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Men and women react differently to acute stress
Topline
Methodology
- The study included 80 healthy participants, mean age 24 years.
- Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
- Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
- Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
- Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.
Takeaway
- In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
- In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
- Direct stress effects on ER were smaller than expected.
In practice
The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.
Source
The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.
Limitations
The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.
Disclosures
The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.
A version of this article originally appeared on Medscape.com.
Topline
Methodology
- The study included 80 healthy participants, mean age 24 years.
- Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
- Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
- Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
- Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.
Takeaway
- In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
- In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
- Direct stress effects on ER were smaller than expected.
In practice
The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.
Source
The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.
Limitations
The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.
Disclosures
The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.
A version of this article originally appeared on Medscape.com.
Topline
Methodology
- The study included 80 healthy participants, mean age 24 years.
- Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
- Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
- Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
- Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.
Takeaway
- In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
- In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
- Direct stress effects on ER were smaller than expected.
In practice
The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.
Source
The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.
Limitations
The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.
Disclosures
The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.
A version of this article originally appeared on Medscape.com.
30 days in, UHC offers little guidance on advance notification
It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.
The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.
While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.
“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.
The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.
AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.
UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”
“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”
However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.
“AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
How advance notification works
Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.
The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.
Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.
Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.
UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”
The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.
Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.
“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.
For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.
It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.
The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.
While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.
“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.
The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.
AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.
UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”
“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”
However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.
“AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
How advance notification works
Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.
The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.
Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.
Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.
UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”
The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.
Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.
“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.
For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.
It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.
The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.
While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.
“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.
The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.
AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.
UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”
“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”
However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.
“AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
How advance notification works
Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.
The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.
Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.
Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.
UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”
The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.
Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.
“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.
For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.
FDA adds safety-related information to its dermal filler webpage
On July 6, the .
Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.
“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.
The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”
Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.
Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.
Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment about the FDA update on dermal fillers, said that the agency “is doing its job by making consumers aware of all possible complications [common and uncommon], as it does when it creates a package insert for a medication. Fortunately, however, comprehensive reviews published in the peer-reviewed dermatology literature show delayed inflammation to be a very rare event. So, while it is important for dermatologists during informed consent – prior to filler – to discuss that redness and/or nodules after infection/vaccinations, etc. are possible, it is important to add that based on the data, they are also highly unlikely.”
Sue Ellen Cox, MD, a dermatologist who practices in Chapel Hill, N.C., said that she was glad to see separate sections of recommendations geared to patients and health care providers. For example, the website recommends that patients seek a physician in the field of dermatology or plastic surgery to perform procedures that use dermal fillers. “These are not procedures to be done in an unsupervised spa setting,” said Dr. Cox, a past president of the American Society for Dermatologic Surgery and one of the task force authors of recommendations on preventing and treating adverse events of injectable fillers.
“It also makes the point of using products that are acquired from FDA-approved manufacturers, not products sold online or bootlegged from other countries. Finally, it goes into detail about the importance of in-depth knowledge of anatomy, which is crucial for safe injections and reviews potential complications such as intravascular events and hypersensitivity reactions. The administering physician should have extensive knowledge regarding how to treat any potential problems that arise.”
Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies. Dr. Cox disclosed that she has been a clinical investigator for many injectable companies including AbbVie, Galderma, Revance, and Chroma.
Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.
On July 6, the .
Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.
“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.
The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”
Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.
Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.
Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment about the FDA update on dermal fillers, said that the agency “is doing its job by making consumers aware of all possible complications [common and uncommon], as it does when it creates a package insert for a medication. Fortunately, however, comprehensive reviews published in the peer-reviewed dermatology literature show delayed inflammation to be a very rare event. So, while it is important for dermatologists during informed consent – prior to filler – to discuss that redness and/or nodules after infection/vaccinations, etc. are possible, it is important to add that based on the data, they are also highly unlikely.”
Sue Ellen Cox, MD, a dermatologist who practices in Chapel Hill, N.C., said that she was glad to see separate sections of recommendations geared to patients and health care providers. For example, the website recommends that patients seek a physician in the field of dermatology or plastic surgery to perform procedures that use dermal fillers. “These are not procedures to be done in an unsupervised spa setting,” said Dr. Cox, a past president of the American Society for Dermatologic Surgery and one of the task force authors of recommendations on preventing and treating adverse events of injectable fillers.
“It also makes the point of using products that are acquired from FDA-approved manufacturers, not products sold online or bootlegged from other countries. Finally, it goes into detail about the importance of in-depth knowledge of anatomy, which is crucial for safe injections and reviews potential complications such as intravascular events and hypersensitivity reactions. The administering physician should have extensive knowledge regarding how to treat any potential problems that arise.”
Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies. Dr. Cox disclosed that she has been a clinical investigator for many injectable companies including AbbVie, Galderma, Revance, and Chroma.
Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.
On July 6, the .
Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.
“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.
The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”
Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.
Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.
Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment about the FDA update on dermal fillers, said that the agency “is doing its job by making consumers aware of all possible complications [common and uncommon], as it does when it creates a package insert for a medication. Fortunately, however, comprehensive reviews published in the peer-reviewed dermatology literature show delayed inflammation to be a very rare event. So, while it is important for dermatologists during informed consent – prior to filler – to discuss that redness and/or nodules after infection/vaccinations, etc. are possible, it is important to add that based on the data, they are also highly unlikely.”
Sue Ellen Cox, MD, a dermatologist who practices in Chapel Hill, N.C., said that she was glad to see separate sections of recommendations geared to patients and health care providers. For example, the website recommends that patients seek a physician in the field of dermatology or plastic surgery to perform procedures that use dermal fillers. “These are not procedures to be done in an unsupervised spa setting,” said Dr. Cox, a past president of the American Society for Dermatologic Surgery and one of the task force authors of recommendations on preventing and treating adverse events of injectable fillers.
“It also makes the point of using products that are acquired from FDA-approved manufacturers, not products sold online or bootlegged from other countries. Finally, it goes into detail about the importance of in-depth knowledge of anatomy, which is crucial for safe injections and reviews potential complications such as intravascular events and hypersensitivity reactions. The administering physician should have extensive knowledge regarding how to treat any potential problems that arise.”
Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies. Dr. Cox disclosed that she has been a clinical investigator for many injectable companies including AbbVie, Galderma, Revance, and Chroma.
Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.
Smartwatches able to detect very early signs of Parkinson’s
new research shows.
An analysis of wearable motion-tracking data from UK Biobank participants showed a strong correlation between reduced daytime movement over 1 week and a clinical diagnosis of PD up to 7 years later.
“Smartwatch data is easily accessible and low cost. By using this type of data, we would potentially be able to identify individuals in the very early stages of Parkinson’s disease within the general population,” lead researcher Cynthia Sandor, PhD, from Cardiff (Wales) University, said in a statement.
“We have shown here that a single week of data captured can predict events up to 7 years in the future. With these results we could develop a valuable screening tool to aid in the early detection of Parkinson’s,” she added.
“This has implications both for research, in improving recruitment into clinical trials, and in clinical practice, in allowing patients to access treatments at an earlier stage, in future when such treatments become available,” said Dr. Sandor.
The study was published online in Nature Medicine.
Novel biomarker for PD
Using machine learning, the researchers analyzed accelerometry data from 103,712 UK Biobank participants who wore a medical-grade smartwatch for a 7-day period during 2013-2016.
At the time of or within 2 years after accelerometry data collection, 273 participants were diagnosed with PD. An additional 196 individuals received a new PD diagnosis more than 2 years after accelerometry data collection (the prodromal group).
The patients with prodromal symptoms of PD and those who were diagnosed with PD showed a significantly reduced daytime acceleration profile up to 7 years before diagnosis, compared with age- and sex-matched healthy control persons, the researchers found.
The reduction in acceleration both before and following diagnosis was unique to patients with PD, “suggesting this measure to be disease specific with potential for use in early identification of individuals likely to be diagnosed with PD,” they wrote.
Accelerometry data proved more accurate than other risk factors (lifestyle, genetics, blood chemistry) or recognized prodromal symptoms of PD in predicting whether an individual would develop PD.
“Our results suggest that accelerometry collected with wearable devices in the general population could be used to identify those at elevated risk for PD on an unprecedented scale and, importantly, individuals who will likely convert within the next few years can be included in studies for neuroprotective treatments,” the researchers conclude in their article.
High-quality research
In a statement from the U.K.-based nonprofit Science Media Centre, José López Barneo, MD, PhD, with the University of Seville (Spain), said this “good quality” study “fits well with current knowledge.”
Dr. Barneo noted that other investigators have also observed that slowness of movement is a characteristic feature of some people who subsequently develop PD.
But these studies involved preselected cohorts of persons at risk of developing PD, or they were carried out in a hospital that required healthcare staff to conduct the movement analysis. In contrast, the current study was conducted in a very large cohort from the general U.K. population.
Also weighing in, José Luis Lanciego, MD, PhD, with the University of Navarra (Spain), said the “main value of this study is that it has demonstrated that accelerometry measurements obtained using wearable devices (such as a smartwatch or other similar devices) are more useful than the assessment of any other potentially prodromal symptom in identifying which people in the [general] population are at increased risk of developing Parkinson’s disease in the future, as well as being able to estimate how many years it will take to start suffering from this neurodegenerative process.
“In these diseases, early diagnosis is to some extent questionable, as early diagnosis is of little use if neuroprotective treatment is not available,” Dr. Lanciego noted.
“However, it is of great importance for use in clinical trials aimed at evaluating the efficacy of new potentially neuroprotective treatments whose main objective is to slow down – and, ideally, even halt ― the clinical progression that typically characterizes Parkinson’s disease,” Dr. Lanciego added.
The study was funded by the UK Dementia Research Institute, the Welsh government, and Cardiff University. Dr. Sandor, Dr. Barneo, and Dr. Lanciego have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
new research shows.
An analysis of wearable motion-tracking data from UK Biobank participants showed a strong correlation between reduced daytime movement over 1 week and a clinical diagnosis of PD up to 7 years later.
“Smartwatch data is easily accessible and low cost. By using this type of data, we would potentially be able to identify individuals in the very early stages of Parkinson’s disease within the general population,” lead researcher Cynthia Sandor, PhD, from Cardiff (Wales) University, said in a statement.
“We have shown here that a single week of data captured can predict events up to 7 years in the future. With these results we could develop a valuable screening tool to aid in the early detection of Parkinson’s,” she added.
“This has implications both for research, in improving recruitment into clinical trials, and in clinical practice, in allowing patients to access treatments at an earlier stage, in future when such treatments become available,” said Dr. Sandor.
The study was published online in Nature Medicine.
Novel biomarker for PD
Using machine learning, the researchers analyzed accelerometry data from 103,712 UK Biobank participants who wore a medical-grade smartwatch for a 7-day period during 2013-2016.
At the time of or within 2 years after accelerometry data collection, 273 participants were diagnosed with PD. An additional 196 individuals received a new PD diagnosis more than 2 years after accelerometry data collection (the prodromal group).
The patients with prodromal symptoms of PD and those who were diagnosed with PD showed a significantly reduced daytime acceleration profile up to 7 years before diagnosis, compared with age- and sex-matched healthy control persons, the researchers found.
The reduction in acceleration both before and following diagnosis was unique to patients with PD, “suggesting this measure to be disease specific with potential for use in early identification of individuals likely to be diagnosed with PD,” they wrote.
Accelerometry data proved more accurate than other risk factors (lifestyle, genetics, blood chemistry) or recognized prodromal symptoms of PD in predicting whether an individual would develop PD.
“Our results suggest that accelerometry collected with wearable devices in the general population could be used to identify those at elevated risk for PD on an unprecedented scale and, importantly, individuals who will likely convert within the next few years can be included in studies for neuroprotective treatments,” the researchers conclude in their article.
High-quality research
In a statement from the U.K.-based nonprofit Science Media Centre, José López Barneo, MD, PhD, with the University of Seville (Spain), said this “good quality” study “fits well with current knowledge.”
Dr. Barneo noted that other investigators have also observed that slowness of movement is a characteristic feature of some people who subsequently develop PD.
But these studies involved preselected cohorts of persons at risk of developing PD, or they were carried out in a hospital that required healthcare staff to conduct the movement analysis. In contrast, the current study was conducted in a very large cohort from the general U.K. population.
Also weighing in, José Luis Lanciego, MD, PhD, with the University of Navarra (Spain), said the “main value of this study is that it has demonstrated that accelerometry measurements obtained using wearable devices (such as a smartwatch or other similar devices) are more useful than the assessment of any other potentially prodromal symptom in identifying which people in the [general] population are at increased risk of developing Parkinson’s disease in the future, as well as being able to estimate how many years it will take to start suffering from this neurodegenerative process.
“In these diseases, early diagnosis is to some extent questionable, as early diagnosis is of little use if neuroprotective treatment is not available,” Dr. Lanciego noted.
“However, it is of great importance for use in clinical trials aimed at evaluating the efficacy of new potentially neuroprotective treatments whose main objective is to slow down – and, ideally, even halt ― the clinical progression that typically characterizes Parkinson’s disease,” Dr. Lanciego added.
The study was funded by the UK Dementia Research Institute, the Welsh government, and Cardiff University. Dr. Sandor, Dr. Barneo, and Dr. Lanciego have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
new research shows.
An analysis of wearable motion-tracking data from UK Biobank participants showed a strong correlation between reduced daytime movement over 1 week and a clinical diagnosis of PD up to 7 years later.
“Smartwatch data is easily accessible and low cost. By using this type of data, we would potentially be able to identify individuals in the very early stages of Parkinson’s disease within the general population,” lead researcher Cynthia Sandor, PhD, from Cardiff (Wales) University, said in a statement.
“We have shown here that a single week of data captured can predict events up to 7 years in the future. With these results we could develop a valuable screening tool to aid in the early detection of Parkinson’s,” she added.
“This has implications both for research, in improving recruitment into clinical trials, and in clinical practice, in allowing patients to access treatments at an earlier stage, in future when such treatments become available,” said Dr. Sandor.
The study was published online in Nature Medicine.
Novel biomarker for PD
Using machine learning, the researchers analyzed accelerometry data from 103,712 UK Biobank participants who wore a medical-grade smartwatch for a 7-day period during 2013-2016.
At the time of or within 2 years after accelerometry data collection, 273 participants were diagnosed with PD. An additional 196 individuals received a new PD diagnosis more than 2 years after accelerometry data collection (the prodromal group).
The patients with prodromal symptoms of PD and those who were diagnosed with PD showed a significantly reduced daytime acceleration profile up to 7 years before diagnosis, compared with age- and sex-matched healthy control persons, the researchers found.
The reduction in acceleration both before and following diagnosis was unique to patients with PD, “suggesting this measure to be disease specific with potential for use in early identification of individuals likely to be diagnosed with PD,” they wrote.
Accelerometry data proved more accurate than other risk factors (lifestyle, genetics, blood chemistry) or recognized prodromal symptoms of PD in predicting whether an individual would develop PD.
“Our results suggest that accelerometry collected with wearable devices in the general population could be used to identify those at elevated risk for PD on an unprecedented scale and, importantly, individuals who will likely convert within the next few years can be included in studies for neuroprotective treatments,” the researchers conclude in their article.
High-quality research
In a statement from the U.K.-based nonprofit Science Media Centre, José López Barneo, MD, PhD, with the University of Seville (Spain), said this “good quality” study “fits well with current knowledge.”
Dr. Barneo noted that other investigators have also observed that slowness of movement is a characteristic feature of some people who subsequently develop PD.
But these studies involved preselected cohorts of persons at risk of developing PD, or they were carried out in a hospital that required healthcare staff to conduct the movement analysis. In contrast, the current study was conducted in a very large cohort from the general U.K. population.
Also weighing in, José Luis Lanciego, MD, PhD, with the University of Navarra (Spain), said the “main value of this study is that it has demonstrated that accelerometry measurements obtained using wearable devices (such as a smartwatch or other similar devices) are more useful than the assessment of any other potentially prodromal symptom in identifying which people in the [general] population are at increased risk of developing Parkinson’s disease in the future, as well as being able to estimate how many years it will take to start suffering from this neurodegenerative process.
“In these diseases, early diagnosis is to some extent questionable, as early diagnosis is of little use if neuroprotective treatment is not available,” Dr. Lanciego noted.
“However, it is of great importance for use in clinical trials aimed at evaluating the efficacy of new potentially neuroprotective treatments whose main objective is to slow down – and, ideally, even halt ― the clinical progression that typically characterizes Parkinson’s disease,” Dr. Lanciego added.
The study was funded by the UK Dementia Research Institute, the Welsh government, and Cardiff University. Dr. Sandor, Dr. Barneo, and Dr. Lanciego have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
FROM NATURE MEDICINE
Does racial bias taint the Apgar score?
Experts say overhaul needed
In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.
Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).
“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.
But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.
“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”
Propagating ‘race-based medicine’
Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.
“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”
Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”
In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.
Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.
“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.
And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.
Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.
But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.
In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.
“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
Bias ‘creeping in’ to neonatal care
Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.
Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.
“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.
This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.
Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.
The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
New scoring system needed
Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.
“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”
That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”
Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.
In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”
Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.
Experts say overhaul needed
Experts say overhaul needed
In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.
Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).
“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.
But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.
“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”
Propagating ‘race-based medicine’
Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.
“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”
Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”
In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.
Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.
“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.
And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.
Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.
But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.
In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.
“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
Bias ‘creeping in’ to neonatal care
Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.
Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.
“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.
This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.
Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.
The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
New scoring system needed
Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.
“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”
That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”
Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.
In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”
Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.
In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.
Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).
“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.
But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.
“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”
Propagating ‘race-based medicine’
Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.
“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”
Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”
In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.
Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.
“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.
And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.
Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.
But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.
In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.
“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
Bias ‘creeping in’ to neonatal care
Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.
Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.
“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.
This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.
Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.
The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
New scoring system needed
Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.
“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”
That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”
Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.
In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”
Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.
AMA supports APRN oversight by both medical and nursing boards
In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.
The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.
APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.
The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.
Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.
The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.
“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.
Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”
“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.
Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.
The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”
The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.
While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.
In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.
Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.
A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.
A version of this article first appeared on Medscape.com.
In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.
The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.
APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.
The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.
Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.
The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.
“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.
Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”
“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.
Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.
The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”
The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.
While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.
In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.
Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.
A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.
A version of this article first appeared on Medscape.com.
In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.
The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.
APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.
The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.
Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.
The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.
“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.
Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”
“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.
Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.
The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”
The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.
While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.
In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.
Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.
A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.
A version of this article first appeared on Medscape.com.
Nearly one in five in U.S. still hadn’t gotten COVID by end of 2022
, according to a new estimate.
The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.
Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.
In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.
As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.
A version of this article first appeared on WebMD.com.
, according to a new estimate.
The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.
Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.
In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.
As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.
A version of this article first appeared on WebMD.com.
, according to a new estimate.
The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.
Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.
In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.
As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.
A version of this article first appeared on WebMD.com.
The ‘psychological warfare’ of prior authorization
Shikha Jain, MD, felt the urgency of the moment.
It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.
The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.
Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.
“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”
The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.
Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.
That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.
But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.
“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”
Her patient received the regimen that evening. He later went into remission.
This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.
There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.
There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.
And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.
“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”
For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”
The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.
According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”
“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”
In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”
Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.
“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”
A version of this article originally appeared on Medscape.com.
Shikha Jain, MD, felt the urgency of the moment.
It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.
The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.
Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.
“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”
The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.
Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.
That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.
But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.
“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”
Her patient received the regimen that evening. He later went into remission.
This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.
There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.
There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.
And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.
“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”
For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”
The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.
According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”
“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”
In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”
Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.
“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”
A version of this article originally appeared on Medscape.com.
Shikha Jain, MD, felt the urgency of the moment.
It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.
The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.
Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.
“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”
The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.
Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.
That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.
But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.
“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”
Her patient received the regimen that evening. He later went into remission.
This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.
There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.
There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.
And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.
“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”
For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”
The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.
According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”
“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”
In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”
Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.
“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”
A version of this article originally appeared on Medscape.com.
Parsing the split-decision victory for biologics in COPD
It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.
A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
Latest research
A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.
This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.
However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.
Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
Key takeaways
If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.
More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.
Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.
A version of this article first appeared on Medscape.com.
It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.
A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
Latest research
A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.
This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.
However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.
Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
Key takeaways
If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.
More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.
Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.
A version of this article first appeared on Medscape.com.
It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.
A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
Latest research
A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.
This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.
However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.
Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
Key takeaways
If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.
More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.
Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.
A version of this article first appeared on Medscape.com.
Coffee’s brain-boosting effect goes beyond caffeine
“There is a widespread anticipation that coffee boosts alertness and psychomotor performance. By gaining a deeper understanding of the mechanisms underlying this biological phenomenon, we pave the way for investigating the factors that can influence it and even exploring the potential advantages of those mechanisms,” study investigator Nuno Sousa, MD, PhD, with the University of Minho, Braga, Portugal, said in a statement.
The study was published online in Frontiers in Behavioral Neuroscience.
Caffeine can’t take all the credit
Certain compounds in coffee, including caffeine and chlorogenic acids, have well-documented psychoactive effects, but the psychological impact of coffee/caffeine consumption as a whole remains a matter of debate.
The researchers investigated the neurobiological impact of coffee drinking on brain connectivity using resting-state functional MRI (fMRI).
They recruited 47 generally healthy adults (mean age, 30 years; 31 women) who regularly drank a minimum of one cup of coffee per day. Participants refrained from eating or drinking caffeinated beverages for at least 3 hours prior to undergoing fMRI.
To tease out the specific impact of caffeinated coffee intake, 30 habitual coffee drinkers (mean age, 32 years; 27 women) were given hot water containing the same amount of caffeine, but they were not given coffee.
The investigators conducted two fMRI scans – one before, and one 30 minutes after drinking coffee or caffeine-infused water.
Both drinking coffee and drinking plain caffeine in water led to a decrease in functional connectivity of the brain’s default mode network, which is typically active during self-reflection in resting states.
This finding suggests that consuming either coffee or caffeine heightened individuals’ readiness to transition from a state of rest to engaging in task-related activities, the researchers noted.
However, drinking a cup of coffee also boosted connectivity in the higher visual network and the right executive control network, which are linked to working memory, cognitive control, and goal-directed behavior – something that did not occur from drinking caffeinated water.
“Put simply, individuals exhibited a heightened state of preparedness, being more responsive and attentive to external stimuli after drinking coffee,” said first author Maria Picó-Pérez, PhD, with the University of Minho.
Given that some of the effects of coffee also occurred with caffeine alone, it’s “plausible to assume that other caffeinated beverages may share similar effects,” she added.
Still, certain effects were specific to coffee drinking, “likely influenced by factors such as the distinct aroma and taste of coffee or the psychological expectations associated with consuming this particular beverage,” the researcher wrote.
The investigators report that the observations could provide a scientific foundation for the common belief that coffee increases alertness and cognitive functioning. Further research is needed to differentiate the effects of caffeine from the overall experience of drinking coffee.
A limitation of the study is the absence of a nondrinker control sample (to rule out the withdrawal effect) or an alternative group that consumed decaffeinated coffee (to rule out the placebo effect of coffee intake) – something that should be considered in future studies, the researchers noted.
The study was funded by the Institute for the Scientific Information on Coffee. The authors declared no relevant conflicts of interest.
A version of this article originally appeared on Medscape.com.
“There is a widespread anticipation that coffee boosts alertness and psychomotor performance. By gaining a deeper understanding of the mechanisms underlying this biological phenomenon, we pave the way for investigating the factors that can influence it and even exploring the potential advantages of those mechanisms,” study investigator Nuno Sousa, MD, PhD, with the University of Minho, Braga, Portugal, said in a statement.
The study was published online in Frontiers in Behavioral Neuroscience.
Caffeine can’t take all the credit
Certain compounds in coffee, including caffeine and chlorogenic acids, have well-documented psychoactive effects, but the psychological impact of coffee/caffeine consumption as a whole remains a matter of debate.
The researchers investigated the neurobiological impact of coffee drinking on brain connectivity using resting-state functional MRI (fMRI).
They recruited 47 generally healthy adults (mean age, 30 years; 31 women) who regularly drank a minimum of one cup of coffee per day. Participants refrained from eating or drinking caffeinated beverages for at least 3 hours prior to undergoing fMRI.
To tease out the specific impact of caffeinated coffee intake, 30 habitual coffee drinkers (mean age, 32 years; 27 women) were given hot water containing the same amount of caffeine, but they were not given coffee.
The investigators conducted two fMRI scans – one before, and one 30 minutes after drinking coffee or caffeine-infused water.
Both drinking coffee and drinking plain caffeine in water led to a decrease in functional connectivity of the brain’s default mode network, which is typically active during self-reflection in resting states.
This finding suggests that consuming either coffee or caffeine heightened individuals’ readiness to transition from a state of rest to engaging in task-related activities, the researchers noted.
However, drinking a cup of coffee also boosted connectivity in the higher visual network and the right executive control network, which are linked to working memory, cognitive control, and goal-directed behavior – something that did not occur from drinking caffeinated water.
“Put simply, individuals exhibited a heightened state of preparedness, being more responsive and attentive to external stimuli after drinking coffee,” said first author Maria Picó-Pérez, PhD, with the University of Minho.
Given that some of the effects of coffee also occurred with caffeine alone, it’s “plausible to assume that other caffeinated beverages may share similar effects,” she added.
Still, certain effects were specific to coffee drinking, “likely influenced by factors such as the distinct aroma and taste of coffee or the psychological expectations associated with consuming this particular beverage,” the researcher wrote.
The investigators report that the observations could provide a scientific foundation for the common belief that coffee increases alertness and cognitive functioning. Further research is needed to differentiate the effects of caffeine from the overall experience of drinking coffee.
A limitation of the study is the absence of a nondrinker control sample (to rule out the withdrawal effect) or an alternative group that consumed decaffeinated coffee (to rule out the placebo effect of coffee intake) – something that should be considered in future studies, the researchers noted.
The study was funded by the Institute for the Scientific Information on Coffee. The authors declared no relevant conflicts of interest.
A version of this article originally appeared on Medscape.com.
“There is a widespread anticipation that coffee boosts alertness and psychomotor performance. By gaining a deeper understanding of the mechanisms underlying this biological phenomenon, we pave the way for investigating the factors that can influence it and even exploring the potential advantages of those mechanisms,” study investigator Nuno Sousa, MD, PhD, with the University of Minho, Braga, Portugal, said in a statement.
The study was published online in Frontiers in Behavioral Neuroscience.
Caffeine can’t take all the credit
Certain compounds in coffee, including caffeine and chlorogenic acids, have well-documented psychoactive effects, but the psychological impact of coffee/caffeine consumption as a whole remains a matter of debate.
The researchers investigated the neurobiological impact of coffee drinking on brain connectivity using resting-state functional MRI (fMRI).
They recruited 47 generally healthy adults (mean age, 30 years; 31 women) who regularly drank a minimum of one cup of coffee per day. Participants refrained from eating or drinking caffeinated beverages for at least 3 hours prior to undergoing fMRI.
To tease out the specific impact of caffeinated coffee intake, 30 habitual coffee drinkers (mean age, 32 years; 27 women) were given hot water containing the same amount of caffeine, but they were not given coffee.
The investigators conducted two fMRI scans – one before, and one 30 minutes after drinking coffee or caffeine-infused water.
Both drinking coffee and drinking plain caffeine in water led to a decrease in functional connectivity of the brain’s default mode network, which is typically active during self-reflection in resting states.
This finding suggests that consuming either coffee or caffeine heightened individuals’ readiness to transition from a state of rest to engaging in task-related activities, the researchers noted.
However, drinking a cup of coffee also boosted connectivity in the higher visual network and the right executive control network, which are linked to working memory, cognitive control, and goal-directed behavior – something that did not occur from drinking caffeinated water.
“Put simply, individuals exhibited a heightened state of preparedness, being more responsive and attentive to external stimuli after drinking coffee,” said first author Maria Picó-Pérez, PhD, with the University of Minho.
Given that some of the effects of coffee also occurred with caffeine alone, it’s “plausible to assume that other caffeinated beverages may share similar effects,” she added.
Still, certain effects were specific to coffee drinking, “likely influenced by factors such as the distinct aroma and taste of coffee or the psychological expectations associated with consuming this particular beverage,” the researcher wrote.
The investigators report that the observations could provide a scientific foundation for the common belief that coffee increases alertness and cognitive functioning. Further research is needed to differentiate the effects of caffeine from the overall experience of drinking coffee.
A limitation of the study is the absence of a nondrinker control sample (to rule out the withdrawal effect) or an alternative group that consumed decaffeinated coffee (to rule out the placebo effect of coffee intake) – something that should be considered in future studies, the researchers noted.
The study was funded by the Institute for the Scientific Information on Coffee. The authors declared no relevant conflicts of interest.
A version of this article originally appeared on Medscape.com.
FROM FRONTIERS IN BEHAVIORAL NEUROSCIENCE