During the early phase of the novel coronavirus disease 2019 (COVID-19) epidemic in the United States, public health strategies focused on “flattening the curve” to ensure that healthcare systems in hard-hit regions had the ability to care for surges of acutely ill patients. Now, COVID-19 cases and hospitalizations are rising sharply throughout the country, and many healthcare systems are facing intense strain due to an influx of patients.

In this issue of JHM, Horwitz et al provide important insights on evolving inpatient care and healthcare system strain for patients with COVID-19. The authors evaluated 5,121 adults hospitalized with SARS-CoV-2 infection at a 3-hospital health system in New York City from March through August 2020,¹ and found that patients hospitalized later during the time period were much younger and had fewer comorbidities. Importantly, the authors observed a marked decline in adjusted in-hospital mortality or hospice rates, from 25.6% in March to 7.6% in August.

What might explain the dramatic improvement in risk-adjusted mortality? The authors’ use of granular data from the electronic health record allowed them to account for temporal changes in demographics and clinical severity of hospitalized patients, indicating that other factors have contributed to the decline in adjusted mortality. One likely explanation is that increasing clinical experience in the management of patients with COVID-19 has resulted in the delivery of better inpatient care, while the use of evidence-based therapies for COVID-19 has also grown. Although important gains have been made in treatment, the care of patients with COVID-19 largely remains supportive. But supportive care requires an adequate number of hospital beds, healthcare staff, and sufficient critical care resources, at minimum.

Healthcare system strain has undoubtedly played a critical role in the outcomes of hospitalized patients. Horwitz et al found that the number of COVID-19 hospitalizations in March and April, when death rates were highest, was more than 10 times greater than in July and August, when death rates were lowest. As noted in the early epidemic in China, COVID-19 death rates partially reflect access to high-quality medical care.² And, in the US, hospitals’ capacity to care for critically ill patients with COVID-19 is an important predictor of death.³

As COVID-19 cases now surge across the country, ensuring that healthcare systems have the resources needed to care for patients will be paramount. Unfortunately, the spread of COVID-19 is exponential, while hospitals’ ability to scale-up surge capacity over a short timeframe is not. Already, reports are emerging across the country of hospitals reaching bed capacity and experiencing shortages of physicians and nurses.

To curtail escalating healthcare system stress in the coming months, we must minimize the cluster-based super-spreading that drives epidemic surges. Approximately 15% to 20% of infected cases account for up to 80% of disease transmission.⁴ Therefore, strategies must address high-risk scenarios that involve crowding, close prolonged contact, and poor ventilation, such as weddings, sporting events, religious gatherings, and indoor dining and bars.

Without adequate testing or tracing capacity during viral surges, employing nonpharmaceutical interventions to mitigate spread is key. Japan, which created the “3 Cs” campaign (avoid close contact, closed spaces, and crowds), utilized a response framework that specifically targeted super-spreading. The US should follow a similar strategy in the coming months to protect healthcare systems, healthcare workers, and most importantly, our patients.

During the early phase of the novel coronavirus disease 2019 (COVID-19) epidemic in the United States, public health strategies focused on “flattening the curve” to ensure that healthcare systems in hard-hit regions had the ability to care for surges of acutely ill patients. Now, COVID-19 cases and hospitalizations are rising sharply throughout the country, and many healthcare systems are facing intense strain due to an influx of patients.

In this issue of JHM, Horwitz et al provide important insights on evolving inpatient care and healthcare system strain for patients with COVID-19. The authors evaluated 5,121 adults hospitalized with SARS-CoV-2 infection at a 3-hospital health system in New York City from March through August 2020,¹ and found that patients hospitalized later during the time period were much younger and had fewer comorbidities. Importantly, the authors observed a marked decline in adjusted in-hospital mortality or hospice rates, from 25.6% in March to 7.6% in August.

What might explain the dramatic improvement in risk-adjusted mortality? The authors’ use of granular data from the electronic health record allowed them to account for temporal changes in demographics and clinical severity of hospitalized patients, indicating that other factors have contributed to the decline in adjusted mortality. One likely explanation is that increasing clinical experience in the management of patients with COVID-19 has resulted in the delivery of better inpatient care, while the use of evidence-based therapies for COVID-19 has also grown. Although important gains have been made in treatment, the care of patients with COVID-19 largely remains supportive. But supportive care requires an adequate number of hospital beds, healthcare staff, and sufficient critical care resources, at minimum.

Healthcare system strain has undoubtedly played a critical role in the outcomes of hospitalized patients. Horwitz et al found that the number of COVID-19 hospitalizations in March and April, when death rates were highest, was more than 10 times greater than in July and August, when death rates were lowest. As noted in the early epidemic in China, COVID-19 death rates partially reflect access to high-quality medical care.² And, in the US, hospitals’ capacity to care for critically ill patients with COVID-19 is an important predictor of death.³

As COVID-19 cases now surge across the country, ensuring that healthcare systems have the resources needed to care for patients will be paramount. Unfortunately, the spread of COVID-19 is exponential, while hospitals’ ability to scale-up surge capacity over a short timeframe is not. Already, reports are emerging across the country of hospitals reaching bed capacity and experiencing shortages of physicians and nurses.

To curtail escalating healthcare system stress in the coming months, we must minimize the cluster-based super-spreading that drives epidemic surges. Approximately 15% to 20% of infected cases account for up to 80% of disease transmission.⁴ Therefore, strategies must address high-risk scenarios that involve crowding, close prolonged contact, and poor ventilation, such as weddings, sporting events, religious gatherings, and indoor dining and bars.

Without adequate testing or tracing capacity during viral surges, employing nonpharmaceutical interventions to mitigate spread is key. Japan, which created the “3 Cs” campaign (avoid close contact, closed spaces, and crowds), utilized a response framework that specifically targeted super-spreading. The US should follow a similar strategy in the coming months to protect healthcare systems, healthcare workers, and most importantly, our patients.

During the early phase of the novel coronavirus disease 2019 (COVID-19) epidemic in the United States, public health strategies focused on “flattening the curve” to ensure that healthcare systems in hard-hit regions had the ability to care for surges of acutely ill patients. Now, COVID-19 cases and hospitalizations are rising sharply throughout the country, and many healthcare systems are facing intense strain due to an influx of patients.

In this issue of JHM, Horwitz et al provide important insights on evolving inpatient care and healthcare system strain for patients with COVID-19. The authors evaluated 5,121 adults hospitalized with SARS-CoV-2 infection at a 3-hospital health system in New York City from March through August 2020,¹ and found that patients hospitalized later during the time period were much younger and had fewer comorbidities. Importantly, the authors observed a marked decline in adjusted in-hospital mortality or hospice rates, from 25.6% in March to 7.6% in August.

What might explain the dramatic improvement in risk-adjusted mortality? The authors’ use of granular data from the electronic health record allowed them to account for temporal changes in demographics and clinical severity of hospitalized patients, indicating that other factors have contributed to the decline in adjusted mortality. One likely explanation is that increasing clinical experience in the management of patients with COVID-19 has resulted in the delivery of better inpatient care, while the use of evidence-based therapies for COVID-19 has also grown. Although important gains have been made in treatment, the care of patients with COVID-19 largely remains supportive. But supportive care requires an adequate number of hospital beds, healthcare staff, and sufficient critical care resources, at minimum.

Healthcare system strain has undoubtedly played a critical role in the outcomes of hospitalized patients. Horwitz et al found that the number of COVID-19 hospitalizations in March and April, when death rates were highest, was more than 10 times greater than in July and August, when death rates were lowest. As noted in the early epidemic in China, COVID-19 death rates partially reflect access to high-quality medical care.² And, in the US, hospitals’ capacity to care for critically ill patients with COVID-19 is an important predictor of death.³

As COVID-19 cases now surge across the country, ensuring that healthcare systems have the resources needed to care for patients will be paramount. Unfortunately, the spread of COVID-19 is exponential, while hospitals’ ability to scale-up surge capacity over a short timeframe is not. Already, reports are emerging across the country of hospitals reaching bed capacity and experiencing shortages of physicians and nurses.

To curtail escalating healthcare system stress in the coming months, we must minimize the cluster-based super-spreading that drives epidemic surges. Approximately 15% to 20% of infected cases account for up to 80% of disease transmission.⁴ Therefore, strategies must address high-risk scenarios that involve crowding, close prolonged contact, and poor ventilation, such as weddings, sporting events, religious gatherings, and indoor dining and bars.

Without adequate testing or tracing capacity during viral surges, employing nonpharmaceutical interventions to mitigate spread is key. Japan, which created the “3 Cs” campaign (avoid close contact, closed spaces, and crowds), utilized a response framework that specifically targeted super-spreading. The US should follow a similar strategy in the coming months to protect healthcare systems, healthcare workers, and most importantly, our patients.

Hospitalists are known as change agents for their fierce patient advocacy and expertise in hospital systems redesign. The field of hospital medicine has claimed numerous successes and the hospitalist model has been embraced by institutions across the country. Yet the lived experiences of hospitalists surveyed by Bhandari et al in this month’s issue of JHM suggest a grim undertone.¹ Hospital medicine is a field with high physician burnout rates, stark gender inequities in pay, leadership, and academic opportunities, and an unacceptably high prevalence of sexual harassment and gender discrimination. Women hospitalists disproportionately bear the brunt of these inequities. All hospitalists, however, can and should be an integral part of the path forward by recognizing the impact of these inequities on colleagues and hospital systems.

The study by Bhandari et al adds to the increasing body of knowledge documenting high levels of sexual harassment and gender discrimination in medicine and highlights important gender differences in these experiences among hospitalists nationally.^1,2 Among 336 respondents across 18 academic institutions, sexual harassment and gender discrimination were both common and highly problematic within the field of hospital medicine, confirming what prior narratives have only anecdotally shared. Both men and women experienced harassment, from patients and colleagues alike, but women endured higher levels compared with men on all the measures studied.¹

Qualitative comments in this study are noteworthy, including one about a hospitalist’s institution allowing potential faculty to be interviewed about plans for pregnancy, childcare, and personal household division of labor. One might argue that this knowledge is necessary for shift-based inpatient work in the context of a worldwide pandemic in which pregnant workers are likely at higher risk of increased morbidity and mortality. It remains illegal, however, to ask such questions, which are representative of the types of characteristics that constitute a toxic workplace environment. Moreover, such practices are particularly problematic given that pregnancy and childbearing for women in medicine come with their own set of well-documented unique challenges.³

The considerable body of research in this field should help guide new research priorities and targets for intervention. Does the experience of sexual harassment impact hospitalists’ intentions to leave their institutions or the career as a whole? Does sexual harassment originating from colleagues or from patients and families affect patient safety or quality of care? Do interventions in other international hospital settings specifically targeting respectfulness translate to American hospitals?⁴ These questions and a host of others merit our attention.

Hospital system leaders should work with hospital medicine leaders to support wholesale institutional cultural transformation. Implementation of antiharassment measures recommended in the 2018 report on sexual harassment from the National Academies of Sciences, Engineering, and Medicine is critical.² This means supporting diverse, inclusive, and respectful environments at all levels within the organization, improving transparency and accountability for how incidents are handled, striving for strong and diverse leadership, providing meaningful support for targets of harassment, measuring prevalence over time, and encouraging professional societies to adopt similar actions. Furthermore, we believe it is critical to adopt a zero-tolerance policy for harassing behaviors and to hold individuals accountable. Encouraging all individuals within health care systems to uphold their ethical obligations to combat harassment and bias on a personal level is important.⁵ If left unaddressed, the unmet needs of those who are subjected to harassment and bias will continue to be problematic for generations to come, with detrimental effects throughout healthcare systems and the broader populations they serve.

Hospitalists are known as change agents for their fierce patient advocacy and expertise in hospital systems redesign. The field of hospital medicine has claimed numerous successes and the hospitalist model has been embraced by institutions across the country. Yet the lived experiences of hospitalists surveyed by Bhandari et al in this month’s issue of JHM suggest a grim undertone.¹ Hospital medicine is a field with high physician burnout rates, stark gender inequities in pay, leadership, and academic opportunities, and an unacceptably high prevalence of sexual harassment and gender discrimination. Women hospitalists disproportionately bear the brunt of these inequities. All hospitalists, however, can and should be an integral part of the path forward by recognizing the impact of these inequities on colleagues and hospital systems.

The study by Bhandari et al adds to the increasing body of knowledge documenting high levels of sexual harassment and gender discrimination in medicine and highlights important gender differences in these experiences among hospitalists nationally.^1,2 Among 336 respondents across 18 academic institutions, sexual harassment and gender discrimination were both common and highly problematic within the field of hospital medicine, confirming what prior narratives have only anecdotally shared. Both men and women experienced harassment, from patients and colleagues alike, but women endured higher levels compared with men on all the measures studied.¹

Qualitative comments in this study are noteworthy, including one about a hospitalist’s institution allowing potential faculty to be interviewed about plans for pregnancy, childcare, and personal household division of labor. One might argue that this knowledge is necessary for shift-based inpatient work in the context of a worldwide pandemic in which pregnant workers are likely at higher risk of increased morbidity and mortality. It remains illegal, however, to ask such questions, which are representative of the types of characteristics that constitute a toxic workplace environment. Moreover, such practices are particularly problematic given that pregnancy and childbearing for women in medicine come with their own set of well-documented unique challenges.³

The considerable body of research in this field should help guide new research priorities and targets for intervention. Does the experience of sexual harassment impact hospitalists’ intentions to leave their institutions or the career as a whole? Does sexual harassment originating from colleagues or from patients and families affect patient safety or quality of care? Do interventions in other international hospital settings specifically targeting respectfulness translate to American hospitals?⁴ These questions and a host of others merit our attention.

Hospital system leaders should work with hospital medicine leaders to support wholesale institutional cultural transformation. Implementation of antiharassment measures recommended in the 2018 report on sexual harassment from the National Academies of Sciences, Engineering, and Medicine is critical.² This means supporting diverse, inclusive, and respectful environments at all levels within the organization, improving transparency and accountability for how incidents are handled, striving for strong and diverse leadership, providing meaningful support for targets of harassment, measuring prevalence over time, and encouraging professional societies to adopt similar actions. Furthermore, we believe it is critical to adopt a zero-tolerance policy for harassing behaviors and to hold individuals accountable. Encouraging all individuals within health care systems to uphold their ethical obligations to combat harassment and bias on a personal level is important.⁵ If left unaddressed, the unmet needs of those who are subjected to harassment and bias will continue to be problematic for generations to come, with detrimental effects throughout healthcare systems and the broader populations they serve.

Hospitalists are known as change agents for their fierce patient advocacy and expertise in hospital systems redesign. The field of hospital medicine has claimed numerous successes and the hospitalist model has been embraced by institutions across the country. Yet the lived experiences of hospitalists surveyed by Bhandari et al in this month’s issue of JHM suggest a grim undertone.¹ Hospital medicine is a field with high physician burnout rates, stark gender inequities in pay, leadership, and academic opportunities, and an unacceptably high prevalence of sexual harassment and gender discrimination. Women hospitalists disproportionately bear the brunt of these inequities. All hospitalists, however, can and should be an integral part of the path forward by recognizing the impact of these inequities on colleagues and hospital systems.

The study by Bhandari et al adds to the increasing body of knowledge documenting high levels of sexual harassment and gender discrimination in medicine and highlights important gender differences in these experiences among hospitalists nationally.^1,2 Among 336 respondents across 18 academic institutions, sexual harassment and gender discrimination were both common and highly problematic within the field of hospital medicine, confirming what prior narratives have only anecdotally shared. Both men and women experienced harassment, from patients and colleagues alike, but women endured higher levels compared with men on all the measures studied.¹

Qualitative comments in this study are noteworthy, including one about a hospitalist’s institution allowing potential faculty to be interviewed about plans for pregnancy, childcare, and personal household division of labor. One might argue that this knowledge is necessary for shift-based inpatient work in the context of a worldwide pandemic in which pregnant workers are likely at higher risk of increased morbidity and mortality. It remains illegal, however, to ask such questions, which are representative of the types of characteristics that constitute a toxic workplace environment. Moreover, such practices are particularly problematic given that pregnancy and childbearing for women in medicine come with their own set of well-documented unique challenges.³

The considerable body of research in this field should help guide new research priorities and targets for intervention. Does the experience of sexual harassment impact hospitalists’ intentions to leave their institutions or the career as a whole? Does sexual harassment originating from colleagues or from patients and families affect patient safety or quality of care? Do interventions in other international hospital settings specifically targeting respectfulness translate to American hospitals?⁴ These questions and a host of others merit our attention.

Hospital system leaders should work with hospital medicine leaders to support wholesale institutional cultural transformation. Implementation of antiharassment measures recommended in the 2018 report on sexual harassment from the National Academies of Sciences, Engineering, and Medicine is critical.² This means supporting diverse, inclusive, and respectful environments at all levels within the organization, improving transparency and accountability for how incidents are handled, striving for strong and diverse leadership, providing meaningful support for targets of harassment, measuring prevalence over time, and encouraging professional societies to adopt similar actions. Furthermore, we believe it is critical to adopt a zero-tolerance policy for harassing behaviors and to hold individuals accountable. Encouraging all individuals within health care systems to uphold their ethical obligations to combat harassment and bias on a personal level is important.⁵ If left unaddressed, the unmet needs of those who are subjected to harassment and bias will continue to be problematic for generations to come, with detrimental effects throughout healthcare systems and the broader populations they serve.

Historically, bacterial infections in hospitalized children were treated with intravenous (IV) antibiotics for the duration of therapy—frequently with placement of a vascular catheter. Risks associated with vascular catheters and the limitations they impose on a child’s quality of life are increasingly being recognized—including thrombi, catheter dislodgement, and secondary infections as catheters provide a portal of entry for bacteria into the bloodstream (ie, catheter-associated bloodstream infections) or along the catheter wall (ie, phlebitis). This potential for harm underscores the importance of transitioning to oral antibiotic therapy whenever possible.

In this issue of the Journal of Hospital Medicine, Cotter et al used an administrative database to investigate opportunities to transition from IV to oral antibiotics for patients across multiple pediatric hospitals.¹ Their novel metric, “percent opportunity,” represents the percent of days that there was the opportunity to transition from IV to oral antibiotics. They found that over 50% of the time, IV antibiotics could have been switched to equivalent oral agents. Furthermore, there was wide variability across institutions in IV-to-oral transitioning practices; 45% of the variation was seemingly attributable to institution-level preferences.

The large sample size and multicenter nature of this study improve its external validity. However, using administrative data to make assumptions about clinical decision-making has limitations. The definition of opportunity days assumes that any day a child receives other enteral medications provides an “opportunity” to prescribe oral antibiotics instead. This does not account for other reasonable indications to continue IV therapy (eg, endocarditis) and may overestimate true opportunities for conversion to oral therapy. Alternatively, their conservative approach of excluding days when a child received both IV and oral antibiotics may underestimate opportunities for oral transition. Regardless of the precision of their estimates, their findings highlight that there is room to improve the culture of transitioning hospitalized children from IV to oral antibiotic therapy.

Admittedly, the evidence for clinically effective conversion to oral therapy in children remains incomplete. Data support oral antibiotics for hospitalized children with pneumonia, cellulitis, pyelonephritis, and osteoarticular infections—even with associated bacteremia.² There is also evidence for successful conversion to oral therapy for complicated appendicitis, retropharyngeal abscesses, mastoiditis, and orbital cellulitis.²

The decision to transition to oral therapy does not need to be delayed until the time of hospital discharge because each additional day of IV therapy poses a cumulative risk. Rather, prescribers should apply a structured approach, such as the “Four Moments of Antibiotic Decision Making,” on a daily basis for every hospitalized child receiving antibiotics to prompt timely decisions about discontinuing IV therapy, narrowing IV therapy, or transitioning from IV to oral antibiotic therapy.³ We applaud Cotter et al for shedding light on an area in need of standardization of care, which could optimize patient outcomes and minimize harm for a large number of children.¹ The “percent opportunity” to switch from IV to oral antibiotic therapy is a promising antibiotic stewardship metric, and its association with clinical outcomes merits further investigation.

Historically, bacterial infections in hospitalized children were treated with intravenous (IV) antibiotics for the duration of therapy—frequently with placement of a vascular catheter. Risks associated with vascular catheters and the limitations they impose on a child’s quality of life are increasingly being recognized—including thrombi, catheter dislodgement, and secondary infections as catheters provide a portal of entry for bacteria into the bloodstream (ie, catheter-associated bloodstream infections) or along the catheter wall (ie, phlebitis). This potential for harm underscores the importance of transitioning to oral antibiotic therapy whenever possible.

In this issue of the Journal of Hospital Medicine, Cotter et al used an administrative database to investigate opportunities to transition from IV to oral antibiotics for patients across multiple pediatric hospitals.¹ Their novel metric, “percent opportunity,” represents the percent of days that there was the opportunity to transition from IV to oral antibiotics. They found that over 50% of the time, IV antibiotics could have been switched to equivalent oral agents. Furthermore, there was wide variability across institutions in IV-to-oral transitioning practices; 45% of the variation was seemingly attributable to institution-level preferences.

The large sample size and multicenter nature of this study improve its external validity. However, using administrative data to make assumptions about clinical decision-making has limitations. The definition of opportunity days assumes that any day a child receives other enteral medications provides an “opportunity” to prescribe oral antibiotics instead. This does not account for other reasonable indications to continue IV therapy (eg, endocarditis) and may overestimate true opportunities for conversion to oral therapy. Alternatively, their conservative approach of excluding days when a child received both IV and oral antibiotics may underestimate opportunities for oral transition. Regardless of the precision of their estimates, their findings highlight that there is room to improve the culture of transitioning hospitalized children from IV to oral antibiotic therapy.

Admittedly, the evidence for clinically effective conversion to oral therapy in children remains incomplete. Data support oral antibiotics for hospitalized children with pneumonia, cellulitis, pyelonephritis, and osteoarticular infections—even with associated bacteremia.² There is also evidence for successful conversion to oral therapy for complicated appendicitis, retropharyngeal abscesses, mastoiditis, and orbital cellulitis.²

The decision to transition to oral therapy does not need to be delayed until the time of hospital discharge because each additional day of IV therapy poses a cumulative risk. Rather, prescribers should apply a structured approach, such as the “Four Moments of Antibiotic Decision Making,” on a daily basis for every hospitalized child receiving antibiotics to prompt timely decisions about discontinuing IV therapy, narrowing IV therapy, or transitioning from IV to oral antibiotic therapy.³ We applaud Cotter et al for shedding light on an area in need of standardization of care, which could optimize patient outcomes and minimize harm for a large number of children.¹ The “percent opportunity” to switch from IV to oral antibiotic therapy is a promising antibiotic stewardship metric, and its association with clinical outcomes merits further investigation.

Historically, bacterial infections in hospitalized children were treated with intravenous (IV) antibiotics for the duration of therapy—frequently with placement of a vascular catheter. Risks associated with vascular catheters and the limitations they impose on a child’s quality of life are increasingly being recognized—including thrombi, catheter dislodgement, and secondary infections as catheters provide a portal of entry for bacteria into the bloodstream (ie, catheter-associated bloodstream infections) or along the catheter wall (ie, phlebitis). This potential for harm underscores the importance of transitioning to oral antibiotic therapy whenever possible.

In this issue of the Journal of Hospital Medicine, Cotter et al used an administrative database to investigate opportunities to transition from IV to oral antibiotics for patients across multiple pediatric hospitals.¹ Their novel metric, “percent opportunity,” represents the percent of days that there was the opportunity to transition from IV to oral antibiotics. They found that over 50% of the time, IV antibiotics could have been switched to equivalent oral agents. Furthermore, there was wide variability across institutions in IV-to-oral transitioning practices; 45% of the variation was seemingly attributable to institution-level preferences.

The large sample size and multicenter nature of this study improve its external validity. However, using administrative data to make assumptions about clinical decision-making has limitations. The definition of opportunity days assumes that any day a child receives other enteral medications provides an “opportunity” to prescribe oral antibiotics instead. This does not account for other reasonable indications to continue IV therapy (eg, endocarditis) and may overestimate true opportunities for conversion to oral therapy. Alternatively, their conservative approach of excluding days when a child received both IV and oral antibiotics may underestimate opportunities for oral transition. Regardless of the precision of their estimates, their findings highlight that there is room to improve the culture of transitioning hospitalized children from IV to oral antibiotic therapy.

Admittedly, the evidence for clinically effective conversion to oral therapy in children remains incomplete. Data support oral antibiotics for hospitalized children with pneumonia, cellulitis, pyelonephritis, and osteoarticular infections—even with associated bacteremia.² There is also evidence for successful conversion to oral therapy for complicated appendicitis, retropharyngeal abscesses, mastoiditis, and orbital cellulitis.²

The decision to transition to oral therapy does not need to be delayed until the time of hospital discharge because each additional day of IV therapy poses a cumulative risk. Rather, prescribers should apply a structured approach, such as the “Four Moments of Antibiotic Decision Making,” on a daily basis for every hospitalized child receiving antibiotics to prompt timely decisions about discontinuing IV therapy, narrowing IV therapy, or transitioning from IV to oral antibiotic therapy.³ We applaud Cotter et al for shedding light on an area in need of standardization of care, which could optimize patient outcomes and minimize harm for a large number of children.¹ The “percent opportunity” to switch from IV to oral antibiotic therapy is a promising antibiotic stewardship metric, and its association with clinical outcomes merits further investigation.

“Success starts with saying yes. Saying no maintains it.”

—Anonymous

You have just received an opportunity that seems worthwhile. However, you already have a lot on your plate. What do you do? The balance of when to say “yes” and when to say “no” to opportunities, projects, and collaborations is often challenging, especially for busy clinicians. There is a trend, with good basis, to encourage individuals to say “no” more often. While there is much to be said for that, many good opportunities can be missed that way. As Amy Poehler put it, “Saying ‘yes’ doesn’t mean I don’t know how to say no.”

So how does one arrive at a good balance?

Most importantly, figure out who you are, what you want your “brand” to be and where you envision your career going. This is likely the most difficult step. Start with a roadmap and recalibrate as your career unfolds. Early in your career, seek breadth rather than depth.

As your career progresses, the “yes-no” balance may shift. We recommend you say “yes” frequently early on. Be open to opportunities that come up, even if they do not perfectly align with your goals. Explore opportunities beyond the limits of your job description. After all, opportunities beget more opportunities. Consider “stretch opportunities.” If you are offered an opportunity that you may not have 100% of the skills for—and is, therefore, a “stretch”—but which aligns with your career goals, do not turn it down. Consider saying “yes” and learn on the job. A mentor or coach can help you navigate these decisions.

Sometimes, it is important to say “yes” as part of being a “good citizen” in your department. Examples include mentoring learners, serving on a safety committee, teaching student lectures, or coaching a colleague. Often it is possible to align service with career goals.

Another consideration is the benefit of networking: developing alliances and building bridges. In addition to the service or productivity that come with projects or collaborations, these can be powerful networking opportunities. Networking broadly, both within and beyond your field of practice and within and outside your institution, is an important way to create “bonding capital” and “bridging capital,” ie, relationships based on your commonalities and relationships built across differences, respectively.¹

Remember, when you say “yes,” you must deliver: every time, on time, and with excellence. When saying “yes” to more opportunities starts to impact your ability to deliver for what you have already committed to, it is time to say “no.” This will help you maintain balance, avoid burnout, and stay focused.

When juggling a busy schedule, consider effort vs impact. There are many low-effort opportunities that have relatively high impact. For instance, as a junior faculty member interested in medical education, participating in a grading committee is low effort but can help you understand the process, connect you with educational leaders, and open doors to future opportunities. An effective strategy may be to incorporate a combination of low-effort and high-effort activities at any one time, while considering the impact of each, to help maintain balance. The effort-vs-impact balance may shift as you grow in your career.

Know where you are going, explore the opportunities that may get you there, and recalibrate often. The path to success is typically a circuitous one, so enjoy the journey and give it your all every step of the way.

“Success starts with saying yes. Saying no maintains it.”

—Anonymous

You have just received an opportunity that seems worthwhile. However, you already have a lot on your plate. What do you do? The balance of when to say “yes” and when to say “no” to opportunities, projects, and collaborations is often challenging, especially for busy clinicians. There is a trend, with good basis, to encourage individuals to say “no” more often. While there is much to be said for that, many good opportunities can be missed that way. As Amy Poehler put it, “Saying ‘yes’ doesn’t mean I don’t know how to say no.”

So how does one arrive at a good balance?

Most importantly, figure out who you are, what you want your “brand” to be and where you envision your career going. This is likely the most difficult step. Start with a roadmap and recalibrate as your career unfolds. Early in your career, seek breadth rather than depth.

As your career progresses, the “yes-no” balance may shift. We recommend you say “yes” frequently early on. Be open to opportunities that come up, even if they do not perfectly align with your goals. Explore opportunities beyond the limits of your job description. After all, opportunities beget more opportunities. Consider “stretch opportunities.” If you are offered an opportunity that you may not have 100% of the skills for—and is, therefore, a “stretch”—but which aligns with your career goals, do not turn it down. Consider saying “yes” and learn on the job. A mentor or coach can help you navigate these decisions.

Sometimes, it is important to say “yes” as part of being a “good citizen” in your department. Examples include mentoring learners, serving on a safety committee, teaching student lectures, or coaching a colleague. Often it is possible to align service with career goals.

Another consideration is the benefit of networking: developing alliances and building bridges. In addition to the service or productivity that come with projects or collaborations, these can be powerful networking opportunities. Networking broadly, both within and beyond your field of practice and within and outside your institution, is an important way to create “bonding capital” and “bridging capital,” ie, relationships based on your commonalities and relationships built across differences, respectively.¹

Remember, when you say “yes,” you must deliver: every time, on time, and with excellence. When saying “yes” to more opportunities starts to impact your ability to deliver for what you have already committed to, it is time to say “no.” This will help you maintain balance, avoid burnout, and stay focused.

When juggling a busy schedule, consider effort vs impact. There are many low-effort opportunities that have relatively high impact. For instance, as a junior faculty member interested in medical education, participating in a grading committee is low effort but can help you understand the process, connect you with educational leaders, and open doors to future opportunities. An effective strategy may be to incorporate a combination of low-effort and high-effort activities at any one time, while considering the impact of each, to help maintain balance. The effort-vs-impact balance may shift as you grow in your career.

Know where you are going, explore the opportunities that may get you there, and recalibrate often. The path to success is typically a circuitous one, so enjoy the journey and give it your all every step of the way.

“Success starts with saying yes. Saying no maintains it.”

—Anonymous

You have just received an opportunity that seems worthwhile. However, you already have a lot on your plate. What do you do? The balance of when to say “yes” and when to say “no” to opportunities, projects, and collaborations is often challenging, especially for busy clinicians. There is a trend, with good basis, to encourage individuals to say “no” more often. While there is much to be said for that, many good opportunities can be missed that way. As Amy Poehler put it, “Saying ‘yes’ doesn’t mean I don’t know how to say no.”

So how does one arrive at a good balance?

Most importantly, figure out who you are, what you want your “brand” to be and where you envision your career going. This is likely the most difficult step. Start with a roadmap and recalibrate as your career unfolds. Early in your career, seek breadth rather than depth.

As your career progresses, the “yes-no” balance may shift. We recommend you say “yes” frequently early on. Be open to opportunities that come up, even if they do not perfectly align with your goals. Explore opportunities beyond the limits of your job description. After all, opportunities beget more opportunities. Consider “stretch opportunities.” If you are offered an opportunity that you may not have 100% of the skills for—and is, therefore, a “stretch”—but which aligns with your career goals, do not turn it down. Consider saying “yes” and learn on the job. A mentor or coach can help you navigate these decisions.

Sometimes, it is important to say “yes” as part of being a “good citizen” in your department. Examples include mentoring learners, serving on a safety committee, teaching student lectures, or coaching a colleague. Often it is possible to align service with career goals.

Another consideration is the benefit of networking: developing alliances and building bridges. In addition to the service or productivity that come with projects or collaborations, these can be powerful networking opportunities. Networking broadly, both within and beyond your field of practice and within and outside your institution, is an important way to create “bonding capital” and “bridging capital,” ie, relationships based on your commonalities and relationships built across differences, respectively.¹

Remember, when you say “yes,” you must deliver: every time, on time, and with excellence. When saying “yes” to more opportunities starts to impact your ability to deliver for what you have already committed to, it is time to say “no.” This will help you maintain balance, avoid burnout, and stay focused.

When juggling a busy schedule, consider effort vs impact. There are many low-effort opportunities that have relatively high impact. For instance, as a junior faculty member interested in medical education, participating in a grading committee is low effort but can help you understand the process, connect you with educational leaders, and open doors to future opportunities. An effective strategy may be to incorporate a combination of low-effort and high-effort activities at any one time, while considering the impact of each, to help maintain balance. The effort-vs-impact balance may shift as you grow in your career.

Know where you are going, explore the opportunities that may get you there, and recalibrate often. The path to success is typically a circuitous one, so enjoy the journey and give it your all every step of the way.

Many of us are interested in developing or refining our skillsets. To do so, we need mentorship, which in the still-young field of hospital medicine can sometimes be challenging to obtain.

As a physician-investigator and editor, I commonly encounter young and even mid-career physicians wrestling with how to develop or refine their academic skills, and they’re usually pondering the challenges in finding someone in their own division or hospitalist group to help them. When this happens, I talk to them about bagels and cream cheese. I ask them two questions: “What’s your cream cheese?” and “Where’s your bagel?” Their natural reaction of puzzlement, perhaps mixed with hunger if they haven’t yet had breakfast, is similar to the one you’ve likely just experienced, so let me explain.

In medical school, I had a friend who absolutely loved cream cheese. If it had been socially acceptable, he would have simply walked around scooping cream cheese from a large tub. Had he done that, people would likely have given him funny looks and taken a few steps away. So, instead, my friend found an acceptable solution, which is that he would eat a lot of bagels. And those bagels would be piled high with cream cheese because what he wanted was the cream cheese and the bagel provided a reasonable means by which to get it.

So now I ask you: What’s your passion? What is the thing that you want to scoop from the tub (of learning and doing) every day for the rest of your life? That’s the cream cheese. Now, all you have to do is to find your bagel, the vehicle that allows you to get there.

Let’s see those principles in action. Say that you’re a hospitalist who wants to learn how to conduct randomized clinical trials, enhance medication reconciliation, or improve transitions of care. You can read about randomization schemes or improvement cycles but that’s clearly not enough. You need someone to help you frame the question, understand how to navigate the system, and avoid potential pitfalls. You need someone with relevant experience and expertise, someone with whom you can discuss nuances such as the trade-offs between different outcome measures or analytic approaches. You need your bagel.

There may not be anyone in your division with such expertise. You may need to branch out to find that bagel. You talk to a few people and they all point you to a cardiologist who runs clinical trials. What other field has such witty study acronyms as MRFIT or MIRACL or PROVE IT? If you’re interested in medication reconciliation, they may direct you to a pharmacist who studies medication errors. If you’re interested in improving care transitions, they may connect you with a critical care physician with expertise in interhospital transfers. You can meet with these folks to learn about their work. If their personality and mentorship style are a good fit, you can offer to assist in some aspect of their ongoing studies and, in return, ask for mentorship. You may have only a limited interest in the clinical content area, but if there is someone willing to invest their time in teaching, mentoring, and sponsoring you, then you’ve found your bagel.

Think about what you’re hoping to accomplish and keep an open mind to unexpected venues for mentorship and skill development. That bagel may be in your division or department, or it may be somewhere else in your institution, or it may not be in your institution at all but elsewhere regionally or nationally. The sequence is important. What’s your cream cheese? Figured it out? Great, now go find that bagel.

Many of us are interested in developing or refining our skillsets. To do so, we need mentorship, which in the still-young field of hospital medicine can sometimes be challenging to obtain.

As a physician-investigator and editor, I commonly encounter young and even mid-career physicians wrestling with how to develop or refine their academic skills, and they’re usually pondering the challenges in finding someone in their own division or hospitalist group to help them. When this happens, I talk to them about bagels and cream cheese. I ask them two questions: “What’s your cream cheese?” and “Where’s your bagel?” Their natural reaction of puzzlement, perhaps mixed with hunger if they haven’t yet had breakfast, is similar to the one you’ve likely just experienced, so let me explain.

In medical school, I had a friend who absolutely loved cream cheese. If it had been socially acceptable, he would have simply walked around scooping cream cheese from a large tub. Had he done that, people would likely have given him funny looks and taken a few steps away. So, instead, my friend found an acceptable solution, which is that he would eat a lot of bagels. And those bagels would be piled high with cream cheese because what he wanted was the cream cheese and the bagel provided a reasonable means by which to get it.

So now I ask you: What’s your passion? What is the thing that you want to scoop from the tub (of learning and doing) every day for the rest of your life? That’s the cream cheese. Now, all you have to do is to find your bagel, the vehicle that allows you to get there.

Let’s see those principles in action. Say that you’re a hospitalist who wants to learn how to conduct randomized clinical trials, enhance medication reconciliation, or improve transitions of care. You can read about randomization schemes or improvement cycles but that’s clearly not enough. You need someone to help you frame the question, understand how to navigate the system, and avoid potential pitfalls. You need someone with relevant experience and expertise, someone with whom you can discuss nuances such as the trade-offs between different outcome measures or analytic approaches. You need your bagel.

There may not be anyone in your division with such expertise. You may need to branch out to find that bagel. You talk to a few people and they all point you to a cardiologist who runs clinical trials. What other field has such witty study acronyms as MRFIT or MIRACL or PROVE IT? If you’re interested in medication reconciliation, they may direct you to a pharmacist who studies medication errors. If you’re interested in improving care transitions, they may connect you with a critical care physician with expertise in interhospital transfers. You can meet with these folks to learn about their work. If their personality and mentorship style are a good fit, you can offer to assist in some aspect of their ongoing studies and, in return, ask for mentorship. You may have only a limited interest in the clinical content area, but if there is someone willing to invest their time in teaching, mentoring, and sponsoring you, then you’ve found your bagel.

Think about what you’re hoping to accomplish and keep an open mind to unexpected venues for mentorship and skill development. That bagel may be in your division or department, or it may be somewhere else in your institution, or it may not be in your institution at all but elsewhere regionally or nationally. The sequence is important. What’s your cream cheese? Figured it out? Great, now go find that bagel.

Many of us are interested in developing or refining our skillsets. To do so, we need mentorship, which in the still-young field of hospital medicine can sometimes be challenging to obtain.

As a physician-investigator and editor, I commonly encounter young and even mid-career physicians wrestling with how to develop or refine their academic skills, and they’re usually pondering the challenges in finding someone in their own division or hospitalist group to help them. When this happens, I talk to them about bagels and cream cheese. I ask them two questions: “What’s your cream cheese?” and “Where’s your bagel?” Their natural reaction of puzzlement, perhaps mixed with hunger if they haven’t yet had breakfast, is similar to the one you’ve likely just experienced, so let me explain.

In medical school, I had a friend who absolutely loved cream cheese. If it had been socially acceptable, he would have simply walked around scooping cream cheese from a large tub. Had he done that, people would likely have given him funny looks and taken a few steps away. So, instead, my friend found an acceptable solution, which is that he would eat a lot of bagels. And those bagels would be piled high with cream cheese because what he wanted was the cream cheese and the bagel provided a reasonable means by which to get it.

So now I ask you: What’s your passion? What is the thing that you want to scoop from the tub (of learning and doing) every day for the rest of your life? That’s the cream cheese. Now, all you have to do is to find your bagel, the vehicle that allows you to get there.

Let’s see those principles in action. Say that you’re a hospitalist who wants to learn how to conduct randomized clinical trials, enhance medication reconciliation, or improve transitions of care. You can read about randomization schemes or improvement cycles but that’s clearly not enough. You need someone to help you frame the question, understand how to navigate the system, and avoid potential pitfalls. You need someone with relevant experience and expertise, someone with whom you can discuss nuances such as the trade-offs between different outcome measures or analytic approaches. You need your bagel.

There may not be anyone in your division with such expertise. You may need to branch out to find that bagel. You talk to a few people and they all point you to a cardiologist who runs clinical trials. What other field has such witty study acronyms as MRFIT or MIRACL or PROVE IT? If you’re interested in medication reconciliation, they may direct you to a pharmacist who studies medication errors. If you’re interested in improving care transitions, they may connect you with a critical care physician with expertise in interhospital transfers. You can meet with these folks to learn about their work. If their personality and mentorship style are a good fit, you can offer to assist in some aspect of their ongoing studies and, in return, ask for mentorship. You may have only a limited interest in the clinical content area, but if there is someone willing to invest their time in teaching, mentoring, and sponsoring you, then you’ve found your bagel.

Think about what you’re hoping to accomplish and keep an open mind to unexpected venues for mentorship and skill development. That bagel may be in your division or department, or it may be somewhere else in your institution, or it may not be in your institution at all but elsewhere regionally or nationally. The sequence is important. What’s your cream cheese? Figured it out? Great, now go find that bagel.

About 60% of children taking antipsychotic medication do not receive recommended metabolic monitoring, according to an analysis of Medicaid data from two states.

The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.

The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.

“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”


 

Comparing specialties

Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.

To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.

They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.

About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.

Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.

Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.

Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.

Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
 

Slipping through the cracks

Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.

The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.

“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.

These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.

“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.

A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”

Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.

“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”

It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.

The study authors and Dr. Volkmar had no disclosures.

[email protected]

About 60% of children taking antipsychotic medication do not receive recommended metabolic monitoring, according to an analysis of Medicaid data from two states.

The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.

The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.

“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”


 

Comparing specialties

Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.

To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.

They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.

About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.

Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.

Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.

Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.

Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
 

Slipping through the cracks

Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.

The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.

“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.

These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.

“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.

A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”

Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.

“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”

It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.

The study authors and Dr. Volkmar had no disclosures.

[email protected]

About 60% of children taking antipsychotic medication do not receive recommended metabolic monitoring, according to an analysis of Medicaid data from two states.

The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.

The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.

“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”


 

Comparing specialties

Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.

To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.

They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.

About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.

Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.

Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.

Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.

Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
 

Slipping through the cracks

Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.

The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.

“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.

These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.

“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.

A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”

Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.

“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”

It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.

The study authors and Dr. Volkmar had no disclosures.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

The current COVID-19 vaccines may not be as effective against new coronavirus variants, but they should be powerful enough to still be beneficial, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during a news briefing on Jan. 21.

Both vaccines from Pfizer-BioNTech and Moderna have such high efficacy rates that it creates a “cushion effect,” he said, meaning that new variants will likely only diminish vaccine efficacy slightly. To slow the spread of the new strains, Dr. Fauci said, people should get vaccinated as soon as possible. If viruses can’t spread as far or as quickly, they won’t mutate as much.

“Bottom line: We’re paying very close attention to it,” he said. “There are alternative plans if we ever have to modify the vaccine.”

The U.S. has reported 144 cases of the B.1.1.7 variant, which was first identified in the United Kingdom, according to the latest update from the CDC. So far, no cases of the variant strain identified in South Africa have been reported in the U.S., but Dr. Fauci said public health officials are looking for it.

“We’re following very carefully the one in South Africa, which is a little bit more concerning, but nonetheless not something that we don’t think we can handle,” he said.

Despite challenges with vaccine distribution and administration, the U.S. “can and should” vaccinate 70% to 85% of adults by the end of the summer, Dr. Fauci told CNN. If that happens, people could begin to return to some sense of normalcy by the fall, he added.

“When you put ... the pedal to the floor, you can get it done,” he said.

If the U.S. administered one million shots per day, it would take until the end of 2021 to fully vaccine 75% of adults, according to a CNN analysis. Dr. Fauci said he believes the U.S. can give more than one million shots per day. An updated tally from the CDC showed that 1.6 million shots were given in the past 24 hours, which was the largest single-day increase yet reported.

“I’d like it to be a lot more,” Dr. Fauci told CNN. “If we can do better than that, which I personally think we likely will, then great.”

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

The current COVID-19 vaccines may not be as effective against new coronavirus variants, but they should be powerful enough to still be beneficial, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during a news briefing on Jan. 21.

Both vaccines from Pfizer-BioNTech and Moderna have such high efficacy rates that it creates a “cushion effect,” he said, meaning that new variants will likely only diminish vaccine efficacy slightly. To slow the spread of the new strains, Dr. Fauci said, people should get vaccinated as soon as possible. If viruses can’t spread as far or as quickly, they won’t mutate as much.

“Bottom line: We’re paying very close attention to it,” he said. “There are alternative plans if we ever have to modify the vaccine.”

The U.S. has reported 144 cases of the B.1.1.7 variant, which was first identified in the United Kingdom, according to the latest update from the CDC. So far, no cases of the variant strain identified in South Africa have been reported in the U.S., but Dr. Fauci said public health officials are looking for it.

“We’re following very carefully the one in South Africa, which is a little bit more concerning, but nonetheless not something that we don’t think we can handle,” he said.

Despite challenges with vaccine distribution and administration, the U.S. “can and should” vaccinate 70% to 85% of adults by the end of the summer, Dr. Fauci told CNN. If that happens, people could begin to return to some sense of normalcy by the fall, he added.

“When you put ... the pedal to the floor, you can get it done,” he said.

If the U.S. administered one million shots per day, it would take until the end of 2021 to fully vaccine 75% of adults, according to a CNN analysis. Dr. Fauci said he believes the U.S. can give more than one million shots per day. An updated tally from the CDC showed that 1.6 million shots were given in the past 24 hours, which was the largest single-day increase yet reported.

“I’d like it to be a lot more,” Dr. Fauci told CNN. “If we can do better than that, which I personally think we likely will, then great.”

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

The current COVID-19 vaccines may not be as effective against new coronavirus variants, but they should be powerful enough to still be beneficial, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during a news briefing on Jan. 21.

Both vaccines from Pfizer-BioNTech and Moderna have such high efficacy rates that it creates a “cushion effect,” he said, meaning that new variants will likely only diminish vaccine efficacy slightly. To slow the spread of the new strains, Dr. Fauci said, people should get vaccinated as soon as possible. If viruses can’t spread as far or as quickly, they won’t mutate as much.

“Bottom line: We’re paying very close attention to it,” he said. “There are alternative plans if we ever have to modify the vaccine.”

The U.S. has reported 144 cases of the B.1.1.7 variant, which was first identified in the United Kingdom, according to the latest update from the CDC. So far, no cases of the variant strain identified in South Africa have been reported in the U.S., but Dr. Fauci said public health officials are looking for it.

“We’re following very carefully the one in South Africa, which is a little bit more concerning, but nonetheless not something that we don’t think we can handle,” he said.

Despite challenges with vaccine distribution and administration, the U.S. “can and should” vaccinate 70% to 85% of adults by the end of the summer, Dr. Fauci told CNN. If that happens, people could begin to return to some sense of normalcy by the fall, he added.

“When you put ... the pedal to the floor, you can get it done,” he said.

If the U.S. administered one million shots per day, it would take until the end of 2021 to fully vaccine 75% of adults, according to a CNN analysis. Dr. Fauci said he believes the U.S. can give more than one million shots per day. An updated tally from the CDC showed that 1.6 million shots were given in the past 24 hours, which was the largest single-day increase yet reported.

“I’d like it to be a lot more,” Dr. Fauci told CNN. “If we can do better than that, which I personally think we likely will, then great.”

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

The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in nonhospitalized patients newly diagnosed with COVID-19, according to a press release from the ColCORONA trial investigators.

After 1 month of therapy, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance, compared with placebo among 4,488 outpatients enrolled in the global, phase 3 trial.

After excluding 329 patients without a confirmatory polymerase chain reaction test, however, the use of colchicine was reported to significantly reduce hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.

“We believe that this is a medical breakthrough. There’s no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” lead investigator Jean-Claude Tardif, MD, from the Montreal Heart Institute, said in an interview.

“I know that several countries will be reviewing the data very rapidly and that Greece approved it today,” he said. “So this is providing hope for patients.”

Having been burned by hydroxychloroquine and other treatments brought forth without peer review, the response to the announcement was tempered by a desire for more details.

Asked for comment, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, was cautious. “The press release about the trial is vague and lacks details such as hazard ratios, confidence intervals, and P values,” he said in an interview.

“It is impossible to evaluate the results of this trial without these details. It is also uncertain how rigorously data were collected,” he added. “We’ll need to see the manuscript to adequately interpret the results.”

The evidence in the press release is hard to interpret, but early intervention with anti-inflammatory therapy has considerable biologic appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the anti-inflammatory drug canakinumab in the post-MI setting, and is also chair of the ACTIV-4B trial currently investigating anticoagulants and antithrombotics in outpatient COVID-19.

“Colchicine is both inexpensive and generally well tolerated, and the apparent benefits so far reported are substantial,” Dr. Ridker, from Brigham and Women’s Hospital in Boston, said in an interview. “We are eager to see the full data as rapidly as possible.”

The commonly used gout and rheumatic disease agent costs about 26 cents in Canada and between $4 and $6 in the United States. As previously reported, it reduced the time to clinical deterioration and hospital stay but not mortality in the 105-patient Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) study.

Dr. Tardif said he’s looking forward to having the data in the public domain and that they acted swiftly because the evidence was “clinically persuasive” and “the health system is congested now.”

“We received the results Friday, Jan. 22 at 5 p.m., an hour later we were in meetings with our data safety monitoring board [DSMB], 2 hours later we issued a press release, and a day later we’re submitting a full manuscript to a major scientific journal, so I don’t know if anyone has done this at this speed,” he said. “So we are actually very proud of what we did.”

ColCORONA was designed to enroll 6,000 outpatients, at least 40 years of age, who were diagnosed with COVID-19 infection within the previous 24 hours, and had a least one high-risk criterion, including age at least 70 years, body mass index of at least 30 kg/m², diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever of at least 38.4° C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.

Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.

The number needed to prevent one COVID-19 complication is about 60 patients, Dr. Tardif said.

Colchicine was well tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. Caution should be used, however, in treating patients with severe renal disease.

Dr. Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who doesn’t have any concomitant diseases, but would for those meeting the study protocol.

“As long as a patient appears to me to be at risk of a complication, I would prescribe it, without a doubt,” he said. “I can tell you that when we held the meeting with the DSMB Friday evening, I actually put each member on the spot and asked them: ‘If it were you – not even treating a patient, but if you had COVID today, would you take it based on the data you’ve seen?’ and all of the DSMB members said they would.

“So we’ll have that debate in the public domain when the paper is out, but I believe most physicians will use it to treat their patients.”

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the U.S. National Heart, Lung, and Blood Institute; 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.

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

The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in nonhospitalized patients newly diagnosed with COVID-19, according to a press release from the ColCORONA trial investigators.

After 1 month of therapy, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance, compared with placebo among 4,488 outpatients enrolled in the global, phase 3 trial.

After excluding 329 patients without a confirmatory polymerase chain reaction test, however, the use of colchicine was reported to significantly reduce hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.

“We believe that this is a medical breakthrough. There’s no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” lead investigator Jean-Claude Tardif, MD, from the Montreal Heart Institute, said in an interview.

“I know that several countries will be reviewing the data very rapidly and that Greece approved it today,” he said. “So this is providing hope for patients.”

Having been burned by hydroxychloroquine and other treatments brought forth without peer review, the response to the announcement was tempered by a desire for more details.

Asked for comment, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, was cautious. “The press release about the trial is vague and lacks details such as hazard ratios, confidence intervals, and P values,” he said in an interview.

“It is impossible to evaluate the results of this trial without these details. It is also uncertain how rigorously data were collected,” he added. “We’ll need to see the manuscript to adequately interpret the results.”

The evidence in the press release is hard to interpret, but early intervention with anti-inflammatory therapy has considerable biologic appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the anti-inflammatory drug canakinumab in the post-MI setting, and is also chair of the ACTIV-4B trial currently investigating anticoagulants and antithrombotics in outpatient COVID-19.

“Colchicine is both inexpensive and generally well tolerated, and the apparent benefits so far reported are substantial,” Dr. Ridker, from Brigham and Women’s Hospital in Boston, said in an interview. “We are eager to see the full data as rapidly as possible.”

The commonly used gout and rheumatic disease agent costs about 26 cents in Canada and between $4 and $6 in the United States. As previously reported, it reduced the time to clinical deterioration and hospital stay but not mortality in the 105-patient Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) study.

Dr. Tardif said he’s looking forward to having the data in the public domain and that they acted swiftly because the evidence was “clinically persuasive” and “the health system is congested now.”

“We received the results Friday, Jan. 22 at 5 p.m., an hour later we were in meetings with our data safety monitoring board [DSMB], 2 hours later we issued a press release, and a day later we’re submitting a full manuscript to a major scientific journal, so I don’t know if anyone has done this at this speed,” he said. “So we are actually very proud of what we did.”

ColCORONA was designed to enroll 6,000 outpatients, at least 40 years of age, who were diagnosed with COVID-19 infection within the previous 24 hours, and had a least one high-risk criterion, including age at least 70 years, body mass index of at least 30 kg/m², diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever of at least 38.4° C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.

Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.

The number needed to prevent one COVID-19 complication is about 60 patients, Dr. Tardif said.

Colchicine was well tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. Caution should be used, however, in treating patients with severe renal disease.

Dr. Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who doesn’t have any concomitant diseases, but would for those meeting the study protocol.

“As long as a patient appears to me to be at risk of a complication, I would prescribe it, without a doubt,” he said. “I can tell you that when we held the meeting with the DSMB Friday evening, I actually put each member on the spot and asked them: ‘If it were you – not even treating a patient, but if you had COVID today, would you take it based on the data you’ve seen?’ and all of the DSMB members said they would.

“So we’ll have that debate in the public domain when the paper is out, but I believe most physicians will use it to treat their patients.”

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the U.S. National Heart, Lung, and Blood Institute; 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.

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

The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in nonhospitalized patients newly diagnosed with COVID-19, according to a press release from the ColCORONA trial investigators.

After 1 month of therapy, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance, compared with placebo among 4,488 outpatients enrolled in the global, phase 3 trial.

After excluding 329 patients without a confirmatory polymerase chain reaction test, however, the use of colchicine was reported to significantly reduce hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.

“We believe that this is a medical breakthrough. There’s no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” lead investigator Jean-Claude Tardif, MD, from the Montreal Heart Institute, said in an interview.

“I know that several countries will be reviewing the data very rapidly and that Greece approved it today,” he said. “So this is providing hope for patients.”

Having been burned by hydroxychloroquine and other treatments brought forth without peer review, the response to the announcement was tempered by a desire for more details.

Asked for comment, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, was cautious. “The press release about the trial is vague and lacks details such as hazard ratios, confidence intervals, and P values,” he said in an interview.

“It is impossible to evaluate the results of this trial without these details. It is also uncertain how rigorously data were collected,” he added. “We’ll need to see the manuscript to adequately interpret the results.”

The evidence in the press release is hard to interpret, but early intervention with anti-inflammatory therapy has considerable biologic appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the anti-inflammatory drug canakinumab in the post-MI setting, and is also chair of the ACTIV-4B trial currently investigating anticoagulants and antithrombotics in outpatient COVID-19.

“Colchicine is both inexpensive and generally well tolerated, and the apparent benefits so far reported are substantial,” Dr. Ridker, from Brigham and Women’s Hospital in Boston, said in an interview. “We are eager to see the full data as rapidly as possible.”

The commonly used gout and rheumatic disease agent costs about 26 cents in Canada and between $4 and $6 in the United States. As previously reported, it reduced the time to clinical deterioration and hospital stay but not mortality in the 105-patient Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) study.

Dr. Tardif said he’s looking forward to having the data in the public domain and that they acted swiftly because the evidence was “clinically persuasive” and “the health system is congested now.”

“We received the results Friday, Jan. 22 at 5 p.m., an hour later we were in meetings with our data safety monitoring board [DSMB], 2 hours later we issued a press release, and a day later we’re submitting a full manuscript to a major scientific journal, so I don’t know if anyone has done this at this speed,” he said. “So we are actually very proud of what we did.”

ColCORONA was designed to enroll 6,000 outpatients, at least 40 years of age, who were diagnosed with COVID-19 infection within the previous 24 hours, and had a least one high-risk criterion, including age at least 70 years, body mass index of at least 30 kg/m², diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever of at least 38.4° C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.

Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.

The number needed to prevent one COVID-19 complication is about 60 patients, Dr. Tardif said.

Colchicine was well tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. Caution should be used, however, in treating patients with severe renal disease.

Dr. Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who doesn’t have any concomitant diseases, but would for those meeting the study protocol.

“As long as a patient appears to me to be at risk of a complication, I would prescribe it, without a doubt,” he said. “I can tell you that when we held the meeting with the DSMB Friday evening, I actually put each member on the spot and asked them: ‘If it were you – not even treating a patient, but if you had COVID today, would you take it based on the data you’ve seen?’ and all of the DSMB members said they would.

“So we’ll have that debate in the public domain when the paper is out, but I believe most physicians will use it to treat their patients.”

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the U.S. National Heart, Lung, and Blood Institute; 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.

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

Full-dose anticoagulation was superior to low, prophylactic doses in reducing the need for vital organ support such as ventilation in moderately ill patients hospitalized for COVID-19, according to a report released Jan. 22 by the National Institutes of Health (NIH).

“This is a major advance for patients hospitalized with COVID. Full dose of anticoagulation in these non-ICU patients improved outcomes and there’s a trend toward a reduction in mortality,” Judith Hochman, MD, director of the Cardiovascular Clinical Research Center at NYU Langone Medical Center, New York, said in an interview.

“We have treatments that are improving outcomes but not as many that reduce mortality, so we’re hopeful when the full dataset comes in that will be confirmed,” she said.

The observation of increased rates of blood clots and inflammation among COVID-19 patients, which can lead to complications such as lung failure, heart attack, and stroke, has given rise to various anticoagulant treatment protocols and a need for randomized data on routinely administering increased doses of anticoagulation to hospitalized patients.

Today’s top-line findings come from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – examining the safety and efficacy of full-dose anticoagulation to treat moderately ill or critically ill adults hospitalized with COVID-19 compared with a lower dose typically used to prevent blood clots in hospitalized patients.

In December 2020, all three trials paused enrollment of the critically ill subgroup after results showed that full-dose anticoagulation started in the intensive care unit (ICU) was not beneficial and may have been harmful in some patients.

Moderately ill patients with COVID-19, defined as those who did not require ICU care or organ support, made up 80% of participants at enrollment in the three trials, Dr. Hochman said.

Among more than 1,000 moderately ill patients reviewed as of the data cut with the data safety monitoring board, full doses of low molecular weight or unfractionated heparin were superior to low prophylactic doses for the primary endpoint of need for ventilation or other organ supportive interventions at 21 days after randomization.

This met the predefined threshold for 99% probability of superiority and recruitment was stopped, Dr. Hochman reported. “Obviously safety figured into this decision. The risk/benefit ratio was very clear.”

The results do not pertain to patients with a previous indication for anticoagulation, who were excluded from the trials.

Data from an additional 1,000 patients will be reviewed and the data published sometime in the next 2-3 months, she said.

With large numbers of COVID-19 patients requiring hospitalization, the outcomes could help reduce the overload on intensive care units around the world, the NIH noted.

The results also highlight the critical role of timing in the course of COVID-19.

“We believe that full anticoagulation is effective early in the disease course,” Dr. Hochman said. “Based on the results so far from these three platform trials, those that were very, very sick at the time of enrollment really didn’t benefit and we needed to have caught them at an earlier stage.

“It’s possible that the people in the ICU are just different and the minute they get sick they need the ICU; so we haven’t clearly demonstrated this time course and when to intervene, but that’s the implication of the findings.”

The question of even earlier treatment is being examined in the partner ACTIV-4B trial, which is enrolling patients with COVID-19 illness not requiring hospitalization and randomizing them to the direct oral anticoagulant apixaban or aspirin or placebo.

“It’s a very important trial and we really want to get the message out that patients should volunteer for it,” said Dr. Hochman, principal investigator of the ACTIV-4 trial.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.

The REMAP-CAP, ACTIV-4, and ATTACC study platforms span five continents in more than 300 hospitals and are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (United Kingdom), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

Full-dose anticoagulation was superior to low, prophylactic doses in reducing the need for vital organ support such as ventilation in moderately ill patients hospitalized for COVID-19, according to a report released Jan. 22 by the National Institutes of Health (NIH).

“This is a major advance for patients hospitalized with COVID. Full dose of anticoagulation in these non-ICU patients improved outcomes and there’s a trend toward a reduction in mortality,” Judith Hochman, MD, director of the Cardiovascular Clinical Research Center at NYU Langone Medical Center, New York, said in an interview.

“We have treatments that are improving outcomes but not as many that reduce mortality, so we’re hopeful when the full dataset comes in that will be confirmed,” she said.

The observation of increased rates of blood clots and inflammation among COVID-19 patients, which can lead to complications such as lung failure, heart attack, and stroke, has given rise to various anticoagulant treatment protocols and a need for randomized data on routinely administering increased doses of anticoagulation to hospitalized patients.

Today’s top-line findings come from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – examining the safety and efficacy of full-dose anticoagulation to treat moderately ill or critically ill adults hospitalized with COVID-19 compared with a lower dose typically used to prevent blood clots in hospitalized patients.

In December 2020, all three trials paused enrollment of the critically ill subgroup after results showed that full-dose anticoagulation started in the intensive care unit (ICU) was not beneficial and may have been harmful in some patients.

Moderately ill patients with COVID-19, defined as those who did not require ICU care or organ support, made up 80% of participants at enrollment in the three trials, Dr. Hochman said.

Among more than 1,000 moderately ill patients reviewed as of the data cut with the data safety monitoring board, full doses of low molecular weight or unfractionated heparin were superior to low prophylactic doses for the primary endpoint of need for ventilation or other organ supportive interventions at 21 days after randomization.

This met the predefined threshold for 99% probability of superiority and recruitment was stopped, Dr. Hochman reported. “Obviously safety figured into this decision. The risk/benefit ratio was very clear.”

The results do not pertain to patients with a previous indication for anticoagulation, who were excluded from the trials.

Data from an additional 1,000 patients will be reviewed and the data published sometime in the next 2-3 months, she said.

With large numbers of COVID-19 patients requiring hospitalization, the outcomes could help reduce the overload on intensive care units around the world, the NIH noted.

The results also highlight the critical role of timing in the course of COVID-19.

“We believe that full anticoagulation is effective early in the disease course,” Dr. Hochman said. “Based on the results so far from these three platform trials, those that were very, very sick at the time of enrollment really didn’t benefit and we needed to have caught them at an earlier stage.

“It’s possible that the people in the ICU are just different and the minute they get sick they need the ICU; so we haven’t clearly demonstrated this time course and when to intervene, but that’s the implication of the findings.”

The question of even earlier treatment is being examined in the partner ACTIV-4B trial, which is enrolling patients with COVID-19 illness not requiring hospitalization and randomizing them to the direct oral anticoagulant apixaban or aspirin or placebo.

“It’s a very important trial and we really want to get the message out that patients should volunteer for it,” said Dr. Hochman, principal investigator of the ACTIV-4 trial.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.

The REMAP-CAP, ACTIV-4, and ATTACC study platforms span five continents in more than 300 hospitals and are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (United Kingdom), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

Full-dose anticoagulation was superior to low, prophylactic doses in reducing the need for vital organ support such as ventilation in moderately ill patients hospitalized for COVID-19, according to a report released Jan. 22 by the National Institutes of Health (NIH).

“This is a major advance for patients hospitalized with COVID. Full dose of anticoagulation in these non-ICU patients improved outcomes and there’s a trend toward a reduction in mortality,” Judith Hochman, MD, director of the Cardiovascular Clinical Research Center at NYU Langone Medical Center, New York, said in an interview.

“We have treatments that are improving outcomes but not as many that reduce mortality, so we’re hopeful when the full dataset comes in that will be confirmed,” she said.

The observation of increased rates of blood clots and inflammation among COVID-19 patients, which can lead to complications such as lung failure, heart attack, and stroke, has given rise to various anticoagulant treatment protocols and a need for randomized data on routinely administering increased doses of anticoagulation to hospitalized patients.

Today’s top-line findings come from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – examining the safety and efficacy of full-dose anticoagulation to treat moderately ill or critically ill adults hospitalized with COVID-19 compared with a lower dose typically used to prevent blood clots in hospitalized patients.

In December 2020, all three trials paused enrollment of the critically ill subgroup after results showed that full-dose anticoagulation started in the intensive care unit (ICU) was not beneficial and may have been harmful in some patients.

Moderately ill patients with COVID-19, defined as those who did not require ICU care or organ support, made up 80% of participants at enrollment in the three trials, Dr. Hochman said.

Among more than 1,000 moderately ill patients reviewed as of the data cut with the data safety monitoring board, full doses of low molecular weight or unfractionated heparin were superior to low prophylactic doses for the primary endpoint of need for ventilation or other organ supportive interventions at 21 days after randomization.

This met the predefined threshold for 99% probability of superiority and recruitment was stopped, Dr. Hochman reported. “Obviously safety figured into this decision. The risk/benefit ratio was very clear.”

The results do not pertain to patients with a previous indication for anticoagulation, who were excluded from the trials.

Data from an additional 1,000 patients will be reviewed and the data published sometime in the next 2-3 months, she said.

With large numbers of COVID-19 patients requiring hospitalization, the outcomes could help reduce the overload on intensive care units around the world, the NIH noted.

The results also highlight the critical role of timing in the course of COVID-19.

“We believe that full anticoagulation is effective early in the disease course,” Dr. Hochman said. “Based on the results so far from these three platform trials, those that were very, very sick at the time of enrollment really didn’t benefit and we needed to have caught them at an earlier stage.

“It’s possible that the people in the ICU are just different and the minute they get sick they need the ICU; so we haven’t clearly demonstrated this time course and when to intervene, but that’s the implication of the findings.”

The question of even earlier treatment is being examined in the partner ACTIV-4B trial, which is enrolling patients with COVID-19 illness not requiring hospitalization and randomizing them to the direct oral anticoagulant apixaban or aspirin or placebo.

“It’s a very important trial and we really want to get the message out that patients should volunteer for it,” said Dr. Hochman, principal investigator of the ACTIV-4 trial.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.

The REMAP-CAP, ACTIV-4, and ATTACC study platforms span five continents in more than 300 hospitals and are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (United Kingdom), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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