MDedge Endocrinology

A sense of safety and stability, both emotional and physical, is crucial in promoting the healthy development of youth. Between the global pandemic, need for social distancing, economic downturn, and increased awareness of racial disparities, for many this sense of stability has been rattled.

Ryan McVay/ThinkStock

School closures have led to a loss of social interaction, challenges to continued academic growth, and, for some students, lack of access to nutrition and increased food insecurity. For students with learning or mental health challenges, closures may have eliminated or significantly reduced desperately needed supports received in school.¹ While these trying circumstances have been difficult for many, the transition back to school in the fall also may be challenging because of the uncertainty about what this will look like and possible change in routine. Some students or their families may have anxiety about returning, either because of a history of adverse experiences at school such as bullying, or because of fears about exposure for themselves or others to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The past several months also brought about greater awareness of systemic racial disparities, whether as reflected in health care, education, or the criminal justice system. According to the Centers for Disease Control and Prevention data, Latinx and African-American individuals in the United States have had a threefold greater chance of contracting SARS-CoV-2 and have a twofold greater risk of death, compared with white people in the same communities.² Other social determinants of health – economic stability, education, social factors such as incarceration and discrimination, and neighborhood factors including access to healthy food – play a role in this vulnerability.

The pandemic has resulted in a need for social distancing, and as a result, isolation. Children and teens exposed to the news may have anxiety about what they see or hear. Additional pressures in the family can include economic uncertainty, loss of employment for the primary wage earner of the household, or stress related to family members being first responders.

Any one of these factors is a potentially significant stressor, so how do we best support youth to help them survive and hopefully thrive during this time?
 

• It is important to establish a sense of routine; this can help create a sense of stability and safety. Recognizing that circumstances are not the same as they were 5 or 6 months ago, encouraging structure should not come at the cost of preserving connection.
• Note positive behavior and choices made by children and make sure they know it was observed.
• Many children have experienced increased screen time with the lack of structure of the traditional school day or summer camp and extracurricular activities. Limiting screen time and being mindful of its potential impact on mood is prudent.
• Self-care for parents and guardians is important. This is clearly a marathon and not a sprint; parents’ caring for themselves will place them in a better position to support their children. This time is stressful for the adults of the household, let alone children who are learning self-regulation skills.
• Listen to children’s or teens’ concerns and share information in developmentally appropriate ways. It is okay to not have all of the answers.
• Balance fostering a sense of gratitude with not invalidating a child’s or teen’s experience. Showing empathy during this time is vital. While there may be other soccer seasons, it is normal to experience grief about the loss of experiences during this time.
• Parents and guardians know their children best, so it is prudent for them to be mindful of concerning changes such as an increase in sadness, anxiety, or irritability that negatively impacts daily functioning such as sleeping, eating, or relationships with family and friends.
• Promote social interactions with appropriate safeguards in place. Unfortunately, the number of SARS-CoV-2 infections is increasing in multiple states, and there is the potential to return to some of the previous restrictions. However, encouraging social interaction while following local guidelines and with cautions such as limiting the number of people present, meeting outside, or considering interacting with others who are similarly social distancing can help foster social connection and development.
• Maintain connection digitally when in-person contact is not an option.³ Social groups, places of worship, and other activities have been agile in developing virtual communities. Communication by voice and/or video is thought to be more powerful than by written communication (text, email) alone.⁴ However, it is important to consider those who may have limited to no access to electronic methods.
• Encourage open communication with children about diversity and bias, and consider how our interactions with others may affect our children’s perspectives.⁵
• As providers, it is crucial that we address structural and institutional systems that negatively impact the health, safety, and access to care including our Black, indigenous, and people of color (BIPOC) and lesbian, gay, bisexual, transgender/transsexual, queer/questioning, intersex, and allied/asexual/aromantic/agender (LGBTQIA) patients.

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. Dr. Strange has no relevant financial disclosures. Email her at pdnews@mdedge.com.

Online resources for parents and families

• Child Mind Institute: Coping With the Coronavirus Crisis: Supporting Your Kids.
• American Psychological Association: Talking with children about discrimination.
• Common Sense Media: Help with determining appropriateness of media for children.

Hotlines

• National Suicide Prevention Hotline: 1-800-273-8255
• GLBT National Hotline: 888-843-4564
• The California Peer-Run Warm Line: 1-855-845-7415
• Trevor Project: 866-488-7386 or text TREVOR to 1-202-304-1200
• Trans Lifeline: 877-565-8860
• Crisis Text Line: Text HOME to 741741

References

1. JAMA Pediatr. 2020 Apr 14. doi: 10.1001/jamapediatrics.2020.1456.

2. CDC: COVID-19 in Racial and Ethnic Minority Groups.

3. JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4469.

4. JAMA Intern Med. 2020 Apr 10. doi: 10.1001/jamainternmed.2020.1562.

5. American Psychological Association: Talking with children about discrimination.

A sense of safety and stability, both emotional and physical, is crucial in promoting the healthy development of youth. Between the global pandemic, need for social distancing, economic downturn, and increased awareness of racial disparities, for many this sense of stability has been rattled.

Ryan McVay/ThinkStock

School closures have led to a loss of social interaction, challenges to continued academic growth, and, for some students, lack of access to nutrition and increased food insecurity. For students with learning or mental health challenges, closures may have eliminated or significantly reduced desperately needed supports received in school.¹ While these trying circumstances have been difficult for many, the transition back to school in the fall also may be challenging because of the uncertainty about what this will look like and possible change in routine. Some students or their families may have anxiety about returning, either because of a history of adverse experiences at school such as bullying, or because of fears about exposure for themselves or others to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The past several months also brought about greater awareness of systemic racial disparities, whether as reflected in health care, education, or the criminal justice system. According to the Centers for Disease Control and Prevention data, Latinx and African-American individuals in the United States have had a threefold greater chance of contracting SARS-CoV-2 and have a twofold greater risk of death, compared with white people in the same communities.² Other social determinants of health – economic stability, education, social factors such as incarceration and discrimination, and neighborhood factors including access to healthy food – play a role in this vulnerability.

The pandemic has resulted in a need for social distancing, and as a result, isolation. Children and teens exposed to the news may have anxiety about what they see or hear. Additional pressures in the family can include economic uncertainty, loss of employment for the primary wage earner of the household, or stress related to family members being first responders.

Any one of these factors is a potentially significant stressor, so how do we best support youth to help them survive and hopefully thrive during this time?
 

• It is important to establish a sense of routine; this can help create a sense of stability and safety. Recognizing that circumstances are not the same as they were 5 or 6 months ago, encouraging structure should not come at the cost of preserving connection.
• Note positive behavior and choices made by children and make sure they know it was observed.
• Many children have experienced increased screen time with the lack of structure of the traditional school day or summer camp and extracurricular activities. Limiting screen time and being mindful of its potential impact on mood is prudent.
• Self-care for parents and guardians is important. This is clearly a marathon and not a sprint; parents’ caring for themselves will place them in a better position to support their children. This time is stressful for the adults of the household, let alone children who are learning self-regulation skills.
• Listen to children’s or teens’ concerns and share information in developmentally appropriate ways. It is okay to not have all of the answers.
• Balance fostering a sense of gratitude with not invalidating a child’s or teen’s experience. Showing empathy during this time is vital. While there may be other soccer seasons, it is normal to experience grief about the loss of experiences during this time.
• Parents and guardians know their children best, so it is prudent for them to be mindful of concerning changes such as an increase in sadness, anxiety, or irritability that negatively impacts daily functioning such as sleeping, eating, or relationships with family and friends.
• Promote social interactions with appropriate safeguards in place. Unfortunately, the number of SARS-CoV-2 infections is increasing in multiple states, and there is the potential to return to some of the previous restrictions. However, encouraging social interaction while following local guidelines and with cautions such as limiting the number of people present, meeting outside, or considering interacting with others who are similarly social distancing can help foster social connection and development.
• Maintain connection digitally when in-person contact is not an option.³ Social groups, places of worship, and other activities have been agile in developing virtual communities. Communication by voice and/or video is thought to be more powerful than by written communication (text, email) alone.⁴ However, it is important to consider those who may have limited to no access to electronic methods.
• Encourage open communication with children about diversity and bias, and consider how our interactions with others may affect our children’s perspectives.⁵
• As providers, it is crucial that we address structural and institutional systems that negatively impact the health, safety, and access to care including our Black, indigenous, and people of color (BIPOC) and lesbian, gay, bisexual, transgender/transsexual, queer/questioning, intersex, and allied/asexual/aromantic/agender (LGBTQIA) patients.

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. Dr. Strange has no relevant financial disclosures. Email her at pdnews@mdedge.com.

Online resources for parents and families

• Child Mind Institute: Coping With the Coronavirus Crisis: Supporting Your Kids.
• American Psychological Association: Talking with children about discrimination.
• Common Sense Media: Help with determining appropriateness of media for children.

Hotlines

• National Suicide Prevention Hotline: 1-800-273-8255
• GLBT National Hotline: 888-843-4564
• The California Peer-Run Warm Line: 1-855-845-7415
• Trevor Project: 866-488-7386 or text TREVOR to 1-202-304-1200
• Trans Lifeline: 877-565-8860
• Crisis Text Line: Text HOME to 741741

References

1. JAMA Pediatr. 2020 Apr 14. doi: 10.1001/jamapediatrics.2020.1456.

2. CDC: COVID-19 in Racial and Ethnic Minority Groups.

3. JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4469.

4. JAMA Intern Med. 2020 Apr 10. doi: 10.1001/jamainternmed.2020.1562.

5. American Psychological Association: Talking with children about discrimination.

A sense of safety and stability, both emotional and physical, is crucial in promoting the healthy development of youth. Between the global pandemic, need for social distancing, economic downturn, and increased awareness of racial disparities, for many this sense of stability has been rattled.

Ryan McVay/ThinkStock

School closures have led to a loss of social interaction, challenges to continued academic growth, and, for some students, lack of access to nutrition and increased food insecurity. For students with learning or mental health challenges, closures may have eliminated or significantly reduced desperately needed supports received in school.¹ While these trying circumstances have been difficult for many, the transition back to school in the fall also may be challenging because of the uncertainty about what this will look like and possible change in routine. Some students or their families may have anxiety about returning, either because of a history of adverse experiences at school such as bullying, or because of fears about exposure for themselves or others to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The past several months also brought about greater awareness of systemic racial disparities, whether as reflected in health care, education, or the criminal justice system. According to the Centers for Disease Control and Prevention data, Latinx and African-American individuals in the United States have had a threefold greater chance of contracting SARS-CoV-2 and have a twofold greater risk of death, compared with white people in the same communities.² Other social determinants of health – economic stability, education, social factors such as incarceration and discrimination, and neighborhood factors including access to healthy food – play a role in this vulnerability.

The pandemic has resulted in a need for social distancing, and as a result, isolation. Children and teens exposed to the news may have anxiety about what they see or hear. Additional pressures in the family can include economic uncertainty, loss of employment for the primary wage earner of the household, or stress related to family members being first responders.

Any one of these factors is a potentially significant stressor, so how do we best support youth to help them survive and hopefully thrive during this time?
 

• It is important to establish a sense of routine; this can help create a sense of stability and safety. Recognizing that circumstances are not the same as they were 5 or 6 months ago, encouraging structure should not come at the cost of preserving connection.
• Note positive behavior and choices made by children and make sure they know it was observed.
• Many children have experienced increased screen time with the lack of structure of the traditional school day or summer camp and extracurricular activities. Limiting screen time and being mindful of its potential impact on mood is prudent.
• Self-care for parents and guardians is important. This is clearly a marathon and not a sprint; parents’ caring for themselves will place them in a better position to support their children. This time is stressful for the adults of the household, let alone children who are learning self-regulation skills.
• Listen to children’s or teens’ concerns and share information in developmentally appropriate ways. It is okay to not have all of the answers.
• Balance fostering a sense of gratitude with not invalidating a child’s or teen’s experience. Showing empathy during this time is vital. While there may be other soccer seasons, it is normal to experience grief about the loss of experiences during this time.
• Parents and guardians know their children best, so it is prudent for them to be mindful of concerning changes such as an increase in sadness, anxiety, or irritability that negatively impacts daily functioning such as sleeping, eating, or relationships with family and friends.
• Promote social interactions with appropriate safeguards in place. Unfortunately, the number of SARS-CoV-2 infections is increasing in multiple states, and there is the potential to return to some of the previous restrictions. However, encouraging social interaction while following local guidelines and with cautions such as limiting the number of people present, meeting outside, or considering interacting with others who are similarly social distancing can help foster social connection and development.
• Maintain connection digitally when in-person contact is not an option.³ Social groups, places of worship, and other activities have been agile in developing virtual communities. Communication by voice and/or video is thought to be more powerful than by written communication (text, email) alone.⁴ However, it is important to consider those who may have limited to no access to electronic methods.
• Encourage open communication with children about diversity and bias, and consider how our interactions with others may affect our children’s perspectives.⁵
• As providers, it is crucial that we address structural and institutional systems that negatively impact the health, safety, and access to care including our Black, indigenous, and people of color (BIPOC) and lesbian, gay, bisexual, transgender/transsexual, queer/questioning, intersex, and allied/asexual/aromantic/agender (LGBTQIA) patients.

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. Dr. Strange has no relevant financial disclosures. Email her at pdnews@mdedge.com.

Online resources for parents and families

• Child Mind Institute: Coping With the Coronavirus Crisis: Supporting Your Kids.
• American Psychological Association: Talking with children about discrimination.
• Common Sense Media: Help with determining appropriateness of media for children.

Hotlines

• National Suicide Prevention Hotline: 1-800-273-8255
• GLBT National Hotline: 888-843-4564
• The California Peer-Run Warm Line: 1-855-845-7415
• Trevor Project: 866-488-7386 or text TREVOR to 1-202-304-1200
• Trans Lifeline: 877-565-8860
• Crisis Text Line: Text HOME to 741741

References

1. JAMA Pediatr. 2020 Apr 14. doi: 10.1001/jamapediatrics.2020.1456.

2. CDC: COVID-19 in Racial and Ethnic Minority Groups.

3. JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4469.

4. JAMA Intern Med. 2020 Apr 10. doi: 10.1001/jamainternmed.2020.1562.

5. American Psychological Association: Talking with children about discrimination.

Starting July 1, 2021, residents and fellows will be allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

The “ABMS Policy on Parental, Caregiver and Family Leave” announced July 13 was developed after a report from the Accreditation Council for Graduate Medical Education’s Council of Review Committee Residents in June 2019.

Richard E. Hawkins, MD, ABMS President and CEO, said in a statement that “the growing shifts in viewpoints regarding work-life balance and parental roles had a great influence in the creation of this policy, which fosters an environment that supports our trainees’ ability to care not only for patients, but also for themselves and their families.”

Specifically, the time can be taken for birth and care of a newborn, adopting a child, or becoming a foster parent; care of a child, spouse, or parent with a serious health condition; or the trainee’s own serious health condition. The policy applies to member boards with training programs of at least 2 years.

Boards must communicate when a leave will require an official extension to avoid disruptions to a physician’s career trajectory, a delay in starting a fellowship, or moving into a salaried position.

Work/life balance was by far the biggest challenge reported in the Medscape Residents Lifestyle & Happiness Report 2019.

Several member boards had already implemented policies that offered more flexibility without unduly delaying board certification; now ABMS is extending that to all boards.

ABMS says member boards may limit the maximum time away in a single year or level of training and directed member boards to “make reasonable testing accommodations” – for example, by allowing candidates to take an exam provided the candidate completes all training requirements by a certain date.

Kristy Rialon, MD, an author of the ACGME report and assistant professor of surgery at Baylor College of Medicine and the Texas Children’s Hospital, both in Houston, noted the significance of the change in a news release.

“By virtue of their ages, residents and fellows – male and female – often find themselves having and raising children, as well as serving as family members’ caregivers,” Dr. Rialon said. “By adopting more realistic and compassionate approaches, the ABMS member boards will significantly improve the quality of life for residents and fellows. This also will support our female physicians, helping to narrow the gender gap in their career advancement by allowing for greater leave flexibility.”

A Medscape survey published July 15 said work-life balance was the No. 1 concern of female physicians, far outpacing pay.

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

Starting July 1, 2021, residents and fellows will be allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

The “ABMS Policy on Parental, Caregiver and Family Leave” announced July 13 was developed after a report from the Accreditation Council for Graduate Medical Education’s Council of Review Committee Residents in June 2019.

Richard E. Hawkins, MD, ABMS President and CEO, said in a statement that “the growing shifts in viewpoints regarding work-life balance and parental roles had a great influence in the creation of this policy, which fosters an environment that supports our trainees’ ability to care not only for patients, but also for themselves and their families.”

Specifically, the time can be taken for birth and care of a newborn, adopting a child, or becoming a foster parent; care of a child, spouse, or parent with a serious health condition; or the trainee’s own serious health condition. The policy applies to member boards with training programs of at least 2 years.

Boards must communicate when a leave will require an official extension to avoid disruptions to a physician’s career trajectory, a delay in starting a fellowship, or moving into a salaried position.

Work/life balance was by far the biggest challenge reported in the Medscape Residents Lifestyle & Happiness Report 2019.

Several member boards had already implemented policies that offered more flexibility without unduly delaying board certification; now ABMS is extending that to all boards.

ABMS says member boards may limit the maximum time away in a single year or level of training and directed member boards to “make reasonable testing accommodations” – for example, by allowing candidates to take an exam provided the candidate completes all training requirements by a certain date.

Kristy Rialon, MD, an author of the ACGME report and assistant professor of surgery at Baylor College of Medicine and the Texas Children’s Hospital, both in Houston, noted the significance of the change in a news release.

“By virtue of their ages, residents and fellows – male and female – often find themselves having and raising children, as well as serving as family members’ caregivers,” Dr. Rialon said. “By adopting more realistic and compassionate approaches, the ABMS member boards will significantly improve the quality of life for residents and fellows. This also will support our female physicians, helping to narrow the gender gap in their career advancement by allowing for greater leave flexibility.”

A Medscape survey published July 15 said work-life balance was the No. 1 concern of female physicians, far outpacing pay.

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

Starting July 1, 2021, residents and fellows will be allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

The “ABMS Policy on Parental, Caregiver and Family Leave” announced July 13 was developed after a report from the Accreditation Council for Graduate Medical Education’s Council of Review Committee Residents in June 2019.

Richard E. Hawkins, MD, ABMS President and CEO, said in a statement that “the growing shifts in viewpoints regarding work-life balance and parental roles had a great influence in the creation of this policy, which fosters an environment that supports our trainees’ ability to care not only for patients, but also for themselves and their families.”

Specifically, the time can be taken for birth and care of a newborn, adopting a child, or becoming a foster parent; care of a child, spouse, or parent with a serious health condition; or the trainee’s own serious health condition. The policy applies to member boards with training programs of at least 2 years.

Boards must communicate when a leave will require an official extension to avoid disruptions to a physician’s career trajectory, a delay in starting a fellowship, or moving into a salaried position.

Work/life balance was by far the biggest challenge reported in the Medscape Residents Lifestyle & Happiness Report 2019.

Several member boards had already implemented policies that offered more flexibility without unduly delaying board certification; now ABMS is extending that to all boards.

ABMS says member boards may limit the maximum time away in a single year or level of training and directed member boards to “make reasonable testing accommodations” – for example, by allowing candidates to take an exam provided the candidate completes all training requirements by a certain date.

Kristy Rialon, MD, an author of the ACGME report and assistant professor of surgery at Baylor College of Medicine and the Texas Children’s Hospital, both in Houston, noted the significance of the change in a news release.

“By virtue of their ages, residents and fellows – male and female – often find themselves having and raising children, as well as serving as family members’ caregivers,” Dr. Rialon said. “By adopting more realistic and compassionate approaches, the ABMS member boards will significantly improve the quality of life for residents and fellows. This also will support our female physicians, helping to narrow the gender gap in their career advancement by allowing for greater leave flexibility.”

A Medscape survey published July 15 said work-life balance was the No. 1 concern of female physicians, far outpacing pay.

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

Two experts in geriatric diabetes are offering some contemporary practical recommendations for diabetes management in older adults during the COVID-19 pandemic.  

The viewpoint, entitled, “Caring for Older Adults With Diabetes During the COVID-19 Pandemic,” was published online in JAMA Internal Medicine by Medha N. Munshi, MD, director of the geriatrics program at the Joslin Diabetes Center, Boston, and Sarah L. Sy, MD, a geriatrician in the same program.

Adults aged 70 years and older with comorbidities such as diabetes are among those at highest risk for adverse outcomes and mortality due to COVID-19.

At the same time, those who don’t have the illness face major challenges in avoiding it, including disruptions in normal activities and barriers to receiving health care.

Although telemedicine has become much more widely adopted in diabetes management since the pandemic began, older adults may not be as tech savvy, may not have computer or Internet access, and/or may have cognitive dysfunction that precludes its use.

“These unprecedented times pose a great challenge to this heterogeneous population with varying levels of complexity, frailty, and multimorbidity,” Munshi and Sy point out, noting that “clinicians can lessen the load by guiding, reassuring, and supporting them through this pandemic time.”

Because the pandemic could last for several months longer, the authors offer the following advice for clinicians who care for older adults with diabetes.

• Accessibility to health care: When possible, use telemedicine, diabetes care apps, or platforms to obtain data from glucose meters, continuous glucose monitors, and/or pumps. When use of technology isn’t possible, schedule telephone appointments and have the patient or caregiver read the glucose values.
• Multicomplexity and geriatric syndromes: Identify high-risk patients, such as those with or recurrent , and prioritize patient goals. If appropriate, simplify the diabetes treatment plan and reinforce with repeated education and instructions. Glucose goals may need to be liberalized. Advise patients to stay hydrated to minimize the risk of dehydration and falls. Take steps to avoid hypoglycemia, reduce polypharmacy, and consolidate medication doses.
• Burden of diabetes self-care: Bloodwork for can be delayed by a few months. Patients with  can decrease the frequency of blood glucose checks if their glucose levels are generally within acceptable range. Encourage patients to eat healthily with regular meals rather than optimizing the diet for glucose levels, and adjust medications for any changes in diet. Advise safe options for physical activity such as walking inside the home or walking in place for 10 minutes, three times per day, and incorporating strength training, such as with resistance bands. Online exercise programs are another option.
• Psychological stress: Check in with patients and encourage them to stay as connected as possible using technology (phone, video chat, text message), letters, or cards with family, friends, and/or religious communities. Screen for , using either the Geriatric Depression Scale or Patient Health Questionnaire-2, and refer to mental health colleagues if appropriate. Speak or email with caregivers to assess the patient’s mental health state and offer local support resources, if needed.
• Medication and equipment issues: Refill 90-day prescriptions and equipment, and request mail or home (contactless) delivery. Patients should also have backups in case of equipment failures, such as syringes and long-acting insulin in case of pump failure, and test strips/meter for continuous glucose monitor problems.

Munshi and Sy conclude: “Many of the recommendations presented in this article are practical and will continue to be relevant after COVID-19. When this is all over, patients will remember how we made them feel, and how we kept them safe and healthy at home.”

Munshi is a consultant for Sanofi and Lilly. Sy has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Two experts in geriatric diabetes are offering some contemporary practical recommendations for diabetes management in older adults during the COVID-19 pandemic.  

The viewpoint, entitled, “Caring for Older Adults With Diabetes During the COVID-19 Pandemic,” was published online in JAMA Internal Medicine by Medha N. Munshi, MD, director of the geriatrics program at the Joslin Diabetes Center, Boston, and Sarah L. Sy, MD, a geriatrician in the same program.

Adults aged 70 years and older with comorbidities such as diabetes are among those at highest risk for adverse outcomes and mortality due to COVID-19.

At the same time, those who don’t have the illness face major challenges in avoiding it, including disruptions in normal activities and barriers to receiving health care.

Although telemedicine has become much more widely adopted in diabetes management since the pandemic began, older adults may not be as tech savvy, may not have computer or Internet access, and/or may have cognitive dysfunction that precludes its use.

“These unprecedented times pose a great challenge to this heterogeneous population with varying levels of complexity, frailty, and multimorbidity,” Munshi and Sy point out, noting that “clinicians can lessen the load by guiding, reassuring, and supporting them through this pandemic time.”

Because the pandemic could last for several months longer, the authors offer the following advice for clinicians who care for older adults with diabetes.

• Accessibility to health care: When possible, use telemedicine, diabetes care apps, or platforms to obtain data from glucose meters, continuous glucose monitors, and/or pumps. When use of technology isn’t possible, schedule telephone appointments and have the patient or caregiver read the glucose values.
• Multicomplexity and geriatric syndromes: Identify high-risk patients, such as those with or recurrent , and prioritize patient goals. If appropriate, simplify the diabetes treatment plan and reinforce with repeated education and instructions. Glucose goals may need to be liberalized. Advise patients to stay hydrated to minimize the risk of dehydration and falls. Take steps to avoid hypoglycemia, reduce polypharmacy, and consolidate medication doses.
• Burden of diabetes self-care: Bloodwork for can be delayed by a few months. Patients with  can decrease the frequency of blood glucose checks if their glucose levels are generally within acceptable range. Encourage patients to eat healthily with regular meals rather than optimizing the diet for glucose levels, and adjust medications for any changes in diet. Advise safe options for physical activity such as walking inside the home or walking in place for 10 minutes, three times per day, and incorporating strength training, such as with resistance bands. Online exercise programs are another option.
• Psychological stress: Check in with patients and encourage them to stay as connected as possible using technology (phone, video chat, text message), letters, or cards with family, friends, and/or religious communities. Screen for , using either the Geriatric Depression Scale or Patient Health Questionnaire-2, and refer to mental health colleagues if appropriate. Speak or email with caregivers to assess the patient’s mental health state and offer local support resources, if needed.
• Medication and equipment issues: Refill 90-day prescriptions and equipment, and request mail or home (contactless) delivery. Patients should also have backups in case of equipment failures, such as syringes and long-acting insulin in case of pump failure, and test strips/meter for continuous glucose monitor problems.

Munshi and Sy conclude: “Many of the recommendations presented in this article are practical and will continue to be relevant after COVID-19. When this is all over, patients will remember how we made them feel, and how we kept them safe and healthy at home.”

Munshi is a consultant for Sanofi and Lilly. Sy has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Two experts in geriatric diabetes are offering some contemporary practical recommendations for diabetes management in older adults during the COVID-19 pandemic.  

The viewpoint, entitled, “Caring for Older Adults With Diabetes During the COVID-19 Pandemic,” was published online in JAMA Internal Medicine by Medha N. Munshi, MD, director of the geriatrics program at the Joslin Diabetes Center, Boston, and Sarah L. Sy, MD, a geriatrician in the same program.

Adults aged 70 years and older with comorbidities such as diabetes are among those at highest risk for adverse outcomes and mortality due to COVID-19.

At the same time, those who don’t have the illness face major challenges in avoiding it, including disruptions in normal activities and barriers to receiving health care.

Although telemedicine has become much more widely adopted in diabetes management since the pandemic began, older adults may not be as tech savvy, may not have computer or Internet access, and/or may have cognitive dysfunction that precludes its use.

“These unprecedented times pose a great challenge to this heterogeneous population with varying levels of complexity, frailty, and multimorbidity,” Munshi and Sy point out, noting that “clinicians can lessen the load by guiding, reassuring, and supporting them through this pandemic time.”

Because the pandemic could last for several months longer, the authors offer the following advice for clinicians who care for older adults with diabetes.

• Accessibility to health care: When possible, use telemedicine, diabetes care apps, or platforms to obtain data from glucose meters, continuous glucose monitors, and/or pumps. When use of technology isn’t possible, schedule telephone appointments and have the patient or caregiver read the glucose values.
• Multicomplexity and geriatric syndromes: Identify high-risk patients, such as those with or recurrent , and prioritize patient goals. If appropriate, simplify the diabetes treatment plan and reinforce with repeated education and instructions. Glucose goals may need to be liberalized. Advise patients to stay hydrated to minimize the risk of dehydration and falls. Take steps to avoid hypoglycemia, reduce polypharmacy, and consolidate medication doses.
• Burden of diabetes self-care: Bloodwork for can be delayed by a few months. Patients with  can decrease the frequency of blood glucose checks if their glucose levels are generally within acceptable range. Encourage patients to eat healthily with regular meals rather than optimizing the diet for glucose levels, and adjust medications for any changes in diet. Advise safe options for physical activity such as walking inside the home or walking in place for 10 minutes, three times per day, and incorporating strength training, such as with resistance bands. Online exercise programs are another option.
• Psychological stress: Check in with patients and encourage them to stay as connected as possible using technology (phone, video chat, text message), letters, or cards with family, friends, and/or religious communities. Screen for , using either the Geriatric Depression Scale or Patient Health Questionnaire-2, and refer to mental health colleagues if appropriate. Speak or email with caregivers to assess the patient’s mental health state and offer local support resources, if needed.
• Medication and equipment issues: Refill 90-day prescriptions and equipment, and request mail or home (contactless) delivery. Patients should also have backups in case of equipment failures, such as syringes and long-acting insulin in case of pump failure, and test strips/meter for continuous glucose monitor problems.

Munshi and Sy conclude: “Many of the recommendations presented in this article are practical and will continue to be relevant after COVID-19. When this is all over, patients will remember how we made them feel, and how we kept them safe and healthy at home.”

Munshi is a consultant for Sanofi and Lilly. Sy has reported no relevant financial relationships.

This article first appeared on Medscape.com.

An online, lifestyle-based weight loss initiative known as the Balance After Baby (BAB) program is effective at reducing weight retention a year after birth among women with recent gestational diabetes.

Specifically, results of the study were positive in women of most ethnicities, bar those of a small group of Hispanic origin.

Jacinda Nicklas, MD, from the University of Colorado at Denver, Aurora, presented findings of the BAB trial during the virtual annual scientific sessions of the American Diabetes Association. She was coprincipal investigator alongside Ellen Seely, MD, from Brigham and Women’s Hospital, Boston.

“Looking at the entire population of women on the BAB program, there was a trend in weight loss from 6 weeks postpartum to 12 months (P = .09), and significantly less postpartum weight retention at 12 months (P = .04),” Dr. Nicklas said.

“Through this effect on postpartum weight retention, the BAB program has potential to delay or prevent development of type 2 diabetes in women with recent gestational diabetes, while the web-based, remote nature of the program is scalable and very relevant in current times,” she added. “However, the lack of efficacy in Hispanic women means it needs to be modified to be successful in this ethnic group.”

Frank Qian, MD, who also presented during the same session, said the BAB program has potential as a viable way of preventing both future pregnancy complications and the progression to overt type 2 diabetes in this high-risk population.

“Large-scale epidemiologic studies show us that weight gain from pregnancy is a major risk factor for long-term cardiometabolic risk, particularly for women with a history of gestational diabetes,” he observed. “In turn, it is critical to implement lifestyle interventions that can help women get as close to the weight they were before pregnancy as possible and keep that weight off.”
 

Postpartum weight retention a modifiable risk factor for type 2 diabetes

Current evidence shows that a large proportion of women who develop gestational diabetes go on to develop type 2 diabetes within 10 years and that women with a history of gestational diabetes are more likely to retain or gain weight postpartum.

Dr. Nicklas also pointed out that obesity and weight gain are the strongest modifiable risk factors for type 2 diabetes.

“We know from the Diabetes Prevention Program [DPP] that an intensive lifestyle program in women who had had gestational diabetes led to a 53% reduction in type 2 diabetes,” Dr. Nicklas noted.

However, she added there were barriers to adhering to the intensive DPP program – which required 16 one-on-one meetings in the first 24 weeks – including travel, as some participants lived quite remotely, or family responsibilities. Consequently, Dr. Nicklas and colleagues developed the BAB pilot trial, which involved web-based delivery with remote coaching.

The trial involved women with a history of gestational diabetes who were, on average, 7 weeks postpartum. The key outcome was weight at 12 months, compared with both 6-week postpartum weight and prepregnancy weight.

Based on encouraging results in the pilot trial – in which the intervention group showed significant weight loss from 6-week postpartum weight and in 12-month weight retention – a larger, two-site trial was initiated, the BAB Intervention randomized, controlled trial.

Outcome measures were the same as for the pilot study. The 181 participants were aged 18-45 years, had recent gestational diabetes, and had a mean prepregnancy body mass index of approximately 29 kg/m². Around half were college educated, and 28% were from lower income households. Overall, 48% were white, 22% Asian, 17% African American, and 13% were of other ethnicities, with just over a third being Hispanic.

The initial study visit was at 6 weeks postpartum. Women were randomized to the behavioral intervention website plus a lifestyle coach group or to a control group that consisted of a website plus knowledge links.

The intervention website required women to complete some DPP-derived and bonus modules, and also featured action plans, tracked weight and steps, and had a direct link to contact their lifestyle coach. Follow-up visits were held at 6 and 12 months and A1c, waist circumference, and height/weight were measured. A total of 86% eligible women completed the 6- and 12-month visits.

Why didn’t the BAB program work in Hispanic women?

“The overall result showed that weight change from 6 weeks postpartum to 12 months revealed a slight gain in the control group of 1.3 pounds and a loss in the intervention group of 1.8 pounds, resulting in a between-group difference of 3.1 pounds [P = .09],” reported Dr. Nicklas. Adjustment for gestational weight gain and breastfeeding had no substantial effect.

When 12-month weight retention versus prepregnancy weight was assessed, the former was halved in participants in the BAB program.

The control group gained a mean of 10.1 pounds, and those in the intervention group gained a mean of 5.3 pounds, equivalent to a difference of 4.8 pounds (P = .04).

A prespecified analysis was conducted of 120 non-Hispanic women. At 12 months, weight retention, compared with prepregnancy weight showed an increase of 9 pounds in the control group versus 1.8 pounds in the intervention group (P = .01).

By comparison, in the small group of Hispanic women only, weight retention at 12 months compared to prepregnancy weight showed a 12.7-pound increase and a 13.3-pound increase in the control and intervention groups respectively, reported Dr. Nicklas.

Addressing the key question of why the BAB program was ineffective in Hispanic women, Dr. Nicklas said, “The literature tells us that low income Hispanic women are twice as likely to experience postpartum weight retention compared to white non-Hispanic women. But we also know that low-income Hispanic women generally engage less with interventions, and there is a higher acceptance of overweight among this ethnic group.”

The researchers hope to follow the women from their trial to determine who progresses to type 2 diabetes.

“Hispanic women are a high-risk population for gestational diabetes and type 2 diabetes, and we plan to identify the best options to help Hispanic women with a history of gestational diabetes prevent type 2 diabetes,” Dr. Nicklas said in an interview.

Dr. Qian also remarked on the differences observed in the weight loss outcomes for non-Hispanic versus Hispanic women, noting that it highlights the importance of studying lifestyle interventions in diverse populations. “Environmental and cultural factors that may differ across different racial or ethnic groups could impact the effectiveness of such interventions.

Dr. Nicklas and Dr. Qian have reported no relevant financial relationships.

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

An online, lifestyle-based weight loss initiative known as the Balance After Baby (BAB) program is effective at reducing weight retention a year after birth among women with recent gestational diabetes.

Specifically, results of the study were positive in women of most ethnicities, bar those of a small group of Hispanic origin.

Jacinda Nicklas, MD, from the University of Colorado at Denver, Aurora, presented findings of the BAB trial during the virtual annual scientific sessions of the American Diabetes Association. She was coprincipal investigator alongside Ellen Seely, MD, from Brigham and Women’s Hospital, Boston.

“Looking at the entire population of women on the BAB program, there was a trend in weight loss from 6 weeks postpartum to 12 months (P = .09), and significantly less postpartum weight retention at 12 months (P = .04),” Dr. Nicklas said.

“Through this effect on postpartum weight retention, the BAB program has potential to delay or prevent development of type 2 diabetes in women with recent gestational diabetes, while the web-based, remote nature of the program is scalable and very relevant in current times,” she added. “However, the lack of efficacy in Hispanic women means it needs to be modified to be successful in this ethnic group.”

Frank Qian, MD, who also presented during the same session, said the BAB program has potential as a viable way of preventing both future pregnancy complications and the progression to overt type 2 diabetes in this high-risk population.

“Large-scale epidemiologic studies show us that weight gain from pregnancy is a major risk factor for long-term cardiometabolic risk, particularly for women with a history of gestational diabetes,” he observed. “In turn, it is critical to implement lifestyle interventions that can help women get as close to the weight they were before pregnancy as possible and keep that weight off.”
 

Postpartum weight retention a modifiable risk factor for type 2 diabetes

Current evidence shows that a large proportion of women who develop gestational diabetes go on to develop type 2 diabetes within 10 years and that women with a history of gestational diabetes are more likely to retain or gain weight postpartum.

Dr. Nicklas also pointed out that obesity and weight gain are the strongest modifiable risk factors for type 2 diabetes.

“We know from the Diabetes Prevention Program [DPP] that an intensive lifestyle program in women who had had gestational diabetes led to a 53% reduction in type 2 diabetes,” Dr. Nicklas noted.

However, she added there were barriers to adhering to the intensive DPP program – which required 16 one-on-one meetings in the first 24 weeks – including travel, as some participants lived quite remotely, or family responsibilities. Consequently, Dr. Nicklas and colleagues developed the BAB pilot trial, which involved web-based delivery with remote coaching.

The trial involved women with a history of gestational diabetes who were, on average, 7 weeks postpartum. The key outcome was weight at 12 months, compared with both 6-week postpartum weight and prepregnancy weight.

Based on encouraging results in the pilot trial – in which the intervention group showed significant weight loss from 6-week postpartum weight and in 12-month weight retention – a larger, two-site trial was initiated, the BAB Intervention randomized, controlled trial.

Outcome measures were the same as for the pilot study. The 181 participants were aged 18-45 years, had recent gestational diabetes, and had a mean prepregnancy body mass index of approximately 29 kg/m². Around half were college educated, and 28% were from lower income households. Overall, 48% were white, 22% Asian, 17% African American, and 13% were of other ethnicities, with just over a third being Hispanic.

The initial study visit was at 6 weeks postpartum. Women were randomized to the behavioral intervention website plus a lifestyle coach group or to a control group that consisted of a website plus knowledge links.

The intervention website required women to complete some DPP-derived and bonus modules, and also featured action plans, tracked weight and steps, and had a direct link to contact their lifestyle coach. Follow-up visits were held at 6 and 12 months and A1c, waist circumference, and height/weight were measured. A total of 86% eligible women completed the 6- and 12-month visits.

Why didn’t the BAB program work in Hispanic women?

“The overall result showed that weight change from 6 weeks postpartum to 12 months revealed a slight gain in the control group of 1.3 pounds and a loss in the intervention group of 1.8 pounds, resulting in a between-group difference of 3.1 pounds [P = .09],” reported Dr. Nicklas. Adjustment for gestational weight gain and breastfeeding had no substantial effect.

When 12-month weight retention versus prepregnancy weight was assessed, the former was halved in participants in the BAB program.

The control group gained a mean of 10.1 pounds, and those in the intervention group gained a mean of 5.3 pounds, equivalent to a difference of 4.8 pounds (P = .04).

A prespecified analysis was conducted of 120 non-Hispanic women. At 12 months, weight retention, compared with prepregnancy weight showed an increase of 9 pounds in the control group versus 1.8 pounds in the intervention group (P = .01).

By comparison, in the small group of Hispanic women only, weight retention at 12 months compared to prepregnancy weight showed a 12.7-pound increase and a 13.3-pound increase in the control and intervention groups respectively, reported Dr. Nicklas.

Addressing the key question of why the BAB program was ineffective in Hispanic women, Dr. Nicklas said, “The literature tells us that low income Hispanic women are twice as likely to experience postpartum weight retention compared to white non-Hispanic women. But we also know that low-income Hispanic women generally engage less with interventions, and there is a higher acceptance of overweight among this ethnic group.”

The researchers hope to follow the women from their trial to determine who progresses to type 2 diabetes.

“Hispanic women are a high-risk population for gestational diabetes and type 2 diabetes, and we plan to identify the best options to help Hispanic women with a history of gestational diabetes prevent type 2 diabetes,” Dr. Nicklas said in an interview.

Dr. Qian also remarked on the differences observed in the weight loss outcomes for non-Hispanic versus Hispanic women, noting that it highlights the importance of studying lifestyle interventions in diverse populations. “Environmental and cultural factors that may differ across different racial or ethnic groups could impact the effectiveness of such interventions.

Dr. Nicklas and Dr. Qian have reported no relevant financial relationships.

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

An online, lifestyle-based weight loss initiative known as the Balance After Baby (BAB) program is effective at reducing weight retention a year after birth among women with recent gestational diabetes.

Specifically, results of the study were positive in women of most ethnicities, bar those of a small group of Hispanic origin.

Jacinda Nicklas, MD, from the University of Colorado at Denver, Aurora, presented findings of the BAB trial during the virtual annual scientific sessions of the American Diabetes Association. She was coprincipal investigator alongside Ellen Seely, MD, from Brigham and Women’s Hospital, Boston.

“Looking at the entire population of women on the BAB program, there was a trend in weight loss from 6 weeks postpartum to 12 months (P = .09), and significantly less postpartum weight retention at 12 months (P = .04),” Dr. Nicklas said.

“Through this effect on postpartum weight retention, the BAB program has potential to delay or prevent development of type 2 diabetes in women with recent gestational diabetes, while the web-based, remote nature of the program is scalable and very relevant in current times,” she added. “However, the lack of efficacy in Hispanic women means it needs to be modified to be successful in this ethnic group.”

Frank Qian, MD, who also presented during the same session, said the BAB program has potential as a viable way of preventing both future pregnancy complications and the progression to overt type 2 diabetes in this high-risk population.

“Large-scale epidemiologic studies show us that weight gain from pregnancy is a major risk factor for long-term cardiometabolic risk, particularly for women with a history of gestational diabetes,” he observed. “In turn, it is critical to implement lifestyle interventions that can help women get as close to the weight they were before pregnancy as possible and keep that weight off.”
 

Postpartum weight retention a modifiable risk factor for type 2 diabetes

Current evidence shows that a large proportion of women who develop gestational diabetes go on to develop type 2 diabetes within 10 years and that women with a history of gestational diabetes are more likely to retain or gain weight postpartum.

Dr. Nicklas also pointed out that obesity and weight gain are the strongest modifiable risk factors for type 2 diabetes.

“We know from the Diabetes Prevention Program [DPP] that an intensive lifestyle program in women who had had gestational diabetes led to a 53% reduction in type 2 diabetes,” Dr. Nicklas noted.

However, she added there were barriers to adhering to the intensive DPP program – which required 16 one-on-one meetings in the first 24 weeks – including travel, as some participants lived quite remotely, or family responsibilities. Consequently, Dr. Nicklas and colleagues developed the BAB pilot trial, which involved web-based delivery with remote coaching.

The trial involved women with a history of gestational diabetes who were, on average, 7 weeks postpartum. The key outcome was weight at 12 months, compared with both 6-week postpartum weight and prepregnancy weight.

Based on encouraging results in the pilot trial – in which the intervention group showed significant weight loss from 6-week postpartum weight and in 12-month weight retention – a larger, two-site trial was initiated, the BAB Intervention randomized, controlled trial.

Outcome measures were the same as for the pilot study. The 181 participants were aged 18-45 years, had recent gestational diabetes, and had a mean prepregnancy body mass index of approximately 29 kg/m². Around half were college educated, and 28% were from lower income households. Overall, 48% were white, 22% Asian, 17% African American, and 13% were of other ethnicities, with just over a third being Hispanic.

The initial study visit was at 6 weeks postpartum. Women were randomized to the behavioral intervention website plus a lifestyle coach group or to a control group that consisted of a website plus knowledge links.

The intervention website required women to complete some DPP-derived and bonus modules, and also featured action plans, tracked weight and steps, and had a direct link to contact their lifestyle coach. Follow-up visits were held at 6 and 12 months and A1c, waist circumference, and height/weight were measured. A total of 86% eligible women completed the 6- and 12-month visits.

Why didn’t the BAB program work in Hispanic women?

“The overall result showed that weight change from 6 weeks postpartum to 12 months revealed a slight gain in the control group of 1.3 pounds and a loss in the intervention group of 1.8 pounds, resulting in a between-group difference of 3.1 pounds [P = .09],” reported Dr. Nicklas. Adjustment for gestational weight gain and breastfeeding had no substantial effect.

When 12-month weight retention versus prepregnancy weight was assessed, the former was halved in participants in the BAB program.

The control group gained a mean of 10.1 pounds, and those in the intervention group gained a mean of 5.3 pounds, equivalent to a difference of 4.8 pounds (P = .04).

A prespecified analysis was conducted of 120 non-Hispanic women. At 12 months, weight retention, compared with prepregnancy weight showed an increase of 9 pounds in the control group versus 1.8 pounds in the intervention group (P = .01).

By comparison, in the small group of Hispanic women only, weight retention at 12 months compared to prepregnancy weight showed a 12.7-pound increase and a 13.3-pound increase in the control and intervention groups respectively, reported Dr. Nicklas.

Addressing the key question of why the BAB program was ineffective in Hispanic women, Dr. Nicklas said, “The literature tells us that low income Hispanic women are twice as likely to experience postpartum weight retention compared to white non-Hispanic women. But we also know that low-income Hispanic women generally engage less with interventions, and there is a higher acceptance of overweight among this ethnic group.”

The researchers hope to follow the women from their trial to determine who progresses to type 2 diabetes.

“Hispanic women are a high-risk population for gestational diabetes and type 2 diabetes, and we plan to identify the best options to help Hispanic women with a history of gestational diabetes prevent type 2 diabetes,” Dr. Nicklas said in an interview.

Dr. Qian also remarked on the differences observed in the weight loss outcomes for non-Hispanic versus Hispanic women, noting that it highlights the importance of studying lifestyle interventions in diverse populations. “Environmental and cultural factors that may differ across different racial or ethnic groups could impact the effectiveness of such interventions.

Dr. Nicklas and Dr. Qian have reported no relevant financial relationships.

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

With the COVID-19 pandemic, we are experiencing a once-in-a-100-year event. Dr. Steven A. Schulz, who is serving children on the front line in upstate New York, and I outline some of the challenges primary care pediatricians have been facing and solutions that have succeeded.

Reduction in direct patient care and its consequences

Geber86/E+

Because of the unknowns of COVID-19, many parents have not wanted to bring their children to a medical office because of fear of contracting SARS-CoV-2. At the same time, pediatricians have restricted in-person visits to prevent spread of SARS-CoV-2 and to help flatten the curve of infection. Use of pediatric medical professional services, compared with last year, dropped by 52% in March 2020 and by 58% in April, according to FAIR Health, a nonprofit organization that manages a database of 31 million claims. This is resulting in decreased immunization rates, which increases concern for secondary spikes of other preventable illnesses; for example, data from the Centers for Disease Control and Prevention showed that, from mid-March to mid-April 2020, physicians in the Vaccines for Children program ordered 2.5 million fewer doses of vaccines and 250,000 fewer doses of measles-containing vaccines, compared with the same period in 2019. Fewer children are being seen for well visits, which means opportunities are lost for adequate monitoring of growth, development, physical wellness, and social determinants of health.

This is occurring at a time when families have been experiencing increased stress in terms of finances, social isolation, finding adequate child care, and serving as parent, teacher, and breadwinner. An increase in injuries is occurring because of inadequate parental supervision because many parents have been distracted while working from home. An increase in cases of severe abuse is occurring because schools, child care providers, physicians, and other mandated reporters in the community have decreased interaction with children. Children’s Hospital Colorado in Colorado Springs saw a 118% increase in the number of trauma cases in its ED between January and April 2020. Some of these were accidental injuries caused by falls or bicycle accidents, but there was a 200% increase in nonaccidental trauma, which was associated with a steep fall in calls to the state’s child abuse hotline. Academic gains are being lost, and there has been worry for a prolonged “summer slide” risk, especially for children living in poverty and children with developmental disabilities.

The COVID-19 pandemic also is affecting physicians and staff. As frontline personnel, we are at risk to contract the virus, and news media reminds us of severe illness and deaths among health care workers. The pandemic is affecting financial viability; estimated revenue of pediatric offices fell by 45% in March 2020 and 48% in April, compared with the previous year, according to FAIR Health. Nurses and staff have been furloughed. Practices have had to apply for grants and Paycheck Protection Program funds while extending credit lines.
 

Limited testing capability for SARS-CoV-2

Testing for SARS-CoV-2 has been variably available. There have been problems with false positive and especially false negative results (BMJ. 2020 May 12. doi: 10.1136/bmj.m1808).The best specimen collection method has yet to be determined. Blood testing for antibody has been touted, but it remains unclear if there is clinical benefit because a positive result offers no guarantee of immunity, and immunity may quickly wane. Perhaps widespread primary care office–based testing will be in place by the fall, with hope for future reliable point of care results.

Evolving knowledge regarding SARS-CoV-2 and MIS-C

It initially was thought that children were relatively spared from serious illness caused by COVID-19. Then reports of cases of newly identified multisystem inflammatory syndrome of children occurred. It has been unclear how children contribute to the spread of COVID-19 illness, although emerging evidence indicates it is lower than adult transmission. What will happen when children return to school and daycare in the fall?

The challenges have led to creative solutions for how to deliver care.
 

Adapting to telehealth to provide care

At least for the short term, HIPAA regulations have been relaxed to allow for video visits using platforms such as FaceTime, Skype, Zoom, Doximity, and Doxy.me. Some of these platforms are HIPAA compliant and will be long-term solutions; however, electronic medical record portals allowing for video visits are the more secure option, according to HIPAA.

It has been a learning experience to see what can be accomplished with a video visit. Taking a history and visual examination of injuries and rashes has been possible. Addressing mental health concerns through the video exchange generally has been effective.

However, video visits change the provider-patient interpersonal dynamic and offer only visual exam capabilities, compared with an in-person visit. We cannot look in ears, palpate a liver and spleen, touch and examine a joint or bone, or feel a rash. Video visits also are dependent on the quality of patient Internet access, sufficient data plans, and mutual capabilities to address the inevitable technological glitches on the provider’s end as well. Expanding information technology infrastructure ability and added licensure costs have occurred. Practices and health systems have been working with insurance companies to ensure telephone and video visits are reimbursed on a comparable level to in-office visits.
 

A new type of office visit and developing appropriate safety plans

As understanding of SARS-CoV-2 transmission evolved, office work flows have been modified. Patients must be universally screened prior to arrival during appointment scheduling for well and illness visits. Patients aged older than 2 years and caregivers must wear masks on entering the facility. In many practices, patients are scheduled during specific sick or well visit time slots throughout the day. Waiting rooms chairs need to be spaced for 6-foot social distancing, and cars in the parking lot often serve as waiting rooms until staff can meet patients at the door and take them to the exam room. Alternate entrances, car-side exams, and drive-by and/or tent testing facilities often have become part of the new normal everyday practice. Creating virtual visit time blocks in provider’s schedules has allowed for decreased office congestion. Patients often are checked out from their room, as opposed to waiting in a line at a check out desk. Nurse triage protocols also have been adapted and enhanced to meet needs and concerns.

With the need for summer physicals and many regions opening up, a gradual return toward baseline has been evolving, although some of the twists of a “new normal” will stay in place. The new normal has been for providers and staff to wear surgical masks and face shields; sometimes N95 masks, gloves, and gowns have been needed. Cleaning rooms and equipment between patient visits has become a major, new time-consuming task. Acquiring and maintaining adequate supplies has been a challenge.
 

Summary

The American Academy of Pediatrics, CDC, and state and local health departments have been providing informative and regular updates, webinars, and best practices guidelines. Pediatricians, community organizations, schools, and mental health professionals have been collaborating, overcoming hurdles, and working together to help mitigate the effects of the pandemic on children, their families, and our communities. Continued education, cooperation, and adaptation will be needed in the months ahead. If there is a silver lining to this pandemic experience, it may be that families have grown closer together as they sheltered in place (and we have grown closer to our own families as well). One day perhaps a child who lived through this pandemic might be asked what it was like, and their recollection might be that it was a wonderful time because their parents stayed home all the time, took care of them, taught them their school work, and took lots of long family walks.

Dr. Schulz is pediatric medical director, Rochester (N.Y.) Regional Health. Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz and Dr. Pichichero said they have no relevant financial disclosures. Email them at pdnews@mdedge.com.

This article was updated 7/16/2020.

With the COVID-19 pandemic, we are experiencing a once-in-a-100-year event. Dr. Steven A. Schulz, who is serving children on the front line in upstate New York, and I outline some of the challenges primary care pediatricians have been facing and solutions that have succeeded.

Reduction in direct patient care and its consequences

Geber86/E+

Because of the unknowns of COVID-19, many parents have not wanted to bring their children to a medical office because of fear of contracting SARS-CoV-2. At the same time, pediatricians have restricted in-person visits to prevent spread of SARS-CoV-2 and to help flatten the curve of infection. Use of pediatric medical professional services, compared with last year, dropped by 52% in March 2020 and by 58% in April, according to FAIR Health, a nonprofit organization that manages a database of 31 million claims. This is resulting in decreased immunization rates, which increases concern for secondary spikes of other preventable illnesses; for example, data from the Centers for Disease Control and Prevention showed that, from mid-March to mid-April 2020, physicians in the Vaccines for Children program ordered 2.5 million fewer doses of vaccines and 250,000 fewer doses of measles-containing vaccines, compared with the same period in 2019. Fewer children are being seen for well visits, which means opportunities are lost for adequate monitoring of growth, development, physical wellness, and social determinants of health.

This is occurring at a time when families have been experiencing increased stress in terms of finances, social isolation, finding adequate child care, and serving as parent, teacher, and breadwinner. An increase in injuries is occurring because of inadequate parental supervision because many parents have been distracted while working from home. An increase in cases of severe abuse is occurring because schools, child care providers, physicians, and other mandated reporters in the community have decreased interaction with children. Children’s Hospital Colorado in Colorado Springs saw a 118% increase in the number of trauma cases in its ED between January and April 2020. Some of these were accidental injuries caused by falls or bicycle accidents, but there was a 200% increase in nonaccidental trauma, which was associated with a steep fall in calls to the state’s child abuse hotline. Academic gains are being lost, and there has been worry for a prolonged “summer slide” risk, especially for children living in poverty and children with developmental disabilities.

The COVID-19 pandemic also is affecting physicians and staff. As frontline personnel, we are at risk to contract the virus, and news media reminds us of severe illness and deaths among health care workers. The pandemic is affecting financial viability; estimated revenue of pediatric offices fell by 45% in March 2020 and 48% in April, compared with the previous year, according to FAIR Health. Nurses and staff have been furloughed. Practices have had to apply for grants and Paycheck Protection Program funds while extending credit lines.
 

Limited testing capability for SARS-CoV-2

Testing for SARS-CoV-2 has been variably available. There have been problems with false positive and especially false negative results (BMJ. 2020 May 12. doi: 10.1136/bmj.m1808).The best specimen collection method has yet to be determined. Blood testing for antibody has been touted, but it remains unclear if there is clinical benefit because a positive result offers no guarantee of immunity, and immunity may quickly wane. Perhaps widespread primary care office–based testing will be in place by the fall, with hope for future reliable point of care results.

Evolving knowledge regarding SARS-CoV-2 and MIS-C

It initially was thought that children were relatively spared from serious illness caused by COVID-19. Then reports of cases of newly identified multisystem inflammatory syndrome of children occurred. It has been unclear how children contribute to the spread of COVID-19 illness, although emerging evidence indicates it is lower than adult transmission. What will happen when children return to school and daycare in the fall?

The challenges have led to creative solutions for how to deliver care.
 

Adapting to telehealth to provide care

At least for the short term, HIPAA regulations have been relaxed to allow for video visits using platforms such as FaceTime, Skype, Zoom, Doximity, and Doxy.me. Some of these platforms are HIPAA compliant and will be long-term solutions; however, electronic medical record portals allowing for video visits are the more secure option, according to HIPAA.

It has been a learning experience to see what can be accomplished with a video visit. Taking a history and visual examination of injuries and rashes has been possible. Addressing mental health concerns through the video exchange generally has been effective.

However, video visits change the provider-patient interpersonal dynamic and offer only visual exam capabilities, compared with an in-person visit. We cannot look in ears, palpate a liver and spleen, touch and examine a joint or bone, or feel a rash. Video visits also are dependent on the quality of patient Internet access, sufficient data plans, and mutual capabilities to address the inevitable technological glitches on the provider’s end as well. Expanding information technology infrastructure ability and added licensure costs have occurred. Practices and health systems have been working with insurance companies to ensure telephone and video visits are reimbursed on a comparable level to in-office visits.
 

A new type of office visit and developing appropriate safety plans

As understanding of SARS-CoV-2 transmission evolved, office work flows have been modified. Patients must be universally screened prior to arrival during appointment scheduling for well and illness visits. Patients aged older than 2 years and caregivers must wear masks on entering the facility. In many practices, patients are scheduled during specific sick or well visit time slots throughout the day. Waiting rooms chairs need to be spaced for 6-foot social distancing, and cars in the parking lot often serve as waiting rooms until staff can meet patients at the door and take them to the exam room. Alternate entrances, car-side exams, and drive-by and/or tent testing facilities often have become part of the new normal everyday practice. Creating virtual visit time blocks in provider’s schedules has allowed for decreased office congestion. Patients often are checked out from their room, as opposed to waiting in a line at a check out desk. Nurse triage protocols also have been adapted and enhanced to meet needs and concerns.

With the need for summer physicals and many regions opening up, a gradual return toward baseline has been evolving, although some of the twists of a “new normal” will stay in place. The new normal has been for providers and staff to wear surgical masks and face shields; sometimes N95 masks, gloves, and gowns have been needed. Cleaning rooms and equipment between patient visits has become a major, new time-consuming task. Acquiring and maintaining adequate supplies has been a challenge.
 

Summary

The American Academy of Pediatrics, CDC, and state and local health departments have been providing informative and regular updates, webinars, and best practices guidelines. Pediatricians, community organizations, schools, and mental health professionals have been collaborating, overcoming hurdles, and working together to help mitigate the effects of the pandemic on children, their families, and our communities. Continued education, cooperation, and adaptation will be needed in the months ahead. If there is a silver lining to this pandemic experience, it may be that families have grown closer together as they sheltered in place (and we have grown closer to our own families as well). One day perhaps a child who lived through this pandemic might be asked what it was like, and their recollection might be that it was a wonderful time because their parents stayed home all the time, took care of them, taught them their school work, and took lots of long family walks.

Dr. Schulz is pediatric medical director, Rochester (N.Y.) Regional Health. Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz and Dr. Pichichero said they have no relevant financial disclosures. Email them at pdnews@mdedge.com.

This article was updated 7/16/2020.

With the COVID-19 pandemic, we are experiencing a once-in-a-100-year event. Dr. Steven A. Schulz, who is serving children on the front line in upstate New York, and I outline some of the challenges primary care pediatricians have been facing and solutions that have succeeded.

Reduction in direct patient care and its consequences

Geber86/E+

Because of the unknowns of COVID-19, many parents have not wanted to bring their children to a medical office because of fear of contracting SARS-CoV-2. At the same time, pediatricians have restricted in-person visits to prevent spread of SARS-CoV-2 and to help flatten the curve of infection. Use of pediatric medical professional services, compared with last year, dropped by 52% in March 2020 and by 58% in April, according to FAIR Health, a nonprofit organization that manages a database of 31 million claims. This is resulting in decreased immunization rates, which increases concern for secondary spikes of other preventable illnesses; for example, data from the Centers for Disease Control and Prevention showed that, from mid-March to mid-April 2020, physicians in the Vaccines for Children program ordered 2.5 million fewer doses of vaccines and 250,000 fewer doses of measles-containing vaccines, compared with the same period in 2019. Fewer children are being seen for well visits, which means opportunities are lost for adequate monitoring of growth, development, physical wellness, and social determinants of health.

This is occurring at a time when families have been experiencing increased stress in terms of finances, social isolation, finding adequate child care, and serving as parent, teacher, and breadwinner. An increase in injuries is occurring because of inadequate parental supervision because many parents have been distracted while working from home. An increase in cases of severe abuse is occurring because schools, child care providers, physicians, and other mandated reporters in the community have decreased interaction with children. Children’s Hospital Colorado in Colorado Springs saw a 118% increase in the number of trauma cases in its ED between January and April 2020. Some of these were accidental injuries caused by falls or bicycle accidents, but there was a 200% increase in nonaccidental trauma, which was associated with a steep fall in calls to the state’s child abuse hotline. Academic gains are being lost, and there has been worry for a prolonged “summer slide” risk, especially for children living in poverty and children with developmental disabilities.

The COVID-19 pandemic also is affecting physicians and staff. As frontline personnel, we are at risk to contract the virus, and news media reminds us of severe illness and deaths among health care workers. The pandemic is affecting financial viability; estimated revenue of pediatric offices fell by 45% in March 2020 and 48% in April, compared with the previous year, according to FAIR Health. Nurses and staff have been furloughed. Practices have had to apply for grants and Paycheck Protection Program funds while extending credit lines.
 

Limited testing capability for SARS-CoV-2

Testing for SARS-CoV-2 has been variably available. There have been problems with false positive and especially false negative results (BMJ. 2020 May 12. doi: 10.1136/bmj.m1808).The best specimen collection method has yet to be determined. Blood testing for antibody has been touted, but it remains unclear if there is clinical benefit because a positive result offers no guarantee of immunity, and immunity may quickly wane. Perhaps widespread primary care office–based testing will be in place by the fall, with hope for future reliable point of care results.

Evolving knowledge regarding SARS-CoV-2 and MIS-C

It initially was thought that children were relatively spared from serious illness caused by COVID-19. Then reports of cases of newly identified multisystem inflammatory syndrome of children occurred. It has been unclear how children contribute to the spread of COVID-19 illness, although emerging evidence indicates it is lower than adult transmission. What will happen when children return to school and daycare in the fall?

The challenges have led to creative solutions for how to deliver care.
 

Adapting to telehealth to provide care

At least for the short term, HIPAA regulations have been relaxed to allow for video visits using platforms such as FaceTime, Skype, Zoom, Doximity, and Doxy.me. Some of these platforms are HIPAA compliant and will be long-term solutions; however, electronic medical record portals allowing for video visits are the more secure option, according to HIPAA.

It has been a learning experience to see what can be accomplished with a video visit. Taking a history and visual examination of injuries and rashes has been possible. Addressing mental health concerns through the video exchange generally has been effective.

However, video visits change the provider-patient interpersonal dynamic and offer only visual exam capabilities, compared with an in-person visit. We cannot look in ears, palpate a liver and spleen, touch and examine a joint or bone, or feel a rash. Video visits also are dependent on the quality of patient Internet access, sufficient data plans, and mutual capabilities to address the inevitable technological glitches on the provider’s end as well. Expanding information technology infrastructure ability and added licensure costs have occurred. Practices and health systems have been working with insurance companies to ensure telephone and video visits are reimbursed on a comparable level to in-office visits.
 

A new type of office visit and developing appropriate safety plans

As understanding of SARS-CoV-2 transmission evolved, office work flows have been modified. Patients must be universally screened prior to arrival during appointment scheduling for well and illness visits. Patients aged older than 2 years and caregivers must wear masks on entering the facility. In many practices, patients are scheduled during specific sick or well visit time slots throughout the day. Waiting rooms chairs need to be spaced for 6-foot social distancing, and cars in the parking lot often serve as waiting rooms until staff can meet patients at the door and take them to the exam room. Alternate entrances, car-side exams, and drive-by and/or tent testing facilities often have become part of the new normal everyday practice. Creating virtual visit time blocks in provider’s schedules has allowed for decreased office congestion. Patients often are checked out from their room, as opposed to waiting in a line at a check out desk. Nurse triage protocols also have been adapted and enhanced to meet needs and concerns.

With the need for summer physicals and many regions opening up, a gradual return toward baseline has been evolving, although some of the twists of a “new normal” will stay in place. The new normal has been for providers and staff to wear surgical masks and face shields; sometimes N95 masks, gloves, and gowns have been needed. Cleaning rooms and equipment between patient visits has become a major, new time-consuming task. Acquiring and maintaining adequate supplies has been a challenge.
 

Summary

The American Academy of Pediatrics, CDC, and state and local health departments have been providing informative and regular updates, webinars, and best practices guidelines. Pediatricians, community organizations, schools, and mental health professionals have been collaborating, overcoming hurdles, and working together to help mitigate the effects of the pandemic on children, their families, and our communities. Continued education, cooperation, and adaptation will be needed in the months ahead. If there is a silver lining to this pandemic experience, it may be that families have grown closer together as they sheltered in place (and we have grown closer to our own families as well). One day perhaps a child who lived through this pandemic might be asked what it was like, and their recollection might be that it was a wonderful time because their parents stayed home all the time, took care of them, taught them their school work, and took lots of long family walks.

Dr. Schulz is pediatric medical director, Rochester (N.Y.) Regional Health. Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz and Dr. Pichichero said they have no relevant financial disclosures. Email them at pdnews@mdedge.com.

This article was updated 7/16/2020.

As the Food and Drug Administration focuses on other issues, companies, both big and small, are looking to boost physician and consumer interest in their “medical foods” – products that fall somewhere between drugs and supplements and promise to mitigate symptoms, or even address underlying pathologies, of a range of diseases.

Manufacturers now market an array of medical foods, ranging from powders and capsules for Alzheimer disease to low-protein spaghetti for chronic kidney disease (CKD). The FDA has not been completely absent; it takes a narrow view of what medical conditions qualify for treatment with food products and has warned some manufacturers that their misbranded products are acting more like unapproved drugs.

By the FDA’s definition, medical food is limited to products that provide crucial therapy for patients with inborn errors of metabolism (IEM). An example is specialized baby formula for infants with phenylketonuria. Unlike supplements, medical foods are supposed to be used under the supervision of a physician. This has prompted some sales reps to turn up in the clinic, and most manufacturers have online approval forms for doctors to sign. Manufacturers, advisers, and regulators were interviewed for a closer look at this burgeoning industry.
 

The market

The global market for medical foods – about $18 billion in 2019 – is expected to grow steadily in the near future. It is drawing more interest, especially in Europe, where medical foods are more accepted by physicians and consumers, Meghan Donnelly, MS, RDN, said in an interview. She is a registered dietitian who conducts physician outreach in the United States for Flavis, a division of Dr. Schär. That company, based in northern Italy, started out targeting IEMs but now also sells gluten-free foods for celiac disease and low-protein foods for CKD.

It is still a niche market in the United States – and isn’t likely to ever approach the size of the supplement market, according to Marcus Charuvastra, the managing director of Targeted Medical Pharma, which markets Theramine capsules for pain management, among many other products. But it could still be a big win for a manufacturer if they get a small slice of a big market, such as for Alzheimer disease.
 

Defining medical food

According to an update of the Orphan Drug Act in 1988, a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The FDA issued regulations to accompany that law in 1993 but has since only issued a guidance document that is not legally binding.

Medical foods are not drugs and they are not supplements (the latter are intended only for healthy people). The FDA doesn’t require formal approval of a medical food, but, by law, the ingredients must be generally recognized as safe, and manufacturers must follow good manufacturing practices. However, the agency has taken a narrow view of what conditions require medical foods.

Policing medical foods hasn’t been a priority for the FDA, which is why there has been a proliferation of products that don’t meet the FDA’s view of the statutory definition of medical foods, according to Miriam Guggenheim, a food and drug law attorney in Washington, D.C. The FDA usually takes enforcement action when it sees a risk to the public’s health.

The agency’s stance has led to confusion – among manufacturers, physicians, consumers, and even regulators – making the market a kind of Wild West, according to Paul Hyman, a Washington, D.C.–based attorney who has represented medical food companies.

George A. Burdock, PhD, an Orlando-based regulatory consultant who has worked with medical food makers, believes the FDA will be forced to expand their narrow definition. He foresees a reconsideration of many medical food products in light of an October 2019 White House executive order prohibiting federal agencies from issuing guidance in lieu of rules.
 

Manufacturers and the FDA differ

One example of a product about which regulators and manufacturers differ is Theramine, which is described as “specially designed to supply the nervous system with the fuel it needs to meet the altered metabolic requirements of chronic pain and inflammatory disorders.”

It is not considered a medical food by the FDA, and the company has had numerous discussions with the agency about their diverging views, according to Mr. Charuvastra. “We’ve had our warning letters and we’ve had our sit downs, and we just had an inspection.”

Targeted Medical Pharma continues to market its products as medical foods but steers away from making any claims that they are like drugs, he said.

Confusion about medical foods has been exposed in the California Workers’ Compensation System by Leslie Wilson, PhD, and colleagues at the University of California, San Francisco. They found that physicians regularly wrote medical food prescriptions for non–FDA-approved uses and that the system reimbursed the majority of the products at a cost of $15.5 million from 2011 to 2013. More than half of these prescriptions were for Theramine.

Dr. Wilson reported that, for most products, no evidence supported effectiveness, and they were frequently mislabeled – for all 36 that were studied, submissions for reimbursement were made using a National Drug Code, an impossibility because medical foods are not drugs, and 14 were labeled “Rx only.”
 

Big-name companies joining in

The FDA does not keep a list of approved medical foods or manufacturers. Both small businesses and big food companies like Danone, Nestlé, and Abbott are players. Most products are sold online.

In the United States, Danone’s Nutricia division sells formulas and low-protein foods for IEMs. They also sell Ketocal, a powder or ready-to-drink liquid that is pitched as a balanced medical food to simplify and optimize the ketogenic diet for children with intractable epilepsy. Yet the FDA does not include epilepsy among the conditions that medical foods can treat.

Nestlé sells traditional medical foods for IEMs and also markets a range of what it calls nutritional therapies for such conditions as irritable bowel syndrome and dysphagia.

Nestlé is a minority shareholder in Axona, a product originally developed by Accera (Cerecin as of 2018). Jacquelyn Campo, senior director of global communications at Nestlé Health Sciences, said that the company is not actively involved in the operations management of Cerecin. However, on its website, Nestlé touts Axona, which is only available in the United States, as a “medical food” that “is intended for the clinical dietary management of mild to moderate Alzheimer disease.” The Axona site claims that the main ingredient, caprylic triglyceride, is broken down into ketones that provide fuel to treat cerebral hypometabolism, a precursor to Alzheimer disease. In a 2009 study, daily dosing of a preliminary formulation was associated with improved cognitive performance compared with placebo in patients with mild to moderate Alzheimer disease.

In 2013, the FDA warned Accera that it was misbranding Axona as a medical food and that the therapeutic claims the company was making would make the product an unapproved drug. Ms. Campo said Nestlé is aware of the agency’s warning, but added, “to our knowledge, Cerecin provided answers to the issues raised by the FDA.”

With the goal of getting drug approval, Accera went on to test a tweaked formulation in a 400-patient randomized, placebo-controlled trial called NOURISH AD that ultimately failed. Nevertheless, Axona is still marketed as a medical food. It costs about $100 for a month’s supply.

Repeated requests for comment from Cerecin were not answered. Danielle Schor, an FDA spokesperson, said the agency will not discuss the status of individual products.
 

More disputes and insurance coverage

Mary Ann DeMarco, executive director of sales and marketing for the Scottsdale, Ariz.–based medical food maker Primus Pharmaceuticals, said the company believes its products fit within the FDA’s medical foods rubric.

These include Fosteum Plus capsules, which it markets “for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.” The capsules contain a combination of genistein, zinc, calcium, phosphate, vitamin K2, and vitamin D. As proof of effectiveness, the company cites clinical data on some of the ingredients – not the product itself.

Primus has run afoul of the FDA before when it similarly positioned another product, called Limbrel, as a medical food for osteoarthritis. From 2007 to 2017, the FDA received 194 adverse event reports associated with Limbrel, including reports of drug-induced liver injury, pancreatitis, and hypersensitivity pneumonitis. In December 2017, the agency urged Primus to recall Limbrel, a move that it said was “necessary to protect the public health and welfare.” Primus withdrew the product but laid out a defense of Limbrel on a devoted website.

The FDA would not comment any further, said Ms. Schor. Ms. DeMarco said that Primus is working with the FDA to bring Limbrel back to market.

A lack of insurance coverage – even for approved medical foods for IEMs – has frustrated advocates, parents, and manufacturers. They are putting their weight behind the Medical Nutrition Equity Act, which would mandate public and private payer coverage of medical foods for IEMs and digestive conditions such as Crohn disease. That 2019 House bill has 56 cosponsors; there is no Senate companion bill.

“If you can get reimbursement, it really makes the market,” for Primus and the other manufacturers, Mr. Hyman said.

Primus Pharmaceuticals has launched its own campaign, Cover My Medical Foods, to enlist consumers and others to the cause.
 

Partnering with advocates

Although its low-protein breads, pastas, and baking products are not considered medical foods by the FDA, Dr. Schär is marketing them as such in the United States. They are trying to make a mark in CKD, according to Ms. Donnelly. She added that Dr. Schär has been successful in Europe, where nutrition therapy is more integrated in the health care system.

In 2019, Flavis and the National Kidney Foundation joined forces to raise awareness of nutritional interventions and to build enthusiasm for the Flavis products. The partnership has now ended, mostly because Flavis could no longer afford it, according to Ms. Donnelly.

“Information on diet and nutrition is the most requested subject matter from the NKF,” said Anthony Gucciardo, senior vice president of strategic partnerships at the foundation. The partnership “has never been necessarily about promoting their products per se; it’s promoting a healthy diet and really a diet specific for CKD.”

The NKF developed cobranded materials on low-protein foods for physicians and a teaching tool they could use with patients. Consumers could access nutrition information and a discount on Flavis products on a dedicated webpage. The foundation didn’t describe the low-protein products as medical foods, said Mr. Gucciardo, even if Flavis promoted them as such.

In patients with CKD, dietary management can help prevent the progression to end-stage renal disease. Although Medicare covers medical nutrition therapy – in which patients receive personalized assessments and dietary advice – uptake is abysmally low, according to a 2018 study.

Dr. Burdock thinks low-protein foods for CKD do meet the FDA’s criteria for a medical food but that the agency might not necessarily agree with him. The FDA would not comment.
 

Physician beware

When it comes to medical foods, the FDA has often looked the other way because the ingredients may already have been proven safe and the danger to an individual or to the public’s health is relatively low, according to Dr. Burdock and Mr. Hyman.

However, if the agency “feels that a medical food will prevent people from seeking medical care or there is potential to defraud the public, it is justified in taking action against the company,” said Dr. Burdock.

According to Dr. Wilson, the pharmacist who reported on the inappropriate medical food prescriptions in the California system, the FDA could help by creating a list of approved medical foods. Physicians should take time to learn about the difference between medical foods and supplements, she said, adding that they should also not hesitate to “question the veracity of the claims for them.”

Ms. Guggenheim believed doctors need to know that, for the most part, these are not FDA-approved products. She emphasized the importance of evaluating the products and looking at the data of their impact on a disease or condition.

“Many of these companies strongly believe that the products work and help people, so clinicians need to be very data driven,” she said.

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

As the Food and Drug Administration focuses on other issues, companies, both big and small, are looking to boost physician and consumer interest in their “medical foods” – products that fall somewhere between drugs and supplements and promise to mitigate symptoms, or even address underlying pathologies, of a range of diseases.

Manufacturers now market an array of medical foods, ranging from powders and capsules for Alzheimer disease to low-protein spaghetti for chronic kidney disease (CKD). The FDA has not been completely absent; it takes a narrow view of what medical conditions qualify for treatment with food products and has warned some manufacturers that their misbranded products are acting more like unapproved drugs.

By the FDA’s definition, medical food is limited to products that provide crucial therapy for patients with inborn errors of metabolism (IEM). An example is specialized baby formula for infants with phenylketonuria. Unlike supplements, medical foods are supposed to be used under the supervision of a physician. This has prompted some sales reps to turn up in the clinic, and most manufacturers have online approval forms for doctors to sign. Manufacturers, advisers, and regulators were interviewed for a closer look at this burgeoning industry.
 

The market

The global market for medical foods – about $18 billion in 2019 – is expected to grow steadily in the near future. It is drawing more interest, especially in Europe, where medical foods are more accepted by physicians and consumers, Meghan Donnelly, MS, RDN, said in an interview. She is a registered dietitian who conducts physician outreach in the United States for Flavis, a division of Dr. Schär. That company, based in northern Italy, started out targeting IEMs but now also sells gluten-free foods for celiac disease and low-protein foods for CKD.

It is still a niche market in the United States – and isn’t likely to ever approach the size of the supplement market, according to Marcus Charuvastra, the managing director of Targeted Medical Pharma, which markets Theramine capsules for pain management, among many other products. But it could still be a big win for a manufacturer if they get a small slice of a big market, such as for Alzheimer disease.
 

Defining medical food

According to an update of the Orphan Drug Act in 1988, a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The FDA issued regulations to accompany that law in 1993 but has since only issued a guidance document that is not legally binding.

Medical foods are not drugs and they are not supplements (the latter are intended only for healthy people). The FDA doesn’t require formal approval of a medical food, but, by law, the ingredients must be generally recognized as safe, and manufacturers must follow good manufacturing practices. However, the agency has taken a narrow view of what conditions require medical foods.

Policing medical foods hasn’t been a priority for the FDA, which is why there has been a proliferation of products that don’t meet the FDA’s view of the statutory definition of medical foods, according to Miriam Guggenheim, a food and drug law attorney in Washington, D.C. The FDA usually takes enforcement action when it sees a risk to the public’s health.

The agency’s stance has led to confusion – among manufacturers, physicians, consumers, and even regulators – making the market a kind of Wild West, according to Paul Hyman, a Washington, D.C.–based attorney who has represented medical food companies.

George A. Burdock, PhD, an Orlando-based regulatory consultant who has worked with medical food makers, believes the FDA will be forced to expand their narrow definition. He foresees a reconsideration of many medical food products in light of an October 2019 White House executive order prohibiting federal agencies from issuing guidance in lieu of rules.
 

Manufacturers and the FDA differ

One example of a product about which regulators and manufacturers differ is Theramine, which is described as “specially designed to supply the nervous system with the fuel it needs to meet the altered metabolic requirements of chronic pain and inflammatory disorders.”

It is not considered a medical food by the FDA, and the company has had numerous discussions with the agency about their diverging views, according to Mr. Charuvastra. “We’ve had our warning letters and we’ve had our sit downs, and we just had an inspection.”

Targeted Medical Pharma continues to market its products as medical foods but steers away from making any claims that they are like drugs, he said.

Confusion about medical foods has been exposed in the California Workers’ Compensation System by Leslie Wilson, PhD, and colleagues at the University of California, San Francisco. They found that physicians regularly wrote medical food prescriptions for non–FDA-approved uses and that the system reimbursed the majority of the products at a cost of $15.5 million from 2011 to 2013. More than half of these prescriptions were for Theramine.

Dr. Wilson reported that, for most products, no evidence supported effectiveness, and they were frequently mislabeled – for all 36 that were studied, submissions for reimbursement were made using a National Drug Code, an impossibility because medical foods are not drugs, and 14 were labeled “Rx only.”
 

Big-name companies joining in

The FDA does not keep a list of approved medical foods or manufacturers. Both small businesses and big food companies like Danone, Nestlé, and Abbott are players. Most products are sold online.

In the United States, Danone’s Nutricia division sells formulas and low-protein foods for IEMs. They also sell Ketocal, a powder or ready-to-drink liquid that is pitched as a balanced medical food to simplify and optimize the ketogenic diet for children with intractable epilepsy. Yet the FDA does not include epilepsy among the conditions that medical foods can treat.

Nestlé sells traditional medical foods for IEMs and also markets a range of what it calls nutritional therapies for such conditions as irritable bowel syndrome and dysphagia.

Nestlé is a minority shareholder in Axona, a product originally developed by Accera (Cerecin as of 2018). Jacquelyn Campo, senior director of global communications at Nestlé Health Sciences, said that the company is not actively involved in the operations management of Cerecin. However, on its website, Nestlé touts Axona, which is only available in the United States, as a “medical food” that “is intended for the clinical dietary management of mild to moderate Alzheimer disease.” The Axona site claims that the main ingredient, caprylic triglyceride, is broken down into ketones that provide fuel to treat cerebral hypometabolism, a precursor to Alzheimer disease. In a 2009 study, daily dosing of a preliminary formulation was associated with improved cognitive performance compared with placebo in patients with mild to moderate Alzheimer disease.

In 2013, the FDA warned Accera that it was misbranding Axona as a medical food and that the therapeutic claims the company was making would make the product an unapproved drug. Ms. Campo said Nestlé is aware of the agency’s warning, but added, “to our knowledge, Cerecin provided answers to the issues raised by the FDA.”

With the goal of getting drug approval, Accera went on to test a tweaked formulation in a 400-patient randomized, placebo-controlled trial called NOURISH AD that ultimately failed. Nevertheless, Axona is still marketed as a medical food. It costs about $100 for a month’s supply.

Repeated requests for comment from Cerecin were not answered. Danielle Schor, an FDA spokesperson, said the agency will not discuss the status of individual products.
 

More disputes and insurance coverage

Mary Ann DeMarco, executive director of sales and marketing for the Scottsdale, Ariz.–based medical food maker Primus Pharmaceuticals, said the company believes its products fit within the FDA’s medical foods rubric.

These include Fosteum Plus capsules, which it markets “for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.” The capsules contain a combination of genistein, zinc, calcium, phosphate, vitamin K2, and vitamin D. As proof of effectiveness, the company cites clinical data on some of the ingredients – not the product itself.

Primus has run afoul of the FDA before when it similarly positioned another product, called Limbrel, as a medical food for osteoarthritis. From 2007 to 2017, the FDA received 194 adverse event reports associated with Limbrel, including reports of drug-induced liver injury, pancreatitis, and hypersensitivity pneumonitis. In December 2017, the agency urged Primus to recall Limbrel, a move that it said was “necessary to protect the public health and welfare.” Primus withdrew the product but laid out a defense of Limbrel on a devoted website.

The FDA would not comment any further, said Ms. Schor. Ms. DeMarco said that Primus is working with the FDA to bring Limbrel back to market.

A lack of insurance coverage – even for approved medical foods for IEMs – has frustrated advocates, parents, and manufacturers. They are putting their weight behind the Medical Nutrition Equity Act, which would mandate public and private payer coverage of medical foods for IEMs and digestive conditions such as Crohn disease. That 2019 House bill has 56 cosponsors; there is no Senate companion bill.

“If you can get reimbursement, it really makes the market,” for Primus and the other manufacturers, Mr. Hyman said.

Primus Pharmaceuticals has launched its own campaign, Cover My Medical Foods, to enlist consumers and others to the cause.
 

Partnering with advocates

Although its low-protein breads, pastas, and baking products are not considered medical foods by the FDA, Dr. Schär is marketing them as such in the United States. They are trying to make a mark in CKD, according to Ms. Donnelly. She added that Dr. Schär has been successful in Europe, where nutrition therapy is more integrated in the health care system.

In 2019, Flavis and the National Kidney Foundation joined forces to raise awareness of nutritional interventions and to build enthusiasm for the Flavis products. The partnership has now ended, mostly because Flavis could no longer afford it, according to Ms. Donnelly.

“Information on diet and nutrition is the most requested subject matter from the NKF,” said Anthony Gucciardo, senior vice president of strategic partnerships at the foundation. The partnership “has never been necessarily about promoting their products per se; it’s promoting a healthy diet and really a diet specific for CKD.”

The NKF developed cobranded materials on low-protein foods for physicians and a teaching tool they could use with patients. Consumers could access nutrition information and a discount on Flavis products on a dedicated webpage. The foundation didn’t describe the low-protein products as medical foods, said Mr. Gucciardo, even if Flavis promoted them as such.

In patients with CKD, dietary management can help prevent the progression to end-stage renal disease. Although Medicare covers medical nutrition therapy – in which patients receive personalized assessments and dietary advice – uptake is abysmally low, according to a 2018 study.

Dr. Burdock thinks low-protein foods for CKD do meet the FDA’s criteria for a medical food but that the agency might not necessarily agree with him. The FDA would not comment.
 

Physician beware

When it comes to medical foods, the FDA has often looked the other way because the ingredients may already have been proven safe and the danger to an individual or to the public’s health is relatively low, according to Dr. Burdock and Mr. Hyman.

However, if the agency “feels that a medical food will prevent people from seeking medical care or there is potential to defraud the public, it is justified in taking action against the company,” said Dr. Burdock.

According to Dr. Wilson, the pharmacist who reported on the inappropriate medical food prescriptions in the California system, the FDA could help by creating a list of approved medical foods. Physicians should take time to learn about the difference between medical foods and supplements, she said, adding that they should also not hesitate to “question the veracity of the claims for them.”

Ms. Guggenheim believed doctors need to know that, for the most part, these are not FDA-approved products. She emphasized the importance of evaluating the products and looking at the data of their impact on a disease or condition.

“Many of these companies strongly believe that the products work and help people, so clinicians need to be very data driven,” she said.

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

As the Food and Drug Administration focuses on other issues, companies, both big and small, are looking to boost physician and consumer interest in their “medical foods” – products that fall somewhere between drugs and supplements and promise to mitigate symptoms, or even address underlying pathologies, of a range of diseases.

Manufacturers now market an array of medical foods, ranging from powders and capsules for Alzheimer disease to low-protein spaghetti for chronic kidney disease (CKD). The FDA has not been completely absent; it takes a narrow view of what medical conditions qualify for treatment with food products and has warned some manufacturers that their misbranded products are acting more like unapproved drugs.

By the FDA’s definition, medical food is limited to products that provide crucial therapy for patients with inborn errors of metabolism (IEM). An example is specialized baby formula for infants with phenylketonuria. Unlike supplements, medical foods are supposed to be used under the supervision of a physician. This has prompted some sales reps to turn up in the clinic, and most manufacturers have online approval forms for doctors to sign. Manufacturers, advisers, and regulators were interviewed for a closer look at this burgeoning industry.
 

The market

The global market for medical foods – about $18 billion in 2019 – is expected to grow steadily in the near future. It is drawing more interest, especially in Europe, where medical foods are more accepted by physicians and consumers, Meghan Donnelly, MS, RDN, said in an interview. She is a registered dietitian who conducts physician outreach in the United States for Flavis, a division of Dr. Schär. That company, based in northern Italy, started out targeting IEMs but now also sells gluten-free foods for celiac disease and low-protein foods for CKD.

It is still a niche market in the United States – and isn’t likely to ever approach the size of the supplement market, according to Marcus Charuvastra, the managing director of Targeted Medical Pharma, which markets Theramine capsules for pain management, among many other products. But it could still be a big win for a manufacturer if they get a small slice of a big market, such as for Alzheimer disease.
 

Defining medical food

According to an update of the Orphan Drug Act in 1988, a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The FDA issued regulations to accompany that law in 1993 but has since only issued a guidance document that is not legally binding.

Medical foods are not drugs and they are not supplements (the latter are intended only for healthy people). The FDA doesn’t require formal approval of a medical food, but, by law, the ingredients must be generally recognized as safe, and manufacturers must follow good manufacturing practices. However, the agency has taken a narrow view of what conditions require medical foods.

Policing medical foods hasn’t been a priority for the FDA, which is why there has been a proliferation of products that don’t meet the FDA’s view of the statutory definition of medical foods, according to Miriam Guggenheim, a food and drug law attorney in Washington, D.C. The FDA usually takes enforcement action when it sees a risk to the public’s health.

The agency’s stance has led to confusion – among manufacturers, physicians, consumers, and even regulators – making the market a kind of Wild West, according to Paul Hyman, a Washington, D.C.–based attorney who has represented medical food companies.

George A. Burdock, PhD, an Orlando-based regulatory consultant who has worked with medical food makers, believes the FDA will be forced to expand their narrow definition. He foresees a reconsideration of many medical food products in light of an October 2019 White House executive order prohibiting federal agencies from issuing guidance in lieu of rules.
 

Manufacturers and the FDA differ

One example of a product about which regulators and manufacturers differ is Theramine, which is described as “specially designed to supply the nervous system with the fuel it needs to meet the altered metabolic requirements of chronic pain and inflammatory disorders.”

It is not considered a medical food by the FDA, and the company has had numerous discussions with the agency about their diverging views, according to Mr. Charuvastra. “We’ve had our warning letters and we’ve had our sit downs, and we just had an inspection.”

Targeted Medical Pharma continues to market its products as medical foods but steers away from making any claims that they are like drugs, he said.

Confusion about medical foods has been exposed in the California Workers’ Compensation System by Leslie Wilson, PhD, and colleagues at the University of California, San Francisco. They found that physicians regularly wrote medical food prescriptions for non–FDA-approved uses and that the system reimbursed the majority of the products at a cost of $15.5 million from 2011 to 2013. More than half of these prescriptions were for Theramine.

Dr. Wilson reported that, for most products, no evidence supported effectiveness, and they were frequently mislabeled – for all 36 that were studied, submissions for reimbursement were made using a National Drug Code, an impossibility because medical foods are not drugs, and 14 were labeled “Rx only.”
 

Big-name companies joining in

The FDA does not keep a list of approved medical foods or manufacturers. Both small businesses and big food companies like Danone, Nestlé, and Abbott are players. Most products are sold online.

In the United States, Danone’s Nutricia division sells formulas and low-protein foods for IEMs. They also sell Ketocal, a powder or ready-to-drink liquid that is pitched as a balanced medical food to simplify and optimize the ketogenic diet for children with intractable epilepsy. Yet the FDA does not include epilepsy among the conditions that medical foods can treat.

Nestlé sells traditional medical foods for IEMs and also markets a range of what it calls nutritional therapies for such conditions as irritable bowel syndrome and dysphagia.

Nestlé is a minority shareholder in Axona, a product originally developed by Accera (Cerecin as of 2018). Jacquelyn Campo, senior director of global communications at Nestlé Health Sciences, said that the company is not actively involved in the operations management of Cerecin. However, on its website, Nestlé touts Axona, which is only available in the United States, as a “medical food” that “is intended for the clinical dietary management of mild to moderate Alzheimer disease.” The Axona site claims that the main ingredient, caprylic triglyceride, is broken down into ketones that provide fuel to treat cerebral hypometabolism, a precursor to Alzheimer disease. In a 2009 study, daily dosing of a preliminary formulation was associated with improved cognitive performance compared with placebo in patients with mild to moderate Alzheimer disease.

In 2013, the FDA warned Accera that it was misbranding Axona as a medical food and that the therapeutic claims the company was making would make the product an unapproved drug. Ms. Campo said Nestlé is aware of the agency’s warning, but added, “to our knowledge, Cerecin provided answers to the issues raised by the FDA.”

With the goal of getting drug approval, Accera went on to test a tweaked formulation in a 400-patient randomized, placebo-controlled trial called NOURISH AD that ultimately failed. Nevertheless, Axona is still marketed as a medical food. It costs about $100 for a month’s supply.

Repeated requests for comment from Cerecin were not answered. Danielle Schor, an FDA spokesperson, said the agency will not discuss the status of individual products.
 

More disputes and insurance coverage

Mary Ann DeMarco, executive director of sales and marketing for the Scottsdale, Ariz.–based medical food maker Primus Pharmaceuticals, said the company believes its products fit within the FDA’s medical foods rubric.

These include Fosteum Plus capsules, which it markets “for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.” The capsules contain a combination of genistein, zinc, calcium, phosphate, vitamin K2, and vitamin D. As proof of effectiveness, the company cites clinical data on some of the ingredients – not the product itself.

Primus has run afoul of the FDA before when it similarly positioned another product, called Limbrel, as a medical food for osteoarthritis. From 2007 to 2017, the FDA received 194 adverse event reports associated with Limbrel, including reports of drug-induced liver injury, pancreatitis, and hypersensitivity pneumonitis. In December 2017, the agency urged Primus to recall Limbrel, a move that it said was “necessary to protect the public health and welfare.” Primus withdrew the product but laid out a defense of Limbrel on a devoted website.

The FDA would not comment any further, said Ms. Schor. Ms. DeMarco said that Primus is working with the FDA to bring Limbrel back to market.

A lack of insurance coverage – even for approved medical foods for IEMs – has frustrated advocates, parents, and manufacturers. They are putting their weight behind the Medical Nutrition Equity Act, which would mandate public and private payer coverage of medical foods for IEMs and digestive conditions such as Crohn disease. That 2019 House bill has 56 cosponsors; there is no Senate companion bill.

“If you can get reimbursement, it really makes the market,” for Primus and the other manufacturers, Mr. Hyman said.

Primus Pharmaceuticals has launched its own campaign, Cover My Medical Foods, to enlist consumers and others to the cause.
 

Partnering with advocates

Although its low-protein breads, pastas, and baking products are not considered medical foods by the FDA, Dr. Schär is marketing them as such in the United States. They are trying to make a mark in CKD, according to Ms. Donnelly. She added that Dr. Schär has been successful in Europe, where nutrition therapy is more integrated in the health care system.

In 2019, Flavis and the National Kidney Foundation joined forces to raise awareness of nutritional interventions and to build enthusiasm for the Flavis products. The partnership has now ended, mostly because Flavis could no longer afford it, according to Ms. Donnelly.

“Information on diet and nutrition is the most requested subject matter from the NKF,” said Anthony Gucciardo, senior vice president of strategic partnerships at the foundation. The partnership “has never been necessarily about promoting their products per se; it’s promoting a healthy diet and really a diet specific for CKD.”

The NKF developed cobranded materials on low-protein foods for physicians and a teaching tool they could use with patients. Consumers could access nutrition information and a discount on Flavis products on a dedicated webpage. The foundation didn’t describe the low-protein products as medical foods, said Mr. Gucciardo, even if Flavis promoted them as such.

In patients with CKD, dietary management can help prevent the progression to end-stage renal disease. Although Medicare covers medical nutrition therapy – in which patients receive personalized assessments and dietary advice – uptake is abysmally low, according to a 2018 study.

Dr. Burdock thinks low-protein foods for CKD do meet the FDA’s criteria for a medical food but that the agency might not necessarily agree with him. The FDA would not comment.
 

Physician beware

When it comes to medical foods, the FDA has often looked the other way because the ingredients may already have been proven safe and the danger to an individual or to the public’s health is relatively low, according to Dr. Burdock and Mr. Hyman.

However, if the agency “feels that a medical food will prevent people from seeking medical care or there is potential to defraud the public, it is justified in taking action against the company,” said Dr. Burdock.

According to Dr. Wilson, the pharmacist who reported on the inappropriate medical food prescriptions in the California system, the FDA could help by creating a list of approved medical foods. Physicians should take time to learn about the difference between medical foods and supplements, she said, adding that they should also not hesitate to “question the veracity of the claims for them.”

Ms. Guggenheim believed doctors need to know that, for the most part, these are not FDA-approved products. She emphasized the importance of evaluating the products and looking at the data of their impact on a disease or condition.

“Many of these companies strongly believe that the products work and help people, so clinicians need to be very data driven,” she said.

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

Oh sure, you can treat hand dermatitis by phone. But you might miss something. I almost did.

It’s a mad, mad, mad world. In California, we seem bent on swelling our curve. We’d just begun bringing our patients back into the office. We felt safe, back to business. Then air raid sirens again. Retreat to the Underground. Minimize waiting room waiting, convert to telephone and video. Do what we can to protect our patients and people.

As doctors, we’ve gotten proficient at being triage nurses, examining each appointment request, and sorting who should be seen in person and who could be cared for virtually. We do it for every clinic now.

My 11 a.m. patient last Thursday was an 83-year-old Filipino man with at least a 13-year history of hand dermatitis (based on his long electronic medical record). He had plenty of betamethasone refills. There were even photos of his large, brown hands in his chart. Grandpa hands, calloused by tending his garden and scarred from fixing bikes, building sheds, and doing oil changes for any nephew or niece who asked. The most recent uploads showed a bit of fingertip fissuring, some lichenified plaques. Not much different than they looked after planting persimmon trees a decade ago. I called him early that morning to offer a phone appointment. Perhaps I could save him from venturing out.

“I see that you have an appointment with me in a few hours. If you’d like, I might be able to help you by phone instead.” “Oh, thank you, doc,” he replied. “It’s so kind of you to call. But doc, I think maybe it is better if I come in to see you.” “Are you sure?” “Oh, yes. I will be careful.”

He checked in at 10:45. When I walked into the room he was wearing a face mask and a face shield – good job! He also had a cane and U.S. Navy Destroyer hat. And on the bottom left of his plastic shield was a sticker decal of a U.S. Navy Chief Petty Officer, dress blue insignia. His hands looked just like the photos: no purpura, plenty of lentigines. Fissures, calluses, lichenified plaques. I touched them. In the unaffected areas, his skin was remarkably soft. What stories these hands told. “I was 20 years in the Navy, doc,” he said. “I would have stayed longer but my wife, who’s younger, wanted me back home.” He talked about his nine grandchildren, some of whom went on to join the navy too – but as officers, he noted with pride. Now he spends his days caring for his wife; she has dementia. He can’t stay long because she’s in the waiting room and is likely to get confused if alone for too long.

We quickly reviewed good hand care. I ordered clobetasol ointment. He was pleased; that seemed to work years ago and he was glad to have it again.

So, why did he need to come in? Clearly I could have done this remotely. “Thank you so much for seeing me, doc,” as he stood to walk out. “Proper inspections have to be done in person, right?” Yes, I thought. Otherwise, you might miss something.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Oh sure, you can treat hand dermatitis by phone. But you might miss something. I almost did.

It’s a mad, mad, mad world. In California, we seem bent on swelling our curve. We’d just begun bringing our patients back into the office. We felt safe, back to business. Then air raid sirens again. Retreat to the Underground. Minimize waiting room waiting, convert to telephone and video. Do what we can to protect our patients and people.

As doctors, we’ve gotten proficient at being triage nurses, examining each appointment request, and sorting who should be seen in person and who could be cared for virtually. We do it for every clinic now.

My 11 a.m. patient last Thursday was an 83-year-old Filipino man with at least a 13-year history of hand dermatitis (based on his long electronic medical record). He had plenty of betamethasone refills. There were even photos of his large, brown hands in his chart. Grandpa hands, calloused by tending his garden and scarred from fixing bikes, building sheds, and doing oil changes for any nephew or niece who asked. The most recent uploads showed a bit of fingertip fissuring, some lichenified plaques. Not much different than they looked after planting persimmon trees a decade ago. I called him early that morning to offer a phone appointment. Perhaps I could save him from venturing out.

“I see that you have an appointment with me in a few hours. If you’d like, I might be able to help you by phone instead.” “Oh, thank you, doc,” he replied. “It’s so kind of you to call. But doc, I think maybe it is better if I come in to see you.” “Are you sure?” “Oh, yes. I will be careful.”

He checked in at 10:45. When I walked into the room he was wearing a face mask and a face shield – good job! He also had a cane and U.S. Navy Destroyer hat. And on the bottom left of his plastic shield was a sticker decal of a U.S. Navy Chief Petty Officer, dress blue insignia. His hands looked just like the photos: no purpura, plenty of lentigines. Fissures, calluses, lichenified plaques. I touched them. In the unaffected areas, his skin was remarkably soft. What stories these hands told. “I was 20 years in the Navy, doc,” he said. “I would have stayed longer but my wife, who’s younger, wanted me back home.” He talked about his nine grandchildren, some of whom went on to join the navy too – but as officers, he noted with pride. Now he spends his days caring for his wife; she has dementia. He can’t stay long because she’s in the waiting room and is likely to get confused if alone for too long.

We quickly reviewed good hand care. I ordered clobetasol ointment. He was pleased; that seemed to work years ago and he was glad to have it again.

So, why did he need to come in? Clearly I could have done this remotely. “Thank you so much for seeing me, doc,” as he stood to walk out. “Proper inspections have to be done in person, right?” Yes, I thought. Otherwise, you might miss something.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Oh sure, you can treat hand dermatitis by phone. But you might miss something. I almost did.

It’s a mad, mad, mad world. In California, we seem bent on swelling our curve. We’d just begun bringing our patients back into the office. We felt safe, back to business. Then air raid sirens again. Retreat to the Underground. Minimize waiting room waiting, convert to telephone and video. Do what we can to protect our patients and people.

As doctors, we’ve gotten proficient at being triage nurses, examining each appointment request, and sorting who should be seen in person and who could be cared for virtually. We do it for every clinic now.

My 11 a.m. patient last Thursday was an 83-year-old Filipino man with at least a 13-year history of hand dermatitis (based on his long electronic medical record). He had plenty of betamethasone refills. There were even photos of his large, brown hands in his chart. Grandpa hands, calloused by tending his garden and scarred from fixing bikes, building sheds, and doing oil changes for any nephew or niece who asked. The most recent uploads showed a bit of fingertip fissuring, some lichenified plaques. Not much different than they looked after planting persimmon trees a decade ago. I called him early that morning to offer a phone appointment. Perhaps I could save him from venturing out.

“I see that you have an appointment with me in a few hours. If you’d like, I might be able to help you by phone instead.” “Oh, thank you, doc,” he replied. “It’s so kind of you to call. But doc, I think maybe it is better if I come in to see you.” “Are you sure?” “Oh, yes. I will be careful.”

He checked in at 10:45. When I walked into the room he was wearing a face mask and a face shield – good job! He also had a cane and U.S. Navy Destroyer hat. And on the bottom left of his plastic shield was a sticker decal of a U.S. Navy Chief Petty Officer, dress blue insignia. His hands looked just like the photos: no purpura, plenty of lentigines. Fissures, calluses, lichenified plaques. I touched them. In the unaffected areas, his skin was remarkably soft. What stories these hands told. “I was 20 years in the Navy, doc,” he said. “I would have stayed longer but my wife, who’s younger, wanted me back home.” He talked about his nine grandchildren, some of whom went on to join the navy too – but as officers, he noted with pride. Now he spends his days caring for his wife; she has dementia. He can’t stay long because she’s in the waiting room and is likely to get confused if alone for too long.

We quickly reviewed good hand care. I ordered clobetasol ointment. He was pleased; that seemed to work years ago and he was glad to have it again.

So, why did he need to come in? Clearly I could have done this remotely. “Thank you so much for seeing me, doc,” as he stood to walk out. “Proper inspections have to be done in person, right?” Yes, I thought. Otherwise, you might miss something.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.

Thinkstock

The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but overall the scientific advice on social distancing has had a gigantic impact on the spread of the pandemic in the February to June time frame. The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.

I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.

Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.

For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.

It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.

It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.

A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.

This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.

There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.

Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.

Thinkstock

The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but overall the scientific advice on social distancing has had a gigantic impact on the spread of the pandemic in the February to June time frame. The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.

I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.

Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.

For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.

It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.

It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.

A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.

This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.

There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.

Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.

Thinkstock

The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but overall the scientific advice on social distancing has had a gigantic impact on the spread of the pandemic in the February to June time frame. The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.

I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.

Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.

For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.

It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.

It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.

A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.

This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.

There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.

Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.

In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that 87.4% of 143 previously hospitalized patients had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge.

Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:

• Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
• About 32% of patients had one or two symptoms and 55% had three or more
• None had fever or other signs and symptoms of acute illness
• About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
• About 44% reported worsened quality of life on the EuroQol visual analog scale.

The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.

The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”

Patients can also enroll in a training program in which breathing status is monitored.

In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.

“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.

As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.

The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.

“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.

The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.

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

Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.

In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that 87.4% of 143 previously hospitalized patients had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge.

Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:

• Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
• About 32% of patients had one or two symptoms and 55% had three or more
• None had fever or other signs and symptoms of acute illness
• About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
• About 44% reported worsened quality of life on the EuroQol visual analog scale.

The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.

The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”

Patients can also enroll in a training program in which breathing status is monitored.

In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.

“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.

As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.

The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.

“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.

The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.

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

Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.

In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that 87.4% of 143 previously hospitalized patients had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge.

Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:

• Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
• About 32% of patients had one or two symptoms and 55% had three or more
• None had fever or other signs and symptoms of acute illness
• About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
• About 44% reported worsened quality of life on the EuroQol visual analog scale.

The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.

The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”

Patients can also enroll in a training program in which breathing status is monitored.

In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.

“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.

As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.

The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.

“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.

The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.

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

Ten patients smiled and waved out on the computer monitor, as Jacob Mirsky, MD, greeted each one, asked them to introduce themselves, and inquired as to how each was doing with their stress reduction tactics.

The attendees of the online session had been patients at in-person group visits at the Massachusetts General Hospital Revere HealthCare Center. But those in-person group sessions, known as shared medical appointments (SMAs), were shut down when COVID-19 arrived.

“Our group patients have been missing the sessions,” said Dr. Mirsky, a general internist who codirects the center’s group visit program. The online sessions, called virtual SMAs (V-SMAs), work well with COVID-19 social distancing.

In the group sessions, Dr. Mirsky reads a standardized message that addresses privacy concerns during the session. For the next 60-90 minutes, “we ask them to talk about what has gone well for them and what they are struggling with,” he said. “Then I answer their questions using materials in a PowerPoint to address key points, such as reducing salt for high blood pressure or interpreting blood sugar levels for diabetes.

“I try to end group sessions with one area of focus,” Dr. Mirsky said. “In the stress reduction group, this could be meditation. In the diabetes group, it could be a discussion on weight loss.” Then the program’s health coach goes over some key concepts on behavior change and invites participants to contact her after the session.

“The nice thing is that these virtual sessions are fully reimbursable by all of our insurers in Massachusetts,” Dr. Mirsky said. Through evaluation and management (E/M) codes, each patient in a group visit is paid the same as a patient in an individual visit with the same level of complexity.

Dr. Mirsky writes a note in the chart about each patient who was in the group session. “This includes information about the specific patient, such as the history and physical, and information about the group meeting,” he said. In the next few months, the center plans to put its other group sessions online – on blood pressure, obesity, diabetes, and insomnia.

Attracting doctors who hadn’t done groups before

The COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement, said Marianne Sumego, MD, director of the Cleveland Clinic’s SMA program, which began 21 years ago.

In this era of COVID-19, group visits have either switched to V-SMAs or halted. However, the COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement,

Many of the 100 doctors using SMAs at the Cleveland Clinic have switched over to V-SMAs for now, and the new mode is also attracting colleagues who are new to SMAs, she said.

“When doctors started using telemedicine, virtual group visits started making sense to them,” Dr. Sumego said. “This is a time of a great deal of experimentation in practice design.”

Indeed, V-SMAs have eliminated some problems that had discouraged doctors from trying SMAs, said Amy Wheeler, MD, a general internist who founded the Revere SMA program and codirects it with Dr. Mirsky.

V-SMAs eliminate the need for a large space to hold sessions and reduce the number of staff needed to run sessions, Dr. Wheeler said. “Virtual group visits can actually be easier to use than in-person group visits.”

Dr. Sumego believes small practices in particular will take up V-SMAs because they are easier to run than regular SMAs. “Necessity drives change,” she said. “Across the country everyone is looking at the virtual group model.”

Group visits can help your bottom line

Medicare and many private payers cover group visits. In most cases, they tend to pay the same rate as for an individual office visit. As with telehealth, Medicare and many other payers are temporarily reimbursing for virtual visits at the same rate as for real visits.

Not all payers have a stated policy about covering SMAs, and physicians have to ask. The Centers for Medicare & Medicaid Services, for example, has not published any coding rules on SMAs. But in response to a query by the American Academy of Family Physicians, CMS said it would allow use of CPT codes for E/M services for individual patients.

Blue Cross Blue Shield of North Carolina is one of the few payers with a clearly stated policy on its website. Like Medicare, the insurer accepts E/M codes, and it requires that patients’ attendance must be voluntary; they must be established patients; and the visit must be specific to a disease or condition, although several conditions are allowed.

Dr. Mirsky said his group uses the same E/M level – 99213 – for all of his SMA patients. “Since a regular primary care visit is usually billed at a level 3 or 4, depending on how many topics are covered, we chose level 3 for groups, because the group session deals with just one topic.”

One challenge for billing for SMAs is that most health insurers require patients to provide a copay for each visit, which can discourage patients in groups that meet frequently, says Wayne Dysinger, MD, founder of Lifestyle Medical Solutions, a two-physician primary care practice in Riverside, Calif.

But Dr. Dysinger, who has been using SMAs for 5 years, usually doesn’t have to worry about copays because much of his work is capitated and doesn’t require a copay.

Also, some of Dr. Dysinger’s SMA patients are in direct primary care, in which the patients pay an $18 monthly membership fee. Other practices may charge a flat out-of-pocket fee.
 

How group visits operate

SMAs are based on the observation that patients with the same condition generally ask their doctor the same questions, and rather than repeat the answers each time, why not provide them to a group?

Dr. Wheeler said trying to be more efficient with her time was the primary reason she became interested in SMAs a dozen years ago. “I was trying to squeeze the advice patients needed into a normal patient visit, and it wasn’t working. When I tried to tell them everything they needed to know, I’d run behind for the rest of my day’s visits.”

She found she was continually repeating the same conversation with patients, but these talks weren’t detailed enough to be effective. “When my weight loss patients came back for the next appointment, they had not made the recommended changes in lifestyle. I started to realize how complicated weight loss was.” So Dr. Wheeler founded the SMA program at the Revere Center.

Doctors enjoy the patient interaction

Some doctors who use SMAs talk about how connected they feel with their patients. “For me, the group sessions are the most gratifying part of the week,” Dr. Dysinger says. “I like to see the patients interacting with me and with each other, and watch their health behavior change over time.”

“These groups have a great deal of energy,” he said. “They have a kind of vulnerability that is very raw, very human. People make commitments to meet goals. Will they meet them or not?”

Dr. Dysinger’s enthusiasm has been echoed by other doctors. In a study of older patients, physicians who used SMAs were more satisfied with care than physicians who relied on standard one-to-one interactions. In another study, the researchers surmised that, in SMAs, doctors learn from their patients how they can better meet their needs.

Dr. Dysinger thinks SMAs are widely applicable in primary care. He estimates that 80%-85% of appointments at a primary care practice involve chronic diseases, and this type of patient is a good fit for group visits. SMAs typically treat patients with diabetes, asthma, arthritis, and obesity.

Dr. Sumego said SMAs are used for specialty care at Cleveland Clinic, such as to help patients before and after bariatric surgery. SMAs have also been used to treat patients with ulcerative colitis, multiple sclerosis, cancer, HIV, menopause, insomnia, and stress, according to one report.

Dr. Dysinger, who runs a small practice, organizes his group sessions somewhat differently. He doesn’t organize his groups around conditions like diabetes, but instead his groups focus on four “pillars” of lifestyle medicine: nourishment, movement, resilience (involving sleep and stress), and connectedness.
 

Why patients like group visits

Feeling part of a whole is a major draw for many patients. “Patients seem to like committing to something bigger than just themselves,” Dr. Wheeler said. “They enjoy the sense of community that groups have, the joy of supporting one another.”

“It’s feeling that you’re not alone,” Dr. Mirsky said. “When a patient struggling with diabetes hears how hard it is for another patient, it validates their experience and gives them someone to connect with. There is a positive peer pressure.”

Many programs, including Dr. Wheeler’s and Dr. Mirsky’s in Boston, allow patients to drop in and out of sessions, rather than attending one course all the way through. But even under this format, Dr. Wheeler said that patients often tend to stick together. “At the end of a session, one patient asks another: ‘Which session do you want to go to next?’ ” she said.

Patients also learn from each other in SMAs. Patients exchange experiences and share advice they may not have had the chance to get during an individual visit.

The group dynamic can make it easier for some patients to reveal sensitive information, said Dr. Dysinger. “In these groups, people feel free to talk about their bowel movements, or about having to deal with the influence of a parent on their lives,” Dr. Dysinger said. “The sessions can have the feel of an [Alcoholics Anonymous] meeting, but they’re firmly grounded in medicine.”

Potential downsides of virtual group visits

SMAs and VSMAs may not work for every practice. Some small practices may not have enough patients to organize a group visit around a particular condition – even a common one like diabetes. In a presentation before the Society of General Internal Medicine, a physician from the Medical University of South Carolina, Charleston, warned that it may be difficult for a practice to fill diabetes group visits every year.

Additionally, some patients don’t want to talk about personal matters in a group. “They may not want to reveal certain things about themselves,” Dr. Mirsky said. “So I tell the group that if there is anything that anyone wants to talk about in private, I’m available.”

Another drawback of SMAs is that more experienced patients may have to slog through information they already know, which is a particular problem when patients can drop in and out of sessions. Dr. Mirsky noted that “what often ends up happening is that the experienced participant helps the newcomer.”

Finally, confidentially is a big concern in a group session. “In a one-on-one visit, you can go into details about the patient’s health, and even bring up an entry in the chart,” Dr. Wheeler said. “But in a group visit, you can’t raise any personal details about a patient unless the patient brings it up first.”

SMA patients sign confidentiality agreements in which they agree not to talk about other patients outside the session. Ensuring confidentiality becomes more complicated in virtual group visits, because someone located in the room near a participant could overhear the conversation. For this reason, patients in V-SMAs are advised to use headphones or, at a minimum, close the door to the room they are in.

To address privacy concerns, Zoom encrypts its data, but some privacy breeches have been reported, and a U.S. senator has been looking into Zoom’s privacy vulnerabilities.

Transferring groups to virtual groups

It took the COVID-19 crisis for most doctors to take up virtual SMAs. Dr. Sumego said that the Cleveland Clinic started virtual SMAs more than a year ago, but most other groups operating SMAs were apparently not providing them virtually before COVID-19 started.

Dr. Dysinger said he tried virtual SMAs in 2017 but dropped them because the technology – using Zoom – was challenging at the time, and his staff and most patients were resistant. “Only three to five people were attending the virtual sessions, and the meetings took place in the evening, which was hard on the staff.”

“When COVID-19 first appeared, our initial response was to try to keep the in-person group and add social distancing to it, but that wasn’t workable, so very quickly we shifted to Zoom meetings,” Dr. Dysinger said. “We had experience with Zoom already, and the Zoom technology had improved and was easier to use. COVID-19 forced it all forward.”

Are V-SMAs effective? While there have been many studies showing the effectiveness of in-person SMAs, there have been very few on V-SMAs. One 2018 study of obesity patients found that those attending in-person SMAs lost somewhat more weight than those in V-SMAs.

As with telemedicine, some patients have trouble with the technology of V-SMAs. Dr. Dysinger said 5%-10% of his SMA patients don’t make the switch over to V-SMAs – mainly because of problems in adapting to the technology – but the rest are happy. “We’re averaging 10 people per meeting, and as many as 20.”

Getting comfortable with group visits

Dealing with group visits takes a very different mindset than what doctors normally have, Dr. Wheeler said. “It took me 6-8 months to feel comfortable enough with group sessions to do them myself,” she recalled. “This was a very different way to practice, compared to the one-on-one care I was trained to give patients. Others may find the transition easier, though.

“Doctors are used to being in control of the patient visit, but the exchange in a group visit is more fluid,” Dr. Wheeler said. “Patients offer their own opinions, and this sends the discussion off on a tangent that is often quite useful. As doctors, we have to learn when to let these tangents continue, and know when the discussion might have to be brought back to the theme at hand. Often it’s better not to intercede.”

Do doctors need training to conduct SMAs? Patients in group visits reported worse communication with physicians than those in individual visits, according to a 2014 study. The authors surmised that the doctors needed to learn how to talk to groups and suggested that they get some training.

The potential staying power of V-SMAs post COVID?

Once the COVID-19 crisis is over, Medicare is scheduled to no longer provide the same level of reimbursement for virtual sessions as for real sessions. Dr. Mirsky anticipates a great deal of resistance to this change from thousands of physicians and patients who have become comfortable with telehealth, including virtual SMAs.

Dr. Dysinger thinks V-SMAs will continue. “When COVID-19 clears and we can go back to in-person groups, we expect to keep some virtual groups. People have already come to accept and value virtual groups.”

Dr. Wheeler sees virtual groups playing an essential role post COVID-19, when practices have to get back up to speed. “Virtual group visits could make it easier to deal with a large backlog of patients who couldn’t be seen up until now,” she said. “And virtual groups will be the only way to see patients who are still reluctant to meet in a group.”

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

Ten patients smiled and waved out on the computer monitor, as Jacob Mirsky, MD, greeted each one, asked them to introduce themselves, and inquired as to how each was doing with their stress reduction tactics.

The attendees of the online session had been patients at in-person group visits at the Massachusetts General Hospital Revere HealthCare Center. But those in-person group sessions, known as shared medical appointments (SMAs), were shut down when COVID-19 arrived.

“Our group patients have been missing the sessions,” said Dr. Mirsky, a general internist who codirects the center’s group visit program. The online sessions, called virtual SMAs (V-SMAs), work well with COVID-19 social distancing.

In the group sessions, Dr. Mirsky reads a standardized message that addresses privacy concerns during the session. For the next 60-90 minutes, “we ask them to talk about what has gone well for them and what they are struggling with,” he said. “Then I answer their questions using materials in a PowerPoint to address key points, such as reducing salt for high blood pressure or interpreting blood sugar levels for diabetes.

“I try to end group sessions with one area of focus,” Dr. Mirsky said. “In the stress reduction group, this could be meditation. In the diabetes group, it could be a discussion on weight loss.” Then the program’s health coach goes over some key concepts on behavior change and invites participants to contact her after the session.

“The nice thing is that these virtual sessions are fully reimbursable by all of our insurers in Massachusetts,” Dr. Mirsky said. Through evaluation and management (E/M) codes, each patient in a group visit is paid the same as a patient in an individual visit with the same level of complexity.

Dr. Mirsky writes a note in the chart about each patient who was in the group session. “This includes information about the specific patient, such as the history and physical, and information about the group meeting,” he said. In the next few months, the center plans to put its other group sessions online – on blood pressure, obesity, diabetes, and insomnia.

Attracting doctors who hadn’t done groups before

The COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement, said Marianne Sumego, MD, director of the Cleveland Clinic’s SMA program, which began 21 years ago.

In this era of COVID-19, group visits have either switched to V-SMAs or halted. However, the COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement,

Many of the 100 doctors using SMAs at the Cleveland Clinic have switched over to V-SMAs for now, and the new mode is also attracting colleagues who are new to SMAs, she said.

“When doctors started using telemedicine, virtual group visits started making sense to them,” Dr. Sumego said. “This is a time of a great deal of experimentation in practice design.”

Indeed, V-SMAs have eliminated some problems that had discouraged doctors from trying SMAs, said Amy Wheeler, MD, a general internist who founded the Revere SMA program and codirects it with Dr. Mirsky.

V-SMAs eliminate the need for a large space to hold sessions and reduce the number of staff needed to run sessions, Dr. Wheeler said. “Virtual group visits can actually be easier to use than in-person group visits.”

Dr. Sumego believes small practices in particular will take up V-SMAs because they are easier to run than regular SMAs. “Necessity drives change,” she said. “Across the country everyone is looking at the virtual group model.”

Group visits can help your bottom line

Medicare and many private payers cover group visits. In most cases, they tend to pay the same rate as for an individual office visit. As with telehealth, Medicare and many other payers are temporarily reimbursing for virtual visits at the same rate as for real visits.

Not all payers have a stated policy about covering SMAs, and physicians have to ask. The Centers for Medicare & Medicaid Services, for example, has not published any coding rules on SMAs. But in response to a query by the American Academy of Family Physicians, CMS said it would allow use of CPT codes for E/M services for individual patients.

Blue Cross Blue Shield of North Carolina is one of the few payers with a clearly stated policy on its website. Like Medicare, the insurer accepts E/M codes, and it requires that patients’ attendance must be voluntary; they must be established patients; and the visit must be specific to a disease or condition, although several conditions are allowed.

Dr. Mirsky said his group uses the same E/M level – 99213 – for all of his SMA patients. “Since a regular primary care visit is usually billed at a level 3 or 4, depending on how many topics are covered, we chose level 3 for groups, because the group session deals with just one topic.”

One challenge for billing for SMAs is that most health insurers require patients to provide a copay for each visit, which can discourage patients in groups that meet frequently, says Wayne Dysinger, MD, founder of Lifestyle Medical Solutions, a two-physician primary care practice in Riverside, Calif.

But Dr. Dysinger, who has been using SMAs for 5 years, usually doesn’t have to worry about copays because much of his work is capitated and doesn’t require a copay.

Also, some of Dr. Dysinger’s SMA patients are in direct primary care, in which the patients pay an $18 monthly membership fee. Other practices may charge a flat out-of-pocket fee.
 

How group visits operate

SMAs are based on the observation that patients with the same condition generally ask their doctor the same questions, and rather than repeat the answers each time, why not provide them to a group?

Dr. Wheeler said trying to be more efficient with her time was the primary reason she became interested in SMAs a dozen years ago. “I was trying to squeeze the advice patients needed into a normal patient visit, and it wasn’t working. When I tried to tell them everything they needed to know, I’d run behind for the rest of my day’s visits.”

She found she was continually repeating the same conversation with patients, but these talks weren’t detailed enough to be effective. “When my weight loss patients came back for the next appointment, they had not made the recommended changes in lifestyle. I started to realize how complicated weight loss was.” So Dr. Wheeler founded the SMA program at the Revere Center.

Doctors enjoy the patient interaction

Some doctors who use SMAs talk about how connected they feel with their patients. “For me, the group sessions are the most gratifying part of the week,” Dr. Dysinger says. “I like to see the patients interacting with me and with each other, and watch their health behavior change over time.”

“These groups have a great deal of energy,” he said. “They have a kind of vulnerability that is very raw, very human. People make commitments to meet goals. Will they meet them or not?”

Dr. Dysinger’s enthusiasm has been echoed by other doctors. In a study of older patients, physicians who used SMAs were more satisfied with care than physicians who relied on standard one-to-one interactions. In another study, the researchers surmised that, in SMAs, doctors learn from their patients how they can better meet their needs.

Dr. Dysinger thinks SMAs are widely applicable in primary care. He estimates that 80%-85% of appointments at a primary care practice involve chronic diseases, and this type of patient is a good fit for group visits. SMAs typically treat patients with diabetes, asthma, arthritis, and obesity.

Dr. Sumego said SMAs are used for specialty care at Cleveland Clinic, such as to help patients before and after bariatric surgery. SMAs have also been used to treat patients with ulcerative colitis, multiple sclerosis, cancer, HIV, menopause, insomnia, and stress, according to one report.

Dr. Dysinger, who runs a small practice, organizes his group sessions somewhat differently. He doesn’t organize his groups around conditions like diabetes, but instead his groups focus on four “pillars” of lifestyle medicine: nourishment, movement, resilience (involving sleep and stress), and connectedness.
 

Why patients like group visits

Feeling part of a whole is a major draw for many patients. “Patients seem to like committing to something bigger than just themselves,” Dr. Wheeler said. “They enjoy the sense of community that groups have, the joy of supporting one another.”

“It’s feeling that you’re not alone,” Dr. Mirsky said. “When a patient struggling with diabetes hears how hard it is for another patient, it validates their experience and gives them someone to connect with. There is a positive peer pressure.”

Many programs, including Dr. Wheeler’s and Dr. Mirsky’s in Boston, allow patients to drop in and out of sessions, rather than attending one course all the way through. But even under this format, Dr. Wheeler said that patients often tend to stick together. “At the end of a session, one patient asks another: ‘Which session do you want to go to next?’ ” she said.

Patients also learn from each other in SMAs. Patients exchange experiences and share advice they may not have had the chance to get during an individual visit.

The group dynamic can make it easier for some patients to reveal sensitive information, said Dr. Dysinger. “In these groups, people feel free to talk about their bowel movements, or about having to deal with the influence of a parent on their lives,” Dr. Dysinger said. “The sessions can have the feel of an [Alcoholics Anonymous] meeting, but they’re firmly grounded in medicine.”

Potential downsides of virtual group visits

SMAs and VSMAs may not work for every practice. Some small practices may not have enough patients to organize a group visit around a particular condition – even a common one like diabetes. In a presentation before the Society of General Internal Medicine, a physician from the Medical University of South Carolina, Charleston, warned that it may be difficult for a practice to fill diabetes group visits every year.

Additionally, some patients don’t want to talk about personal matters in a group. “They may not want to reveal certain things about themselves,” Dr. Mirsky said. “So I tell the group that if there is anything that anyone wants to talk about in private, I’m available.”

Another drawback of SMAs is that more experienced patients may have to slog through information they already know, which is a particular problem when patients can drop in and out of sessions. Dr. Mirsky noted that “what often ends up happening is that the experienced participant helps the newcomer.”

Finally, confidentially is a big concern in a group session. “In a one-on-one visit, you can go into details about the patient’s health, and even bring up an entry in the chart,” Dr. Wheeler said. “But in a group visit, you can’t raise any personal details about a patient unless the patient brings it up first.”

SMA patients sign confidentiality agreements in which they agree not to talk about other patients outside the session. Ensuring confidentiality becomes more complicated in virtual group visits, because someone located in the room near a participant could overhear the conversation. For this reason, patients in V-SMAs are advised to use headphones or, at a minimum, close the door to the room they are in.

To address privacy concerns, Zoom encrypts its data, but some privacy breeches have been reported, and a U.S. senator has been looking into Zoom’s privacy vulnerabilities.

Transferring groups to virtual groups

It took the COVID-19 crisis for most doctors to take up virtual SMAs. Dr. Sumego said that the Cleveland Clinic started virtual SMAs more than a year ago, but most other groups operating SMAs were apparently not providing them virtually before COVID-19 started.

Dr. Dysinger said he tried virtual SMAs in 2017 but dropped them because the technology – using Zoom – was challenging at the time, and his staff and most patients were resistant. “Only three to five people were attending the virtual sessions, and the meetings took place in the evening, which was hard on the staff.”

“When COVID-19 first appeared, our initial response was to try to keep the in-person group and add social distancing to it, but that wasn’t workable, so very quickly we shifted to Zoom meetings,” Dr. Dysinger said. “We had experience with Zoom already, and the Zoom technology had improved and was easier to use. COVID-19 forced it all forward.”

Are V-SMAs effective? While there have been many studies showing the effectiveness of in-person SMAs, there have been very few on V-SMAs. One 2018 study of obesity patients found that those attending in-person SMAs lost somewhat more weight than those in V-SMAs.

As with telemedicine, some patients have trouble with the technology of V-SMAs. Dr. Dysinger said 5%-10% of his SMA patients don’t make the switch over to V-SMAs – mainly because of problems in adapting to the technology – but the rest are happy. “We’re averaging 10 people per meeting, and as many as 20.”

Getting comfortable with group visits

Dealing with group visits takes a very different mindset than what doctors normally have, Dr. Wheeler said. “It took me 6-8 months to feel comfortable enough with group sessions to do them myself,” she recalled. “This was a very different way to practice, compared to the one-on-one care I was trained to give patients. Others may find the transition easier, though.

“Doctors are used to being in control of the patient visit, but the exchange in a group visit is more fluid,” Dr. Wheeler said. “Patients offer their own opinions, and this sends the discussion off on a tangent that is often quite useful. As doctors, we have to learn when to let these tangents continue, and know when the discussion might have to be brought back to the theme at hand. Often it’s better not to intercede.”

Do doctors need training to conduct SMAs? Patients in group visits reported worse communication with physicians than those in individual visits, according to a 2014 study. The authors surmised that the doctors needed to learn how to talk to groups and suggested that they get some training.

The potential staying power of V-SMAs post COVID?

Once the COVID-19 crisis is over, Medicare is scheduled to no longer provide the same level of reimbursement for virtual sessions as for real sessions. Dr. Mirsky anticipates a great deal of resistance to this change from thousands of physicians and patients who have become comfortable with telehealth, including virtual SMAs.

Dr. Dysinger thinks V-SMAs will continue. “When COVID-19 clears and we can go back to in-person groups, we expect to keep some virtual groups. People have already come to accept and value virtual groups.”

Dr. Wheeler sees virtual groups playing an essential role post COVID-19, when practices have to get back up to speed. “Virtual group visits could make it easier to deal with a large backlog of patients who couldn’t be seen up until now,” she said. “And virtual groups will be the only way to see patients who are still reluctant to meet in a group.”

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

Ten patients smiled and waved out on the computer monitor, as Jacob Mirsky, MD, greeted each one, asked them to introduce themselves, and inquired as to how each was doing with their stress reduction tactics.

The attendees of the online session had been patients at in-person group visits at the Massachusetts General Hospital Revere HealthCare Center. But those in-person group sessions, known as shared medical appointments (SMAs), were shut down when COVID-19 arrived.

“Our group patients have been missing the sessions,” said Dr. Mirsky, a general internist who codirects the center’s group visit program. The online sessions, called virtual SMAs (V-SMAs), work well with COVID-19 social distancing.

In the group sessions, Dr. Mirsky reads a standardized message that addresses privacy concerns during the session. For the next 60-90 minutes, “we ask them to talk about what has gone well for them and what they are struggling with,” he said. “Then I answer their questions using materials in a PowerPoint to address key points, such as reducing salt for high blood pressure or interpreting blood sugar levels for diabetes.

“I try to end group sessions with one area of focus,” Dr. Mirsky said. “In the stress reduction group, this could be meditation. In the diabetes group, it could be a discussion on weight loss.” Then the program’s health coach goes over some key concepts on behavior change and invites participants to contact her after the session.

“The nice thing is that these virtual sessions are fully reimbursable by all of our insurers in Massachusetts,” Dr. Mirsky said. Through evaluation and management (E/M) codes, each patient in a group visit is paid the same as a patient in an individual visit with the same level of complexity.

Dr. Mirsky writes a note in the chart about each patient who was in the group session. “This includes information about the specific patient, such as the history and physical, and information about the group meeting,” he said. In the next few months, the center plans to put its other group sessions online – on blood pressure, obesity, diabetes, and insomnia.

Attracting doctors who hadn’t done groups before

The COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement, said Marianne Sumego, MD, director of the Cleveland Clinic’s SMA program, which began 21 years ago.

In this era of COVID-19, group visits have either switched to V-SMAs or halted. However, the COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement,

Many of the 100 doctors using SMAs at the Cleveland Clinic have switched over to V-SMAs for now, and the new mode is also attracting colleagues who are new to SMAs, she said.

“When doctors started using telemedicine, virtual group visits started making sense to them,” Dr. Sumego said. “This is a time of a great deal of experimentation in practice design.”

Indeed, V-SMAs have eliminated some problems that had discouraged doctors from trying SMAs, said Amy Wheeler, MD, a general internist who founded the Revere SMA program and codirects it with Dr. Mirsky.

V-SMAs eliminate the need for a large space to hold sessions and reduce the number of staff needed to run sessions, Dr. Wheeler said. “Virtual group visits can actually be easier to use than in-person group visits.”

Dr. Sumego believes small practices in particular will take up V-SMAs because they are easier to run than regular SMAs. “Necessity drives change,” she said. “Across the country everyone is looking at the virtual group model.”

Group visits can help your bottom line

Medicare and many private payers cover group visits. In most cases, they tend to pay the same rate as for an individual office visit. As with telehealth, Medicare and many other payers are temporarily reimbursing for virtual visits at the same rate as for real visits.

Not all payers have a stated policy about covering SMAs, and physicians have to ask. The Centers for Medicare & Medicaid Services, for example, has not published any coding rules on SMAs. But in response to a query by the American Academy of Family Physicians, CMS said it would allow use of CPT codes for E/M services for individual patients.

Blue Cross Blue Shield of North Carolina is one of the few payers with a clearly stated policy on its website. Like Medicare, the insurer accepts E/M codes, and it requires that patients’ attendance must be voluntary; they must be established patients; and the visit must be specific to a disease or condition, although several conditions are allowed.

Dr. Mirsky said his group uses the same E/M level – 99213 – for all of his SMA patients. “Since a regular primary care visit is usually billed at a level 3 or 4, depending on how many topics are covered, we chose level 3 for groups, because the group session deals with just one topic.”

One challenge for billing for SMAs is that most health insurers require patients to provide a copay for each visit, which can discourage patients in groups that meet frequently, says Wayne Dysinger, MD, founder of Lifestyle Medical Solutions, a two-physician primary care practice in Riverside, Calif.

But Dr. Dysinger, who has been using SMAs for 5 years, usually doesn’t have to worry about copays because much of his work is capitated and doesn’t require a copay.

Also, some of Dr. Dysinger’s SMA patients are in direct primary care, in which the patients pay an $18 monthly membership fee. Other practices may charge a flat out-of-pocket fee.
 

How group visits operate

SMAs are based on the observation that patients with the same condition generally ask their doctor the same questions, and rather than repeat the answers each time, why not provide them to a group?

Dr. Wheeler said trying to be more efficient with her time was the primary reason she became interested in SMAs a dozen years ago. “I was trying to squeeze the advice patients needed into a normal patient visit, and it wasn’t working. When I tried to tell them everything they needed to know, I’d run behind for the rest of my day’s visits.”

She found she was continually repeating the same conversation with patients, but these talks weren’t detailed enough to be effective. “When my weight loss patients came back for the next appointment, they had not made the recommended changes in lifestyle. I started to realize how complicated weight loss was.” So Dr. Wheeler founded the SMA program at the Revere Center.

Doctors enjoy the patient interaction

Some doctors who use SMAs talk about how connected they feel with their patients. “For me, the group sessions are the most gratifying part of the week,” Dr. Dysinger says. “I like to see the patients interacting with me and with each other, and watch their health behavior change over time.”

“These groups have a great deal of energy,” he said. “They have a kind of vulnerability that is very raw, very human. People make commitments to meet goals. Will they meet them or not?”

Dr. Dysinger’s enthusiasm has been echoed by other doctors. In a study of older patients, physicians who used SMAs were more satisfied with care than physicians who relied on standard one-to-one interactions. In another study, the researchers surmised that, in SMAs, doctors learn from their patients how they can better meet their needs.

Dr. Dysinger thinks SMAs are widely applicable in primary care. He estimates that 80%-85% of appointments at a primary care practice involve chronic diseases, and this type of patient is a good fit for group visits. SMAs typically treat patients with diabetes, asthma, arthritis, and obesity.

Dr. Sumego said SMAs are used for specialty care at Cleveland Clinic, such as to help patients before and after bariatric surgery. SMAs have also been used to treat patients with ulcerative colitis, multiple sclerosis, cancer, HIV, menopause, insomnia, and stress, according to one report.

Dr. Dysinger, who runs a small practice, organizes his group sessions somewhat differently. He doesn’t organize his groups around conditions like diabetes, but instead his groups focus on four “pillars” of lifestyle medicine: nourishment, movement, resilience (involving sleep and stress), and connectedness.
 

Why patients like group visits

Feeling part of a whole is a major draw for many patients. “Patients seem to like committing to something bigger than just themselves,” Dr. Wheeler said. “They enjoy the sense of community that groups have, the joy of supporting one another.”

“It’s feeling that you’re not alone,” Dr. Mirsky said. “When a patient struggling with diabetes hears how hard it is for another patient, it validates their experience and gives them someone to connect with. There is a positive peer pressure.”

Many programs, including Dr. Wheeler’s and Dr. Mirsky’s in Boston, allow patients to drop in and out of sessions, rather than attending one course all the way through. But even under this format, Dr. Wheeler said that patients often tend to stick together. “At the end of a session, one patient asks another: ‘Which session do you want to go to next?’ ” she said.

Patients also learn from each other in SMAs. Patients exchange experiences and share advice they may not have had the chance to get during an individual visit.

The group dynamic can make it easier for some patients to reveal sensitive information, said Dr. Dysinger. “In these groups, people feel free to talk about their bowel movements, or about having to deal with the influence of a parent on their lives,” Dr. Dysinger said. “The sessions can have the feel of an [Alcoholics Anonymous] meeting, but they’re firmly grounded in medicine.”

Potential downsides of virtual group visits

SMAs and VSMAs may not work for every practice. Some small practices may not have enough patients to organize a group visit around a particular condition – even a common one like diabetes. In a presentation before the Society of General Internal Medicine, a physician from the Medical University of South Carolina, Charleston, warned that it may be difficult for a practice to fill diabetes group visits every year.

Additionally, some patients don’t want to talk about personal matters in a group. “They may not want to reveal certain things about themselves,” Dr. Mirsky said. “So I tell the group that if there is anything that anyone wants to talk about in private, I’m available.”

Another drawback of SMAs is that more experienced patients may have to slog through information they already know, which is a particular problem when patients can drop in and out of sessions. Dr. Mirsky noted that “what often ends up happening is that the experienced participant helps the newcomer.”

Finally, confidentially is a big concern in a group session. “In a one-on-one visit, you can go into details about the patient’s health, and even bring up an entry in the chart,” Dr. Wheeler said. “But in a group visit, you can’t raise any personal details about a patient unless the patient brings it up first.”

SMA patients sign confidentiality agreements in which they agree not to talk about other patients outside the session. Ensuring confidentiality becomes more complicated in virtual group visits, because someone located in the room near a participant could overhear the conversation. For this reason, patients in V-SMAs are advised to use headphones or, at a minimum, close the door to the room they are in.

To address privacy concerns, Zoom encrypts its data, but some privacy breeches have been reported, and a U.S. senator has been looking into Zoom’s privacy vulnerabilities.

Transferring groups to virtual groups

It took the COVID-19 crisis for most doctors to take up virtual SMAs. Dr. Sumego said that the Cleveland Clinic started virtual SMAs more than a year ago, but most other groups operating SMAs were apparently not providing them virtually before COVID-19 started.

Dr. Dysinger said he tried virtual SMAs in 2017 but dropped them because the technology – using Zoom – was challenging at the time, and his staff and most patients were resistant. “Only three to five people were attending the virtual sessions, and the meetings took place in the evening, which was hard on the staff.”

“When COVID-19 first appeared, our initial response was to try to keep the in-person group and add social distancing to it, but that wasn’t workable, so very quickly we shifted to Zoom meetings,” Dr. Dysinger said. “We had experience with Zoom already, and the Zoom technology had improved and was easier to use. COVID-19 forced it all forward.”

Are V-SMAs effective? While there have been many studies showing the effectiveness of in-person SMAs, there have been very few on V-SMAs. One 2018 study of obesity patients found that those attending in-person SMAs lost somewhat more weight than those in V-SMAs.

As with telemedicine, some patients have trouble with the technology of V-SMAs. Dr. Dysinger said 5%-10% of his SMA patients don’t make the switch over to V-SMAs – mainly because of problems in adapting to the technology – but the rest are happy. “We’re averaging 10 people per meeting, and as many as 20.”

Getting comfortable with group visits

Dealing with group visits takes a very different mindset than what doctors normally have, Dr. Wheeler said. “It took me 6-8 months to feel comfortable enough with group sessions to do them myself,” she recalled. “This was a very different way to practice, compared to the one-on-one care I was trained to give patients. Others may find the transition easier, though.

“Doctors are used to being in control of the patient visit, but the exchange in a group visit is more fluid,” Dr. Wheeler said. “Patients offer their own opinions, and this sends the discussion off on a tangent that is often quite useful. As doctors, we have to learn when to let these tangents continue, and know when the discussion might have to be brought back to the theme at hand. Often it’s better not to intercede.”

Do doctors need training to conduct SMAs? Patients in group visits reported worse communication with physicians than those in individual visits, according to a 2014 study. The authors surmised that the doctors needed to learn how to talk to groups and suggested that they get some training.

The potential staying power of V-SMAs post COVID?

Once the COVID-19 crisis is over, Medicare is scheduled to no longer provide the same level of reimbursement for virtual sessions as for real sessions. Dr. Mirsky anticipates a great deal of resistance to this change from thousands of physicians and patients who have become comfortable with telehealth, including virtual SMAs.

Dr. Dysinger thinks V-SMAs will continue. “When COVID-19 clears and we can go back to in-person groups, we expect to keep some virtual groups. People have already come to accept and value virtual groups.”

Dr. Wheeler sees virtual groups playing an essential role post COVID-19, when practices have to get back up to speed. “Virtual group visits could make it easier to deal with a large backlog of patients who couldn’t be seen up until now,” she said. “And virtual groups will be the only way to see patients who are still reluctant to meet in a group.”

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