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Maternal Immunization to Prevent Serious Respiratory Illness
Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
Introduction: The Need for Increased Vigilance About Maternal Immunization
Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.
Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.
Vaccines are our most powerful tool to protect people of all ages against viral threats, and fortunately, we benefit from increasing expertise in vaccinology. Since 1974, the University of Maryland School of Medicine has a Center for Vaccine Development and Global Health that has conducted research on vaccines to defend against the Zika virus, H1N1, Ebola, and SARS-CoV-2.
We’re not alone. Other vaccinology centers across the country — as well as the National Institutes of Health at the national level, through its National Institute of Allergy and Infectious Diseases — are doing research and developing vaccines to combat viral diseases.
In this column, we are focused on viral diseases in pregnancy and the role that vaccines can play in preventing serious respiratory illness in mothers and their newborns. I have invited Laura E. Riley, MD, the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine, to address the importance of maternal immunization and how we can best counsel our patients and improve immunization rates.
As Dr. Riley explains, we are in a new era, and it behooves us all to be more vigilant about recommending vaccines, combating misperceptions, addressing patients’ knowledge gaps, and administering vaccines whenever possible.
Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.
The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.
The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.
The safety of COVID-19 vaccinations in pregnancy is now backed by several years of data from multiple studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
Data also show that pregnant patients are more likely than patients who are not pregnant to need hospitalization and intensive care when infected with SARS-CoV-2 and are at risk of having complications that can affect pregnancy and the newborn, including preterm birth and stillbirth. Vaccination has been shown to reduce the risk of severe illness and the risk of such adverse obstetrical outcomes, in addition to providing protection for the infant early on.
Similarly, influenza has long been more likely to be severe in pregnant patients, with an increased risk of poor obstetrical outcomes. Vaccines similarly provide “two for one protection,” protecting both mother and baby, and are, of course, backed by many years of safety and efficacy data.
With the new maternal respiratory syncytial virus (RSV) vaccine, now in its second year of availability, the goal is to protect the baby from RSV-caused serious lower respiratory tract illness. The illness has contributed to tens of thousands of annual hospitalizations and up to several hundred deaths every year in children younger than 5 years — particularly in those under age 6 months.
The RSV monoclonal antibody nirsevimab is available for the newborn as an alternative to maternal immunization but the maternal vaccine is optimal in that it will provide immediate rather than delayed protection for the newborn. The maternal vaccine is recommended during weeks 32-36 of pregnancy in mothers who were not vaccinated during last year’s RSV season. With real-world experience from year one, the available safety data are reassuring.
Counseling About Influenza and COVID-19 Vaccination
The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.4 Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.5
Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.6
Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.7
It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.
As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.
This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.
I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)
The fact that influenza and COVID-19 vaccination protect the newborn as well as the mother is something that I find is underappreciated by many patients. Explaining that infants likely benefit from the passage of antibodies across the placenta should be part of patient counseling.
Counseling About RSV Vaccination
Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.
The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.
In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.11
When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).
While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.
The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
Take-home Messages
- When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
- Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
- COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
- Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
- Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.
Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.
References
1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.
2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.
3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.
5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.
6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html
7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.
9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.
Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
Introduction: The Need for Increased Vigilance About Maternal Immunization
Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.
Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.
Vaccines are our most powerful tool to protect people of all ages against viral threats, and fortunately, we benefit from increasing expertise in vaccinology. Since 1974, the University of Maryland School of Medicine has a Center for Vaccine Development and Global Health that has conducted research on vaccines to defend against the Zika virus, H1N1, Ebola, and SARS-CoV-2.
We’re not alone. Other vaccinology centers across the country — as well as the National Institutes of Health at the national level, through its National Institute of Allergy and Infectious Diseases — are doing research and developing vaccines to combat viral diseases.
In this column, we are focused on viral diseases in pregnancy and the role that vaccines can play in preventing serious respiratory illness in mothers and their newborns. I have invited Laura E. Riley, MD, the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine, to address the importance of maternal immunization and how we can best counsel our patients and improve immunization rates.
As Dr. Riley explains, we are in a new era, and it behooves us all to be more vigilant about recommending vaccines, combating misperceptions, addressing patients’ knowledge gaps, and administering vaccines whenever possible.
Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.
The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.
The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.
The safety of COVID-19 vaccinations in pregnancy is now backed by several years of data from multiple studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
Data also show that pregnant patients are more likely than patients who are not pregnant to need hospitalization and intensive care when infected with SARS-CoV-2 and are at risk of having complications that can affect pregnancy and the newborn, including preterm birth and stillbirth. Vaccination has been shown to reduce the risk of severe illness and the risk of such adverse obstetrical outcomes, in addition to providing protection for the infant early on.
Similarly, influenza has long been more likely to be severe in pregnant patients, with an increased risk of poor obstetrical outcomes. Vaccines similarly provide “two for one protection,” protecting both mother and baby, and are, of course, backed by many years of safety and efficacy data.
With the new maternal respiratory syncytial virus (RSV) vaccine, now in its second year of availability, the goal is to protect the baby from RSV-caused serious lower respiratory tract illness. The illness has contributed to tens of thousands of annual hospitalizations and up to several hundred deaths every year in children younger than 5 years — particularly in those under age 6 months.
The RSV monoclonal antibody nirsevimab is available for the newborn as an alternative to maternal immunization but the maternal vaccine is optimal in that it will provide immediate rather than delayed protection for the newborn. The maternal vaccine is recommended during weeks 32-36 of pregnancy in mothers who were not vaccinated during last year’s RSV season. With real-world experience from year one, the available safety data are reassuring.
Counseling About Influenza and COVID-19 Vaccination
The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.4 Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.5
Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.6
Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.7
It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.
As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.
This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.
I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)
The fact that influenza and COVID-19 vaccination protect the newborn as well as the mother is something that I find is underappreciated by many patients. Explaining that infants likely benefit from the passage of antibodies across the placenta should be part of patient counseling.
Counseling About RSV Vaccination
Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.
The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.
In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.11
When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).
While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.
The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
Take-home Messages
- When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
- Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
- COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
- Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
- Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.
Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.
References
1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.
2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.
3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.
5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.
6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html
7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.
9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.
Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
Introduction: The Need for Increased Vigilance About Maternal Immunization
Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.
Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.
Vaccines are our most powerful tool to protect people of all ages against viral threats, and fortunately, we benefit from increasing expertise in vaccinology. Since 1974, the University of Maryland School of Medicine has a Center for Vaccine Development and Global Health that has conducted research on vaccines to defend against the Zika virus, H1N1, Ebola, and SARS-CoV-2.
We’re not alone. Other vaccinology centers across the country — as well as the National Institutes of Health at the national level, through its National Institute of Allergy and Infectious Diseases — are doing research and developing vaccines to combat viral diseases.
In this column, we are focused on viral diseases in pregnancy and the role that vaccines can play in preventing serious respiratory illness in mothers and their newborns. I have invited Laura E. Riley, MD, the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine, to address the importance of maternal immunization and how we can best counsel our patients and improve immunization rates.
As Dr. Riley explains, we are in a new era, and it behooves us all to be more vigilant about recommending vaccines, combating misperceptions, addressing patients’ knowledge gaps, and administering vaccines whenever possible.
Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.
The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.
The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.
The safety of COVID-19 vaccinations in pregnancy is now backed by several years of data from multiple studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
Data also show that pregnant patients are more likely than patients who are not pregnant to need hospitalization and intensive care when infected with SARS-CoV-2 and are at risk of having complications that can affect pregnancy and the newborn, including preterm birth and stillbirth. Vaccination has been shown to reduce the risk of severe illness and the risk of such adverse obstetrical outcomes, in addition to providing protection for the infant early on.
Similarly, influenza has long been more likely to be severe in pregnant patients, with an increased risk of poor obstetrical outcomes. Vaccines similarly provide “two for one protection,” protecting both mother and baby, and are, of course, backed by many years of safety and efficacy data.
With the new maternal respiratory syncytial virus (RSV) vaccine, now in its second year of availability, the goal is to protect the baby from RSV-caused serious lower respiratory tract illness. The illness has contributed to tens of thousands of annual hospitalizations and up to several hundred deaths every year in children younger than 5 years — particularly in those under age 6 months.
The RSV monoclonal antibody nirsevimab is available for the newborn as an alternative to maternal immunization but the maternal vaccine is optimal in that it will provide immediate rather than delayed protection for the newborn. The maternal vaccine is recommended during weeks 32-36 of pregnancy in mothers who were not vaccinated during last year’s RSV season. With real-world experience from year one, the available safety data are reassuring.
Counseling About Influenza and COVID-19 Vaccination
The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.4 Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.5
Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.6
Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.7
It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.
As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.
This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.
I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)
The fact that influenza and COVID-19 vaccination protect the newborn as well as the mother is something that I find is underappreciated by many patients. Explaining that infants likely benefit from the passage of antibodies across the placenta should be part of patient counseling.
Counseling About RSV Vaccination
Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.
The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.
In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.11
When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).
While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.
The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
Take-home Messages
- When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
- Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
- COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
- Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
- Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.
Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.
References
1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.
2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.
3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.
5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.
6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html
7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.
9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.
Are Targeted Drugs the Future in Colorectal Cancer?
This transcript has been edited for clarity.
Welcome back, everybody, from the European Society for Medical Oncology (ESMO) Congress in the wonderful city of Barcelona in Spain. I was coming from ESMO drenched in huge amounts of new data.
They looked at molecularly targeted drugs, some early-stage and a later-stage study in which there’s some evidence of promise.
She talked a little about the preliminary results from three trials suggesting some benefits, pretty marginal, of cetuximab plus irinotecan in patients who’d already had epidermal growth factor receptor (EGFR) receptor inhibitory treatment.
Amivantamab plus FOLFOX or FOLFIRI was also discussed. This is a bispecific antibody against EGFR and MET. Again, very early, but there are some potential marginal benefits coming through. She also discussed the results of a larger phase 3 randomized trial with an old friend, ramucirumab, the anti-angiogenic agent, in which the ramucirumab in combination with trifluridine-tipiracil failed to meet its primary endpoint of improving overall survival.
There were some interesting post hoc subgroup analyses showing potential benefits for women, left-sided tumors, and so on. She made an excellent presentation, which she summarized by saying that the future of colorectal cancer treatment lies in further defining molecularly targeted treatment.
Nobody would disagree with that. What is interesting, though, is that, if I were to use the analogy of mining, the more deeply we mine, perhaps the lower marginal the benefits are becoming. There’s no doubt that we’re understanding better the exquisite machinery of cell signaling. We understand that there’s redundancy, there’s repeatability, and the possibility of emergence of resistance can come quite quickly.
Although we can develop ever more precise molecularly targeted drugs, it does seem as if the clinical benefits of these, in some cases, are marginally small. I’d like to suggest that, in addition to Sara’s call for more molecularly targeted drugs, we should think about cellular targets.
We did a large amount of work (as have many others, of course) looking at the immune tumor microenvironment and trying to, in a way, separate and understand the contribution of the individual component cells — of which there are many, including cancer-associated fibroblasts, natural killer (NK) cells, whole hosts of different types of T-cell subsets, B cells, tumor-associated neutrophils, and so on — and how these interact together and of interact with the epithelial colorectal cancer cells.
We are collaborating with Patrick Soon-Shiong, a clever chap, who believes in combination immunotherapy, dissecting and understanding the individual role of these different cells, and coming up with cellular therapies or targeted therapies that either inhibit or stimulate some of the different cell components to be the way ahead for an immunologically cold tumor such as microsatellite-stable colorectal cancer.
For example, we’re looking at combinations of our histone deacetylase (HDAC) inhibitor, which switches on the machinery of antigen presentation, up-regulating major histocompatibility complex (MHC) class 1 and class 2, and some other of the molecules involved in antigen chopping and presentation; it’s like turning a microsatellite-stable immunologically cold tumor hot; an interleukin-15 superagonist that stimulates NK cells; and we’ve found a way to manipulate and reduce the number of Treg cells.
We have various approaches to reducing the microenvironment transforming growth factor beta and some of the downstream elements from that. We can look at combinatorial immunotherapy, but thinking at a cellular level and developing anticancer agents that either activate or inhibit these different cell components. I’d bring the two together.
Of course, the future has got to be better molecularly targeted drugs, but let’s think at a macro level as to how we can look at the different cellular interactions within the tumor microenvironment, and perhaps through that, come up with synergistic immunotherapeutic combinations.
Dr. Kerr is Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and Professor of Cancer Medicine, Oxford Cancer Centre, both in England. He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Genomic Health, and Merck Serono.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome back, everybody, from the European Society for Medical Oncology (ESMO) Congress in the wonderful city of Barcelona in Spain. I was coming from ESMO drenched in huge amounts of new data.
They looked at molecularly targeted drugs, some early-stage and a later-stage study in which there’s some evidence of promise.
She talked a little about the preliminary results from three trials suggesting some benefits, pretty marginal, of cetuximab plus irinotecan in patients who’d already had epidermal growth factor receptor (EGFR) receptor inhibitory treatment.
Amivantamab plus FOLFOX or FOLFIRI was also discussed. This is a bispecific antibody against EGFR and MET. Again, very early, but there are some potential marginal benefits coming through. She also discussed the results of a larger phase 3 randomized trial with an old friend, ramucirumab, the anti-angiogenic agent, in which the ramucirumab in combination with trifluridine-tipiracil failed to meet its primary endpoint of improving overall survival.
There were some interesting post hoc subgroup analyses showing potential benefits for women, left-sided tumors, and so on. She made an excellent presentation, which she summarized by saying that the future of colorectal cancer treatment lies in further defining molecularly targeted treatment.
Nobody would disagree with that. What is interesting, though, is that, if I were to use the analogy of mining, the more deeply we mine, perhaps the lower marginal the benefits are becoming. There’s no doubt that we’re understanding better the exquisite machinery of cell signaling. We understand that there’s redundancy, there’s repeatability, and the possibility of emergence of resistance can come quite quickly.
Although we can develop ever more precise molecularly targeted drugs, it does seem as if the clinical benefits of these, in some cases, are marginally small. I’d like to suggest that, in addition to Sara’s call for more molecularly targeted drugs, we should think about cellular targets.
We did a large amount of work (as have many others, of course) looking at the immune tumor microenvironment and trying to, in a way, separate and understand the contribution of the individual component cells — of which there are many, including cancer-associated fibroblasts, natural killer (NK) cells, whole hosts of different types of T-cell subsets, B cells, tumor-associated neutrophils, and so on — and how these interact together and of interact with the epithelial colorectal cancer cells.
We are collaborating with Patrick Soon-Shiong, a clever chap, who believes in combination immunotherapy, dissecting and understanding the individual role of these different cells, and coming up with cellular therapies or targeted therapies that either inhibit or stimulate some of the different cell components to be the way ahead for an immunologically cold tumor such as microsatellite-stable colorectal cancer.
For example, we’re looking at combinations of our histone deacetylase (HDAC) inhibitor, which switches on the machinery of antigen presentation, up-regulating major histocompatibility complex (MHC) class 1 and class 2, and some other of the molecules involved in antigen chopping and presentation; it’s like turning a microsatellite-stable immunologically cold tumor hot; an interleukin-15 superagonist that stimulates NK cells; and we’ve found a way to manipulate and reduce the number of Treg cells.
We have various approaches to reducing the microenvironment transforming growth factor beta and some of the downstream elements from that. We can look at combinatorial immunotherapy, but thinking at a cellular level and developing anticancer agents that either activate or inhibit these different cell components. I’d bring the two together.
Of course, the future has got to be better molecularly targeted drugs, but let’s think at a macro level as to how we can look at the different cellular interactions within the tumor microenvironment, and perhaps through that, come up with synergistic immunotherapeutic combinations.
Dr. Kerr is Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and Professor of Cancer Medicine, Oxford Cancer Centre, both in England. He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Genomic Health, and Merck Serono.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome back, everybody, from the European Society for Medical Oncology (ESMO) Congress in the wonderful city of Barcelona in Spain. I was coming from ESMO drenched in huge amounts of new data.
They looked at molecularly targeted drugs, some early-stage and a later-stage study in which there’s some evidence of promise.
She talked a little about the preliminary results from three trials suggesting some benefits, pretty marginal, of cetuximab plus irinotecan in patients who’d already had epidermal growth factor receptor (EGFR) receptor inhibitory treatment.
Amivantamab plus FOLFOX or FOLFIRI was also discussed. This is a bispecific antibody against EGFR and MET. Again, very early, but there are some potential marginal benefits coming through. She also discussed the results of a larger phase 3 randomized trial with an old friend, ramucirumab, the anti-angiogenic agent, in which the ramucirumab in combination with trifluridine-tipiracil failed to meet its primary endpoint of improving overall survival.
There were some interesting post hoc subgroup analyses showing potential benefits for women, left-sided tumors, and so on. She made an excellent presentation, which she summarized by saying that the future of colorectal cancer treatment lies in further defining molecularly targeted treatment.
Nobody would disagree with that. What is interesting, though, is that, if I were to use the analogy of mining, the more deeply we mine, perhaps the lower marginal the benefits are becoming. There’s no doubt that we’re understanding better the exquisite machinery of cell signaling. We understand that there’s redundancy, there’s repeatability, and the possibility of emergence of resistance can come quite quickly.
Although we can develop ever more precise molecularly targeted drugs, it does seem as if the clinical benefits of these, in some cases, are marginally small. I’d like to suggest that, in addition to Sara’s call for more molecularly targeted drugs, we should think about cellular targets.
We did a large amount of work (as have many others, of course) looking at the immune tumor microenvironment and trying to, in a way, separate and understand the contribution of the individual component cells — of which there are many, including cancer-associated fibroblasts, natural killer (NK) cells, whole hosts of different types of T-cell subsets, B cells, tumor-associated neutrophils, and so on — and how these interact together and of interact with the epithelial colorectal cancer cells.
We are collaborating with Patrick Soon-Shiong, a clever chap, who believes in combination immunotherapy, dissecting and understanding the individual role of these different cells, and coming up with cellular therapies or targeted therapies that either inhibit or stimulate some of the different cell components to be the way ahead for an immunologically cold tumor such as microsatellite-stable colorectal cancer.
For example, we’re looking at combinations of our histone deacetylase (HDAC) inhibitor, which switches on the machinery of antigen presentation, up-regulating major histocompatibility complex (MHC) class 1 and class 2, and some other of the molecules involved in antigen chopping and presentation; it’s like turning a microsatellite-stable immunologically cold tumor hot; an interleukin-15 superagonist that stimulates NK cells; and we’ve found a way to manipulate and reduce the number of Treg cells.
We have various approaches to reducing the microenvironment transforming growth factor beta and some of the downstream elements from that. We can look at combinatorial immunotherapy, but thinking at a cellular level and developing anticancer agents that either activate or inhibit these different cell components. I’d bring the two together.
Of course, the future has got to be better molecularly targeted drugs, but let’s think at a macro level as to how we can look at the different cellular interactions within the tumor microenvironment, and perhaps through that, come up with synergistic immunotherapeutic combinations.
Dr. Kerr is Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and Professor of Cancer Medicine, Oxford Cancer Centre, both in England. He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Genomic Health, and Merck Serono.
A version of this article first appeared on Medscape.com.
Nonalcoholic Beer and Underage Drinking
Several months ago in a letter about healthcare providers and the decision to use alcohol and other mind-altering substances on the job, I waxed enthusiastically about the new wave of no alcohol (NA) and zero (00) alcohol beers that have come on the market. In the last 2 years our local grocery store’s cooler space for nonalcoholic beer has grown from less than 24 inches to something approaching the height of the average sixth grader.
In a bold act of chivalry at the beginning of the pandemic I accepted the mantle of designated grocery shopper and over the last 3 years have become uncommonly proud of my ability to bring home the groceries efficiently and cost effectively, without catching COVID in the process. I have developed a sixth sense of choosing which human checker/bagger combination is fastest or whether the self-checkout is the way to go.
For obvious reasons the human checkers don’t ask for my ID when I am buying adult beverages. However, the self-check register freezes up instantly when I scan my 12-pack of Run Wild nonalcoholic. This necessitates a search for the MIA store person assigned to patrol the self-check corral, ever on the lookout for shoplifters, underage drinkers, and other generally shifty looking characters.
When I find one of the grocery store detectives (who is likely to have been a former patient), I say: “You know, this doesn’t have any alcohol in it.” They invariably reply with a shrug. “I know. But, the rules are the rules.” Occasionally, they may add: “It doesn’t make sense, does it?”
At first blush checking IDs for a nonalcoholic beverage may sound dumb, certainly to someone who is just a few years on either side of the legal drinking age. Why are we trying to protect some crazy teenager from the futility of getting high on a six-pack of something that at worst will make him spend most of the next couple of hours peeing?
But, there is concern in some corners that nonalcoholic drinks pose a significant threat to teenagers. Two PhDs at Stanford University have recently published a paper in which they worry that the dramatic rise in US sales of nonalcoholic drinks from 15% to 30% since 2018 may be socializing “users of alcohol drinking experiences by exposing them to the taste, look, and even brands of alcoholic beverages”.
Is there evidence to support their concern? I could only find one brief report in the Japanese literature that states that among young people “who experienced the nonalcoholic beverage intake, interest in or motivation for drinking alcoholic beverages, and/or smoking is higher than [among] those who did not.” The study didn’t appear to clearly separate the exposure in a family setting from the actual intake.
Beer is an acquired taste. If someone offered you your first taste of beer after a hot-weather set of tennis most of you would reject it and ask for water or lemonade. I can recall my first taste of beer. For some reason my father thought at age 11 or 12 I might like to try some from his glass. I’m not sure of his motivation, but he tried the same thing with oysters. I didn’t drink beer again until I was 16, motivated at that time by a group dynamic. The oyster trial, however, backfired on him and from then on he had to share his coveted dozen with me. Alcohol, unless heavily disguised by a mixer, is also not a taste that most young people find appealing.
It is unlikely that the average thrill-seeking teenager is going to ask his older-appearing buddy with a fake ID to buy him some nonalcoholic beer. Nor would he go to the effort or risk of acquiring his own fake ID just to see how it tastes. It just doesn’t compute, especially to a self-check corral patroller.
I guess one could envision a scenario in which a teenager wanting to fit in with the fast crowd would ask a trusted adult (or clueless parent) to buy him some nonalcoholic beer to bring to a party. He is running a serious risk of being laughed at by his friends if they find he’s drinking the fake stuff. It also seems unlikely that a parent would buy nonalcoholic beer to introduce his teenager to the taste of beer.
So,
Although it runs counter to my usual commitment to evidence-based decisions, making it difficult for adolescents to buy nonalcoholic beverages feels like the right think to do. As long as alcoholic and nonalcoholic beverages share the same display space and are packaged in nearly identical containers, there is ample opportunity for confusion. Recent evidence suggesting that even small amounts of alcohol increases some health risks should strengthen our resolve to minimize that confusion.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Several months ago in a letter about healthcare providers and the decision to use alcohol and other mind-altering substances on the job, I waxed enthusiastically about the new wave of no alcohol (NA) and zero (00) alcohol beers that have come on the market. In the last 2 years our local grocery store’s cooler space for nonalcoholic beer has grown from less than 24 inches to something approaching the height of the average sixth grader.
In a bold act of chivalry at the beginning of the pandemic I accepted the mantle of designated grocery shopper and over the last 3 years have become uncommonly proud of my ability to bring home the groceries efficiently and cost effectively, without catching COVID in the process. I have developed a sixth sense of choosing which human checker/bagger combination is fastest or whether the self-checkout is the way to go.
For obvious reasons the human checkers don’t ask for my ID when I am buying adult beverages. However, the self-check register freezes up instantly when I scan my 12-pack of Run Wild nonalcoholic. This necessitates a search for the MIA store person assigned to patrol the self-check corral, ever on the lookout for shoplifters, underage drinkers, and other generally shifty looking characters.
When I find one of the grocery store detectives (who is likely to have been a former patient), I say: “You know, this doesn’t have any alcohol in it.” They invariably reply with a shrug. “I know. But, the rules are the rules.” Occasionally, they may add: “It doesn’t make sense, does it?”
At first blush checking IDs for a nonalcoholic beverage may sound dumb, certainly to someone who is just a few years on either side of the legal drinking age. Why are we trying to protect some crazy teenager from the futility of getting high on a six-pack of something that at worst will make him spend most of the next couple of hours peeing?
But, there is concern in some corners that nonalcoholic drinks pose a significant threat to teenagers. Two PhDs at Stanford University have recently published a paper in which they worry that the dramatic rise in US sales of nonalcoholic drinks from 15% to 30% since 2018 may be socializing “users of alcohol drinking experiences by exposing them to the taste, look, and even brands of alcoholic beverages”.
Is there evidence to support their concern? I could only find one brief report in the Japanese literature that states that among young people “who experienced the nonalcoholic beverage intake, interest in or motivation for drinking alcoholic beverages, and/or smoking is higher than [among] those who did not.” The study didn’t appear to clearly separate the exposure in a family setting from the actual intake.
Beer is an acquired taste. If someone offered you your first taste of beer after a hot-weather set of tennis most of you would reject it and ask for water or lemonade. I can recall my first taste of beer. For some reason my father thought at age 11 or 12 I might like to try some from his glass. I’m not sure of his motivation, but he tried the same thing with oysters. I didn’t drink beer again until I was 16, motivated at that time by a group dynamic. The oyster trial, however, backfired on him and from then on he had to share his coveted dozen with me. Alcohol, unless heavily disguised by a mixer, is also not a taste that most young people find appealing.
It is unlikely that the average thrill-seeking teenager is going to ask his older-appearing buddy with a fake ID to buy him some nonalcoholic beer. Nor would he go to the effort or risk of acquiring his own fake ID just to see how it tastes. It just doesn’t compute, especially to a self-check corral patroller.
I guess one could envision a scenario in which a teenager wanting to fit in with the fast crowd would ask a trusted adult (or clueless parent) to buy him some nonalcoholic beer to bring to a party. He is running a serious risk of being laughed at by his friends if they find he’s drinking the fake stuff. It also seems unlikely that a parent would buy nonalcoholic beer to introduce his teenager to the taste of beer.
So,
Although it runs counter to my usual commitment to evidence-based decisions, making it difficult for adolescents to buy nonalcoholic beverages feels like the right think to do. As long as alcoholic and nonalcoholic beverages share the same display space and are packaged in nearly identical containers, there is ample opportunity for confusion. Recent evidence suggesting that even small amounts of alcohol increases some health risks should strengthen our resolve to minimize that confusion.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Several months ago in a letter about healthcare providers and the decision to use alcohol and other mind-altering substances on the job, I waxed enthusiastically about the new wave of no alcohol (NA) and zero (00) alcohol beers that have come on the market. In the last 2 years our local grocery store’s cooler space for nonalcoholic beer has grown from less than 24 inches to something approaching the height of the average sixth grader.
In a bold act of chivalry at the beginning of the pandemic I accepted the mantle of designated grocery shopper and over the last 3 years have become uncommonly proud of my ability to bring home the groceries efficiently and cost effectively, without catching COVID in the process. I have developed a sixth sense of choosing which human checker/bagger combination is fastest or whether the self-checkout is the way to go.
For obvious reasons the human checkers don’t ask for my ID when I am buying adult beverages. However, the self-check register freezes up instantly when I scan my 12-pack of Run Wild nonalcoholic. This necessitates a search for the MIA store person assigned to patrol the self-check corral, ever on the lookout for shoplifters, underage drinkers, and other generally shifty looking characters.
When I find one of the grocery store detectives (who is likely to have been a former patient), I say: “You know, this doesn’t have any alcohol in it.” They invariably reply with a shrug. “I know. But, the rules are the rules.” Occasionally, they may add: “It doesn’t make sense, does it?”
At first blush checking IDs for a nonalcoholic beverage may sound dumb, certainly to someone who is just a few years on either side of the legal drinking age. Why are we trying to protect some crazy teenager from the futility of getting high on a six-pack of something that at worst will make him spend most of the next couple of hours peeing?
But, there is concern in some corners that nonalcoholic drinks pose a significant threat to teenagers. Two PhDs at Stanford University have recently published a paper in which they worry that the dramatic rise in US sales of nonalcoholic drinks from 15% to 30% since 2018 may be socializing “users of alcohol drinking experiences by exposing them to the taste, look, and even brands of alcoholic beverages”.
Is there evidence to support their concern? I could only find one brief report in the Japanese literature that states that among young people “who experienced the nonalcoholic beverage intake, interest in or motivation for drinking alcoholic beverages, and/or smoking is higher than [among] those who did not.” The study didn’t appear to clearly separate the exposure in a family setting from the actual intake.
Beer is an acquired taste. If someone offered you your first taste of beer after a hot-weather set of tennis most of you would reject it and ask for water or lemonade. I can recall my first taste of beer. For some reason my father thought at age 11 or 12 I might like to try some from his glass. I’m not sure of his motivation, but he tried the same thing with oysters. I didn’t drink beer again until I was 16, motivated at that time by a group dynamic. The oyster trial, however, backfired on him and from then on he had to share his coveted dozen with me. Alcohol, unless heavily disguised by a mixer, is also not a taste that most young people find appealing.
It is unlikely that the average thrill-seeking teenager is going to ask his older-appearing buddy with a fake ID to buy him some nonalcoholic beer. Nor would he go to the effort or risk of acquiring his own fake ID just to see how it tastes. It just doesn’t compute, especially to a self-check corral patroller.
I guess one could envision a scenario in which a teenager wanting to fit in with the fast crowd would ask a trusted adult (or clueless parent) to buy him some nonalcoholic beer to bring to a party. He is running a serious risk of being laughed at by his friends if they find he’s drinking the fake stuff. It also seems unlikely that a parent would buy nonalcoholic beer to introduce his teenager to the taste of beer.
So,
Although it runs counter to my usual commitment to evidence-based decisions, making it difficult for adolescents to buy nonalcoholic beverages feels like the right think to do. As long as alcoholic and nonalcoholic beverages share the same display space and are packaged in nearly identical containers, there is ample opportunity for confusion. Recent evidence suggesting that even small amounts of alcohol increases some health risks should strengthen our resolve to minimize that confusion.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Age-Friendly Health Systems Transformation: A Whole Person Approach to Support the Well-Being of Older Adults
The COVID-19 pandemic established a new normal for health care delivery, with leaders rethinking core practices to survive and thrive in a changing environment and improve the health and well-being of patients. The Veterans Health Administration (VHA) is embracing a shift in focus from “what is the matter” to “what really matters” to address pre- and postpandemic challenges through a whole health approach.1 Initially conceptualized by the VHA in 2011, whole health “is an approach to health care that empowers and equips people to take charge of their health and well-being so that they can live their life to the fullest.”1 Whole health integrates evidence-based complementary and integrative health (CIH) therapies to manage pain; this includes acupuncture, meditation, tai chi, yoga, massage therapy, guided imagery, biofeedback, and clinical hypnosis.1 The VHA now recognizes well-being as a core value, helping clinicians respond to emerging challenges related to the social determinants of health (eg, access to health care, physical activity, and healthy foods) and guiding health care decision making.1,2
Well-being through empowerment—elements of whole health and Age-Friendly Health Systems (AFHS)—encourages health care institutions to work with employees, patients, and other stakeholders to address global challenges, clinician burnout, and social issues faced by their communities. This approach focuses on life’s purpose and meaning for individuals and inspires leaders to engage with patients, staff, and communities in new, impactful ways by focusing on wellbeing and wholeness rather than illness and disease. Having a higher sense of purpose is associated with lower all-cause mortality, reduced risk of specific diseases, better health behaviors, greater use of preventive services, and fewer hospital days of care.3
This article describes how AFHS supports the well-being of older adults and aligns with the whole health model of care. It also outlines the VHA investment to transform health care to be more person-centered by documenting what matters in the electronic health record (EHR).
AGE-FRIENDLY CARE
Given that nearly half of veterans enrolled in the VHA are aged ≥ 65 years, there is an increased need to identify models of care to support this aging population.4 This is especially critical because older veterans often have multiple chronic conditions and complex care needs that benefit from a whole person approach. The AFHS movement aims to provide evidence-based care aligned with what matters to older adults and provides a mechanism for transforming care to meet the needs of older veterans. This includes addressing age-related health concerns while promoting optimal health outcomes and quality of life. AFHS follows the 4Ms framework: what matters, medication, mentation, and mobility.5 The 4Ms serve as a guide for the health care of older adults in any setting, where each “M” is assessed and acted on to support what matters.5 Since 2020, > 390 teams have developed a plan to implement the 4Ms at 156 VHA facilities, demonstrating the VHA commitment to transforming health care for veterans.6
When VHA teams join the AFHS movement, they may also engage older veterans in a whole health system (WHS) (Figure). While AFHS is designed to improve care for patients aged ≥ 65 years, it also complements whole health, a person-centered approach available to all veterans enrolled in the VHA. Through the WHS and AFHS, veterans are empowered and equipped to take charge of their health and well-being through conversations about their unique goals, preferences, and health priorities.4 Clinicians are challenged to assess what matters by asking questions like, “What brings you joy?” and, “How can we help you meet your health goals?”1,5 These questions shift the conversation from disease-based treatment and enable clinicians to better understand the veteran as a person.1,5
For whole health and AFHS, conversations about what matters are anchored in the veteran’s goals and preferences, especially those facing a significant health change (ie, a new diagnosis or treatment decision).5,7 Together, the veteran’s goals and priorities serve as the foundation for developing person-centered care plans that often go beyond conventional medical treatments to address the physical, mental, emotional, and social aspects of health.
SYSTEM-WIDE DIRECTIVE
The WHS enhances AFHS discussions about what matters to veterans by adding a system-level lens for conceptualizing health care delivery by leveraging the 3 components of WHS: the “pathway,” well-being programs, and whole health clinical care.
The Pathway
Discovering what matters, or the veteran’s “mission, aspiration, and purpose,” begins with the WHS pathway. When stepping into the pathway, veterans begin completing a personal health inventory, or “walking the circle of health,” which encourages self-reflection that focuses on components of their life that can influence health and well-being.1,8 The circle of health offers a visual representation of the 4 most important aspects of health and well-being: First, “Me” at the center as an individual who is the expert on their life, values, goals, and priorities. Only the individual can know what really matters through mindful awareness and what works for their life. Second, self-care consists of 8 areas that impact health and wellbeing: working your body; surroundings; personal development; food and drink; recharge; family, friends, and coworkers; spirit and soul; and power of the mind. Third, professional care consists of prevention, conventional care, and complementary care. Finally, the community that supports the individual.
Well-Being Programs
VHA provides WHS programs that support veterans in building self-care skills and improving their quality of life, often through integrative care clinics that offer coaching and CIH therapies. For example, a veteran who prioritizes mobility when seeking care at an integrative care clinic will not only receive conventional medical treatment for their physical symptoms but may also be offered CIH therapies depending on their goals. The veteran may set a daily mobility goal with their care team that supports what matters, incorporating CIH approaches, such as yoga and tai chi into the care plan.5 These holistic approaches for moving the body can help alleviate physical symptoms, reduce stress, improve mindful awareness, and provide opportunities for self-discovery and growth, thus promote overall well-being
Whole Health Clinical Care
AFHS and the 4Ms embody the clinical care component of the WHS. Because what matters is the driver of the 4Ms, every action taken by the care team supports wellbeing and quality of life by promoting independence, connection, and support, and addressing external factors, such as social determinants of health. At a minimum, well-being includes “functioning well: the experience of positive emotions such as happiness and contentment as well as the development of one’s potential, having some control over one’s life, having a sense of purpose, and experiencing positive relationships.”9 From a system perspective, the VHA has begun to normalize focusing on what matters to veterans, using an interprofessional approach, one of the first steps to implementing AFHS.
As the programs expand, AFHS teams can learn from whole health well-being programs and increase the capacity for self-care in older veterans. Learning about the key elements included in the circle of health helps clinicians understand each veteran’s perceived strengths and weaknesses to support their self-care. From there, teams can act on the 4Ms and connect older veterans with the most appropriate programs and services at their facility, ensuring continuum of care.
DOCUMENTATION
The VHA leverages several tools and evidence-based practices to assess and act on what matters for veterans of all ages (Table).5,10-16 The VHA EHR and associated dashboards contain a wealth of information about whole health and AFHS implementation, scale up, and spread. A national AFHS 4Ms note template contains standardized data elements called health factors, which provide a mechanism for monitoring 4Ms care via its related dashboard. This template was developed by an interprofessional workgroup of VHA staff and underwent a thorough human factors engineering review and testing process prior to its release. Although teams continue to personalize care based on what matters to the veteran, data from the standardized 4Ms note template and dashboard provide a way to establish consistent, equitable care across multiple care settings.17
Between January 2022 and December 2023, > 612,000 participants aged ≥ 65 years identified what matters to them through 1.35 million assessments. During that period, > 36,000 veterans aged ≥ 65 years participated in AFHS and had what matters conversations documented. A personalized health plan was completed by 585,270 veterans for a total of 1.1 million assessments.11 Whole health coaching has been documented for > 57,000 veterans with > 200,000 assessments completed.13 In fiscal year 2023, a total of 1,802,131 veterans participated in whole health.
When teams share information about what matters to the veteran in a clinicianfacing format in the EHR, this helps ensure that the VHA honors veteran preferences throughout transitions of care and across all phases of health care. Although the EHR captures data on what matters, measurement of the overall impact on veteran and health system outcomes is essential. Further evaluation and ongoing education are needed to ensure clinicians are accurately and efficiently capturing the care provided by completing the appropriate EHR. Additional challenges include identifying ways to balance the documentation burden, while ensuring notes include valuable patient-centered information to guide care. EHR tools and templates have helped to unlock important insights on health care delivery in the VHA; however, health systems must consider how these clinical practices support the overall well-being of patients. How leaders empower frontline clinicians in any care setting to use these data to drive meaningful change is also important.
TRANSFORMING VHA CARE DELIVERY
In Achieving Whole Health: A New Approach for Veterans and the Nation, the National Academy of Science proposes a framework for the transformation of health care institutions to provide better whole health to veterans.3 Transformation requires change in entire systems and leaders who mobilize people “for participation in the process of change, encouraging a sense of collective identity and collective efficacy, which in turn brings stronger feelings of self-worth and self-efficacy,” and an enhanced sense of meaningfulness in their work and lives.18
Shifting health care approaches to equipping and empowering veterans and employees with whole health and AFHS resources is transformational and requires radically different assumptions and approaches that cannot be realized through traditional approaches. This change requires robust and multifaceted cultural transformation spanning all levels of the organization. Whole health and AFHS are facilitating this transformation by supporting documentation and data needs, tracking outcomes across settings, and accelerating spread to new facilities and care settings nationwide to support older veterans in improving their health and well-being.
Whole health and AFHS are complementary approaches to care that can work to empower veterans (as well as caregivers and clinicians) to align services with what matters most to veterans. Lessons such as standardizing person-centered assessments of what matters, creating supportive structures to better align care with veterans’ priorities, and identifying meaningful veteran and system-level outcomes to help sustain transformational change can be applied from whole health to AFHS. Together these programs have the potential to enhance overall health outcomes and quality of life for veterans.
- Kligler B, Hyde J, Gantt C, Bokhour B. The Whole Health transformation at the Veterans Health Administration: moving from “what’s the matter with you?” to “what matters to you?” Med Care. 2022;60(5):387-391. doi:10.1097/MLR.0000000000001706
- Centers for Disease Control and Prevention. Social determinants of health (SDOH) at CDC. January 17, 2024. Accessed September 12, 2024. https://www.cdc.gov/public-health-gateway/php/about/social-determinants-of-health.html
- National Academies of Sciences, Engineering, and Medicine. Achieving Whole Health: A New Approach for Veterans and the Nation. The National Academies Press; 2023. Accessed September 9, 2024. doi:10.17226/26854
- Church K, Munro S, Shaughnessy M, Clancy C. Age-friendly health systems: improving care for older adults in the Veterans Health Administration. Health Serv Res. 2023;58 Suppl 1(Suppl 1):5-8. doi:10.1111/1475-6773.14110
- Laderman M, Jackson C, Little K, Duong T, Pelton L. “What Matters” to older adults? A toolkit for health systems to design better care with older adults. Institute for Healthcare Improvement; 2019. Accessed September 9, 2024. https://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Documents/IHI_Age_Friendly_What_Matters_to_Older_Adults_Toolkit.pdf
- U.S. Department of Veterans Affairs. Age-Friendly Health Systems. Updated September 4, 2024. Accessed September 9, 2024. https://marketplace.va.gov/innovations/age-friendly-health-systems
- Brown TT, Hurley VB, Rodriguez HP, et al. Shared dec i s i o n - m a k i n g l o w e r s m e d i c a l e x p e n d i t u re s a n d the effect is amplified in racially-ethnically concordant relationships. Med Care. 2023;61(8):528-535. doi:10.1097/MLR.0000000000001881
- Kligler B. Whole Health in the Veterans Health Administration. Glob Adv Health Med. 2022;11:2164957X221077214.
- Ruggeri K, Garcia-Garzon E, Maguire Á, Matz S, Huppert FA. Well-being is more than happiness and life satisfaction: a multidimensional analysis of 21 countries. Health Qual Life Outcomes. 2020;18(1):192. doi:10.1186/s12955-020-01423-y
- U.S. Department of Veterans Affairs. Personal Health Inventory. Updated May 2022. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTH/docs/PHI-long-May22-fillable-508.pdf doi:10.1177/2164957X221077214
- Veterans Health Administration. Personal Health Plan. Updated March 2019. Accessed September 9, 2024. https:// www.va.gov/WHOLEHEALTH/docs/PersonalHealthPlan_508_03-2019.pdf
- Veterans Health Administration. Whole Health: My Life, My Story. Updated March 20, 2024. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTH/mylifemystory/index.asp
- U.S. Department of Veterans Affairs. Whole Health Library: Whole Health for Skill Building. Updated April 17, 2024. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTHLIBRARY/courses/whole-health-skill-building.asp
- U.S. Department of Veterans Affairs. Making Decisions: Current Care Planning. Updated May 21, 2024. Accessed September 9, 2024. https://www.va.gov/geriatrics/pages/making_decisions.asp
- U.S. Department of Veterans Affairs. Life-Sustaining Treatment Decisions Initiative (LSTDI). Updated March 2024. Accessed September 12, 2024. https://marketplace.va.gov/innovations/life-sustaining-treatment-decisions-initiative
- U.S. Department of Veterans Affairs. Center for Health Equity Research and Promotion: Surgical Pause Saving Veterans Lives. Updated September 22, 2021. Accessed September 9, 2024. https://www.cherp.research.va.gov/features/Surgical_Pause_Saving_Veterans_Lives.asp
- Munro S, Church K, Berner C, et al. Implementation of an agefriendly template in the Veterans Health Administration electronic health record. J Inform Nurs. 2023;8(3):6-11.
- Burns JM. Transforming Leadership: A New Pursuit of Happiness. Grove Press; 2003.
- US Department of Veterans Affairs, Veterans Health Administration. Whole Health: Circle of Health Overview. Updated May 20, 2024. Accessed September 12, 2024. https://www.va.gov/WHOLEHEALTH/circle-of-health/index.asp
The COVID-19 pandemic established a new normal for health care delivery, with leaders rethinking core practices to survive and thrive in a changing environment and improve the health and well-being of patients. The Veterans Health Administration (VHA) is embracing a shift in focus from “what is the matter” to “what really matters” to address pre- and postpandemic challenges through a whole health approach.1 Initially conceptualized by the VHA in 2011, whole health “is an approach to health care that empowers and equips people to take charge of their health and well-being so that they can live their life to the fullest.”1 Whole health integrates evidence-based complementary and integrative health (CIH) therapies to manage pain; this includes acupuncture, meditation, tai chi, yoga, massage therapy, guided imagery, biofeedback, and clinical hypnosis.1 The VHA now recognizes well-being as a core value, helping clinicians respond to emerging challenges related to the social determinants of health (eg, access to health care, physical activity, and healthy foods) and guiding health care decision making.1,2
Well-being through empowerment—elements of whole health and Age-Friendly Health Systems (AFHS)—encourages health care institutions to work with employees, patients, and other stakeholders to address global challenges, clinician burnout, and social issues faced by their communities. This approach focuses on life’s purpose and meaning for individuals and inspires leaders to engage with patients, staff, and communities in new, impactful ways by focusing on wellbeing and wholeness rather than illness and disease. Having a higher sense of purpose is associated with lower all-cause mortality, reduced risk of specific diseases, better health behaviors, greater use of preventive services, and fewer hospital days of care.3
This article describes how AFHS supports the well-being of older adults and aligns with the whole health model of care. It also outlines the VHA investment to transform health care to be more person-centered by documenting what matters in the electronic health record (EHR).
AGE-FRIENDLY CARE
Given that nearly half of veterans enrolled in the VHA are aged ≥ 65 years, there is an increased need to identify models of care to support this aging population.4 This is especially critical because older veterans often have multiple chronic conditions and complex care needs that benefit from a whole person approach. The AFHS movement aims to provide evidence-based care aligned with what matters to older adults and provides a mechanism for transforming care to meet the needs of older veterans. This includes addressing age-related health concerns while promoting optimal health outcomes and quality of life. AFHS follows the 4Ms framework: what matters, medication, mentation, and mobility.5 The 4Ms serve as a guide for the health care of older adults in any setting, where each “M” is assessed and acted on to support what matters.5 Since 2020, > 390 teams have developed a plan to implement the 4Ms at 156 VHA facilities, demonstrating the VHA commitment to transforming health care for veterans.6
When VHA teams join the AFHS movement, they may also engage older veterans in a whole health system (WHS) (Figure). While AFHS is designed to improve care for patients aged ≥ 65 years, it also complements whole health, a person-centered approach available to all veterans enrolled in the VHA. Through the WHS and AFHS, veterans are empowered and equipped to take charge of their health and well-being through conversations about their unique goals, preferences, and health priorities.4 Clinicians are challenged to assess what matters by asking questions like, “What brings you joy?” and, “How can we help you meet your health goals?”1,5 These questions shift the conversation from disease-based treatment and enable clinicians to better understand the veteran as a person.1,5
For whole health and AFHS, conversations about what matters are anchored in the veteran’s goals and preferences, especially those facing a significant health change (ie, a new diagnosis or treatment decision).5,7 Together, the veteran’s goals and priorities serve as the foundation for developing person-centered care plans that often go beyond conventional medical treatments to address the physical, mental, emotional, and social aspects of health.
SYSTEM-WIDE DIRECTIVE
The WHS enhances AFHS discussions about what matters to veterans by adding a system-level lens for conceptualizing health care delivery by leveraging the 3 components of WHS: the “pathway,” well-being programs, and whole health clinical care.
The Pathway
Discovering what matters, or the veteran’s “mission, aspiration, and purpose,” begins with the WHS pathway. When stepping into the pathway, veterans begin completing a personal health inventory, or “walking the circle of health,” which encourages self-reflection that focuses on components of their life that can influence health and well-being.1,8 The circle of health offers a visual representation of the 4 most important aspects of health and well-being: First, “Me” at the center as an individual who is the expert on their life, values, goals, and priorities. Only the individual can know what really matters through mindful awareness and what works for their life. Second, self-care consists of 8 areas that impact health and wellbeing: working your body; surroundings; personal development; food and drink; recharge; family, friends, and coworkers; spirit and soul; and power of the mind. Third, professional care consists of prevention, conventional care, and complementary care. Finally, the community that supports the individual.
Well-Being Programs
VHA provides WHS programs that support veterans in building self-care skills and improving their quality of life, often through integrative care clinics that offer coaching and CIH therapies. For example, a veteran who prioritizes mobility when seeking care at an integrative care clinic will not only receive conventional medical treatment for their physical symptoms but may also be offered CIH therapies depending on their goals. The veteran may set a daily mobility goal with their care team that supports what matters, incorporating CIH approaches, such as yoga and tai chi into the care plan.5 These holistic approaches for moving the body can help alleviate physical symptoms, reduce stress, improve mindful awareness, and provide opportunities for self-discovery and growth, thus promote overall well-being
Whole Health Clinical Care
AFHS and the 4Ms embody the clinical care component of the WHS. Because what matters is the driver of the 4Ms, every action taken by the care team supports wellbeing and quality of life by promoting independence, connection, and support, and addressing external factors, such as social determinants of health. At a minimum, well-being includes “functioning well: the experience of positive emotions such as happiness and contentment as well as the development of one’s potential, having some control over one’s life, having a sense of purpose, and experiencing positive relationships.”9 From a system perspective, the VHA has begun to normalize focusing on what matters to veterans, using an interprofessional approach, one of the first steps to implementing AFHS.
As the programs expand, AFHS teams can learn from whole health well-being programs and increase the capacity for self-care in older veterans. Learning about the key elements included in the circle of health helps clinicians understand each veteran’s perceived strengths and weaknesses to support their self-care. From there, teams can act on the 4Ms and connect older veterans with the most appropriate programs and services at their facility, ensuring continuum of care.
DOCUMENTATION
The VHA leverages several tools and evidence-based practices to assess and act on what matters for veterans of all ages (Table).5,10-16 The VHA EHR and associated dashboards contain a wealth of information about whole health and AFHS implementation, scale up, and spread. A national AFHS 4Ms note template contains standardized data elements called health factors, which provide a mechanism for monitoring 4Ms care via its related dashboard. This template was developed by an interprofessional workgroup of VHA staff and underwent a thorough human factors engineering review and testing process prior to its release. Although teams continue to personalize care based on what matters to the veteran, data from the standardized 4Ms note template and dashboard provide a way to establish consistent, equitable care across multiple care settings.17
Between January 2022 and December 2023, > 612,000 participants aged ≥ 65 years identified what matters to them through 1.35 million assessments. During that period, > 36,000 veterans aged ≥ 65 years participated in AFHS and had what matters conversations documented. A personalized health plan was completed by 585,270 veterans for a total of 1.1 million assessments.11 Whole health coaching has been documented for > 57,000 veterans with > 200,000 assessments completed.13 In fiscal year 2023, a total of 1,802,131 veterans participated in whole health.
When teams share information about what matters to the veteran in a clinicianfacing format in the EHR, this helps ensure that the VHA honors veteran preferences throughout transitions of care and across all phases of health care. Although the EHR captures data on what matters, measurement of the overall impact on veteran and health system outcomes is essential. Further evaluation and ongoing education are needed to ensure clinicians are accurately and efficiently capturing the care provided by completing the appropriate EHR. Additional challenges include identifying ways to balance the documentation burden, while ensuring notes include valuable patient-centered information to guide care. EHR tools and templates have helped to unlock important insights on health care delivery in the VHA; however, health systems must consider how these clinical practices support the overall well-being of patients. How leaders empower frontline clinicians in any care setting to use these data to drive meaningful change is also important.
TRANSFORMING VHA CARE DELIVERY
In Achieving Whole Health: A New Approach for Veterans and the Nation, the National Academy of Science proposes a framework for the transformation of health care institutions to provide better whole health to veterans.3 Transformation requires change in entire systems and leaders who mobilize people “for participation in the process of change, encouraging a sense of collective identity and collective efficacy, which in turn brings stronger feelings of self-worth and self-efficacy,” and an enhanced sense of meaningfulness in their work and lives.18
Shifting health care approaches to equipping and empowering veterans and employees with whole health and AFHS resources is transformational and requires radically different assumptions and approaches that cannot be realized through traditional approaches. This change requires robust and multifaceted cultural transformation spanning all levels of the organization. Whole health and AFHS are facilitating this transformation by supporting documentation and data needs, tracking outcomes across settings, and accelerating spread to new facilities and care settings nationwide to support older veterans in improving their health and well-being.
Whole health and AFHS are complementary approaches to care that can work to empower veterans (as well as caregivers and clinicians) to align services with what matters most to veterans. Lessons such as standardizing person-centered assessments of what matters, creating supportive structures to better align care with veterans’ priorities, and identifying meaningful veteran and system-level outcomes to help sustain transformational change can be applied from whole health to AFHS. Together these programs have the potential to enhance overall health outcomes and quality of life for veterans.
The COVID-19 pandemic established a new normal for health care delivery, with leaders rethinking core practices to survive and thrive in a changing environment and improve the health and well-being of patients. The Veterans Health Administration (VHA) is embracing a shift in focus from “what is the matter” to “what really matters” to address pre- and postpandemic challenges through a whole health approach.1 Initially conceptualized by the VHA in 2011, whole health “is an approach to health care that empowers and equips people to take charge of their health and well-being so that they can live their life to the fullest.”1 Whole health integrates evidence-based complementary and integrative health (CIH) therapies to manage pain; this includes acupuncture, meditation, tai chi, yoga, massage therapy, guided imagery, biofeedback, and clinical hypnosis.1 The VHA now recognizes well-being as a core value, helping clinicians respond to emerging challenges related to the social determinants of health (eg, access to health care, physical activity, and healthy foods) and guiding health care decision making.1,2
Well-being through empowerment—elements of whole health and Age-Friendly Health Systems (AFHS)—encourages health care institutions to work with employees, patients, and other stakeholders to address global challenges, clinician burnout, and social issues faced by their communities. This approach focuses on life’s purpose and meaning for individuals and inspires leaders to engage with patients, staff, and communities in new, impactful ways by focusing on wellbeing and wholeness rather than illness and disease. Having a higher sense of purpose is associated with lower all-cause mortality, reduced risk of specific diseases, better health behaviors, greater use of preventive services, and fewer hospital days of care.3
This article describes how AFHS supports the well-being of older adults and aligns with the whole health model of care. It also outlines the VHA investment to transform health care to be more person-centered by documenting what matters in the electronic health record (EHR).
AGE-FRIENDLY CARE
Given that nearly half of veterans enrolled in the VHA are aged ≥ 65 years, there is an increased need to identify models of care to support this aging population.4 This is especially critical because older veterans often have multiple chronic conditions and complex care needs that benefit from a whole person approach. The AFHS movement aims to provide evidence-based care aligned with what matters to older adults and provides a mechanism for transforming care to meet the needs of older veterans. This includes addressing age-related health concerns while promoting optimal health outcomes and quality of life. AFHS follows the 4Ms framework: what matters, medication, mentation, and mobility.5 The 4Ms serve as a guide for the health care of older adults in any setting, where each “M” is assessed and acted on to support what matters.5 Since 2020, > 390 teams have developed a plan to implement the 4Ms at 156 VHA facilities, demonstrating the VHA commitment to transforming health care for veterans.6
When VHA teams join the AFHS movement, they may also engage older veterans in a whole health system (WHS) (Figure). While AFHS is designed to improve care for patients aged ≥ 65 years, it also complements whole health, a person-centered approach available to all veterans enrolled in the VHA. Through the WHS and AFHS, veterans are empowered and equipped to take charge of their health and well-being through conversations about their unique goals, preferences, and health priorities.4 Clinicians are challenged to assess what matters by asking questions like, “What brings you joy?” and, “How can we help you meet your health goals?”1,5 These questions shift the conversation from disease-based treatment and enable clinicians to better understand the veteran as a person.1,5
For whole health and AFHS, conversations about what matters are anchored in the veteran’s goals and preferences, especially those facing a significant health change (ie, a new diagnosis or treatment decision).5,7 Together, the veteran’s goals and priorities serve as the foundation for developing person-centered care plans that often go beyond conventional medical treatments to address the physical, mental, emotional, and social aspects of health.
SYSTEM-WIDE DIRECTIVE
The WHS enhances AFHS discussions about what matters to veterans by adding a system-level lens for conceptualizing health care delivery by leveraging the 3 components of WHS: the “pathway,” well-being programs, and whole health clinical care.
The Pathway
Discovering what matters, or the veteran’s “mission, aspiration, and purpose,” begins with the WHS pathway. When stepping into the pathway, veterans begin completing a personal health inventory, or “walking the circle of health,” which encourages self-reflection that focuses on components of their life that can influence health and well-being.1,8 The circle of health offers a visual representation of the 4 most important aspects of health and well-being: First, “Me” at the center as an individual who is the expert on their life, values, goals, and priorities. Only the individual can know what really matters through mindful awareness and what works for their life. Second, self-care consists of 8 areas that impact health and wellbeing: working your body; surroundings; personal development; food and drink; recharge; family, friends, and coworkers; spirit and soul; and power of the mind. Third, professional care consists of prevention, conventional care, and complementary care. Finally, the community that supports the individual.
Well-Being Programs
VHA provides WHS programs that support veterans in building self-care skills and improving their quality of life, often through integrative care clinics that offer coaching and CIH therapies. For example, a veteran who prioritizes mobility when seeking care at an integrative care clinic will not only receive conventional medical treatment for their physical symptoms but may also be offered CIH therapies depending on their goals. The veteran may set a daily mobility goal with their care team that supports what matters, incorporating CIH approaches, such as yoga and tai chi into the care plan.5 These holistic approaches for moving the body can help alleviate physical symptoms, reduce stress, improve mindful awareness, and provide opportunities for self-discovery and growth, thus promote overall well-being
Whole Health Clinical Care
AFHS and the 4Ms embody the clinical care component of the WHS. Because what matters is the driver of the 4Ms, every action taken by the care team supports wellbeing and quality of life by promoting independence, connection, and support, and addressing external factors, such as social determinants of health. At a minimum, well-being includes “functioning well: the experience of positive emotions such as happiness and contentment as well as the development of one’s potential, having some control over one’s life, having a sense of purpose, and experiencing positive relationships.”9 From a system perspective, the VHA has begun to normalize focusing on what matters to veterans, using an interprofessional approach, one of the first steps to implementing AFHS.
As the programs expand, AFHS teams can learn from whole health well-being programs and increase the capacity for self-care in older veterans. Learning about the key elements included in the circle of health helps clinicians understand each veteran’s perceived strengths and weaknesses to support their self-care. From there, teams can act on the 4Ms and connect older veterans with the most appropriate programs and services at their facility, ensuring continuum of care.
DOCUMENTATION
The VHA leverages several tools and evidence-based practices to assess and act on what matters for veterans of all ages (Table).5,10-16 The VHA EHR and associated dashboards contain a wealth of information about whole health and AFHS implementation, scale up, and spread. A national AFHS 4Ms note template contains standardized data elements called health factors, which provide a mechanism for monitoring 4Ms care via its related dashboard. This template was developed by an interprofessional workgroup of VHA staff and underwent a thorough human factors engineering review and testing process prior to its release. Although teams continue to personalize care based on what matters to the veteran, data from the standardized 4Ms note template and dashboard provide a way to establish consistent, equitable care across multiple care settings.17
Between January 2022 and December 2023, > 612,000 participants aged ≥ 65 years identified what matters to them through 1.35 million assessments. During that period, > 36,000 veterans aged ≥ 65 years participated in AFHS and had what matters conversations documented. A personalized health plan was completed by 585,270 veterans for a total of 1.1 million assessments.11 Whole health coaching has been documented for > 57,000 veterans with > 200,000 assessments completed.13 In fiscal year 2023, a total of 1,802,131 veterans participated in whole health.
When teams share information about what matters to the veteran in a clinicianfacing format in the EHR, this helps ensure that the VHA honors veteran preferences throughout transitions of care and across all phases of health care. Although the EHR captures data on what matters, measurement of the overall impact on veteran and health system outcomes is essential. Further evaluation and ongoing education are needed to ensure clinicians are accurately and efficiently capturing the care provided by completing the appropriate EHR. Additional challenges include identifying ways to balance the documentation burden, while ensuring notes include valuable patient-centered information to guide care. EHR tools and templates have helped to unlock important insights on health care delivery in the VHA; however, health systems must consider how these clinical practices support the overall well-being of patients. How leaders empower frontline clinicians in any care setting to use these data to drive meaningful change is also important.
TRANSFORMING VHA CARE DELIVERY
In Achieving Whole Health: A New Approach for Veterans and the Nation, the National Academy of Science proposes a framework for the transformation of health care institutions to provide better whole health to veterans.3 Transformation requires change in entire systems and leaders who mobilize people “for participation in the process of change, encouraging a sense of collective identity and collective efficacy, which in turn brings stronger feelings of self-worth and self-efficacy,” and an enhanced sense of meaningfulness in their work and lives.18
Shifting health care approaches to equipping and empowering veterans and employees with whole health and AFHS resources is transformational and requires radically different assumptions and approaches that cannot be realized through traditional approaches. This change requires robust and multifaceted cultural transformation spanning all levels of the organization. Whole health and AFHS are facilitating this transformation by supporting documentation and data needs, tracking outcomes across settings, and accelerating spread to new facilities and care settings nationwide to support older veterans in improving their health and well-being.
Whole health and AFHS are complementary approaches to care that can work to empower veterans (as well as caregivers and clinicians) to align services with what matters most to veterans. Lessons such as standardizing person-centered assessments of what matters, creating supportive structures to better align care with veterans’ priorities, and identifying meaningful veteran and system-level outcomes to help sustain transformational change can be applied from whole health to AFHS. Together these programs have the potential to enhance overall health outcomes and quality of life for veterans.
- Kligler B, Hyde J, Gantt C, Bokhour B. The Whole Health transformation at the Veterans Health Administration: moving from “what’s the matter with you?” to “what matters to you?” Med Care. 2022;60(5):387-391. doi:10.1097/MLR.0000000000001706
- Centers for Disease Control and Prevention. Social determinants of health (SDOH) at CDC. January 17, 2024. Accessed September 12, 2024. https://www.cdc.gov/public-health-gateway/php/about/social-determinants-of-health.html
- National Academies of Sciences, Engineering, and Medicine. Achieving Whole Health: A New Approach for Veterans and the Nation. The National Academies Press; 2023. Accessed September 9, 2024. doi:10.17226/26854
- Church K, Munro S, Shaughnessy M, Clancy C. Age-friendly health systems: improving care for older adults in the Veterans Health Administration. Health Serv Res. 2023;58 Suppl 1(Suppl 1):5-8. doi:10.1111/1475-6773.14110
- Laderman M, Jackson C, Little K, Duong T, Pelton L. “What Matters” to older adults? A toolkit for health systems to design better care with older adults. Institute for Healthcare Improvement; 2019. Accessed September 9, 2024. https://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Documents/IHI_Age_Friendly_What_Matters_to_Older_Adults_Toolkit.pdf
- U.S. Department of Veterans Affairs. Age-Friendly Health Systems. Updated September 4, 2024. Accessed September 9, 2024. https://marketplace.va.gov/innovations/age-friendly-health-systems
- Brown TT, Hurley VB, Rodriguez HP, et al. Shared dec i s i o n - m a k i n g l o w e r s m e d i c a l e x p e n d i t u re s a n d the effect is amplified in racially-ethnically concordant relationships. Med Care. 2023;61(8):528-535. doi:10.1097/MLR.0000000000001881
- Kligler B. Whole Health in the Veterans Health Administration. Glob Adv Health Med. 2022;11:2164957X221077214.
- Ruggeri K, Garcia-Garzon E, Maguire Á, Matz S, Huppert FA. Well-being is more than happiness and life satisfaction: a multidimensional analysis of 21 countries. Health Qual Life Outcomes. 2020;18(1):192. doi:10.1186/s12955-020-01423-y
- U.S. Department of Veterans Affairs. Personal Health Inventory. Updated May 2022. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTH/docs/PHI-long-May22-fillable-508.pdf doi:10.1177/2164957X221077214
- Veterans Health Administration. Personal Health Plan. Updated March 2019. Accessed September 9, 2024. https:// www.va.gov/WHOLEHEALTH/docs/PersonalHealthPlan_508_03-2019.pdf
- Veterans Health Administration. Whole Health: My Life, My Story. Updated March 20, 2024. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTH/mylifemystory/index.asp
- U.S. Department of Veterans Affairs. Whole Health Library: Whole Health for Skill Building. Updated April 17, 2024. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTHLIBRARY/courses/whole-health-skill-building.asp
- U.S. Department of Veterans Affairs. Making Decisions: Current Care Planning. Updated May 21, 2024. Accessed September 9, 2024. https://www.va.gov/geriatrics/pages/making_decisions.asp
- U.S. Department of Veterans Affairs. Life-Sustaining Treatment Decisions Initiative (LSTDI). Updated March 2024. Accessed September 12, 2024. https://marketplace.va.gov/innovations/life-sustaining-treatment-decisions-initiative
- U.S. Department of Veterans Affairs. Center for Health Equity Research and Promotion: Surgical Pause Saving Veterans Lives. Updated September 22, 2021. Accessed September 9, 2024. https://www.cherp.research.va.gov/features/Surgical_Pause_Saving_Veterans_Lives.asp
- Munro S, Church K, Berner C, et al. Implementation of an agefriendly template in the Veterans Health Administration electronic health record. J Inform Nurs. 2023;8(3):6-11.
- Burns JM. Transforming Leadership: A New Pursuit of Happiness. Grove Press; 2003.
- US Department of Veterans Affairs, Veterans Health Administration. Whole Health: Circle of Health Overview. Updated May 20, 2024. Accessed September 12, 2024. https://www.va.gov/WHOLEHEALTH/circle-of-health/index.asp
- Kligler B, Hyde J, Gantt C, Bokhour B. The Whole Health transformation at the Veterans Health Administration: moving from “what’s the matter with you?” to “what matters to you?” Med Care. 2022;60(5):387-391. doi:10.1097/MLR.0000000000001706
- Centers for Disease Control and Prevention. Social determinants of health (SDOH) at CDC. January 17, 2024. Accessed September 12, 2024. https://www.cdc.gov/public-health-gateway/php/about/social-determinants-of-health.html
- National Academies of Sciences, Engineering, and Medicine. Achieving Whole Health: A New Approach for Veterans and the Nation. The National Academies Press; 2023. Accessed September 9, 2024. doi:10.17226/26854
- Church K, Munro S, Shaughnessy M, Clancy C. Age-friendly health systems: improving care for older adults in the Veterans Health Administration. Health Serv Res. 2023;58 Suppl 1(Suppl 1):5-8. doi:10.1111/1475-6773.14110
- Laderman M, Jackson C, Little K, Duong T, Pelton L. “What Matters” to older adults? A toolkit for health systems to design better care with older adults. Institute for Healthcare Improvement; 2019. Accessed September 9, 2024. https://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Documents/IHI_Age_Friendly_What_Matters_to_Older_Adults_Toolkit.pdf
- U.S. Department of Veterans Affairs. Age-Friendly Health Systems. Updated September 4, 2024. Accessed September 9, 2024. https://marketplace.va.gov/innovations/age-friendly-health-systems
- Brown TT, Hurley VB, Rodriguez HP, et al. Shared dec i s i o n - m a k i n g l o w e r s m e d i c a l e x p e n d i t u re s a n d the effect is amplified in racially-ethnically concordant relationships. Med Care. 2023;61(8):528-535. doi:10.1097/MLR.0000000000001881
- Kligler B. Whole Health in the Veterans Health Administration. Glob Adv Health Med. 2022;11:2164957X221077214.
- Ruggeri K, Garcia-Garzon E, Maguire Á, Matz S, Huppert FA. Well-being is more than happiness and life satisfaction: a multidimensional analysis of 21 countries. Health Qual Life Outcomes. 2020;18(1):192. doi:10.1186/s12955-020-01423-y
- U.S. Department of Veterans Affairs. Personal Health Inventory. Updated May 2022. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTH/docs/PHI-long-May22-fillable-508.pdf doi:10.1177/2164957X221077214
- Veterans Health Administration. Personal Health Plan. Updated March 2019. Accessed September 9, 2024. https:// www.va.gov/WHOLEHEALTH/docs/PersonalHealthPlan_508_03-2019.pdf
- Veterans Health Administration. Whole Health: My Life, My Story. Updated March 20, 2024. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTH/mylifemystory/index.asp
- U.S. Department of Veterans Affairs. Whole Health Library: Whole Health for Skill Building. Updated April 17, 2024. Accessed September 9, 2024. https://www.va.gov/WHOLEHEALTHLIBRARY/courses/whole-health-skill-building.asp
- U.S. Department of Veterans Affairs. Making Decisions: Current Care Planning. Updated May 21, 2024. Accessed September 9, 2024. https://www.va.gov/geriatrics/pages/making_decisions.asp
- U.S. Department of Veterans Affairs. Life-Sustaining Treatment Decisions Initiative (LSTDI). Updated March 2024. Accessed September 12, 2024. https://marketplace.va.gov/innovations/life-sustaining-treatment-decisions-initiative
- U.S. Department of Veterans Affairs. Center for Health Equity Research and Promotion: Surgical Pause Saving Veterans Lives. Updated September 22, 2021. Accessed September 9, 2024. https://www.cherp.research.va.gov/features/Surgical_Pause_Saving_Veterans_Lives.asp
- Munro S, Church K, Berner C, et al. Implementation of an agefriendly template in the Veterans Health Administration electronic health record. J Inform Nurs. 2023;8(3):6-11.
- Burns JM. Transforming Leadership: A New Pursuit of Happiness. Grove Press; 2003.
- US Department of Veterans Affairs, Veterans Health Administration. Whole Health: Circle of Health Overview. Updated May 20, 2024. Accessed September 12, 2024. https://www.va.gov/WHOLEHEALTH/circle-of-health/index.asp
Lifestyle Medicine: Not Just for the Wealthy
Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.
When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.
All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step.
The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
Small Steps to Big Changes
Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients.
Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.
It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.
For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.
To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.
A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort.
Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.
Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.
When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.
All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step.
The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
Small Steps to Big Changes
Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients.
Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.
It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.
For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.
To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.
A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort.
Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.
Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.
When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.
All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step.
The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
Small Steps to Big Changes
Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients.
Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.
It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.
For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.
To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.
A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort.
Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.
Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Time-Restricted Eating Is Not a Metabolic Magic Bullet
This transcript has been edited for clarity.
One out of three American adults — about 100 million people in this country — have the metabolic syndrome. I’m showing you the official criteria here, but essentially this is a syndrome of insulin resistance and visceral adiposity that predisposes us to a host of chronic diseases such as diabetes, heart disease, and even dementia. 
The metabolic syndrome is, fundamentally, a lifestyle disease. There is a direct line between our dietary habits and the wide availability of carbohydrate-rich, highly processed foods, and the rise in the syndrome in the population.
A saying I learned from one of my epidemiology teachers comes to mind: “Lifestyle diseases require lifestyle reinterventions.” But you know what? I’m not so sure anymore.
I’ve been around long enough to see multiple dietary fads come and go with varying efficacy. I grew up in the low-fat era, probably the most detrimental time to our national health as food manufacturers started replacing fats with carbohydrates, driving much of the problem we’re faced with today.
But I was also around for the Atkins diet and the low-carb craze — a healthier approach, all things being equal. And I’ve seen variants of these: the paleo diet (essentially a low-carb, high-protein diet based on minimally processed foods) and the Mediterranean diet, which sought to replace some percentage of fats with healthier fats.
And, of course, there is time-restricted eating.
Time-restricted eating, a variant of intermittent fasting, has the advantage of being very simple. No cookbooks, no recipes. Eat what you want — but limit it to certain hours in the day, ideally a window of less than 10 hours, such as 8 a.m. to 6 p.m.
When it comes to weight loss, the diets that work tend to work because they reduce calorie intake. I know, people will get angry about this, but thermodynamics is not just a good idea, it’s the law.
But weight loss is not the only reason we need to eat healthier. What we eat can impact our health in multiple ways; certain foods lead to more atherosclerosis, more inflammation, increased strain on the kidney and liver, and can affect our glucose homeostasis.
So I was really interested when I saw this article, “Time-Restricted Eating in Adults With Metabolic Syndrome,” appearing in Annals of Internal Medicine October 1, which examined the effect of time-restricted eating on the metabolic syndrome itself. Could this lifestyle intervention cure this lifestyle disease?
In the study, 108 individuals, all of whom had the metabolic syndrome but not full-blown diabetes, were randomized to usual care — basically, nutrition education — vs time-restricted eating. In that group, participants were instructed to reduce their window of eating by at least 4 hours to achieve an 8- to 10-hour eating window. The groups were followed for 3 months.
Now, before we get to the results, it’s important to remember that the success of a lifestyle intervention trial is quite dependent on how well people adhere to the lifestyle intervention. Time-restricted eating is not as easy as taking a pill once a day.
The researchers had participants log their consumption using a smartphone app to confirm whether they were adhering to that restricted eating window.
Broadly speaking, they did. At baseline, both groups had an eating window of about 14 hours a day — think 7 a.m. to 9 p.m. The intervention group reduced that to just under 10 hours, with 10% of days falling outside of the target window.
Lifestyle change achieved, the primary outcome was the change in hemoglobin A1c at 3 months. A1c integrates the serum glucose over time and is thus a good indicator of the success of the intervention in terms of insulin resistance. But the effect was, honestly, disappointing.
Technically, the time-restricted-eating group had a greater A1c change than the control group — by 0.1 percentage points. On average, they went from a baseline A1c of 5.87 to a 3-month A1c of 5.75.
Other metabolic syndrome markers were equally lackluster: no difference in fasting glucose, mean glucose, or fasting insulin.
There was some weight change. The control group, which got that dietary education, lost 1.5% of body weight over the 3 months. The time-restricted-eating group lost 3.3% — about 7 pounds, which is reasonable.
With that weight loss came statistically significant, albeit modest improvements in BMI, body fat percentage, and LDL cholesterol.
Of interest, despite the larger weight loss in the intermittent-fasting group, there was no difference in muscle mass loss, which is encouraging.
Taken together, we can say that, yes, it seems like time-restricted eating can help people lose some weight. This is essentially due to the fact that people eat fewer calories when they do time-restricted eating, as you can see here.
But, in the end, this trial examined whether this relatively straightforward lifestyle intervention would move the needle in terms of metabolic syndrome, and the data are not very compelling for that.
This graph shows how many of those five factors for metabolic syndrome the individuals in this trial had from the start to the end. You see that, over the 3 months, seven people in the time-restricted-eating group moved from having three criteria to two or one — being “cured” of metabolic syndrome, if you will. Nine people in the standard group were cured by that definition. Remember, they had to have at least three to have the syndrome and thus be eligible for the trial. 
So If it just leads to weight loss by forcing people to consume less calories, then we need to acknowledge that we probably have better methods to achieve this same end. Ten years ago, I would have said that lifestyle change is the only way to end the epidemic of the metabolic syndrome in this country. Today, well, we live in a world of GLP-1 weight loss drugs. It is simply a different world now. Yes, they are expensive. Yes, they have side effects. But we need to evaluate them against the comparison. And so far, lifestyle changes alone are really no comparison.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
One out of three American adults — about 100 million people in this country — have the metabolic syndrome. I’m showing you the official criteria here, but essentially this is a syndrome of insulin resistance and visceral adiposity that predisposes us to a host of chronic diseases such as diabetes, heart disease, and even dementia.
The metabolic syndrome is, fundamentally, a lifestyle disease. There is a direct line between our dietary habits and the wide availability of carbohydrate-rich, highly processed foods, and the rise in the syndrome in the population.
A saying I learned from one of my epidemiology teachers comes to mind: “Lifestyle diseases require lifestyle reinterventions.” But you know what? I’m not so sure anymore.
I’ve been around long enough to see multiple dietary fads come and go with varying efficacy. I grew up in the low-fat era, probably the most detrimental time to our national health as food manufacturers started replacing fats with carbohydrates, driving much of the problem we’re faced with today.
But I was also around for the Atkins diet and the low-carb craze — a healthier approach, all things being equal. And I’ve seen variants of these: the paleo diet (essentially a low-carb, high-protein diet based on minimally processed foods) and the Mediterranean diet, which sought to replace some percentage of fats with healthier fats.
And, of course, there is time-restricted eating.
Time-restricted eating, a variant of intermittent fasting, has the advantage of being very simple. No cookbooks, no recipes. Eat what you want — but limit it to certain hours in the day, ideally a window of less than 10 hours, such as 8 a.m. to 6 p.m.
When it comes to weight loss, the diets that work tend to work because they reduce calorie intake. I know, people will get angry about this, but thermodynamics is not just a good idea, it’s the law.
But weight loss is not the only reason we need to eat healthier. What we eat can impact our health in multiple ways; certain foods lead to more atherosclerosis, more inflammation, increased strain on the kidney and liver, and can affect our glucose homeostasis.
So I was really interested when I saw this article, “Time-Restricted Eating in Adults With Metabolic Syndrome,” appearing in Annals of Internal Medicine October 1, which examined the effect of time-restricted eating on the metabolic syndrome itself. Could this lifestyle intervention cure this lifestyle disease?
In the study, 108 individuals, all of whom had the metabolic syndrome but not full-blown diabetes, were randomized to usual care — basically, nutrition education — vs time-restricted eating. In that group, participants were instructed to reduce their window of eating by at least 4 hours to achieve an 8- to 10-hour eating window. The groups were followed for 3 months.
Now, before we get to the results, it’s important to remember that the success of a lifestyle intervention trial is quite dependent on how well people adhere to the lifestyle intervention. Time-restricted eating is not as easy as taking a pill once a day.
The researchers had participants log their consumption using a smartphone app to confirm whether they were adhering to that restricted eating window.
Broadly speaking, they did. At baseline, both groups had an eating window of about 14 hours a day — think 7 a.m. to 9 p.m. The intervention group reduced that to just under 10 hours, with 10% of days falling outside of the target window.
Lifestyle change achieved, the primary outcome was the change in hemoglobin A1c at 3 months. A1c integrates the serum glucose over time and is thus a good indicator of the success of the intervention in terms of insulin resistance. But the effect was, honestly, disappointing.
Technically, the time-restricted-eating group had a greater A1c change than the control group — by 0.1 percentage points. On average, they went from a baseline A1c of 5.87 to a 3-month A1c of 5.75.
Other metabolic syndrome markers were equally lackluster: no difference in fasting glucose, mean glucose, or fasting insulin.
There was some weight change. The control group, which got that dietary education, lost 1.5% of body weight over the 3 months. The time-restricted-eating group lost 3.3% — about 7 pounds, which is reasonable.
With that weight loss came statistically significant, albeit modest improvements in BMI, body fat percentage, and LDL cholesterol.
Of interest, despite the larger weight loss in the intermittent-fasting group, there was no difference in muscle mass loss, which is encouraging.
Taken together, we can say that, yes, it seems like time-restricted eating can help people lose some weight. This is essentially due to the fact that people eat fewer calories when they do time-restricted eating, as you can see here.
But, in the end, this trial examined whether this relatively straightforward lifestyle intervention would move the needle in terms of metabolic syndrome, and the data are not very compelling for that.
This graph shows how many of those five factors for metabolic syndrome the individuals in this trial had from the start to the end. You see that, over the 3 months, seven people in the time-restricted-eating group moved from having three criteria to two or one — being “cured” of metabolic syndrome, if you will. Nine people in the standard group were cured by that definition. Remember, they had to have at least three to have the syndrome and thus be eligible for the trial.
So If it just leads to weight loss by forcing people to consume less calories, then we need to acknowledge that we probably have better methods to achieve this same end. Ten years ago, I would have said that lifestyle change is the only way to end the epidemic of the metabolic syndrome in this country. Today, well, we live in a world of GLP-1 weight loss drugs. It is simply a different world now. Yes, they are expensive. Yes, they have side effects. But we need to evaluate them against the comparison. And so far, lifestyle changes alone are really no comparison.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
One out of three American adults — about 100 million people in this country — have the metabolic syndrome. I’m showing you the official criteria here, but essentially this is a syndrome of insulin resistance and visceral adiposity that predisposes us to a host of chronic diseases such as diabetes, heart disease, and even dementia.
The metabolic syndrome is, fundamentally, a lifestyle disease. There is a direct line between our dietary habits and the wide availability of carbohydrate-rich, highly processed foods, and the rise in the syndrome in the population.
A saying I learned from one of my epidemiology teachers comes to mind: “Lifestyle diseases require lifestyle reinterventions.” But you know what? I’m not so sure anymore.
I’ve been around long enough to see multiple dietary fads come and go with varying efficacy. I grew up in the low-fat era, probably the most detrimental time to our national health as food manufacturers started replacing fats with carbohydrates, driving much of the problem we’re faced with today.
But I was also around for the Atkins diet and the low-carb craze — a healthier approach, all things being equal. And I’ve seen variants of these: the paleo diet (essentially a low-carb, high-protein diet based on minimally processed foods) and the Mediterranean diet, which sought to replace some percentage of fats with healthier fats.
And, of course, there is time-restricted eating.
Time-restricted eating, a variant of intermittent fasting, has the advantage of being very simple. No cookbooks, no recipes. Eat what you want — but limit it to certain hours in the day, ideally a window of less than 10 hours, such as 8 a.m. to 6 p.m.
When it comes to weight loss, the diets that work tend to work because they reduce calorie intake. I know, people will get angry about this, but thermodynamics is not just a good idea, it’s the law.
But weight loss is not the only reason we need to eat healthier. What we eat can impact our health in multiple ways; certain foods lead to more atherosclerosis, more inflammation, increased strain on the kidney and liver, and can affect our glucose homeostasis.
So I was really interested when I saw this article, “Time-Restricted Eating in Adults With Metabolic Syndrome,” appearing in Annals of Internal Medicine October 1, which examined the effect of time-restricted eating on the metabolic syndrome itself. Could this lifestyle intervention cure this lifestyle disease?
In the study, 108 individuals, all of whom had the metabolic syndrome but not full-blown diabetes, were randomized to usual care — basically, nutrition education — vs time-restricted eating. In that group, participants were instructed to reduce their window of eating by at least 4 hours to achieve an 8- to 10-hour eating window. The groups were followed for 3 months.
Now, before we get to the results, it’s important to remember that the success of a lifestyle intervention trial is quite dependent on how well people adhere to the lifestyle intervention. Time-restricted eating is not as easy as taking a pill once a day.
The researchers had participants log their consumption using a smartphone app to confirm whether they were adhering to that restricted eating window.
Broadly speaking, they did. At baseline, both groups had an eating window of about 14 hours a day — think 7 a.m. to 9 p.m. The intervention group reduced that to just under 10 hours, with 10% of days falling outside of the target window.
Lifestyle change achieved, the primary outcome was the change in hemoglobin A1c at 3 months. A1c integrates the serum glucose over time and is thus a good indicator of the success of the intervention in terms of insulin resistance. But the effect was, honestly, disappointing.
Technically, the time-restricted-eating group had a greater A1c change than the control group — by 0.1 percentage points. On average, they went from a baseline A1c of 5.87 to a 3-month A1c of 5.75.
Other metabolic syndrome markers were equally lackluster: no difference in fasting glucose, mean glucose, or fasting insulin.
There was some weight change. The control group, which got that dietary education, lost 1.5% of body weight over the 3 months. The time-restricted-eating group lost 3.3% — about 7 pounds, which is reasonable.
With that weight loss came statistically significant, albeit modest improvements in BMI, body fat percentage, and LDL cholesterol.
Of interest, despite the larger weight loss in the intermittent-fasting group, there was no difference in muscle mass loss, which is encouraging.
Taken together, we can say that, yes, it seems like time-restricted eating can help people lose some weight. This is essentially due to the fact that people eat fewer calories when they do time-restricted eating, as you can see here.
But, in the end, this trial examined whether this relatively straightforward lifestyle intervention would move the needle in terms of metabolic syndrome, and the data are not very compelling for that.
This graph shows how many of those five factors for metabolic syndrome the individuals in this trial had from the start to the end. You see that, over the 3 months, seven people in the time-restricted-eating group moved from having three criteria to two or one — being “cured” of metabolic syndrome, if you will. Nine people in the standard group were cured by that definition. Remember, they had to have at least three to have the syndrome and thus be eligible for the trial.
So If it just leads to weight loss by forcing people to consume less calories, then we need to acknowledge that we probably have better methods to achieve this same end. Ten years ago, I would have said that lifestyle change is the only way to end the epidemic of the metabolic syndrome in this country. Today, well, we live in a world of GLP-1 weight loss drugs. It is simply a different world now. Yes, they are expensive. Yes, they have side effects. But we need to evaluate them against the comparison. And so far, lifestyle changes alone are really no comparison.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Public Health, Not Politics, Should Drive Mask Policies, Says Ethicist
This transcript has been edited for clarity.
I recently saw a ban that has me very worried, concerned, and strongly in opposition.
Basically, the standard kind of medical mask would be captured, although I think their aim in doing this was to try to discourage people at political protests from being able to wear masks and hide their identity. They’re basically trying to discourage that. This is particularly triggered by, I think, protests about the invasion of Israel, the war that resulted in Gaza, and the demonstrations that have gone on around the country, with many people masked.
There may be issues about what is acceptable to wear when you go to a demonstration. I don’t claim to know about the civil rights of that.
In a time at which COVID-19 is flourishing, really on the rebound, expanding fast, and still causing 600 deaths a week; the flu season is going to be upon us soon enough; and there are also concerns about the possibility of avian flu jumping into the human population, it is absolutely the wrong time to single out those who are trying to mask for health reasons.
Basically, there are two strong reasons. One, there are people out there who wear a medical mask or mask for a medical reason because they have an underlying disease. They may have had a transplant or they may feel they’re immunocompromised for some reason. They worry that, if they don’t wear a mask, they’re going to get an infection from something like COVID-19 or flu, which could really be super-dangerous for them.
The other reason people mask is to protect their family members. They may have someone who’s immunocompromised in the family, or they’re doing it kindly and altruistically to protect the rest of us and to stop viruses from circulating.
These bans are not taking into account public health. They’re being brought forward in the midst of political heat about demonstrations and political issues. I think they should be opposed. I do not think they should be enacted.
I think the medical rights of people with disabilities and immunologic disorders, and those who want to mask to prevent getting sick at a time at which infectious diseases are still circulating and killing people, ought to take priority. Public health, in this case, should drive our policies about masks.
Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, NY, served on Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position), and is a contributing author and adviser for Medscape.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I recently saw a ban that has me very worried, concerned, and strongly in opposition.
Basically, the standard kind of medical mask would be captured, although I think their aim in doing this was to try to discourage people at political protests from being able to wear masks and hide their identity. They’re basically trying to discourage that. This is particularly triggered by, I think, protests about the invasion of Israel, the war that resulted in Gaza, and the demonstrations that have gone on around the country, with many people masked.
There may be issues about what is acceptable to wear when you go to a demonstration. I don’t claim to know about the civil rights of that.
In a time at which COVID-19 is flourishing, really on the rebound, expanding fast, and still causing 600 deaths a week; the flu season is going to be upon us soon enough; and there are also concerns about the possibility of avian flu jumping into the human population, it is absolutely the wrong time to single out those who are trying to mask for health reasons.
Basically, there are two strong reasons. One, there are people out there who wear a medical mask or mask for a medical reason because they have an underlying disease. They may have had a transplant or they may feel they’re immunocompromised for some reason. They worry that, if they don’t wear a mask, they’re going to get an infection from something like COVID-19 or flu, which could really be super-dangerous for them.
The other reason people mask is to protect their family members. They may have someone who’s immunocompromised in the family, or they’re doing it kindly and altruistically to protect the rest of us and to stop viruses from circulating.
These bans are not taking into account public health. They’re being brought forward in the midst of political heat about demonstrations and political issues. I think they should be opposed. I do not think they should be enacted.
I think the medical rights of people with disabilities and immunologic disorders, and those who want to mask to prevent getting sick at a time at which infectious diseases are still circulating and killing people, ought to take priority. Public health, in this case, should drive our policies about masks.
Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, NY, served on Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position), and is a contributing author and adviser for Medscape.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I recently saw a ban that has me very worried, concerned, and strongly in opposition.
Basically, the standard kind of medical mask would be captured, although I think their aim in doing this was to try to discourage people at political protests from being able to wear masks and hide their identity. They’re basically trying to discourage that. This is particularly triggered by, I think, protests about the invasion of Israel, the war that resulted in Gaza, and the demonstrations that have gone on around the country, with many people masked.
There may be issues about what is acceptable to wear when you go to a demonstration. I don’t claim to know about the civil rights of that.
In a time at which COVID-19 is flourishing, really on the rebound, expanding fast, and still causing 600 deaths a week; the flu season is going to be upon us soon enough; and there are also concerns about the possibility of avian flu jumping into the human population, it is absolutely the wrong time to single out those who are trying to mask for health reasons.
Basically, there are two strong reasons. One, there are people out there who wear a medical mask or mask for a medical reason because they have an underlying disease. They may have had a transplant or they may feel they’re immunocompromised for some reason. They worry that, if they don’t wear a mask, they’re going to get an infection from something like COVID-19 or flu, which could really be super-dangerous for them.
The other reason people mask is to protect their family members. They may have someone who’s immunocompromised in the family, or they’re doing it kindly and altruistically to protect the rest of us and to stop viruses from circulating.
These bans are not taking into account public health. They’re being brought forward in the midst of political heat about demonstrations and political issues. I think they should be opposed. I do not think they should be enacted.
I think the medical rights of people with disabilities and immunologic disorders, and those who want to mask to prevent getting sick at a time at which infectious diseases are still circulating and killing people, ought to take priority. Public health, in this case, should drive our policies about masks.
Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, NY, served on Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position), and is a contributing author and adviser for Medscape.
A version of this article appeared on Medscape.com.
Considerations for the Use of Biologics in Pregnancy
Biologics have revolutionized dermatologic treatment, offering substantial relief from chronic and debilitating skin conditions such as psoriasis,
Biologics for Cutaneous Conditions
Biologics—tumor necrosis factor (TNF) α inhibitors; IL-17, IL-23, IL-12, and IL-36 inhibitors; and agents such as omalizumab and dupilumab—have shown remarkable efficacy in controlling severe or recalcitrant dermatologic conditions and typically are more effective than traditional systemic therapies.1 For instance, randomized clinical trials (RCTs) and real-world data have shown that patients with psoriasis can achieve considerable skin clearance with biologics, greatly enhancing QOL.2 Adalimumab and secukinumab, which have been approved for use in moderate to severe cases of hidradenitis suppurativa, reduce the frequency of painful nodules and abscesses, thereby decreasing pain and improving QOL. Dupilumab, an IL-4/13 receptor antagonist, has revolutionized the treatment of AD by drastically reducing itch and skin lesions and improving QOL.3 For chronic urticaria, the anti-IgE antibody omalizumab has effectively reduced the incidence of hives and itching, providing pronounced symptom relief when traditional antihistamines fail.4 Use of rituximab, an anti-CD20 monoclonal antibody, has led to remission in severe cases of pemphigus vulgaris and bullous pemphigoid.5
Impact of Untreated Cutaneous Conditions in Pregnancy
When treating patients who are pregnant, dermatologists must consider the health of both the expectant mother and the developing fetus. This dual focus complicates decision-making, particularly with the use of biologics. Untreated cutaneous conditions can profoundly impact a pregnant patient’s health and QOL as well as lead to pregnancy complications affecting the fetus, such as preterm birth or low birth weight. In some studies, moderate to severe psoriasis has been associated with increased risk for complications during pregnancy, including preeclampsia and intrauterine growth restriction.6 Although specific data on hidradenitis suppurativa are lacking, the highly inflammatory nature of the condition suggests similar adverse effects on pregnancy.7 Atopic dermatitis can be exacerbated during pregnancy due to a shift in the immune system to become more allergic dominant.8 Generalized pustular psoriasis manifests with widespread pustules, fever, and systemic inflammation, posing serious risks to both the mother and the fetus if left untreated9; in such a life-threatening scenario, the use of potent treatments such as spesolimab, an IL-36 receptor antagonist, may be warranted. Therefore, managing these conditions effectively is crucial not only for the mother’s health but also for fetal well-being.
Which Biologics Can Dermatologists Safely Prescribe?
Despite the benefits, many dermatologists are hesitant to prescribe biologics to pregnant patients due to the lack of understanding and definitive safety data.10,11 Although there are no RCTs that involve pregnant patients, current evidence suggests that several biologics are not teratogenic and do not cause fetal malformations. Extensive postexposure data support the safety of TNF-α inhibitors during pregnancy.12 Research has shown that children exposed to these agents in utero have normal development, infection rates, and vaccination outcomes comparable to nonexposed children. For example, a systematic review and meta-analysis found no significant increase in the risk for major congenital malformations, spontaneous abortions, or preterm births among patients exposed to anti–TNF-α agents during pregnancy.2 The Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project has provided valuable real-world data indicating that the use of TNF-α inhibitors in pregnancy, particularly during the first trimester, does not substantially elevate the risk for adverse outcomes.13 These findings have been corroborated by several other registry studies and RCTs, providing a robust safety profile for these agents during pregnancy.14
Similarly, postexposure data on IL-17 and IL-12/23 inhibitors indicate a favorable safety profile, though the sample sizes are smaller than those for anti–TNF-α agents.12,14 Studies of drugs such as secukinumab (IL-17 inhibitor), guselkumab (IL-23 inhibitor), or ustekinumab (IL-12/23 inhibitor) have shown no association with teratogenic effects or increased risk for miscarriage.14 However, agents such as spesolimab (IL-36 inhibitor) are relatively new, and ongoing studies are expected to provide more comprehensive safety data.15 Similarly, omalizumab and dupilumab have not been associated with increased risk for fetal malformations or adverse pregnancy outcomes. Omalizumab, indicated for chronic urticaria, has a good safety profile in pregnancy, with no significant increase in adverse outcomes reported in studies and registries.16 Dupilumab, used for AD, has demonstrated safety in pregnancy, with ongoing studies continuing to monitor outcomes.17
Conversely, rituximab (an anti-CD20 antibody for autoimmune bullous diseases) has shown evidence of adverse pregnancy outcomes, including fetal harm.18 Its use generally is discouraged unless deemed absolutely necessary, and no safer alternatives are available. Rituximab can cross the placenta, especially in the second and third trimesters, and has been associated with B-cell depletion in the fetus, leading to potential immunosuppression and increased risk for infections.5
Although the data on the safety of biologics in pregnancy are largely reassuring, it is essential to recognize that potential risks have not been ruled out entirely. There are extensive safety data for anti–TNF-α inhibitors, which provides a level of confidence; although newer agents such as IL-17 and IL-23 inhibitors have shown promising early results, further research is required to solidify their safety profiles during pregnancy.
Dermatologists must balance the risks and benefits of using biologics in pregnant patients. This decision-making process involves careful consideration of the severity of the mother’s condition, the potential risks to the fetus, and the availability of alternative treatments. For many severe dermatologic conditions, the benefits of biologics in controlling disease activity and improving QOL may outweigh the potential risks, especially when other treatments have failed or are not suitable.
Final Thoughts
The increasing use of biologics in dermatology has undoubtedly improved the management of severe skin conditions, substantially enhancing patients’ QOL. As more data become available and clinical guidelines evolve, health care providers will be better equipped to make informed decisions about the use of biologics, particularly in pregnant patients. Collaborative efforts between dermatologists, obstetricians, and researchers will help refine treatment guidelines and ensure that pregnant patients with severe dermatologic conditions receive the best possible care.
For now, although the current evidence supports the safety of many biologics during pregnancy,10,11 individualized care and informed decision-making remain paramount. Careful management and adherence to current guidelines make it possible to navigate the complexities of treating severe dermatologic conditions in pregnant patients, ensuring the best outcomes for both mother and child.
- Sehgal VN, Pandhi D, Khurana A. Biologics in dermatology: an integrated review. Indian J Dermatol. 2014; 59:425-441. doi:10.4103/0019-5154.139859
- Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11:286-292. doi:10.1016/j.cgh.2012.11.011
- Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375:2335-2348.
- Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135:67-75. doi:10.1038/jid.2014.306
- Mariette X, Forger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77:228-233. doi:10.1136/annrheumdis-2017-212196
- Yang Y-W, Chen C-S, Chen Y-H, et al. Psoriasis and pregnancy outcomes: a nationwide population-based study. J Am Acad Dermatol. 2011;64:71-77.
- Zouboulis CC, Del Marmol V, Mrowietz U, et al. Hidradenitis suppurativa/acne inversa: criteria for diagnosis, severity assessment, classification and disease evaluation. Dermatology. 2015;231:184-190.
- Balakirski G, Novak N. Atopic dermatitis and pregnancy. J Allergy Clin Immunol. 2022;149:1185-1194. doi:10.1016/j.jaci.2022.01.010
- Bachelez H, Choon S-E, Marrakchi S, et al. Inhibition of the interleukin-36 pathway for the treatment of generalized pustular psoriasis. N Engl J Med. 2019;380:981-983.
- McMullan P, Yaghi M, Truong TM, et al. Safety of dermatologic medications in pregnancy and lactation: an update—part I: pregnancy. J Am Acad Dermatol. Published online January 25, 2024. doi:10.1016/j.jaad.2023.10.072
- Yaghi M, McMullan P, Truong TM, et al. Safety of dermatologic medications in pregnancy and lactation: an update—part II: lactation. J Am Acad Dermatol. Published online January 25, 2024. doi:10.1016/j.jaad.2023.10.071
- Owczarek W, Walecka I, Lesiak A, et al. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. 2020;37:821-830. doi:10.5114/ada.2020.102089
- Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project. ClinicalTrials.gov identifier: NCT00116272. Updated October 6, 2023. Accessed August 29, 2024. https://clinicaltrials.gov/study/NCT00116272
- Sanchez-Garcia V, Hernandez-Quiles R, de-Miguel-Balsa E, et al. Exposure to biologic therapy before and during pregnancy in patients with psoriasis: systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2023;37:1971-1990. doi:10.1111/jdv.19238
- Silverberg JI, Boguniewicz M, Hanifin J, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis is efficacious regardless of age of disease onset: a post hoc analysis of two phase 3 clinical trials. Dermatol Ther (Heidelb). 2022;12:2731-2746. doi:10.1007/s13555-022-00822-x
- Levi-Schaffer F, Mankuta D. Omalizumab safety in pregnancy. J Allergy Clin Immunol. 2020;145:481-483. doi:10.1016/j.jaci.2019.11.018
- Thaci D, Simpson EL, Beck LA, et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016;387:40-52.
- Chakravarty EF, Murray ER, Kelman A, et al. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011;117:1499-1506. doi:10.1182/blood-2010-07-295444
Biologics have revolutionized dermatologic treatment, offering substantial relief from chronic and debilitating skin conditions such as psoriasis,
Biologics for Cutaneous Conditions
Biologics—tumor necrosis factor (TNF) α inhibitors; IL-17, IL-23, IL-12, and IL-36 inhibitors; and agents such as omalizumab and dupilumab—have shown remarkable efficacy in controlling severe or recalcitrant dermatologic conditions and typically are more effective than traditional systemic therapies.1 For instance, randomized clinical trials (RCTs) and real-world data have shown that patients with psoriasis can achieve considerable skin clearance with biologics, greatly enhancing QOL.2 Adalimumab and secukinumab, which have been approved for use in moderate to severe cases of hidradenitis suppurativa, reduce the frequency of painful nodules and abscesses, thereby decreasing pain and improving QOL. Dupilumab, an IL-4/13 receptor antagonist, has revolutionized the treatment of AD by drastically reducing itch and skin lesions and improving QOL.3 For chronic urticaria, the anti-IgE antibody omalizumab has effectively reduced the incidence of hives and itching, providing pronounced symptom relief when traditional antihistamines fail.4 Use of rituximab, an anti-CD20 monoclonal antibody, has led to remission in severe cases of pemphigus vulgaris and bullous pemphigoid.5
Impact of Untreated Cutaneous Conditions in Pregnancy
When treating patients who are pregnant, dermatologists must consider the health of both the expectant mother and the developing fetus. This dual focus complicates decision-making, particularly with the use of biologics. Untreated cutaneous conditions can profoundly impact a pregnant patient’s health and QOL as well as lead to pregnancy complications affecting the fetus, such as preterm birth or low birth weight. In some studies, moderate to severe psoriasis has been associated with increased risk for complications during pregnancy, including preeclampsia and intrauterine growth restriction.6 Although specific data on hidradenitis suppurativa are lacking, the highly inflammatory nature of the condition suggests similar adverse effects on pregnancy.7 Atopic dermatitis can be exacerbated during pregnancy due to a shift in the immune system to become more allergic dominant.8 Generalized pustular psoriasis manifests with widespread pustules, fever, and systemic inflammation, posing serious risks to both the mother and the fetus if left untreated9; in such a life-threatening scenario, the use of potent treatments such as spesolimab, an IL-36 receptor antagonist, may be warranted. Therefore, managing these conditions effectively is crucial not only for the mother’s health but also for fetal well-being.
Which Biologics Can Dermatologists Safely Prescribe?
Despite the benefits, many dermatologists are hesitant to prescribe biologics to pregnant patients due to the lack of understanding and definitive safety data.10,11 Although there are no RCTs that involve pregnant patients, current evidence suggests that several biologics are not teratogenic and do not cause fetal malformations. Extensive postexposure data support the safety of TNF-α inhibitors during pregnancy.12 Research has shown that children exposed to these agents in utero have normal development, infection rates, and vaccination outcomes comparable to nonexposed children. For example, a systematic review and meta-analysis found no significant increase in the risk for major congenital malformations, spontaneous abortions, or preterm births among patients exposed to anti–TNF-α agents during pregnancy.2 The Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project has provided valuable real-world data indicating that the use of TNF-α inhibitors in pregnancy, particularly during the first trimester, does not substantially elevate the risk for adverse outcomes.13 These findings have been corroborated by several other registry studies and RCTs, providing a robust safety profile for these agents during pregnancy.14
Similarly, postexposure data on IL-17 and IL-12/23 inhibitors indicate a favorable safety profile, though the sample sizes are smaller than those for anti–TNF-α agents.12,14 Studies of drugs such as secukinumab (IL-17 inhibitor), guselkumab (IL-23 inhibitor), or ustekinumab (IL-12/23 inhibitor) have shown no association with teratogenic effects or increased risk for miscarriage.14 However, agents such as spesolimab (IL-36 inhibitor) are relatively new, and ongoing studies are expected to provide more comprehensive safety data.15 Similarly, omalizumab and dupilumab have not been associated with increased risk for fetal malformations or adverse pregnancy outcomes. Omalizumab, indicated for chronic urticaria, has a good safety profile in pregnancy, with no significant increase in adverse outcomes reported in studies and registries.16 Dupilumab, used for AD, has demonstrated safety in pregnancy, with ongoing studies continuing to monitor outcomes.17
Conversely, rituximab (an anti-CD20 antibody for autoimmune bullous diseases) has shown evidence of adverse pregnancy outcomes, including fetal harm.18 Its use generally is discouraged unless deemed absolutely necessary, and no safer alternatives are available. Rituximab can cross the placenta, especially in the second and third trimesters, and has been associated with B-cell depletion in the fetus, leading to potential immunosuppression and increased risk for infections.5
Although the data on the safety of biologics in pregnancy are largely reassuring, it is essential to recognize that potential risks have not been ruled out entirely. There are extensive safety data for anti–TNF-α inhibitors, which provides a level of confidence; although newer agents such as IL-17 and IL-23 inhibitors have shown promising early results, further research is required to solidify their safety profiles during pregnancy.
Dermatologists must balance the risks and benefits of using biologics in pregnant patients. This decision-making process involves careful consideration of the severity of the mother’s condition, the potential risks to the fetus, and the availability of alternative treatments. For many severe dermatologic conditions, the benefits of biologics in controlling disease activity and improving QOL may outweigh the potential risks, especially when other treatments have failed or are not suitable.
Final Thoughts
The increasing use of biologics in dermatology has undoubtedly improved the management of severe skin conditions, substantially enhancing patients’ QOL. As more data become available and clinical guidelines evolve, health care providers will be better equipped to make informed decisions about the use of biologics, particularly in pregnant patients. Collaborative efforts between dermatologists, obstetricians, and researchers will help refine treatment guidelines and ensure that pregnant patients with severe dermatologic conditions receive the best possible care.
For now, although the current evidence supports the safety of many biologics during pregnancy,10,11 individualized care and informed decision-making remain paramount. Careful management and adherence to current guidelines make it possible to navigate the complexities of treating severe dermatologic conditions in pregnant patients, ensuring the best outcomes for both mother and child.
Biologics have revolutionized dermatologic treatment, offering substantial relief from chronic and debilitating skin conditions such as psoriasis,
Biologics for Cutaneous Conditions
Biologics—tumor necrosis factor (TNF) α inhibitors; IL-17, IL-23, IL-12, and IL-36 inhibitors; and agents such as omalizumab and dupilumab—have shown remarkable efficacy in controlling severe or recalcitrant dermatologic conditions and typically are more effective than traditional systemic therapies.1 For instance, randomized clinical trials (RCTs) and real-world data have shown that patients with psoriasis can achieve considerable skin clearance with biologics, greatly enhancing QOL.2 Adalimumab and secukinumab, which have been approved for use in moderate to severe cases of hidradenitis suppurativa, reduce the frequency of painful nodules and abscesses, thereby decreasing pain and improving QOL. Dupilumab, an IL-4/13 receptor antagonist, has revolutionized the treatment of AD by drastically reducing itch and skin lesions and improving QOL.3 For chronic urticaria, the anti-IgE antibody omalizumab has effectively reduced the incidence of hives and itching, providing pronounced symptom relief when traditional antihistamines fail.4 Use of rituximab, an anti-CD20 monoclonal antibody, has led to remission in severe cases of pemphigus vulgaris and bullous pemphigoid.5
Impact of Untreated Cutaneous Conditions in Pregnancy
When treating patients who are pregnant, dermatologists must consider the health of both the expectant mother and the developing fetus. This dual focus complicates decision-making, particularly with the use of biologics. Untreated cutaneous conditions can profoundly impact a pregnant patient’s health and QOL as well as lead to pregnancy complications affecting the fetus, such as preterm birth or low birth weight. In some studies, moderate to severe psoriasis has been associated with increased risk for complications during pregnancy, including preeclampsia and intrauterine growth restriction.6 Although specific data on hidradenitis suppurativa are lacking, the highly inflammatory nature of the condition suggests similar adverse effects on pregnancy.7 Atopic dermatitis can be exacerbated during pregnancy due to a shift in the immune system to become more allergic dominant.8 Generalized pustular psoriasis manifests with widespread pustules, fever, and systemic inflammation, posing serious risks to both the mother and the fetus if left untreated9; in such a life-threatening scenario, the use of potent treatments such as spesolimab, an IL-36 receptor antagonist, may be warranted. Therefore, managing these conditions effectively is crucial not only for the mother’s health but also for fetal well-being.
Which Biologics Can Dermatologists Safely Prescribe?
Despite the benefits, many dermatologists are hesitant to prescribe biologics to pregnant patients due to the lack of understanding and definitive safety data.10,11 Although there are no RCTs that involve pregnant patients, current evidence suggests that several biologics are not teratogenic and do not cause fetal malformations. Extensive postexposure data support the safety of TNF-α inhibitors during pregnancy.12 Research has shown that children exposed to these agents in utero have normal development, infection rates, and vaccination outcomes comparable to nonexposed children. For example, a systematic review and meta-analysis found no significant increase in the risk for major congenital malformations, spontaneous abortions, or preterm births among patients exposed to anti–TNF-α agents during pregnancy.2 The Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project has provided valuable real-world data indicating that the use of TNF-α inhibitors in pregnancy, particularly during the first trimester, does not substantially elevate the risk for adverse outcomes.13 These findings have been corroborated by several other registry studies and RCTs, providing a robust safety profile for these agents during pregnancy.14
Similarly, postexposure data on IL-17 and IL-12/23 inhibitors indicate a favorable safety profile, though the sample sizes are smaller than those for anti–TNF-α agents.12,14 Studies of drugs such as secukinumab (IL-17 inhibitor), guselkumab (IL-23 inhibitor), or ustekinumab (IL-12/23 inhibitor) have shown no association with teratogenic effects or increased risk for miscarriage.14 However, agents such as spesolimab (IL-36 inhibitor) are relatively new, and ongoing studies are expected to provide more comprehensive safety data.15 Similarly, omalizumab and dupilumab have not been associated with increased risk for fetal malformations or adverse pregnancy outcomes. Omalizumab, indicated for chronic urticaria, has a good safety profile in pregnancy, with no significant increase in adverse outcomes reported in studies and registries.16 Dupilumab, used for AD, has demonstrated safety in pregnancy, with ongoing studies continuing to monitor outcomes.17
Conversely, rituximab (an anti-CD20 antibody for autoimmune bullous diseases) has shown evidence of adverse pregnancy outcomes, including fetal harm.18 Its use generally is discouraged unless deemed absolutely necessary, and no safer alternatives are available. Rituximab can cross the placenta, especially in the second and third trimesters, and has been associated with B-cell depletion in the fetus, leading to potential immunosuppression and increased risk for infections.5
Although the data on the safety of biologics in pregnancy are largely reassuring, it is essential to recognize that potential risks have not been ruled out entirely. There are extensive safety data for anti–TNF-α inhibitors, which provides a level of confidence; although newer agents such as IL-17 and IL-23 inhibitors have shown promising early results, further research is required to solidify their safety profiles during pregnancy.
Dermatologists must balance the risks and benefits of using biologics in pregnant patients. This decision-making process involves careful consideration of the severity of the mother’s condition, the potential risks to the fetus, and the availability of alternative treatments. For many severe dermatologic conditions, the benefits of biologics in controlling disease activity and improving QOL may outweigh the potential risks, especially when other treatments have failed or are not suitable.
Final Thoughts
The increasing use of biologics in dermatology has undoubtedly improved the management of severe skin conditions, substantially enhancing patients’ QOL. As more data become available and clinical guidelines evolve, health care providers will be better equipped to make informed decisions about the use of biologics, particularly in pregnant patients. Collaborative efforts between dermatologists, obstetricians, and researchers will help refine treatment guidelines and ensure that pregnant patients with severe dermatologic conditions receive the best possible care.
For now, although the current evidence supports the safety of many biologics during pregnancy,10,11 individualized care and informed decision-making remain paramount. Careful management and adherence to current guidelines make it possible to navigate the complexities of treating severe dermatologic conditions in pregnant patients, ensuring the best outcomes for both mother and child.
- Sehgal VN, Pandhi D, Khurana A. Biologics in dermatology: an integrated review. Indian J Dermatol. 2014; 59:425-441. doi:10.4103/0019-5154.139859
- Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11:286-292. doi:10.1016/j.cgh.2012.11.011
- Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375:2335-2348.
- Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135:67-75. doi:10.1038/jid.2014.306
- Mariette X, Forger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77:228-233. doi:10.1136/annrheumdis-2017-212196
- Yang Y-W, Chen C-S, Chen Y-H, et al. Psoriasis and pregnancy outcomes: a nationwide population-based study. J Am Acad Dermatol. 2011;64:71-77.
- Zouboulis CC, Del Marmol V, Mrowietz U, et al. Hidradenitis suppurativa/acne inversa: criteria for diagnosis, severity assessment, classification and disease evaluation. Dermatology. 2015;231:184-190.
- Balakirski G, Novak N. Atopic dermatitis and pregnancy. J Allergy Clin Immunol. 2022;149:1185-1194. doi:10.1016/j.jaci.2022.01.010
- Bachelez H, Choon S-E, Marrakchi S, et al. Inhibition of the interleukin-36 pathway for the treatment of generalized pustular psoriasis. N Engl J Med. 2019;380:981-983.
- McMullan P, Yaghi M, Truong TM, et al. Safety of dermatologic medications in pregnancy and lactation: an update—part I: pregnancy. J Am Acad Dermatol. Published online January 25, 2024. doi:10.1016/j.jaad.2023.10.072
- Yaghi M, McMullan P, Truong TM, et al. Safety of dermatologic medications in pregnancy and lactation: an update—part II: lactation. J Am Acad Dermatol. Published online January 25, 2024. doi:10.1016/j.jaad.2023.10.071
- Owczarek W, Walecka I, Lesiak A, et al. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. 2020;37:821-830. doi:10.5114/ada.2020.102089
- Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project. ClinicalTrials.gov identifier: NCT00116272. Updated October 6, 2023. Accessed August 29, 2024. https://clinicaltrials.gov/study/NCT00116272
- Sanchez-Garcia V, Hernandez-Quiles R, de-Miguel-Balsa E, et al. Exposure to biologic therapy before and during pregnancy in patients with psoriasis: systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2023;37:1971-1990. doi:10.1111/jdv.19238
- Silverberg JI, Boguniewicz M, Hanifin J, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis is efficacious regardless of age of disease onset: a post hoc analysis of two phase 3 clinical trials. Dermatol Ther (Heidelb). 2022;12:2731-2746. doi:10.1007/s13555-022-00822-x
- Levi-Schaffer F, Mankuta D. Omalizumab safety in pregnancy. J Allergy Clin Immunol. 2020;145:481-483. doi:10.1016/j.jaci.2019.11.018
- Thaci D, Simpson EL, Beck LA, et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016;387:40-52.
- Chakravarty EF, Murray ER, Kelman A, et al. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011;117:1499-1506. doi:10.1182/blood-2010-07-295444
- Sehgal VN, Pandhi D, Khurana A. Biologics in dermatology: an integrated review. Indian J Dermatol. 2014; 59:425-441. doi:10.4103/0019-5154.139859
- Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11:286-292. doi:10.1016/j.cgh.2012.11.011
- Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375:2335-2348.
- Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135:67-75. doi:10.1038/jid.2014.306
- Mariette X, Forger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77:228-233. doi:10.1136/annrheumdis-2017-212196
- Yang Y-W, Chen C-S, Chen Y-H, et al. Psoriasis and pregnancy outcomes: a nationwide population-based study. J Am Acad Dermatol. 2011;64:71-77.
- Zouboulis CC, Del Marmol V, Mrowietz U, et al. Hidradenitis suppurativa/acne inversa: criteria for diagnosis, severity assessment, classification and disease evaluation. Dermatology. 2015;231:184-190.
- Balakirski G, Novak N. Atopic dermatitis and pregnancy. J Allergy Clin Immunol. 2022;149:1185-1194. doi:10.1016/j.jaci.2022.01.010
- Bachelez H, Choon S-E, Marrakchi S, et al. Inhibition of the interleukin-36 pathway for the treatment of generalized pustular psoriasis. N Engl J Med. 2019;380:981-983.
- McMullan P, Yaghi M, Truong TM, et al. Safety of dermatologic medications in pregnancy and lactation: an update—part I: pregnancy. J Am Acad Dermatol. Published online January 25, 2024. doi:10.1016/j.jaad.2023.10.072
- Yaghi M, McMullan P, Truong TM, et al. Safety of dermatologic medications in pregnancy and lactation: an update—part II: lactation. J Am Acad Dermatol. Published online January 25, 2024. doi:10.1016/j.jaad.2023.10.071
- Owczarek W, Walecka I, Lesiak A, et al. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. 2020;37:821-830. doi:10.5114/ada.2020.102089
- Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project. ClinicalTrials.gov identifier: NCT00116272. Updated October 6, 2023. Accessed August 29, 2024. https://clinicaltrials.gov/study/NCT00116272
- Sanchez-Garcia V, Hernandez-Quiles R, de-Miguel-Balsa E, et al. Exposure to biologic therapy before and during pregnancy in patients with psoriasis: systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2023;37:1971-1990. doi:10.1111/jdv.19238
- Silverberg JI, Boguniewicz M, Hanifin J, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis is efficacious regardless of age of disease onset: a post hoc analysis of two phase 3 clinical trials. Dermatol Ther (Heidelb). 2022;12:2731-2746. doi:10.1007/s13555-022-00822-x
- Levi-Schaffer F, Mankuta D. Omalizumab safety in pregnancy. J Allergy Clin Immunol. 2020;145:481-483. doi:10.1016/j.jaci.2019.11.018
- Thaci D, Simpson EL, Beck LA, et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016;387:40-52.
- Chakravarty EF, Murray ER, Kelman A, et al. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011;117:1499-1506. doi:10.1182/blood-2010-07-295444
Alzheimer’s and Comorbidities: Implications for Patient Care
Alzheimer’s disease (AD), the most common cause of dementia, is the fifth leading cause of death in the United States. An estimated 6.9 million Americans aged 65 years or older have AD. Comorbid conditions in AD may exacerbate the progression of dementia and negatively affect overall health.
Although the exact mechanisms remain unclear, systemic inflammation is thought to play a significant role in the development of many common comorbidities associated with AD. Among the most frequently observed comorbid conditions are hypertension, diabetes, and depression. The presence of these comorbidities affects the treatment and management of AD, underscoring the need to understand the mechanisms of their interrelationship and develop effective management strategies.
Hypertension
Hypertension is a well-established risk factor for numerous health conditions, including AD. A comprehensive review of five meta-analyses and 52 primary studies revealed that elevated systolic blood pressure (SBP) correlates with an 11 % increased risk of developing AD, raising the question of whether early intervention and control of blood pressure would mitigate the risk for AD later in life.
Findings from the Northern Manhattan Study suggest that although elevated SBP contributes to cognitive decline in older patients, the use of antihypertensive medications can neutralize the effects of high SBP on certain cognitive functions. Furthermore, a systematic review and meta-analysis comprising 12 trials (92,135 participants) demonstrated a significant reduction in the risk for dementia and cognitive impairment with antihypertensive treatment.
Notably, a retrospective cohort study involving 69,081 participants treated with beta-blockers for hypertension found that beta-blockers with high blood-brain barrier permeability were associated with a reduced risk for AD compared with those with low blood-brain barrier permeability. Additionally, a secondary analysis of the SPRINT trial found antihypertensive medications that stimulate vs inhibit type 2 and 4 angiotensin II receptors were associated with a lower incidence of cognitive impairment. Although further clinical trials are necessary to directly assess specific medications, these findings emphasize the potential of antihypertensive treatment as a strategic approach to reduce the risk for AD.
Type 2 Diabetes
The connection between AD and type 2 diabetes is such that AD is sometimes referred to as “type 3 diabetes.” Both diseases share some of the same underlying pathophysiologic mechanisms, particularly the development of insulin resistance and oxidative stress. A prospective cohort study of 10,095 participants showed that diabetes was significantly associated with a higher risk of developing dementia; this risk is even greater in patients who develop diabetes at an earlier age.
In an interview with this news organization, Alvaro Pascual-Leone, MD, PhD, a professor of neurology at Harvard Medical School, Boston, said, “In addition to being a comorbidity factor, diabetes appears to be a predisposing risk factor for AD.” This is supported by a comprehensive literature review showing an increased progression from mild cognitive impairment (MCI) to dementia in patients with diabetes, prediabetes, or metabolic syndrome, with a pooled odds ratio for dementia progression in individuals with diabetes of 1.53.
Owing to the overlapping pathophysiologic mechanisms in AD and diabetes, treating one condition may have beneficial effects on the other. A systematic umbrella review and meta-analysis that included 10 meta-analyses across nine classes of diabetes drugs found a protective effect against dementia with the use of metformin, thiazolidinediones (including pioglitazone), glucagon-like peptide 1 receptor agonists, and sodium-glucose cotransporter 2 inhibitors. Moreover, a cohort study of 12,220 patients who discontinued metformin early (ie, stopped using metformin without a prior history of abnormal kidney function) and 29,126 patients considered routine users found an increased risk for dementia in the early terminator group. Although further research is warranted, the concurrent treatment of AD and diabetes with antidiabetic agents holds considerable promise.
Depression and Anxiety
Anxiety and depression are significant risk factors for AD, and conversely, AD increases the likelihood of developing these psychiatric conditions. A systematic review of 14,760 studies showed dysthymia often emerges during the early stages of AD as an emotional response to cognitive decline.
Data from the Australian Imaging Biomarkers and Lifestyle study showed a markedly elevated risk for AD and MCI among individuals with preexisting anxiety or depression. This study also found that age, sex, and marital status are important determinants, with men and single individuals with depression being particularly susceptible to developing AD. Conversely, a cohort study of 129,410 AD patients with AD, 390,088 patients with all-cause dementia, and 3,900,880 age-matched controls without a history of depression showed a cumulative incidence of depression of 13% in the AD group vs 3% in the control group, suggesting a heightened risk for depression following an AD diagnosis.
These findings underscore the importance of targeted screening and assessment for patients with anxiety and depression who may be at risk for AD or those diagnosed with AD who are at risk for subsequent depression and anxiety. Although antidepressants are effective in treating depression in general, their efficacy in AD-related depression is of variable quality, probably owing to differing pathophysiologic mechanisms of the disease. Further research is necessary to explore both pharmacologic and nonpharmacologic interventions for treating depression in AD patients. Some studies have found that cognitive behavioral-therapy can be effective in improving depression in patients with AD.
Sleep Disorders
Research has shown a strong correlation between AD and sleep disorders, particularly obstructive sleep apnea, insomnia, and circadian rhythm disruptions. Additionally, studies suggest that insomnia and sleep deprivation contribute to increased amyloid beta production and tau pathology, hallmark features of AD. A scoping review of 70 studies proposed that this relationship is mediated by the glymphatic system (glial-dependent waste clearance pathway in the central nervous system), and that sleep deprivation disrupts its function, leading to protein accumulation and subsequent neurologic symptoms of AD. Another study showed that sleep deprivation triggers glial cell activation, initiating an inflammatory cascade that accelerates AD progression.
Given that the gold standard treatment for obstructive sleep apnea is continuous positive airway pressure (CPAP), it has been hypothesized that CPAP could also alleviate AD symptoms owing to shared pathophysiologic mechanisms of these conditions. A large systemic review found that CPAP use improved AD symptoms in patients with mild AD or MCI, though other sleep interventions, such as cognitive-behavioral therapy and melatonin supplementation, have yielded mixed outcomes. However, most studies in this area are small in scale, and there remains a paucity of research on treating sleep disorders in AD patients, indicating a need for further investigation.
Musculoskeletal Disorders
Although no direct causative link has been established, research indicates an association between osteoarthritis (OA) and dementia, likely because of similar pathophysiologic mechanisms, including systemic inflammation. Longitudinal analyses of data from the Alzheimer’s Disease Neuroimaging Initiative study found cognitively normal older individuals with OA experience more rapid declines in hippocampal volumes compared to those without OA, suggesting that OA may elevate the risk of cognitive impairment. Current treatments for OA, such as nonsteroidal anti-inflammatory drugs, glucocorticoids, and disease-modifying OA drugs, might also help alleviate AD symptoms related to inflammation, though the research in this area is limited.
AD has also been linked to osteoporosis. In a longitudinal follow-up study involving 78,994 patients with osteoporosis and 78,994 controls, AD developed in 5856 patients with osteoporosis compared with 3761 patients in the control group. These findings represent a 1.27-fold higher incidence of AD in patients with osteoporosis than in the control group, suggesting that osteoporosis might be a risk factor for AD.
Additionally, research has identified a relationship between AD and increased fracture risk and decreased bone mineral density, with AD patients exhibiting a significantly higher likelihood of bone fractures compared with those without AD. “Falls and fractures, aside from the risk they pose in all geriatric patients, in individuals with cognitive impairment — whether due to AD or another cause — have higher risk to cause delirium and that can result in greater morbidity and mortality and a lasting increase in cognitive disability,” stated Dr. Pascual-Leone. Current recommendations emphasize exercise and fall prevention strategies to reduce fracture risk in patients with AD, but there is a lack of comprehensive research on the safety and efficacy of osteoporosis medications in this population.
Implications for Clinical Practice
The intricate interplay between AD and its comorbidities highlights the need for a comprehensive and integrated approach to patient care. The overlapping pathophysiologic mechanisms suggest that these comorbidities can contribute to the evolution and progression of AD. Likewise, AD can exacerbate comorbid conditions. As such, a holistic assessment strategy that prioritizes early detection and management of comorbid conditions to mitigate their impact on AD progression would be beneficial. Dr. Pascual-Leone added, “The presence of any of these comorbidities suggests a need to screen for MCI earlier than might otherwise be indicated or as part of the treatment for the comorbid condition. In many cases, patients can make lifestyle modifications that improve not only the comorbid condition but also reduce its effect on dementia.” In doing so, healthcare providers can help improve patient outcomes and enhance the overall quality of life for individuals living with AD.
Alissa Hershberger, Professor of Nursing, University of Central Missouri, Lee’s Summit, Missouri, has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Alzheimer’s disease (AD), the most common cause of dementia, is the fifth leading cause of death in the United States. An estimated 6.9 million Americans aged 65 years or older have AD. Comorbid conditions in AD may exacerbate the progression of dementia and negatively affect overall health.
Although the exact mechanisms remain unclear, systemic inflammation is thought to play a significant role in the development of many common comorbidities associated with AD. Among the most frequently observed comorbid conditions are hypertension, diabetes, and depression. The presence of these comorbidities affects the treatment and management of AD, underscoring the need to understand the mechanisms of their interrelationship and develop effective management strategies.
Hypertension
Hypertension is a well-established risk factor for numerous health conditions, including AD. A comprehensive review of five meta-analyses and 52 primary studies revealed that elevated systolic blood pressure (SBP) correlates with an 11 % increased risk of developing AD, raising the question of whether early intervention and control of blood pressure would mitigate the risk for AD later in life.
Findings from the Northern Manhattan Study suggest that although elevated SBP contributes to cognitive decline in older patients, the use of antihypertensive medications can neutralize the effects of high SBP on certain cognitive functions. Furthermore, a systematic review and meta-analysis comprising 12 trials (92,135 participants) demonstrated a significant reduction in the risk for dementia and cognitive impairment with antihypertensive treatment.
Notably, a retrospective cohort study involving 69,081 participants treated with beta-blockers for hypertension found that beta-blockers with high blood-brain barrier permeability were associated with a reduced risk for AD compared with those with low blood-brain barrier permeability. Additionally, a secondary analysis of the SPRINT trial found antihypertensive medications that stimulate vs inhibit type 2 and 4 angiotensin II receptors were associated with a lower incidence of cognitive impairment. Although further clinical trials are necessary to directly assess specific medications, these findings emphasize the potential of antihypertensive treatment as a strategic approach to reduce the risk for AD.
Type 2 Diabetes
The connection between AD and type 2 diabetes is such that AD is sometimes referred to as “type 3 diabetes.” Both diseases share some of the same underlying pathophysiologic mechanisms, particularly the development of insulin resistance and oxidative stress. A prospective cohort study of 10,095 participants showed that diabetes was significantly associated with a higher risk of developing dementia; this risk is even greater in patients who develop diabetes at an earlier age.
In an interview with this news organization, Alvaro Pascual-Leone, MD, PhD, a professor of neurology at Harvard Medical School, Boston, said, “In addition to being a comorbidity factor, diabetes appears to be a predisposing risk factor for AD.” This is supported by a comprehensive literature review showing an increased progression from mild cognitive impairment (MCI) to dementia in patients with diabetes, prediabetes, or metabolic syndrome, with a pooled odds ratio for dementia progression in individuals with diabetes of 1.53.
Owing to the overlapping pathophysiologic mechanisms in AD and diabetes, treating one condition may have beneficial effects on the other. A systematic umbrella review and meta-analysis that included 10 meta-analyses across nine classes of diabetes drugs found a protective effect against dementia with the use of metformin, thiazolidinediones (including pioglitazone), glucagon-like peptide 1 receptor agonists, and sodium-glucose cotransporter 2 inhibitors. Moreover, a cohort study of 12,220 patients who discontinued metformin early (ie, stopped using metformin without a prior history of abnormal kidney function) and 29,126 patients considered routine users found an increased risk for dementia in the early terminator group. Although further research is warranted, the concurrent treatment of AD and diabetes with antidiabetic agents holds considerable promise.
Depression and Anxiety
Anxiety and depression are significant risk factors for AD, and conversely, AD increases the likelihood of developing these psychiatric conditions. A systematic review of 14,760 studies showed dysthymia often emerges during the early stages of AD as an emotional response to cognitive decline.
Data from the Australian Imaging Biomarkers and Lifestyle study showed a markedly elevated risk for AD and MCI among individuals with preexisting anxiety or depression. This study also found that age, sex, and marital status are important determinants, with men and single individuals with depression being particularly susceptible to developing AD. Conversely, a cohort study of 129,410 AD patients with AD, 390,088 patients with all-cause dementia, and 3,900,880 age-matched controls without a history of depression showed a cumulative incidence of depression of 13% in the AD group vs 3% in the control group, suggesting a heightened risk for depression following an AD diagnosis.
These findings underscore the importance of targeted screening and assessment for patients with anxiety and depression who may be at risk for AD or those diagnosed with AD who are at risk for subsequent depression and anxiety. Although antidepressants are effective in treating depression in general, their efficacy in AD-related depression is of variable quality, probably owing to differing pathophysiologic mechanisms of the disease. Further research is necessary to explore both pharmacologic and nonpharmacologic interventions for treating depression in AD patients. Some studies have found that cognitive behavioral-therapy can be effective in improving depression in patients with AD.
Sleep Disorders
Research has shown a strong correlation between AD and sleep disorders, particularly obstructive sleep apnea, insomnia, and circadian rhythm disruptions. Additionally, studies suggest that insomnia and sleep deprivation contribute to increased amyloid beta production and tau pathology, hallmark features of AD. A scoping review of 70 studies proposed that this relationship is mediated by the glymphatic system (glial-dependent waste clearance pathway in the central nervous system), and that sleep deprivation disrupts its function, leading to protein accumulation and subsequent neurologic symptoms of AD. Another study showed that sleep deprivation triggers glial cell activation, initiating an inflammatory cascade that accelerates AD progression.
Given that the gold standard treatment for obstructive sleep apnea is continuous positive airway pressure (CPAP), it has been hypothesized that CPAP could also alleviate AD symptoms owing to shared pathophysiologic mechanisms of these conditions. A large systemic review found that CPAP use improved AD symptoms in patients with mild AD or MCI, though other sleep interventions, such as cognitive-behavioral therapy and melatonin supplementation, have yielded mixed outcomes. However, most studies in this area are small in scale, and there remains a paucity of research on treating sleep disorders in AD patients, indicating a need for further investigation.
Musculoskeletal Disorders
Although no direct causative link has been established, research indicates an association between osteoarthritis (OA) and dementia, likely because of similar pathophysiologic mechanisms, including systemic inflammation. Longitudinal analyses of data from the Alzheimer’s Disease Neuroimaging Initiative study found cognitively normal older individuals with OA experience more rapid declines in hippocampal volumes compared to those without OA, suggesting that OA may elevate the risk of cognitive impairment. Current treatments for OA, such as nonsteroidal anti-inflammatory drugs, glucocorticoids, and disease-modifying OA drugs, might also help alleviate AD symptoms related to inflammation, though the research in this area is limited.
AD has also been linked to osteoporosis. In a longitudinal follow-up study involving 78,994 patients with osteoporosis and 78,994 controls, AD developed in 5856 patients with osteoporosis compared with 3761 patients in the control group. These findings represent a 1.27-fold higher incidence of AD in patients with osteoporosis than in the control group, suggesting that osteoporosis might be a risk factor for AD.
Additionally, research has identified a relationship between AD and increased fracture risk and decreased bone mineral density, with AD patients exhibiting a significantly higher likelihood of bone fractures compared with those without AD. “Falls and fractures, aside from the risk they pose in all geriatric patients, in individuals with cognitive impairment — whether due to AD or another cause — have higher risk to cause delirium and that can result in greater morbidity and mortality and a lasting increase in cognitive disability,” stated Dr. Pascual-Leone. Current recommendations emphasize exercise and fall prevention strategies to reduce fracture risk in patients with AD, but there is a lack of comprehensive research on the safety and efficacy of osteoporosis medications in this population.
Implications for Clinical Practice
The intricate interplay between AD and its comorbidities highlights the need for a comprehensive and integrated approach to patient care. The overlapping pathophysiologic mechanisms suggest that these comorbidities can contribute to the evolution and progression of AD. Likewise, AD can exacerbate comorbid conditions. As such, a holistic assessment strategy that prioritizes early detection and management of comorbid conditions to mitigate their impact on AD progression would be beneficial. Dr. Pascual-Leone added, “The presence of any of these comorbidities suggests a need to screen for MCI earlier than might otherwise be indicated or as part of the treatment for the comorbid condition. In many cases, patients can make lifestyle modifications that improve not only the comorbid condition but also reduce its effect on dementia.” In doing so, healthcare providers can help improve patient outcomes and enhance the overall quality of life for individuals living with AD.
Alissa Hershberger, Professor of Nursing, University of Central Missouri, Lee’s Summit, Missouri, has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Alzheimer’s disease (AD), the most common cause of dementia, is the fifth leading cause of death in the United States. An estimated 6.9 million Americans aged 65 years or older have AD. Comorbid conditions in AD may exacerbate the progression of dementia and negatively affect overall health.
Although the exact mechanisms remain unclear, systemic inflammation is thought to play a significant role in the development of many common comorbidities associated with AD. Among the most frequently observed comorbid conditions are hypertension, diabetes, and depression. The presence of these comorbidities affects the treatment and management of AD, underscoring the need to understand the mechanisms of their interrelationship and develop effective management strategies.
Hypertension
Hypertension is a well-established risk factor for numerous health conditions, including AD. A comprehensive review of five meta-analyses and 52 primary studies revealed that elevated systolic blood pressure (SBP) correlates with an 11 % increased risk of developing AD, raising the question of whether early intervention and control of blood pressure would mitigate the risk for AD later in life.
Findings from the Northern Manhattan Study suggest that although elevated SBP contributes to cognitive decline in older patients, the use of antihypertensive medications can neutralize the effects of high SBP on certain cognitive functions. Furthermore, a systematic review and meta-analysis comprising 12 trials (92,135 participants) demonstrated a significant reduction in the risk for dementia and cognitive impairment with antihypertensive treatment.
Notably, a retrospective cohort study involving 69,081 participants treated with beta-blockers for hypertension found that beta-blockers with high blood-brain barrier permeability were associated with a reduced risk for AD compared with those with low blood-brain barrier permeability. Additionally, a secondary analysis of the SPRINT trial found antihypertensive medications that stimulate vs inhibit type 2 and 4 angiotensin II receptors were associated with a lower incidence of cognitive impairment. Although further clinical trials are necessary to directly assess specific medications, these findings emphasize the potential of antihypertensive treatment as a strategic approach to reduce the risk for AD.
Type 2 Diabetes
The connection between AD and type 2 diabetes is such that AD is sometimes referred to as “type 3 diabetes.” Both diseases share some of the same underlying pathophysiologic mechanisms, particularly the development of insulin resistance and oxidative stress. A prospective cohort study of 10,095 participants showed that diabetes was significantly associated with a higher risk of developing dementia; this risk is even greater in patients who develop diabetes at an earlier age.
In an interview with this news organization, Alvaro Pascual-Leone, MD, PhD, a professor of neurology at Harvard Medical School, Boston, said, “In addition to being a comorbidity factor, diabetes appears to be a predisposing risk factor for AD.” This is supported by a comprehensive literature review showing an increased progression from mild cognitive impairment (MCI) to dementia in patients with diabetes, prediabetes, or metabolic syndrome, with a pooled odds ratio for dementia progression in individuals with diabetes of 1.53.
Owing to the overlapping pathophysiologic mechanisms in AD and diabetes, treating one condition may have beneficial effects on the other. A systematic umbrella review and meta-analysis that included 10 meta-analyses across nine classes of diabetes drugs found a protective effect against dementia with the use of metformin, thiazolidinediones (including pioglitazone), glucagon-like peptide 1 receptor agonists, and sodium-glucose cotransporter 2 inhibitors. Moreover, a cohort study of 12,220 patients who discontinued metformin early (ie, stopped using metformin without a prior history of abnormal kidney function) and 29,126 patients considered routine users found an increased risk for dementia in the early terminator group. Although further research is warranted, the concurrent treatment of AD and diabetes with antidiabetic agents holds considerable promise.
Depression and Anxiety
Anxiety and depression are significant risk factors for AD, and conversely, AD increases the likelihood of developing these psychiatric conditions. A systematic review of 14,760 studies showed dysthymia often emerges during the early stages of AD as an emotional response to cognitive decline.
Data from the Australian Imaging Biomarkers and Lifestyle study showed a markedly elevated risk for AD and MCI among individuals with preexisting anxiety or depression. This study also found that age, sex, and marital status are important determinants, with men and single individuals with depression being particularly susceptible to developing AD. Conversely, a cohort study of 129,410 AD patients with AD, 390,088 patients with all-cause dementia, and 3,900,880 age-matched controls without a history of depression showed a cumulative incidence of depression of 13% in the AD group vs 3% in the control group, suggesting a heightened risk for depression following an AD diagnosis.
These findings underscore the importance of targeted screening and assessment for patients with anxiety and depression who may be at risk for AD or those diagnosed with AD who are at risk for subsequent depression and anxiety. Although antidepressants are effective in treating depression in general, their efficacy in AD-related depression is of variable quality, probably owing to differing pathophysiologic mechanisms of the disease. Further research is necessary to explore both pharmacologic and nonpharmacologic interventions for treating depression in AD patients. Some studies have found that cognitive behavioral-therapy can be effective in improving depression in patients with AD.
Sleep Disorders
Research has shown a strong correlation between AD and sleep disorders, particularly obstructive sleep apnea, insomnia, and circadian rhythm disruptions. Additionally, studies suggest that insomnia and sleep deprivation contribute to increased amyloid beta production and tau pathology, hallmark features of AD. A scoping review of 70 studies proposed that this relationship is mediated by the glymphatic system (glial-dependent waste clearance pathway in the central nervous system), and that sleep deprivation disrupts its function, leading to protein accumulation and subsequent neurologic symptoms of AD. Another study showed that sleep deprivation triggers glial cell activation, initiating an inflammatory cascade that accelerates AD progression.
Given that the gold standard treatment for obstructive sleep apnea is continuous positive airway pressure (CPAP), it has been hypothesized that CPAP could also alleviate AD symptoms owing to shared pathophysiologic mechanisms of these conditions. A large systemic review found that CPAP use improved AD symptoms in patients with mild AD or MCI, though other sleep interventions, such as cognitive-behavioral therapy and melatonin supplementation, have yielded mixed outcomes. However, most studies in this area are small in scale, and there remains a paucity of research on treating sleep disorders in AD patients, indicating a need for further investigation.
Musculoskeletal Disorders
Although no direct causative link has been established, research indicates an association between osteoarthritis (OA) and dementia, likely because of similar pathophysiologic mechanisms, including systemic inflammation. Longitudinal analyses of data from the Alzheimer’s Disease Neuroimaging Initiative study found cognitively normal older individuals with OA experience more rapid declines in hippocampal volumes compared to those without OA, suggesting that OA may elevate the risk of cognitive impairment. Current treatments for OA, such as nonsteroidal anti-inflammatory drugs, glucocorticoids, and disease-modifying OA drugs, might also help alleviate AD symptoms related to inflammation, though the research in this area is limited.
AD has also been linked to osteoporosis. In a longitudinal follow-up study involving 78,994 patients with osteoporosis and 78,994 controls, AD developed in 5856 patients with osteoporosis compared with 3761 patients in the control group. These findings represent a 1.27-fold higher incidence of AD in patients with osteoporosis than in the control group, suggesting that osteoporosis might be a risk factor for AD.
Additionally, research has identified a relationship between AD and increased fracture risk and decreased bone mineral density, with AD patients exhibiting a significantly higher likelihood of bone fractures compared with those without AD. “Falls and fractures, aside from the risk they pose in all geriatric patients, in individuals with cognitive impairment — whether due to AD or another cause — have higher risk to cause delirium and that can result in greater morbidity and mortality and a lasting increase in cognitive disability,” stated Dr. Pascual-Leone. Current recommendations emphasize exercise and fall prevention strategies to reduce fracture risk in patients with AD, but there is a lack of comprehensive research on the safety and efficacy of osteoporosis medications in this population.
Implications for Clinical Practice
The intricate interplay between AD and its comorbidities highlights the need for a comprehensive and integrated approach to patient care. The overlapping pathophysiologic mechanisms suggest that these comorbidities can contribute to the evolution and progression of AD. Likewise, AD can exacerbate comorbid conditions. As such, a holistic assessment strategy that prioritizes early detection and management of comorbid conditions to mitigate their impact on AD progression would be beneficial. Dr. Pascual-Leone added, “The presence of any of these comorbidities suggests a need to screen for MCI earlier than might otherwise be indicated or as part of the treatment for the comorbid condition. In many cases, patients can make lifestyle modifications that improve not only the comorbid condition but also reduce its effect on dementia.” In doing so, healthcare providers can help improve patient outcomes and enhance the overall quality of life for individuals living with AD.
Alissa Hershberger, Professor of Nursing, University of Central Missouri, Lee’s Summit, Missouri, has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Following the Light
Percutaneous endoscopic gastrostomy (PEG) was first introduced in the early 1980s by surgeons Michael Gauderer and Jeffrey Ponsky as a less-invasive alternative to surgical gastrostomy via open laparotomy. The concept was born after the pair observed that the light from an endoscope in an infant undergoing endoscopy caused the abdominal wall to glow in the darkened operating room.
In fact, PEG was among the first procedures that defined minimally invasive surgery, a concept that has now revolutionized the surgical field. Since that time, PEG has evolved as a preferred method for patients needing long-term nutritional support for various indications. By 2001, approximately 216,000 PEGs were placed annually in the United States. While the volume of PEG procedures has declined in recent years at some institutions as practice patterns have shifted toward interventional radiology–placed gastrostomy tubes, evaluation of patients for PEG insertion, removal, or management of PEG complications remains a core area of gastroenterology practice.
Among the most important roles of the gastroenterologist in considering potential PEG candidates is to determine whether an appropriate indication exists, a decision that requires a detailed understanding of a patient’s overall clinical condition, goals of care, values, and preferences. a common GI consultation that deserves thoughtful consideration and demands effective communication among members of the multidisciplinary team and with patients.
Also in our October issue, we highlight a recently published large multicohort study from Gastroenterology elucidating clinical, serologic, and genetic factors associated with extraintestinal manifestations in IBD. We also review key updates to colonoscopy quality indicators, including modifications to existing indicators such as ADR and the addition of two new “priority indicators” — rate of inadequate bowel prep and sessile serrated lesion detection rate.
In this month’s Member Spotlight, Dr. Stephanie Pointer of Digestive & Liver Health Specialists in Nashville, Tennessee, shares the many ways in which she has given back to her community through music and mentoring while leading a thriving GI practice. We hope you enjoy this, and all the coverage included in our October issue.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Percutaneous endoscopic gastrostomy (PEG) was first introduced in the early 1980s by surgeons Michael Gauderer and Jeffrey Ponsky as a less-invasive alternative to surgical gastrostomy via open laparotomy. The concept was born after the pair observed that the light from an endoscope in an infant undergoing endoscopy caused the abdominal wall to glow in the darkened operating room.
In fact, PEG was among the first procedures that defined minimally invasive surgery, a concept that has now revolutionized the surgical field. Since that time, PEG has evolved as a preferred method for patients needing long-term nutritional support for various indications. By 2001, approximately 216,000 PEGs were placed annually in the United States. While the volume of PEG procedures has declined in recent years at some institutions as practice patterns have shifted toward interventional radiology–placed gastrostomy tubes, evaluation of patients for PEG insertion, removal, or management of PEG complications remains a core area of gastroenterology practice.
Among the most important roles of the gastroenterologist in considering potential PEG candidates is to determine whether an appropriate indication exists, a decision that requires a detailed understanding of a patient’s overall clinical condition, goals of care, values, and preferences. a common GI consultation that deserves thoughtful consideration and demands effective communication among members of the multidisciplinary team and with patients.
Also in our October issue, we highlight a recently published large multicohort study from Gastroenterology elucidating clinical, serologic, and genetic factors associated with extraintestinal manifestations in IBD. We also review key updates to colonoscopy quality indicators, including modifications to existing indicators such as ADR and the addition of two new “priority indicators” — rate of inadequate bowel prep and sessile serrated lesion detection rate.
In this month’s Member Spotlight, Dr. Stephanie Pointer of Digestive & Liver Health Specialists in Nashville, Tennessee, shares the many ways in which she has given back to her community through music and mentoring while leading a thriving GI practice. We hope you enjoy this, and all the coverage included in our October issue.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Percutaneous endoscopic gastrostomy (PEG) was first introduced in the early 1980s by surgeons Michael Gauderer and Jeffrey Ponsky as a less-invasive alternative to surgical gastrostomy via open laparotomy. The concept was born after the pair observed that the light from an endoscope in an infant undergoing endoscopy caused the abdominal wall to glow in the darkened operating room.
In fact, PEG was among the first procedures that defined minimally invasive surgery, a concept that has now revolutionized the surgical field. Since that time, PEG has evolved as a preferred method for patients needing long-term nutritional support for various indications. By 2001, approximately 216,000 PEGs were placed annually in the United States. While the volume of PEG procedures has declined in recent years at some institutions as practice patterns have shifted toward interventional radiology–placed gastrostomy tubes, evaluation of patients for PEG insertion, removal, or management of PEG complications remains a core area of gastroenterology practice.
Among the most important roles of the gastroenterologist in considering potential PEG candidates is to determine whether an appropriate indication exists, a decision that requires a detailed understanding of a patient’s overall clinical condition, goals of care, values, and preferences. a common GI consultation that deserves thoughtful consideration and demands effective communication among members of the multidisciplinary team and with patients.
Also in our October issue, we highlight a recently published large multicohort study from Gastroenterology elucidating clinical, serologic, and genetic factors associated with extraintestinal manifestations in IBD. We also review key updates to colonoscopy quality indicators, including modifications to existing indicators such as ADR and the addition of two new “priority indicators” — rate of inadequate bowel prep and sessile serrated lesion detection rate.
In this month’s Member Spotlight, Dr. Stephanie Pointer of Digestive & Liver Health Specialists in Nashville, Tennessee, shares the many ways in which she has given back to her community through music and mentoring while leading a thriving GI practice. We hope you enjoy this, and all the coverage included in our October issue.
Megan A. Adams, MD, JD, MSc
Editor in Chief