Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

AGA fosters and promotes involvement and advancement of women members and addresses concerns relative to their professional endeavors. Visit www.gastro.org to learn more.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

AGA fosters and promotes involvement and advancement of women members and addresses concerns relative to their professional endeavors. Visit www.gastro.org to learn more.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

AGA fosters and promotes involvement and advancement of women members and addresses concerns relative to their professional endeavors. Visit www.gastro.org to learn more.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

THE CASE

A 50-year-old man presented to the primary care office for evaluation of foot pain. The day before, his left fifth toe had become exquisitely tender. He distinctly remembered that when he awoke, there was no discoloration or pain, but the toe later became “purple.” He denied any trauma. His medical record was notable for an extensive smoking history and a family history of early cardiovascular disease.

The patient appeared well but in obvious distress, secondary to the pain. His vital signs were unremarkable. His head, neck, lung, and cardiac exams revealed no abnormalities. Physical examination revealed a left fifth toe that was dusky purple and warm to the touch. Pain disproportionate to examination was noted on the anterior aspect of the toe, with limited range of motion. The patient walked with a compensated gait. Pulses were palpable on the posterior tibial (PT) and dorsalis pedis (DP) regions.

DIAGNOSIS

Based on our exam findings, we suspected a vascular injury and recommended an emergency consult by Podiatry, for which he was scheduled the following morning. The podiatric evaluation confirmed concern for a vascular injury and prompted a request for an emergent evaluation by Vascular Surgery.

The patient was seen emergently on Day 4 for a vascular surgery evaluation. Examination at that time showed a nearly absent femoral pulse on the left side and diminished and monophasic DP and PT pulses. His left foot demonstrated nonblanchable purpura that was clinically consistent with cholesterol embolization syndrome (CES).

We calculated the patient’s ankle-brachial index, and computed tomography angiography (CTA) was performed. While results were pending, the patient was started on aspirin 81 mg, clopidogrel 75 mg, and atorvastatin 40 mg, for a suspected slowly progressing iliac artery stenosis with a resulting acute atheroembolic event.

The CTA report showed a high-grade stenosis at the bifurcation of the left iliac artery, extending into both external and internal arteries. Of note, mild atherosclerotic disease without significant occlusion and runoff to the foot was observed into the tibial arteries. The stenosis extended into the profonda femoris artery, as well.

DISCUSSION

Atherosclerotic plaques are commonly encountered in patients with atherosclerotic disease; however, there are 2 varieties of emboli that arise from these plaques and one is often overlooked.^1-4 The more common of these variants, thromboemboli, originates from an atherosclerotic plaque and can become lodged in a medium or large vessel as a single embolus.

Continue to: By contrast...

By contrast, atheroemboli (commonly known as cholesterol emboli or cholesterol crystal embolization) originate from atherosclerotic plaques in the aorta or another large artery,⁵ which are prone to embolize if the underlying plaque experiences stress. As the plaque erodes, cholesterol crystals break off and embolize distally. These smaller crystals flood into the circulation, allowing a shower of emboli over time to occlude the arterioles. As occlusion spreads through the arterioles, multiple organ systems are affected. (It was previously thought that procedure-associated cases were common, but a literature review has not borne this out.⁵)

The shower of emboli often triggers a systemic inflammatory response, causing nondescript abnormalities of laboratory inflammatory markers.^6,7 Interestingly, hypereosinophilia is noted in about 80% of patients with CES.⁸It is not uncommon for atheroemboli of the lower extremity to manifest, as it did in this case, as “blue toe syndrome.”

No disease-specific testing. A confounding factor in validating the diagnosis of CES is the lack of disease-specific testing. However, CES should be considered in a patient with acute kidney injury and hypereosinophilia. Making the diagnosis requires a high degree of clinical suspicion. Any organ can be affected, although the brain, kidneys, gastrointestinal tract, skin, and skeletal muscles of the lower extremities are most frequently involved.⁹ If left undiagnosed, the results can be devastating: slow and chronic injury to a variety of organ systems over time, which may not be recognized as a harbinger of an insidious underlying process causing end-organ damage.

Technically, definitive diagnosis can be made by biopsy of an affected organ. However, biopsy’s utility is limited due to potential for sampling error, accessibility (as noted, the location of the involved organ[s] may make biopsy nearly impossible without additional surgical risk⁹), and risk of poor healing to the biopsy site.¹⁰

Treatment is two-fold: supportive care for the affected end organ and prevention of subsequent embolic events. The latter entails aggressive risk factor reduction strategies, such as smoking cessation, statin therapy, blood pressure control, and blood sugar control. Warfarin is not recommended for treatment of CES due to the risk of further plaque rupture, hemorrhage, acute and chronic renal failure, and cholesterol microembolization to other organs.^11,12

Continue to: Our patient

Our patient. After testing confirmed the diagnosis, the patient underwent an angioplasty. A stent was placed in his left iliac artery. He was continued on antiplatelet and statin therapy and was again counseled regarding smoking cessation.

THE TAKEAWAY

When patients present with symptoms suggestive of a vascular origin, consider CES. Although it can affect a multitude of organs, acute kidney injury and hypereosinophilia are the most common signs. Immediate intervention is required to save the affected organ; strategizing to reduce the risk for further embolic events is also key.

Warfarin is not recommended for treatment of cholesterol embolization syndrome due to the risk of further plaque rupture, hemorrhage, and cholesterol microembolization to other organs.

Prompt recognition of vascular emergencies, including those that are harbingers of atherosclerotic disease, is essential. As clinicians, it is imperative that we use all resources to address significant population health burdens. If CES is more prevalent than commonly thought, consideration should be given to increasing education about early detection and treatment of this disorder, including the reinforcement of primary prevention and aggressive treatment of risk factors for atherosclerotic cardiovascular disease.

CORRESPONDENCE
Meagan Vermeulen, MD, FAAFP, Department of Family Medicine, Rowan University School of Osteopathic Medicine, 42 East Laurel Road, Suite 2100A, Stratford, NJ 08084; vermeulen@rowan.edu

THE CASE

A 50-year-old man presented to the primary care office for evaluation of foot pain. The day before, his left fifth toe had become exquisitely tender. He distinctly remembered that when he awoke, there was no discoloration or pain, but the toe later became “purple.” He denied any trauma. His medical record was notable for an extensive smoking history and a family history of early cardiovascular disease.

The patient appeared well but in obvious distress, secondary to the pain. His vital signs were unremarkable. His head, neck, lung, and cardiac exams revealed no abnormalities. Physical examination revealed a left fifth toe that was dusky purple and warm to the touch. Pain disproportionate to examination was noted on the anterior aspect of the toe, with limited range of motion. The patient walked with a compensated gait. Pulses were palpable on the posterior tibial (PT) and dorsalis pedis (DP) regions.

DIAGNOSIS

Based on our exam findings, we suspected a vascular injury and recommended an emergency consult by Podiatry, for which he was scheduled the following morning. The podiatric evaluation confirmed concern for a vascular injury and prompted a request for an emergent evaluation by Vascular Surgery.

The patient was seen emergently on Day 4 for a vascular surgery evaluation. Examination at that time showed a nearly absent femoral pulse on the left side and diminished and monophasic DP and PT pulses. His left foot demonstrated nonblanchable purpura that was clinically consistent with cholesterol embolization syndrome (CES).

We calculated the patient’s ankle-brachial index, and computed tomography angiography (CTA) was performed. While results were pending, the patient was started on aspirin 81 mg, clopidogrel 75 mg, and atorvastatin 40 mg, for a suspected slowly progressing iliac artery stenosis with a resulting acute atheroembolic event.

The CTA report showed a high-grade stenosis at the bifurcation of the left iliac artery, extending into both external and internal arteries. Of note, mild atherosclerotic disease without significant occlusion and runoff to the foot was observed into the tibial arteries. The stenosis extended into the profonda femoris artery, as well.

DISCUSSION

Atherosclerotic plaques are commonly encountered in patients with atherosclerotic disease; however, there are 2 varieties of emboli that arise from these plaques and one is often overlooked.^1-4 The more common of these variants, thromboemboli, originates from an atherosclerotic plaque and can become lodged in a medium or large vessel as a single embolus.

Continue to: By contrast...

By contrast, atheroemboli (commonly known as cholesterol emboli or cholesterol crystal embolization) originate from atherosclerotic plaques in the aorta or another large artery,⁵ which are prone to embolize if the underlying plaque experiences stress. As the plaque erodes, cholesterol crystals break off and embolize distally. These smaller crystals flood into the circulation, allowing a shower of emboli over time to occlude the arterioles. As occlusion spreads through the arterioles, multiple organ systems are affected. (It was previously thought that procedure-associated cases were common, but a literature review has not borne this out.⁵)

The shower of emboli often triggers a systemic inflammatory response, causing nondescript abnormalities of laboratory inflammatory markers.^6,7 Interestingly, hypereosinophilia is noted in about 80% of patients with CES.⁸It is not uncommon for atheroemboli of the lower extremity to manifest, as it did in this case, as “blue toe syndrome.”

No disease-specific testing. A confounding factor in validating the diagnosis of CES is the lack of disease-specific testing. However, CES should be considered in a patient with acute kidney injury and hypereosinophilia. Making the diagnosis requires a high degree of clinical suspicion. Any organ can be affected, although the brain, kidneys, gastrointestinal tract, skin, and skeletal muscles of the lower extremities are most frequently involved.⁹ If left undiagnosed, the results can be devastating: slow and chronic injury to a variety of organ systems over time, which may not be recognized as a harbinger of an insidious underlying process causing end-organ damage.

Technically, definitive diagnosis can be made by biopsy of an affected organ. However, biopsy’s utility is limited due to potential for sampling error, accessibility (as noted, the location of the involved organ[s] may make biopsy nearly impossible without additional surgical risk⁹), and risk of poor healing to the biopsy site.¹⁰

Treatment is two-fold: supportive care for the affected end organ and prevention of subsequent embolic events. The latter entails aggressive risk factor reduction strategies, such as smoking cessation, statin therapy, blood pressure control, and blood sugar control. Warfarin is not recommended for treatment of CES due to the risk of further plaque rupture, hemorrhage, acute and chronic renal failure, and cholesterol microembolization to other organs.^11,12

Continue to: Our patient

Our patient. After testing confirmed the diagnosis, the patient underwent an angioplasty. A stent was placed in his left iliac artery. He was continued on antiplatelet and statin therapy and was again counseled regarding smoking cessation.

THE TAKEAWAY

When patients present with symptoms suggestive of a vascular origin, consider CES. Although it can affect a multitude of organs, acute kidney injury and hypereosinophilia are the most common signs. Immediate intervention is required to save the affected organ; strategizing to reduce the risk for further embolic events is also key.

Warfarin is not recommended for treatment of cholesterol embolization syndrome due to the risk of further plaque rupture, hemorrhage, and cholesterol microembolization to other organs.

Prompt recognition of vascular emergencies, including those that are harbingers of atherosclerotic disease, is essential. As clinicians, it is imperative that we use all resources to address significant population health burdens. If CES is more prevalent than commonly thought, consideration should be given to increasing education about early detection and treatment of this disorder, including the reinforcement of primary prevention and aggressive treatment of risk factors for atherosclerotic cardiovascular disease.

CORRESPONDENCE
Meagan Vermeulen, MD, FAAFP, Department of Family Medicine, Rowan University School of Osteopathic Medicine, 42 East Laurel Road, Suite 2100A, Stratford, NJ 08084; vermeulen@rowan.edu

THE CASE

A 50-year-old man presented to the primary care office for evaluation of foot pain. The day before, his left fifth toe had become exquisitely tender. He distinctly remembered that when he awoke, there was no discoloration or pain, but the toe later became “purple.” He denied any trauma. His medical record was notable for an extensive smoking history and a family history of early cardiovascular disease.

The patient appeared well but in obvious distress, secondary to the pain. His vital signs were unremarkable. His head, neck, lung, and cardiac exams revealed no abnormalities. Physical examination revealed a left fifth toe that was dusky purple and warm to the touch. Pain disproportionate to examination was noted on the anterior aspect of the toe, with limited range of motion. The patient walked with a compensated gait. Pulses were palpable on the posterior tibial (PT) and dorsalis pedis (DP) regions.

DIAGNOSIS

Based on our exam findings, we suspected a vascular injury and recommended an emergency consult by Podiatry, for which he was scheduled the following morning. The podiatric evaluation confirmed concern for a vascular injury and prompted a request for an emergent evaluation by Vascular Surgery.

The patient was seen emergently on Day 4 for a vascular surgery evaluation. Examination at that time showed a nearly absent femoral pulse on the left side and diminished and monophasic DP and PT pulses. His left foot demonstrated nonblanchable purpura that was clinically consistent with cholesterol embolization syndrome (CES).

We calculated the patient’s ankle-brachial index, and computed tomography angiography (CTA) was performed. While results were pending, the patient was started on aspirin 81 mg, clopidogrel 75 mg, and atorvastatin 40 mg, for a suspected slowly progressing iliac artery stenosis with a resulting acute atheroembolic event.

The CTA report showed a high-grade stenosis at the bifurcation of the left iliac artery, extending into both external and internal arteries. Of note, mild atherosclerotic disease without significant occlusion and runoff to the foot was observed into the tibial arteries. The stenosis extended into the profonda femoris artery, as well.

DISCUSSION

Atherosclerotic plaques are commonly encountered in patients with atherosclerotic disease; however, there are 2 varieties of emboli that arise from these plaques and one is often overlooked.^1-4 The more common of these variants, thromboemboli, originates from an atherosclerotic plaque and can become lodged in a medium or large vessel as a single embolus.

Continue to: By contrast...

By contrast, atheroemboli (commonly known as cholesterol emboli or cholesterol crystal embolization) originate from atherosclerotic plaques in the aorta or another large artery,⁵ which are prone to embolize if the underlying plaque experiences stress. As the plaque erodes, cholesterol crystals break off and embolize distally. These smaller crystals flood into the circulation, allowing a shower of emboli over time to occlude the arterioles. As occlusion spreads through the arterioles, multiple organ systems are affected. (It was previously thought that procedure-associated cases were common, but a literature review has not borne this out.⁵)

The shower of emboli often triggers a systemic inflammatory response, causing nondescript abnormalities of laboratory inflammatory markers.^6,7 Interestingly, hypereosinophilia is noted in about 80% of patients with CES.⁸It is not uncommon for atheroemboli of the lower extremity to manifest, as it did in this case, as “blue toe syndrome.”

No disease-specific testing. A confounding factor in validating the diagnosis of CES is the lack of disease-specific testing. However, CES should be considered in a patient with acute kidney injury and hypereosinophilia. Making the diagnosis requires a high degree of clinical suspicion. Any organ can be affected, although the brain, kidneys, gastrointestinal tract, skin, and skeletal muscles of the lower extremities are most frequently involved.⁹ If left undiagnosed, the results can be devastating: slow and chronic injury to a variety of organ systems over time, which may not be recognized as a harbinger of an insidious underlying process causing end-organ damage.

Technically, definitive diagnosis can be made by biopsy of an affected organ. However, biopsy’s utility is limited due to potential for sampling error, accessibility (as noted, the location of the involved organ[s] may make biopsy nearly impossible without additional surgical risk⁹), and risk of poor healing to the biopsy site.¹⁰

Treatment is two-fold: supportive care for the affected end organ and prevention of subsequent embolic events. The latter entails aggressive risk factor reduction strategies, such as smoking cessation, statin therapy, blood pressure control, and blood sugar control. Warfarin is not recommended for treatment of CES due to the risk of further plaque rupture, hemorrhage, acute and chronic renal failure, and cholesterol microembolization to other organs.^11,12

Continue to: Our patient

Our patient. After testing confirmed the diagnosis, the patient underwent an angioplasty. A stent was placed in his left iliac artery. He was continued on antiplatelet and statin therapy and was again counseled regarding smoking cessation.

THE TAKEAWAY

When patients present with symptoms suggestive of a vascular origin, consider CES. Although it can affect a multitude of organs, acute kidney injury and hypereosinophilia are the most common signs. Immediate intervention is required to save the affected organ; strategizing to reduce the risk for further embolic events is also key.

Warfarin is not recommended for treatment of cholesterol embolization syndrome due to the risk of further plaque rupture, hemorrhage, and cholesterol microembolization to other organs.

Prompt recognition of vascular emergencies, including those that are harbingers of atherosclerotic disease, is essential. As clinicians, it is imperative that we use all resources to address significant population health burdens. If CES is more prevalent than commonly thought, consideration should be given to increasing education about early detection and treatment of this disorder, including the reinforcement of primary prevention and aggressive treatment of risk factors for atherosclerotic cardiovascular disease.

CORRESPONDENCE
Meagan Vermeulen, MD, FAAFP, Department of Family Medicine, Rowan University School of Osteopathic Medicine, 42 East Laurel Road, Suite 2100A, Stratford, NJ 08084; vermeulen@rowan.edu

In a pilot study, intravenous gentamicin improved wound closure and quality of life while dampening disease activity in patients with recessive dystrophic epidermolysis bullosa attributable to nonsense mutations, Michelle Hao said at the virtual annual meeting of the American Academy of Dermatology.

Serial skin biopsies and immunofluorescent staining demonstrated the mechanism of benefit: The aminoglycoside promoted creation of new full-length functional collagen fibrils at the dermal-epidermal junction in affected patients, added Ms. Hao, a medical student at the University of Southern California, Los Angeles.

“Glycoside-mediated nonsense suppression therapy may provide a novel, low cost, and readily available treatment for RDEB [recessive dystrophic epidermolysis bullosa] patients harboring nonsense mutations,” she declared.

RDEB is a rare, incurable, life-threatening genetic skin disease which manifests as severe skin fragility and widespread blistering. The disease is caused by mutations in a gene coding for collagen type VII alpha 1 (COL7A1), the building block for the anchoring fibrils responsible for dermal-epidermal adherence. Roughly 30% of COL7A1 mutations are nonsense mutations, which result in truncated, nonfunctional collagen type VII.

Ms. Hao and her senior coinvestigators have previously shown that aminoglycoside antibiotics can override nonsense mutations to produce full-length, functioning protein. Indeed, they demonstrated that topical gentamicin in particular induces formation of new collagen type VII and improves wound closure in RDEB patients with nonsense mutations. However, RDEB skin lesions are so widespread that topical therapy becomes impractical. This was the impetus for the phase 1/2 clinical trial of IV gentamicin.

The open-label study included four patients with RDEB with nonsense mutations. All participants received IV gentamicin at 7.5 mg/kg/day for 2 weeks. Two of the four patients then got additional twice-weekly infusions at the same dose for another 3 months. Skin biopsies were obtained from two prospectively monitored open erosive wound sites and two intact skin sites at baseline and 1 and 3 months after treatment.

The primary endpoint was evidence of new collagen type VII at the dermal-epidermal junction post treatment. At baseline, patients averaged only 2% of the amount present in normal skin. One month post treatment, all four patients showed significant gains in expression of functioning collagen type VII, with levels 30%-130% of what’s present in normal skin. This effect proved durable 3 months post treatment.

At the same visits when biopsies were obtained, participants were assessed regarding wound closure, disease activity as measured using the validated Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), and quality of life as reflected in Skindex-16 scores. All four patients showed improved wound closure at 1 and 3 months post treatment at the monitored sites, as well as better EBDASI and Skindex-16 Symptoms and Skindex-16 Emotion scores, Ms. Hao continued.

Safety assessments revealed no evidence of oto- or nephrotoxicity in the gentamicin-treated patients. And no one developed autoantibodies to collagen type VII in skin or sera in response to the aminoglycoside-induced creation of new collagen type VII.

Ms. Hao said preliminary analysis of the study data suggests that the more convenient schedule of twice-weekly IV gentamicin was as effective with regard to wound closure as daily infusion therapy.

She reported having no financial conflicts regarding the study, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the EB Research Partnership, and the EB Research Foundation.

bjancin@mdedge.com
 

In a pilot study, intravenous gentamicin improved wound closure and quality of life while dampening disease activity in patients with recessive dystrophic epidermolysis bullosa attributable to nonsense mutations, Michelle Hao said at the virtual annual meeting of the American Academy of Dermatology.

Serial skin biopsies and immunofluorescent staining demonstrated the mechanism of benefit: The aminoglycoside promoted creation of new full-length functional collagen fibrils at the dermal-epidermal junction in affected patients, added Ms. Hao, a medical student at the University of Southern California, Los Angeles.

“Glycoside-mediated nonsense suppression therapy may provide a novel, low cost, and readily available treatment for RDEB [recessive dystrophic epidermolysis bullosa] patients harboring nonsense mutations,” she declared.

RDEB is a rare, incurable, life-threatening genetic skin disease which manifests as severe skin fragility and widespread blistering. The disease is caused by mutations in a gene coding for collagen type VII alpha 1 (COL7A1), the building block for the anchoring fibrils responsible for dermal-epidermal adherence. Roughly 30% of COL7A1 mutations are nonsense mutations, which result in truncated, nonfunctional collagen type VII.

Ms. Hao and her senior coinvestigators have previously shown that aminoglycoside antibiotics can override nonsense mutations to produce full-length, functioning protein. Indeed, they demonstrated that topical gentamicin in particular induces formation of new collagen type VII and improves wound closure in RDEB patients with nonsense mutations. However, RDEB skin lesions are so widespread that topical therapy becomes impractical. This was the impetus for the phase 1/2 clinical trial of IV gentamicin.

The open-label study included four patients with RDEB with nonsense mutations. All participants received IV gentamicin at 7.5 mg/kg/day for 2 weeks. Two of the four patients then got additional twice-weekly infusions at the same dose for another 3 months. Skin biopsies were obtained from two prospectively monitored open erosive wound sites and two intact skin sites at baseline and 1 and 3 months after treatment.

The primary endpoint was evidence of new collagen type VII at the dermal-epidermal junction post treatment. At baseline, patients averaged only 2% of the amount present in normal skin. One month post treatment, all four patients showed significant gains in expression of functioning collagen type VII, with levels 30%-130% of what’s present in normal skin. This effect proved durable 3 months post treatment.

At the same visits when biopsies were obtained, participants were assessed regarding wound closure, disease activity as measured using the validated Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), and quality of life as reflected in Skindex-16 scores. All four patients showed improved wound closure at 1 and 3 months post treatment at the monitored sites, as well as better EBDASI and Skindex-16 Symptoms and Skindex-16 Emotion scores, Ms. Hao continued.

Safety assessments revealed no evidence of oto- or nephrotoxicity in the gentamicin-treated patients. And no one developed autoantibodies to collagen type VII in skin or sera in response to the aminoglycoside-induced creation of new collagen type VII.

Ms. Hao said preliminary analysis of the study data suggests that the more convenient schedule of twice-weekly IV gentamicin was as effective with regard to wound closure as daily infusion therapy.

She reported having no financial conflicts regarding the study, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the EB Research Partnership, and the EB Research Foundation.

bjancin@mdedge.com
 

In a pilot study, intravenous gentamicin improved wound closure and quality of life while dampening disease activity in patients with recessive dystrophic epidermolysis bullosa attributable to nonsense mutations, Michelle Hao said at the virtual annual meeting of the American Academy of Dermatology.

Serial skin biopsies and immunofluorescent staining demonstrated the mechanism of benefit: The aminoglycoside promoted creation of new full-length functional collagen fibrils at the dermal-epidermal junction in affected patients, added Ms. Hao, a medical student at the University of Southern California, Los Angeles.

“Glycoside-mediated nonsense suppression therapy may provide a novel, low cost, and readily available treatment for RDEB [recessive dystrophic epidermolysis bullosa] patients harboring nonsense mutations,” she declared.

RDEB is a rare, incurable, life-threatening genetic skin disease which manifests as severe skin fragility and widespread blistering. The disease is caused by mutations in a gene coding for collagen type VII alpha 1 (COL7A1), the building block for the anchoring fibrils responsible for dermal-epidermal adherence. Roughly 30% of COL7A1 mutations are nonsense mutations, which result in truncated, nonfunctional collagen type VII.

Ms. Hao and her senior coinvestigators have previously shown that aminoglycoside antibiotics can override nonsense mutations to produce full-length, functioning protein. Indeed, they demonstrated that topical gentamicin in particular induces formation of new collagen type VII and improves wound closure in RDEB patients with nonsense mutations. However, RDEB skin lesions are so widespread that topical therapy becomes impractical. This was the impetus for the phase 1/2 clinical trial of IV gentamicin.

The open-label study included four patients with RDEB with nonsense mutations. All participants received IV gentamicin at 7.5 mg/kg/day for 2 weeks. Two of the four patients then got additional twice-weekly infusions at the same dose for another 3 months. Skin biopsies were obtained from two prospectively monitored open erosive wound sites and two intact skin sites at baseline and 1 and 3 months after treatment.

The primary endpoint was evidence of new collagen type VII at the dermal-epidermal junction post treatment. At baseline, patients averaged only 2% of the amount present in normal skin. One month post treatment, all four patients showed significant gains in expression of functioning collagen type VII, with levels 30%-130% of what’s present in normal skin. This effect proved durable 3 months post treatment.

At the same visits when biopsies were obtained, participants were assessed regarding wound closure, disease activity as measured using the validated Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), and quality of life as reflected in Skindex-16 scores. All four patients showed improved wound closure at 1 and 3 months post treatment at the monitored sites, as well as better EBDASI and Skindex-16 Symptoms and Skindex-16 Emotion scores, Ms. Hao continued.

Safety assessments revealed no evidence of oto- or nephrotoxicity in the gentamicin-treated patients. And no one developed autoantibodies to collagen type VII in skin or sera in response to the aminoglycoside-induced creation of new collagen type VII.

Ms. Hao said preliminary analysis of the study data suggests that the more convenient schedule of twice-weekly IV gentamicin was as effective with regard to wound closure as daily infusion therapy.

She reported having no financial conflicts regarding the study, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the EB Research Partnership, and the EB Research Foundation.

bjancin@mdedge.com
 

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

Medicare beneficiary who requires skilled care in a nursing home? Better be admitted for at least 3 days in the hospital first if you want the nursing home paid for. Govt doesn’t always make sense. We’re listening to feedback.

—Centers for Medicare & Medicaid Services Administrator Seema Verma, @SeemaCMS, August 4, 2019, via Twitter.¹

On March 13, 2020, the president of the United States declared a national health emergency, granting the secretary of the United States Department of Health & Human Services authority to grant waivers intended to ease certain Medicare and Medicaid program requirements.² Broad waiver categories include those that may be requested by an individual institution, as well as “COVID-19 Emergency Declaration Blanket Waivers,” which automatically apply across all facilities and providers. As stated by the Centers for Medicare & Medicaid Services (CMS), waivers are intended to create “regulatory flexibilities to help healthcare providers contain the spread of 2019 Novel Coronavirus Disease (COVID-19).” These provisions are retroactive to March 1, 2020, expire at the end of the “emergency period or 60 days from the date the waiver . . . is first published” and can be extended by the secretary.²

The issued blanket waivers remove administrative requirements in a wide range of care settings including home health, hospice, hospitals, and skilled nursing facilities (SNF), among others. The waiving of many of these administrative requirements are welcomed by providers and administrators alike in this time of national crisis. For example, relaxation of verbal order signage requirements and expanded coverage of telehealth will, almost certainly, improve accessibility, efficiency, and requisite coordination and care across settings. Emergence of these new “COVID-19” waivers also present rare and valuable opportunities to examine care improvement in areas long believed to need permanent regulatory change. Perhaps the most important of these long over-due changes is the current CMS process for determining Part A eligibility for post-acute skilled nursing facility coverage for traditional Medicare beneficiaries following an inpatient hospitalization. Under COVID-19, CMS has now granted a waiver that “authorizes the Secretary to provide for Skilled Nursing Facilities (SNF) coverage in the absence of a qualifying [three consecutive inpatient midnight] hospital stay. . . .”² Although demand for SNF placement may shift during the pandemic, hospitals facing capacity issues will more easily be able to discharge Medicare beneficiaries ready for post-acute care.

When Medicare was established in 1965, approximately half of Americans over age 65 did not have health insurance, and older adults were the most likely demographic to be living in poverty.³ Originally called “Hospital Insurance” or “Medicare Part A,” these “Inpatient Hospital Services” are described in Social Security statute as “items and services furnished to an inpatient of a hospital” including room and board, nursing services, pharmaceuticals, and medical and surgical services delivered in the hospital.⁴ In 1967, Medicare beneficiaries staying three consecutive inpatient hospital midnights were also afforded post-acute SNF coverage for up to 100 days. As expected, hospital use increased as seniors had coverage for hospital care and were also, in many cases, able to access higher quality post-hospital care.⁵

Over the past 50 years, two important changes have shifted Medicare beneficiary SNF coverage. First, due to efficiencies and changes in care delivery, average length of hospital stay for Americans over age 65 has shrunk from 14 days in 1965 to approximately 5 days currently.^5,6 Now, fewer beneficiaries spend the necessary three or more nights in the hospital to qualify for post-acute SNF coverage. Second, and most importantly, CMS created “observation status” in the 1980s, which allowed for patients to be observed as “outpatients” in a hospital instead of as inpatients. Notably, these observation nights fall under outpatient status (Part B), and therefore do not count toward the statutory SNF coverage requirement of three inpatient midnights.

According to CMS, observation should be used so that a “decision can be made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital. . . . In the majority of cases, the decision can be made in less than 48 hours, usually in less than 24 hours.”⁷ At the time of its development, this concept fit the growing use of Emergency Department observation units, in which patients presented for an acute issue but could usually discharge home in the stated time frame.

In reality, outpatient (observation) status is not synonymous with observation units. Because observation is a billing determination, not a specific type of clinical care, observation care may be delivered anywhere in a hospital—including an observation unit, a hospital ward, or even an intensive care unit (ICU). While all hospitals may deliver observation care, only about one-third of hospitals have observation units, and even hospitals with observation units deliver observation care outside of these units. Traditional Medicare beneficiaries who stay three or more nights in the hospital but cannot meet the three inpatient midnight requirement to access their SNF coverage benefits because of outpatient (observation) nights are often left vulnerable and confused, saddling them with an average of $10,503 for each uncovered SNF stay.⁸ As emergent evidence demonstrates striking racial, geographic, and socioeconomic-based health disparities in COVID-19, renewal of the “three-midnight rule” could have disproportionate and long-lasting ramifications for these populations in particular.⁹

Hospital observation stays (or observation nights) can look identical to inpatient hospital stays, as defined by the Social Security statute⁴; yet never count toward the three-inpatient-midnight tally. In 2014, the Office of Inspector General (OIG) found there were 633,148 hospital stays that lasted three midnights or longer but did not contain three consecutive inpatient midnights, which resulted in nonqualifying stays for purposes of SNF coverage, if that coverage was needed.¹⁰ A more recent OIG report found that Medicare was paying erroneously for some SNF stays because even CMS could not distinguish between three midnights that were all inpatient or a combination of inpatient and observation.¹¹ Additionally, because care provided is often indistinguishable, status changes between outpatient and inpatient are common; in 2014, 40% of Medicare observation stays occurring within 30 days of an inpatient stay changed to inpatient over the course of a single hospitalization.¹² Now, in the time of COVID-19, this untenable decades-long problem has the potential to be definitively addressed by a permanent removal of the three midnight requirement altogether.

PROGRESS TOWARD REFORM

Several recent signals suggest that change is supported by a diverse group of stakeholders. In their 2019 Top 25 Unimplemented Recommendations, the OIG acknowledged the similarity in observation and inpatient care, recommending that “CMS . . . analyze the potential impacts of counting time spent as an outpatient toward the 3-night requirement for skilled nursing facility (SNF) services so that beneficiaries receiving similar hospital care have similar access to these services.”¹³ The “Improving Access to Medicare Coverage Act of 2019,” reintroduced in the 116th Congress, would count all midnights spent in the hospital, whether those nights are inpatient or observation, toward the three midnight requirement.¹⁴ This bill has bipartisan, bicameral support, which demonstrates unified legislative interest across the political spectrum. More recently in March 2020, a federal judge in the class action lawsuit Alexander v Azar determined that Medicare beneficiaries had the right to appeal to Medicare if a physician placed a patient in inpatient status and this decision was overturned administratively by a hospital, resulting in loss of a beneficiary’s SNF coverage.¹⁵ Although now under appeal, this judicial decision signals the importance of beneficiary rights to appeal directly to CMS.

Given the mounting support for reform, it is probable that cost concerns and allocation of resources to the Part A vs Part B “buckets” remain the only barrier to permanently reforming the three-midnight inpatient stay policy. Pilot programs testing Medicare SNF waivers more than 30 years ago suggested increased cost and SNF usage.¹⁶ However, more contemporary experience from Medicare Advantage programs suggest just the opposite. Grebla et al showed there was no increased SNF use nor SNF length of stay for beneficiaries in Medicare Advantage plans that waived the three inpatient midnight requirement.¹⁷

Arguably, the current COVID-19 emergency blanket SNF waiver is not a perfect test of short- or long-term Medicare costs. First, factors such as reduced hospital elective surgeries that may typically drive post-acute SNF admissions, as well as potentially reduced SNF utilization caused by fear of COVID-19 outbreaks, may temporarily lower SNF use and associated Medicare expenditures. The existing waiver of statute is also financially constrained, stipulating that “this action does not increase overall program payments. . . .”² Longer term, innovations in care delivery prompted by accelerated telehealth reforms may shift more post-acute care from SNFs to the home setting, changing patterns of SNF utilization altogether. Despite these limitations, this regulatory relief will still provide valuable utilization and cost information on SNF use under a system absent the three-midnight requirement.

Rarely, if ever, does a national healthcare system experience such a rapid and marked change as that seen with the COVID-19 pandemic. Despite the tragic emergency circumstances prompting CMS’s blanket waivers, it provides CMS and stakeholders with a rare opportunity to evaluate potential improvements revealed by each individual aspect of COVID-19 regulatory relief. CMS has in the past argued the three-midnight SNF requirement is a statutory issue and thus not within their control, yet they have used their regulatory authority to waive this policy to facilitate efficient care in a national health crisis. This is a change that many believe is long overdue, and one that should be maintained even after COVID-19 abates. “Govt doesn’t always make sense,” as Administrator Verma wrote,¹ should be a cry for government to make better sense of existing legislation and regulation. Reform of the three-midnight inpatient rule is the right place to start.

Medicare beneficiary who requires skilled care in a nursing home? Better be admitted for at least 3 days in the hospital first if you want the nursing home paid for. Govt doesn’t always make sense. We’re listening to feedback.

—Centers for Medicare & Medicaid Services Administrator Seema Verma, @SeemaCMS, August 4, 2019, via Twitter.¹

On March 13, 2020, the president of the United States declared a national health emergency, granting the secretary of the United States Department of Health & Human Services authority to grant waivers intended to ease certain Medicare and Medicaid program requirements.² Broad waiver categories include those that may be requested by an individual institution, as well as “COVID-19 Emergency Declaration Blanket Waivers,” which automatically apply across all facilities and providers. As stated by the Centers for Medicare & Medicaid Services (CMS), waivers are intended to create “regulatory flexibilities to help healthcare providers contain the spread of 2019 Novel Coronavirus Disease (COVID-19).” These provisions are retroactive to March 1, 2020, expire at the end of the “emergency period or 60 days from the date the waiver . . . is first published” and can be extended by the secretary.²

The issued blanket waivers remove administrative requirements in a wide range of care settings including home health, hospice, hospitals, and skilled nursing facilities (SNF), among others. The waiving of many of these administrative requirements are welcomed by providers and administrators alike in this time of national crisis. For example, relaxation of verbal order signage requirements and expanded coverage of telehealth will, almost certainly, improve accessibility, efficiency, and requisite coordination and care across settings. Emergence of these new “COVID-19” waivers also present rare and valuable opportunities to examine care improvement in areas long believed to need permanent regulatory change. Perhaps the most important of these long over-due changes is the current CMS process for determining Part A eligibility for post-acute skilled nursing facility coverage for traditional Medicare beneficiaries following an inpatient hospitalization. Under COVID-19, CMS has now granted a waiver that “authorizes the Secretary to provide for Skilled Nursing Facilities (SNF) coverage in the absence of a qualifying [three consecutive inpatient midnight] hospital stay. . . .”² Although demand for SNF placement may shift during the pandemic, hospitals facing capacity issues will more easily be able to discharge Medicare beneficiaries ready for post-acute care.

When Medicare was established in 1965, approximately half of Americans over age 65 did not have health insurance, and older adults were the most likely demographic to be living in poverty.³ Originally called “Hospital Insurance” or “Medicare Part A,” these “Inpatient Hospital Services” are described in Social Security statute as “items and services furnished to an inpatient of a hospital” including room and board, nursing services, pharmaceuticals, and medical and surgical services delivered in the hospital.⁴ In 1967, Medicare beneficiaries staying three consecutive inpatient hospital midnights were also afforded post-acute SNF coverage for up to 100 days. As expected, hospital use increased as seniors had coverage for hospital care and were also, in many cases, able to access higher quality post-hospital care.⁵

Over the past 50 years, two important changes have shifted Medicare beneficiary SNF coverage. First, due to efficiencies and changes in care delivery, average length of hospital stay for Americans over age 65 has shrunk from 14 days in 1965 to approximately 5 days currently.^5,6 Now, fewer beneficiaries spend the necessary three or more nights in the hospital to qualify for post-acute SNF coverage. Second, and most importantly, CMS created “observation status” in the 1980s, which allowed for patients to be observed as “outpatients” in a hospital instead of as inpatients. Notably, these observation nights fall under outpatient status (Part B), and therefore do not count toward the statutory SNF coverage requirement of three inpatient midnights.

According to CMS, observation should be used so that a “decision can be made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital. . . . In the majority of cases, the decision can be made in less than 48 hours, usually in less than 24 hours.”⁷ At the time of its development, this concept fit the growing use of Emergency Department observation units, in which patients presented for an acute issue but could usually discharge home in the stated time frame.

In reality, outpatient (observation) status is not synonymous with observation units. Because observation is a billing determination, not a specific type of clinical care, observation care may be delivered anywhere in a hospital—including an observation unit, a hospital ward, or even an intensive care unit (ICU). While all hospitals may deliver observation care, only about one-third of hospitals have observation units, and even hospitals with observation units deliver observation care outside of these units. Traditional Medicare beneficiaries who stay three or more nights in the hospital but cannot meet the three inpatient midnight requirement to access their SNF coverage benefits because of outpatient (observation) nights are often left vulnerable and confused, saddling them with an average of $10,503 for each uncovered SNF stay.⁸ As emergent evidence demonstrates striking racial, geographic, and socioeconomic-based health disparities in COVID-19, renewal of the “three-midnight rule” could have disproportionate and long-lasting ramifications for these populations in particular.⁹

Hospital observation stays (or observation nights) can look identical to inpatient hospital stays, as defined by the Social Security statute⁴; yet never count toward the three-inpatient-midnight tally. In 2014, the Office of Inspector General (OIG) found there were 633,148 hospital stays that lasted three midnights or longer but did not contain three consecutive inpatient midnights, which resulted in nonqualifying stays for purposes of SNF coverage, if that coverage was needed.¹⁰ A more recent OIG report found that Medicare was paying erroneously for some SNF stays because even CMS could not distinguish between three midnights that were all inpatient or a combination of inpatient and observation.¹¹ Additionally, because care provided is often indistinguishable, status changes between outpatient and inpatient are common; in 2014, 40% of Medicare observation stays occurring within 30 days of an inpatient stay changed to inpatient over the course of a single hospitalization.¹² Now, in the time of COVID-19, this untenable decades-long problem has the potential to be definitively addressed by a permanent removal of the three midnight requirement altogether.

PROGRESS TOWARD REFORM

Several recent signals suggest that change is supported by a diverse group of stakeholders. In their 2019 Top 25 Unimplemented Recommendations, the OIG acknowledged the similarity in observation and inpatient care, recommending that “CMS . . . analyze the potential impacts of counting time spent as an outpatient toward the 3-night requirement for skilled nursing facility (SNF) services so that beneficiaries receiving similar hospital care have similar access to these services.”¹³ The “Improving Access to Medicare Coverage Act of 2019,” reintroduced in the 116th Congress, would count all midnights spent in the hospital, whether those nights are inpatient or observation, toward the three midnight requirement.¹⁴ This bill has bipartisan, bicameral support, which demonstrates unified legislative interest across the political spectrum. More recently in March 2020, a federal judge in the class action lawsuit Alexander v Azar determined that Medicare beneficiaries had the right to appeal to Medicare if a physician placed a patient in inpatient status and this decision was overturned administratively by a hospital, resulting in loss of a beneficiary’s SNF coverage.¹⁵ Although now under appeal, this judicial decision signals the importance of beneficiary rights to appeal directly to CMS.

Given the mounting support for reform, it is probable that cost concerns and allocation of resources to the Part A vs Part B “buckets” remain the only barrier to permanently reforming the three-midnight inpatient stay policy. Pilot programs testing Medicare SNF waivers more than 30 years ago suggested increased cost and SNF usage.¹⁶ However, more contemporary experience from Medicare Advantage programs suggest just the opposite. Grebla et al showed there was no increased SNF use nor SNF length of stay for beneficiaries in Medicare Advantage plans that waived the three inpatient midnight requirement.¹⁷

Arguably, the current COVID-19 emergency blanket SNF waiver is not a perfect test of short- or long-term Medicare costs. First, factors such as reduced hospital elective surgeries that may typically drive post-acute SNF admissions, as well as potentially reduced SNF utilization caused by fear of COVID-19 outbreaks, may temporarily lower SNF use and associated Medicare expenditures. The existing waiver of statute is also financially constrained, stipulating that “this action does not increase overall program payments. . . .”² Longer term, innovations in care delivery prompted by accelerated telehealth reforms may shift more post-acute care from SNFs to the home setting, changing patterns of SNF utilization altogether. Despite these limitations, this regulatory relief will still provide valuable utilization and cost information on SNF use under a system absent the three-midnight requirement.

Rarely, if ever, does a national healthcare system experience such a rapid and marked change as that seen with the COVID-19 pandemic. Despite the tragic emergency circumstances prompting CMS’s blanket waivers, it provides CMS and stakeholders with a rare opportunity to evaluate potential improvements revealed by each individual aspect of COVID-19 regulatory relief. CMS has in the past argued the three-midnight SNF requirement is a statutory issue and thus not within their control, yet they have used their regulatory authority to waive this policy to facilitate efficient care in a national health crisis. This is a change that many believe is long overdue, and one that should be maintained even after COVID-19 abates. “Govt doesn’t always make sense,” as Administrator Verma wrote,¹ should be a cry for government to make better sense of existing legislation and regulation. Reform of the three-midnight inpatient rule is the right place to start.

Medicare beneficiary who requires skilled care in a nursing home? Better be admitted for at least 3 days in the hospital first if you want the nursing home paid for. Govt doesn’t always make sense. We’re listening to feedback.

—Centers for Medicare & Medicaid Services Administrator Seema Verma, @SeemaCMS, August 4, 2019, via Twitter.¹

On March 13, 2020, the president of the United States declared a national health emergency, granting the secretary of the United States Department of Health & Human Services authority to grant waivers intended to ease certain Medicare and Medicaid program requirements.² Broad waiver categories include those that may be requested by an individual institution, as well as “COVID-19 Emergency Declaration Blanket Waivers,” which automatically apply across all facilities and providers. As stated by the Centers for Medicare & Medicaid Services (CMS), waivers are intended to create “regulatory flexibilities to help healthcare providers contain the spread of 2019 Novel Coronavirus Disease (COVID-19).” These provisions are retroactive to March 1, 2020, expire at the end of the “emergency period or 60 days from the date the waiver . . . is first published” and can be extended by the secretary.²

The issued blanket waivers remove administrative requirements in a wide range of care settings including home health, hospice, hospitals, and skilled nursing facilities (SNF), among others. The waiving of many of these administrative requirements are welcomed by providers and administrators alike in this time of national crisis. For example, relaxation of verbal order signage requirements and expanded coverage of telehealth will, almost certainly, improve accessibility, efficiency, and requisite coordination and care across settings. Emergence of these new “COVID-19” waivers also present rare and valuable opportunities to examine care improvement in areas long believed to need permanent regulatory change. Perhaps the most important of these long over-due changes is the current CMS process for determining Part A eligibility for post-acute skilled nursing facility coverage for traditional Medicare beneficiaries following an inpatient hospitalization. Under COVID-19, CMS has now granted a waiver that “authorizes the Secretary to provide for Skilled Nursing Facilities (SNF) coverage in the absence of a qualifying [three consecutive inpatient midnight] hospital stay. . . .”² Although demand for SNF placement may shift during the pandemic, hospitals facing capacity issues will more easily be able to discharge Medicare beneficiaries ready for post-acute care.

When Medicare was established in 1965, approximately half of Americans over age 65 did not have health insurance, and older adults were the most likely demographic to be living in poverty.³ Originally called “Hospital Insurance” or “Medicare Part A,” these “Inpatient Hospital Services” are described in Social Security statute as “items and services furnished to an inpatient of a hospital” including room and board, nursing services, pharmaceuticals, and medical and surgical services delivered in the hospital.⁴ In 1967, Medicare beneficiaries staying three consecutive inpatient hospital midnights were also afforded post-acute SNF coverage for up to 100 days. As expected, hospital use increased as seniors had coverage for hospital care and were also, in many cases, able to access higher quality post-hospital care.⁵

Over the past 50 years, two important changes have shifted Medicare beneficiary SNF coverage. First, due to efficiencies and changes in care delivery, average length of hospital stay for Americans over age 65 has shrunk from 14 days in 1965 to approximately 5 days currently.^5,6 Now, fewer beneficiaries spend the necessary three or more nights in the hospital to qualify for post-acute SNF coverage. Second, and most importantly, CMS created “observation status” in the 1980s, which allowed for patients to be observed as “outpatients” in a hospital instead of as inpatients. Notably, these observation nights fall under outpatient status (Part B), and therefore do not count toward the statutory SNF coverage requirement of three inpatient midnights.

According to CMS, observation should be used so that a “decision can be made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital. . . . In the majority of cases, the decision can be made in less than 48 hours, usually in less than 24 hours.”⁷ At the time of its development, this concept fit the growing use of Emergency Department observation units, in which patients presented for an acute issue but could usually discharge home in the stated time frame.

In reality, outpatient (observation) status is not synonymous with observation units. Because observation is a billing determination, not a specific type of clinical care, observation care may be delivered anywhere in a hospital—including an observation unit, a hospital ward, or even an intensive care unit (ICU). While all hospitals may deliver observation care, only about one-third of hospitals have observation units, and even hospitals with observation units deliver observation care outside of these units. Traditional Medicare beneficiaries who stay three or more nights in the hospital but cannot meet the three inpatient midnight requirement to access their SNF coverage benefits because of outpatient (observation) nights are often left vulnerable and confused, saddling them with an average of $10,503 for each uncovered SNF stay.⁸ As emergent evidence demonstrates striking racial, geographic, and socioeconomic-based health disparities in COVID-19, renewal of the “three-midnight rule” could have disproportionate and long-lasting ramifications for these populations in particular.⁹

Hospital observation stays (or observation nights) can look identical to inpatient hospital stays, as defined by the Social Security statute⁴; yet never count toward the three-inpatient-midnight tally. In 2014, the Office of Inspector General (OIG) found there were 633,148 hospital stays that lasted three midnights or longer but did not contain three consecutive inpatient midnights, which resulted in nonqualifying stays for purposes of SNF coverage, if that coverage was needed.¹⁰ A more recent OIG report found that Medicare was paying erroneously for some SNF stays because even CMS could not distinguish between three midnights that were all inpatient or a combination of inpatient and observation.¹¹ Additionally, because care provided is often indistinguishable, status changes between outpatient and inpatient are common; in 2014, 40% of Medicare observation stays occurring within 30 days of an inpatient stay changed to inpatient over the course of a single hospitalization.¹² Now, in the time of COVID-19, this untenable decades-long problem has the potential to be definitively addressed by a permanent removal of the three midnight requirement altogether.

PROGRESS TOWARD REFORM

Several recent signals suggest that change is supported by a diverse group of stakeholders. In their 2019 Top 25 Unimplemented Recommendations, the OIG acknowledged the similarity in observation and inpatient care, recommending that “CMS . . . analyze the potential impacts of counting time spent as an outpatient toward the 3-night requirement for skilled nursing facility (SNF) services so that beneficiaries receiving similar hospital care have similar access to these services.”¹³ The “Improving Access to Medicare Coverage Act of 2019,” reintroduced in the 116th Congress, would count all midnights spent in the hospital, whether those nights are inpatient or observation, toward the three midnight requirement.¹⁴ This bill has bipartisan, bicameral support, which demonstrates unified legislative interest across the political spectrum. More recently in March 2020, a federal judge in the class action lawsuit Alexander v Azar determined that Medicare beneficiaries had the right to appeal to Medicare if a physician placed a patient in inpatient status and this decision was overturned administratively by a hospital, resulting in loss of a beneficiary’s SNF coverage.¹⁵ Although now under appeal, this judicial decision signals the importance of beneficiary rights to appeal directly to CMS.

Given the mounting support for reform, it is probable that cost concerns and allocation of resources to the Part A vs Part B “buckets” remain the only barrier to permanently reforming the three-midnight inpatient stay policy. Pilot programs testing Medicare SNF waivers more than 30 years ago suggested increased cost and SNF usage.¹⁶ However, more contemporary experience from Medicare Advantage programs suggest just the opposite. Grebla et al showed there was no increased SNF use nor SNF length of stay for beneficiaries in Medicare Advantage plans that waived the three inpatient midnight requirement.¹⁷

Arguably, the current COVID-19 emergency blanket SNF waiver is not a perfect test of short- or long-term Medicare costs. First, factors such as reduced hospital elective surgeries that may typically drive post-acute SNF admissions, as well as potentially reduced SNF utilization caused by fear of COVID-19 outbreaks, may temporarily lower SNF use and associated Medicare expenditures. The existing waiver of statute is also financially constrained, stipulating that “this action does not increase overall program payments. . . .”² Longer term, innovations in care delivery prompted by accelerated telehealth reforms may shift more post-acute care from SNFs to the home setting, changing patterns of SNF utilization altogether. Despite these limitations, this regulatory relief will still provide valuable utilization and cost information on SNF use under a system absent the three-midnight requirement.

Rarely, if ever, does a national healthcare system experience such a rapid and marked change as that seen with the COVID-19 pandemic. Despite the tragic emergency circumstances prompting CMS’s blanket waivers, it provides CMS and stakeholders with a rare opportunity to evaluate potential improvements revealed by each individual aspect of COVID-19 regulatory relief. CMS has in the past argued the three-midnight SNF requirement is a statutory issue and thus not within their control, yet they have used their regulatory authority to waive this policy to facilitate efficient care in a national health crisis. This is a change that many believe is long overdue, and one that should be maintained even after COVID-19 abates. “Govt doesn’t always make sense,” as Administrator Verma wrote,¹ should be a cry for government to make better sense of existing legislation and regulation. Reform of the three-midnight inpatient rule is the right place to start.