Seventy-three. That is the average number of questions asked daily by preschool-aged children.

Children ask questions to make sense of their world, to learn how things work, to verify their safety, and to interact with others. As a physician, a child and adolescent psychiatrist, and a father to 6-year-old twin daughters, I too am asking more questions these days. Both professionally and personally, these questions are prompted by shifts in routines, uncertainty, and anxiety brought on by the ongoing coronavirus disease 2019 (COVID-19) pandemic. In parallel, I find myself reflecting on my twin daughters’ questions; their questions reverberate with my own, and with the increased anxiety and fears of my patients and their parents.

With this in mind, I’d like to share 2 questions related to pediatric anxiety that may sculpt our clinical work—whether with children, adolescents, or adults—as we provide treatment and comfort to our patients during this pandemic of anxiety.

How do parents affect children’s anxiety?

First, children take cues from their parents. Almost a half century ago, child and adolescent psychiatrist Robert Emde, MD, and others, using elegantly designed experimental settings, documented that a mother’s response strongly influences her young son or daughter’s emotional reaction to a stranger, or to new situations.¹ Specifically, very young children were less afraid and interacted more with a stranger and did so more quickly when their mother had a positive (as opposed to neutral or fearful) reaction to the situation.² Further, in these studies, when the parent’s face was partially covered, very young children became more fearful. Taken together, these findings remind us that children actively seek to read the affective states of those who care for them, and use these reactions to anchor their responses to shifts in routine, such as those brought on by the ongoing COVID-19 pandemic.

Second, in reacting to the pandemic, parents model emotional regulation—an important skill that children and adolescents must develop as they experience intense affect and anxiety. As mental health clinicians, we know that emotional regulation is an essential component of mental health, and problems with it are a hallmark characteristic of several disorders, including anxiety disorders. Further, neuroimaging studies over the past decade have demonstrated that the way in which the medial prefrontal cortex and lower limbic structures (eg, the amygdala) are connected shifts from early childhood through adolescence and into early adulthood.³ It is likely that these shifts in functional connectivity are shaped by the environment as well as intrinsic aspects of the patient’s biology, and that these shifts subtend the developmental expression of anxiety, particularly in times of stress.

How should we talk to children about the pandemic?

Trust is not only the scaffold of our therapeutic relationships, but also a critical component of our conversations with children about the pandemic. Having established a trusting relationship prior to talking with children about their anxiety and about the pandemic, we will do well to remember that there is often more to a question than the actual direct interrogative. From a developmental standpoint, children may repeatedly ask the same question because they are struggling to understand an abstract concept, or are unable to make the same implicit causal link that we—as adults—have made. Also, children may ask the same question multiple times as a way of seeking reassurance. Finally, when a child asks her father “How many people are going to die?” she may actually be asking whether her parents, grandparents, or friends will be safe and healthy. Thus, as we talk with children, we must remember that they may be implicitly asking for more than a number, date, or mechanism. We must think about the motivation for their questions vis a vis their specific fears and past experiences.

For children, adolescents, and adults, the anxiety created by the pandemic constantly shifts, is hard-to-define, and pervades their lives. This ensuing chronic variable stress can worsen both physical and mental health.⁴ But, it also creates an opportunity for resiliency which—like the coronavirus—can be contagious.^5,6 Knowing this, I’d like to ask 4 questions, based on David Brooks’ recent Op-Ed in the New York Times⁷:

1. Can we become “softer and wiser” as a result of the pandemic?
2. How can we inoculate our patients against the loneliness and isolation that worsen most psychiatric disorders?
3. How can we “see deeper into [our]selves” to provide comfort to our patients, families, and each other as we confront this viral pandemic of anxiety?
4. Following “social distancing,” how do we rekindle “social trust”?

Seventy-three. That is the average number of questions asked daily by preschool-aged children.

Children ask questions to make sense of their world, to learn how things work, to verify their safety, and to interact with others. As a physician, a child and adolescent psychiatrist, and a father to 6-year-old twin daughters, I too am asking more questions these days. Both professionally and personally, these questions are prompted by shifts in routines, uncertainty, and anxiety brought on by the ongoing coronavirus disease 2019 (COVID-19) pandemic. In parallel, I find myself reflecting on my twin daughters’ questions; their questions reverberate with my own, and with the increased anxiety and fears of my patients and their parents.

With this in mind, I’d like to share 2 questions related to pediatric anxiety that may sculpt our clinical work—whether with children, adolescents, or adults—as we provide treatment and comfort to our patients during this pandemic of anxiety.

How do parents affect children’s anxiety?

First, children take cues from their parents. Almost a half century ago, child and adolescent psychiatrist Robert Emde, MD, and others, using elegantly designed experimental settings, documented that a mother’s response strongly influences her young son or daughter’s emotional reaction to a stranger, or to new situations.¹ Specifically, very young children were less afraid and interacted more with a stranger and did so more quickly when their mother had a positive (as opposed to neutral or fearful) reaction to the situation.² Further, in these studies, when the parent’s face was partially covered, very young children became more fearful. Taken together, these findings remind us that children actively seek to read the affective states of those who care for them, and use these reactions to anchor their responses to shifts in routine, such as those brought on by the ongoing COVID-19 pandemic.

Second, in reacting to the pandemic, parents model emotional regulation—an important skill that children and adolescents must develop as they experience intense affect and anxiety. As mental health clinicians, we know that emotional regulation is an essential component of mental health, and problems with it are a hallmark characteristic of several disorders, including anxiety disorders. Further, neuroimaging studies over the past decade have demonstrated that the way in which the medial prefrontal cortex and lower limbic structures (eg, the amygdala) are connected shifts from early childhood through adolescence and into early adulthood.³ It is likely that these shifts in functional connectivity are shaped by the environment as well as intrinsic aspects of the patient’s biology, and that these shifts subtend the developmental expression of anxiety, particularly in times of stress.

How should we talk to children about the pandemic?

Trust is not only the scaffold of our therapeutic relationships, but also a critical component of our conversations with children about the pandemic. Having established a trusting relationship prior to talking with children about their anxiety and about the pandemic, we will do well to remember that there is often more to a question than the actual direct interrogative. From a developmental standpoint, children may repeatedly ask the same question because they are struggling to understand an abstract concept, or are unable to make the same implicit causal link that we—as adults—have made. Also, children may ask the same question multiple times as a way of seeking reassurance. Finally, when a child asks her father “How many people are going to die?” she may actually be asking whether her parents, grandparents, or friends will be safe and healthy. Thus, as we talk with children, we must remember that they may be implicitly asking for more than a number, date, or mechanism. We must think about the motivation for their questions vis a vis their specific fears and past experiences.

For children, adolescents, and adults, the anxiety created by the pandemic constantly shifts, is hard-to-define, and pervades their lives. This ensuing chronic variable stress can worsen both physical and mental health.⁴ But, it also creates an opportunity for resiliency which—like the coronavirus—can be contagious.^5,6 Knowing this, I’d like to ask 4 questions, based on David Brooks’ recent Op-Ed in the New York Times⁷:

1. Can we become “softer and wiser” as a result of the pandemic?
2. How can we inoculate our patients against the loneliness and isolation that worsen most psychiatric disorders?
3. How can we “see deeper into [our]selves” to provide comfort to our patients, families, and each other as we confront this viral pandemic of anxiety?
4. Following “social distancing,” how do we rekindle “social trust”?

Seventy-three. That is the average number of questions asked daily by preschool-aged children.

Children ask questions to make sense of their world, to learn how things work, to verify their safety, and to interact with others. As a physician, a child and adolescent psychiatrist, and a father to 6-year-old twin daughters, I too am asking more questions these days. Both professionally and personally, these questions are prompted by shifts in routines, uncertainty, and anxiety brought on by the ongoing coronavirus disease 2019 (COVID-19) pandemic. In parallel, I find myself reflecting on my twin daughters’ questions; their questions reverberate with my own, and with the increased anxiety and fears of my patients and their parents.

With this in mind, I’d like to share 2 questions related to pediatric anxiety that may sculpt our clinical work—whether with children, adolescents, or adults—as we provide treatment and comfort to our patients during this pandemic of anxiety.

How do parents affect children’s anxiety?

First, children take cues from their parents. Almost a half century ago, child and adolescent psychiatrist Robert Emde, MD, and others, using elegantly designed experimental settings, documented that a mother’s response strongly influences her young son or daughter’s emotional reaction to a stranger, or to new situations.¹ Specifically, very young children were less afraid and interacted more with a stranger and did so more quickly when their mother had a positive (as opposed to neutral or fearful) reaction to the situation.² Further, in these studies, when the parent’s face was partially covered, very young children became more fearful. Taken together, these findings remind us that children actively seek to read the affective states of those who care for them, and use these reactions to anchor their responses to shifts in routine, such as those brought on by the ongoing COVID-19 pandemic.

Second, in reacting to the pandemic, parents model emotional regulation—an important skill that children and adolescents must develop as they experience intense affect and anxiety. As mental health clinicians, we know that emotional regulation is an essential component of mental health, and problems with it are a hallmark characteristic of several disorders, including anxiety disorders. Further, neuroimaging studies over the past decade have demonstrated that the way in which the medial prefrontal cortex and lower limbic structures (eg, the amygdala) are connected shifts from early childhood through adolescence and into early adulthood.³ It is likely that these shifts in functional connectivity are shaped by the environment as well as intrinsic aspects of the patient’s biology, and that these shifts subtend the developmental expression of anxiety, particularly in times of stress.

How should we talk to children about the pandemic?

Trust is not only the scaffold of our therapeutic relationships, but also a critical component of our conversations with children about the pandemic. Having established a trusting relationship prior to talking with children about their anxiety and about the pandemic, we will do well to remember that there is often more to a question than the actual direct interrogative. From a developmental standpoint, children may repeatedly ask the same question because they are struggling to understand an abstract concept, or are unable to make the same implicit causal link that we—as adults—have made. Also, children may ask the same question multiple times as a way of seeking reassurance. Finally, when a child asks her father “How many people are going to die?” she may actually be asking whether her parents, grandparents, or friends will be safe and healthy. Thus, as we talk with children, we must remember that they may be implicitly asking for more than a number, date, or mechanism. We must think about the motivation for their questions vis a vis their specific fears and past experiences.

For children, adolescents, and adults, the anxiety created by the pandemic constantly shifts, is hard-to-define, and pervades their lives. This ensuing chronic variable stress can worsen both physical and mental health.⁴ But, it also creates an opportunity for resiliency which—like the coronavirus—can be contagious.^5,6 Knowing this, I’d like to ask 4 questions, based on David Brooks’ recent Op-Ed in the New York Times⁷:

1. Can we become “softer and wiser” as a result of the pandemic?
2. How can we inoculate our patients against the loneliness and isolation that worsen most psychiatric disorders?
3. How can we “see deeper into [our]selves” to provide comfort to our patients, families, and each other as we confront this viral pandemic of anxiety?
4. Following “social distancing,” how do we rekindle “social trust”?

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

[email protected]

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

[email protected]

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

[email protected]

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

Visit the AGA GI Patient Center for information on pancreatitis to share with your patients at https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

Visit the AGA GI Patient Center for information on pancreatitis to share with your patients at https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

Visit the AGA GI Patient Center for information on pancreatitis to share with your patients at https://www.gastro.org/practice-guidance/gi-patient-center/topic/pancreatitis.

Because of stark racial disparities in COVID-19 infection and mortality, the pandemic is being called a “sentinel” and “bellwether” event that should push the United States to finally come to grips with disparities in health care.

When it comes to COVID-19, the pattern is “irrefutable”: Blacks in the United States are being infected with SARS-CoV-2 and are dying of COVID-19 at higher rates than whites, Clyde W. Yancy, MD, Northwestern University, Chicago, wrote in a viewpoint article published online April 15 in JAMA.

According to one recent survey, he noted, the infection rate is threefold higher and the death rate is sixfold higher in predominantly black counties in the United States relative to predominantly white counties.

A sixfold increase in the rate of death for blacks due to a now ubiquitous virus should be deemed “unconscionable” and a moment of “ethical reckoning,” Dr. Yancy wrote.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

The COVID-19 pandemic may be the “bellwether” event that the United States has needed to fully address disparities in health care, Dr. Yancy said.

“Public health is complicated and social reengineering is complex, but change of this magnitude does not happen without a new resolve,” he concluded. “The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event. Certainly, within the broad and powerful economic and legislative engines of the U.S., there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain.”

The question is, he asks, will the nation finally “think differently, and, as has been done in response to other major diseases, declare that a civil society will no longer accept disproportionate suffering?”

Keith C. Ferdinand, MD, Tulane University, New Orleans, doesn’t think so.

In a related editorial published online April 17 in the Journal of the American College of Cardiology, he points out that the 1985 Heckler Report, from the Department of Health and Human Services, documented higher racial/ethnic mortality rates and the need to correct them. This was followed in 2002 by a report from the Institute of Medicine called Unequal Treatment that also underscored health disparities.

Despite some progress, the goal of reducing and eventually eliminating racial/ethnic disparities has not been realized, Dr. Ferdinand said. “I think baked into the consciousness of the American psyche is that there are some people who have and some who have not,” he said in an interview.

“To some extent, some societies at some point become immune. We would not like to think that America, with its sense of egalitarianism, would get to that point, but maybe we have,” said Dr. Ferdinand.
 

A ‘sentinel event’

He points out that black people are not genetically or biologically predisposed to COVID-19 but are socially prone to coronavirus exposure and are more likely to have comorbid conditions, such as hypertension, diabetes, obesity, and heart disease, that fuel complications.

The “tragic” higher COVID-19 mortality among African Americans and other racial/ethnic minorities confirms “inadequate” efforts on the part of society to eliminate disparities in cardiovascular disease (CVD) and is a “sentinel event,” Dr. Ferdinand wrote.

A sentinel event, as defined by the Joint Commission, is an unexpected occurrence that leads to death or serious physical or psychological injury or the risk thereof, he explained.

“Conventionally identified sentinel events, such as unintended retention of foreign objects and fall-related events, are used to evaluate quality in hospital care. Similarly, disparate [African American] COVID-19 mortality reflects long-standing, unacceptable U.S. racial/ethnic and socioeconomic CVD inequities and unmasks system failures and unacceptable care to be caught and mitigated,” Dr. Ferdinand concluded.

Dr. Yancy and Dr. Ferdinand have disclosed no relevant financial relationships.

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

Because of stark racial disparities in COVID-19 infection and mortality, the pandemic is being called a “sentinel” and “bellwether” event that should push the United States to finally come to grips with disparities in health care.

When it comes to COVID-19, the pattern is “irrefutable”: Blacks in the United States are being infected with SARS-CoV-2 and are dying of COVID-19 at higher rates than whites, Clyde W. Yancy, MD, Northwestern University, Chicago, wrote in a viewpoint article published online April 15 in JAMA.

According to one recent survey, he noted, the infection rate is threefold higher and the death rate is sixfold higher in predominantly black counties in the United States relative to predominantly white counties.

A sixfold increase in the rate of death for blacks due to a now ubiquitous virus should be deemed “unconscionable” and a moment of “ethical reckoning,” Dr. Yancy wrote.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

The COVID-19 pandemic may be the “bellwether” event that the United States has needed to fully address disparities in health care, Dr. Yancy said.

“Public health is complicated and social reengineering is complex, but change of this magnitude does not happen without a new resolve,” he concluded. “The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event. Certainly, within the broad and powerful economic and legislative engines of the U.S., there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain.”

The question is, he asks, will the nation finally “think differently, and, as has been done in response to other major diseases, declare that a civil society will no longer accept disproportionate suffering?”

Keith C. Ferdinand, MD, Tulane University, New Orleans, doesn’t think so.

In a related editorial published online April 17 in the Journal of the American College of Cardiology, he points out that the 1985 Heckler Report, from the Department of Health and Human Services, documented higher racial/ethnic mortality rates and the need to correct them. This was followed in 2002 by a report from the Institute of Medicine called Unequal Treatment that also underscored health disparities.

Despite some progress, the goal of reducing and eventually eliminating racial/ethnic disparities has not been realized, Dr. Ferdinand said. “I think baked into the consciousness of the American psyche is that there are some people who have and some who have not,” he said in an interview.

“To some extent, some societies at some point become immune. We would not like to think that America, with its sense of egalitarianism, would get to that point, but maybe we have,” said Dr. Ferdinand.
 

A ‘sentinel event’

He points out that black people are not genetically or biologically predisposed to COVID-19 but are socially prone to coronavirus exposure and are more likely to have comorbid conditions, such as hypertension, diabetes, obesity, and heart disease, that fuel complications.

The “tragic” higher COVID-19 mortality among African Americans and other racial/ethnic minorities confirms “inadequate” efforts on the part of society to eliminate disparities in cardiovascular disease (CVD) and is a “sentinel event,” Dr. Ferdinand wrote.

A sentinel event, as defined by the Joint Commission, is an unexpected occurrence that leads to death or serious physical or psychological injury or the risk thereof, he explained.

“Conventionally identified sentinel events, such as unintended retention of foreign objects and fall-related events, are used to evaluate quality in hospital care. Similarly, disparate [African American] COVID-19 mortality reflects long-standing, unacceptable U.S. racial/ethnic and socioeconomic CVD inequities and unmasks system failures and unacceptable care to be caught and mitigated,” Dr. Ferdinand concluded.

Dr. Yancy and Dr. Ferdinand have disclosed no relevant financial relationships.

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

Because of stark racial disparities in COVID-19 infection and mortality, the pandemic is being called a “sentinel” and “bellwether” event that should push the United States to finally come to grips with disparities in health care.

When it comes to COVID-19, the pattern is “irrefutable”: Blacks in the United States are being infected with SARS-CoV-2 and are dying of COVID-19 at higher rates than whites, Clyde W. Yancy, MD, Northwestern University, Chicago, wrote in a viewpoint article published online April 15 in JAMA.

According to one recent survey, he noted, the infection rate is threefold higher and the death rate is sixfold higher in predominantly black counties in the United States relative to predominantly white counties.

A sixfold increase in the rate of death for blacks due to a now ubiquitous virus should be deemed “unconscionable” and a moment of “ethical reckoning,” Dr. Yancy wrote.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

The COVID-19 pandemic may be the “bellwether” event that the United States has needed to fully address disparities in health care, Dr. Yancy said.

“Public health is complicated and social reengineering is complex, but change of this magnitude does not happen without a new resolve,” he concluded. “The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event. Certainly, within the broad and powerful economic and legislative engines of the U.S., there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain.”

The question is, he asks, will the nation finally “think differently, and, as has been done in response to other major diseases, declare that a civil society will no longer accept disproportionate suffering?”

Keith C. Ferdinand, MD, Tulane University, New Orleans, doesn’t think so.

In a related editorial published online April 17 in the Journal of the American College of Cardiology, he points out that the 1985 Heckler Report, from the Department of Health and Human Services, documented higher racial/ethnic mortality rates and the need to correct them. This was followed in 2002 by a report from the Institute of Medicine called Unequal Treatment that also underscored health disparities.

Despite some progress, the goal of reducing and eventually eliminating racial/ethnic disparities has not been realized, Dr. Ferdinand said. “I think baked into the consciousness of the American psyche is that there are some people who have and some who have not,” he said in an interview.

“To some extent, some societies at some point become immune. We would not like to think that America, with its sense of egalitarianism, would get to that point, but maybe we have,” said Dr. Ferdinand.
 

A ‘sentinel event’

He points out that black people are not genetically or biologically predisposed to COVID-19 but are socially prone to coronavirus exposure and are more likely to have comorbid conditions, such as hypertension, diabetes, obesity, and heart disease, that fuel complications.

The “tragic” higher COVID-19 mortality among African Americans and other racial/ethnic minorities confirms “inadequate” efforts on the part of society to eliminate disparities in cardiovascular disease (CVD) and is a “sentinel event,” Dr. Ferdinand wrote.

A sentinel event, as defined by the Joint Commission, is an unexpected occurrence that leads to death or serious physical or psychological injury or the risk thereof, he explained.

“Conventionally identified sentinel events, such as unintended retention of foreign objects and fall-related events, are used to evaluate quality in hospital care. Similarly, disparate [African American] COVID-19 mortality reflects long-standing, unacceptable U.S. racial/ethnic and socioeconomic CVD inequities and unmasks system failures and unacceptable care to be caught and mitigated,” Dr. Ferdinand concluded.

Dr. Yancy and Dr. Ferdinand have disclosed no relevant financial relationships.

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

Like other agencies, the European Society for Medical Oncology has developed guidelines for managing breast cancer patients during the COVID-19 pandemic, recommending when care should be prioritized, delayed, or modified.

ESMO’s breast cancer guidelines expand upon guidelines issued by other groups, addressing a broad spectrum of patient profiles and providing a creative array of treatment options in COVID-19–era clinical practice.

As with ESMO’s other disease-focused COVID-19 guidelines, the breast cancer guidelines are organized by priority levels – high, medium, and low – which are applied to several domains of diagnosis and treatment.

High-priority recommendations apply to patients whose condition is either clinically unstable or whose cancer burden is immediately life-threatening.

Medium-priority recommendations apply to patients for whom delaying care beyond 6 weeks would probably lower the likelihood of a significant benefit from the intervention.

Low-priority recommendations apply to patients for whom services can be delayed for the duration of the COVID-19 pandemic.
 

Personalized care and high-priority situations

ESMO’s guidelines suggest that multidisciplinary tumor boards should guide decisions about the urgency of care for individual patients, given the complexity of breast cancer biology, the multiplicity of evidence-based treatments, and the possibility of cure or durable high-quality remissions.

The guidelines deliver a clear message that prepandemic discussions about delivering personalized care are even more important now.

ESMO prioritizes investigating high-risk screening mammography results (i.e., BIRADS 5), lumps noted on breast self-examination, clinical evidence of local-regional recurrence, and breast cancer in pregnant women.

Making these scenarios “high priority” will facilitate the best long-term outcomes in time-sensitive scenarios and improve patient satisfaction with care.

Modifications to consider

ESMO provides explicit options for treatment of common breast cancer profiles in which short-term modifications of standard management strategies can safely be considered. Given the generally long natural history of most breast cancer subtypes, these temporary modifications are unlikely to compromise long-term outcomes.

For patients with a new diagnosis of localized breast cancer, the guidelines recommend neoadjuvant chemotherapy, targeted therapy, or hormonal therapy to achieve optimal breast cancer outcomes and safely delay surgery or radiotherapy.

In the metastatic setting, ESMO advises providers to consider:

• Symptom-oriented testing, recognizing the arguable benefit of frequent imaging or serum tumor marker measurement (J Clin Oncol. 2016 Aug 20;34[24]:2820-6).
• Drug holidays, de-escalated maintenance therapy, and protracted schedules of bone-modifying agents.
• Avoiding mTOR and PI3KCA inhibitors as an addition to standard hormonal therapy because of pneumonitis, hyperglycemia, and immunosuppression risks. The guidelines suggest careful thought about adding CDK4/6 inhibitors to standard hormonal therapy because of the added burden of remote safety monitoring with the biologic agents.

ESMO makes suggestions about trimming the duration of adjuvant trastuzumab to 6 months, as in the PERSEPHONE study (Lancet. 2019 Jun 29;393[10191]:2599-612), and modifying the schedule of luteinizing hormone–releasing hormone agonist administration, in an effort to reduce patient exposure to health care personnel (and vice versa).

The guidelines recommend continuing clinical trials if benefits to patients outweigh risks and trials can be modified to enhance patient safety while preserving study endpoint evaluations.
 

Lower-priority situations

ESMO pointedly assigns a low priority to follow-up of patients who are at high risk of relapse but lack signs or symptoms of relapse.

Like other groups, ESMO recommends that patients with equivocal (i.e., BIRADS 3) screening mammograms should have 6-month follow-up imaging in preference to immediate core needle biopsy of the area(s) of concern.

ESMO uses age to assign priority for postponing adjuvant breast radiation in patients with low- to moderate-risk lesions. However, the guidelines stop surprisingly short of recommending that adjuvant radiation be withheld for older patients with low-risk, stage I, hormonally sensitive, HER2-negative breast cancers who receive endocrine therapy.
 

Bottom line

The pragmatic adjustments ESMO suggests address the challenges of evaluating and treating breast cancer patients during the COVID-19 pandemic. The guidelines protect each patient’s right to care and safety as well as protecting the safety of caregivers.

The guidelines will likely heighten patients’ satisfaction with care and decrease concern about adequacy of timely evaluation and treatment.
 

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Like other agencies, the European Society for Medical Oncology has developed guidelines for managing breast cancer patients during the COVID-19 pandemic, recommending when care should be prioritized, delayed, or modified.

ESMO’s breast cancer guidelines expand upon guidelines issued by other groups, addressing a broad spectrum of patient profiles and providing a creative array of treatment options in COVID-19–era clinical practice.

As with ESMO’s other disease-focused COVID-19 guidelines, the breast cancer guidelines are organized by priority levels – high, medium, and low – which are applied to several domains of diagnosis and treatment.

High-priority recommendations apply to patients whose condition is either clinically unstable or whose cancer burden is immediately life-threatening.

Medium-priority recommendations apply to patients for whom delaying care beyond 6 weeks would probably lower the likelihood of a significant benefit from the intervention.

Low-priority recommendations apply to patients for whom services can be delayed for the duration of the COVID-19 pandemic.
 

Personalized care and high-priority situations

ESMO’s guidelines suggest that multidisciplinary tumor boards should guide decisions about the urgency of care for individual patients, given the complexity of breast cancer biology, the multiplicity of evidence-based treatments, and the possibility of cure or durable high-quality remissions.

The guidelines deliver a clear message that prepandemic discussions about delivering personalized care are even more important now.

ESMO prioritizes investigating high-risk screening mammography results (i.e., BIRADS 5), lumps noted on breast self-examination, clinical evidence of local-regional recurrence, and breast cancer in pregnant women.

Making these scenarios “high priority” will facilitate the best long-term outcomes in time-sensitive scenarios and improve patient satisfaction with care.

Modifications to consider

ESMO provides explicit options for treatment of common breast cancer profiles in which short-term modifications of standard management strategies can safely be considered. Given the generally long natural history of most breast cancer subtypes, these temporary modifications are unlikely to compromise long-term outcomes.

For patients with a new diagnosis of localized breast cancer, the guidelines recommend neoadjuvant chemotherapy, targeted therapy, or hormonal therapy to achieve optimal breast cancer outcomes and safely delay surgery or radiotherapy.

In the metastatic setting, ESMO advises providers to consider:

• Symptom-oriented testing, recognizing the arguable benefit of frequent imaging or serum tumor marker measurement (J Clin Oncol. 2016 Aug 20;34[24]:2820-6).
• Drug holidays, de-escalated maintenance therapy, and protracted schedules of bone-modifying agents.
• Avoiding mTOR and PI3KCA inhibitors as an addition to standard hormonal therapy because of pneumonitis, hyperglycemia, and immunosuppression risks. The guidelines suggest careful thought about adding CDK4/6 inhibitors to standard hormonal therapy because of the added burden of remote safety monitoring with the biologic agents.

ESMO makes suggestions about trimming the duration of adjuvant trastuzumab to 6 months, as in the PERSEPHONE study (Lancet. 2019 Jun 29;393[10191]:2599-612), and modifying the schedule of luteinizing hormone–releasing hormone agonist administration, in an effort to reduce patient exposure to health care personnel (and vice versa).

The guidelines recommend continuing clinical trials if benefits to patients outweigh risks and trials can be modified to enhance patient safety while preserving study endpoint evaluations.
 

Lower-priority situations

ESMO pointedly assigns a low priority to follow-up of patients who are at high risk of relapse but lack signs or symptoms of relapse.

Like other groups, ESMO recommends that patients with equivocal (i.e., BIRADS 3) screening mammograms should have 6-month follow-up imaging in preference to immediate core needle biopsy of the area(s) of concern.

ESMO uses age to assign priority for postponing adjuvant breast radiation in patients with low- to moderate-risk lesions. However, the guidelines stop surprisingly short of recommending that adjuvant radiation be withheld for older patients with low-risk, stage I, hormonally sensitive, HER2-negative breast cancers who receive endocrine therapy.
 

Bottom line

The pragmatic adjustments ESMO suggests address the challenges of evaluating and treating breast cancer patients during the COVID-19 pandemic. The guidelines protect each patient’s right to care and safety as well as protecting the safety of caregivers.

The guidelines will likely heighten patients’ satisfaction with care and decrease concern about adequacy of timely evaluation and treatment.
 

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Like other agencies, the European Society for Medical Oncology has developed guidelines for managing breast cancer patients during the COVID-19 pandemic, recommending when care should be prioritized, delayed, or modified.

ESMO’s breast cancer guidelines expand upon guidelines issued by other groups, addressing a broad spectrum of patient profiles and providing a creative array of treatment options in COVID-19–era clinical practice.

As with ESMO’s other disease-focused COVID-19 guidelines, the breast cancer guidelines are organized by priority levels – high, medium, and low – which are applied to several domains of diagnosis and treatment.

High-priority recommendations apply to patients whose condition is either clinically unstable or whose cancer burden is immediately life-threatening.

Medium-priority recommendations apply to patients for whom delaying care beyond 6 weeks would probably lower the likelihood of a significant benefit from the intervention.

Low-priority recommendations apply to patients for whom services can be delayed for the duration of the COVID-19 pandemic.
 

Personalized care and high-priority situations

ESMO’s guidelines suggest that multidisciplinary tumor boards should guide decisions about the urgency of care for individual patients, given the complexity of breast cancer biology, the multiplicity of evidence-based treatments, and the possibility of cure or durable high-quality remissions.

The guidelines deliver a clear message that prepandemic discussions about delivering personalized care are even more important now.

ESMO prioritizes investigating high-risk screening mammography results (i.e., BIRADS 5), lumps noted on breast self-examination, clinical evidence of local-regional recurrence, and breast cancer in pregnant women.

Making these scenarios “high priority” will facilitate the best long-term outcomes in time-sensitive scenarios and improve patient satisfaction with care.

Modifications to consider

ESMO provides explicit options for treatment of common breast cancer profiles in which short-term modifications of standard management strategies can safely be considered. Given the generally long natural history of most breast cancer subtypes, these temporary modifications are unlikely to compromise long-term outcomes.

For patients with a new diagnosis of localized breast cancer, the guidelines recommend neoadjuvant chemotherapy, targeted therapy, or hormonal therapy to achieve optimal breast cancer outcomes and safely delay surgery or radiotherapy.

In the metastatic setting, ESMO advises providers to consider:

• Symptom-oriented testing, recognizing the arguable benefit of frequent imaging or serum tumor marker measurement (J Clin Oncol. 2016 Aug 20;34[24]:2820-6).
• Drug holidays, de-escalated maintenance therapy, and protracted schedules of bone-modifying agents.
• Avoiding mTOR and PI3KCA inhibitors as an addition to standard hormonal therapy because of pneumonitis, hyperglycemia, and immunosuppression risks. The guidelines suggest careful thought about adding CDK4/6 inhibitors to standard hormonal therapy because of the added burden of remote safety monitoring with the biologic agents.

ESMO makes suggestions about trimming the duration of adjuvant trastuzumab to 6 months, as in the PERSEPHONE study (Lancet. 2019 Jun 29;393[10191]:2599-612), and modifying the schedule of luteinizing hormone–releasing hormone agonist administration, in an effort to reduce patient exposure to health care personnel (and vice versa).

The guidelines recommend continuing clinical trials if benefits to patients outweigh risks and trials can be modified to enhance patient safety while preserving study endpoint evaluations.
 

Lower-priority situations

ESMO pointedly assigns a low priority to follow-up of patients who are at high risk of relapse but lack signs or symptoms of relapse.

Like other groups, ESMO recommends that patients with equivocal (i.e., BIRADS 3) screening mammograms should have 6-month follow-up imaging in preference to immediate core needle biopsy of the area(s) of concern.

ESMO uses age to assign priority for postponing adjuvant breast radiation in patients with low- to moderate-risk lesions. However, the guidelines stop surprisingly short of recommending that adjuvant radiation be withheld for older patients with low-risk, stage I, hormonally sensitive, HER2-negative breast cancers who receive endocrine therapy.
 

Bottom line

The pragmatic adjustments ESMO suggests address the challenges of evaluating and treating breast cancer patients during the COVID-19 pandemic. The guidelines protect each patient’s right to care and safety as well as protecting the safety of caregivers.

The guidelines will likely heighten patients’ satisfaction with care and decrease concern about adequacy of timely evaluation and treatment.
 

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Both antiadalimumab (Humira) antibodies and adalimumab serum levels fell short on predicting drug responses in rheumatoid arthritis patients who failed initial adalimumab therapy, based on a retrospective cohort study of 137 adults.

Biologic disease-modifying antirheumatic drugs (bDMARDs), notably adalimumab, are often prescribed for RA, but “approximately 41% of RA patients do not achieve good response after 6 months of treatment with adalimumab,” wrote Evy Ulijn of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues. Preliminary studies have suggested that antiadalimumab antibodies (antidrug antibodies, ADA) and adalimumab serum levels (ADL) may predict the response to a second bDMARD in patients who fail initial adalimumab treatment, they said.

In a study published in Annals of the Rheumatic Diseases, the researchers examined data from 137 adult RA patients seen at the clinic during Jan. 2012–Jan. 2018 who failed to respond to adalimumab after at least 3 months of treatment and started another bDMARD. The average age of the patients was 64 years, and approximately 69% were women.

Overall, the presence of ADA was not a significant predictor of a European League Against Rheumatism good response in patients who switched to another TNFi (etanercept, golimumab, infliximab, or certolizumab pegol), with sensitivity of 18% and specificity of 75%. ADA also was not predictive of response to a non-TNFi bDMARD (rituximab, tocilizumab, or abatacept), with sensitivity and specificity of 33% and 70%, respectively.

Similarly, ADL levels in patients who switched to a TNFi or non-TNFi were not significant predictors of treatment response, with sensitivities and specificities of 50% and 52%, respectively, for TNFi and 32% and 69%, respectively, for non-TNFi.

The findings that neither ADA nor ADL showed predictive values contrast with previous studies, the researchers said.

“Not only did the results of this study show no predictive values, in some analyses a prediction is found in the opposite direction of what was expected,” they wrote.

The study findings were limited by several factors, including the random timing of sample collection, retrospective study design, and potential for misclassification of responders or nonresponders, the researchers noted.

However, the results were strengthened by the blinded choice of treatment and outcome assessment, larger sample size than previous studies, and focus on adalimumab in particular, they said.

“While counterintuitive, it is hard to find an explanation for the lack of a positive finding,” they concluded.

More research is needed to confirm the predictive value of ADA and ADL, they said. In the meantime, rheumatologists should base decisions to switch patients to TNFi or non-TNFi treatment after adalimumab failure based on factors including side effects, local protocol, economical aspects, and patient preferences, they said.

The study received no external funding. The researchers had no financial conflicts to disclose.

SOURCE: Ulijn E et al. Ann Rheum Dis. 2020 Apr 21. doi: 10.1136/annrheumdis-2020-216996.

Both antiadalimumab (Humira) antibodies and adalimumab serum levels fell short on predicting drug responses in rheumatoid arthritis patients who failed initial adalimumab therapy, based on a retrospective cohort study of 137 adults.

Biologic disease-modifying antirheumatic drugs (bDMARDs), notably adalimumab, are often prescribed for RA, but “approximately 41% of RA patients do not achieve good response after 6 months of treatment with adalimumab,” wrote Evy Ulijn of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues. Preliminary studies have suggested that antiadalimumab antibodies (antidrug antibodies, ADA) and adalimumab serum levels (ADL) may predict the response to a second bDMARD in patients who fail initial adalimumab treatment, they said.

In a study published in Annals of the Rheumatic Diseases, the researchers examined data from 137 adult RA patients seen at the clinic during Jan. 2012–Jan. 2018 who failed to respond to adalimumab after at least 3 months of treatment and started another bDMARD. The average age of the patients was 64 years, and approximately 69% were women.

Overall, the presence of ADA was not a significant predictor of a European League Against Rheumatism good response in patients who switched to another TNFi (etanercept, golimumab, infliximab, or certolizumab pegol), with sensitivity of 18% and specificity of 75%. ADA also was not predictive of response to a non-TNFi bDMARD (rituximab, tocilizumab, or abatacept), with sensitivity and specificity of 33% and 70%, respectively.

Similarly, ADL levels in patients who switched to a TNFi or non-TNFi were not significant predictors of treatment response, with sensitivities and specificities of 50% and 52%, respectively, for TNFi and 32% and 69%, respectively, for non-TNFi.

The findings that neither ADA nor ADL showed predictive values contrast with previous studies, the researchers said.

“Not only did the results of this study show no predictive values, in some analyses a prediction is found in the opposite direction of what was expected,” they wrote.

The study findings were limited by several factors, including the random timing of sample collection, retrospective study design, and potential for misclassification of responders or nonresponders, the researchers noted.

However, the results were strengthened by the blinded choice of treatment and outcome assessment, larger sample size than previous studies, and focus on adalimumab in particular, they said.

“While counterintuitive, it is hard to find an explanation for the lack of a positive finding,” they concluded.

More research is needed to confirm the predictive value of ADA and ADL, they said. In the meantime, rheumatologists should base decisions to switch patients to TNFi or non-TNFi treatment after adalimumab failure based on factors including side effects, local protocol, economical aspects, and patient preferences, they said.

The study received no external funding. The researchers had no financial conflicts to disclose.

SOURCE: Ulijn E et al. Ann Rheum Dis. 2020 Apr 21. doi: 10.1136/annrheumdis-2020-216996.

Both antiadalimumab (Humira) antibodies and adalimumab serum levels fell short on predicting drug responses in rheumatoid arthritis patients who failed initial adalimumab therapy, based on a retrospective cohort study of 137 adults.

Biologic disease-modifying antirheumatic drugs (bDMARDs), notably adalimumab, are often prescribed for RA, but “approximately 41% of RA patients do not achieve good response after 6 months of treatment with adalimumab,” wrote Evy Ulijn of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues. Preliminary studies have suggested that antiadalimumab antibodies (antidrug antibodies, ADA) and adalimumab serum levels (ADL) may predict the response to a second bDMARD in patients who fail initial adalimumab treatment, they said.

In a study published in Annals of the Rheumatic Diseases, the researchers examined data from 137 adult RA patients seen at the clinic during Jan. 2012–Jan. 2018 who failed to respond to adalimumab after at least 3 months of treatment and started another bDMARD. The average age of the patients was 64 years, and approximately 69% were women.

Overall, the presence of ADA was not a significant predictor of a European League Against Rheumatism good response in patients who switched to another TNFi (etanercept, golimumab, infliximab, or certolizumab pegol), with sensitivity of 18% and specificity of 75%. ADA also was not predictive of response to a non-TNFi bDMARD (rituximab, tocilizumab, or abatacept), with sensitivity and specificity of 33% and 70%, respectively.

Similarly, ADL levels in patients who switched to a TNFi or non-TNFi were not significant predictors of treatment response, with sensitivities and specificities of 50% and 52%, respectively, for TNFi and 32% and 69%, respectively, for non-TNFi.

The findings that neither ADA nor ADL showed predictive values contrast with previous studies, the researchers said.

“Not only did the results of this study show no predictive values, in some analyses a prediction is found in the opposite direction of what was expected,” they wrote.

The study findings were limited by several factors, including the random timing of sample collection, retrospective study design, and potential for misclassification of responders or nonresponders, the researchers noted.

However, the results were strengthened by the blinded choice of treatment and outcome assessment, larger sample size than previous studies, and focus on adalimumab in particular, they said.

“While counterintuitive, it is hard to find an explanation for the lack of a positive finding,” they concluded.

More research is needed to confirm the predictive value of ADA and ADL, they said. In the meantime, rheumatologists should base decisions to switch patients to TNFi or non-TNFi treatment after adalimumab failure based on factors including side effects, local protocol, economical aspects, and patient preferences, they said.

The study received no external funding. The researchers had no financial conflicts to disclose.

SOURCE: Ulijn E et al. Ann Rheum Dis. 2020 Apr 21. doi: 10.1136/annrheumdis-2020-216996.

The first case of coronavirus disease 2019 (COVID-19) in the United States was identified in Washington state in late January 2020. As of mid-April 2020, the number of US cases has increased to more than 800,000 with over 40,000 deaths. The limited available knowledge to guide medical decision-making combined with rapid progression of the pandemic has resulted in an urgent need to better define clinical, radiologic, and laboratory features of the disease, predictors of disease progression, predominant modes of transmission, and effective treatments. This urgency has led to a flood of manuscript submissions, which strains the scientific vetting process and leads to the spread of medical misinformation and potential for serious harm. As an example, a small observational (noncontrolled) study that used an antimalarial drug to treat COVID-19 patients was touted by several national leaders as proof of its effectiveness, despite substantial methodologic limitations.^1,2 While the article has not yet been retracted, the International Society of Antimicrobial Chemotherapy, the publishing journal’s society sponsor, subsequently issued a statement that “the article does not meet the Society’s expected standard.”³

With these concerns in mind, we recognize the importance of addressing the current pandemic and identifying areas where we can advance the field responsibly in the face of limited evidence in a rapidly evolving situation. Hospitalists throughout the world are facing unprecedented leadership challenges, navigating ethical stressors, and redesigning their care systems while learning rapidly and adapting nimbly. In this issue, we share leadership strategies, explore ethical challenges and controversies, describe successful practices, and provide personal reflections from a diverse group of hospitalists and leaders. As a journal, we have intentionally avoided rapid publication of articles with substantial methodologic limitations that are unlikely to advance our knowledge of COVID-19 even though such articles may generate substantial media coverage. Different regions of the country are at different stages of the pandemic; some hospitals are experiencing high patient volumes and struggling with shortages of equipment and supplies, while others are weeks away from peak disease activity or have avoided periods of high prevalence altogether. These varied experiences offer an opportunity to share our learnings and perspectives as we wait for more definitive evidence on best management practices. As part of our commitment to our colleagues in healthcare and to the broader scientific community, all Journal of Hospital Medicine articles related to COVID-19 and published during the pandemic will be open access (ie, freely accessible).

The first case of coronavirus disease 2019 (COVID-19) in the United States was identified in Washington state in late January 2020. As of mid-April 2020, the number of US cases has increased to more than 800,000 with over 40,000 deaths. The limited available knowledge to guide medical decision-making combined with rapid progression of the pandemic has resulted in an urgent need to better define clinical, radiologic, and laboratory features of the disease, predictors of disease progression, predominant modes of transmission, and effective treatments. This urgency has led to a flood of manuscript submissions, which strains the scientific vetting process and leads to the spread of medical misinformation and potential for serious harm. As an example, a small observational (noncontrolled) study that used an antimalarial drug to treat COVID-19 patients was touted by several national leaders as proof of its effectiveness, despite substantial methodologic limitations.^1,2 While the article has not yet been retracted, the International Society of Antimicrobial Chemotherapy, the publishing journal’s society sponsor, subsequently issued a statement that “the article does not meet the Society’s expected standard.”³

With these concerns in mind, we recognize the importance of addressing the current pandemic and identifying areas where we can advance the field responsibly in the face of limited evidence in a rapidly evolving situation. Hospitalists throughout the world are facing unprecedented leadership challenges, navigating ethical stressors, and redesigning their care systems while learning rapidly and adapting nimbly. In this issue, we share leadership strategies, explore ethical challenges and controversies, describe successful practices, and provide personal reflections from a diverse group of hospitalists and leaders. As a journal, we have intentionally avoided rapid publication of articles with substantial methodologic limitations that are unlikely to advance our knowledge of COVID-19 even though such articles may generate substantial media coverage. Different regions of the country are at different stages of the pandemic; some hospitals are experiencing high patient volumes and struggling with shortages of equipment and supplies, while others are weeks away from peak disease activity or have avoided periods of high prevalence altogether. These varied experiences offer an opportunity to share our learnings and perspectives as we wait for more definitive evidence on best management practices. As part of our commitment to our colleagues in healthcare and to the broader scientific community, all Journal of Hospital Medicine articles related to COVID-19 and published during the pandemic will be open access (ie, freely accessible).

The first case of coronavirus disease 2019 (COVID-19) in the United States was identified in Washington state in late January 2020. As of mid-April 2020, the number of US cases has increased to more than 800,000 with over 40,000 deaths. The limited available knowledge to guide medical decision-making combined with rapid progression of the pandemic has resulted in an urgent need to better define clinical, radiologic, and laboratory features of the disease, predictors of disease progression, predominant modes of transmission, and effective treatments. This urgency has led to a flood of manuscript submissions, which strains the scientific vetting process and leads to the spread of medical misinformation and potential for serious harm. As an example, a small observational (noncontrolled) study that used an antimalarial drug to treat COVID-19 patients was touted by several national leaders as proof of its effectiveness, despite substantial methodologic limitations.^1,2 While the article has not yet been retracted, the International Society of Antimicrobial Chemotherapy, the publishing journal’s society sponsor, subsequently issued a statement that “the article does not meet the Society’s expected standard.”³

With these concerns in mind, we recognize the importance of addressing the current pandemic and identifying areas where we can advance the field responsibly in the face of limited evidence in a rapidly evolving situation. Hospitalists throughout the world are facing unprecedented leadership challenges, navigating ethical stressors, and redesigning their care systems while learning rapidly and adapting nimbly. In this issue, we share leadership strategies, explore ethical challenges and controversies, describe successful practices, and provide personal reflections from a diverse group of hospitalists and leaders. As a journal, we have intentionally avoided rapid publication of articles with substantial methodologic limitations that are unlikely to advance our knowledge of COVID-19 even though such articles may generate substantial media coverage. Different regions of the country are at different stages of the pandemic; some hospitals are experiencing high patient volumes and struggling with shortages of equipment and supplies, while others are weeks away from peak disease activity or have avoided periods of high prevalence altogether. These varied experiences offer an opportunity to share our learnings and perspectives as we wait for more definitive evidence on best management practices. As part of our commitment to our colleagues in healthcare and to the broader scientific community, all Journal of Hospital Medicine articles related to COVID-19 and published during the pandemic will be open access (ie, freely accessible).

A consensus statement from the American College of Cardiology (ACC), the American College of Emergency Physicians (ACEP), and the Society for Cardiovascular Angiography & Interventions (SCAI) outlines recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic.

The statement was published in the Journal of the American College of Cardiology.

During the COVID-19 pandemic, percutaneous coronary intervention (PCI) remains the standard of care for patients with ST-segment elevation MI (STEMI) at PCI-capable hospitals when it can be provided in a timely fashion in a dedicated cardiac catheterization laboratory with an expert care team wearing personal protection equipment (PPE), the writing group advised.

“A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option,” they said.

SCAI President Ehtisham Mahmud, MD, of the University of California, San Diego, and the writing group also said that clinicians should recognize that cardiovascular manifestations of COVID-19 are “complex” in patients presenting with AMI, myocarditis simulating a STEMI, stress cardiomyopathy, nonischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury.

A “broad differential diagnosis for ST elevations (including COVID-associated myocarditis) should be considered in the ED prior to choosing a reperfusion strategy,” they advised.

In the absence of hemodynamic instability or ongoing ischemic symptoms, non-STEMI patients with known or suspected COVID-19 are best managed with an initial medical stabilization strategy, the group said.

They also said it is “imperative that health care workers use appropriate PPE for all invasive procedures during this pandemic” and that new rapid COVID-19 testing be “expeditiously” disseminated to all hospitals that manage patients with AMI.

Major challenges are that the prevalence of the COVID-19 in the United States remains unknown and there is the risk for asymptomatic spread.

The writing group said it’s “critical” to “inform the public that we can minimize exposure to the coronavirus so they can continue to call the Emergency Medical System (EMS) for acute ischemic heart disease symptoms and therefore get the appropriate level of cardiac care that their presentation warrants.”

This research had no commercial funding. Dr. Mahmud reported receiving clinical trial research support from Corindus, Abbott Vascular, and CSI; consulting with Medtronic; and consulting and equity with Abiomed. A complete list of author disclosures is included with the original article.

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

A consensus statement from the American College of Cardiology (ACC), the American College of Emergency Physicians (ACEP), and the Society for Cardiovascular Angiography & Interventions (SCAI) outlines recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic.

The statement was published in the Journal of the American College of Cardiology.

During the COVID-19 pandemic, percutaneous coronary intervention (PCI) remains the standard of care for patients with ST-segment elevation MI (STEMI) at PCI-capable hospitals when it can be provided in a timely fashion in a dedicated cardiac catheterization laboratory with an expert care team wearing personal protection equipment (PPE), the writing group advised.

“A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option,” they said.

SCAI President Ehtisham Mahmud, MD, of the University of California, San Diego, and the writing group also said that clinicians should recognize that cardiovascular manifestations of COVID-19 are “complex” in patients presenting with AMI, myocarditis simulating a STEMI, stress cardiomyopathy, nonischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury.

A “broad differential diagnosis for ST elevations (including COVID-associated myocarditis) should be considered in the ED prior to choosing a reperfusion strategy,” they advised.

In the absence of hemodynamic instability or ongoing ischemic symptoms, non-STEMI patients with known or suspected COVID-19 are best managed with an initial medical stabilization strategy, the group said.

They also said it is “imperative that health care workers use appropriate PPE for all invasive procedures during this pandemic” and that new rapid COVID-19 testing be “expeditiously” disseminated to all hospitals that manage patients with AMI.

Major challenges are that the prevalence of the COVID-19 in the United States remains unknown and there is the risk for asymptomatic spread.

The writing group said it’s “critical” to “inform the public that we can minimize exposure to the coronavirus so they can continue to call the Emergency Medical System (EMS) for acute ischemic heart disease symptoms and therefore get the appropriate level of cardiac care that their presentation warrants.”

This research had no commercial funding. Dr. Mahmud reported receiving clinical trial research support from Corindus, Abbott Vascular, and CSI; consulting with Medtronic; and consulting and equity with Abiomed. A complete list of author disclosures is included with the original article.

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

A consensus statement from the American College of Cardiology (ACC), the American College of Emergency Physicians (ACEP), and the Society for Cardiovascular Angiography & Interventions (SCAI) outlines recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic.

The statement was published in the Journal of the American College of Cardiology.

During the COVID-19 pandemic, percutaneous coronary intervention (PCI) remains the standard of care for patients with ST-segment elevation MI (STEMI) at PCI-capable hospitals when it can be provided in a timely fashion in a dedicated cardiac catheterization laboratory with an expert care team wearing personal protection equipment (PPE), the writing group advised.

“A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option,” they said.

SCAI President Ehtisham Mahmud, MD, of the University of California, San Diego, and the writing group also said that clinicians should recognize that cardiovascular manifestations of COVID-19 are “complex” in patients presenting with AMI, myocarditis simulating a STEMI, stress cardiomyopathy, nonischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury.

A “broad differential diagnosis for ST elevations (including COVID-associated myocarditis) should be considered in the ED prior to choosing a reperfusion strategy,” they advised.

In the absence of hemodynamic instability or ongoing ischemic symptoms, non-STEMI patients with known or suspected COVID-19 are best managed with an initial medical stabilization strategy, the group said.

They also said it is “imperative that health care workers use appropriate PPE for all invasive procedures during this pandemic” and that new rapid COVID-19 testing be “expeditiously” disseminated to all hospitals that manage patients with AMI.

Major challenges are that the prevalence of the COVID-19 in the United States remains unknown and there is the risk for asymptomatic spread.

The writing group said it’s “critical” to “inform the public that we can minimize exposure to the coronavirus so they can continue to call the Emergency Medical System (EMS) for acute ischemic heart disease symptoms and therefore get the appropriate level of cardiac care that their presentation warrants.”

This research had no commercial funding. Dr. Mahmud reported receiving clinical trial research support from Corindus, Abbott Vascular, and CSI; consulting with Medtronic; and consulting and equity with Abiomed. A complete list of author disclosures is included with the original article.

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

Background: Federal health system programs, including TRICARE for military personnel, spent $259 million in 2013 and $746 million in 2014 for compounded analgesic medications despite a dearth of efficacy data. The purpose of this trial was to evaluate the efficacy and functional impact of this class of medications for chronic localized pain.

The primary outcome was the average pain score at 1 month follow-up, based on self-recorded arithmetic mean pain scores in the preceding week. Secondary outcomes included mean worst pain over the past week, functional improvement (assessed by validated Short-Form 36 Health Survey scores), and satisfaction (measured on a 1 to 5 Likert scale) with the individual treatment regimen.

Patients had small improvements in average pain scores at 1 month in the compounded formulation and placebo subgroups in all pain type categories. No significant differences were noted in the average pain scores compared to baseline, functional improvement or satisfaction in the compounded formulation and placebo groups of the total cohort or in any of the subgroups.

Bottom line: Compounded topical analgesics are costly and ineffective in the treatment of all types of chronic localized pain.

Citation: Brutcher RE et al. Compounded topical pain creams to treat localized chronic pain. Ann Intern Med. 2019;170(5):309-18.

Dr. Lambert is a hospital medicine clinician and addiction medicine specialist in the division of hospital medicine at Massachusetts General Hospital.

Background: Federal health system programs, including TRICARE for military personnel, spent $259 million in 2013 and $746 million in 2014 for compounded analgesic medications despite a dearth of efficacy data. The purpose of this trial was to evaluate the efficacy and functional impact of this class of medications for chronic localized pain.

The primary outcome was the average pain score at 1 month follow-up, based on self-recorded arithmetic mean pain scores in the preceding week. Secondary outcomes included mean worst pain over the past week, functional improvement (assessed by validated Short-Form 36 Health Survey scores), and satisfaction (measured on a 1 to 5 Likert scale) with the individual treatment regimen.

Patients had small improvements in average pain scores at 1 month in the compounded formulation and placebo subgroups in all pain type categories. No significant differences were noted in the average pain scores compared to baseline, functional improvement or satisfaction in the compounded formulation and placebo groups of the total cohort or in any of the subgroups.

Bottom line: Compounded topical analgesics are costly and ineffective in the treatment of all types of chronic localized pain.

Citation: Brutcher RE et al. Compounded topical pain creams to treat localized chronic pain. Ann Intern Med. 2019;170(5):309-18.

Dr. Lambert is a hospital medicine clinician and addiction medicine specialist in the division of hospital medicine at Massachusetts General Hospital.

Background: Federal health system programs, including TRICARE for military personnel, spent $259 million in 2013 and $746 million in 2014 for compounded analgesic medications despite a dearth of efficacy data. The purpose of this trial was to evaluate the efficacy and functional impact of this class of medications for chronic localized pain.

The primary outcome was the average pain score at 1 month follow-up, based on self-recorded arithmetic mean pain scores in the preceding week. Secondary outcomes included mean worst pain over the past week, functional improvement (assessed by validated Short-Form 36 Health Survey scores), and satisfaction (measured on a 1 to 5 Likert scale) with the individual treatment regimen.

Patients had small improvements in average pain scores at 1 month in the compounded formulation and placebo subgroups in all pain type categories. No significant differences were noted in the average pain scores compared to baseline, functional improvement or satisfaction in the compounded formulation and placebo groups of the total cohort or in any of the subgroups.

Bottom line: Compounded topical analgesics are costly and ineffective in the treatment of all types of chronic localized pain.

Citation: Brutcher RE et al. Compounded topical pain creams to treat localized chronic pain. Ann Intern Med. 2019;170(5):309-18.

Dr. Lambert is a hospital medicine clinician and addiction medicine specialist in the division of hospital medicine at Massachusetts General Hospital.

A new advocacy organization is launching on April 28 to give “every physician” a voice in decisions that affect their professional lives. But this group doesn’t intend to use the top-down approach to decision making seen in many medical societies.

Paul Teirstein, MD, chief of cardiology for Scripps Clinic in La Jolla, Calif., and founder of the new organization United Physicians, said in an interviewit is a nonprofit group that will operate through online participation.

He said the intention is to use online voting and discussions among physicians across specialties to advocate for more and better legislation on pressing issues for their profession and, as noted on the group’s website, “protect the physician-patient relationship.”

Projects would need the support of a two-thirds majority of United Physicians’ members to proceed with any proposals. Meetings will be held publicly online, Dr. Teirstein explained.

There is a need for a broad-based organization that will respond to the voice of practicing physicians rather than dictate legislative priorities from management ranks, he said.

Dr. Teirstein said he learned how challenging it is to bring physicians together on issues in 2014 in his battles against changes in maintenance of certification rules. The result of his efforts was the National Board of Physicians and Surgeons (NBPAS), set up to provide a means of certification different from the one offered by the American Board of Internal Medicine.

Dr. Teirstein has argued that the approach of ABIM unfairly burdened physicians with a stepped-up schedule of testing and relied on an outdated approach to the practice of medicine.

Physicians busy with their practices feel they lack a unified voice in contesting the growing administrative burden and unproductive federal and state policies, Dr. Teirstein said.

He cited the limited enrollment in the largest physician groups as evidence of how disenfranchised many clinicians feel. There are about 1 million professional active physicians in the United States, according to the nonprofit Kaiser Family Foundation. Yet, even the largest physician group, the American Medical Association, has about 250,000 members, according to its 2018 annual report

“Clearly, most physicians believe they have little voice when it comes to health care decisions,” Dr. Teirstein said. “Our physician associations are governed from the top down. The leaders set the agenda. There may be delegates, but does leadership really listen to the delegates? Do the delegates really listen to the physician community?”

On its website, AMA describes itself as “physicians’ powerful ally in patient care” that works with more than 190 state and specialty medical societies. In recent months, James L. Madara, MD, the group’s chief executive officer, has urged governors to remove obstacles for physicians who want to fill workforce gaps in COVID-19 hot spots, among other actions.

In its annual report, the AMA, which declined to comment for this article, said its membership rose by 3.4% in 2018, double the growth rate of the previous year, thanks to a membership drive.

“The campaign celebrates the powerful work of our physician members and showcases how their individual efforts – along with the AMA – are moving medicine forward,” wrote Dr. Madara and other organization leaders in the report.

What Dr. Teirstein proposes is an inversion of the structure used by other medical societies, in which he says leaders and delegates dictate priorities.

United Physicians will use meetings and votes held by members online to decide which projects to pursue. Fees would be kept nominal, likely about $10 a year, depending on the number of members. Fees would be subject to change on the basis of expenses. The AMA has a sliding fee schedule that tops out with annual dues for physicians in regular practice of $420.

“There are no delegates, no representatives, and no board of directors. We want every physician to join and every physician to vote on every issue,” Dr. Teirstein said.

He stressed that he sees United Physicians as being complementary to the AMA.

“We do not compete with other organizations. Ideally, other organizations will use the platform,” Dr. Teirstein said. “If the AMA is considering a new policy, it can use the United Physicians platform to measure physician support. For example, through online discussions, petitions, and voting, it might learn a proposed policy needs a few tweaks to be accepted by most physicians.”

No compensation

Dr. Teirstein is among physician leaders who in recent years have sought to rally their colleagues to fight back against growing administrative burdens.

In a 2015 article in JAMA that was written with Medscape’s editor in chief, Eric Topol, MD, Dr. Teirstein criticized the ABIM’s drive to have physicians complete tests every 2 years and participate in continuous certification instead of recertifying once a decade, as had been the practice.

Dr. Teirstein formed the NBPAS as an alternative path for certification, with Dr. Topol serving on the board for that organization. Dr. Topol also will serve as a member of the advisory board for Teirstein’s United Physicians.

Dr. Topol wrote an article that appeared in the New Yorker last August that argued for physicians to move beyond the confines of medical societies and seek a path for broad-based activism. He said he intended to challenge medical societies, which, for all the good they do, can sometimes lose focus on that core relationship in favor of the bottom line.

Dr. Topol said in an interview that his colleague’s new project is a “good idea for a democratized platform at a time when physician solidarity is needed more than ever.”

Dr. Teirstein plans to run United Physicians on a volunteer basis. This builds on the approach he has used for NBPAS. He and the directors of the NBPAS will receive no compensation, he said, as was confirmed by the NBPAS.

In contrast, Dr. Madara made about $2.5 million in total compensation for 2018, according to the organization’s Internal Revenue Service filing. Physicians who served as trustees and officials for the AMA that year received annual compensation that ranged from around $60,000 to $291,980, depending on their duties.

“Having volunteer leadership mitigates conflict of interest. It also ensures leadership has a ‘day job’ that keeps them in touch with issues impacting practicing physicians,” Dr. Teirstein said

Start-up costs for United Physicians will be supported by NBPAS, but it will function as a completely independent organization, he added.

In introducing the group, Dr. Teirstein outlined suggestions for proposals it might pursue. These include making hospitals secure adequate supplies of personal protective equipment ahead of health crises such as the COVID-19 pandemic.

His outline also includes suggestions for issues that likely will persist beyond the response to the pandemic.

Dr. Teirstein proposed a project for persuading insurance companies to provide online calendar appointments for peer-to-peer patient preauthorization. Failure of the insurer’s representative to attend would trigger approval of authorization under this proposal. He also suggested a lobbying effort for specific reimbursement for peer-to-peer, patient preauthorization phone calls.

Dr. Teirstein said he hopes most of the proposals will come from physicians who join United Physicians. Still, it is unclear whether United Physicians will succeed. An initial challenge could be in sorting through a barrage of competing ideas submitted to United Physicians.

But Dr. Teirstein appears hopeful about the changes for this experiment in online advocacy. He intends for United Physicians to be a pathway for clinicians to translate their complaints about policies into calls for action, with only a short investment of their time.

“Most of us have wonderful, engrossing jobs. It’s hard to beat helping a patient, and most of us get to do it every day,” Dr. .Teirstein said. “Will we take the 30 seconds required to sign up and become a United Physicians member? Will we spend a little time each week reviewing the issues and voting? I think it’s an experiment worth watching.”

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

A new advocacy organization is launching on April 28 to give “every physician” a voice in decisions that affect their professional lives. But this group doesn’t intend to use the top-down approach to decision making seen in many medical societies.

Paul Teirstein, MD, chief of cardiology for Scripps Clinic in La Jolla, Calif., and founder of the new organization United Physicians, said in an interviewit is a nonprofit group that will operate through online participation.

He said the intention is to use online voting and discussions among physicians across specialties to advocate for more and better legislation on pressing issues for their profession and, as noted on the group’s website, “protect the physician-patient relationship.”

Projects would need the support of a two-thirds majority of United Physicians’ members to proceed with any proposals. Meetings will be held publicly online, Dr. Teirstein explained.

There is a need for a broad-based organization that will respond to the voice of practicing physicians rather than dictate legislative priorities from management ranks, he said.

Dr. Teirstein said he learned how challenging it is to bring physicians together on issues in 2014 in his battles against changes in maintenance of certification rules. The result of his efforts was the National Board of Physicians and Surgeons (NBPAS), set up to provide a means of certification different from the one offered by the American Board of Internal Medicine.

Dr. Teirstein has argued that the approach of ABIM unfairly burdened physicians with a stepped-up schedule of testing and relied on an outdated approach to the practice of medicine.

Physicians busy with their practices feel they lack a unified voice in contesting the growing administrative burden and unproductive federal and state policies, Dr. Teirstein said.

He cited the limited enrollment in the largest physician groups as evidence of how disenfranchised many clinicians feel. There are about 1 million professional active physicians in the United States, according to the nonprofit Kaiser Family Foundation. Yet, even the largest physician group, the American Medical Association, has about 250,000 members, according to its 2018 annual report

“Clearly, most physicians believe they have little voice when it comes to health care decisions,” Dr. Teirstein said. “Our physician associations are governed from the top down. The leaders set the agenda. There may be delegates, but does leadership really listen to the delegates? Do the delegates really listen to the physician community?”

On its website, AMA describes itself as “physicians’ powerful ally in patient care” that works with more than 190 state and specialty medical societies. In recent months, James L. Madara, MD, the group’s chief executive officer, has urged governors to remove obstacles for physicians who want to fill workforce gaps in COVID-19 hot spots, among other actions.

In its annual report, the AMA, which declined to comment for this article, said its membership rose by 3.4% in 2018, double the growth rate of the previous year, thanks to a membership drive.

“The campaign celebrates the powerful work of our physician members and showcases how their individual efforts – along with the AMA – are moving medicine forward,” wrote Dr. Madara and other organization leaders in the report.

What Dr. Teirstein proposes is an inversion of the structure used by other medical societies, in which he says leaders and delegates dictate priorities.

United Physicians will use meetings and votes held by members online to decide which projects to pursue. Fees would be kept nominal, likely about $10 a year, depending on the number of members. Fees would be subject to change on the basis of expenses. The AMA has a sliding fee schedule that tops out with annual dues for physicians in regular practice of $420.

“There are no delegates, no representatives, and no board of directors. We want every physician to join and every physician to vote on every issue,” Dr. Teirstein said.

He stressed that he sees United Physicians as being complementary to the AMA.

“We do not compete with other organizations. Ideally, other organizations will use the platform,” Dr. Teirstein said. “If the AMA is considering a new policy, it can use the United Physicians platform to measure physician support. For example, through online discussions, petitions, and voting, it might learn a proposed policy needs a few tweaks to be accepted by most physicians.”

No compensation

Dr. Teirstein is among physician leaders who in recent years have sought to rally their colleagues to fight back against growing administrative burdens.

In a 2015 article in JAMA that was written with Medscape’s editor in chief, Eric Topol, MD, Dr. Teirstein criticized the ABIM’s drive to have physicians complete tests every 2 years and participate in continuous certification instead of recertifying once a decade, as had been the practice.

Dr. Teirstein formed the NBPAS as an alternative path for certification, with Dr. Topol serving on the board for that organization. Dr. Topol also will serve as a member of the advisory board for Teirstein’s United Physicians.

Dr. Topol wrote an article that appeared in the New Yorker last August that argued for physicians to move beyond the confines of medical societies and seek a path for broad-based activism. He said he intended to challenge medical societies, which, for all the good they do, can sometimes lose focus on that core relationship in favor of the bottom line.

Dr. Topol said in an interview that his colleague’s new project is a “good idea for a democratized platform at a time when physician solidarity is needed more than ever.”

Dr. Teirstein plans to run United Physicians on a volunteer basis. This builds on the approach he has used for NBPAS. He and the directors of the NBPAS will receive no compensation, he said, as was confirmed by the NBPAS.

In contrast, Dr. Madara made about $2.5 million in total compensation for 2018, according to the organization’s Internal Revenue Service filing. Physicians who served as trustees and officials for the AMA that year received annual compensation that ranged from around $60,000 to $291,980, depending on their duties.

“Having volunteer leadership mitigates conflict of interest. It also ensures leadership has a ‘day job’ that keeps them in touch with issues impacting practicing physicians,” Dr. Teirstein said

Start-up costs for United Physicians will be supported by NBPAS, but it will function as a completely independent organization, he added.

In introducing the group, Dr. Teirstein outlined suggestions for proposals it might pursue. These include making hospitals secure adequate supplies of personal protective equipment ahead of health crises such as the COVID-19 pandemic.

His outline also includes suggestions for issues that likely will persist beyond the response to the pandemic.

Dr. Teirstein proposed a project for persuading insurance companies to provide online calendar appointments for peer-to-peer patient preauthorization. Failure of the insurer’s representative to attend would trigger approval of authorization under this proposal. He also suggested a lobbying effort for specific reimbursement for peer-to-peer, patient preauthorization phone calls.

Dr. Teirstein said he hopes most of the proposals will come from physicians who join United Physicians. Still, it is unclear whether United Physicians will succeed. An initial challenge could be in sorting through a barrage of competing ideas submitted to United Physicians.

But Dr. Teirstein appears hopeful about the changes for this experiment in online advocacy. He intends for United Physicians to be a pathway for clinicians to translate their complaints about policies into calls for action, with only a short investment of their time.

“Most of us have wonderful, engrossing jobs. It’s hard to beat helping a patient, and most of us get to do it every day,” Dr. .Teirstein said. “Will we take the 30 seconds required to sign up and become a United Physicians member? Will we spend a little time each week reviewing the issues and voting? I think it’s an experiment worth watching.”

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

A new advocacy organization is launching on April 28 to give “every physician” a voice in decisions that affect their professional lives. But this group doesn’t intend to use the top-down approach to decision making seen in many medical societies.

Paul Teirstein, MD, chief of cardiology for Scripps Clinic in La Jolla, Calif., and founder of the new organization United Physicians, said in an interviewit is a nonprofit group that will operate through online participation.

He said the intention is to use online voting and discussions among physicians across specialties to advocate for more and better legislation on pressing issues for their profession and, as noted on the group’s website, “protect the physician-patient relationship.”

Projects would need the support of a two-thirds majority of United Physicians’ members to proceed with any proposals. Meetings will be held publicly online, Dr. Teirstein explained.

There is a need for a broad-based organization that will respond to the voice of practicing physicians rather than dictate legislative priorities from management ranks, he said.

Dr. Teirstein said he learned how challenging it is to bring physicians together on issues in 2014 in his battles against changes in maintenance of certification rules. The result of his efforts was the National Board of Physicians and Surgeons (NBPAS), set up to provide a means of certification different from the one offered by the American Board of Internal Medicine.

Dr. Teirstein has argued that the approach of ABIM unfairly burdened physicians with a stepped-up schedule of testing and relied on an outdated approach to the practice of medicine.

Physicians busy with their practices feel they lack a unified voice in contesting the growing administrative burden and unproductive federal and state policies, Dr. Teirstein said.

He cited the limited enrollment in the largest physician groups as evidence of how disenfranchised many clinicians feel. There are about 1 million professional active physicians in the United States, according to the nonprofit Kaiser Family Foundation. Yet, even the largest physician group, the American Medical Association, has about 250,000 members, according to its 2018 annual report

“Clearly, most physicians believe they have little voice when it comes to health care decisions,” Dr. Teirstein said. “Our physician associations are governed from the top down. The leaders set the agenda. There may be delegates, but does leadership really listen to the delegates? Do the delegates really listen to the physician community?”

On its website, AMA describes itself as “physicians’ powerful ally in patient care” that works with more than 190 state and specialty medical societies. In recent months, James L. Madara, MD, the group’s chief executive officer, has urged governors to remove obstacles for physicians who want to fill workforce gaps in COVID-19 hot spots, among other actions.

In its annual report, the AMA, which declined to comment for this article, said its membership rose by 3.4% in 2018, double the growth rate of the previous year, thanks to a membership drive.

“The campaign celebrates the powerful work of our physician members and showcases how their individual efforts – along with the AMA – are moving medicine forward,” wrote Dr. Madara and other organization leaders in the report.

What Dr. Teirstein proposes is an inversion of the structure used by other medical societies, in which he says leaders and delegates dictate priorities.

United Physicians will use meetings and votes held by members online to decide which projects to pursue. Fees would be kept nominal, likely about $10 a year, depending on the number of members. Fees would be subject to change on the basis of expenses. The AMA has a sliding fee schedule that tops out with annual dues for physicians in regular practice of $420.

“There are no delegates, no representatives, and no board of directors. We want every physician to join and every physician to vote on every issue,” Dr. Teirstein said.

He stressed that he sees United Physicians as being complementary to the AMA.

“We do not compete with other organizations. Ideally, other organizations will use the platform,” Dr. Teirstein said. “If the AMA is considering a new policy, it can use the United Physicians platform to measure physician support. For example, through online discussions, petitions, and voting, it might learn a proposed policy needs a few tweaks to be accepted by most physicians.”

No compensation

Dr. Teirstein is among physician leaders who in recent years have sought to rally their colleagues to fight back against growing administrative burdens.

In a 2015 article in JAMA that was written with Medscape’s editor in chief, Eric Topol, MD, Dr. Teirstein criticized the ABIM’s drive to have physicians complete tests every 2 years and participate in continuous certification instead of recertifying once a decade, as had been the practice.

Dr. Teirstein formed the NBPAS as an alternative path for certification, with Dr. Topol serving on the board for that organization. Dr. Topol also will serve as a member of the advisory board for Teirstein’s United Physicians.

Dr. Topol wrote an article that appeared in the New Yorker last August that argued for physicians to move beyond the confines of medical societies and seek a path for broad-based activism. He said he intended to challenge medical societies, which, for all the good they do, can sometimes lose focus on that core relationship in favor of the bottom line.

Dr. Topol said in an interview that his colleague’s new project is a “good idea for a democratized platform at a time when physician solidarity is needed more than ever.”

Dr. Teirstein plans to run United Physicians on a volunteer basis. This builds on the approach he has used for NBPAS. He and the directors of the NBPAS will receive no compensation, he said, as was confirmed by the NBPAS.

In contrast, Dr. Madara made about $2.5 million in total compensation for 2018, according to the organization’s Internal Revenue Service filing. Physicians who served as trustees and officials for the AMA that year received annual compensation that ranged from around $60,000 to $291,980, depending on their duties.

“Having volunteer leadership mitigates conflict of interest. It also ensures leadership has a ‘day job’ that keeps them in touch with issues impacting practicing physicians,” Dr. Teirstein said

Start-up costs for United Physicians will be supported by NBPAS, but it will function as a completely independent organization, he added.

In introducing the group, Dr. Teirstein outlined suggestions for proposals it might pursue. These include making hospitals secure adequate supplies of personal protective equipment ahead of health crises such as the COVID-19 pandemic.

His outline also includes suggestions for issues that likely will persist beyond the response to the pandemic.

Dr. Teirstein proposed a project for persuading insurance companies to provide online calendar appointments for peer-to-peer patient preauthorization. Failure of the insurer’s representative to attend would trigger approval of authorization under this proposal. He also suggested a lobbying effort for specific reimbursement for peer-to-peer, patient preauthorization phone calls.

Dr. Teirstein said he hopes most of the proposals will come from physicians who join United Physicians. Still, it is unclear whether United Physicians will succeed. An initial challenge could be in sorting through a barrage of competing ideas submitted to United Physicians.

But Dr. Teirstein appears hopeful about the changes for this experiment in online advocacy. He intends for United Physicians to be a pathway for clinicians to translate their complaints about policies into calls for action, with only a short investment of their time.

“Most of us have wonderful, engrossing jobs. It’s hard to beat helping a patient, and most of us get to do it every day,” Dr. .Teirstein said. “Will we take the 30 seconds required to sign up and become a United Physicians member? Will we spend a little time each week reviewing the issues and voting? I think it’s an experiment worth watching.”

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