This May, DDW will again be a virtual meeting. Not only does this pandemic continue, but it has re-emerged with a vengeance in several states. Michigan leads the nation in cases per 100,000, with the UK variant now predominant. Younger adults are being most impacted. There have been almost 250 confirmed COVID-19 cases in fully vaccinated people in Michigan. COVID-19 will be with us for a long time.

Despite the disruption caused by the coronavirus, scientific research and the need for up-to-date education continues. There are numerous educational sessions that will be available for us to view and opportunities for interacting with speakers in many. I hope you will take advantage of a virtual DDW to refresh knowledge and learn about new modalities to care for our patients.

Three cover stories this month should be of interest. A new AGA guideline has been published and it recognizes the advances made in construction and use of intragastric balloons. Current balloons positively add to weigh loss and, when used correctly, are safer and more effective than in the past. Gastroenterologists should enter the bariatric arena in multiple ways from lifestyle counseling to endoscopic therapies. We have much to add to this field. Another cover article concerns infliximab’s influence on development of COVID-19 antibodies. The last discusses how minority status influences liver transplant listing; we continue to uncover the impact of implicit bias in our medical decisions.

I hope you continue to take care of yourself, your families, and those in your communities. We are close to a return to normalcy but are not out of the woods yet. This is a time of reset in our nation, and we all should remember that we are a social network that works only when we look beyond ourselves. I have quoted Tom Friedman before: “Respect science, respect nature, respect each other.”

Have a happy and healthy spring.

John I. Allen, MD, MBA, AGAF
Editor in Chief

This May, DDW will again be a virtual meeting. Not only does this pandemic continue, but it has re-emerged with a vengeance in several states. Michigan leads the nation in cases per 100,000, with the UK variant now predominant. Younger adults are being most impacted. There have been almost 250 confirmed COVID-19 cases in fully vaccinated people in Michigan. COVID-19 will be with us for a long time.

Despite the disruption caused by the coronavirus, scientific research and the need for up-to-date education continues. There are numerous educational sessions that will be available for us to view and opportunities for interacting with speakers in many. I hope you will take advantage of a virtual DDW to refresh knowledge and learn about new modalities to care for our patients.

Three cover stories this month should be of interest. A new AGA guideline has been published and it recognizes the advances made in construction and use of intragastric balloons. Current balloons positively add to weigh loss and, when used correctly, are safer and more effective than in the past. Gastroenterologists should enter the bariatric arena in multiple ways from lifestyle counseling to endoscopic therapies. We have much to add to this field. Another cover article concerns infliximab’s influence on development of COVID-19 antibodies. The last discusses how minority status influences liver transplant listing; we continue to uncover the impact of implicit bias in our medical decisions.

I hope you continue to take care of yourself, your families, and those in your communities. We are close to a return to normalcy but are not out of the woods yet. This is a time of reset in our nation, and we all should remember that we are a social network that works only when we look beyond ourselves. I have quoted Tom Friedman before: “Respect science, respect nature, respect each other.”

Have a happy and healthy spring.

John I. Allen, MD, MBA, AGAF
Editor in Chief

This May, DDW will again be a virtual meeting. Not only does this pandemic continue, but it has re-emerged with a vengeance in several states. Michigan leads the nation in cases per 100,000, with the UK variant now predominant. Younger adults are being most impacted. There have been almost 250 confirmed COVID-19 cases in fully vaccinated people in Michigan. COVID-19 will be with us for a long time.

Despite the disruption caused by the coronavirus, scientific research and the need for up-to-date education continues. There are numerous educational sessions that will be available for us to view and opportunities for interacting with speakers in many. I hope you will take advantage of a virtual DDW to refresh knowledge and learn about new modalities to care for our patients.

Three cover stories this month should be of interest. A new AGA guideline has been published and it recognizes the advances made in construction and use of intragastric balloons. Current balloons positively add to weigh loss and, when used correctly, are safer and more effective than in the past. Gastroenterologists should enter the bariatric arena in multiple ways from lifestyle counseling to endoscopic therapies. We have much to add to this field. Another cover article concerns infliximab’s influence on development of COVID-19 antibodies. The last discusses how minority status influences liver transplant listing; we continue to uncover the impact of implicit bias in our medical decisions.

I hope you continue to take care of yourself, your families, and those in your communities. We are close to a return to normalcy but are not out of the woods yet. This is a time of reset in our nation, and we all should remember that we are a social network that works only when we look beyond ourselves. I have quoted Tom Friedman before: “Respect science, respect nature, respect each other.”

Have a happy and healthy spring.

John I. Allen, MD, MBA, AGAF
Editor in Chief

Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.

Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.

These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.

In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”¹ They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.

Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”

COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”

And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.

People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
 

What is moral distress?

Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.² Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.

Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.

Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”

Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.³ “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.

“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”

COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
 

What to call it

Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.⁴ More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”⁵

In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.

“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”

Courtesy Avera Health

“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.

“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
 

Where is the leadership?

“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.

“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”

David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.

“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”

In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.

But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.

“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
 

What can be done?

What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.

Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.

“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”

Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”

The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”

The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”

SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
 

Respect, advocacy, self-care

Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.

“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”

A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”

Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
 

References

1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.

2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.

3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.

4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.

5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.

Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.

Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.

These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.

In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”¹ They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.

Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”

COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”

And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.

People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
 

What is moral distress?

Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.² Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.

Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.

Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”

Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.³ “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.

“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”

COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
 

What to call it

Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.⁴ More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”⁵

In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.

“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”

Courtesy Avera Health

“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.

“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
 

Where is the leadership?

“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.

“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”

David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.

“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”

In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.

But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.

“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
 

What can be done?

What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.

Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.

“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”

Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”

The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”

The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”

SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
 

Respect, advocacy, self-care

Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.

“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”

A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”

Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
 

References

1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.

2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.

3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.

4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.

5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.

Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.

Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.

These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.

In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”¹ They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.

Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”

COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”

And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.

People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
 

What is moral distress?

Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.² Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.

Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.

Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”

Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.³ “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.

“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”

COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
 

What to call it

Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.⁴ More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”⁵

In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.

“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”

Courtesy Avera Health

“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.

“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
 

Where is the leadership?

“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.

“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”

David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.

“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”

In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.

But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.

“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
 

What can be done?

What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.

Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.

“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”

Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”

The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”

The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”

SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
 

Respect, advocacy, self-care

Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.

“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”

A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”

Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
 

References

1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.

2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.

3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.

4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.

5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

Potential advantages of a neoadjuvant systemic therapy approach including downstaging of the primary breast tumor and axilla, as well the ability to assess tumor response which can have prognostic and adjuvant therapy implications. Samiei and colleagues performed a systematic review and meta-analysis of 33 studies (57,531 patients) in the neoadjuvant setting to assess axillary pathologic complete response (pCR) rates among clinically node-positive breast cancer of various subtypes. HR-negative/HER2-positive subtype was associated with the highest pCR rate (60%) followed by 59% for HER2-positive, 48% for triple-negative, 45% for HR+/HER2-positive, 35% for luminal B, 18% for HR+/HER2-negative, and 13% for luminal A. Achievement of axillary pCR after pre-operative chemotherapy has been associated with improvement in relapse-free survival and overall survival. Furthermore, this data stimulates consideration of less invasive axillary staging in certain patients pending chemotherapy response, and the contribution of breast cancer subtype and impact on outcomes deserves further investigation.

Chemotherapy-induced alopecia (CIA) during breast cancer treatment can affect an individual’s perception of their own appearance, body image, overall health and therefore may impact quality of life. Wang et al performed a meta-analysis including 27 studies with 2,202 participants and demonstrated a 61% effectiveness rate of scalp cooling to protect hair loss. The effectiveness rates of scalp cooling when taxanes and anthracyclines were used alone were higher compared to combination therapy (74% for taxanes, 66% for anthracyclines, and 54% for combination). A prospective study including 139 patients treated with anthracycline chemotherapy for breast cancer receiving scalp cooling found a 43% success rate (hair loss £50%). It is important to consider chemotherapy regimen, side effects (headache, dizziness, pain, nausea), resources and cost when counseling patients regarding scalp cooling. Future studies exploring ways to address these potential challenges will be beneficial to improve patient access and tolerance to scalp cooling.

Obesity is associated with increased risk of various types of cancers, and can have a detrimental effect on cancer prognosis as well as treatment response and tolerance. Potential mechanisms to explain the relationship between obesity, physical activity and breast cancer prognosis include increased levels of sex and metabolic hormones, alteration in adipokine levels, and increased inflammation, oxidative stress and angiogenesis. A retrospective cohort study including 6,481 patients with an initial non-metastatic breast cancer diagnosis, majority of whom were overweight (33.4%) or obese (33.8%), observed increasing BMI (for every 5 kg/m² BMI increase) was associated with an increased risk of second cancer development (7%, RR=1.07; p=0.01), obesity-related cancer (13%, RR=1.13; p<0.001), second breast cancer (11%, RR=1.11; p0.01) and second ER-positive breast cancer (15%, RR1.15; p0.008). There are several ongoing clinical trials that are examining the impact of diet and weight loss interventions on breast cancer outcomes (DIANA-5, B-AHEAD3, Breast Cancer Weight Loss Study). These studies will be key to counseling and empowering patients to address potentially modifiable variables that can positively impact their health.

References:

Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O’Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldengerg DM, Sharkey RM, Maliakel P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/ HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31:1709-1718.

Mougalian SS, Hernandez M, Lei X, Lynch S, Kuerer HM, Symmans WF, Theriault RL, Fornage BD, Hsu L, Buchholz TA, Sahin AA, Hunt KK, Yang WT, Hortobagyi GN, Valero V. Ten-year outcomes of patients with breast cancer with cytologically confirmed axillary lymph node metastases and pathologic complete response after primary systemic chemotherapy. JAMA Oncol. 2016;2:508-516.

Munzone M, Bagnardi V, Campennì G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019;121:325–331.

McTiernan A. Weight, physical activity and breast cancer survival. Proc Nutr Soc. 2018;77:403–411.

Potential advantages of a neoadjuvant systemic therapy approach including downstaging of the primary breast tumor and axilla, as well the ability to assess tumor response which can have prognostic and adjuvant therapy implications. Samiei and colleagues performed a systematic review and meta-analysis of 33 studies (57,531 patients) in the neoadjuvant setting to assess axillary pathologic complete response (pCR) rates among clinically node-positive breast cancer of various subtypes. HR-negative/HER2-positive subtype was associated with the highest pCR rate (60%) followed by 59% for HER2-positive, 48% for triple-negative, 45% for HR+/HER2-positive, 35% for luminal B, 18% for HR+/HER2-negative, and 13% for luminal A. Achievement of axillary pCR after pre-operative chemotherapy has been associated with improvement in relapse-free survival and overall survival. Furthermore, this data stimulates consideration of less invasive axillary staging in certain patients pending chemotherapy response, and the contribution of breast cancer subtype and impact on outcomes deserves further investigation.

Chemotherapy-induced alopecia (CIA) during breast cancer treatment can affect an individual’s perception of their own appearance, body image, overall health and therefore may impact quality of life. Wang et al performed a meta-analysis including 27 studies with 2,202 participants and demonstrated a 61% effectiveness rate of scalp cooling to protect hair loss. The effectiveness rates of scalp cooling when taxanes and anthracyclines were used alone were higher compared to combination therapy (74% for taxanes, 66% for anthracyclines, and 54% for combination). A prospective study including 139 patients treated with anthracycline chemotherapy for breast cancer receiving scalp cooling found a 43% success rate (hair loss £50%). It is important to consider chemotherapy regimen, side effects (headache, dizziness, pain, nausea), resources and cost when counseling patients regarding scalp cooling. Future studies exploring ways to address these potential challenges will be beneficial to improve patient access and tolerance to scalp cooling.

Obesity is associated with increased risk of various types of cancers, and can have a detrimental effect on cancer prognosis as well as treatment response and tolerance. Potential mechanisms to explain the relationship between obesity, physical activity and breast cancer prognosis include increased levels of sex and metabolic hormones, alteration in adipokine levels, and increased inflammation, oxidative stress and angiogenesis. A retrospective cohort study including 6,481 patients with an initial non-metastatic breast cancer diagnosis, majority of whom were overweight (33.4%) or obese (33.8%), observed increasing BMI (for every 5 kg/m² BMI increase) was associated with an increased risk of second cancer development (7%, RR=1.07; p=0.01), obesity-related cancer (13%, RR=1.13; p<0.001), second breast cancer (11%, RR=1.11; p0.01) and second ER-positive breast cancer (15%, RR1.15; p0.008). There are several ongoing clinical trials that are examining the impact of diet and weight loss interventions on breast cancer outcomes (DIANA-5, B-AHEAD3, Breast Cancer Weight Loss Study). These studies will be key to counseling and empowering patients to address potentially modifiable variables that can positively impact their health.

References:

Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O’Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldengerg DM, Sharkey RM, Maliakel P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/ HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31:1709-1718.

Mougalian SS, Hernandez M, Lei X, Lynch S, Kuerer HM, Symmans WF, Theriault RL, Fornage BD, Hsu L, Buchholz TA, Sahin AA, Hunt KK, Yang WT, Hortobagyi GN, Valero V. Ten-year outcomes of patients with breast cancer with cytologically confirmed axillary lymph node metastases and pathologic complete response after primary systemic chemotherapy. JAMA Oncol. 2016;2:508-516.

Munzone M, Bagnardi V, Campennì G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019;121:325–331.

McTiernan A. Weight, physical activity and breast cancer survival. Proc Nutr Soc. 2018;77:403–411.

Potential advantages of a neoadjuvant systemic therapy approach including downstaging of the primary breast tumor and axilla, as well the ability to assess tumor response which can have prognostic and adjuvant therapy implications. Samiei and colleagues performed a systematic review and meta-analysis of 33 studies (57,531 patients) in the neoadjuvant setting to assess axillary pathologic complete response (pCR) rates among clinically node-positive breast cancer of various subtypes. HR-negative/HER2-positive subtype was associated with the highest pCR rate (60%) followed by 59% for HER2-positive, 48% for triple-negative, 45% for HR+/HER2-positive, 35% for luminal B, 18% for HR+/HER2-negative, and 13% for luminal A. Achievement of axillary pCR after pre-operative chemotherapy has been associated with improvement in relapse-free survival and overall survival. Furthermore, this data stimulates consideration of less invasive axillary staging in certain patients pending chemotherapy response, and the contribution of breast cancer subtype and impact on outcomes deserves further investigation.

Chemotherapy-induced alopecia (CIA) during breast cancer treatment can affect an individual’s perception of their own appearance, body image, overall health and therefore may impact quality of life. Wang et al performed a meta-analysis including 27 studies with 2,202 participants and demonstrated a 61% effectiveness rate of scalp cooling to protect hair loss. The effectiveness rates of scalp cooling when taxanes and anthracyclines were used alone were higher compared to combination therapy (74% for taxanes, 66% for anthracyclines, and 54% for combination). A prospective study including 139 patients treated with anthracycline chemotherapy for breast cancer receiving scalp cooling found a 43% success rate (hair loss £50%). It is important to consider chemotherapy regimen, side effects (headache, dizziness, pain, nausea), resources and cost when counseling patients regarding scalp cooling. Future studies exploring ways to address these potential challenges will be beneficial to improve patient access and tolerance to scalp cooling.

Obesity is associated with increased risk of various types of cancers, and can have a detrimental effect on cancer prognosis as well as treatment response and tolerance. Potential mechanisms to explain the relationship between obesity, physical activity and breast cancer prognosis include increased levels of sex and metabolic hormones, alteration in adipokine levels, and increased inflammation, oxidative stress and angiogenesis. A retrospective cohort study including 6,481 patients with an initial non-metastatic breast cancer diagnosis, majority of whom were overweight (33.4%) or obese (33.8%), observed increasing BMI (for every 5 kg/m² BMI increase) was associated with an increased risk of second cancer development (7%, RR=1.07; p=0.01), obesity-related cancer (13%, RR=1.13; p<0.001), second breast cancer (11%, RR=1.11; p0.01) and second ER-positive breast cancer (15%, RR1.15; p0.008). There are several ongoing clinical trials that are examining the impact of diet and weight loss interventions on breast cancer outcomes (DIANA-5, B-AHEAD3, Breast Cancer Weight Loss Study). These studies will be key to counseling and empowering patients to address potentially modifiable variables that can positively impact their health.

References:

Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O’Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldengerg DM, Sharkey RM, Maliakel P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/ HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31:1709-1718.

Mougalian SS, Hernandez M, Lei X, Lynch S, Kuerer HM, Symmans WF, Theriault RL, Fornage BD, Hsu L, Buchholz TA, Sahin AA, Hunt KK, Yang WT, Hortobagyi GN, Valero V. Ten-year outcomes of patients with breast cancer with cytologically confirmed axillary lymph node metastases and pathologic complete response after primary systemic chemotherapy. JAMA Oncol. 2016;2:508-516.

Munzone M, Bagnardi V, Campennì G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019;121:325–331.

McTiernan A. Weight, physical activity and breast cancer survival. Proc Nutr Soc. 2018;77:403–411.

Although PsA affects men and women equally, the impact of the disease is often worse in women. In a large study from the Netherlands, in which 855 patients were carefully evaluated and follow up, Mulder MLM et al show that both subjective and objective measures of disease activity is more severe in women than men. The PsA Disease Activity Score, a validated composite measure of PsA disease activity, was also higher in women than men. The impact of disease on quality of life and function was significantly more in women and they were less often meeting treatment target. Further research into the impact of sex and gender in PsA is warranted and sex/gender-specific measures for managing PsA is required.

Janus kinase inhibitors (JAKi) are important new molecules increasingly being used in the management of inflammatory diseases. Tofacitinib is already available for the treatment of PsA. McInnes IB et al published results on the efficacy of upadacitinib, a more selective JAK1i already approved for treatment of RA, in treating PsA. In this phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs, the proportion of patients achieving at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) than with placebo (36.2%; P less than .001). Upadacitinib 15mg was found to have comparable efficacy as adalimumab (ACR20 65.0%), a well-established anti-TNF agent. However, adverse events were more frequent with upadacitinib.

Adverse events when on treatment with JAKi have recently come into sharp focus. Reassuringly, results from the OPAL Balance study, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA on treatment with tofacitinib confirmed the long-term safety and efficacy of tofacitinib in patients with PsA. Nash P et al reported 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent with previous reports. However, given the reports of higher adverse events with tofacitinib compared to anti-TNF drugs in high-risk rheumatoid arthritis patients, more data is required to fully understand the risk profile of JAKi in patients with immune-mediated inflammatory diseases, including PsA.

With several drugs currently available to treat PsA and the paucity of head-to-head trials between them, choosing the most efficacious drug for treating patients with PsA has become challenging. To address this issue a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA was conducted. In a study sponsored by Janssen, Mease PJ et al report that guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to anti IL-17A and subcutaneous anti-TNF agents for achieving ACR20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents. The results indicate that guselkumab is as effective as other established agents in treating PsA, but formal head-to-head clinical trials will provide better evidence of relative efficacy and safety.

Although PsA affects men and women equally, the impact of the disease is often worse in women. In a large study from the Netherlands, in which 855 patients were carefully evaluated and follow up, Mulder MLM et al show that both subjective and objective measures of disease activity is more severe in women than men. The PsA Disease Activity Score, a validated composite measure of PsA disease activity, was also higher in women than men. The impact of disease on quality of life and function was significantly more in women and they were less often meeting treatment target. Further research into the impact of sex and gender in PsA is warranted and sex/gender-specific measures for managing PsA is required.

Janus kinase inhibitors (JAKi) are important new molecules increasingly being used in the management of inflammatory diseases. Tofacitinib is already available for the treatment of PsA. McInnes IB et al published results on the efficacy of upadacitinib, a more selective JAK1i already approved for treatment of RA, in treating PsA. In this phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs, the proportion of patients achieving at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) than with placebo (36.2%; P less than .001). Upadacitinib 15mg was found to have comparable efficacy as adalimumab (ACR20 65.0%), a well-established anti-TNF agent. However, adverse events were more frequent with upadacitinib.

Adverse events when on treatment with JAKi have recently come into sharp focus. Reassuringly, results from the OPAL Balance study, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA on treatment with tofacitinib confirmed the long-term safety and efficacy of tofacitinib in patients with PsA. Nash P et al reported 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent with previous reports. However, given the reports of higher adverse events with tofacitinib compared to anti-TNF drugs in high-risk rheumatoid arthritis patients, more data is required to fully understand the risk profile of JAKi in patients with immune-mediated inflammatory diseases, including PsA.

With several drugs currently available to treat PsA and the paucity of head-to-head trials between them, choosing the most efficacious drug for treating patients with PsA has become challenging. To address this issue a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA was conducted. In a study sponsored by Janssen, Mease PJ et al report that guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to anti IL-17A and subcutaneous anti-TNF agents for achieving ACR20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents. The results indicate that guselkumab is as effective as other established agents in treating PsA, but formal head-to-head clinical trials will provide better evidence of relative efficacy and safety.

Although PsA affects men and women equally, the impact of the disease is often worse in women. In a large study from the Netherlands, in which 855 patients were carefully evaluated and follow up, Mulder MLM et al show that both subjective and objective measures of disease activity is more severe in women than men. The PsA Disease Activity Score, a validated composite measure of PsA disease activity, was also higher in women than men. The impact of disease on quality of life and function was significantly more in women and they were less often meeting treatment target. Further research into the impact of sex and gender in PsA is warranted and sex/gender-specific measures for managing PsA is required.

Janus kinase inhibitors (JAKi) are important new molecules increasingly being used in the management of inflammatory diseases. Tofacitinib is already available for the treatment of PsA. McInnes IB et al published results on the efficacy of upadacitinib, a more selective JAK1i already approved for treatment of RA, in treating PsA. In this phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs, the proportion of patients achieving at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) than with placebo (36.2%; P less than .001). Upadacitinib 15mg was found to have comparable efficacy as adalimumab (ACR20 65.0%), a well-established anti-TNF agent. However, adverse events were more frequent with upadacitinib.

Adverse events when on treatment with JAKi have recently come into sharp focus. Reassuringly, results from the OPAL Balance study, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA on treatment with tofacitinib confirmed the long-term safety and efficacy of tofacitinib in patients with PsA. Nash P et al reported 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent with previous reports. However, given the reports of higher adverse events with tofacitinib compared to anti-TNF drugs in high-risk rheumatoid arthritis patients, more data is required to fully understand the risk profile of JAKi in patients with immune-mediated inflammatory diseases, including PsA.

With several drugs currently available to treat PsA and the paucity of head-to-head trials between them, choosing the most efficacious drug for treating patients with PsA has become challenging. To address this issue a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA was conducted. In a study sponsored by Janssen, Mease PJ et al report that guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to anti IL-17A and subcutaneous anti-TNF agents for achieving ACR20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents. The results indicate that guselkumab is as effective as other established agents in treating PsA, but formal head-to-head clinical trials will provide better evidence of relative efficacy and safety.

Key clinical point: In this real-world analysis of patients with psoriatic arthritis (PsA), interleukin-12/23 inhibitor (IL-12/23i) demonstrated longer persistence and higher adherence than tumor necrosis factor inhibitors (TNFi) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Major finding: At 1 year, persistence was significantly longer among patients who initiated IL-12/23i vs. TNFi (269 vs. 215 days) or tsDMARD (269 vs. 213 days; both P less than .001). Adherence was significantly higher among patients who initiated IL-12/23i vs. TNFi (0.64 vs. 0.56; P = .004) or tsDMARDs (0.64 vs. 0.58; P = .027).

Study details: In this retrospective observational analysis, 7,205 patients with PsA who newly initiated a targeted immune modulator were matched (1:1) in IL-12/23i vs. TNFi (n=238), IL-12/23i vs. tsDMARD (n=238), and IL-12/23i vs. IL-17i (n=189) patient pairs.

Disclosures: This study was funded by Janssen Scientific Affairs, LLC. LA Walsh declared receiving grants and/or serving as a consultant for various pharmaceutical companies. Q Cai, I Lin, CD Pericone, and SD Chakravarty declared being current employees of Janssen Scientific Affairs, LLC and stockholders in Johnson & Johnson.

Source: Walsh JA et al. Adv Ther. 2021 Mar 23. doi: 10.1007/s12325-021-01687-w.

Key clinical point: In this real-world analysis of patients with psoriatic arthritis (PsA), interleukin-12/23 inhibitor (IL-12/23i) demonstrated longer persistence and higher adherence than tumor necrosis factor inhibitors (TNFi) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Major finding: At 1 year, persistence was significantly longer among patients who initiated IL-12/23i vs. TNFi (269 vs. 215 days) or tsDMARD (269 vs. 213 days; both P less than .001). Adherence was significantly higher among patients who initiated IL-12/23i vs. TNFi (0.64 vs. 0.56; P = .004) or tsDMARDs (0.64 vs. 0.58; P = .027).

Study details: In this retrospective observational analysis, 7,205 patients with PsA who newly initiated a targeted immune modulator were matched (1:1) in IL-12/23i vs. TNFi (n=238), IL-12/23i vs. tsDMARD (n=238), and IL-12/23i vs. IL-17i (n=189) patient pairs.

Disclosures: This study was funded by Janssen Scientific Affairs, LLC. LA Walsh declared receiving grants and/or serving as a consultant for various pharmaceutical companies. Q Cai, I Lin, CD Pericone, and SD Chakravarty declared being current employees of Janssen Scientific Affairs, LLC and stockholders in Johnson & Johnson.

Source: Walsh JA et al. Adv Ther. 2021 Mar 23. doi: 10.1007/s12325-021-01687-w.

Key clinical point: In this real-world analysis of patients with psoriatic arthritis (PsA), interleukin-12/23 inhibitor (IL-12/23i) demonstrated longer persistence and higher adherence than tumor necrosis factor inhibitors (TNFi) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Major finding: At 1 year, persistence was significantly longer among patients who initiated IL-12/23i vs. TNFi (269 vs. 215 days) or tsDMARD (269 vs. 213 days; both P less than .001). Adherence was significantly higher among patients who initiated IL-12/23i vs. TNFi (0.64 vs. 0.56; P = .004) or tsDMARDs (0.64 vs. 0.58; P = .027).

Study details: In this retrospective observational analysis, 7,205 patients with PsA who newly initiated a targeted immune modulator were matched (1:1) in IL-12/23i vs. TNFi (n=238), IL-12/23i vs. tsDMARD (n=238), and IL-12/23i vs. IL-17i (n=189) patient pairs.

Disclosures: This study was funded by Janssen Scientific Affairs, LLC. LA Walsh declared receiving grants and/or serving as a consultant for various pharmaceutical companies. Q Cai, I Lin, CD Pericone, and SD Chakravarty declared being current employees of Janssen Scientific Affairs, LLC and stockholders in Johnson & Johnson.

Source: Walsh JA et al. Adv Ther. 2021 Mar 23. doi: 10.1007/s12325-021-01687-w.

Key clinical point: Fatigue is a prevalent phenomenon among patients with psoriatic arthritis (PsA) and strongly correlated with quality of life (QoL), disease activity, and levels of serum interleukin-17 (IL-17).

Major finding: Level of PsA disease activity was significantly correlated with measures of fatigue, functional capacity, and QoL (P less than .001). Moreover, QoL (P = .001), disease activity (P = .019), and serum IL-17 (P = .029) were significant independent predictive factors for fatigue.

Study details: The findings come from an analysis of 80 adults with PsA from the outpatient clinics of Physical Medicine, Rheumatology, & Rehabilitation Department, Tanta University Hospitals randomly selected during the period from December 2019 to August 2020.

Disclosures: This study did not receive any funding. All the authors declared no conflicts of interest.

Source: Gado SE et al. Expert Rev Clin Immunol. 2021 Apr 2. doi: 10.1080/1744666X.2021.1905522.

Key clinical point: Fatigue is a prevalent phenomenon among patients with psoriatic arthritis (PsA) and strongly correlated with quality of life (QoL), disease activity, and levels of serum interleukin-17 (IL-17).

Major finding: Level of PsA disease activity was significantly correlated with measures of fatigue, functional capacity, and QoL (P less than .001). Moreover, QoL (P = .001), disease activity (P = .019), and serum IL-17 (P = .029) were significant independent predictive factors for fatigue.

Study details: The findings come from an analysis of 80 adults with PsA from the outpatient clinics of Physical Medicine, Rheumatology, & Rehabilitation Department, Tanta University Hospitals randomly selected during the period from December 2019 to August 2020.

Disclosures: This study did not receive any funding. All the authors declared no conflicts of interest.

Source: Gado SE et al. Expert Rev Clin Immunol. 2021 Apr 2. doi: 10.1080/1744666X.2021.1905522.

Key clinical point: Fatigue is a prevalent phenomenon among patients with psoriatic arthritis (PsA) and strongly correlated with quality of life (QoL), disease activity, and levels of serum interleukin-17 (IL-17).

Major finding: Level of PsA disease activity was significantly correlated with measures of fatigue, functional capacity, and QoL (P less than .001). Moreover, QoL (P = .001), disease activity (P = .019), and serum IL-17 (P = .029) were significant independent predictive factors for fatigue.

Study details: The findings come from an analysis of 80 adults with PsA from the outpatient clinics of Physical Medicine, Rheumatology, & Rehabilitation Department, Tanta University Hospitals randomly selected during the period from December 2019 to August 2020.

Disclosures: This study did not receive any funding. All the authors declared no conflicts of interest.

Source: Gado SE et al. Expert Rev Clin Immunol. 2021 Apr 2. doi: 10.1080/1744666X.2021.1905522.

Key clinical point: Among biologic-naive individuals with psoriatic arthritis (PsA), interleukin-12/23 (IL-12/23) antagonists were less effective than tumor necrosis factor-alpha (TNF-α) inhibitors. PDE4 treatment was significantly less effective than TNF-α inhibitors among biologic-experienced individuals.

Major finding: Among biologic-naïve individuals, IL-12/23 was less effective than TNF-α (adjusted relative risk [aRR], 0.63; 95% confidence interval [CI], 0.45-0.89), whereas PDE4 treatment was less effective than TNF-α inhibitor among biologic-experienced individuals (aRR, 0.67; 95% CI, 0.46-0.96).

Study details: Findings are from a retrospective study of 2,730 commercially insured and Medicare Advantage beneficiaries with PsA.

Disclosures: The authors did not declare any specific funding for this research. GC Alexander declared being Chair of FDA’s peripheral and central nervous system advisory committee, serving as a paid advisor to IQVIA, and being a consultant and holding equity in Monument Analytics. JR Curtis declared receiving consultancies and funding from pharmaceutical companies.

Source: Zhang H et al. RMD Open. 2021 Apr 16. doi: 10.1136/rmdopen-2020-001399.

Key clinical point: Among biologic-naive individuals with psoriatic arthritis (PsA), interleukin-12/23 (IL-12/23) antagonists were less effective than tumor necrosis factor-alpha (TNF-α) inhibitors. PDE4 treatment was significantly less effective than TNF-α inhibitors among biologic-experienced individuals.

Major finding: Among biologic-naïve individuals, IL-12/23 was less effective than TNF-α (adjusted relative risk [aRR], 0.63; 95% confidence interval [CI], 0.45-0.89), whereas PDE4 treatment was less effective than TNF-α inhibitor among biologic-experienced individuals (aRR, 0.67; 95% CI, 0.46-0.96).

Study details: Findings are from a retrospective study of 2,730 commercially insured and Medicare Advantage beneficiaries with PsA.

Disclosures: The authors did not declare any specific funding for this research. GC Alexander declared being Chair of FDA’s peripheral and central nervous system advisory committee, serving as a paid advisor to IQVIA, and being a consultant and holding equity in Monument Analytics. JR Curtis declared receiving consultancies and funding from pharmaceutical companies.

Source: Zhang H et al. RMD Open. 2021 Apr 16. doi: 10.1136/rmdopen-2020-001399.

Key clinical point: Among biologic-naive individuals with psoriatic arthritis (PsA), interleukin-12/23 (IL-12/23) antagonists were less effective than tumor necrosis factor-alpha (TNF-α) inhibitors. PDE4 treatment was significantly less effective than TNF-α inhibitors among biologic-experienced individuals.

Major finding: Among biologic-naïve individuals, IL-12/23 was less effective than TNF-α (adjusted relative risk [aRR], 0.63; 95% confidence interval [CI], 0.45-0.89), whereas PDE4 treatment was less effective than TNF-α inhibitor among biologic-experienced individuals (aRR, 0.67; 95% CI, 0.46-0.96).

Study details: Findings are from a retrospective study of 2,730 commercially insured and Medicare Advantage beneficiaries with PsA.

Disclosures: The authors did not declare any specific funding for this research. GC Alexander declared being Chair of FDA’s peripheral and central nervous system advisory committee, serving as a paid advisor to IQVIA, and being a consultant and holding equity in Monument Analytics. JR Curtis declared receiving consultancies and funding from pharmaceutical companies.

Source: Zhang H et al. RMD Open. 2021 Apr 16. doi: 10.1136/rmdopen-2020-001399.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.