish symptoms of acute joint bleeding from chronic arthritis pain, with the potential for either under- or overtreatment, and subjective reporting is likely to miss subclinical bleeding that can occur even when patients are on prophylaxis.
Health-related quality of life tools, whether generic or specific for hemophilia, are not sensitive to small improvements, and they are not always used in routine clinical practice.
Objective measures include physical examination with scoring according to the World Federation of Hemophilia (Gilbert Scale) score or Hemophilia Joint Health Score, but these measures have limited ability to identify early or subclinical joint abnormalities.
“Therefore, joint physical examination on its own is not a sufficient measure of treatment efficacy, and it should be used in combination with other tools more objective, such as imaging,” Dr. Gualtierotti said.
Get the picture?
Imaging with x-rays, MRI, and, recently in some centers, point-of-care ultrasound can provide clinicians with important real-time information about the joint stability and health.
Point-of-care ultrasound in particular offers promise as a practical tool, with no ionizing radiation and high sensitivity for synovial hyperplasia subclinical joint effusion. It’s relatively inexpensive, can be used to image multiple joints, and allows for ease of follow-up, she said. The technique requires specialized training, however, and there is a lack of prospective data about its utility in hemophilia.
Various ultrasound scoring systems have been proposed, and home-based ultrasound is currently being explored in several clinical trials, Dr. Gualtierotti noted.
Other avenues for remote joint health monitoring under consideration are serum or synovial biomarkers for joint bleeding and arthropathy that could be employed at bedside or at home, smartphone apps for breakthrough bleeding and patient-reported outcomes, and sensors for detecting abnormalities in gait that may signal joint dysfunction, she said.
Best practice
In the question-and-answer session following the talk, Fernando Zikan, MD, from the Federal University of Rio de Janeiro noted that, “in underdeveloped countries, we still find it very difficult to guide good practices for joint health control by the patient and family members. Which strategy do you think is fundamental for the patient to feel safe to notice changes in his body?”
“It would be useful to educate patients to come to the center whenever the patient has trauma and whenever an increase in his physical activity occurs. If this is far, a bedside ultrasound evaluation by the general practitioner could help avoid joint damage. Finally, a correct rehabilitation is fundamental,” Dr. Gualtierotti replied.
Asked by several others whether she used ultrasound in her daily practice, Dr. Gualtierotti said that “we use joint ultrasound in our clinical practice in the regular annual check-up examination and whenever the patient suspects and reports hemarthrosis.”
Dr. Gualtierotti reported participation in advisory boards for Biomarin, Pfizer, Bayer, and Takeda, and in educational seminars sponsored by Pfizer, Sobi, and Roche. She has received support for congress travel and/or attendance by Bayer and Pfizer. Dr. Zikan reported no relevant disclosures.
FROM EAHAD 2021
Vaginal pH may predict CIN 2 progression in HIV-positive women
Elevated vaginal pH at the time of cervical intraepithelial neoplasia 2 diagnosis may be a useful marker of CIN 2 persistence/progression, as well as the rate of persistence/progression in HIV-positive women, new research suggests.
“We analyzed data from the Women’s Interagency HIV Study [WIHS], an observational, longitudinal cohort of women with and without HIV to determine factors that may influence CIN 2 natural history,” said Kate Michel, PhD, MPH, of Georgetown University, Washington. She presented the results at the Conference on Retroviruses and Opportunistic Infections.
As previous data have shown a high incidence of CIN 2 progression among women with HIV, the researchers evaluated the role of human papillomavirus (HPV) type, local immune response, and markers of the cervicovaginal microbiome on the risk of CIN 2 persistence/progression.
Within the cohort, follow-up visits occur every 6 months, and clinical data is collected via questionnaires, physical and gynecologic exams, and biological samples. As no specific treatment is offered in the WIHS, treatment for cervical abnormalities is abstracted from medical records.
In the present study, Dr. Michel and colleagues selected up to four banked cervicovaginal lavage (CVL) samples per woman, with the first sample selected 6-12 months prior to CIN 2 diagnosis, the second at CIN 2 diagnosis, the third between CIN 2 diagnosis and outcome, and the fourth at the outcome visit.
The investigators performed HPV typing and muiltiplex immune mediator testing on each CVL sample. Lab results from WIHS core testing were also extracted, including plasma CD4+ T-cell count and HIV viral load, as well as vaginal pH and Nugent’s score.
Study outcomes included persistence/progression and regression, defined as a subsequent CIN 2 or CIN 3 diagnosis and subsequent CIN 1 or normal diagnosis, respectively. Logistic regression models were used to determine CIN 2 regression versus persistence/progression.
Results
A total of 337 samples were obtained and 94 women were included in the analysis. Key demographic and behavioral factor were similar at CIN 2 diagnosis.
The majority of participants were African American (53.2%) and on antiretroviral therapy (66.0%). The most prevalent high-risk types were HPV-58 (18.4%) and HPV-16 (17.5%).
After a median 12.5 years of follow-up, 33 participants (35.1%) with incident CIN 2 had a subsequent CIN 2/CIN 3 diagnosis and those who regressed had a higher CD4 T-cell count at CIN 2 diagnosis (P = .02).
Each subsequent high-risk HPV type identified at the pre–CIN 2 visit was associated with higher odds of CIN2 persistence/progression (odds ratio, 2.27; 95% confidence interval, 1.15-4.50).
Bacterial vaginosis (adjusted OR, 5.08; 95% CI, 1.30-19.94) and vaginal pH (aOR, 2.27; 95% CI, 1.15-4.50) at the CIN 2 diagnosis visit were each associated with increased odds of CIN 2 persistence/progression.
Vaginal pH greater than 4.5 at CIN 2 diagnosis was also associated with unadjusted time to CIN 2 persistence/progression (log rank P = .002) and an increased rate of CIN 2 persistence/progression (adjusted hazard ratio, 3.37; 95% CI, 1.26-8.99).
Furthermore, among participants who did not receive CIN 2 treatment, vaginal pH remained associated with greater odds of CIN 2 persistence/progression (OR, 2.46; 95% CI, 1.19-5.13). Cervicovaginal immune mediator levels were not associated with CIN 2 persistence/progression.
“The most striking finding from this work was that vaginal pH was associated with higher odds of, quicker time to, and increased hazard of CIN 2 persistence/progression,” Dr. Michel said. “We postulate this effect is mediated by the cervical microbiome, but more work is needed to establish the exact mechanism.”
“It would be interesting to test whether this association might be explained by different vaginal cleaning techniques, such as douching,” said moderator Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles.
“We’re currently working on an analysis of cervicovaginal bacterial species to explore the microbiome in more detail,” Dr. Michel concluded.
Dr. Michel disclosed no conflicts of interest. The study was supported by multiple sources, including the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, and the Georgetown-Howard Universities Center for Clinical and Translational Science.
Elevated vaginal pH at the time of cervical intraepithelial neoplasia 2 diagnosis may be a useful marker of CIN 2 persistence/progression, as well as the rate of persistence/progression in HIV-positive women, new research suggests.
“We analyzed data from the Women’s Interagency HIV Study [WIHS], an observational, longitudinal cohort of women with and without HIV to determine factors that may influence CIN 2 natural history,” said Kate Michel, PhD, MPH, of Georgetown University, Washington. She presented the results at the Conference on Retroviruses and Opportunistic Infections.
As previous data have shown a high incidence of CIN 2 progression among women with HIV, the researchers evaluated the role of human papillomavirus (HPV) type, local immune response, and markers of the cervicovaginal microbiome on the risk of CIN 2 persistence/progression.
Within the cohort, follow-up visits occur every 6 months, and clinical data is collected via questionnaires, physical and gynecologic exams, and biological samples. As no specific treatment is offered in the WIHS, treatment for cervical abnormalities is abstracted from medical records.
In the present study, Dr. Michel and colleagues selected up to four banked cervicovaginal lavage (CVL) samples per woman, with the first sample selected 6-12 months prior to CIN 2 diagnosis, the second at CIN 2 diagnosis, the third between CIN 2 diagnosis and outcome, and the fourth at the outcome visit.
The investigators performed HPV typing and muiltiplex immune mediator testing on each CVL sample. Lab results from WIHS core testing were also extracted, including plasma CD4+ T-cell count and HIV viral load, as well as vaginal pH and Nugent’s score.
Study outcomes included persistence/progression and regression, defined as a subsequent CIN 2 or CIN 3 diagnosis and subsequent CIN 1 or normal diagnosis, respectively. Logistic regression models were used to determine CIN 2 regression versus persistence/progression.
Results
A total of 337 samples were obtained and 94 women were included in the analysis. Key demographic and behavioral factor were similar at CIN 2 diagnosis.
The majority of participants were African American (53.2%) and on antiretroviral therapy (66.0%). The most prevalent high-risk types were HPV-58 (18.4%) and HPV-16 (17.5%).
After a median 12.5 years of follow-up, 33 participants (35.1%) with incident CIN 2 had a subsequent CIN 2/CIN 3 diagnosis and those who regressed had a higher CD4 T-cell count at CIN 2 diagnosis (P = .02).
Each subsequent high-risk HPV type identified at the pre–CIN 2 visit was associated with higher odds of CIN2 persistence/progression (odds ratio, 2.27; 95% confidence interval, 1.15-4.50).
Bacterial vaginosis (adjusted OR, 5.08; 95% CI, 1.30-19.94) and vaginal pH (aOR, 2.27; 95% CI, 1.15-4.50) at the CIN 2 diagnosis visit were each associated with increased odds of CIN 2 persistence/progression.
Vaginal pH greater than 4.5 at CIN 2 diagnosis was also associated with unadjusted time to CIN 2 persistence/progression (log rank P = .002) and an increased rate of CIN 2 persistence/progression (adjusted hazard ratio, 3.37; 95% CI, 1.26-8.99).
Furthermore, among participants who did not receive CIN 2 treatment, vaginal pH remained associated with greater odds of CIN 2 persistence/progression (OR, 2.46; 95% CI, 1.19-5.13). Cervicovaginal immune mediator levels were not associated with CIN 2 persistence/progression.
“The most striking finding from this work was that vaginal pH was associated with higher odds of, quicker time to, and increased hazard of CIN 2 persistence/progression,” Dr. Michel said. “We postulate this effect is mediated by the cervical microbiome, but more work is needed to establish the exact mechanism.”
“It would be interesting to test whether this association might be explained by different vaginal cleaning techniques, such as douching,” said moderator Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles.
“We’re currently working on an analysis of cervicovaginal bacterial species to explore the microbiome in more detail,” Dr. Michel concluded.
Dr. Michel disclosed no conflicts of interest. The study was supported by multiple sources, including the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, and the Georgetown-Howard Universities Center for Clinical and Translational Science.
Elevated vaginal pH at the time of cervical intraepithelial neoplasia 2 diagnosis may be a useful marker of CIN 2 persistence/progression, as well as the rate of persistence/progression in HIV-positive women, new research suggests.
“We analyzed data from the Women’s Interagency HIV Study [WIHS], an observational, longitudinal cohort of women with and without HIV to determine factors that may influence CIN 2 natural history,” said Kate Michel, PhD, MPH, of Georgetown University, Washington. She presented the results at the Conference on Retroviruses and Opportunistic Infections.
As previous data have shown a high incidence of CIN 2 progression among women with HIV, the researchers evaluated the role of human papillomavirus (HPV) type, local immune response, and markers of the cervicovaginal microbiome on the risk of CIN 2 persistence/progression.
Within the cohort, follow-up visits occur every 6 months, and clinical data is collected via questionnaires, physical and gynecologic exams, and biological samples. As no specific treatment is offered in the WIHS, treatment for cervical abnormalities is abstracted from medical records.
In the present study, Dr. Michel and colleagues selected up to four banked cervicovaginal lavage (CVL) samples per woman, with the first sample selected 6-12 months prior to CIN 2 diagnosis, the second at CIN 2 diagnosis, the third between CIN 2 diagnosis and outcome, and the fourth at the outcome visit.
The investigators performed HPV typing and muiltiplex immune mediator testing on each CVL sample. Lab results from WIHS core testing were also extracted, including plasma CD4+ T-cell count and HIV viral load, as well as vaginal pH and Nugent’s score.
Study outcomes included persistence/progression and regression, defined as a subsequent CIN 2 or CIN 3 diagnosis and subsequent CIN 1 or normal diagnosis, respectively. Logistic regression models were used to determine CIN 2 regression versus persistence/progression.
Results
A total of 337 samples were obtained and 94 women were included in the analysis. Key demographic and behavioral factor were similar at CIN 2 diagnosis.
The majority of participants were African American (53.2%) and on antiretroviral therapy (66.0%). The most prevalent high-risk types were HPV-58 (18.4%) and HPV-16 (17.5%).
After a median 12.5 years of follow-up, 33 participants (35.1%) with incident CIN 2 had a subsequent CIN 2/CIN 3 diagnosis and those who regressed had a higher CD4 T-cell count at CIN 2 diagnosis (P = .02).
Each subsequent high-risk HPV type identified at the pre–CIN 2 visit was associated with higher odds of CIN2 persistence/progression (odds ratio, 2.27; 95% confidence interval, 1.15-4.50).
Bacterial vaginosis (adjusted OR, 5.08; 95% CI, 1.30-19.94) and vaginal pH (aOR, 2.27; 95% CI, 1.15-4.50) at the CIN 2 diagnosis visit were each associated with increased odds of CIN 2 persistence/progression.
Vaginal pH greater than 4.5 at CIN 2 diagnosis was also associated with unadjusted time to CIN 2 persistence/progression (log rank P = .002) and an increased rate of CIN 2 persistence/progression (adjusted hazard ratio, 3.37; 95% CI, 1.26-8.99).
Furthermore, among participants who did not receive CIN 2 treatment, vaginal pH remained associated with greater odds of CIN 2 persistence/progression (OR, 2.46; 95% CI, 1.19-5.13). Cervicovaginal immune mediator levels were not associated with CIN 2 persistence/progression.
“The most striking finding from this work was that vaginal pH was associated with higher odds of, quicker time to, and increased hazard of CIN 2 persistence/progression,” Dr. Michel said. “We postulate this effect is mediated by the cervical microbiome, but more work is needed to establish the exact mechanism.”
“It would be interesting to test whether this association might be explained by different vaginal cleaning techniques, such as douching,” said moderator Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles.
“We’re currently working on an analysis of cervicovaginal bacterial species to explore the microbiome in more detail,” Dr. Michel concluded.
Dr. Michel disclosed no conflicts of interest. The study was supported by multiple sources, including the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, and the Georgetown-Howard Universities Center for Clinical and Translational Science.
FROM CROI 2021