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The Food and Drug Administration has approved a groundbreaking expanded indication for sacubitril/valsartan (Entresto), making it the first drug in the United States indicated for chronic heart failure not specifically characterized by ejection fraction.

The new labeling, as provided by Novartis, grants physicians a good deal of discretion in prescribing sacubitril/valsartan for patients with HF beyond those with HF and reduced ejection fraction (HFrEF), for which the drug was approved in 2015 primarily on the basis of the PARADIGM-HF trial.

The indication now reads, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.”

Of note, the labeling cautions that “LVEF is a variable measure, so use clinical judgment in deciding whom to treat.”

The expanded indication essentially extends the sacubitril/valsartan option to many patients with HF and preserved LVEF (HFpEF), who in practice are most likely to have an LVEF in the range adjacent to “reduced,” long defined as “preserved” but lately categorized as “mid-range.”

But the FDA did not get so specific. In granting the expanded indication, which Novartis announced Feb. 16 in a press release, the agency accommodated the Dec. 15 majority recommendation of its Cardiovascular and Renal Drugs Advisory Committee that the PARAGON-HF trial “provided sufficient evidence to support” an indication beyond HFrEF.

The nature of the PARAGON-HF trial, along with detailed discussion among committee members after their vote tally, made it clear that the 12-to-1 majority favored an indication that would include clinically appropriate patients with “below normal” LVEF.

PARAGON-HF had assigned more than 4,800 patients whose LVEF was 45% or higher and were in NYHA class 2-4 to receive sacubitril/valsartan or valsartan only. Those taking the combo drug showed a 13% drop in risk for HF hospitalization or cardiovascular deaths over an average of 3 years, which narrowly missed significance (P = .059).

But a subgroup analysis garnered attention for its hint of benefit for patients with “mid-range” LVEF, in this case, below the median of 57%. The finding was supported by a later PARAGON-HF and PARADIGM-HF meta-analysis that pointed to a significant benefit for patients with HFpEF at its lowest LVEF levels, especially in women.

The expanded approval “is a significant advancement, providing a treatment to many patients who were not eligible for treatment before, because their ejection fraction was above the region we normally considered reduced,” Scott Solomon, MD, of Brigham and Women’s Hospital, Boston, said in the Novartis press release. “We can now offer a treatment to a wider range of patients who have an LVEF below normal,” added Dr. Solomon, PARAGON-HF executive committee cochair.

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

The Food and Drug Administration has approved a groundbreaking expanded indication for sacubitril/valsartan (Entresto), making it the first drug in the United States indicated for chronic heart failure not specifically characterized by ejection fraction.

The new labeling, as provided by Novartis, grants physicians a good deal of discretion in prescribing sacubitril/valsartan for patients with HF beyond those with HF and reduced ejection fraction (HFrEF), for which the drug was approved in 2015 primarily on the basis of the PARADIGM-HF trial.

The indication now reads, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.”

Of note, the labeling cautions that “LVEF is a variable measure, so use clinical judgment in deciding whom to treat.”

The expanded indication essentially extends the sacubitril/valsartan option to many patients with HF and preserved LVEF (HFpEF), who in practice are most likely to have an LVEF in the range adjacent to “reduced,” long defined as “preserved” but lately categorized as “mid-range.”

But the FDA did not get so specific. In granting the expanded indication, which Novartis announced Feb. 16 in a press release, the agency accommodated the Dec. 15 majority recommendation of its Cardiovascular and Renal Drugs Advisory Committee that the PARAGON-HF trial “provided sufficient evidence to support” an indication beyond HFrEF.

The nature of the PARAGON-HF trial, along with detailed discussion among committee members after their vote tally, made it clear that the 12-to-1 majority favored an indication that would include clinically appropriate patients with “below normal” LVEF.

PARAGON-HF had assigned more than 4,800 patients whose LVEF was 45% or higher and were in NYHA class 2-4 to receive sacubitril/valsartan or valsartan only. Those taking the combo drug showed a 13% drop in risk for HF hospitalization or cardiovascular deaths over an average of 3 years, which narrowly missed significance (P = .059).

But a subgroup analysis garnered attention for its hint of benefit for patients with “mid-range” LVEF, in this case, below the median of 57%. The finding was supported by a later PARAGON-HF and PARADIGM-HF meta-analysis that pointed to a significant benefit for patients with HFpEF at its lowest LVEF levels, especially in women.

The expanded approval “is a significant advancement, providing a treatment to many patients who were not eligible for treatment before, because their ejection fraction was above the region we normally considered reduced,” Scott Solomon, MD, of Brigham and Women’s Hospital, Boston, said in the Novartis press release. “We can now offer a treatment to a wider range of patients who have an LVEF below normal,” added Dr. Solomon, PARAGON-HF executive committee cochair.

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

The Food and Drug Administration has approved a groundbreaking expanded indication for sacubitril/valsartan (Entresto), making it the first drug in the United States indicated for chronic heart failure not specifically characterized by ejection fraction.

The new labeling, as provided by Novartis, grants physicians a good deal of discretion in prescribing sacubitril/valsartan for patients with HF beyond those with HF and reduced ejection fraction (HFrEF), for which the drug was approved in 2015 primarily on the basis of the PARADIGM-HF trial.

The indication now reads, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.”

Of note, the labeling cautions that “LVEF is a variable measure, so use clinical judgment in deciding whom to treat.”

The expanded indication essentially extends the sacubitril/valsartan option to many patients with HF and preserved LVEF (HFpEF), who in practice are most likely to have an LVEF in the range adjacent to “reduced,” long defined as “preserved” but lately categorized as “mid-range.”

But the FDA did not get so specific. In granting the expanded indication, which Novartis announced Feb. 16 in a press release, the agency accommodated the Dec. 15 majority recommendation of its Cardiovascular and Renal Drugs Advisory Committee that the PARAGON-HF trial “provided sufficient evidence to support” an indication beyond HFrEF.

The nature of the PARAGON-HF trial, along with detailed discussion among committee members after their vote tally, made it clear that the 12-to-1 majority favored an indication that would include clinically appropriate patients with “below normal” LVEF.

PARAGON-HF had assigned more than 4,800 patients whose LVEF was 45% or higher and were in NYHA class 2-4 to receive sacubitril/valsartan or valsartan only. Those taking the combo drug showed a 13% drop in risk for HF hospitalization or cardiovascular deaths over an average of 3 years, which narrowly missed significance (P = .059).

But a subgroup analysis garnered attention for its hint of benefit for patients with “mid-range” LVEF, in this case, below the median of 57%. The finding was supported by a later PARAGON-HF and PARADIGM-HF meta-analysis that pointed to a significant benefit for patients with HFpEF at its lowest LVEF levels, especially in women.

The expanded approval “is a significant advancement, providing a treatment to many patients who were not eligible for treatment before, because their ejection fraction was above the region we normally considered reduced,” Scott Solomon, MD, of Brigham and Women’s Hospital, Boston, said in the Novartis press release. “We can now offer a treatment to a wider range of patients who have an LVEF below normal,” added Dr. Solomon, PARAGON-HF executive committee cochair.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Heart failure (HF) hospitalizations and readmissions are on the rise in the United States, reversing a multiyear downward trend, a new national cohort study shows.

Overall primary HF hospitalization rates per 1,000 adults declined from 4.4 in 2010 to 4.1 in 2013, and then increased from 4.2 in 2014 to 4.9 in 2017.

Rates of unique patient visits for HF were also on the way down – falling from 3.4 in 2010 to 3.2 in 2013 and 2014 – before climbing to 3.8 in 2017.

Similar trends were observed for rates of postdischarge HF readmissions (from 1.0 in 2010 to 0.9 in 2014 to 1.1 in 2017) and all-cause 30-day readmissions (from 0.8 in 2010 to 0.7 in 2014 to 0.9 in 2017).

“We should be emphasizing the things we know work to reduce heart failure hospitalization, which is, No. 1, prevention,” senior author Boback Ziaeian, MD, PhD, said in an interview.

Comorbidities that can lead to heart failure crept up over the study period, such that by 2017, hypertension was present in 91.4% of patients, diabetes in 48.9%, and lipid disorders in 53.1%, up from 76.5%, 44.9%, and 40.4%, respectively, in 2010. Half of all patients had coronary artery disease at both time points. Renal disease shot up from 45.9% to 60.6% by 2017.

“If we did a better job of controlling our known risk factors, we would really cut down on the incidence of heart failure being developed and then, among those estimated 6.6 million heart failure patients, we need to get them on our cornerstone therapies,” said Dr. Ziaeian, of the Veterans Affairts Greater Los Angeles Healthcare System and the University of California, Los Angeles.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors, which have shown clear efficacy and safety in trials like DAPA-HF and EMPEROR-Reduced, provide a “huge opportunity” to add on to standard therapies, he noted. Competition for VA contracts has brought the price down to about $50 a month for veterans, compared with a cash price of about $500-$600 a month.

Yet in routine practice, only 8% of veterans with HF at his center are on an SGLT2 inhibitor, compared with 80% on ACE inhibitors or beta blockers, observed Dr. Ziaeian. “This medication has been indicated for the last year and a half and we’re only at 8% in a system where we have pretty easy access to medications.”

As reported online Feb. 10 in JAMA Cardiology, notable sex differences were found in hospitalization, with higher rates per 1,000 persons among men.

In contrast, a 2020 report on HF trends in the VA system showed a 2% decrease in unadjusted 30-day readmissions from 2007 to 2017 and a decline in the adjusted 30-day readmission risk.

The present study did not risk-adjust readmission risk and included a population that was 51% male, compared with about 98% male in the VA, the investigators noted.

“The increasing hospitalization rate in our study may represent an actual increase in HF hospitalizations or shifts in administrative coding practices, increased use of HF biomarkers, or lower thresholds for diagnosis of HF with preserved ejection fraction,” they wrote.

The analysis was based on data from the Nationwide Readmission Database, which included 35,197,725 hospitalizations with a primary or secondary diagnosis of HF and 8,273,270 primary HF hospitalizations from January 2010 to December 2017.

A single primary HF admission occurred in 5,092,626 unique patients and 1,269,109 had two or more HF hospitalizations. The mean age was 72.1 years.

The administrative database did not include clinical data, so it wasn’t possible to differentiate between HF with preserved or reduced ejection fraction, the authors noted. Patient race and ethnicity data also were not available.

“Future studies are needed to verify our findings to better develop and improve individualized strategies for HF prevention, management, and surveillance for men and women,” the investigators concluded.

One coauthor reporting receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards Lifesciences, Janssen Pharmaceuticals, Medtronic, Merck, and Novartis. No other disclosures were reported.

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

Heart failure (HF) hospitalizations and readmissions are on the rise in the United States, reversing a multiyear downward trend, a new national cohort study shows.

Overall primary HF hospitalization rates per 1,000 adults declined from 4.4 in 2010 to 4.1 in 2013, and then increased from 4.2 in 2014 to 4.9 in 2017.

Rates of unique patient visits for HF were also on the way down – falling from 3.4 in 2010 to 3.2 in 2013 and 2014 – before climbing to 3.8 in 2017.

Similar trends were observed for rates of postdischarge HF readmissions (from 1.0 in 2010 to 0.9 in 2014 to 1.1 in 2017) and all-cause 30-day readmissions (from 0.8 in 2010 to 0.7 in 2014 to 0.9 in 2017).

“We should be emphasizing the things we know work to reduce heart failure hospitalization, which is, No. 1, prevention,” senior author Boback Ziaeian, MD, PhD, said in an interview.

Comorbidities that can lead to heart failure crept up over the study period, such that by 2017, hypertension was present in 91.4% of patients, diabetes in 48.9%, and lipid disorders in 53.1%, up from 76.5%, 44.9%, and 40.4%, respectively, in 2010. Half of all patients had coronary artery disease at both time points. Renal disease shot up from 45.9% to 60.6% by 2017.

“If we did a better job of controlling our known risk factors, we would really cut down on the incidence of heart failure being developed and then, among those estimated 6.6 million heart failure patients, we need to get them on our cornerstone therapies,” said Dr. Ziaeian, of the Veterans Affairts Greater Los Angeles Healthcare System and the University of California, Los Angeles.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors, which have shown clear efficacy and safety in trials like DAPA-HF and EMPEROR-Reduced, provide a “huge opportunity” to add on to standard therapies, he noted. Competition for VA contracts has brought the price down to about $50 a month for veterans, compared with a cash price of about $500-$600 a month.

Yet in routine practice, only 8% of veterans with HF at his center are on an SGLT2 inhibitor, compared with 80% on ACE inhibitors or beta blockers, observed Dr. Ziaeian. “This medication has been indicated for the last year and a half and we’re only at 8% in a system where we have pretty easy access to medications.”

As reported online Feb. 10 in JAMA Cardiology, notable sex differences were found in hospitalization, with higher rates per 1,000 persons among men.

In contrast, a 2020 report on HF trends in the VA system showed a 2% decrease in unadjusted 30-day readmissions from 2007 to 2017 and a decline in the adjusted 30-day readmission risk.

The present study did not risk-adjust readmission risk and included a population that was 51% male, compared with about 98% male in the VA, the investigators noted.

“The increasing hospitalization rate in our study may represent an actual increase in HF hospitalizations or shifts in administrative coding practices, increased use of HF biomarkers, or lower thresholds for diagnosis of HF with preserved ejection fraction,” they wrote.

The analysis was based on data from the Nationwide Readmission Database, which included 35,197,725 hospitalizations with a primary or secondary diagnosis of HF and 8,273,270 primary HF hospitalizations from January 2010 to December 2017.

A single primary HF admission occurred in 5,092,626 unique patients and 1,269,109 had two or more HF hospitalizations. The mean age was 72.1 years.

The administrative database did not include clinical data, so it wasn’t possible to differentiate between HF with preserved or reduced ejection fraction, the authors noted. Patient race and ethnicity data also were not available.

“Future studies are needed to verify our findings to better develop and improve individualized strategies for HF prevention, management, and surveillance for men and women,” the investigators concluded.

One coauthor reporting receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards Lifesciences, Janssen Pharmaceuticals, Medtronic, Merck, and Novartis. No other disclosures were reported.

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

Heart failure (HF) hospitalizations and readmissions are on the rise in the United States, reversing a multiyear downward trend, a new national cohort study shows.

Overall primary HF hospitalization rates per 1,000 adults declined from 4.4 in 2010 to 4.1 in 2013, and then increased from 4.2 in 2014 to 4.9 in 2017.

Rates of unique patient visits for HF were also on the way down – falling from 3.4 in 2010 to 3.2 in 2013 and 2014 – before climbing to 3.8 in 2017.

Similar trends were observed for rates of postdischarge HF readmissions (from 1.0 in 2010 to 0.9 in 2014 to 1.1 in 2017) and all-cause 30-day readmissions (from 0.8 in 2010 to 0.7 in 2014 to 0.9 in 2017).

“We should be emphasizing the things we know work to reduce heart failure hospitalization, which is, No. 1, prevention,” senior author Boback Ziaeian, MD, PhD, said in an interview.

Comorbidities that can lead to heart failure crept up over the study period, such that by 2017, hypertension was present in 91.4% of patients, diabetes in 48.9%, and lipid disorders in 53.1%, up from 76.5%, 44.9%, and 40.4%, respectively, in 2010. Half of all patients had coronary artery disease at both time points. Renal disease shot up from 45.9% to 60.6% by 2017.

“If we did a better job of controlling our known risk factors, we would really cut down on the incidence of heart failure being developed and then, among those estimated 6.6 million heart failure patients, we need to get them on our cornerstone therapies,” said Dr. Ziaeian, of the Veterans Affairts Greater Los Angeles Healthcare System and the University of California, Los Angeles.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors, which have shown clear efficacy and safety in trials like DAPA-HF and EMPEROR-Reduced, provide a “huge opportunity” to add on to standard therapies, he noted. Competition for VA contracts has brought the price down to about $50 a month for veterans, compared with a cash price of about $500-$600 a month.

Yet in routine practice, only 8% of veterans with HF at his center are on an SGLT2 inhibitor, compared with 80% on ACE inhibitors or beta blockers, observed Dr. Ziaeian. “This medication has been indicated for the last year and a half and we’re only at 8% in a system where we have pretty easy access to medications.”

As reported online Feb. 10 in JAMA Cardiology, notable sex differences were found in hospitalization, with higher rates per 1,000 persons among men.

In contrast, a 2020 report on HF trends in the VA system showed a 2% decrease in unadjusted 30-day readmissions from 2007 to 2017 and a decline in the adjusted 30-day readmission risk.

The present study did not risk-adjust readmission risk and included a population that was 51% male, compared with about 98% male in the VA, the investigators noted.

“The increasing hospitalization rate in our study may represent an actual increase in HF hospitalizations or shifts in administrative coding practices, increased use of HF biomarkers, or lower thresholds for diagnosis of HF with preserved ejection fraction,” they wrote.

The analysis was based on data from the Nationwide Readmission Database, which included 35,197,725 hospitalizations with a primary or secondary diagnosis of HF and 8,273,270 primary HF hospitalizations from January 2010 to December 2017.

A single primary HF admission occurred in 5,092,626 unique patients and 1,269,109 had two or more HF hospitalizations. The mean age was 72.1 years.

The administrative database did not include clinical data, so it wasn’t possible to differentiate between HF with preserved or reduced ejection fraction, the authors noted. Patient race and ethnicity data also were not available.

“Future studies are needed to verify our findings to better develop and improve individualized strategies for HF prevention, management, and surveillance for men and women,” the investigators concluded.

One coauthor reporting receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards Lifesciences, Janssen Pharmaceuticals, Medtronic, Merck, and Novartis. No other disclosures were reported.

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

Before the pandemic, the biggest parent-related challenge for Charlie Wray, DO, MS, a hospitalist and assistant clinical professor of medicine at the University of California, San Francisco, was “figuring out what I was going to pack in my kids’ lunches. Like most people, we were very much in our groove – we knew when my wife was going to leave work, and which day I’d pick up the kids,” Dr. Wray said. “I reflect back on that and think how easy it was.”

The old life – the one that seems so comparatively effortless – has been gone for close to a year now. And with the reopening of schools in the fall of 2020, hospitalists with school-age kids felt – and are still feeling – the strain in a variety of ways.
 

‘Podding up’

“The largest struggles that we have had involve dealing with the daily logistics of doing at-home learning,” said Dr. Wray, father to a 6-year-old and a 3-year-old. Dr. Wray and his wife are both physicians and have been juggling full work schedules with virtual school for their older child, who is not old enough to be autonomous. “For parents who have younger children who require one-on-one attention for the vast majority of their learning, that certainly takes more of a toll on your time, energy, and resources.”

Uncertainty has created anxiety about the future. “We have no idea what’s going to be happening next month. How do we plan for that? How do we allocate our time for that? That has been a real struggle for us, especially for a two-physician household where we are both considered front line and are both needing to be at the hospital or the clinic on a fairly regular basis,” he said.

Then there is the never-ending stress. Dr. Wray observed that physicians are used to operating under stress, especially at work. “What I think is gnawing at me, and probably a lot of other physicians out there, is you go home and that stress is still there. It’s really hard to escape it. And you wake up in the morning and it’s there, whereas in the past, you could have a nice day. There’s little separation between work and domestic life right now.”

Having to work later into the evening has eaten into time for himself and time with his wife too. “That’s another side effect of the pandemic – it not only takes your time during the day, it takes the time you used to have at night to relax.”

To manage these challenges, Dr. Wray said he and his wife regularly double check their schedules. The family has also created a pod – “I think ‘podded up’ is a verb now,” he laughed – with another family and hired a recent college graduate to help the kids with their virtual learning. “Is it as good as being at school and amongst friends and having an actual teacher there? Of course not. But I think it’s the best that we can do.”

Dr. Wray said his employers have been flexible and understanding regarding scheduling conflicts that parents can have. “It’s really difficult for us, so oftentimes I struggle to see how other people are pulling this off. We recognize how fortunate we are, so that’s something I never want to overlook.”
 

Dividing and conquering

The biggest prepandemic issue for Sridevi Alla, MD, a hospitalist at Baptist Memorial Health in Jackson, Miss., and mother to four children – a 10-year-old, 6-year-old, 2-year-old, and a 9-month-old – was finding a babysitter on the weekend to take her kids out somewhere to burn off energy.

That’s a noticeable departure from the current demand to be not just a parent, but a teacher and a counselor too, thanks to virtual school, noted Dr. Alla. “You are their everything now,” she said. “They don’t have friends. They don’t have any other atmosphere or learning environment to let out their energy, their emotions. You have become their world.”

The beginning of the pandemic was particularly stressful for Dr. Alla, who is in the United States on an H-1B visa. “It was totally worrisome because you’re putting yourself at risk with patients who have the coronavirus, despite not knowing what your future itself is going to be like or what your family’s future is going to be like if anything happens to you,” she said. “We are fortunate we have our jobs. A lot of my immigrant friends lost theirs in the middle of this and they’re still trying to find jobs.”

Dr. Alla’s first challenge was whether to send her older two children to school or keep them at home to do virtual learning. The lack of information from the schools at first did not help that process, but she and her husband ended up choosing virtual school, a decision they still occasionally question.

Next, they had to find child care, and not just someone who could look after the younger two kids – they needed someone with the ability to also help the older ones with their homework.

Though initially the family had help, their first nanny had to quit because her roommate contracted COVID. “After that, we didn’t have help and my husband decided to work from home,” said Dr. Alla. “As of now, we’re still looking for child care. And the main issues are the late hours and the hospitalist week-on, week-off schedule.”

“It’s extremely hard,” she reflected. “At home, there’s no line. A 2-year-old doesn’t understand office time or personal time.” Still, Dr. Alla and her husband are maintaining by dividing up responsibilities and making sure they are always planning ahead.
 

Maintaining a routine

The greatest challenge for Heather Nye, MD, PhD, a hospitalist and professor of clinical medicine at UCSF, has been “maintaining normalcy for the kids.” She mourns the loss of a normal childhood for her kids, however temporary. “Living with abandon, feeling like you’re invincible, going out there and breaking your arm, meeting people, not fearing the world – those are not things we can instill in them right now,” she said.

The mother of an eighth grader and a second grader, Dr. Nye said their school district did not communicate well about how school would proceed. The district ended up offering only virtual school, with no plans for even hybrid learning in the future, leaving parents scrambling to plan.

Dr. Nye lucked out when her youngest child was accepted for a slot at a day camp offered through a partnership between the YMCA and UCSF. However, her eighth grader did not do well with distance learning in the spring, so having that virtual school as the only option has been difficult.

“Neither of the kids are doing really well in school,” she said. Her older one is overwhelmed by all the disparate online platforms and her youngest is having a hard time adjusting to differences like using a virtual pen. “The learning itself without question has suffered. You wonder about evaluation and this whole cohort of children in what will probably be more or less a lost year.”

Routines are the backbone of the family’s survival. “I think one of the most important things for kids in any stage of development is having a routine and being comfortable with that routine because that creates a sense of wellbeing in this time of uncertainty,” Dr. Nye said.

Neither Dr. Nye nor her husband, a geriatrician, have cut back on their work, so they are balancing a full plate of activities with parenting. Though their family is managing, “there are streaks of days where we’re like: ‘Are we failing our children?’ I’m sure every parent out there is asking themselves: ‘Am I doing enough?’” But she said, “We’re very, very lucky. We got that [camp] slot, we have the money to pay for it, and we both have flexible jobs.”
 

Rallying resources

Avital O’Glasser, MD, a hospitalist and associate professor of medicine at Oregon Health and Science University, Portland, fervently wished she could clone herself when the pandemic first started. Not only were her kids suddenly thrown into online classes, but she was pulled in to create a new service line for the COVID response at her clinic.

“The number of times that I said I think I need a time turner from Harry Potter. ... I felt that nothing was getting done even close to adequately because we were cutting corners left and right,” she said.

Thankfully, things have simmered down and Dr. O’Glasser is now working from home 5 or 6 days a week while her husband, a lawyer, goes to his job. “I think stress is lower now, but that’s in large part because, by the end of June, I really had to just stop and acknowledge how stressed I was and do a dramatic realignment of what I was doing for myself in terms of mental health support and bandwidth,” she said. Part of that involved realizing that the family needed a homeschool nanny for their 10-year-old and 7-year-old. “It’s been a lifesaver,” said Dr. O’Glasser.

Though life is on more of an even keel now, stress pops up in unexpected ways. “My youngest has pretty intense separation anxiety from me. Even with getting attention all day from our homeschool nanny, the day after I’m out of the house at the hospital, he really clings to me,” Dr. O’Glasser said. There’s sibling rivalry too, in an attempt to get parental attention.

Setting boundaries between work and home was her biggest challenge prepandemic, and that has not changed. “You’re trying to find that happy balance between professional development and family,” Dr. O’Glasser said. “Where do I cut corners? Do I try to multitask but spread myself thin? How do I say no to things? When am I going to find time to do laundry? When am I disconnecting? I think that now it’s facets of the same conundrum, but just manifested in different ways.”

She emphasized that parents should go easy on themselves right now. “A lot of parenting rules went out the window. My kids have had more screen time…and the amount of junk food they eat right now? Celebrate the wins.” Dr. O’Glasser chuckled about how her definition of a “win” has changed. “The bar now is something that I may never have considered a win before. Just seize those small moments. If my 7-year-old needs to do reading at my feet while I’m finishing notes from the day before, that’s okay,” she said.
 

How hospitalist groups can help

All four hospitalists had ideas about how hospitalist groups can help parents with school-age kids during the pandemic.

Providing child care at health care systems gives employees additional support, said Dr. Alla. Some of her friends have been unable to find child care because they are physicians who care for COVID patients and people do not want the extra risk. “I think any institution should think about this option because it’s very beneficial for an employee, especially for the long hours.”

Dr. Wray said he saw a program that matches up a hospitalist who has kids with one who does not in a type of buddy system, and they check in with each other. Then, if the parent has something come up, the other hospitalist can fill in and the parent can “pay it back” at another time. “This doesn’t put all the impetus on the schedule or on a single individual but spreads the risk out a little more and gives parents a bit of a parachute to make them feel like the system is supporting them,” he said.

“I would encourage groups to reach appropriate accommodations that are equitable and that don’t create discord because they’re perceived as unfair,” said Dr. O’Glasser. For instance, giving child care stipends, but limiting them to care at a licensed facility when some people might need to pay for a homeschool tutor. “Some of the policies that I saw seem to leave out the elementary school lot. You can’t just lump all kids together.”

Dr. Nye thought group leaders should take unseen pressures into account when evaluating employee performance. “I think we’re going to need to shift our yardstick because we can’t do everything now,” she said. “I’m talking about the extra things that people do that they’re evaluated on at the end of the year like volunteering for more shifts, sitting on committees, the things that likely aren’t in their job description. We’re going to have times when people are filling every last minute for their families. Face it with kindness and understanding and know that, in future years, things are going to go back to normal.”
 

Before the pandemic, the biggest parent-related challenge for Charlie Wray, DO, MS, a hospitalist and assistant clinical professor of medicine at the University of California, San Francisco, was “figuring out what I was going to pack in my kids’ lunches. Like most people, we were very much in our groove – we knew when my wife was going to leave work, and which day I’d pick up the kids,” Dr. Wray said. “I reflect back on that and think how easy it was.”

The old life – the one that seems so comparatively effortless – has been gone for close to a year now. And with the reopening of schools in the fall of 2020, hospitalists with school-age kids felt – and are still feeling – the strain in a variety of ways.
 

‘Podding up’

“The largest struggles that we have had involve dealing with the daily logistics of doing at-home learning,” said Dr. Wray, father to a 6-year-old and a 3-year-old. Dr. Wray and his wife are both physicians and have been juggling full work schedules with virtual school for their older child, who is not old enough to be autonomous. “For parents who have younger children who require one-on-one attention for the vast majority of their learning, that certainly takes more of a toll on your time, energy, and resources.”

Uncertainty has created anxiety about the future. “We have no idea what’s going to be happening next month. How do we plan for that? How do we allocate our time for that? That has been a real struggle for us, especially for a two-physician household where we are both considered front line and are both needing to be at the hospital or the clinic on a fairly regular basis,” he said.

Then there is the never-ending stress. Dr. Wray observed that physicians are used to operating under stress, especially at work. “What I think is gnawing at me, and probably a lot of other physicians out there, is you go home and that stress is still there. It’s really hard to escape it. And you wake up in the morning and it’s there, whereas in the past, you could have a nice day. There’s little separation between work and domestic life right now.”

Having to work later into the evening has eaten into time for himself and time with his wife too. “That’s another side effect of the pandemic – it not only takes your time during the day, it takes the time you used to have at night to relax.”

To manage these challenges, Dr. Wray said he and his wife regularly double check their schedules. The family has also created a pod – “I think ‘podded up’ is a verb now,” he laughed – with another family and hired a recent college graduate to help the kids with their virtual learning. “Is it as good as being at school and amongst friends and having an actual teacher there? Of course not. But I think it’s the best that we can do.”

Dr. Wray said his employers have been flexible and understanding regarding scheduling conflicts that parents can have. “It’s really difficult for us, so oftentimes I struggle to see how other people are pulling this off. We recognize how fortunate we are, so that’s something I never want to overlook.”
 

Dividing and conquering

The biggest prepandemic issue for Sridevi Alla, MD, a hospitalist at Baptist Memorial Health in Jackson, Miss., and mother to four children – a 10-year-old, 6-year-old, 2-year-old, and a 9-month-old – was finding a babysitter on the weekend to take her kids out somewhere to burn off energy.

That’s a noticeable departure from the current demand to be not just a parent, but a teacher and a counselor too, thanks to virtual school, noted Dr. Alla. “You are their everything now,” she said. “They don’t have friends. They don’t have any other atmosphere or learning environment to let out their energy, their emotions. You have become their world.”

The beginning of the pandemic was particularly stressful for Dr. Alla, who is in the United States on an H-1B visa. “It was totally worrisome because you’re putting yourself at risk with patients who have the coronavirus, despite not knowing what your future itself is going to be like or what your family’s future is going to be like if anything happens to you,” she said. “We are fortunate we have our jobs. A lot of my immigrant friends lost theirs in the middle of this and they’re still trying to find jobs.”

Dr. Alla’s first challenge was whether to send her older two children to school or keep them at home to do virtual learning. The lack of information from the schools at first did not help that process, but she and her husband ended up choosing virtual school, a decision they still occasionally question.

Next, they had to find child care, and not just someone who could look after the younger two kids – they needed someone with the ability to also help the older ones with their homework.

Though initially the family had help, their first nanny had to quit because her roommate contracted COVID. “After that, we didn’t have help and my husband decided to work from home,” said Dr. Alla. “As of now, we’re still looking for child care. And the main issues are the late hours and the hospitalist week-on, week-off schedule.”

“It’s extremely hard,” she reflected. “At home, there’s no line. A 2-year-old doesn’t understand office time or personal time.” Still, Dr. Alla and her husband are maintaining by dividing up responsibilities and making sure they are always planning ahead.
 

Maintaining a routine

The greatest challenge for Heather Nye, MD, PhD, a hospitalist and professor of clinical medicine at UCSF, has been “maintaining normalcy for the kids.” She mourns the loss of a normal childhood for her kids, however temporary. “Living with abandon, feeling like you’re invincible, going out there and breaking your arm, meeting people, not fearing the world – those are not things we can instill in them right now,” she said.

The mother of an eighth grader and a second grader, Dr. Nye said their school district did not communicate well about how school would proceed. The district ended up offering only virtual school, with no plans for even hybrid learning in the future, leaving parents scrambling to plan.

Dr. Nye lucked out when her youngest child was accepted for a slot at a day camp offered through a partnership between the YMCA and UCSF. However, her eighth grader did not do well with distance learning in the spring, so having that virtual school as the only option has been difficult.

“Neither of the kids are doing really well in school,” she said. Her older one is overwhelmed by all the disparate online platforms and her youngest is having a hard time adjusting to differences like using a virtual pen. “The learning itself without question has suffered. You wonder about evaluation and this whole cohort of children in what will probably be more or less a lost year.”

Routines are the backbone of the family’s survival. “I think one of the most important things for kids in any stage of development is having a routine and being comfortable with that routine because that creates a sense of wellbeing in this time of uncertainty,” Dr. Nye said.

Neither Dr. Nye nor her husband, a geriatrician, have cut back on their work, so they are balancing a full plate of activities with parenting. Though their family is managing, “there are streaks of days where we’re like: ‘Are we failing our children?’ I’m sure every parent out there is asking themselves: ‘Am I doing enough?’” But she said, “We’re very, very lucky. We got that [camp] slot, we have the money to pay for it, and we both have flexible jobs.”
 

Rallying resources

Avital O’Glasser, MD, a hospitalist and associate professor of medicine at Oregon Health and Science University, Portland, fervently wished she could clone herself when the pandemic first started. Not only were her kids suddenly thrown into online classes, but she was pulled in to create a new service line for the COVID response at her clinic.

“The number of times that I said I think I need a time turner from Harry Potter. ... I felt that nothing was getting done even close to adequately because we were cutting corners left and right,” she said.

Thankfully, things have simmered down and Dr. O’Glasser is now working from home 5 or 6 days a week while her husband, a lawyer, goes to his job. “I think stress is lower now, but that’s in large part because, by the end of June, I really had to just stop and acknowledge how stressed I was and do a dramatic realignment of what I was doing for myself in terms of mental health support and bandwidth,” she said. Part of that involved realizing that the family needed a homeschool nanny for their 10-year-old and 7-year-old. “It’s been a lifesaver,” said Dr. O’Glasser.

Though life is on more of an even keel now, stress pops up in unexpected ways. “My youngest has pretty intense separation anxiety from me. Even with getting attention all day from our homeschool nanny, the day after I’m out of the house at the hospital, he really clings to me,” Dr. O’Glasser said. There’s sibling rivalry too, in an attempt to get parental attention.

Setting boundaries between work and home was her biggest challenge prepandemic, and that has not changed. “You’re trying to find that happy balance between professional development and family,” Dr. O’Glasser said. “Where do I cut corners? Do I try to multitask but spread myself thin? How do I say no to things? When am I going to find time to do laundry? When am I disconnecting? I think that now it’s facets of the same conundrum, but just manifested in different ways.”

She emphasized that parents should go easy on themselves right now. “A lot of parenting rules went out the window. My kids have had more screen time…and the amount of junk food they eat right now? Celebrate the wins.” Dr. O’Glasser chuckled about how her definition of a “win” has changed. “The bar now is something that I may never have considered a win before. Just seize those small moments. If my 7-year-old needs to do reading at my feet while I’m finishing notes from the day before, that’s okay,” she said.
 

How hospitalist groups can help

All four hospitalists had ideas about how hospitalist groups can help parents with school-age kids during the pandemic.

Providing child care at health care systems gives employees additional support, said Dr. Alla. Some of her friends have been unable to find child care because they are physicians who care for COVID patients and people do not want the extra risk. “I think any institution should think about this option because it’s very beneficial for an employee, especially for the long hours.”

Dr. Wray said he saw a program that matches up a hospitalist who has kids with one who does not in a type of buddy system, and they check in with each other. Then, if the parent has something come up, the other hospitalist can fill in and the parent can “pay it back” at another time. “This doesn’t put all the impetus on the schedule or on a single individual but spreads the risk out a little more and gives parents a bit of a parachute to make them feel like the system is supporting them,” he said.

“I would encourage groups to reach appropriate accommodations that are equitable and that don’t create discord because they’re perceived as unfair,” said Dr. O’Glasser. For instance, giving child care stipends, but limiting them to care at a licensed facility when some people might need to pay for a homeschool tutor. “Some of the policies that I saw seem to leave out the elementary school lot. You can’t just lump all kids together.”

Dr. Nye thought group leaders should take unseen pressures into account when evaluating employee performance. “I think we’re going to need to shift our yardstick because we can’t do everything now,” she said. “I’m talking about the extra things that people do that they’re evaluated on at the end of the year like volunteering for more shifts, sitting on committees, the things that likely aren’t in their job description. We’re going to have times when people are filling every last minute for their families. Face it with kindness and understanding and know that, in future years, things are going to go back to normal.”
 

Before the pandemic, the biggest parent-related challenge for Charlie Wray, DO, MS, a hospitalist and assistant clinical professor of medicine at the University of California, San Francisco, was “figuring out what I was going to pack in my kids’ lunches. Like most people, we were very much in our groove – we knew when my wife was going to leave work, and which day I’d pick up the kids,” Dr. Wray said. “I reflect back on that and think how easy it was.”

The old life – the one that seems so comparatively effortless – has been gone for close to a year now. And with the reopening of schools in the fall of 2020, hospitalists with school-age kids felt – and are still feeling – the strain in a variety of ways.
 

‘Podding up’

“The largest struggles that we have had involve dealing with the daily logistics of doing at-home learning,” said Dr. Wray, father to a 6-year-old and a 3-year-old. Dr. Wray and his wife are both physicians and have been juggling full work schedules with virtual school for their older child, who is not old enough to be autonomous. “For parents who have younger children who require one-on-one attention for the vast majority of their learning, that certainly takes more of a toll on your time, energy, and resources.”

Uncertainty has created anxiety about the future. “We have no idea what’s going to be happening next month. How do we plan for that? How do we allocate our time for that? That has been a real struggle for us, especially for a two-physician household where we are both considered front line and are both needing to be at the hospital or the clinic on a fairly regular basis,” he said.

Then there is the never-ending stress. Dr. Wray observed that physicians are used to operating under stress, especially at work. “What I think is gnawing at me, and probably a lot of other physicians out there, is you go home and that stress is still there. It’s really hard to escape it. And you wake up in the morning and it’s there, whereas in the past, you could have a nice day. There’s little separation between work and domestic life right now.”

Having to work later into the evening has eaten into time for himself and time with his wife too. “That’s another side effect of the pandemic – it not only takes your time during the day, it takes the time you used to have at night to relax.”

To manage these challenges, Dr. Wray said he and his wife regularly double check their schedules. The family has also created a pod – “I think ‘podded up’ is a verb now,” he laughed – with another family and hired a recent college graduate to help the kids with their virtual learning. “Is it as good as being at school and amongst friends and having an actual teacher there? Of course not. But I think it’s the best that we can do.”

Dr. Wray said his employers have been flexible and understanding regarding scheduling conflicts that parents can have. “It’s really difficult for us, so oftentimes I struggle to see how other people are pulling this off. We recognize how fortunate we are, so that’s something I never want to overlook.”
 

Dividing and conquering

The biggest prepandemic issue for Sridevi Alla, MD, a hospitalist at Baptist Memorial Health in Jackson, Miss., and mother to four children – a 10-year-old, 6-year-old, 2-year-old, and a 9-month-old – was finding a babysitter on the weekend to take her kids out somewhere to burn off energy.

That’s a noticeable departure from the current demand to be not just a parent, but a teacher and a counselor too, thanks to virtual school, noted Dr. Alla. “You are their everything now,” she said. “They don’t have friends. They don’t have any other atmosphere or learning environment to let out their energy, their emotions. You have become their world.”

The beginning of the pandemic was particularly stressful for Dr. Alla, who is in the United States on an H-1B visa. “It was totally worrisome because you’re putting yourself at risk with patients who have the coronavirus, despite not knowing what your future itself is going to be like or what your family’s future is going to be like if anything happens to you,” she said. “We are fortunate we have our jobs. A lot of my immigrant friends lost theirs in the middle of this and they’re still trying to find jobs.”

Dr. Alla’s first challenge was whether to send her older two children to school or keep them at home to do virtual learning. The lack of information from the schools at first did not help that process, but she and her husband ended up choosing virtual school, a decision they still occasionally question.

Next, they had to find child care, and not just someone who could look after the younger two kids – they needed someone with the ability to also help the older ones with their homework.

Though initially the family had help, their first nanny had to quit because her roommate contracted COVID. “After that, we didn’t have help and my husband decided to work from home,” said Dr. Alla. “As of now, we’re still looking for child care. And the main issues are the late hours and the hospitalist week-on, week-off schedule.”

“It’s extremely hard,” she reflected. “At home, there’s no line. A 2-year-old doesn’t understand office time or personal time.” Still, Dr. Alla and her husband are maintaining by dividing up responsibilities and making sure they are always planning ahead.
 

Maintaining a routine

The greatest challenge for Heather Nye, MD, PhD, a hospitalist and professor of clinical medicine at UCSF, has been “maintaining normalcy for the kids.” She mourns the loss of a normal childhood for her kids, however temporary. “Living with abandon, feeling like you’re invincible, going out there and breaking your arm, meeting people, not fearing the world – those are not things we can instill in them right now,” she said.

The mother of an eighth grader and a second grader, Dr. Nye said their school district did not communicate well about how school would proceed. The district ended up offering only virtual school, with no plans for even hybrid learning in the future, leaving parents scrambling to plan.

Dr. Nye lucked out when her youngest child was accepted for a slot at a day camp offered through a partnership between the YMCA and UCSF. However, her eighth grader did not do well with distance learning in the spring, so having that virtual school as the only option has been difficult.

“Neither of the kids are doing really well in school,” she said. Her older one is overwhelmed by all the disparate online platforms and her youngest is having a hard time adjusting to differences like using a virtual pen. “The learning itself without question has suffered. You wonder about evaluation and this whole cohort of children in what will probably be more or less a lost year.”

Routines are the backbone of the family’s survival. “I think one of the most important things for kids in any stage of development is having a routine and being comfortable with that routine because that creates a sense of wellbeing in this time of uncertainty,” Dr. Nye said.

Neither Dr. Nye nor her husband, a geriatrician, have cut back on their work, so they are balancing a full plate of activities with parenting. Though their family is managing, “there are streaks of days where we’re like: ‘Are we failing our children?’ I’m sure every parent out there is asking themselves: ‘Am I doing enough?’” But she said, “We’re very, very lucky. We got that [camp] slot, we have the money to pay for it, and we both have flexible jobs.”
 

Rallying resources

Avital O’Glasser, MD, a hospitalist and associate professor of medicine at Oregon Health and Science University, Portland, fervently wished she could clone herself when the pandemic first started. Not only were her kids suddenly thrown into online classes, but she was pulled in to create a new service line for the COVID response at her clinic.

“The number of times that I said I think I need a time turner from Harry Potter. ... I felt that nothing was getting done even close to adequately because we were cutting corners left and right,” she said.

Thankfully, things have simmered down and Dr. O’Glasser is now working from home 5 or 6 days a week while her husband, a lawyer, goes to his job. “I think stress is lower now, but that’s in large part because, by the end of June, I really had to just stop and acknowledge how stressed I was and do a dramatic realignment of what I was doing for myself in terms of mental health support and bandwidth,” she said. Part of that involved realizing that the family needed a homeschool nanny for their 10-year-old and 7-year-old. “It’s been a lifesaver,” said Dr. O’Glasser.

Though life is on more of an even keel now, stress pops up in unexpected ways. “My youngest has pretty intense separation anxiety from me. Even with getting attention all day from our homeschool nanny, the day after I’m out of the house at the hospital, he really clings to me,” Dr. O’Glasser said. There’s sibling rivalry too, in an attempt to get parental attention.

Setting boundaries between work and home was her biggest challenge prepandemic, and that has not changed. “You’re trying to find that happy balance between professional development and family,” Dr. O’Glasser said. “Where do I cut corners? Do I try to multitask but spread myself thin? How do I say no to things? When am I going to find time to do laundry? When am I disconnecting? I think that now it’s facets of the same conundrum, but just manifested in different ways.”

She emphasized that parents should go easy on themselves right now. “A lot of parenting rules went out the window. My kids have had more screen time…and the amount of junk food they eat right now? Celebrate the wins.” Dr. O’Glasser chuckled about how her definition of a “win” has changed. “The bar now is something that I may never have considered a win before. Just seize those small moments. If my 7-year-old needs to do reading at my feet while I’m finishing notes from the day before, that’s okay,” she said.
 

How hospitalist groups can help

All four hospitalists had ideas about how hospitalist groups can help parents with school-age kids during the pandemic.

Providing child care at health care systems gives employees additional support, said Dr. Alla. Some of her friends have been unable to find child care because they are physicians who care for COVID patients and people do not want the extra risk. “I think any institution should think about this option because it’s very beneficial for an employee, especially for the long hours.”

Dr. Wray said he saw a program that matches up a hospitalist who has kids with one who does not in a type of buddy system, and they check in with each other. Then, if the parent has something come up, the other hospitalist can fill in and the parent can “pay it back” at another time. “This doesn’t put all the impetus on the schedule or on a single individual but spreads the risk out a little more and gives parents a bit of a parachute to make them feel like the system is supporting them,” he said.

“I would encourage groups to reach appropriate accommodations that are equitable and that don’t create discord because they’re perceived as unfair,” said Dr. O’Glasser. For instance, giving child care stipends, but limiting them to care at a licensed facility when some people might need to pay for a homeschool tutor. “Some of the policies that I saw seem to leave out the elementary school lot. You can’t just lump all kids together.”

Dr. Nye thought group leaders should take unseen pressures into account when evaluating employee performance. “I think we’re going to need to shift our yardstick because we can’t do everything now,” she said. “I’m talking about the extra things that people do that they’re evaluated on at the end of the year like volunteering for more shifts, sitting on committees, the things that likely aren’t in their job description. We’re going to have times when people are filling every last minute for their families. Face it with kindness and understanding and know that, in future years, things are going to go back to normal.”
 

In a time of tremendous uncertainty, there is one trend that seems consistent year over year – the undisputed value of hospitalists. In the 2020 State of Hospital Medicine (SoHM) Report, the Society of Hospital Medicine partnered with the Medical Group Management Association (MGMA) to provide data on hospitalist compensation and productivity. The Report provides resounding evidence that hospitalists continue to be compensated at rising rates. This may be driven by both the continued demand-supply mismatch and a recognition of the overall value they generate rather than strictly the volume of their productivity.

In 2020, the median total compensation nationally for adult hospitalists (internal medicine and family medicine) was $307,633, representing an increase of over 6% from the 2018 Survey (see Figure 1).

Source: 2020 State of Hospital Medicine Report

Source: 2020 State of Hospital Medicine Report

However, the total compensation continues to be lower for academic hospitalists, with a median compensation difference of approximately $70,000 compared to their non-academic colleagues. Some of this sizable variance is offset by the fact that academic HMGs receive more in employee benefits packages than non-academic groups – a difference in median value of $10,500. Ideally, academic hospitalist compensation models should appropriately reflect and value their work efforts toward the tripartite academic mission of clinical care, education, and research. It would be valuable for future surveys to define and measure academic production in order to develop national standards for compensation models that recognize these non-billable forms of productivity.

While it’s important to review compensation benchmarks to remain competitive, it’s difficult to put a price on some factors that many may consider more valuable – group culture, opportunities for professional growth, and schedules that afford better work-life integration. Indirect measures of such benefits include paid time off, paid sick days, CME allowances and time, and retirement benefits programs. In 2020, the median employer contribution to retirement plans was reported to be $13,955, with respondents in the Midwest receiving the highest retirement benefit of $33,771.

It’s encouraging to see that hospitalist compensation continues to rise compared to previous years, despite relatively flat trends in wRVUs and total patient encounters. Another continued trend over the past years is the rising amount of financial support per physician that hospitals or other organizations provide HMGs (see Figure 3).

Source: 2020 State of Hospital Medicine Report

In 2020, the median financial support per FTE (full time equivalent) physician serving adult patients increased by 12% over 2018, to $198,750. Collectively these trends indicate hospitals are willing to compensate hospitalists for more than just their clinical volume.

There’s no doubt that the COVID-19 pandemic had some financial impact on hospital medicine groups in 2020. To assess this impact, SHM conducted a follow-up survey and compiled a COVID-19 Addendum to the SoHM Report. While 20.5% of HMG group respondents from the East reported providing hazard pay to clinicians caring for COVID-19 patients, nationally only 9.8% of groups said they offered this benefit. Of the 121 HMGs responding from across the country, 42% reported reductions in compensation, which included measures such as reductions in pay level and elimination or delays to bonus payments. The degree of reductions was not quantified, but fortunately the vast majority of these groups reported that these changes were likely to be temporary. To access all data in the 2020 SoHM Report and COVID-19 Addendum, visit hospitalmedicine.org/sohm to purchase your copy.

It’s certainly unclear what the future holds, but despite any transient changes observed during the COVID-19 pandemic, I believe that historical trends in hospitalist compensation will continue. If 2020 has taught us anything, it’s that hospitalists are essential, not only during an acute care crisis but for daily operations of any hospital.
 

Dr. Kurian is chief of the Division of Hospital Medicine at Northwell Health in New York. She is a member of SHM’s Practice Analysis Committee.

In a time of tremendous uncertainty, there is one trend that seems consistent year over year – the undisputed value of hospitalists. In the 2020 State of Hospital Medicine (SoHM) Report, the Society of Hospital Medicine partnered with the Medical Group Management Association (MGMA) to provide data on hospitalist compensation and productivity. The Report provides resounding evidence that hospitalists continue to be compensated at rising rates. This may be driven by both the continued demand-supply mismatch and a recognition of the overall value they generate rather than strictly the volume of their productivity.

In 2020, the median total compensation nationally for adult hospitalists (internal medicine and family medicine) was $307,633, representing an increase of over 6% from the 2018 Survey (see Figure 1).

Source: 2020 State of Hospital Medicine Report

Source: 2020 State of Hospital Medicine Report

However, the total compensation continues to be lower for academic hospitalists, with a median compensation difference of approximately $70,000 compared to their non-academic colleagues. Some of this sizable variance is offset by the fact that academic HMGs receive more in employee benefits packages than non-academic groups – a difference in median value of $10,500. Ideally, academic hospitalist compensation models should appropriately reflect and value their work efforts toward the tripartite academic mission of clinical care, education, and research. It would be valuable for future surveys to define and measure academic production in order to develop national standards for compensation models that recognize these non-billable forms of productivity.

While it’s important to review compensation benchmarks to remain competitive, it’s difficult to put a price on some factors that many may consider more valuable – group culture, opportunities for professional growth, and schedules that afford better work-life integration. Indirect measures of such benefits include paid time off, paid sick days, CME allowances and time, and retirement benefits programs. In 2020, the median employer contribution to retirement plans was reported to be $13,955, with respondents in the Midwest receiving the highest retirement benefit of $33,771.

It’s encouraging to see that hospitalist compensation continues to rise compared to previous years, despite relatively flat trends in wRVUs and total patient encounters. Another continued trend over the past years is the rising amount of financial support per physician that hospitals or other organizations provide HMGs (see Figure 3).

Source: 2020 State of Hospital Medicine Report

In 2020, the median financial support per FTE (full time equivalent) physician serving adult patients increased by 12% over 2018, to $198,750. Collectively these trends indicate hospitals are willing to compensate hospitalists for more than just their clinical volume.

There’s no doubt that the COVID-19 pandemic had some financial impact on hospital medicine groups in 2020. To assess this impact, SHM conducted a follow-up survey and compiled a COVID-19 Addendum to the SoHM Report. While 20.5% of HMG group respondents from the East reported providing hazard pay to clinicians caring for COVID-19 patients, nationally only 9.8% of groups said they offered this benefit. Of the 121 HMGs responding from across the country, 42% reported reductions in compensation, which included measures such as reductions in pay level and elimination or delays to bonus payments. The degree of reductions was not quantified, but fortunately the vast majority of these groups reported that these changes were likely to be temporary. To access all data in the 2020 SoHM Report and COVID-19 Addendum, visit hospitalmedicine.org/sohm to purchase your copy.

It’s certainly unclear what the future holds, but despite any transient changes observed during the COVID-19 pandemic, I believe that historical trends in hospitalist compensation will continue. If 2020 has taught us anything, it’s that hospitalists are essential, not only during an acute care crisis but for daily operations of any hospital.
 

Dr. Kurian is chief of the Division of Hospital Medicine at Northwell Health in New York. She is a member of SHM’s Practice Analysis Committee.

In a time of tremendous uncertainty, there is one trend that seems consistent year over year – the undisputed value of hospitalists. In the 2020 State of Hospital Medicine (SoHM) Report, the Society of Hospital Medicine partnered with the Medical Group Management Association (MGMA) to provide data on hospitalist compensation and productivity. The Report provides resounding evidence that hospitalists continue to be compensated at rising rates. This may be driven by both the continued demand-supply mismatch and a recognition of the overall value they generate rather than strictly the volume of their productivity.

In 2020, the median total compensation nationally for adult hospitalists (internal medicine and family medicine) was $307,633, representing an increase of over 6% from the 2018 Survey (see Figure 1).

Source: 2020 State of Hospital Medicine Report

Source: 2020 State of Hospital Medicine Report

However, the total compensation continues to be lower for academic hospitalists, with a median compensation difference of approximately $70,000 compared to their non-academic colleagues. Some of this sizable variance is offset by the fact that academic HMGs receive more in employee benefits packages than non-academic groups – a difference in median value of $10,500. Ideally, academic hospitalist compensation models should appropriately reflect and value their work efforts toward the tripartite academic mission of clinical care, education, and research. It would be valuable for future surveys to define and measure academic production in order to develop national standards for compensation models that recognize these non-billable forms of productivity.

While it’s important to review compensation benchmarks to remain competitive, it’s difficult to put a price on some factors that many may consider more valuable – group culture, opportunities for professional growth, and schedules that afford better work-life integration. Indirect measures of such benefits include paid time off, paid sick days, CME allowances and time, and retirement benefits programs. In 2020, the median employer contribution to retirement plans was reported to be $13,955, with respondents in the Midwest receiving the highest retirement benefit of $33,771.

It’s encouraging to see that hospitalist compensation continues to rise compared to previous years, despite relatively flat trends in wRVUs and total patient encounters. Another continued trend over the past years is the rising amount of financial support per physician that hospitals or other organizations provide HMGs (see Figure 3).

Source: 2020 State of Hospital Medicine Report

In 2020, the median financial support per FTE (full time equivalent) physician serving adult patients increased by 12% over 2018, to $198,750. Collectively these trends indicate hospitals are willing to compensate hospitalists for more than just their clinical volume.

There’s no doubt that the COVID-19 pandemic had some financial impact on hospital medicine groups in 2020. To assess this impact, SHM conducted a follow-up survey and compiled a COVID-19 Addendum to the SoHM Report. While 20.5% of HMG group respondents from the East reported providing hazard pay to clinicians caring for COVID-19 patients, nationally only 9.8% of groups said they offered this benefit. Of the 121 HMGs responding from across the country, 42% reported reductions in compensation, which included measures such as reductions in pay level and elimination or delays to bonus payments. The degree of reductions was not quantified, but fortunately the vast majority of these groups reported that these changes were likely to be temporary. To access all data in the 2020 SoHM Report and COVID-19 Addendum, visit hospitalmedicine.org/sohm to purchase your copy.

It’s certainly unclear what the future holds, but despite any transient changes observed during the COVID-19 pandemic, I believe that historical trends in hospitalist compensation will continue. If 2020 has taught us anything, it’s that hospitalists are essential, not only during an acute care crisis but for daily operations of any hospital.
 

Dr. Kurian is chief of the Division of Hospital Medicine at Northwell Health in New York. She is a member of SHM’s Practice Analysis Committee.

The combination of methylprednisolone and intravenous immunoglobulins works better than intravenous immunoglobulins alone for multisystem inflammatory syndrome in children (MIS-C), researchers say.

“I’m not sure it’s the best treatment because we have not studied every possible treatment,” François Angoulvant, MD, PhD, told this news organization, “but right now, it’s the standard of care.”

Dr. Angoulvant, a professor of pediatrics at University of Paris, and colleagues published a comparison of the two treatments in the Journal of the American Medical Association.

A small percentage of children infected with SARS-CoV-2 develop MIS-C about 2 to 4 weeks later. It is considered a separate disease entity from COVID-19 and is associated with persistent fever, digestive symptoms, rash, bilateral nonpurulent conjunctivitis, mucocutaneous inflammation signs, and frequent cardiovascular involvement. In more than 60% of cases, it leads to hemodynamic failure, with acute cardiac dysfunction.

Because MIS-C resembles Kawasaki disease, clinicians modeled their treatment on that condition and started with immunoglobulins alone, Dr. Angoulvant said.

Based on expert opinion, the National Health Service in the United Kingdom published a consensus statement in Sept. listing immunoglobulins alone as the first-line treatment.

But anecdotal reports have emerged that combining the immunoglobulins with a corticosteroid worked better. To investigate this possibility, Dr. Angoulvant and colleagues analyzed records of MIS-C cases in France, where physicians are required to report all suspected cases of MIS-C to the French National Public Health Agency.

Among the 181 cases they scrutinized, 111 fulfilled the World Health Organization criteria for MIS-C. Of these, the researchers were able to match 64 patients who had received immunoglobulins alone with 32 who had received the combined therapy and could be matched using propensity scores.

The researchers defined treatment failure as persistence of fever for 2 days after the start of therapy or recurrence of fever within a week. By this measure, the combination treatment failed in only 9% of cases while immunoglobulins alone failed in 38% of cases. The difference was statistically significant (P = .008). Most of those for whom these treatments failed received second-line treatments such as steroids or biological agents.

Patients treated with the combination therapy also had a lower risk of secondary acute left ventricular dysfunction (odds ratio, 0.20; 95% confidence interval, 0.06-0.66) and a lower risk of needing hemodynamic support (OR, 0.21; 95% CI, 0.06-0.76).

Those receiving the combination therapy spent a mean of 4 days in the pediatric intensive care unit compared with 6 days for those receiving immunoglobulins alone. (Difference in days, −2.4; 95% CI, −4.0 to −0.7; P = .005).

There are few drawbacks to the combination approach, Dr. Angoulvant said, as the side effects of corticosteroids are generally not severe and they can be anticipated because this class of medications has been used for many years.

The study raises the question of whether corticosteroids might work as well by themselves, but it could not be answered with this database as no one is using that approach in France, Dr. Angoulvant said. “I hope other teams around the world could bring us the answer.”

In the United States, most physicians appear to already be using the combination therapy, said David Teachey, MD, an associate professor of pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia.

The reduction in time in pediatric intensive care and the reduced risk of cardiac dysfunction are important findings, he said.

This retrospective study falls short of the evidence provided by a randomized clinical trial, Dr. Teachey noted. But he acknowledged that few families would agree to participate in such a trial as they would have to take a chance that the sick children would receive a less effective therapy than what they would otherwise get. “It’s hard to [talk] about a therapy reduction,” he told this news organization.

Given that impediment, he agreed with Dr. Angoulvant that the current study and others like it may provide the best data available pointing to a treatment approach for MIS-C.

The study received an unrestricted grant from Pfizer. The French COVID-19 Paediatric Inflammation Consortium received an unrestricted grant from the Square Foundation (Grandir–Fonds de Solidarité pour L’Enfance). Dr. Angoulvant and Dr. Teachey have disclosed no relevant financial relationships.

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

The combination of methylprednisolone and intravenous immunoglobulins works better than intravenous immunoglobulins alone for multisystem inflammatory syndrome in children (MIS-C), researchers say.

“I’m not sure it’s the best treatment because we have not studied every possible treatment,” François Angoulvant, MD, PhD, told this news organization, “but right now, it’s the standard of care.”

Dr. Angoulvant, a professor of pediatrics at University of Paris, and colleagues published a comparison of the two treatments in the Journal of the American Medical Association.

A small percentage of children infected with SARS-CoV-2 develop MIS-C about 2 to 4 weeks later. It is considered a separate disease entity from COVID-19 and is associated with persistent fever, digestive symptoms, rash, bilateral nonpurulent conjunctivitis, mucocutaneous inflammation signs, and frequent cardiovascular involvement. In more than 60% of cases, it leads to hemodynamic failure, with acute cardiac dysfunction.

Because MIS-C resembles Kawasaki disease, clinicians modeled their treatment on that condition and started with immunoglobulins alone, Dr. Angoulvant said.

Based on expert opinion, the National Health Service in the United Kingdom published a consensus statement in Sept. listing immunoglobulins alone as the first-line treatment.

But anecdotal reports have emerged that combining the immunoglobulins with a corticosteroid worked better. To investigate this possibility, Dr. Angoulvant and colleagues analyzed records of MIS-C cases in France, where physicians are required to report all suspected cases of MIS-C to the French National Public Health Agency.

Among the 181 cases they scrutinized, 111 fulfilled the World Health Organization criteria for MIS-C. Of these, the researchers were able to match 64 patients who had received immunoglobulins alone with 32 who had received the combined therapy and could be matched using propensity scores.

The researchers defined treatment failure as persistence of fever for 2 days after the start of therapy or recurrence of fever within a week. By this measure, the combination treatment failed in only 9% of cases while immunoglobulins alone failed in 38% of cases. The difference was statistically significant (P = .008). Most of those for whom these treatments failed received second-line treatments such as steroids or biological agents.

Patients treated with the combination therapy also had a lower risk of secondary acute left ventricular dysfunction (odds ratio, 0.20; 95% confidence interval, 0.06-0.66) and a lower risk of needing hemodynamic support (OR, 0.21; 95% CI, 0.06-0.76).

Those receiving the combination therapy spent a mean of 4 days in the pediatric intensive care unit compared with 6 days for those receiving immunoglobulins alone. (Difference in days, −2.4; 95% CI, −4.0 to −0.7; P = .005).

There are few drawbacks to the combination approach, Dr. Angoulvant said, as the side effects of corticosteroids are generally not severe and they can be anticipated because this class of medications has been used for many years.

The study raises the question of whether corticosteroids might work as well by themselves, but it could not be answered with this database as no one is using that approach in France, Dr. Angoulvant said. “I hope other teams around the world could bring us the answer.”

In the United States, most physicians appear to already be using the combination therapy, said David Teachey, MD, an associate professor of pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia.

The reduction in time in pediatric intensive care and the reduced risk of cardiac dysfunction are important findings, he said.

This retrospective study falls short of the evidence provided by a randomized clinical trial, Dr. Teachey noted. But he acknowledged that few families would agree to participate in such a trial as they would have to take a chance that the sick children would receive a less effective therapy than what they would otherwise get. “It’s hard to [talk] about a therapy reduction,” he told this news organization.

Given that impediment, he agreed with Dr. Angoulvant that the current study and others like it may provide the best data available pointing to a treatment approach for MIS-C.

The study received an unrestricted grant from Pfizer. The French COVID-19 Paediatric Inflammation Consortium received an unrestricted grant from the Square Foundation (Grandir–Fonds de Solidarité pour L’Enfance). Dr. Angoulvant and Dr. Teachey have disclosed no relevant financial relationships.

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

The combination of methylprednisolone and intravenous immunoglobulins works better than intravenous immunoglobulins alone for multisystem inflammatory syndrome in children (MIS-C), researchers say.

“I’m not sure it’s the best treatment because we have not studied every possible treatment,” François Angoulvant, MD, PhD, told this news organization, “but right now, it’s the standard of care.”

Dr. Angoulvant, a professor of pediatrics at University of Paris, and colleagues published a comparison of the two treatments in the Journal of the American Medical Association.

A small percentage of children infected with SARS-CoV-2 develop MIS-C about 2 to 4 weeks later. It is considered a separate disease entity from COVID-19 and is associated with persistent fever, digestive symptoms, rash, bilateral nonpurulent conjunctivitis, mucocutaneous inflammation signs, and frequent cardiovascular involvement. In more than 60% of cases, it leads to hemodynamic failure, with acute cardiac dysfunction.

Because MIS-C resembles Kawasaki disease, clinicians modeled their treatment on that condition and started with immunoglobulins alone, Dr. Angoulvant said.

Based on expert opinion, the National Health Service in the United Kingdom published a consensus statement in Sept. listing immunoglobulins alone as the first-line treatment.

But anecdotal reports have emerged that combining the immunoglobulins with a corticosteroid worked better. To investigate this possibility, Dr. Angoulvant and colleagues analyzed records of MIS-C cases in France, where physicians are required to report all suspected cases of MIS-C to the French National Public Health Agency.

Among the 181 cases they scrutinized, 111 fulfilled the World Health Organization criteria for MIS-C. Of these, the researchers were able to match 64 patients who had received immunoglobulins alone with 32 who had received the combined therapy and could be matched using propensity scores.

The researchers defined treatment failure as persistence of fever for 2 days after the start of therapy or recurrence of fever within a week. By this measure, the combination treatment failed in only 9% of cases while immunoglobulins alone failed in 38% of cases. The difference was statistically significant (P = .008). Most of those for whom these treatments failed received second-line treatments such as steroids or biological agents.

Patients treated with the combination therapy also had a lower risk of secondary acute left ventricular dysfunction (odds ratio, 0.20; 95% confidence interval, 0.06-0.66) and a lower risk of needing hemodynamic support (OR, 0.21; 95% CI, 0.06-0.76).

Those receiving the combination therapy spent a mean of 4 days in the pediatric intensive care unit compared with 6 days for those receiving immunoglobulins alone. (Difference in days, −2.4; 95% CI, −4.0 to −0.7; P = .005).

There are few drawbacks to the combination approach, Dr. Angoulvant said, as the side effects of corticosteroids are generally not severe and they can be anticipated because this class of medications has been used for many years.

The study raises the question of whether corticosteroids might work as well by themselves, but it could not be answered with this database as no one is using that approach in France, Dr. Angoulvant said. “I hope other teams around the world could bring us the answer.”

In the United States, most physicians appear to already be using the combination therapy, said David Teachey, MD, an associate professor of pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia.

The reduction in time in pediatric intensive care and the reduced risk of cardiac dysfunction are important findings, he said.

This retrospective study falls short of the evidence provided by a randomized clinical trial, Dr. Teachey noted. But he acknowledged that few families would agree to participate in such a trial as they would have to take a chance that the sick children would receive a less effective therapy than what they would otherwise get. “It’s hard to [talk] about a therapy reduction,” he told this news organization.

Given that impediment, he agreed with Dr. Angoulvant that the current study and others like it may provide the best data available pointing to a treatment approach for MIS-C.

The study received an unrestricted grant from Pfizer. The French COVID-19 Paediatric Inflammation Consortium received an unrestricted grant from the Square Foundation (Grandir–Fonds de Solidarité pour L’Enfance). Dr. Angoulvant and Dr. Teachey have disclosed no relevant financial relationships.

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

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Health care professionals working in critical care settings have been overburdened because of the plethora of COVID-19 cases, which has led to symptoms of burnout in both physicians and nurses, findings from a new study show.

XiXinXing/ThinkStock

“Overburdening ICU professionals during an extended period of time leads to burnout,” said lead study author Niek Kok, MSc, of IQ healthcare, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. “All ICU professionals are at the risk of this, and in our study, the incidence of physicians experiencing burnout was significantly higher than that of nurses in June 2020.”

This burnout can be explained by conditions caused by the pandemic, he noted, such as the scarcity of staff and resources and having to work with colleagues who were not qualified to work in critical care but who were there out of necessity.

Mr. Kok presented the findings of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
 

Burnout highest among critical care physicians

The ICU can be a stressful environment for both patients and health care personnel, and burnout is not uncommon among ICU clinicians. However, COVID-19 has amplified the degree of burnout being experienced by clinicians working in this setting. Critical care physicians now top the list of physicians experiencing burnout, at 51%, up from 44% last year, according to the Medscape report ‘Death by 1000 Thousand Cuts’: Physician Burnout and Suicide Report 2021.

The Medscape Nurse Career Satisfaction Report 2020, while not restricted to those working in critical care, also reported higher rates of burnout, compared with the prepandemic period. The percentage of nurses reporting being “very burned out” prior to the pandemic was 4%. Six months into the pandemic, that percentage soared to 18%.

In this study, Mr. Kok and colleagues examined the prevalence and incidence of burnout symptoms and moral distress in health care professionals working in the ICU, both before and during the COVID-19 pandemic.

“When the COVID-19 pandemic surfaced in the Netherlands, the health care professionals in our hospitals were motivated to do everything they could to provide the best care possible,” said Mr. Kok. “Many of the ICU professionals immediately realized that they would have to work longer hours.”

However, the health care professionals that he spoke with did have mixed feelings. Some were afraid of being infected with the virus, while others said that “it was very interesting times for them and that gave them extra motivation to do the work.

“Some physicians [and] the WHO warned that COVID-19 is not going to weathered by a heroic sprint – it is an arduous marathon that is going to go hand in hand with burnout symptoms,” Mr. Kok added. “It will eat away at our qualified ICU staff.”
 

Before and after data on burnout

It was widely believed that the COVID-19 pandemic would increase burnout symptoms, as had been demonstrated in studies of previous pandemics. However, Mr. Kok emphasized that there are no before and after measurements that transcend cross-sectional designs.

“The claim [has been] that it increases burnout – but there are no assessments of how it progresses in ICU professionals through time,” he said. “So what we really need is a comparison [of] before and after the pandemic.”

It is quite difficult to obtain this type of information because disruptive events like the COVID-19 pandemic cannot be predicted, he said. Thus, it is challenging to get a baseline measurement. But Mr. Kok pointed out that the study has both “before and after” measurements.

“By coincidence really, we had baseline data to measure the impact of the COVID-19 pandemic and had information that was collected before the pandemic,” he said.

In January 2020, a study began looking at the effects of ethics meetings on moral distress in ICU professionals. Data had been collected on moral distress and burnout on ICU professionals in December 2019. The first COVID-19 cases appeared in the Netherlands in February 2020.

A follow-up study was then conducted in May and June 2020, several months into the pandemic.

The longitudinal open cohort study included all ICU personnel who were working in five units within a single university medical center, plus another adult ICU that was based in a separate teaching hospital.

A total of 352 health care professionals responded to a baseline survey in October through December 2019, and then 233 responded to a follow-up survey sent in May and June 2020. The authors measured burnout symptoms and moral distress with the Maslach Burnout Inventory and the Moral Distress Scale, respectively.
 

Findings

The overall prevalence of burnout symptoms was 23.0% prior to the pandemic, and that jumped to 36.1% at post-peak time. Higher rates of burnout were reported by nurses (38.0%) than physicians (28.6%).

However, the incidence rate of new burnout cases was higher among physicians, compared with nurses (26.7% vs 21.9%). Not surprisingly, a higher prevalence of burnout symptoms was observed in the post-peak period for all clinicians (odds ratio, 1.83; 95% confidence interval, 1.32-2.53), and was higher for nurses (odds ratio, 1.77; 95% confidence interval, 1.03-3.04), for those working overtime (OR, 2.11; 95% CI, 1.48-3.02), and for personnel who directly engaged in patient care (OR, 1.87; 95% CI, 1.35-2.60).

Physicians in general were much more likely to develop burnout symptoms related to the pandemic, compared with nurses (OR, 3.56; 95% CI, 1.06-12.21).

When looking at findings on moral distress, Kok pointed out that it often arises in situations when the health care professional knows the right thing to do but is prevented from doing so. “Morally distressful situations all rose from December to June,” said Mr. Kok. “Scarcity was the most distressing. The other was where colleagues were perceived to be less skilled, and this had to do with the recruitment of people from outside of the ICU to provide care.”

Moral distress from scarcity and unskilled colleagues were both significantly related to burnout, he noted.

In the final model, working in a COVID-19 unit, stress from scarcity of resources and people, stress from unskilled colleagues, and stress from unsafe conditions were all related to burnout. “The stress of physicians was significantly higher,” said Kok. “Even though nurses had higher baseline burnout, it became less pronounced in June 2020. This indicates that burnout was significantly higher in physicians.”

Thus, Mr. Kok and colleagues concluded that overburdening ICU professionals during an extended period of time leads to burnout, and all ICU workers are at risk.
 

Burnout rates higher in physicians

Weighing in on the study, Greg S. Martin, MD, FCCP, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that the differences observed between physicians and nurses may have to do with the fact that “nurses have been smoldering all along and experiencing higher rates of burnout.

“They may have adapted better to the pandemic conditions, since they are more used to working overtime and short staffed, and spending far more time at the bedside,” he said. “Because of the volume of patients, physicians may be spending more hours doing patient care and are experiencing more burnout.”

Health care professionals working in critical care settings have been overburdened because of the plethora of COVID-19 cases, which has led to symptoms of burnout in both physicians and nurses, findings from a new study show.

XiXinXing/ThinkStock

“Overburdening ICU professionals during an extended period of time leads to burnout,” said lead study author Niek Kok, MSc, of IQ healthcare, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. “All ICU professionals are at the risk of this, and in our study, the incidence of physicians experiencing burnout was significantly higher than that of nurses in June 2020.”

This burnout can be explained by conditions caused by the pandemic, he noted, such as the scarcity of staff and resources and having to work with colleagues who were not qualified to work in critical care but who were there out of necessity.

Mr. Kok presented the findings of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
 

Burnout highest among critical care physicians

The ICU can be a stressful environment for both patients and health care personnel, and burnout is not uncommon among ICU clinicians. However, COVID-19 has amplified the degree of burnout being experienced by clinicians working in this setting. Critical care physicians now top the list of physicians experiencing burnout, at 51%, up from 44% last year, according to the Medscape report ‘Death by 1000 Thousand Cuts’: Physician Burnout and Suicide Report 2021.

The Medscape Nurse Career Satisfaction Report 2020, while not restricted to those working in critical care, also reported higher rates of burnout, compared with the prepandemic period. The percentage of nurses reporting being “very burned out” prior to the pandemic was 4%. Six months into the pandemic, that percentage soared to 18%.

In this study, Mr. Kok and colleagues examined the prevalence and incidence of burnout symptoms and moral distress in health care professionals working in the ICU, both before and during the COVID-19 pandemic.

“When the COVID-19 pandemic surfaced in the Netherlands, the health care professionals in our hospitals were motivated to do everything they could to provide the best care possible,” said Mr. Kok. “Many of the ICU professionals immediately realized that they would have to work longer hours.”

However, the health care professionals that he spoke with did have mixed feelings. Some were afraid of being infected with the virus, while others said that “it was very interesting times for them and that gave them extra motivation to do the work.

“Some physicians [and] the WHO warned that COVID-19 is not going to weathered by a heroic sprint – it is an arduous marathon that is going to go hand in hand with burnout symptoms,” Mr. Kok added. “It will eat away at our qualified ICU staff.”
 

Before and after data on burnout

It was widely believed that the COVID-19 pandemic would increase burnout symptoms, as had been demonstrated in studies of previous pandemics. However, Mr. Kok emphasized that there are no before and after measurements that transcend cross-sectional designs.

“The claim [has been] that it increases burnout – but there are no assessments of how it progresses in ICU professionals through time,” he said. “So what we really need is a comparison [of] before and after the pandemic.”

It is quite difficult to obtain this type of information because disruptive events like the COVID-19 pandemic cannot be predicted, he said. Thus, it is challenging to get a baseline measurement. But Mr. Kok pointed out that the study has both “before and after” measurements.

“By coincidence really, we had baseline data to measure the impact of the COVID-19 pandemic and had information that was collected before the pandemic,” he said.

In January 2020, a study began looking at the effects of ethics meetings on moral distress in ICU professionals. Data had been collected on moral distress and burnout on ICU professionals in December 2019. The first COVID-19 cases appeared in the Netherlands in February 2020.

A follow-up study was then conducted in May and June 2020, several months into the pandemic.

The longitudinal open cohort study included all ICU personnel who were working in five units within a single university medical center, plus another adult ICU that was based in a separate teaching hospital.

A total of 352 health care professionals responded to a baseline survey in October through December 2019, and then 233 responded to a follow-up survey sent in May and June 2020. The authors measured burnout symptoms and moral distress with the Maslach Burnout Inventory and the Moral Distress Scale, respectively.
 

Findings

The overall prevalence of burnout symptoms was 23.0% prior to the pandemic, and that jumped to 36.1% at post-peak time. Higher rates of burnout were reported by nurses (38.0%) than physicians (28.6%).

However, the incidence rate of new burnout cases was higher among physicians, compared with nurses (26.7% vs 21.9%). Not surprisingly, a higher prevalence of burnout symptoms was observed in the post-peak period for all clinicians (odds ratio, 1.83; 95% confidence interval, 1.32-2.53), and was higher for nurses (odds ratio, 1.77; 95% confidence interval, 1.03-3.04), for those working overtime (OR, 2.11; 95% CI, 1.48-3.02), and for personnel who directly engaged in patient care (OR, 1.87; 95% CI, 1.35-2.60).

Physicians in general were much more likely to develop burnout symptoms related to the pandemic, compared with nurses (OR, 3.56; 95% CI, 1.06-12.21).

When looking at findings on moral distress, Kok pointed out that it often arises in situations when the health care professional knows the right thing to do but is prevented from doing so. “Morally distressful situations all rose from December to June,” said Mr. Kok. “Scarcity was the most distressing. The other was where colleagues were perceived to be less skilled, and this had to do with the recruitment of people from outside of the ICU to provide care.”

Moral distress from scarcity and unskilled colleagues were both significantly related to burnout, he noted.

In the final model, working in a COVID-19 unit, stress from scarcity of resources and people, stress from unskilled colleagues, and stress from unsafe conditions were all related to burnout. “The stress of physicians was significantly higher,” said Kok. “Even though nurses had higher baseline burnout, it became less pronounced in June 2020. This indicates that burnout was significantly higher in physicians.”

Thus, Mr. Kok and colleagues concluded that overburdening ICU professionals during an extended period of time leads to burnout, and all ICU workers are at risk.
 

Burnout rates higher in physicians

Weighing in on the study, Greg S. Martin, MD, FCCP, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that the differences observed between physicians and nurses may have to do with the fact that “nurses have been smoldering all along and experiencing higher rates of burnout.

“They may have adapted better to the pandemic conditions, since they are more used to working overtime and short staffed, and spending far more time at the bedside,” he said. “Because of the volume of patients, physicians may be spending more hours doing patient care and are experiencing more burnout.”

Health care professionals working in critical care settings have been overburdened because of the plethora of COVID-19 cases, which has led to symptoms of burnout in both physicians and nurses, findings from a new study show.

XiXinXing/ThinkStock

“Overburdening ICU professionals during an extended period of time leads to burnout,” said lead study author Niek Kok, MSc, of IQ healthcare, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. “All ICU professionals are at the risk of this, and in our study, the incidence of physicians experiencing burnout was significantly higher than that of nurses in June 2020.”

This burnout can be explained by conditions caused by the pandemic, he noted, such as the scarcity of staff and resources and having to work with colleagues who were not qualified to work in critical care but who were there out of necessity.

Mr. Kok presented the findings of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
 

Burnout highest among critical care physicians

The ICU can be a stressful environment for both patients and health care personnel, and burnout is not uncommon among ICU clinicians. However, COVID-19 has amplified the degree of burnout being experienced by clinicians working in this setting. Critical care physicians now top the list of physicians experiencing burnout, at 51%, up from 44% last year, according to the Medscape report ‘Death by 1000 Thousand Cuts’: Physician Burnout and Suicide Report 2021.

The Medscape Nurse Career Satisfaction Report 2020, while not restricted to those working in critical care, also reported higher rates of burnout, compared with the prepandemic period. The percentage of nurses reporting being “very burned out” prior to the pandemic was 4%. Six months into the pandemic, that percentage soared to 18%.

In this study, Mr. Kok and colleagues examined the prevalence and incidence of burnout symptoms and moral distress in health care professionals working in the ICU, both before and during the COVID-19 pandemic.

“When the COVID-19 pandemic surfaced in the Netherlands, the health care professionals in our hospitals were motivated to do everything they could to provide the best care possible,” said Mr. Kok. “Many of the ICU professionals immediately realized that they would have to work longer hours.”

However, the health care professionals that he spoke with did have mixed feelings. Some were afraid of being infected with the virus, while others said that “it was very interesting times for them and that gave them extra motivation to do the work.

“Some physicians [and] the WHO warned that COVID-19 is not going to weathered by a heroic sprint – it is an arduous marathon that is going to go hand in hand with burnout symptoms,” Mr. Kok added. “It will eat away at our qualified ICU staff.”
 

Before and after data on burnout

It was widely believed that the COVID-19 pandemic would increase burnout symptoms, as had been demonstrated in studies of previous pandemics. However, Mr. Kok emphasized that there are no before and after measurements that transcend cross-sectional designs.

“The claim [has been] that it increases burnout – but there are no assessments of how it progresses in ICU professionals through time,” he said. “So what we really need is a comparison [of] before and after the pandemic.”

It is quite difficult to obtain this type of information because disruptive events like the COVID-19 pandemic cannot be predicted, he said. Thus, it is challenging to get a baseline measurement. But Mr. Kok pointed out that the study has both “before and after” measurements.

“By coincidence really, we had baseline data to measure the impact of the COVID-19 pandemic and had information that was collected before the pandemic,” he said.

In January 2020, a study began looking at the effects of ethics meetings on moral distress in ICU professionals. Data had been collected on moral distress and burnout on ICU professionals in December 2019. The first COVID-19 cases appeared in the Netherlands in February 2020.

A follow-up study was then conducted in May and June 2020, several months into the pandemic.

The longitudinal open cohort study included all ICU personnel who were working in five units within a single university medical center, plus another adult ICU that was based in a separate teaching hospital.

A total of 352 health care professionals responded to a baseline survey in October through December 2019, and then 233 responded to a follow-up survey sent in May and June 2020. The authors measured burnout symptoms and moral distress with the Maslach Burnout Inventory and the Moral Distress Scale, respectively.
 

Findings

The overall prevalence of burnout symptoms was 23.0% prior to the pandemic, and that jumped to 36.1% at post-peak time. Higher rates of burnout were reported by nurses (38.0%) than physicians (28.6%).

However, the incidence rate of new burnout cases was higher among physicians, compared with nurses (26.7% vs 21.9%). Not surprisingly, a higher prevalence of burnout symptoms was observed in the post-peak period for all clinicians (odds ratio, 1.83; 95% confidence interval, 1.32-2.53), and was higher for nurses (odds ratio, 1.77; 95% confidence interval, 1.03-3.04), for those working overtime (OR, 2.11; 95% CI, 1.48-3.02), and for personnel who directly engaged in patient care (OR, 1.87; 95% CI, 1.35-2.60).

Physicians in general were much more likely to develop burnout symptoms related to the pandemic, compared with nurses (OR, 3.56; 95% CI, 1.06-12.21).

When looking at findings on moral distress, Kok pointed out that it often arises in situations when the health care professional knows the right thing to do but is prevented from doing so. “Morally distressful situations all rose from December to June,” said Mr. Kok. “Scarcity was the most distressing. The other was where colleagues were perceived to be less skilled, and this had to do with the recruitment of people from outside of the ICU to provide care.”

Moral distress from scarcity and unskilled colleagues were both significantly related to burnout, he noted.

In the final model, working in a COVID-19 unit, stress from scarcity of resources and people, stress from unskilled colleagues, and stress from unsafe conditions were all related to burnout. “The stress of physicians was significantly higher,” said Kok. “Even though nurses had higher baseline burnout, it became less pronounced in June 2020. This indicates that burnout was significantly higher in physicians.”

Thus, Mr. Kok and colleagues concluded that overburdening ICU professionals during an extended period of time leads to burnout, and all ICU workers are at risk.
 

Burnout rates higher in physicians

Weighing in on the study, Greg S. Martin, MD, FCCP, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that the differences observed between physicians and nurses may have to do with the fact that “nurses have been smoldering all along and experiencing higher rates of burnout.

“They may have adapted better to the pandemic conditions, since they are more used to working overtime and short staffed, and spending far more time at the bedside,” he said. “Because of the volume of patients, physicians may be spending more hours doing patient care and are experiencing more burnout.”

Science by press release and preprint has cooled clinician enthusiasm for the use of colchicine in nonhospitalized patients with COVID-19, despite a pressing need for early treatments.

Photo by Jimmy Hamelin

As previously reported by this news organization, a Jan. 22 press release announced that the massive ColCORONA study missed its primary endpoint of hospitalization or death among 4,488 newly diagnosed patients at increased risk for hospitalization.

But it also touted that use of the anti-inflammatory drug significantly reduced the primary endpoint in 4,159 of those patients with polymerase chain reaction–confirmed COVID and led to reductions of 25%, 50%, and 44%, respectively, for hospitalizations, ventilations, and death.

Lead investigator Jean-Claude Tardif, MD, director of the Montreal Heart Institute Research Centre, deemed the findings a “medical breakthrough.”

When the preprint released a few days later, however, newly revealed confidence intervals showed colchicine did not meaningfully reduce the need for mechanical ventilation (odds ratio, 0.50; 95% confidence interval, 0.23-1.07) or death alone (OR, 0.56; 95% CI, 0.19-1.66).

Further, the significant benefit on the primary outcome came at the cost of a fivefold increase in pulmonary embolism (11 vs. 2; P = .01), which was not mentioned in the press release.

“Whether this represents a real phenomenon or simply the play of chance is not known,” Dr. Tardif and colleagues noted later in the preprint.

“I read the preprint on colchicine and I have so many questions,” Aaron E. Glatt, MD, spokesperson for the Infectious Diseases Society of America and chief of infectious diseases, Mount Sinai South Nassau, Hewlett, N.Y., said in an interview. “I’ve been burned too many times with COVID and prefer to see better data.

“People sometimes say if you wait for perfect data, people are going to die,” he said. “Yeah, but we have no idea if people are going to die from getting this drug more than not getting it. That’s what concerns me. How many pulmonary emboli are going to be fatal versus the slight benefit that the study showed?”

The pushback to the non–peer-reviewed data on social media and via emails was so strong that Dr. Tardif posted a nearly 2,000-word letter responding to the many questions at play.

Chief among them was why the trial, originally planned for 6,000 patients, was stopped early by the investigators without consultation with the data safety monitoring board (DSMB).

The explanation in the letter that logistical issues like running the study call center, budget constraints, and a perceived need to quickly communicate the results left some calling foul that the study wasn’t allowed to finish and come to a more definitive conclusion.

“I can be a little bit sympathetic to their cause but at the same time the DSMB should have said no,” said David Boulware, MD, MPH, who led a recent hydroxychloroquine trial in COVID-19. “The problem is we’re sort of left in limbo, where some people kind of believe it and some say it’s not really a thing. So it’s not really moving the needle, as far as guidelines go.”

Indeed, a Twitter poll by cardiologist James Januzzi Jr., MD, captured the uncertainty, with 28% of respondents saying the trial was “neutral,” 58% saying “maybe but meh,” and 14% saying “colchicine for all.”

Another poll cheekily asked whether ColCORONA was the Gamestop/Reddit equivalent of COVID.

“The press release really didn’t help things because it very much oversold the effect. That, I think, poisoned the well,” said Dr. Boulware, professor of medicine in infectious diseases at the University of Minnesota, Minneapolis.

“The question I’m left with is not whether colchicine works, but who does it work in,” he said. “That’s really the fundamental question because it does seem that there are probably high-risk groups in their trial and others where they benefit, whereas other groups don’t benefit. In the subgroup analysis, there was absolutely no beneficial effect in women.”

According to the authors, the number needed to treat to prevent one death or hospitalization was 71 overall, but 29 for patients with diabetes, 31 for those aged 70 years and older, 53 for patients with respiratory disease, and 25 for those with coronary disease or heart failure.

Men are at higher risk overall for poor outcomes. But “the authors didn’t present a multivariable analysis, so it is unclear if another factor, such as a differential prevalence of smoking or cardiovascular risk factors, contributed to the differential benefit,” Rachel Bender Ignacio, MD, MPH, infectious disease specialist, University of Washington, Seattle, said in an interview.

Importantly, in this pragmatic study, duration and severity of symptoms were not reported, observed Dr. Bender Ignacio, who is also a STOP-COVID-2 investigator. “We don’t yet have data as to whether colchicine shortens duration or severity of symptoms or prevents long COVID, so we need more data on that.”

The overall risk for serious adverse events was lower in the colchicine group, but the difference in pulmonary embolism (PE) was striking, she said. This could be caused by a real biologic effect, or it’s possible that persons with shortness of breath and hypoxia, without evident viral pneumonia on chest x-ray after a positive COVID-19 test, were more likely to receive a CT-PE study.

The press release also failed to include information, later noted in the preprint, that the MHI has submitted two patents related to colchicine: “Methods of treating a coronavirus infection using colchicine” and “Early administration of low-dose colchicine after myocardial infarction.”

Reached for clarification, MHI communications adviser Camille Turbide said in an interview that the first patent “simply refers to the novel concept of preventing complications of COVID-19, such as admission to the hospital, with colchicine as tested in the ColCORONA study.”

The second patent, she said, refers to the “novel concept that administering colchicine early after a major adverse cardiovascular event is better than waiting several days,” as supported by the COLCOT study, which Dr. Tardif also led.

The patents are being reviewed by authorities and “Dr. Tardif has waived his rights in these patents and does not stand to benefit financially at all if colchicine becomes used as a treatment for COVID-19,” Ms. Turbide said.

Dr. Tardif did not respond to interview requests for this story. Dr. Glatt said conflicts of interest must be assessed and are “something that is of great concern in any scientific study.”

Cardiologist Steve Nissen, MD, of the Cleveland Clinic said in an interview that, “despite the negative results, the study does suggest that colchicine might have a benefit and should be studied in future trials. These findings are not sufficient evidence to suggest use of the drug in patients infected with COVID-19.”

He noted that adverse effects like diarrhea were expected but that the excess PE was unexpected and needs greater clarification.

“Stopping the trial for administrative reasons is puzzling and undermined the ability of the trial to give a reliable answer,” Dr. Nissen said. “This is a reasonable pilot study that should be viewed as hypothesis generating but inconclusive.”

Several sources said a new trial is unlikely, particularly given the cost and 28 trials already evaluating colchicine. Among these are RECOVERY and COLCOVID, testing whether colchicine can reduce the duration of hospitalization or death in hospitalized patients with COVID-19.

Because there are so many trials ongoing right now, including for antivirals and other immunomodulators, it’s important that, if colchicine comes to routine clinical use, it provides access to treatment for those not able or willing to access clinical trials, rather than impeding clinical trial enrollment, Dr. Bender Ignacio suggested.

“We have already learned the lesson in the pandemic that early adoption of potentially promising therapies can negatively impact our ability to study and develop other promising treatments,” she said.

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the National Heart, Lung, and Blood Institute of the National Institutes of Health; Montreal philanthropist Sophie Desmarais, and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators. Dr. Glatt reported no conflicts of interest. Dr. Boulware reported receiving $18 in food and beverages from Gilead Sciences in 2018.
 

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

Science by press release and preprint has cooled clinician enthusiasm for the use of colchicine in nonhospitalized patients with COVID-19, despite a pressing need for early treatments.

Photo by Jimmy Hamelin

As previously reported by this news organization, a Jan. 22 press release announced that the massive ColCORONA study missed its primary endpoint of hospitalization or death among 4,488 newly diagnosed patients at increased risk for hospitalization.

But it also touted that use of the anti-inflammatory drug significantly reduced the primary endpoint in 4,159 of those patients with polymerase chain reaction–confirmed COVID and led to reductions of 25%, 50%, and 44%, respectively, for hospitalizations, ventilations, and death.

Lead investigator Jean-Claude Tardif, MD, director of the Montreal Heart Institute Research Centre, deemed the findings a “medical breakthrough.”

When the preprint released a few days later, however, newly revealed confidence intervals showed colchicine did not meaningfully reduce the need for mechanical ventilation (odds ratio, 0.50; 95% confidence interval, 0.23-1.07) or death alone (OR, 0.56; 95% CI, 0.19-1.66).

Further, the significant benefit on the primary outcome came at the cost of a fivefold increase in pulmonary embolism (11 vs. 2; P = .01), which was not mentioned in the press release.

“Whether this represents a real phenomenon or simply the play of chance is not known,” Dr. Tardif and colleagues noted later in the preprint.

“I read the preprint on colchicine and I have so many questions,” Aaron E. Glatt, MD, spokesperson for the Infectious Diseases Society of America and chief of infectious diseases, Mount Sinai South Nassau, Hewlett, N.Y., said in an interview. “I’ve been burned too many times with COVID and prefer to see better data.

“People sometimes say if you wait for perfect data, people are going to die,” he said. “Yeah, but we have no idea if people are going to die from getting this drug more than not getting it. That’s what concerns me. How many pulmonary emboli are going to be fatal versus the slight benefit that the study showed?”

The pushback to the non–peer-reviewed data on social media and via emails was so strong that Dr. Tardif posted a nearly 2,000-word letter responding to the many questions at play.

Chief among them was why the trial, originally planned for 6,000 patients, was stopped early by the investigators without consultation with the data safety monitoring board (DSMB).

The explanation in the letter that logistical issues like running the study call center, budget constraints, and a perceived need to quickly communicate the results left some calling foul that the study wasn’t allowed to finish and come to a more definitive conclusion.

“I can be a little bit sympathetic to their cause but at the same time the DSMB should have said no,” said David Boulware, MD, MPH, who led a recent hydroxychloroquine trial in COVID-19. “The problem is we’re sort of left in limbo, where some people kind of believe it and some say it’s not really a thing. So it’s not really moving the needle, as far as guidelines go.”

Indeed, a Twitter poll by cardiologist James Januzzi Jr., MD, captured the uncertainty, with 28% of respondents saying the trial was “neutral,” 58% saying “maybe but meh,” and 14% saying “colchicine for all.”

Another poll cheekily asked whether ColCORONA was the Gamestop/Reddit equivalent of COVID.

“The press release really didn’t help things because it very much oversold the effect. That, I think, poisoned the well,” said Dr. Boulware, professor of medicine in infectious diseases at the University of Minnesota, Minneapolis.

“The question I’m left with is not whether colchicine works, but who does it work in,” he said. “That’s really the fundamental question because it does seem that there are probably high-risk groups in their trial and others where they benefit, whereas other groups don’t benefit. In the subgroup analysis, there was absolutely no beneficial effect in women.”

According to the authors, the number needed to treat to prevent one death or hospitalization was 71 overall, but 29 for patients with diabetes, 31 for those aged 70 years and older, 53 for patients with respiratory disease, and 25 for those with coronary disease or heart failure.

Men are at higher risk overall for poor outcomes. But “the authors didn’t present a multivariable analysis, so it is unclear if another factor, such as a differential prevalence of smoking or cardiovascular risk factors, contributed to the differential benefit,” Rachel Bender Ignacio, MD, MPH, infectious disease specialist, University of Washington, Seattle, said in an interview.

Importantly, in this pragmatic study, duration and severity of symptoms were not reported, observed Dr. Bender Ignacio, who is also a STOP-COVID-2 investigator. “We don’t yet have data as to whether colchicine shortens duration or severity of symptoms or prevents long COVID, so we need more data on that.”

The overall risk for serious adverse events was lower in the colchicine group, but the difference in pulmonary embolism (PE) was striking, she said. This could be caused by a real biologic effect, or it’s possible that persons with shortness of breath and hypoxia, without evident viral pneumonia on chest x-ray after a positive COVID-19 test, were more likely to receive a CT-PE study.

The press release also failed to include information, later noted in the preprint, that the MHI has submitted two patents related to colchicine: “Methods of treating a coronavirus infection using colchicine” and “Early administration of low-dose colchicine after myocardial infarction.”

Reached for clarification, MHI communications adviser Camille Turbide said in an interview that the first patent “simply refers to the novel concept of preventing complications of COVID-19, such as admission to the hospital, with colchicine as tested in the ColCORONA study.”

The second patent, she said, refers to the “novel concept that administering colchicine early after a major adverse cardiovascular event is better than waiting several days,” as supported by the COLCOT study, which Dr. Tardif also led.

The patents are being reviewed by authorities and “Dr. Tardif has waived his rights in these patents and does not stand to benefit financially at all if colchicine becomes used as a treatment for COVID-19,” Ms. Turbide said.

Dr. Tardif did not respond to interview requests for this story. Dr. Glatt said conflicts of interest must be assessed and are “something that is of great concern in any scientific study.”

Cardiologist Steve Nissen, MD, of the Cleveland Clinic said in an interview that, “despite the negative results, the study does suggest that colchicine might have a benefit and should be studied in future trials. These findings are not sufficient evidence to suggest use of the drug in patients infected with COVID-19.”

He noted that adverse effects like diarrhea were expected but that the excess PE was unexpected and needs greater clarification.

“Stopping the trial for administrative reasons is puzzling and undermined the ability of the trial to give a reliable answer,” Dr. Nissen said. “This is a reasonable pilot study that should be viewed as hypothesis generating but inconclusive.”

Several sources said a new trial is unlikely, particularly given the cost and 28 trials already evaluating colchicine. Among these are RECOVERY and COLCOVID, testing whether colchicine can reduce the duration of hospitalization or death in hospitalized patients with COVID-19.

Because there are so many trials ongoing right now, including for antivirals and other immunomodulators, it’s important that, if colchicine comes to routine clinical use, it provides access to treatment for those not able or willing to access clinical trials, rather than impeding clinical trial enrollment, Dr. Bender Ignacio suggested.

“We have already learned the lesson in the pandemic that early adoption of potentially promising therapies can negatively impact our ability to study and develop other promising treatments,” she said.

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the National Heart, Lung, and Blood Institute of the National Institutes of Health; Montreal philanthropist Sophie Desmarais, and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators. Dr. Glatt reported no conflicts of interest. Dr. Boulware reported receiving $18 in food and beverages from Gilead Sciences in 2018.
 

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

Science by press release and preprint has cooled clinician enthusiasm for the use of colchicine in nonhospitalized patients with COVID-19, despite a pressing need for early treatments.

Photo by Jimmy Hamelin

As previously reported by this news organization, a Jan. 22 press release announced that the massive ColCORONA study missed its primary endpoint of hospitalization or death among 4,488 newly diagnosed patients at increased risk for hospitalization.

But it also touted that use of the anti-inflammatory drug significantly reduced the primary endpoint in 4,159 of those patients with polymerase chain reaction–confirmed COVID and led to reductions of 25%, 50%, and 44%, respectively, for hospitalizations, ventilations, and death.

Lead investigator Jean-Claude Tardif, MD, director of the Montreal Heart Institute Research Centre, deemed the findings a “medical breakthrough.”

When the preprint released a few days later, however, newly revealed confidence intervals showed colchicine did not meaningfully reduce the need for mechanical ventilation (odds ratio, 0.50; 95% confidence interval, 0.23-1.07) or death alone (OR, 0.56; 95% CI, 0.19-1.66).

Further, the significant benefit on the primary outcome came at the cost of a fivefold increase in pulmonary embolism (11 vs. 2; P = .01), which was not mentioned in the press release.

“Whether this represents a real phenomenon or simply the play of chance is not known,” Dr. Tardif and colleagues noted later in the preprint.

“I read the preprint on colchicine and I have so many questions,” Aaron E. Glatt, MD, spokesperson for the Infectious Diseases Society of America and chief of infectious diseases, Mount Sinai South Nassau, Hewlett, N.Y., said in an interview. “I’ve been burned too many times with COVID and prefer to see better data.

“People sometimes say if you wait for perfect data, people are going to die,” he said. “Yeah, but we have no idea if people are going to die from getting this drug more than not getting it. That’s what concerns me. How many pulmonary emboli are going to be fatal versus the slight benefit that the study showed?”

The pushback to the non–peer-reviewed data on social media and via emails was so strong that Dr. Tardif posted a nearly 2,000-word letter responding to the many questions at play.

Chief among them was why the trial, originally planned for 6,000 patients, was stopped early by the investigators without consultation with the data safety monitoring board (DSMB).

The explanation in the letter that logistical issues like running the study call center, budget constraints, and a perceived need to quickly communicate the results left some calling foul that the study wasn’t allowed to finish and come to a more definitive conclusion.

“I can be a little bit sympathetic to their cause but at the same time the DSMB should have said no,” said David Boulware, MD, MPH, who led a recent hydroxychloroquine trial in COVID-19. “The problem is we’re sort of left in limbo, where some people kind of believe it and some say it’s not really a thing. So it’s not really moving the needle, as far as guidelines go.”

Indeed, a Twitter poll by cardiologist James Januzzi Jr., MD, captured the uncertainty, with 28% of respondents saying the trial was “neutral,” 58% saying “maybe but meh,” and 14% saying “colchicine for all.”

Another poll cheekily asked whether ColCORONA was the Gamestop/Reddit equivalent of COVID.

“The press release really didn’t help things because it very much oversold the effect. That, I think, poisoned the well,” said Dr. Boulware, professor of medicine in infectious diseases at the University of Minnesota, Minneapolis.

“The question I’m left with is not whether colchicine works, but who does it work in,” he said. “That’s really the fundamental question because it does seem that there are probably high-risk groups in their trial and others where they benefit, whereas other groups don’t benefit. In the subgroup analysis, there was absolutely no beneficial effect in women.”

According to the authors, the number needed to treat to prevent one death or hospitalization was 71 overall, but 29 for patients with diabetes, 31 for those aged 70 years and older, 53 for patients with respiratory disease, and 25 for those with coronary disease or heart failure.

Men are at higher risk overall for poor outcomes. But “the authors didn’t present a multivariable analysis, so it is unclear if another factor, such as a differential prevalence of smoking or cardiovascular risk factors, contributed to the differential benefit,” Rachel Bender Ignacio, MD, MPH, infectious disease specialist, University of Washington, Seattle, said in an interview.

Importantly, in this pragmatic study, duration and severity of symptoms were not reported, observed Dr. Bender Ignacio, who is also a STOP-COVID-2 investigator. “We don’t yet have data as to whether colchicine shortens duration or severity of symptoms or prevents long COVID, so we need more data on that.”

The overall risk for serious adverse events was lower in the colchicine group, but the difference in pulmonary embolism (PE) was striking, she said. This could be caused by a real biologic effect, or it’s possible that persons with shortness of breath and hypoxia, without evident viral pneumonia on chest x-ray after a positive COVID-19 test, were more likely to receive a CT-PE study.

The press release also failed to include information, later noted in the preprint, that the MHI has submitted two patents related to colchicine: “Methods of treating a coronavirus infection using colchicine” and “Early administration of low-dose colchicine after myocardial infarction.”

Reached for clarification, MHI communications adviser Camille Turbide said in an interview that the first patent “simply refers to the novel concept of preventing complications of COVID-19, such as admission to the hospital, with colchicine as tested in the ColCORONA study.”

The second patent, she said, refers to the “novel concept that administering colchicine early after a major adverse cardiovascular event is better than waiting several days,” as supported by the COLCOT study, which Dr. Tardif also led.

The patents are being reviewed by authorities and “Dr. Tardif has waived his rights in these patents and does not stand to benefit financially at all if colchicine becomes used as a treatment for COVID-19,” Ms. Turbide said.

Dr. Tardif did not respond to interview requests for this story. Dr. Glatt said conflicts of interest must be assessed and are “something that is of great concern in any scientific study.”

Cardiologist Steve Nissen, MD, of the Cleveland Clinic said in an interview that, “despite the negative results, the study does suggest that colchicine might have a benefit and should be studied in future trials. These findings are not sufficient evidence to suggest use of the drug in patients infected with COVID-19.”

He noted that adverse effects like diarrhea were expected but that the excess PE was unexpected and needs greater clarification.

“Stopping the trial for administrative reasons is puzzling and undermined the ability of the trial to give a reliable answer,” Dr. Nissen said. “This is a reasonable pilot study that should be viewed as hypothesis generating but inconclusive.”

Several sources said a new trial is unlikely, particularly given the cost and 28 trials already evaluating colchicine. Among these are RECOVERY and COLCOVID, testing whether colchicine can reduce the duration of hospitalization or death in hospitalized patients with COVID-19.

Because there are so many trials ongoing right now, including for antivirals and other immunomodulators, it’s important that, if colchicine comes to routine clinical use, it provides access to treatment for those not able or willing to access clinical trials, rather than impeding clinical trial enrollment, Dr. Bender Ignacio suggested.

“We have already learned the lesson in the pandemic that early adoption of potentially promising therapies can negatively impact our ability to study and develop other promising treatments,” she said.

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the National Heart, Lung, and Blood Institute of the National Institutes of Health; Montreal philanthropist Sophie Desmarais, and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators. Dr. Glatt reported no conflicts of interest. Dr. Boulware reported receiving $18 in food and beverages from Gilead Sciences in 2018.
 

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

Beyond its clinical objective, the Socrates Project also seeks to further the discovery of previously unrecognized disease processes.

Many patients do not have a diagnosis that explains their signs and symptoms, despite a thorough evaluation, said Benjamin Singer, MD, assistant professor of pulmonology and critical care at Northwestern Medicine in Chicago. To address that problem, he and his colleagues launched the Socrates Project. The service is intended for difficult diagnoses and is based on Socratic principles, particularly the role of iterative hypothesis testing in the process of diagnosis.

“We began the Socrates Project to assist physicians caring for patients who lack a specific diagnosis. In creating this service, we have found ourselves to be doctors for doctors – formalizing the curbside consultation,” Dr. Singer said.

Northwestern Medicine launched the Socrates Project in 2015. It’s a physician-to-physician consultation service that assists doctors working to diagnose conditions that have so far eluded detection. “Our service’s goal is to improve patient care by providing an opinion to the referring physician on diagnostic possibilities for a particular case and ideas to reduce – or at least manage – diagnostic uncertainty,” they write. “Our service model is similar to a tumor board, which exists as an interdisciplinary group operating in parallel to the clinical services, to provide consensus-based recommendations.”

Hospitalists at other institutions may be interested in starting a similar type of service at their own institution or collaborating with institutions who offer this type of service, Dr. Singer said.

At Northwestern Medicine, they are at work on the project’s next steps. “We are working to generate systematic data about our practice, particularly the types of referrals and outcomes,” he said.
 

Reference

1. Singer BD, et al. The Socrates Project for Difficult Diagnosis at Northwestern Medicine. J Hosp Med. 2020 February;15(2):116-125. doi:10.12788/jhm.3335.

Beyond its clinical objective, the Socrates Project also seeks to further the discovery of previously unrecognized disease processes.

Many patients do not have a diagnosis that explains their signs and symptoms, despite a thorough evaluation, said Benjamin Singer, MD, assistant professor of pulmonology and critical care at Northwestern Medicine in Chicago. To address that problem, he and his colleagues launched the Socrates Project. The service is intended for difficult diagnoses and is based on Socratic principles, particularly the role of iterative hypothesis testing in the process of diagnosis.

“We began the Socrates Project to assist physicians caring for patients who lack a specific diagnosis. In creating this service, we have found ourselves to be doctors for doctors – formalizing the curbside consultation,” Dr. Singer said.

Northwestern Medicine launched the Socrates Project in 2015. It’s a physician-to-physician consultation service that assists doctors working to diagnose conditions that have so far eluded detection. “Our service’s goal is to improve patient care by providing an opinion to the referring physician on diagnostic possibilities for a particular case and ideas to reduce – or at least manage – diagnostic uncertainty,” they write. “Our service model is similar to a tumor board, which exists as an interdisciplinary group operating in parallel to the clinical services, to provide consensus-based recommendations.”

Hospitalists at other institutions may be interested in starting a similar type of service at their own institution or collaborating with institutions who offer this type of service, Dr. Singer said.

At Northwestern Medicine, they are at work on the project’s next steps. “We are working to generate systematic data about our practice, particularly the types of referrals and outcomes,” he said.
 

Reference

1. Singer BD, et al. The Socrates Project for Difficult Diagnosis at Northwestern Medicine. J Hosp Med. 2020 February;15(2):116-125. doi:10.12788/jhm.3335.

Beyond its clinical objective, the Socrates Project also seeks to further the discovery of previously unrecognized disease processes.

Many patients do not have a diagnosis that explains their signs and symptoms, despite a thorough evaluation, said Benjamin Singer, MD, assistant professor of pulmonology and critical care at Northwestern Medicine in Chicago. To address that problem, he and his colleagues launched the Socrates Project. The service is intended for difficult diagnoses and is based on Socratic principles, particularly the role of iterative hypothesis testing in the process of diagnosis.

“We began the Socrates Project to assist physicians caring for patients who lack a specific diagnosis. In creating this service, we have found ourselves to be doctors for doctors – formalizing the curbside consultation,” Dr. Singer said.

Northwestern Medicine launched the Socrates Project in 2015. It’s a physician-to-physician consultation service that assists doctors working to diagnose conditions that have so far eluded detection. “Our service’s goal is to improve patient care by providing an opinion to the referring physician on diagnostic possibilities for a particular case and ideas to reduce – or at least manage – diagnostic uncertainty,” they write. “Our service model is similar to a tumor board, which exists as an interdisciplinary group operating in parallel to the clinical services, to provide consensus-based recommendations.”

Hospitalists at other institutions may be interested in starting a similar type of service at their own institution or collaborating with institutions who offer this type of service, Dr. Singer said.

At Northwestern Medicine, they are at work on the project’s next steps. “We are working to generate systematic data about our practice, particularly the types of referrals and outcomes,” he said.
 

Reference

1. Singer BD, et al. The Socrates Project for Difficult Diagnosis at Northwestern Medicine. J Hosp Med. 2020 February;15(2):116-125. doi:10.12788/jhm.3335.